Dangerous Drugs

July 23rd, 2019 by Rieders Travis in Dangerous Drugs

Defendant AbbVie Seeks to Delay Androgel Bellwether Selection in Multi-District Litigation

Androgel lawsuits continue to be filed in federal court alleging that Defendant manufacturer AbbVie failed to adequately warn about the risk of heart attacks, blood clots and other side effects associated with the popular testosterone replacement therapy. Defendant is now seeking to delay the bellwether trial selection process in the federal multi-district litigation (MDL) which is centered in federal district court for the Northern District of Illinois before Judge Matthew Kennelly. As part of the coordinated pretrial proceedings in the MDL, the parties have been directed to exchange fact sheets containing specific information about each claim, so that a small group of Androgel injury lawsuits can be selected for a bellwether trial process.

AbbVie currently faces about 800 product liability lawsuits filed in U.S. District Courts nationwide involving use of the testosterone gel Androgel, which recent studies have linked to serious and potentially life-threatening cardiovascular risks.

Earlier in May, AbbVie filed a submission with the Court for the MDL with respect to Plaintiff fact sheets alleging that information about many of the cases have not been timely filed or have contained deficiencies. As a result, the drug maker seeks an extension of the time provided for identifying the group of bellwether cases, and has requested other changes in the selection process that plaintiffs counsel describe as “extraordinary.” In a response filed with the Court, Plaintiffs Steering Committee alleges that these concerns are unfounded.

According to a prior case management order, each side is to identify eight lawsuits involving a blood clot injury and another eight involving a heart injury, from androgel. These 32 lawsuits will then go through case specific discovery as bellwether cases and will be reduced to a series of six trial dates for trial expected to last one month each between October 2016 and April 2017.

If you or someone you love suffered a heart attack, stroke or blood clot while taking testostosterone replacement therapies Androgel, Testim or Axiron, contact Cliff Rieders, Esq. of the Rieders Travis Firm for a confidential evaluation.

Xarelto Cases To Be Selected for Early Trial Dates

As a growing number Xarelto bleeding lawsuits continue to be filed nationwide, the U.S. District Judge presiding over the federal multidistrict litigation (MDL) has ordered the parties to identify between 40 and 60 plaintiffs to go through case-specific discovery and possible early test trials.

There are currently more than 400 product liability lawsuits filed against Bayer and Johnson & Johnson’s Janssen unit in the federal court system, which all involve similar allegations that the drug makers failed to adequately warn about the potential of serious adverse events, mainly uncontrollable bleeding and hemorrhagic stroke. In addition, numerous Xarelto cases have also been filed in the Philadelphia Court of Common Pleas, where a mass tort proceeding has been organized. In December 2014, the federally filed Xarelto cases have been organized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of a multidistrict litigation (MDL).

A May 4, 2015 case management order was issued in the federal MDL by Judge Fallon, ordering both parties to meet and confer before June 15, to propose a process for identifying between 40 and 60 cases to be part of a “bellwether” pool. These cases will go through additional discovery specific to the circumstances surrounding the claim and be prepared for early trial dates designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated during the court of the litigation.

Xarelto (rivaroxoaban) is a new-generation anticoagulant introduced in 2011 as a superior replacement for Coumadin (warfarin), which has been the “go-to” medication for prevention of blood clots and strokes among patients with atrial fibrillation for decades.

of problems as more and more patients are switched to the novel anticoagulant. Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims Plaintiffs claim in the lawsuits that the drug makers failed to warn about the dangers associated with the drug with respect to bleeding events, misrepresented the blood monitoring need with Xarelto and concealed information about the lack of an antidote or reversal agent for Xarelto-associated bleeding events.

If you or someone you loved suffered an uncontrollable severe bleedign event or hemorrhagic stroke while taking Xarelto, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Actos Bladder Cancer Settlement Reached

Takeda Pharmaceuticals, the manufacturer of the diabetes drug, Actos, has agreed to pay approximately $2.4 billion to settle Actos lawsuits, which may resolve the litigation alleging that Takeda failed to adequately warn consumers and the medical community about the risk of bladder cancer with the drug.

There are currently more than 8,000 product liability lawsuits pending throughout the U.S. involving allegations that Takeda Pharmaceutical and Eli Lilly withheld information about the link between Actos and bladder cancer. Half of those cases are pending in federal court, while the other half are pending in state courts.

The Actos settlement agreement will take effect if 95% of the plaintiffs involved in the individual lawsuits agree to opt in. At a 95% participation rate, Takeda is expected to pay $2.37 billion to resolve the product liability lawsuits. However, at virtually full compliance of 97%, that number would rise to $2.4 billion. The settlement comes after several juries in various courts have returned multi-million dollar awards in individual cases that have gone to trial.

In April 2014, the first Actos trial resulted in a $9 billion dollar jury award in federal court, after spoliation evidence was presented that indicated that the drug makers destroyed evidence about the risk of bladder cancer with Actos. However, the U.S. District Court Judge presiding over the litigation later reduced the punitive damages award in the case to $37 million. However, the Judge indicated that the Supreme Court needs to update rules on what is considered excessive in order to effectively deter large corporations from engaging in the type of bad behavior exhibited by Takeda and Eli Lilly.

The parties have reached a settlement in advance of the next bellwether trial, which was scheduled to begin in May 2016.

The average payout in the Actos cases is expected to be approximately $296,000 per case. The settlement is one of the largest in U.S. history involving drug side effects.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm for a confidential evaluation. 

Pradaxa Reversal Agent Gets Expedited FDA Review

The FDA has agreed to a fast-track review process for a potential reversal agent for the blood thinner Pradaxa, which has been linked to thousands of serious and sometimes fatal injuries due to uncontrollable bleeding events.

Boehringer Ingelheim, the makers of Pradaxa, announced on April 23 that the FDA has announced expedited review for a drug which may be able to rapidly reverse the blood thinning effects of the anticoagulant. The decision means that the drug’s review will be accelerated and, if approved, could get to patients faster than normal for new drugs.

If approved by the FDA, idarucizumab, the name of the reversal agent, would be the first reversal agent to hit the market for a new generation of oral anticoagulants used to prevent strokes in patients with atrial fibrillation. The class, which includes the blockbuster drugs Pradaxa, Xarelto, and Eliquis, has been linked to uncontrollable bleeding events because they were released without antidotes that doctors can use in the event patients suffer hemorrhages or other bleeding events.

The drugs have been promoted as superior replacements for generic warfarin, which has been on the market for many years, with the manufactures of these new generation anticoagulants indicating that they are easier to use and require less frequent blood monitoring. However, unlike warfarin, which can be quickly reversed with a dose of vitamin K and fresh frozen plasma, there are no approved reversal agents for the medications.

The FDA’s standard for granting a Priority Review is that it should apply in cases where a drug can significantly improve the safety or effectiveness of a treatment of serious conditions. The agency previously gave the drug breakthrough status during clinical testing.

The announcement comes just days after Portola Pharmaceuticals announced that testing indicated that its own reversal agent, andexanet alfa, had shown to be effective in reversing the blood thinning effects of Xarelto and Eliquis.  The manufacturer said the phase 3 trials had met both primary and secondary endpoint goals. It has also been granted breakthrough status for development..

Pradaxa (dabigatran) was the first member of this class to hit the market, introduced by Boehringer Ingelheim in October 2010. More than 4,000 Pradaxa lawsuits were filed on behalf of former users who alleged that inadequate warnings about the lack of a reversal agent were provided for consumers and the medical community. Following several years of litigation, a Pradaxa settlement was reached and announced last year, with Boehringer Ingelheim agreeing to pay $650 million to resolve the claims for an average of about $150,000 each.

Xarelto (rivaroxoaban) was introduced in 2011, as the second member of this class, and it has since grown to become the best seller of the two. Bayer and Johnson & Johnson now face a growing number of Xarelto lawsuits which raise nearly identical allegations from former users who suffered severe bleeding problems.

Eliquis (apixaban) was approved by the FDA in early 2013 by Bristol-Myers Squibb.

If you have suffered a serious bleeding event or hemorrhage while taking Xarelto, contact Cliff Rieders, Esq, of the Rieders Travis Firm for a confidential evaluation. 

Attorneys Involved in the Testosterone Multi-District Litigation are Scheduled to meet with the Presiding District Court Judge Today at Status Conference

According to a status report filed before the conference, several generic drug makers indicate that they intend to file motions to dismiss cases involving use of their products, arguing that the plaintiffs are barred from pursuing compensation if they received generic testosterone replacement products.

 

There are presently about 1,500 product liability lawsuits filed throughout the federal court system involving men who allege that manufacturers of various testosterone replacement therapies on the market provided inadequate warnings about heart attack, stroke  and other injuries.

 

Most of the complaints are filed against the makers of brand name drugs, Axiron, Androgel and Testim, but a few are filed against generic testosterone replacement therapy manufacturers.

 

recent years, generic drug makers have sought to insulate themselves from liability for injuries caused by side effects of their medication, even when the manufacturers know about risks that are not disclosed on the warning label. Known as federal preemption, generic pharmaceutical companies have argued that they are protected from failure to warn lawsuits since FDA regulations currently require their warning labels to be the same as those provided with the name-brand drug they copy.

 

In Pliva v. Mensing, the U.S. Supreme Court in 2011 upheld the preemption argument with respect to generic manufactures , resulting in the dismissal of lawsuits filed over the drug Reglan, Accutane and other products. The Supreme Court found that it is an impossible standard for generic drug makers to comply with federal regulations and state law warning requirements. Therefore, many individuals who have suffered injuries from known side effects of medications have been prevented from seeking any damages, just because they were given a generic.

 

The testosterone MDL is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

 

Acording to a status report filed before the conference, several generic drug makers indicate that they intend to file motions to dismiss cases involving use of their products, arguing that the plaintiffs are barred from pursuing compensation if they received generic testosterone replacement products.  Other items on the agenda for the status conference include the status of discovery in the bellwether cases and the coordination of federal and state litigations.

 

If you took testosterone replacement therapy Axiron, Testim or Androgel and suffered a heart attack or stroke, you may have a claim.  Contact Cliff Rieders, Esq. of the Rieders Travis Firm for a confidential evaluation.

Benicar Cases Consolidated In New Jersey MDL

The U.S. Judical Panel on Multidistrict Litigation has decided to consolidate and centralize all Benicar lawsuits pending in federal courts that involve claims that former users experienced chronic diarrhea or sprue-like enteropathy  in a multi-district litigation (MDL).

A transfer order was issued on April 3, 2015, transferring all cases pending in federal court nationwide to U.S. District Judge Robert Kugler for an MDL in the District of New Jersey.

There are currently more than 35 enteropathy lawsuits over Benicar pending in 23 different U.S. District Courts, which will all be centralized before Judge Kugler to reduce duplicative discovery.

Given the widespread use of Benicar and other blood pressure drugs that contain the active incredient olmesartan, including Benicar HCT, Azor and Tribenzor, it is ultimately expected that several thousand lawsuits will be brought on behalf of individuals who have experienced sprue-like enteropathy, lymphocytic colitis, microscopic colitis, collagenous colitis and other serious gastrointestinal injuries. These enteropathy problems from Benicar typically result in severe and chronic diarrhea, malnutrition and weight loss, which can surface months or even years after first use of the medication.
If you took Benicar to regulate your blood pressure and developed chronic diarrhea, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

First Lipitor Bellwether Trial Scheduled

The federal Judge presiding over all federal lipitor product liability lawsuits brought by women nationwide alleging that Pfizer failed to warn about the risk of developing Type 2 diabetes has scheduled the first bellwehter case to go to trial beginning on November 4, 2015.

Pfizer currently faces more than 2000 Lipitor product liability lawsuits over the risk of developing ype 2 diabetes in women on the drug. The cases are are currently centralized in the federal court system as part of a Multidistrict Litigation (MDL) before U.S. District Judge Richard Gergel in the District of South Carolina.

Earlier this year, Judge Gergel selected the Lipitor case brougth by Wilma Daniels as the first case for trial. Following a status conference late last week, a text order was entered scheduling jury selections to begin on November 3, 2015, with the trial expected to begin the following day.

The allegations raised by Daniels are similar to those presented in many other Lipitor lawsuits, indicating that she was very healthy before she started using the medication as a preventative measure to lower her levels of low-density lipoprotein (LDL) and decrease her risk of developing cardiovascular disease, and subsequently developedType 2 diabetes.

Daniels began taking Lipitor in 1998, and was diagnosed with type 2 diabetes in 2004. The lawsuit notes that she must undergo regular testing for the rest of her life, adhere to a restrictive diabetic diet and take medications to control her diabetes. Instead of lowering her risk of heart disease by lowering her cholesterol, Daniels’ lawsuit points out that she is now instead at an increased risk of heart disease, blindness, neuropathy, and kidney disease due to Lipitor side effects.

The next Lipitor status conference in the MDL is scheduled for April 23, 2015.

If you are an otherwise healthy woman who is not obese (BMI under 30), who developed Type 2 diabetes while taking Lipitor to lower your cholesterol, you may have a claim. Contact Cliff Rieders, Esq. for a confidential evaluation today.

Xarelto Related Bleeding More Likely in Patients at Higher Risk for Pulmonary Embolism According to New Research Sponsored by Drugs’ Manufacturers

New research raises more concerns about the potential side effects of Xarelto, a new generation anticoagulant used to reduce the risks of blood clots, particularly in patients diagnosed with atrial fibrillation. The research indicated that certain patients at risk for suffering a pulmonary embolism may be more likely to experience major and uncontrollable bleeding on Xarelto.

In a new study published in the March Issue in the Journal, Academic Emergency Medicine, researchers found that while use of Xarelto to treat pulmonary embolism was relatively safe for patients facing a low to moderate risk of blood clots traveling to the lungs, those with a high risk for pulmonary embolism face a higher risk of Xarelto bleeding than normally associated with the blood thinner.

The research was sponsored by the two companies manufacturing and marketing the drug, Bayer HealthCare and Janssen Pharmaceuticals, looking at data on about 5,000 patients at risk of pulmonary embolism. Researchers assigned patients simplified Pulmonary Embolism Severity Index (PESI) scores, with 0 meaning low risk, 1 meaning intermediate risk and 2 or greater meaning a patient faced high risk of pulmonary embolism. The score was based on a number of factors, including age, history of cancer, chronic cardiopulmonary disease, arterial oxyhemoglobin saturation levels and pulse.

Researchers looked at which patients on Xarelto suffered recurrent venous thromboembolism (VTE), fatal pulmonary embolism (PE), major bleeding and death. They found low levels of such events in lower PE risk patients, but high levels in patients at higher risk of PE.

If you or someone you loved took Xaretlo and suffered a major bleeding event or hemorrhagic stroke while on Xarelto, contact Cliff Rieders, Esq. of the Rieders Travis Firm to see if you have a case. We are presently handling numerous filed Xarelto cases in a mass tort proceeding in Pennsylvania state court and in a federal multi-district litigation. Note that we are not handling coumadin cases.

Arguments Over Benicar Multi-District Litigation Centralization

A panel of federal judges heard oral arguments over whether Benicar lawsuits pending in U.S. District Courts nationwide should be centralized before one judge for coordinated pretrial proceedings, as part of an MDL, or Multidistrict Litigation.

Daiichi Sankyo and Forest Laboratories currently face more than 33 product liability lawsuits spread throughout the federal court system involving injuries allegedly caused by the side effects of Benicar, a popular blood pressure drug that has been linked to a risk of chronic diarrhea, weight loss and other symptoms of sprue-like enteropathy.

Plaintiffs’ lawyers filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to establish a Benicar MDL which would centralize the lawsuits before one judge in a coordinated proceeding.  The  Benicar litigation is currently spread out among at least 19 different U.S. District Court The number of cases is expected to grow with cases filed for persons who took Benicar and experienced chronic diarrhea and other intestinal problems.

Defendants Daiichi Sankyo and Forest Laboratories have opposed the creation of a federal MDL,  arguing that there are an insufficient number of claims and that informal coordination among the attorneys involved can achieve the same purposes. However, it appears that the litigation is growing at such a quick rate that it would be impractical to coordinate proceedings without a formal MDL established.

The U.S. JPML heard oral arguments with respect to creation of an MDL during a hearing scheduled in San Diego, California.

Benicar (olmesartan medoxomil) is part of a family of Daiichi Sankyo hypertension drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the blood pressure drugs include the active ingredient olmesartan, which has been linked to the development sprue-like enteropathy. With the medication first introduced over a decade ago, plaintiffs allege that the drug makers knew or should have known about the risks associated with Benicar, withheld information from consumers and physicians.

In July 2013, the FDA required the defendants to change the drug label to indicate that users may experience symptoms of sprue-like enteropathy long after they start using the medication. Based on adverse event data that has been available to the drug makers for years, FDA officials concluded that there is “clear evidence” that Benicar may cause users to suffer chronic diarrhea, abdominal pain, weight loss and other gastrointestinal symptoms, which typically resolve when the medication is no longer used.

Did  you take Benicar and experience the onset of severe chronic diarrhea, sprue-like enteropathy  or other intestinal problems? Contact Cliff Rieders, Esq. of the Rieders Travis Firm to see if you may have a case.

Settlement Reached in Ethicon Vaginal Mesh Lawsuit During Trial

Several days after Ethicon was dealt a $5.7 million dollar verdict in a California state court in a vaginal mesh trial, the medical device manufacturer reached a settlement in a  federal bellwether trial underway in the U.S. District Court for the Southern District of West Virginia. The lawsuit was settled on the fifth day or trial.

The case is one of more than 70,000 similar vaginal mesh cases pending against Ethicon and other manufacturers of similar products, including Boston Scientific, C.R. Bard, American Medical Systems (AMS), Coloplast, Cook Medical, Neomedic and others.

As part of the coordinated litigation, the Bellew case was the latest in a series of “bellwether” trials scheduled to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout other claims. While manufacturers have had limited success defending the safety of their product in a few cases, most of the claims that have gone before a jury so far have resulted in substantial damages, often including multi-million dollar punitive damage awards designed to punish the manufacturer.

The terms of the settlement are not yet known as the agreement has not been released.  Thus far, only AMS has settled the majority of their vaginal mesh cases for about $1.6 billion to resolve 20,000 lawsuits.  It has been suggested that if manufacturers do not start reaching large numbers of settlements in vaginal mesh cases, they may face billions of dollars in judgments from juries.

The Rieders Travis Firm is handling vaginal mesh cases.  If you think you may have a claim, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Xarelto Clinical Study Data Scrutinized

A recent report on clinical trial misconduct suggests that there were major problems with at least one clinical study on the drug Xarelto, indicating that data involving the safety of the new generation anticoagulant may have been falsified and destroyed.

Charles Seife, of the Arthur L. Carter Institute of Journalism at New York University, published a report in JAMA Internal Medicine earlier this month, which found that the FDA often identifies clinical trial misconduct and discrepancies in studies conducted by drug makers, but that the information is rarely reported to medical journals who run the studies. The end result is that those studies get published in medical journals, with no indication that the FDA discovered problems such as falsified data, unsafe practices and a disregard for scientific protocols. These incidents are usually referred to as Official Action Indicated (OAI). During the research, Seife found that almost all of the FDA’s clinical trial inspection records were littered with redacted, or blacked out, sections that removed the name of the drugs, companies and researchers involved, so it is hard to tell which clinical trials had serious problems, except for Xarelto.

The report indicates that one of the Xarelto study RECORD 4 was so badly conducted, and so full of dubious behavior and outright scientific misconduct, that the FDA rejected the report entirely when considering whether to approve the new-generation anticoagulant. However, the FDA’s findings of falsified data, purposely destroyed medical records and other problems did not stop researchers from publishing RECORD 4 in May 2009. The publication of the study found that Xarelto is safe and effective for the prevention of deep vein thrombosis and pulmonary embolism following knee replacement surgery. It does not disclose that the FDA discovered that researchers faked some of the data and destroyed medical records, which may have been done to hide questionable practices. Bayer and Johnson & Johnson’s Janssen unit, successfully obtained FDA approval for Xarelto (rivaroxoaban) in 2011. Xarelto was initially approved for the prevention of strokes among patients with atrial fibrillation, but it later received the expanded indication for the prevention of deep vein thrombosis and pulmonary embolism following knee and hip surgery, which is what the four RECORD trials set out to do.

We are currently handling Xarelto cases in state and federal court. If you or a loved one suffered a serious bleeding event or hemorrhage while taking Xarelto contact Cliff Rieders, Esq. to determine whether you may have a claim.

Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) – Case Summary

The straightforward question in this case is whether a pharmaceutical company is immune from responsibility to respond in damages for lack of due care resulting in personal injury or death, except for two discreet grounds, namely, on account of drug impurities or deficient warnings.  The drug regimen which gave rise to the shorthand terms, “Fen-Phen” and “Phen-Fen” is at the center of this case.

 

Justice Saylor’s writing for the majority argued that there is greater flexibility with regard to traditional fault-based liability, i.e., negligence, where the conduct of manufacturers and/or suppliers are squarely in issue.  For policy reasons the court has declined to extend strict liability into prescription drug arena.  However, it has not immunized other drug companies from other governing aspects of Pennsylvania tort law delineating product manufacturer duties and liabilities.

 

The court wisely noted the importance of direct-to-consumer advertising and the evolution of the health-care delivery system encompassing new forms of managed care.  In the situation where no warning would be sufficient, the learned intermediary doctrine should not apply to diminished duties of pharmaceutical companies, or to insulate them from liability for lack of due care.

 

A company which is responsible for tending into the market a drug which it knows or should know is so dangerous that it should not be taken by anyone can be said to have violated its duty of care either in design or marketing.  How the claim is presented is up to the plaintiff.  The court also noted that the American Law Institute has chosen to categorize the type of claim advanced under the rubric of design defect and the general requirement otherwise pertaining under the Restatement of a reasonable alternative design to establish a design defect has not been extended to the prescription-drugs context.  See Restatement (Third) of Torts:  Products Liability § 6(c) and § 2(b).

 

Footnote 37 notes that the court adopts appellee’s position that Pennsylvania law at the very least overlaps or intersects with the Restatement Third principle that a manufacturer marketing a prescription drug which it knows or should know is too dangerous for anyone to use violates the standard of due care and may be held liable under fault-based tort law.

 

Finally, appellee may couch the lack of due care manifested as negligent marketing.  This is consistent with her prerogative as master of her own claim.  Whatever the policy considerations may be in the recall-retrofit arena, the court was convinced that a manufacturer or supplier has a duty to cease further distribution of a product at such point as it may know, or may reasonably be charged with knowledge that the commodity is too dangerous to be used by anyone.

 

 

Under Pennsylvania law, pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone.

Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. 2014) Summary

was an appeal by McNeil-PPC, Inc., from a $10 million verdict plus statutory and post-judgment interest in a pharmaceutical failure to warn case.  A child was given over-the-counter Children’s Motrin, a medication manufactured by defendant McNeil.  The drug was given for seizure.  The child developed toxic epidermal necrolysis (TEN), described as an especially severe form of Stevens Johnson Syndrome (SJS), a rare but life-threatening disease that causes severe blistering and sloughing off of skin, together with serious damage to the mouth, eyes, throat and esophagus.  The court held that the fact that the label which did not mention skin reddening, rash or blisters was not non-defective just because such warnings were not required by the FDA.  The court cited, among others, Wyeth v. Levine, 555 U.S. 555, 570-571 (2009).  The court also rejected Neil’s contention that the plaintiffs failed to establish causation, i.e., that adding the warnings would have prevented or mitigated the child’s injuries.  The learned intermediary doctrine did not apply because Children’s Motrin is an over-the-counter drug.  The court rejected a number of other evidentiary challenges, including the failure of the court to give a heeding presumption instruction to the jury.  The court noted that neither side objected to the omission of the instruction, and besides, McNeil still could have argued to the jury that plaintiff’s failure to prove an adequate warning would have prevented the child from receiving additional doses of Children’s Motrin after she developed the rash and blisters.  The court said that the Standard Jury Instruction Committee charge on Concurring Causes was applicable to defective products of two or more manufacturers, Pennsylvania Suggested Standard Jury Instruction SSJI Civ. 3.26 Concurrent Causes (Subcommittee Draft 1978).

Xarelto Lawsuits in Pennsylvania Organized as Mass Tort

A large number of Xarelto lawsuits continue to be filed around the country.  A mass tort proceeding has been established in the Philadelphia Court of Common Please for state court cases brought in Pennsylvania over side effects of Xarelto, the controversial anticoagulant used to treat atrial fibrillation.  There have been numerous cases filed linking Xarelto to uncontrollable bleeding, hemorrhage and death.

At least 75 complaints have been filed against Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the Philadelphia Court of Common Pleas, all of which involve allegations that the drug manufacturers failed to adequately warn about the risk of bleeding from Xarelto and the lack of an effective antidote to allow doctors to treat hemorrhages.

On Wednesday, Philadelphia Court of Common Pleas Administrative Judge Kevin Dougherty ordered that all Xarelto cases filed throughout the state will be centralized for pretrial proceedings as part of a “mass tort”.

The consolidation is similar to the multi-district litigation that has been established in the federal court system, where an MDL has been established in U.S District Court in Louisiana.

The Pennsylvania Xarelto lawsuits will be transferred to the state’s Complex Litigation Center, despite objections raised by the drug makers. Attorneys for Bayer and Janssen opposed the establishment of a Xarelto mass tort in Pennsylvania, arguing it was unnecessary and not appropriate because many of the plaintiffs bringing the cases were from out-of-state.

In the federal court system, pretrial proceedings have been centralized before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana, where at least 86 cases are currently pending.

The Rieders Travis Law Firm is handling Xarlto cases in the Philadelphia mass tort.  If you or someone you love suffered uncontrollable, severe bleeding or hemorrhagic stroke while taking Xarelto call Cliff Rieders, Esq. today for a confidential consultation.

New Clinical Study : First Time Testosterone Users Face Increased Heart Attack Risk

The findings of a new study seems to provide support for the growing number of Androgel and other lawsuits involving various forms of testosterone replacement therapy.

 

Researchers from the University of British Columbia found that first-time users of testosterone replacement therapy (TRT) are 40% more likely to have a heart attack than men who do not use the drugs.

 

The findings were published in the medical journal Pharmacotherapty on January 13, following an evaluation of data on nearly 1 million men from ages 45-80. While the researchers did not find a statistically significant increase in heart attack risk among current testosterone drug users, those classified as first-time users were 41% more likely to have a myocardial infarction (MI), or heart attack.

 

“In this large observational study, an association between MI and past or current TRT use was not found,” the researchers noted. “However, a statistically significant association was observed between first-time TRT exposure and MI, although the absolute risk was low.”

 

In September, a panel of independent advisors to the FDA reviewed the available data surrounding the widely used and aggressively marketed “low T” drugs, and concluded that that there is currently insufficient data to reach a conclusion about the link between testosterone drugs such as Androgel (the market leader) and heart attacks and stroke. owever, the panel did determine that the medications are widely overused and recommended that the FDA limit use and require additional studies by the manufacturers.

 

Many of the prescriptions for low testosterone treatments in recent years have been given to men who do not suffer from medically proven hypogonadism, usually caused by disease or injury affecting the testicles or certain parts of the brain. Several studies have suggested that a large portion of men given the drugs have no medical need, but rather are prescribed the drugs for “lifestyle reasons”, treating the natural declines in testosterone levels as all men Throughout the United States, a growing number of men are now pursuing product liability lawsuits against the makers of testosterone replacement therapy, alleging that they recklessly promoted the medications without adequately warning consumers and the medical community about the potential risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis and other potentially life-threatening injury.

 

The cases filed in federal court have been consolidated in an MDL in the Northern District of Illinois before U.S. District Judge Matthew Kennerley.

 

If you took Androgel or other testosterone replacement therapy, and suffered a heart attack or stroke, contact Cliff Rieders, Esq, of the Rieders Travis Firm,

Portola Pharmaceuticals Says it Developed Antidote to Xarelto Bleeding

Portola Pharmaceuticals claims it has developed an antidote to Xarelto, which could be used to help reverse the blood thinning effects of the blockbuster drug and reduce the risk of uncontrollable bleeding probloems that have caused many users to suffere severe and often fatal injuries. In a press release, issued on January 9, 2014, the drug maker claims that a clinical trial shows that a drug called andexanet alfa may be an effective Xarelto reversal agent.

Results showed that the study met its primary endpoint with high statistical significance,” according to Portola. “Andexanet alfa administered as an intravenous (IV) bolus significantly and immediately reversed the steady-state anticoagulation activity of XARELTO and was well tolerated.” Xarelto (rivaroxoaban) is a new-generation anticoagulant introduced jointly by Bayer and Johnson & Johnson’s Janssen subsidiary in 2011, as an alternative to Coumadin (warfarin), which has been the go-to treatment for prevention of blood clots for years. However, unlike warfarin, which can be quickly reversed if bleeding problems develop, Xarelto was introduced without an approved and effective antidote.

Portola indicates that it plans to release the full data on the potential Xarelto antidote at the American College of Cardiology’s 64th Annual Scientific Session in March

Bayer and Johnson & Johnson face a growing number of Xarelto lawsuits in state and federal court. behalf of individuals who have suffered severe bleeding problems that doctors were unable to stop, alleging that the drug makers should have developed an antidote before introducing the medication. Plaintiffs also allege that inadequate warnings were provided for consumers about the potential bleeding risks associated with Xarelto.

Xarelto is one of several new blood thinners introduced in recent years as a superior alternative to warfarin. Known as Factor Xa inhibitors, other members of this new-generation of drugs includes the widely marketed Pradaxa, which is manufactured by Boehringer Ingelheim, and Eliquis, which is sold by Bristol-Myers Squibb and Pfizer The FDA also recently annoucned a fourth member of this class of medications, Savayasa (edoxaban) which will be markete4d by Daiichi Sanyo.

About 4000 claism were filed against the manufacturers of Pradaxa agaisnt the drug maker Boehringer Ingelheim. Those cases recently settled late last year.

Bayer and Janssen now face a growing number of lawsuits over Xarelto, which raise similar allegations that the drug makers placed their desire for profits before the safety of consumers by aggressively marekting the drug without adequate warnings, and for failing to fully explore all potential reversal agents that may have made the medication safer.

In June, the FDA granted Breakthrough Therapy Designation to the drug idarucizumab, being developed by a reversal agent for Pradaxa. In November, Boehringer Ingelheim, which is developing the drug, issued a press release claiming that idarucizumab can reverse the effects of Pradaxa. The FDA breakthrough status puts the drug’s development on a fast track, as many observers indicate that the new blood thinner which releases a reversal agent first may claim a significant increase in its market share among blood thinners used to prevent strokes in patients with atrial fibrillation.

A multi district litigation (MDL) has been set up for federally-filed Xarleto cases while a motion for a mass tort is pending in the Philadelphia County Court of Common Pleas.

Have you or someone you love been injured by Xaretlo and suffered severe uncontrolled bleeding, or hemorrhagic stroke? Contact Cliff Rieders of the Rieders Travis Firm

Benicar Diarrhea Case Numbers Grow

Daiich Sankyo and Forest Laboratories have been given two extra weeks in which to respond to a recent motion filed to centralize all Benicar lawsuits brought throughout the federal court system on behalf of individuals who allege that the popular blood pressure drug caused them to suffer chronic diarrhea and other gastrointestinal problems.

Plaintiffs’ made a request to consolidate all Benicar diarrhea lawsuits in a multi-district litigation (MDL) on December 18, 2014.  The drug makers were supposed to file a response with their position this week.  However, Defendants filed a motion for an extension of time due to the holidays.

The U.S. Judicial Panel on Multidistrict Litigation granted the request on December 29, indicating that the drug makers have until January 23, 2015 to file their response.

All of the complaints raise nearly identical allegations, claiming that the drug makers failed to adequately warn about the potential adverse events relating to Benicar, which have prevented doctors and the medical community from recognizing that chronic diarrhea problems experienced by users may be caused by the hypertension drug.

The litigation arose after the FDA required the drug makers to update the Benicar warning label in July 2013, alerting that users of the blood pressure medication may face an increased risk of developing sprue-like enteropathy from Benicar. This may cause users to experience symptoms like chronic diarrhea, abdominal pain, weight loss and other gastrointestinal problems that can surface months or even years after the medication is started. Although the drug has been on the market for more than 10 years, the issue with chronic diarrhea was not well known in the medical community until the FDA warning in 2013.

Since many states require that any complaint be filed within two years from when an individual first learns that an injury may have been caused by use of a medication, the statute of limitations in many states may require that individuals who experienced Benicar problems file their complaint prior to July 2015. –

If you took Benicar to regulate your blood pressure and developed chronic diarrhea, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Link Between Risperdal and Prolactin Examined in New Study

New research raises questions as to whether side effects of the antipsychotic medication Risperdal cause high prolactin levels, which some say is the underlying reason the medication may cause breast growth in young men; a condition known as gynecomastia.

A new study was published online this month by the journal International Clinical Psychopharmacology, where Italian researchers examined variations of serum prolactin hormone levels (PRL) among new users of risperidone, the generic name for Risperdal. Among 34 patients with a mean age of 13 years, researchers found that increases in the levels of prolactin may not only be linked to use of Risperdal, but may also be impacted by autoimmune disorders, sex, stages of puberty, and the underlying psychiatric disease for which they are being treated.

Rsiperdal (risperdone) is an atypical antipshycotic drug aprpoved for schizoprenia, btu has been widely used off lable for children wtih behavoral disorders including schizophrenia, bi-polar disorder, autism and aggression.

There has been much concern about one of Risperdal’s potential size effects – that over use of the medication among boys involves the development of gynecomastia, where abnormal breast growth can occur in males. Some boys and young men using Risperdal have experienced the development of breasts up to a D-cup, often resulting in the need for surgical removal.

A growing number of Risperdal lawsuits are currently pending in the Philadelphia county court of common pleas , alleging that inadequate warnings about the gynecomastia risk were provided for families and the medical community. In addition to the physical injury, the complaints often allege that the young boys who experienced breast growth face humiliation, bullying and other emotional trauma as a result of developing gynecomastia from taking Risperdal.

The development of breasts among boys on Risperdal is believed to be caused by an increase in the amount of the hormone prolactin in the blood. Prolactin induces and maintains lactation among women following childbirth, and it may cause boys to develop gynecomastia from Risperdal. In this latest study, researchers took samples from 34 children who started taking Risperdal, then looked at them after almost three months on the drug. They found an increase in prolactin levels, which was higher among girls than it was in boys. About 20% of the patients suffered from hyperprolactinemia (high PRL) before they started the Risperdal treatment. After three months, 38% had high PRL.

If you or your child took Risperdal as an adolecent and developed gynecomastia you may have a claim. Contact Cliff Rieders, Esq. today. 

Xarelto MDL Consolidated in Louisiana

The U.S. Judicial Panel on Multidistrict litigation has decided to consolidate and centralize all federally filed Xarelto lawsuits in Louisiana federal court in a multi-district litigation (MDL) before District Judge Eldon E. Fallon in the Eastern District of Louisiana.

Oral argument was held earlier this month and a transfer order issued on December 12, 2014, establishing the Xarelto MDL in Louisiana.

There are currently at least 21 complaints filed in 10 different U.S. District Courts that will be transferred to the MDL, but dozen of additional cases are likely to be transferred in the coming weeks. In addition there are approximately 50 cases field in the Philadelphia Court of Common Pleas in state court, where a motion for a mass tort has been made.

All of the cases allege that plaintiffs have suffered uncontrollable bleeding as a result of taking Xarelto. All of the cases involve similar allegations that Bayer and Johnson & Johnson’s Janssen subsidiary failed to adequately warn consumers and the medical community about the potential  bleeding risks associate with Xarleto, and failed to develop an antidote before introducing the drug to market.

Xarelto is a new-generation anti-coagulant that has been introduced in recent years as an alternative to warfarin. However, unlike warfarin, there is no reversal agent for Xarelto to stop the blood thinning effects of the medication, leading to a number of reports involving severe injury or death associated with uncontrollable bleeding.

The MDL order comes in response to a request filed by a group of plaintiffs in October, which urged the U.S. JPML to centralize the cases in an MDL in the Southern District of Illinois before the same Judge who presided over the Pradaxa mutli-district litigation.

While both manufacturer Defendants opposed the creation of an MDL, indicating that the litigation will be dominated by individualized facts of each case, Bayer and Janssen argued that if the U.S JPML does centralize the cases, they should be transferred to the District of New Jersey, where both manufacturers are based.  The manufacturers also have offices in Indiana and Pennsylvania.

Following a hearing session on December 4, the U.S. JPML determined that all of the complaints involve sufficiently similar questions of fact and law to justify centralized management before one judge as part of an MDL.

Despite the reports of bleeding problems, Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that blood monitoring would held doctors identify patients at the greatest risk for bleeding events.

If you or someone you love has suffered a severe uncontrolled bleeding event or hemorrhagic stroke while taking Xarelto contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

New Study: Pradaxa and Xarelto are No Safer than Generic Warfarin, Despite Manufacturer Claims

New blood thinners released in recent years, such as Xarelto and Pradaxa, have been promoted as superior to warfarin, which has been the leading anticoagulation treatment. However, the findings of a new study suggest that these new generation medications may be no safer than the older drug.

In a study published in this month’s edition of the Canadian Jorunal of Cardiology, researchers from the Southlake Regional Health Centre in Ontario, Canada, found that the safety profiles of the drugs were nearly identical when it came to bleeding risks and other side effects common to blood thinners used to treat patients with atrial fibrillation.

Researchers looked at data on 901 patients who underwent cardioversion and were given either warfarin, also sold under the brand name Coumadin, and the newer drugs Pradaxa and Xarelto. Researchers looked at the number of strokes, transient ischemic attacks, and bleeding events suffered by patients taking the drugs.

“Bleeding rates were low, with no significant difference between the groups,” the researchers reported. The researchers say that all three drugs appear to be reasonable options for patients with atrial fibrillation.

The manufacturers of the new “Factor Xa” anticoagulants have aggressively promoted the drugs as safer than warfarin, claiming that patients need less blood monitoring to ensure that levels of the drugs did not get to high and increase the risk of bleeding events.  However, this new study and others, as well as questions raised in litigation have raised serious questions about those claims, suggesting that blood monitoring and developing an antidote may have prevented or mitigated many life threatening bleeding problems.

We are currently accepting new Xarelto cases.  If you ro someone you love was injured by Xarleto and suffered a severe, life threatening bleeding event or hemorrhagic stroke, contact Cliff Rieders, Esq. of the Rieders Travis Firm.  

JPML to Hear Oral Argument Regarding Potential Xarelto MDL

Oral argument is scheduled to commence this afternoon before the U.S. Judical Panel on Multidistrict Litigation (JPML) over whether the consolidate all federal Xarelto lawsuits filed on behalf of individuals nationwide who have experienced bleeding complocations.

 

On October 15, 2014, a group of plaintiffs field a motion requesting centralization of all federally filed Xarelto lawsuits before one judge in a multi-district litigation centralized in the Southern District of Illinois, before the same judge who oversaw the Pradaxa multi-district litigation.

 

All of the complaints involve nearly identical allegations that Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary failed to adequately warn about the risk of uncontrollable bleeding, hemorrhage and stroke from Xarelto.  The complaints further allege that the drug manufacturers withheld information about the importance of routine blood monitoring and the lack of a reversal agent or antidote to stop the blood thinning effects of the drug.

 

Defendants Bayer and Janssen have opposed the creation of an MDL. Bayer indicates that although the number of cases filed nationwide has now grown to 48 in federal court, the drug maker continues to maintain that centralization is not appropriate.

 

In addition, numerous Xarelto cases (about 20) have been filed in state courts, including a number of cases in the Philadelphia Court of Common Pleas.

 

The panel of federal judges on the JPML is expected to hear from interested parties during an afternoon session today in the U.S. District Court in Charleston, South Carolina.

If you or someone you love has been injured by Xarelto and suffered a significant and severe bleeding injury, hemorrhage or hemorrhagic stroke, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Xarelto MDL Consolidated in Louisiana

The U.S. Judicial Panel on Multidistrict litigation has decided to consolidate and centralize all federally filed Xarelto lawsuits in Louisiana federal court in a multi-district litigation (MDL) before District Judge Eldon E. Fallon in the Eastern District of Louisiana.

Oral argument was held earlier this month and a transfer order issued on December 12, 2014, establishing the Xarelto MDL in Louisiana.

There are currently at least 21 complaints filed in 10 different U.S. District Courts that will be transferred to the MDL, but dozen of additional cases are likely to be transferred in the coming weeks. In addition there are approximately 50 cases field in the Philadelphia Court of Common Pleas in state court, where a motion for a mass tort has been made.

All of the cases allege that plaintiffs have suffered uncontrollable bleeding as a result of taking Xarelto. All of the cases involve similar allegations that Bayer and Johnson & Johnson’s Janssen subsidiary failed to adequately warn consumers and the medical community about the potential  bleeding risks associate with Xarleto, and failed to develop an antidote before introducing the drug to market.

Xarelto is a new-generation anti-coagulant that has been introduced in recent years as an alternative to warfarin. However, unlike warfarin, there is no reversal agent for Xarelto to stop the blood thinning effects of the medication, leading to a number of reports involving severe injury or death associated with uncontrollable bleeding.

The MDL order comes in response to a request filed by a group of plaintiffs in October, which urged the U.S. JPML to centralize the cases in an MDL in the Southern District of Illinois before the same Judge who presided over the Pradaxa mutli-district litigation.

While both manufacturer Defendants opposed the creation of an MDL, indicating that the litigation will be dominated by individualized facts of each case, Bayer and Janssen argued that if the U.S JPML does centralize the cases, they should be transferred to the District of New Jersey, where both manufacturers are based.  The manufacturers also have offices in Indiana and Pennsylvania.

Following a hearing session on December 4, the U.S. JPML determined that all of the complaints involve sufficiently similar questions of fact and law to justify centralized management before one judge as part of an MDL.

Despite the reports of bleeding problems, Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that blood monitoring would held doctors identify patients at the greatest risk for bleeding events.

If you or someone you love has suffered a severe uncontrolled bleeding event or hemorrhagic stroke while taking Xarelto contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Case Summary – U.S. v. Astrazeneca Pharmaceuticals, LP, 769 F.3d 837 (3d Cir. 2014)

False Claims Act suit is dismissed where the plaintiff does not have direct and independent knowledge to satisfy the original source exception to the False Claim Acts public disclosure bar. The FCA makes it unlawful to knowingly submit a fraudulent claim to the Government.  This is sometimes called a qui tam provision of the FCA.  Prior to 1986 suits were barred if the information on which they were based was already in the Government’s possession.  In 1986 Congress amended the FCA to encourage private plaintiffs to bring civil cases if they had information that someone had defrauded the Government.  Congress added the public disclosure bar to withdraw jurisdiction over, among other things, suits based on information that had been previously disclosed unless the person bringing the action is an original source of the information.  Congress defined an original source as an individual who has direct and independent knowledge of the information on which the allegations are based and has voluntarily provided the information to the Government before filing an action under this section which is based on the information.

GranuFlo and NaturaLyte Lawsuits on the Rise

An update issued on November 18, 2013 by the joint panel on multidistrict litigation (JPML) indicates that 393 lawsuits have been filed against Fresenius Medical Care regarding its recalled dialysis products GranuFlo and NaturaLyte in the U.S. District Court for the District of Massachusetts in a multi district litigation (MDL). The presiding judge is Judge Douglas Woodlock.

The two acid concentrate dialysis products, GranuFlo and NaturaLyte were recalled in June 2012 or their potential to increase a patients’ risk for strokes, sudden cardiac death, heart attacks, cardiopulmonary arrest, and other life-threatening side effects. These cases similarly allege that Fresenius failed to adequately warn doctors and patients about the serious side effects associated with its products prior to the recall. Fresenius is a leading supplier of dialysis products, and also manages and runs its own network of dialysis clinics.

While Fresenius had issued an Urgent Product Notification prior to the recall, in March 2012, the cases filed in the litigation allege that it was issued far to late and after Fresenius already knew of the problems associated with its products. Lawsuits against Fresenius also allege that an internal memo sent in November 2011 to physicians operating in its dialysis clinics that warned of 900 deaths that occurred in patients who underwent treatments using GranuFlo or NaturaLyte. Doctors outside the company’s network were not informed of these deaths until March 2012.

If you or someone you love died or was injured because you received GranuFlo or NaturaLyte for your kidney dialysis, contact the Rieders Travis law firm today to determine whether you may have a claim for relief.

Mirena Lawsuits Increase Over Device Perforation and Migration

Bayer Healthcare faces nearly 2,500 product liability lawsuits over the Mirena Intrauterine Device (IUD) alleging that the device migrated out of position after implantation, perforating organics and causing infections and other serious injuries.

Half of the lawsuits concerning Mirena are consolidated in a federal multi district litigation (MDL) before Judge Cathy Seibel in the Southern District of New York.  About 1000 lawsuits are pending in that MDL.

Another 1,250 Mirena lawsuits are pending in New Jersey State Court before Judge Brian Martinotti.

All of the complaints allege that Bayer should have known or knew of the risk of Mirena IUD complications which plaintiffs allege led the device to spontaneously migrate and perforate internal organs.

The first Mirena bellwether trials in the federal MDL will begin in March 2016.

Information about the potential for Mirena puncturing the uterus were included in the drug warnings, but plaintiffs maintain that the information misleadingly and incorrectly suggests that the risk only exists at the time of insertion. However, most of the lawsuits filed nationwide involve situations where Mirena migrated spontaneously, often long after the IUD was inserted and confirmed by the doctors to be in the correct position.

More than 70,000 Mirena adverse event reports have been field with the FDA since 2009 including at least 5000 adverse event reports where Mirena moved out of place and 1,322 where women alleged that Mirena punctured the uterus.

First Round of Federal Bellwether Trials Draws to Close in Transvaginal Mesh Litigation Against C.R. Bard

The first round of bellwether trials is coming to a close in the Bard C.R. transvaginal mesh litigation. The litigation is pending in a federal multi-district litigation (MDL) in the Southern District of West Virginia. Six different MDLs are pending before the same Judge concerning transvaginal mesh products in the Southern District of West Virginia, organized by manufacturer. The bellwether trials in the C.R. Bard MDL are the first trials among the six MDLs. There are approximately 5,400 transvaginal mesh lawsuits filed against C.R. Bard in the MDL against Bard. The MDL against C.R. Bard is entitled In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2187.

The final bellwether trial against C.R. Bard involves Bard’s POP Avaulta mesh product, and is scheduled to begin on December 3, 2013 in the Southern District of West Virginia. The Judge presiding over the bellwether trials and the cases in all six transvaginal mesh MDLs in the Southern District of Virginia is Judge Joseph R. Goodwin.

The first bellwether trial against C.R. Bard concluded in August 2013 with a $2 million award for the Plaintiff in California state court. That case also involved an Avaulta POP transvaginal mesh product, and the Plaintiff, who required multiple surgieres to remove the mesh, was awarded both compensatory and punitive damages. In July 2012, the Defendant lost a another case in California state court against C.R. Bard involving an Avaulta Plus mesh product. The court awarded the plaintiff $3.6 million, while the surgeon who operated on the plaintiff and installed the mesh was ordered to pay a $5.5 million award.

As the first round of bellwether trials in the federal MDL in West Virginia against C.R. Bard comes to a conclusion next month, thousands of additional mesh cases continue to move forward, and new cases are still being filed. Separate MDL proceedings have been established in West Virginia, as noted above, for mesh products manufactured by American Medical Systems, Ethicon (a subsidiary of Johnson & Johnson) and Boston Scientific.

If you were injured by a faulty transvaginal mesh, contact the Rieders Travis firm today to determine if you have a claim against the manufacturer, as we are handling and reviewing complex mesh cases. Contact the firm for a confidential consultation.

First Status Conference Next Week in Byetta/Januvia/Janumet/Victoza MDL

The first status conference is currently scheduled for November 21, 2013 in the new multidistrict litigation (MDL) centered in federal district court for the Southern District of California in the incretin mimetic diabetes drug litigation. Court records indicate that at least 150 claims have been filed so far on behalf of plaintiffs alleging that the incretin mimetic diabetes drugs caused pancreatic cancer in the plaintiffs. The drugs at issue in the cases are Amylin Pharmaceuticals and Bristol Myers Squibb’s Byetta, Merck’s Januvia and Janumet and Novo Nordisk’s Victoza.

Court documents indicate that the litigation involving Byetta and similar drugs began to grow substantially after the U.S. Food & Drug Administration (FDA) announced this March that it was investigating findings from an unpublished study that indicated drugs like Byetta could cause precancerous changes in the cells of the pancreas. The FDA has since noted that it was unable to reach any conclusion regarding this possible risk, but its review is ongoing. However, there has been no FDA warning to date about the risk of pancreatic cancer, though the FDA issued a public warning several years ago with respect to pancreatitis.

Byetta, Januvia, Janumet and Victoza users who have been diagnosed with pancreatic cancer, or thyroid cancer may be entitled to file a lawsuit in conjunction with the federal MDL proceeding. If you think you may have a claim, contact the Rieders Travis law firm today for a confidential consultation.

Marketing Claims Over Lack of Blood Monitoring to be Key Issue in All Xarelto Lawsuits

Makers of the anticoagulant medication, Xarelto, are opposing centralization for the mounting litigation into a federal multi-district litigation (MDL) brought by individuals who have suffered major bleeding injuries, claiming that the cases will be dominated by the individualized facts surrounding each injury. However, lawyers representing former users of the anticoagulant point out that common allegations will be raised in all of the lawsuits about whether Xarelto should be prescribed without blood monitoring and dose adjustments. There are also numerous Xarelto cases field in Pennsylvania state court and other state courts which will raise this issue.

A motion is currently pending before the U.S. Judicial Panel on Multidistrict Litigation (JPML), which seeks to consolidate Xarelto lawsuits filed in U.S. District Courts throughout the country, calling for the cases to be centralized before one judge, given similar questions of law and fact raised by plaintiffs.

There are currently 30 complaints filed in federal court, but thousands are expected.  Another 20 or so cases are currently pending in Pennsylvania state court in Philadelphia county.

The Defendants filed their reply to the MDL motion on October 31, arguing that the cases will be dominated by the “individual facts” about the circumstances leading to each plaintiff’s bleeding injury on Xarelto. They also suggested that the mounting litigation was driven by “aggressive advertising” by plaintiffs’ attorneys.

However, in a reply brief, filed in support of the creation of an MDL on November 7, a group of plaintiffs point out that it is actually the drug makers’ own marketing claims that are one of the main common issues present in all of the cases.

The U.S. JPML is scheduled to hear oral arguments on the motion to establish a Xarelto MDL at an upcoming hearing session set for December 4, in Charleston, South Carolina.

Xarelto (rivaroxoaban) was introduced by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals in 2011, as the second member of a new generation of anticoagulants that were promoted as superior to Coumadin (warfarin), which had been the go-to blood thinner for prevention of strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding problems, Xarelto lacks an approved antidote that can be used to reverse bleeding and blood thinning, unlike generic warfarin which has been used for decades and has an effective antidote in Vitamin K.

In addition, while the drug makers have promoted and advertised that users do not need regular blood monitoring, recent studies have suggested that blood monitoring may help doctors identify patients at risk of bleeding.

In recent years, about 4,000 lawsuits were filed against Boehringer Ingelheim on behalf of former users of Pradaxa. Those claims involved allegations very similar to those currently involving Xarelto. Following several years of litigation, the Pradaxa litigation settled for $650 million earlier in 2014.

If you or someone you loved suffered a severe bleeding injury, hemorrhage or hemorrhagic stroke while taking Xarelto contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you have a case.

First Androgel Testosterone MDL Trial Dates Set for Late 2016

The federal Judge presiding over the testosterone replacement therapy lawsuits in a federal multi-district litigation (MDL) issued a case management order on November 6, 2014 outlining the process for bellwether cases and trials.  The first Androgel cases are scheduled to be tried before juries in late 2016 and early 2017.

 

Since June 2014, all product liability lawsuits filed throughout the federal court system involving injuries allegedly caused by testosterone replacement therapies before U.S. District Judge Matthew Kennelly in federal court for the Northern District of Illinois.

 

All of the complaints raise similar claims that men suffered a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other injury after using a testosterone gel, cream, patch, injection or other therapy, alleging that the drug makers failed to adequately research the drugs or warn about the potential risks associated with testosterone treatments.

Most of the cases are Androgel cases against AbbVie, the manufacturer of the testosterone replacement therapy Androgel.  However, there are some cases in the MDL against the manufacturers of other testosterone replacement therapies such as Testim, Axiron, Depo-Testosterone and AndroDerm.

In the November 6 case management order, Judge Kennelly outlined the process for selecting a group of bellwether lawsuits that only involve the drug maker AbbVie as a defendant. These claims will will go through case-specific discovery and culminate in a series of six trial dates that are expected to begin about one-per-month between October 2016 and April 2017.

The cases against AbbVie will be divided into two tiers – the first tier is for cases alleging pulmonary embolism, blood clots or deep vein thrombosis.  The second tier of cases alleges plaintiffs suffered from heart attacks or other cardiovascular injuries.

There are currently at least 223 testosterone lawsuits filed in federal court that have been transferred into the MDL.

In November 2013, a study published in the Journal of the American Medical Association suggested that testosterone replacement therapies may increase the risk of heart attack, stroke or death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low T treatments may double the risk of heart attacks for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

The FDA launched an investigation shortly after the release of this research.  Two FDA advisory committees met this summer to evaluate the available data and voted 20-to-1 to recommend that the drug makers be forced to conduct additional clinical trials to evaluate the potential heart risks. The panels also recommended that the FDA restrict use of the widely used medications to men actually suffering from testosterone deficiencies caused by hypogonadism or another medical condition.

Have you or someone you loved suffered a heart attack, stroke, pulmonary embolism or severe blood clot while taking Androgel or other testosterone treatments such as Axiron, Testim, Depo-Testosterone or AndroDerm? Contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a case. 

Xarelto Consolidated Federal Lawsuit Opposed by Bayer and Johnson & Johnson

The manufacturers of the controversial blood thinner Xarelto are urging a panel of federal judges not to centralize the cases before one judge for coordinated pretrial proceedings in a multidistrict litigation (MDL).

 

On December 4, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to hear oral arguments on a motion filed last month by a group of plaintiffs, which seeks to consolidate all Xarelto lawsuits filed throughout the federal court system as part of an MDL, or multi-district litigation.

 

Bayer and Johson & Johnson’s Janssen Pharmaceuticals subsidiary, the manufacturers and distributors of Xarelto, filed responses urging the JPML to reject the request, arguing the cases will be too individualized for consolidation and that informal coordination will serve the same purpose.

 

So far, there are at least 30 different lawsuits filed in federal court involving allegations that the drug makers failed to warn about the bleeding risk with Xarelto and that the lack of a reversal agent for the medication if bleeding or hemorrhage occurs.

 

On October 15, 2014, a group of plaintiffs filed a motion to consolidate the Xarelto litigation in a federal MDL. The original request proposed that the litigation be centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois, who was previously assigned to preside over the MDL for all Pradaxa lawsuits, which raised similar allegations.

 

In the event that the JPML does decide to establish a Xarelto MDL, the drug makers indicate that the cases should not be transferred to the Southern District of Illinois, but rather indicate that the most appropriate venue is the District of New Jersey, where both drug makers’ U.S. headquarters are located and where allegedly a large number of witnesses and documents are located.

 

In addition, about 20 Xarelto cases have been filed in state court in the Philadelphia County Court of Common Pleas.

 

Plaintiffs maintain that the drug makers provided false and misleading information about the bleeding risks, burying information about the lack of a reversal agent on the drug label. In addition, many of the claims allege that Xarelto was marketed in a reckless manner.

Thousands of Xarelto lawsuits are ultimately expected.

 

If you or someone you love has been injured by Xarelto and developed uncontrolled bleeding, hemorrhage or stroke, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm.

Lipitor Diabetes MDL Moves Forward

Discovery continues to move forward in a federal multi-district litigation over the risk of women developing type 2 diabetes from the cholesterol lowering drug Lipitor.

 

All federal Lipitor lawsuits filed by women who allege the drug caused them to develop type 2 diabetes are centralized before Judge Richard Gergel in the District of South Carolina as a federal MDL.  There are currently more than 1,350 complaints that have been filed in the MDL.

 

All of the complaints involve similar claims that Pfizer failed to adequately warn about the link between Lipitor and diabetes, alleging that the drug maker placed their desire for profits before consumer safety by withholding information about the importance of monitoring for blood glucose changes during use of the blockbuster cholesterol drug.

 

In advance of a conference on discovery before Judge Gergel this Friday the parties submitted a joint status report detailing the status of discovery as Pfizer continues to turn over millions of pages of internal company records surrounding the research and development of the medication.

 

Many of the women involved in the litigation allege that they were generally healthy before being prescribed Lipitor, and that they only agreed to take the medication as a precautionary measure. Plaintiffs maintain that if they had been provided adequate warnings about the diabetes risk, they never would have agreed to take Lipitor or may have avoided the disease by closely monitoring their blood glucose levels.

 

The first Lipitor bellwether trials are expected to begin in October 2015.

 

If you are an otherwise healthy woman with a BMI under 30 who took Lipitor and subsequently developed Type 2 diabetes, contact the Rieders Travis Firm to see if you have a case against Pfizer.

Xarelto Monitoring May Identify Bleeding Risk Among AFib Patients – Study

In a new study published in the Journal of Cardiology researchers found that measuring the coagulation function with Xarelto may help doctors understand the effects of the drug on a particular patient and the associated bleeding risk.

The findings raise questions about marketing claims made by the drug makers, which have promoted Xarelto as superior to the decades-old anticoagulant Coumadin (warfarin) by indicating that the newer drug is easier to use because it does not require blood monitoring.

According to researchers from the Nagoya University Graduate School of Medicine in Japan, the amount of time Xarelto was at its peak in patients, and most likely to cause uncontrollable bleeding events, was highly variable depending on a number of factors that may be identified by measuring coagulation function.

Many patients given Xarelto, particularly women, those given high doses, and those with high levels of brain natriuretic peptides, experienced peak levels, known as prothrombin time (PT), that lasted for prolonged periods of time. It was in these prolonged peak times where patients were most likely to suffer major bleeding events.

Unlike warfarin which has an approved antidote that doctors can use to reverse the blood thinning effects of the medication, there is no approved Xarelto antiodote or reversal agent. Therefore, the findings of this latest study raise concerns about the way the drug was marketed and suggest that many users may have suffered severe bleeding injury due to the lack of warnings about the importance of blood monitoring on Xarelto.

 

Xarelto (Rivaroxaban) was introduced in late 2011, as a joint development by Bayer and Johnson & Johnson’s Janssen subsidiary. It is part of a new generation of anticoagulants, known as “direct thrombin inhibitors,” which are designed to reduce the risk of blood clots and strokes by thinning the blood.

Amid aggressive promotion of the medication to doctors and directly to consumers, Xarelto sales have grown quickly, with estimates suggesting that it may soon gain blockbuster status, with more than $1 billion in annual sales.

While the medical community has been quick to adopt use of Xarelto over warfarin, there have increasing reports of severe and uncontrollable bleeding associated with Xarelto. However, it now appears that many of these injuries and deaths may have been avoided if Bayer and Johnson & Johnson had provided warnings about the importance of blood monitoring.

The Rieders Travis Firm is accepting new Xarelto cases.  If you or someone you love has suffered a severe bleeding injury, hemorrhage or hemorrhagic stroke from taking Xarelto contact Cliff Rieders of the Rieders Travis Firm today.

Motion Filed to Centralize Xarelto Lawsuits in MDL

As a growing number of Xarelto lawsuits continue to be filed in U.S. District Courts nationwide, a group of plaintiffs are seeking to consolidated the federal cases before one judge for coordinated pretrial proceedings as part of an MDL, or Multi-District Litigation.

There are currently at least 21 product liability lawsuits pending in 10 different federal district courts involving injuries or deaths associated with uncontrollable bleeding and stroke from Xarelto, used to prevent stroke among patients with atrial fibrillation and for prevention of blood clots.

It is expected that several thousand cases may be brought in the coming months, all involving similar allegations that the manufacturers of the drug failed to provide adequate warnings about the risk of severe bleeding and the lack of an approved reversal agent.

A group of plaintiffs have called on the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all cases before U.S. District Judge David R. Herndon in the Southern District of Illinois in an MDL.  The same Judge and Court presided over the Pradaxa MDL.

Xarelto (rivaroxoaban) was introduced by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals in 2011, as part of a new generation of anticoagulants promoted as a superior alternative to Coumadin (warfarin), which has been the go-to blood thinner for prevention of strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding problems, Xarelto and other members of this new generation of anticoagulants lack an approved antidote that doctors can use to reverse the effects of the drug. While doctors can quickly stop the blood thinning effects of warfarin, users of Xarelto have reported experiencing uncontrollable bleeding that physicians were unable to stop, often leading to severe injury or death.

The U.S. JPML is expected to hear oral arguments on the motion to establish a Xarelto MDL at an upcoming hearing session scheduled for either December 4, 2014 in Charleston, South Carolina, or January 29, 2015 in Miami, Florida.

The Rieders Travis Firm is handling Xarelto cases.  If you or someone you love has suffered a severe bleeding injury, hemorrhage or stroke while on Xarelto, contact Cliff Rieders, Esq., of the Rieders Travis Firm. 

Motion Filed to Centralize Xarelto Lawsuits in MDL

As a growing number of Xarelto lawsuits continue to be filed in U.S. District Courts nationwide, a group of plaintiffs are seeking to consolidated the federal cases before one judge for coordinated pretrial proceedings as part of an MDL, or Multi-District Litigation.

There are currently at least 21 product liability lawsuits pending in 10 different federal district courts involving injuries or deaths associated with uncontrollable bleeding and stroke from Xarelto, used to prevent stroke among patients with atrial fibrillation and for prevention of blood clots.

It is expected that several thousand cases may be brought in the coming months, all involving similar allegations that the manufacturers of the drug failed to provide adequate warnings about the risk of severe bleeding and the lack of an approved reversal agent.

A group of plaintiffs have called on the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all cases before U.S. District Judge David R. Herndon in the Southern District of Illinois in an MDL.  The same Judge and Court presided over the Pradaxa MDL.

Xarelto (rivaroxoaban) was introduced by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals in 2011, as part of a new generation of anticoagulants promoted as a superior alternative to Coumadin (warfarin), which has been the go-to blood thinner for prevention of strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding problems, Xarelto and other members of this new generation of anticoagulants lack an approved antidote that doctors can use to reverse the effects of the drug. While doctors can quickly stop the blood thinning effects of warfarin, users of Xarelto have reported experiencing uncontrollable bleeding that physicians were unable to stop, often leading to severe injury or death.

The U.S. JPML is expected to hear oral arguments on the motion to establish a Xarelto MDL at an upcoming hearing session scheduled for either December 4, 2014 in Charleston, South Carolina, or January 29, 2015 in Miami, Florida.

The Rieders Travis Firm is handling Xarelto cases.  If you or someone you love has suffered a severe bleeding injury, hemorrhage or stroke while on Xarelto, contact Cliff Rieders, Esq., of the Rieders Travis Firm. 

Cook IVC Filter Litigation Centralized in Indiana Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation has decided to consolidate all Cook IVC filter lawsuits pending in federal courts in a multidistrict litigation (MDL) before U.S. Judge Richard Young in the Southern District of Indiana.

 

Product liability lawsuits concerning the Cook interior vena cava (IVC) filters, which are small spider like devices implanted to prevent blood clots from travelling to the lungs and causing pulmonary embolisms will be centralized in the DML.  There are currently 32 complaints filed nationwide raising similar allegations that the Cook Celect and Gunther Tulip filters make the devices prone to fractue, migrate , tilt or perforate the interior vena cava.

 

According to the lawsuits, an April 2012 study published in the medical journal Cardiovascular Interventional Radiology found that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal caval wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.

 

Cook Medical opposed centralization of the IVC filter lawsuits, arguing that the unique facts surrounding each case will predominate the litigation, and that the various different models of Cook IVC filter lawsuits involved in the cases reduce the overlapping discovery in the cases.

The U.S. JPML rejected these arguments, finding that while individual issues of fact are presented in all product liability cases, the litigation will benefit from centralized management, since the actions “do share paramount issues concerning the design, manufacture, testing, and marketing of a single medical device.”

If you have been injured by a Cook IVC filter used to prevent pulmonary embolism contact Cliff Rieders, Esq. of the Rieders Travis Firm

Eliquis Antidote May Be Available Before Xarelto or Pradaxa Antidote

As concerns continue about the risk of serious and life threatening bleeding with Eliquis, Xarelto and Pradaxa, it appears that the makers of Eliquis may be closer to introducing the first reversal agent for any of these drugs, which are part of a new generation of anticoagulants.

 

Pradaxa, Xarelto and Eliquis have all been introduced in recent years as a replacement for warfarin, which has been the go-to-drug for prevention of strokes due to atrial fibrillation for decades, and the manufacturers are all competing to gain the market advantage in this lucrative sector.

 

These new medications have been promoted by their manufacturers as superior alternatives to warfarin since the manufacturers indicate they require less monitoring, but all three have been linked to thousands of reports of uncontrollable bleeding which doctors have been unable to stop due to the lack of any reversal agents for the medications.  Warfarin has an effective antidote, however, Vitamin K.

 

The makers of Pradaxa, Xarelto and Eliquis have all been working to identify and obtain approval for a safe and effective reversal agent for their medication, which would likely provide the first to market with such an antidote a clear market advantage.

 

Portola Pharmaceuticals indicated that a potential antidote for Eliquis has met both primary and secondary endpoints with high statistical significance in a phase 3 clinical trial, suggesting that they are close to confirming that Andexanet Alfa can reliably stop the blood thinning effects of the drug in an emergency.

 

Pradaxa was introduced in October 2010 and was associate with thousands of adverse event reports submitted to the FDA concerning bleeding events and hemorrhage.  Boehringer Ingelheim faced 4000 Pradaxa lawsuits in federal court which ultimately settled earlier this year for $650 million.

 

Xarelto is currently the subject of litigation, and was introduced to the market in late 2011.

 

Eliquis was introduced to market in 2012. The drug makers have also obtained expanded approval for the anticoagulant, with the FDA approving use for the prevention and treatment of blood-clot related problems, such as deep vein thrombosis and pulmonary embolism, as well as atrial fibrillation.  Pradaxa and Xarelto are only approved to treat atrial fibrillation.

 

In February 2013, Bayer, Johnson & Johnson and Portola Pharmaceuticals announced that they planned to partner on development of a Xarelto reversal agent, ndicating that the companies will study the potential use of the recombinant protein PRT4445.

 

Earlier this year, the FDA granted breakthrough status to a potential Pradaxa antidote, darucizumab, meaning that the drug would go to the front of the line for development and review in hopes of getting it to the market more rapidly.

 

Detailed data on the use of andexanet alfa as a potential Eliquis antidote will be presented during a session at the American Heart Association’s 2014 Scientific Sessions, on Monday, November 17. The statement issued last week indicates that the reversal agent for Eliquis has the potential to be the first antidote approved for Factor Xa inhibitors, with the drug makers anticipating the filing of a Biologics License Application with the FDA for Accelerated Approval at the end of 2015.

 

The Rieders Travis Firm is currently reviewing Xarelto cases.  If you or someone you loved suffered a severe bleeding event, hemorrhage or hemorrhagic stroke while on Xarelto, contact Cliff Rieders, Esq. of the Rieders Travis Firm.  Due to the settlement, we are no longer accepting Pradaxa case.

Transvaginal Mesh Settlements Reached to Settle Nearly All AMS Cases

According to a report by Endo International, substantially all of the transvaginal mesh cases pending against its American Medical Systems (AMS) subsidiary have been settled.

 

Tens of thousands of women nationwide were pursuing AMS mesh lawsuits after experiencing painful and debilitating complications associated with the use of bladder sling and transvaginal mesh products for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), including erosion of the mesh through the vagina, infections and other problems.

 

Earlier this year, Endo agreed to settle more than 22,000 cases for $830 million, leaving thousands of claims unsettled.

 

If you have been injured by transvaginal mesh used in surgical repair for pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Bellwether Trials Set in Risperdal Lawsuits

A series of Riperdal gynecomastia lawsuits are set for trial to beign later this year in Pennsylvania state court involving claims brought on behalf of boys and young men who experienced problems with male breast growth following the use of the antipsychotic drug.

 

Johnson & Johnson currently faces hundreds of product liability lawsuits involving use of the medication by young males for treatment of bi-polar disorders, autism, irritability, aggression or other behavior disorders.

 

The complaints allege that Defendant Johnson & Johnson failed to adequately warn that the side effects of Risperdal may include gynecomastia.  The three trials, which are bellwether trials in the large mass tort coordinated litigation are scheduled to begin November 3, 2014, January 3, 2014 and sometime in February 2015.

 

If you took Risperdal as a teenager and developed gynecomastia, contact Cliff Rieders, Esq. of the Rieders Travis Firm

Breaking News: Testosterone Cardiovascular Risks Require Additional Clinical Studies According to FDA advisory Committee

Following two full days of meetings by independent advisors to the FDA,  two separate FDA advisory committees voted 20-1 to recommend that manufacturers of popular testosterone replacement therapies such as Androgel, Testim, Axiron and other low T treatments be forced  to do additional clinical studies to look into the potential testosterone heart risks, following a series of clinical studies published earlier this year that raised concerns that some users of the medications may be more likely to suffer a heart attack or stroke.

 

This recommendation from the FDA advisory committees came a day after another 20-1 vote from the advisory committee calling on the FDA to restrict low T drugs to use by men who have actual illness or disease that is impacting their testosterone levels,  in attempt to reduce the number of prescriptions given for “life style reasons” to address symptoms associated with natural drops in testosterone experienced by men as they age.

 

The FDA Bone Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met on Wednesday and Thursday this week, to review available data on the potential heart risks with testosterone replacement therapy and to make recommendations to the FDA on what regulatory actiosn should be taken to protect consumers.

 

On Thursday, the panel was nearly unanimous in its vote to order testosterone manufacturers to conduct more comprehensive clinical trials to determine if concerns over heart attacks are warranted. The panels said that the FDA should threaten companies that do not comply with civil penalties.

The only dissenting vote came from Dr. Abraham Thomas, the division head and Whitehouse Chair in Endocrinology at Henry Ford Medical center in Detroit, Michigan, who actually only voted against the recommendation because he did not believe the studies should be conducted by the manufacturers themselves. Dr. Thomas said that the trials should be conducted by the National Institutes of Health, with the pharmaceutical companies footing part of the bill.

The recommendations raise serious questions about why the drug makers did not complete adequate and thorough testing for the impact of testosterone therapy on the heart earlier, as most of the drugs have been on the market for more than 10 years and generate billions a year in sales.

In 2010, 1.3 million men had received prescriptions for testosterone replacement medications.  In 2012, the number was 2.3 million,  with the largest increase among men aged 40 to 64.

Only about half of the men taking testosterone drugs appear to have been diagnosed with hypgonadism, and about 25% have not even had their testosterone concentrations tested prior to initiating therapy, according to a report by FDA reviewers prior to the panel meetings.

Hundreds of men are now suing the manufacturers of Androgel, Testim, Axiron and other testosteorne replacement drugs alleging that information about the potential heart risks was withheld from consumers and the medical community.

A study was published in November 2013 in the Journal of the American Medical Association that found that the side effects of these testosterone drugs may increase the risk of heart attack for older men after a coronary angiography, due to build up of plaque in the arteries.  In January 2014, a second study was published in PLOSOne that determined that low T treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions. Shortly after that study the FDA launched its own investigation and announced that it would convene the advisory panels that ultimately voted this week to further evaluate the risks.

Lawsuits have been filed on behalf of men who allege that these drugs caused them to suffer heart attacks, blood clots and strokes.  The lawsuits are centralized in a MDL or multi-district litigation, as of last month, which is before U.S. District Judge Mattheew Kennelly in the Northern District of Illinois.

 If you or someone you love took testosterone replacement therapies including Axiron, Androgel, Androderm or Testim, contact Cliff Rieders, Esq. of the Rieders Travis Firm

Testosterone Drug Safety Risks to be Weighted by FDA Panel

The FDA only approved testosterone drugs to treat a condition known as hypogonadism, which is usually caused by testicular disease or an injury or disease affecting the hypothalamus or pituitary glands in the brain.

Many experts have suggested that a growing number of men are being prescribed testosterone drugs for “life-style reasons” or to treat “age-related hypogonadism,” where testosterone levels drop due to the natural effects of getting older.

The FDA found that in 2010, 1.3 million men had received testosterone prescriptions. By 2013, that number had increased to 2.3 million. The largest increase was among men age 40 to 64, jumping from 850,000 in 2010 to 1.5 million by 2013.

In a study that was published in 2013 in the Journal of the American Medical Association, researchers found that the side effects of testosterone drugs may increase the risk of heart problems for older men.

In a second study published in the medical journal PLOSOne in January 2014, researchers found that low testosterone treatments may double the risk of heart attach for younger men with heart disease and men over 65 regardless of their prior heart conditions.

In the wake of these studies, the FDA launched its own investigation. However, the FDA reviewers’ report released earlier this month suggested that the current studies had limitations that may make the agency unable to draw firm conclusions about the safety of testosterone drugs, indicating that there may be insufficient evidence of cardiovascular risks.

The advisory committees will review the available data and determine for themselves whether the FDA should take regulatory steps to address the testosterone heart risks. The committees are also expected to make recommendations regarding whether and how testosterone drug prescriptions should be controlled or regulated so that they go to the men who actually need them.

There are a growing number of lawsuits that have been filed against the manufacturers of Androgel, Testim and Axiron.  A multidistrict litigation or MDL has been set up to establish a coordinated pretrial proceeding for these lawsuits in federal court before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

 If you or someone you love took testosterone replacement therapy such as Axiron, Androgel, Androderm or Testim, and suffered a heart attack or stroke, contact Cliff Rieders of the Rieders Travis Firm to determine whether you have a claim.

Second MDL Motion Filed by Defendants over OxyElite Pro Lawsuits in Federal Court

USP Labs continues to face liver damage lawsuits over a forced recall of OxyElite pro and Jack3d dietary supplements issued last year.  The manufacturer has filed a second request that all litigation filed in federal court be centralized by one judge for coordinated pretrial proceedings.

 

At least 17 product liability lawsuits have been field thus far by 46 different individuals who allege that they suffered liver damage or hepatitis after using OxyElite Pro or Jack3d.  In some cases plaintiffs have required liver transplants and/or have died as a result.

 

All of the complaints involve similar allegations that USPLabs used unsafe ingredients in its products and failed to adequately warn consumers of the risks of liver damage associated with OxyElite Pro and Jack3d supplements.

 

In February of this year, USPLabs field a request with the U.S. Judicial Panel on Multidistrict Litigation (JPML) asking that the OxyElite Pro litigation be centralized in a multi-district litigation.  Following a hearing in March, the panel rejected this request because there were several different formulations of the products t issue and there may not be a lot of overlapping discovery. The panel recommended voluntary coordination between the then pending nine federal cases.

 

USP Labs filed another petition to the JPML on September 11 because additional cases have continued to be filed. The manufacturer points out that claims have been filed on behalf of more than 40 new plaintiffs since the panel originally rejected their first request. The company has asked that the cases be consolidated din the Southern District of California or the Northern District of Texas.

 

Concerns about the safety of OxyElite Pro first surfaced in September 2013, when Hawaii health officials noted a growing number of liver injury and hepatitis claims from consumers who had all the supplement, which is designed to help users put on muscle mass.

After nearly 60 cases of OxyElite Pro liver damage were identified by state and federal agencies, the FDA forced USPLabs to remove the product from the market on November 10, 2013.

The FDA and other health agencies determined that the weight supplement contained aegeline, an extract from the Bael tree, which is native to India and southeast Asia. The FDA ruled that the product was adulterated because aegeline is relatively untested and its side effects are unknown.

 

If you or someone you love took OxyElite pro and suffered severe liver injuries, contact Cliff Rieders of the Rieders Travis Firm. 

Boston Scientific Vaginal Mesh Trial Results in $73 million Plaintiff’s Verdict in Texas State Court

A trial against manufacturer Boston Scientific concerning their vaginal mesh product has resulted in a $73 million Plaintiff’s verdict in Texas state court.  The case was filed by a woman who experienced problems with Boston Scietific’s Obtryx mesh for treatment for stress urinary incontinence (SUI).  The Plaintiff suffered a number of complications from the mesh, resulting in nerve damage.

There are approximately 60,000 pending vaginal mesh product liability lawsuits pending against the various manufacturers of transvaginal mesh and bladder sling product used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Other manufacturers involved in the litigation include Johnson & Johnson’s Ethicon subsidiary, C.R. Bard, American Medical Systems (AMS), Coloplast Corp, Cook Medical, Neomedic and others.

This case was the first Boston Scientific vaginal mesh lawsuit to be hear by a jury, and the first victory of the plaintiff.  Boston Scientific prevailed earlier this year in two other trial in Massachusetts state court.

Most of the Boston Scientific mesh cases are pending in the federal court system, where roughly 12,000 cases filed in U.S. District Courts nationwide have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the Southern District of West Virginia before Judge Joseph R. Goodwin.  A series of bellwether trials in the MDL are scheduled to begin before Judge Goodwin later this year.

If you have been seriously injured by a faulty vaginal mesh product, contact Cliff Rieders, Esq. of the Rieders Travis firm.

Jury Awards $3.27 Million Award Against Vaginal Mesh Manufacturer

Johnson & Johnson’s Ethicon subdivision has been ordered to pay $3.27 million in damages in a bellwether trial concerning its bladder sling, the company’s Gynecare TVT-obturator in a complaint brought by Jo Huskey that was tried in the multidistrict litigation (MDL) in West Virginia federal court before the presiding Judge, Joseph R. Goodwin.  Tens of thousands of similar cases are pending in the MDL before Judge Goodwin.

 

Ethicon is one of several medical device manufacturers involved in the litigation, with other products manufactured by C.R Bard, Boston Scientific, American Medical Systems (AMS), Coloplast Corp., Cook Medical and Neomedic linked to similar reports of painful and debilitating injuries when the pelvic mesh eroded through the vagina, caused infections or other issues.

 

At trial, the Plaintiff’s attorneys argued that the Ethicon mesh was defectively designed and became entangled in her internal organs, and that doctors were unable to effectively remove the mesh in a subsequent surgery, leaving her with permanent physical injuries.

 

The jury deliberated for three hours before announcing a $3.27 million dollar Plaintiff verdict in compensatory damages.

 

The Huskey case was the second in a series of Ethicon bellwether trials in the West Virginia MDL.  The first Ethicon mesh bellwether trial ended in a defense verdict earlier this year. A third Ethicon bellwether trial is scheduled to begin December 4, 2014.

 

Judge Goodwin is presiding over seven different MDLs against the manufactures of vaginal mesh products.  There are about 19,000 lawsuits against Ethicon, 1`2,000 against Boston Scientific, 9,500 against Bard, 18,000 against American Medical Systems, 1600 against Coloplast, 250 against Cook and 66 against Neomedic.

 

 

The first federal bellwether trial in the transvaginal mesh litigation began in July 2013, when a jury awarded Donna Cisson $2 million dollar sin a Bard Avaulta lawsuit, including punitive damages designed to punish the manufacturer. Since that time, Bard has agreed to settle at least two other cases that were set for trial to begin.

 

Prior to the next Ethicon bellwether trial in December, at least two other trials are set to go forward before Judge Goodwin involving products manufactured by Boston Scientific.

 

If you were injured by a transvaginal mesh contact, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim.

Xarelto Lawsuits Mount as Manufacturer Seeks to Expand Indications for Use

As the number of Xarelto bleeding lawsuits filed in federal and state court continues to grow, Johsnon & Johsnon and Bayer, the marketers of Xarelto plant to proceed with seeking additional approved uses for the anticoagulant, despite prior FDA rejections.

 

Although it was just introduced in late 2011, Xarelto is already nearing blockbuster status, with sales that may exceed $1 billion by the end of the year. However, serious concerns have been raised to the FDA and in numerous lawsuits about the bleeding risks associated with Xarelto, given concerns of over lack of an antidote to reverse bleeding effects of the medication.

 

Amid concerns over the safety of Xarelto, Johnson & Johnson and Bayer, which jointly manufacture and sell the drug, indicated recently that they still plan to seek expanded FDA approvals that would allow them to market the blood thinner among a wider population of users, including patients with acute coronary syndrome (ACS).   Last month the manufacturer announced three new clinical trials in this indication.  However, the FDA has rejected three previous attempts to expand Xarelto use in that direction, expressing concern over the risk of bleeding events linked to the drug and other medications like it, such as Boehringer Ingelheim’s Pradaxa.

 

While the manufacturers have claimed that the drug is easier to use than warfarin, since patients do not require regular monitoring during treatment, a growing number of lawsuits filed nationwide allege that the Xarelto warnings fail to adequately disclose the risk of uncontrollable bleeding due to the lack of an approved antidote.

 

If you or someone you love suffered severe bleeding or hemorrhage due to taking Xarelto contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you have a claim. 

PRODUCTS LIABILITY-PHARMACEUTICALS-PREEMPTION

In re Fosamax (Alendronate Sodium), 751 F.3d 150 (3rd Cir. 2014) involved products liability claimed by individuals who allegedly suffered bone fractures because they took Fosamax, a drug used to treat or prevent osteoporosis and Paget’s Disease or the generic equivalent of that drug, Alendronate Sodium.  The case was filed in the District of New Jersey and would appear to be applicable in Pennsylvania as well.  Together prior case law in PLI-VA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual Pharmaceutical Company v. Bartlett, 133 S. Ct. 2466 (2013) establish that under the Food, Drug and Cosmetic Act a generic drug manufacturer may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability.  To the extent that it is impossible for a generic drug manufacturer to comply with its duty under a state tort law unless it takes one of those actions, the law is preempted by the FDCA.  In sum, Mensing and Bartlett recognize that manufacturers have no control over the design or labeling of generic drugs.  Short of exiting the market, which Bartlettrejects, the patients have failed to identify anything that the Generic Defendants can do to reconcile their conflicting duties under state and federal law.  Therefore the strict liability design defect claims are preempted.

Bayer Faces Thousands of Additional Birth Control Lawsuits re Yasim and Yaz

Despite paying more than $1.8 billion in Yasmin and Yaz related settlements, Bayer continues to face about 5000 lawsuits filed by women who allege they suffered injuries after using the popular birth control pills.  Bayer’s settlement resolved about 17,000 complaints.

 

The company has agreed to pay about $1.8 billion to resolve claims involving allegations that women suffered blood clot related injuries, such as deep vein thrombosis and pulmonary embolism. However, about 5,00 such lawsuits remain unresolved. Bayer’s  2014 second quarter financial statement indicates that about 2,400 of the remaining claims involve injuries that the drug maker is considering settling on a case-by-case basis, after a review of medical records.

 

Yaz and Yasmin are popular birth control pills that contain the fourth-generation progestin drospirenone, which has been associated with an increased risk of blood clots compared to the risk associated with some older birth control pills.

 

In federal court, the majority of the lawsuits were consolidated as part of a MDL or multi-district litigation in the Southern District of Illinois.

 

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis law firm.

Mirena IUD – First Bellwether Trial Set for March 2016

The U.S. District Judge presiding over the federal litigation concerning Mirena IUD lawsuits has established a bellwether trial schedule that calls for the first trial to begin in March 2016 in federal court.

 

Mirena is an IUD birth control device marketed by Bayer Healthcare.  All of the complaints allege that women have suffered injuries as a result of the device migrating spontaneously and puncturing the uterus or causing other injuries.  Plaintiffs allege that the manufacturer failed to provide adequate warnings about the risk of these injuries.

 

Bayer currently faces more than 2,000 Mirena product liability lawsuits in the United States. In federal court, about 600 of these lawsuits have been centralized before U.S. District Judge Cathy Seibel in the Southern District to New York in a MDL or multi-district litigation.

 

Judge Seibel outlined the process for completing discovery in the group of 12 bellwether trials, which will be narrowed down to six cases by May 2015. Following expert witness discovery and dispositive motions, the Court indicates that the first trial setting will be selected for that March trial date.

If you have been injured by a Mirena IUD device, contract Cliff Rieders, Esq. of the Rieders Travis Firm. 

Bard Settles 500 Vaginal Mesh Cases

Defendant C.R. Bard has reportedly agreed to settle more than 500 vaginal mesh  lawsuits but continues to face thousands of other claims brought by women nationwide.  A federal Judge presiding over the multi-district litigation is preparing to send several hundred cases back to U.S. District Courts throughout the country for individual trial dates.

There are about 12,500 Bard Avaulta mesh cases pending with most of the lawsuits pending in a federal multi-district litigation which is centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia. All of the complaints involve similar allegations, indicating that women suffered painful and debilitating complications from transvaginal mesh implanted to repair pelvic organ prolapse (POP) or female stress urinary incontinence (SUI).

In a recent SEC filing, Bard acknowledged that two settlements were reached during the second quarter of 2014 with two separate Plaintiffs firms, resolving more than 500 cases for an undisclosed amount.  This represents only a small fraction of the cases pending, but the manufacturer indicates it is in discussions with to her Plaintiffs’ firms, which may result in additional settlements. Previously the only confirmed agreements to settle Bard mesh cases came in individual cases that were set for early trial dates, known as “bellwether” cases.

The disclosure that the medical device manufacturer has settled what appears to be the first large “chunk” of cases comes as Judge Goodwin prepares to remand up to 200 cases currently pending in Bard Avaulta MDL, potentially sending cases back to various U.S. District Courts nationwide for trial.

If you have been injured by a pharmaceutical or medical device, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim.

New Study Highlights Diabetes Risks with Statin Drugs Including Lipitor and Crestor

Italian researchers indicate that the findings of a new study adds to the mounting evidence that side effects of Lipitor, Crestor and other statin-based cholesterol drugs increase the risk of new-onset diabetes.

In a study published late last month in the medical journal Diabetes Care, researchers from the University of Milano-Bicocca indicate that they have found a dose-specific response that suggests the longer a user adheres to statin therapy, the higher the risk of diabetes they may face.

Researchers examined data on 115,709 residents in the Italian Lombardy region, who were newly prescribed Lipitor, Crestor or another statin between 2003 and 2004. The study looked at their adherence to the popular cholesterol therapy by 2010, and compared patients with a low adherence, medium adherence, and high adherence to statin therapy over the intervening years.

The results suggest that low adherence patients were 12% more likely to be diagnosed with diabetes than those who did not take statins, while patients with a medium level of statin therapy adherence were 22% more likely to be diagnosed with diabetes, and those with the most adherence to statin therapy also had the highest risk of diabetes; 32% higher than people not taking the drugs.

An ongoing multi-district litigation is centered in the District of South Carolina against Pfizer, the manufacturer of Lipitor, alleging that wome n who took Lipitor developed Type 2 diabetes as a result of taking the drug.  Hundreds of Lipitor lawsuits have been filed as part of the multi-district litigation.

 

In February 2012, the FDA required the manufactures of Lipitor and Crestor and other statins to add new warning of the drugs’ impact on blood glucose levels.  However, plaintiffs in the MDL allege that this warning is not strong enough as it does not warn of the risk of diabetes, particularly in women.

 

If you are a woman with a BMI under 30, who developed Type 2 diabetes while taking Lipitor and otherwise were in good health, contact Cliff Rieders, Esq. of the Rieders Travis firm. 

Link Between Testosterone and Cardiovascular Adverse Events Results in Warning from Health Canada

Canadian health officials are warning citizens of that country about the potential risk of heart problems associated with the adverse events of testosterone replacement therapy, such as AndroGel, Testim and Axiron.

 

In a safety update issued July 14, 2014, Health Canada dicated that a review of a “growing body of evidence” suggests that there is a causal link between use of testosterone replacement therapy (TRT) and an increased risk of men experiencing cardiovascular problems, such as a heart attack, stroke, pulmonary embolism, deep vein thrombosis or irregular heart rates. The U.S. FDA had launched an investigation into the potential risk of testoterone related cardiovascular events in January 2014, following several clinical studies that raised similar concerns.

 

Health Canada indicates that it recently completed it’s evaluation of published scientific literature and case reports, and that it is working with drug manufacturers to update testosterone warnings provided on the product labels for medications sold in Canada. –

 

In the United States, hundreds of lawsuits have been filed against AbbVie, the manufacturer of AndroGel and the manufactures of other testosterone replacement therapies as part of a newly formed multi district litigation (MDL).   The lawsuits in the MDL are consolidated before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

 

If you or someone you love took testosteorne replacement therapies, including Axiron, AndroGel, Testim or AndroDerm and suffered from a heart attack, stroke or pulmonary embolism, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

FDA Advisory Committee Hearings Scheduled to Consider Testosterone Replacement Drug Risks

The FDA has asked two of its advisory committees to evaluate the potential health risks and issue recommendations about what regulatory actions may be necessary.

A joint meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee has been scheduled for September 17.

The FDA advisory committees have been asked to make recommendations about the potential cardiovascular risks with the so-called “Low T” drugs, such as Axiron, AndroDerm, AndroGel and Testim.  The outside experts will also discus what factors should be considered when deciding whether men need to use testosterone replacement therapy (TRT).  While the FDA advisory committees do not have any regulatory authority, their recommendations tend to significantly influence the FDA’s final actions.

HealthCanada recently announced that they found a strong link between low T drugs and cardiovascular events The FDA launched its own investigation into the testosterone drug risks in January 2014, following several studies that suggested men may using the Low T treatments may face an increased risk of heart attacks, strokes and sudden death.

In November 2013, a study published in the Journal of the American Medical Association (JAMA)found that various testosterone drugs were linked to cardiovascular adverse events in men with preexisting conditions.

That research was followed by a larger study published in the medical journal PLOSOne in January 2014.  The study found that testosterone replacement therapy may double the disk of myocardial infarction in men under 65 with no preexisting conditions.

Earlier this year, the consumer watchdog group Public Citizen petitioned the FDA to add a black box warning to low testosterone products  The FDA said it would render a determination when its own review was complete.

Public Citizen drew attention to what it sees as the absurdity of the agency’s stance given the evidence put forward by Canadian health officials.

On June 19, the FDA announced that it was requiring new venous thrombosis warning that testosterone replacement therapies could increase the risk of blood clots.

If you took AndroGel, Testim, AndroDerm, Axiron, or other testosterone replacement therapies and suffered from a heart attack, stroke or severe blood clot, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a claim that can be filed in conjunction with ongoing litigation. 

Xarelto Complications Increase, With Adverse Event Reports Exceeding Pradaxa

As more patients are taking the anticoagulant Xarelto (rivaroxaban) as an alternative to warfarin or Boehringer Ingelheim’s Pradaxam the number of severe bleeding complications ayt are being reported as associated with the drug has also increased.  Xarelto, like Pradaxa, is part of a new generation of blood thinners as an alterative to generic warfarin  (COumidin) which has been the most commonly used anticoagulant for over 50 years.

 

According to the Institute for Safe Medication Practices, Xarleot ranked tent last year ion the list of drugs most commonly having adverse events reported to the FDA.  The drug was approved in 2011.  IN May 2014, a New Institue for Safe Medication Practices report found that such adverse event reports with Xarelto were “steadily increasing” with more than 680 adverse events reported to the FDA in the first quarter of 2013 alone.  This exceeded the number of complications for Pradaxa, which has also been the subject of litigation.   Boehrigner Ingeheim, recently paid a $650 million settlement to settle more than 4000 Pradaxa lawsuits involving severe bleeding complications.

 

The Rieders Travis Firm is currently reviewing and filing cases against the manufacturer of Xarelto where the patients experienced severe bleeding or hemorrhage.  If you or someone you love took Xaretlo and experienced these complications contact Cliff Rieders, Esq. of the Rieders Travis Firm to have your case reviewed. 

Discovery Progressing in Byetta, Januvia, Janumet, Victoza Lawsuits

The federal judge presiding over a multi-district the litigation with over 440 Januvia, Byetta, Januemt and Victoza lawsuits recently laid out key dates for discovery into common issues surrounding the link between use of the diabetes drugs and the development of pancreatic cancer.

There are currently more than 440 product liability lawsuits pending in the federal court system involving individuals who allege they developed pancreatic cancer following use of Byetta, Januvia, Janumet or Victoza. All of the complaints raise similar allegations that inadequate warnings were provided about the potential side effects of the incretin mimetic class of diabetes drugs.

The cases are centralized in federal court for the Southern District of California before Judge Anthony Battaglia.

In a status conference dated July 1, 2014, a case management order was set out detailing further discovery on preemption. The Rieders Travis Firm has cases pending in the multi-district litigation and was a participant in this conference.

Judge Battaglia indicates that depositions of custodians will commence on September 2, and to be completed by October 14. Plaintiffs disclosure of experts and their reports must be filed and served by November 17, with defendants having a December 17 deadline. Plaintiffs have until January 30, 2015 to file rebuttal reports and all depositions of experts must be completed by March 6, 2015.

Ultimately, it is expected that Judge Battaglia will schedule a series of early trial dates involving the different diabetes drugs, known as bellwether trials.

If you took Byetta, Januvia, Janumet or Victoza to manage your Type 2 diabetes and developed pancreatic cancer, contact Cliff Rieders, Esq. to determine whether you have a case that can be filed as part of the ongoing litigation.

Defendant Takeda Seeks New Trial Following $9 Billion Actos Verdict

Following a landmark $9 billion verdict in an Actos bladder cancer lawsuit earlier this year, Takeda Pharmaceuticals and Eli Lilly are seeking to have the judgment reversed for a new trial, suggesting that the sheer size of the award shows the jury acted with passion and prejudice.

In April, a federal jury in Louisiana hit the drug makers with $1.5 million in compensatory damages and an additional $9 billion in punitive damages in a case brought by Terrance Allen and his wife, which was the first out of several thousand Actos lawsuits pending in the federal court system to go to trial, as part of the multi-district litigation or MDL.

he punitive damage award, which was the seventh largest in U.S. history and the highest ever in a pharmaceutical product liability lawsuit, was designed to punish Takeda and Eli Lilly for recklessly endangering patients’ lives to make money by withholding information about the cancer risks with Actos.

On June 27, 2014, Takeda filed its post-trial motions, including a request for a judgment as a matter of law and for a new trial.

The Allen trial was the first in a series of Actos bellwether cases scheduled or trial in the federal court system as part of the MDL. There are about 3000 pending Actos lawsuits in the MDL involving similar allegations.

Evidence presented during the Allen trial, and likely to be presented in other cases, included internal memos indicating that Takeda Pharmaceutical executives knew about the bladder cancer risks before Actos was even on the market. Rather than warning about the risk, the drug maker downplayed it, allegedly manipulated data and doing everything possible to avoid placing any hint of a concern on the Actos warning label.

Prior to the start of the case, U.S. District Judge Rebecca Doherty ruled that Takeda has acted in bad faith during the litigation, failing to properly preserve evidence relevant to the cases. The jury in the Allen case was instructed to weigh the evidence of the company’s bad faith in reaching its decision.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Testosterone Blood Clot Warnings Added by FDA

Federal drug regulators are requiring the manufacturers of AndroGel, Testim, Axiron, Depo-Testosterone and others “Low T” drugs to add new warnings about the link between blood clots, pulmonary embolisms and testosterone replacement therapy.

On June 19, the FDA indicated that additional information about he risk of blood clots would be added to testosterone labels. The statement comes as the FDA continues to investigate the potential link between testosterone and heart problems following several studies released earlier this year that men using the Low T drugs may face increased risk of heart attack and stroke.

Side effects of testosterone therapy were already known to increase the risk of blood clots due to a problem called polycythemia, an abnormal increase in red blood cells. However, the FDA now reports that it has found reports of blood clots above and beyond those linked to polycythemia. The new label warning changes the existing blood clot warning from one linking the problem to polycythemia, to a more generalized VTE warning.

An investigation into to cardiovascular risks of these drugs was launched by the FDA on January 31, following at least two studies that raised concerns about the safety of the widely used and aggressively promoted medications.

If you took testosterone replacement therapies such as Axiron, AndroGel, AndroDerm or Testim and suffered a stroke, heart attack of blood clot, contact Cliff Rieders, Esq, of the Rieders Travis Firm.

First Status Conference Scheduled in Testosterone MDL

The U.S. District Court Judge appointed to preside over all of the federal testosterone lawsuits in a coordinated multi-district litigation (MDL) has scheduled an initial status conference for early next month.

On June 6, 2014, all of the Androgel, Testim, Axiron, Androgel and other lawsuits involving testosterone replacement therapy were centralized before U.S> District Judge Matthew Kennelly in the Eastern District of Illinois. The initial status conference will be held on July 10, 2014.

All of the complaints in the MDL involve similar allegations that the side effects of testosterone replacement therapy caused plaintiffs to suffer from heart attacks, strokes blood clots or other cardiovascular injuries. Most of the lawsuits have been filed in the wake of an FDA announcement issued on January 31, which indicated that the agency was in the process of reviewing these cardiovascular risks.

In addition, on June 20, 2014, the FDA informed manufacturers of testosterone replacement therapies that they need to add a new warning about an increased risk of blood clots with these products. While the FDA previously had warned that such clots could occur in certain patients who developed an abnormal increase in the number of red blood cells…the agency has recently received numerous reports of such clots” occurring in individuals who do not “have this complication.

If you took a testosterone replacement therapy such as AndroGel, AndroDerm, Axiron or Testim and suffered a heart attack, stroke or blood clot, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

GranuFlo Bellwether Trial Schedule Set

The U.S. District Judge presiding over all federal Granuflo lawsuits pending against Fresenius Meidcal Care ordered that the first bellwether test trials will go forward in early 2016.

Fresenius Medical Care faces more than 1800 product liability lawsuits involving problems with their GranuFlo and NautaLyte dialusate solutions. These cases are pending in a multi-district litigation (MDL) before U.S> District Judge Douglas P. Woodlock in the District of Massachusetts.

All of the complaints involve similar claims that patients suffered sudden cardiac arrest following treatments involving GranuFlo or NaturaLyte acid concentrates.

A case management order on June 6, 2014 ordered that the first Granuflo dialysate lawsuit will be scheduled for trial on January 11, 2016, with a second bellwether trial set to begin on February 16, 2016. – As part of the coordinated pretrial proceedings, a small group of lawsuits are being prepared for early trial dates, known as “bellwether” cases, since they are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

If you or someone you love suffered a severe injury from a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

———- Forwarded message ———-
From: Sasha Coffiner <scoffiner@gmail.com>
Date: Wed, Jun 18, 2014 at 9:06 AM
Subject: GranuFlo blog post
To: Dad <crieders@riederstravis.com>, Amber Birk <abirk@riederstravis.com>

GranuFlo Bellwether Trail Schedule Set

The U.S. District Judge presiding over all federal Granuflo lawsuits pending against Fresenius Meidcal Care ordered that the first bellwether test trials will go forward in early 2016.

Fresenius Medical Care faces more than 1800 product liability lawsuits involving problems with their GranuFlo and NautaLyte dialusate solutions. These cases are pending in a multi-district litigation (MDL) before U.S> District Judge Douglas P. Woodlock in the District of Massachusetts.

All of the complaints involve similar claims that patients suffered sudden cardiac arrest following treatments involving GranuFlo or NaturaLyte acid concentrates.

A case management order on June 6, 2014 ordered that the first Granuflo dialysate lawsuit will be scheduled for trial on January 11, 2016, with a second bellwether trial set to begin on February 16, 2016. – As part of the coordinated pretrial proceedings, a small group of lawsuits are being prepared for early trial dates, known as “bellwether” cases, since they are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

If you or someone you love suffered a severe injury from a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

Xarelto cases Expected to Increase

While only a handful of Xarelto cases has been field thus far nationwide, the number of cases is expected to increase dramatically in the coming months with more lawsuits field against Defendants Bayer and Johnson & Johnson.

Xarelto (rivaroxaban) is part of a new generation of anticoagulants, known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots and strokes. The medication was jointly developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, and introduced in late 2011.

Pradaxa was the first member of this new class of medications, introduced by Boehringer Ingelheim in October 2010. More than 4,000 Pradaxa lawsuits have been filed over bleeding problems, which the drug maker recently agreed to settle for USD $650 million. While Pradaxa had an early market advantage, Xarelto has quickly grown to surpass sales of the competitor and has been associated with similar reports of uncontrollable bleeding problems.

Earlier this month, a federal judge in Pennsylvania remanded one of the first lawsuits filed over Xarelto back to state court. U.S. District Judge Joel Slomsky, sent the case back to the Philadelphia Court of Common Pleas on June 6, indicating that Janssen removed the case before other defendants in Pennsylvania were served with the complaint, in an effort to side step rules governing whether cases should be tried in state or federal courts.

Although Xarelto and Pradaxa have been promoted as superior alternatives to Coumadin (warfarin), which has long been the standard anticoagulation therapy, the medications lacks an approved reversal agent that allows doctors to control bleeding problems that may develop during use. As a result, a large number of severe and often life-threatening injuries have been associated with the medications.

If you or someone you loved suffered a severe bleeding event, hemorrhage or stroke while taking Xarelto contact Cliff Rieders, Esq. o f the Rieders Travis Firm. 

Effexor Bellwether Trials to Begin in November 2015

The district court judge presiding over the Effexor birth defect lawsuits has scheduled the first bellwether trial to begin in November 2015 against Defendant Pfizer.

There are currently more than 60 product liability lawsuits filed in federal court against Pfizer in a multi-district litigation (MDL) alleging that Effexor caused birth defects. The cases have been centralized in the MDL since August 2013 before Judge Cynthia Rufe in the Eastern District of Pennsylvania.

A case management order issued on June 1, 2014 held that the first Effexor bellwether trial will begin on November 2, 2015. In addition to establishing the first Effexor trial date, Judge Rufe laid out the plan for attorneys involved in the litigation to follow to get the case ready for trial, setting deadlines for providing Plaintiff Fact Sheets and turning over discovery documents.

The lawsuits allege that Pfizer’s Wyeth subsidiary aggressively marketed the drug as safe for pregnant women, when no such assertion could be justified when looking at the scientific data.

Several studies have suggested that exposure to Effexor before birth may cause children to develop a number of different serious health problems, including heart defects, malformations or abnormal developments.

Lipitor Lawsuits Involving Over 3,000 Women to be Transferred to MDL

134 additional Lipitor cases involving 3,000 different Plaintiffs will be transferred into the Lipitor multi-district litigation (MDL) in the coming weeks. All of the complaints involve similar claims that Pfizer’s blockbuster cholesterol drug caused otherwise healthy women to develop type 2 diabetes, alleging that the drug maker knew about the link between Lipitor and diabetes for years, but withheld information from consumers and the medical community.

District Judge Richard Gergel is presiding over the MDL in the District of South Carolina. The MDL was established less than six months ago for all product liability lawsuits filed by women against Pfizer for failure to warn of the risk of Lipitor causing Type 2 diabetes.

In addition to cases pending in the federal Lipitor MDL, a number of cases have also been filed at the state court level. According to the status report submitted to Judge Gergel on June 6, there are cases pending in Missouri, West Virginia and New York state courts involving nearly 300 different plaintiffs. There are already more than 700 cases filed in the Lipitor MDL.

If you took Lipitor and are a woman with a BMI under 30 and were otherwise in good health, but developed Type 2 diabetes, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

New Clinical Study Shows Slight Increased Risk of Diabetes with High Dose Statin Drugs

A new clinical study published in May 29, 2014 by Canadian researchers in the British Medical Journal (BMJ) indicated that patients taking high doses of statin drugs, including Lipitor and Crestor face a statistically significant increased risk of being diagnosed with Type 2 diabetes.

While Lipitor, Zocor and Crestor are typically prescribed as a precautionary measure for individuals with high cholesterol to reduce the risk of heart disease, a diabetes diagnosis may lead to a raft of health problems, including a risk of blindness and the heart disease they were attempting to avoid.

Researchers looked at data on more than 100,000 patient records collected by the Canadian Network for Observational Drug Effect Studies, which included anonymous patients from Canada, the United States and the United Kingdom. –

This study comes less than three months after researchers in the U.K reached similar conclusions of a slight uptick in Type 2 diabetes among statin patients. In a separate study published in the European Jourbnal of Preventative Cardiology, researchers for the National Heart and Lung Instititue in London found that 3% of those taking statin were diagnosed with diabetes compared with 2.4% who were given placebo.

If you took Lipitor and are an otherwise healthy woman who developed Type 2 diabetes, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Mirena IUD Cases Selected for Initial Trial Pool in NJ State Litigation

As a growing number of Mirena IUD lawsuits ontinue to move forward nationwide, a small group of cases pending in New Jersey state court are being prepared for early trial dates to help gauge how juries may respond.

Defendant and manufacturer, Bayer Healthcare currently faces about 2,000 product liability lawsuits filed by women who experienced the Mirena IUD, alleging that the small, T-shaped implant perforated the uterus, migrated to other areas of the body or caused other internal injuries.

More than 800 cases are pending in New Jersye state court against Bayer concerning Mirena. Bayer’s U.S. headquarters is in New Jersye. The litigation is centralized before Superior Court Judge Brian Martinotti in Bergen Count as a part of a coordinated multi-county litigation (MCL).

According to a court order issued by Judge Martinotti last month, the parties were each directed to submit a list of eight cases by June 3, which will be included in an Initial Disposition Pool. It is expected that these 16 cases will go through case-specific discovery in preparation for the first state court Mirena trials in New Jersey, which will be scheduled at a future date.

Bayer introduced Mirena in 2000, aggressively promoting the IUD as a hassle-free form of birth control. However, a growing number of women and their doctors have reported problems where the Mirena IUD migrated from its initial implant location, perforating the uterus and other organs, causing infections and abscesses, and leaving women unknowingly unprotected against the chance of pregnancy.

In addition, a second litigation, a federal mutli-district litigation (MDL) is currenly pending in federal Court for the Southern District of New York before Judge Cathy Seibel.

If you have been injured by the Mirena IUD contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

New Research Study: Viagra Causes 84% Increase in Melanoma

According to a new study published in this month’s issue of JAMA Internal Medicine, researchers from Harvard Medical School indicate that men taking Viagra may face an 84% increase in developing melanoma.

The prospective cohort study involved a review of data for nearly 26,000 men, with the findings released on-line in April, ahead of print in the journal this month.

As a result of this new study, it appears that Pfizer, Viagra’s manufacturer, may face product liability lawsuits over the failure to adequately warn about the potential risks associated with their popular erectile dysfunction drug.

Researchers suggested that Viagra’s active ingredient, sildenafil citrate, appears to lower levels of a cancer-fighting protein called PDE5A, which could potentially increase the invasiveness of melanoma cancer cells. They found no evidence of increases in the risks of other forms of skin cancer.

Viagra has been on the market since 1998, when it was approved by the FDA for the treatment of erectile dysfunction. In 2012, the blockbuster drug raked in $2 billion in sales for Pfizer, and the findings of this study have raised questions about how the drug maker failed to detect and warn users about the potential risk of melanoma.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Breaking News: Testosterone Replacement Therapy Lawsuits Consolidated in Single MDL in Illinois Federal Court

A panel of federal judges has ordered all product liability lawsuits filed in U.S. District Courts nationwide that are associated with any testosterone replacement therapy to be to be consolidated in a single multi-district litigation (MDL). The MDL will be centered in the Northern District of Illinois federal court. The cases have been assigned to U.S. District Judge Matthew F. Kennedy.

The ruling affects at least 45 lawsuits filed against the makers of AndroGel, Axiron, Testim, Foresta, AndroDerm and Depo-Testosterone. However, any future cases filed involving any testosterone gel, cream, injectiom or other prescription treatment will also be transferred to the MDL

All of the currently filed Low T product liability lawsuits involve allegations that men suffered heart attacks, strokes, blood clots or other cardiovascular injuries.

While most of the complaints filed so far have involved problems associated with the use of AndroGel, which is the most widely used testosterone treatment, a number of the lawsuits have been filed against the makers of competing low T drugs, including Axiron, Testim, AndroDerm, Depo-Testosterone and others.

The panel of judges heard various proposals regarding how the mounting lawsuits over low T drugs should be managed during a hearing on May 29.

The Panel noted that all of the lawsuits involve common factual questions regarding general causation and the background science regarding the role of testosterone in the aging male body.

Common regulatory issues will also impact all of the different medications, according to the Panel, as most of the lawsuits have been filed in the wake of an FDA announcement issued on January 31, which indicated that the agency was reviewing the risk of adverse events, including stroke, heart attack and death among men taking FDA-approved testosterone drugs. The FDA investigation was launched following several studies published in recent months involving the link between low T drugs and heart attacks.

It is ultimately expected that the testosterone MDL will include several thousand cases.

If you took testosteorne replacement therapy such as AndroGel, AndroDerm, Testim, Axiron, Forestra or Depo-Testosterone and suffered a heart attack, stroke or blood clot, contact Cliff Rieders, Esq. of the Rieders Travis Firm to have your claim.

Second Wave of Boston Scientific Lawsuits Selected in Vaginal Mesh MDL

Another two hundred vaginal mesh lawsuits involving products manufactured by Defendant Boston Scientific are now being prepared for early trial dates as the second wave of cases selected by the parties last month pursuant to the Court’s order.

Boston Scientific currently faces more than 10,000 product liability lawsuits filed throughout the federal court system by women who experienced problems from transvaginal mesh products implanted for repair of pelvic organ prolapse (POP) or stress urinary incontinence (SUI). There are currently seven MDL pending in the District Court for the Southern District of West Virginia involving various vaginal mesh manufacturers and products.

Over the remainder of this year, case-specific discovery will move forward in this second round of bellwether cases, with the first lawsuits expected to be trial-ready by January 30, 2015.

Judge Goodwin currenbtly is presiding over moiré than 50,000 lawsuits against various vaginal mesh manufacturers which are centralized in the Southern District of West Virginia in seven MDLs.

If you have been injured by a vaginal mesh product used for pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Pfizer Settles Neurontin Antitrust Lawsuit

Pfizer has agreed to pay $325 million to settle a lawsuit brought by health care benefit providers who claim that Pfizer marketed the epilepsy drug Neurontin for unapproved uses.

The settlement is pending approval from a federal judge in Massachusetts. It ends a lawsuit claiming that Pfizer marketed the drug for unapproved uses as early as 1994.

The Boston accord will resolve “all third-party payer claims regarding off-label promotion” and state antitrust claims over Neurontin sales, Steve Danehy, a company spokesman, said in a statement. Pfizer didn’t admit wrongdoing, he said.

The insurance companies bringing the lawsuit alleged that Parke-Davis, part of Warner-Lambert Co., paid kickbacks to doctors to encourage them to prescribe the anti-seizure drug for unapproved uses such as bipolar and panic disorders. Pfizer acquired Warner-Lambert in 2000.

Companies including Louisiana Blue Cross/Blue Shield sought to recover “billions of dollars” they paid as a result of a scheme to market and sell Neurontin “for a variety of uses for which it is not approved or medically efficacious,” according to the complaint. The drug is approved for treatment of epilepsy and pain from shingles.

According to the lawsuit, which was filed 12 years ago, Pfizer delayed competition by improperly listing certain patents with the FDA, engaging in illegal promotion and sales of Neurontin, maintinaing sham litigations with respect to certain patents and paying kickbacks to physicians.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. at the Rieders Travis Firm. 

Testosterone Lawyers Argue MDL Consolidation Before JPML

On May 29, 2014, lawyers involved in the testosterone lawsuits went before the U.S. Judicial Panel on Multidistrict Litigation (JPML) with respect to whether a multidistrict litigation will include cases involving injuries associated with entire class of popular low Y drugs, or will just be limited to AndroGel lawsuits.

There are currently more than 100 product liability lawsuits filed in nearly a dozen different U.S. District Courts nationwide involving allegations testosterone drugs s caused men to suffer heart attacks, strokes, blood clots and other serious injuries.

While most of the complaints have been filed over problems associated with the use of AndroGel, which is the most widely used testosterone treatment, many of the lawsuits have been filed against the makers of competing low T drugs, including Axiron, Testim, AndroDerm, Depo-Testosterone and others.

The JPML arguments were heard in Chicago. A motion was originally filed in late March, seeking to establish a centralized multidistrict litigation (MDL) in the Southern District of Illinois for all lawsuits against AbbVie concerning AndroGel. However, since then, additional proposals have been submitted calling for all low T drug product liability cases to be consolidated in a single MDL.

All of the lawsuits involve similar allegations that the different manufacturers of testosterone drugs withheld important safety information from consumers and the medical community, failing to adequately warn about the risk of men suffering cardiovascular problems. –

If you or someone you love took a low testosterone or Low T treatment such as AndroGel, Axiron or Testim and suffered a heart attack or stroke, contract Cliff Rieders, Esq. of the Rieders Travis Firm. 

Trial Dates Scheduled for Stryker Rejuvenate Hip Lawsuits in New Jersey Action

The first bellwether trials in the Stryker Rejuvenate hip action have been scheduled in a centralized multi-county proceeding in Bergen County, New Jersey for summer 2015.

Howmedica Osteonics currently faces more than 2,000 product liability lawsuits by individuals who experienced problems with the Stryker Rejuvenate or ABG II hip implants which were recalled in July 2012.

All of the complaints involve similar allegations that the Stryker Rejuvenate modular hip stem was defectively designed and unreasonably dangerous as sold by Howmedica.

About half of the cases filed nationwide are centralized in the Superior Court of Bergen County, New Jersey before Judge Brian R. Martinotti, who is presiding over a Multicounty Litigation (MCL) in the state, which is where the manufacturer’s U.S. headquarters are based.

On May 20, 2014, Judge Maritonotti issued a case management order that provides updated information on court-mandated mediation efforts that are underway in a handful of cases and outlines the process for selecting and preparing a group of cases for early trial dates, which are currently scheduled to begin on June 15, 2015 and July 13, 2015.

Approximately 20,000 patients were implanted with the device before it was recalled in 2012.

Meanwhile preparations are underway for the bellwether trial dates, Judge Martinotti is continuing with efforts to see settlements may be reached early in the litigation process.

Over the past year, small groups of cases have been going through pretrial mediation efforts on a case-by-case basis

According to the latest update provided by the Court last week, all 12 cases that have gone through the mediation process so far in New Jersey have resolved. Three additional cases were scheduled for mediation last week and additional cases are scheduled over the course of the next 30 days.

A multidistrict litigation in federal court is also proceewding in the District of Minnesota before Judge Donavan Frank. small group of cases are also being prepared for early trial dates in the federal Stryker Rejuvenate MDL before Judge Frank, who has indicated that a series of cases will go before juries five different classes of cases, based on the specific implant model, whether the hip replacement was prior to 2011 and whether the revision was complicated or uncomplicated.

If you have been injured by a failed Stryker Rejuvenate or ABG II hip implant, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Breaking News – Pradaxa MDL Settlement Reached

Boehringer Ingelheim has agreed to pay $650 million to settle Pradaxa lawsuits filed by 4,000 people who allege the drug maker failed to adequately warn about the risk of severe and potentially life threatening bleeding problems associated with the controversial anticoagnualnt.

The agreement was announced one day after the presiding U.S. District Court Judge David Herndon appointed a committee of lawyers to negotiate the terms of a global Pradaxa settlement. Reports suggest that the deal will result in an average payment of about $165,000 per claim. Most if not all of the plaintiffs are expected to agree to the settlement terms.

Pradaxa was first approved by the FDA in October 2010 for the prevention of strokes among patients with atrial fibrillation. It was the first in a new class of blood thinner designed to compete with warfarin, also known by the brand name Coumadin, which had dominated that market for decades.

However, shortly after its release, Pradaxa racked up a large number of adverse event complaints by doctors and patients who saw incidents of Pradaxa bleeding that could not be stopped. Unlike warfarin, whose anticoagulant effects can be reversed using vitamin K, Pradaxa had no reversal agent.

About 4,000 product liability lawsuits over Pradaxa have been filed in both state and federal courts nationwide. In the federal court system, more than 2,350 of the Pradaxa cases have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.

The settlement comes about six months before the first trials were set to begin and only a few weeks after the FDA announced that it has concluded a review of the medication, determining that additional warnings are not necessary. However, the drug regulatory agency indicated that Pradaxa was found to increase the risk of certain bleeding events when compared to its older competitor, warfarin.

Boehringer Ingelheim officials said that the settlement is not an admission of guilt or that Pradaxa is unsafe.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Breaking News – Committee of Lawyers Appointed to Negotiate Pradaxa Settlement

The U.S. District Judge presiding over all federal Pradaxa lawsuits has issued a stay in the litigation and created a committee of attorneys to negotiate the terms of a master settlement agreement that may resolve several thousand failure to warn complaints against Boehringer Ingelheim.

In the federal court system, more than 2,350 product liability lawsuits over Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.

All of the complaints involve allegatiosn that the manufacturer of Pradaxa, Boehringer Ingelheim failed to warn about the risks of serious bleeding events and hemorrhage with Pradaxa, as well as the lack of an antidote or reversal agent.

A small group of cases were being prepared for early trials which were set to begin in September 2014.

On May 20, Judge Herndon issued a case management order (CMO) that stayed all aspects of the Pradaxa litigation, including a scheduled deposition of Boehringer Ingelheim’s CEO. The order required the court appointed mediator and a group of plaintiffs’ attorneys to appear in Judge Herndon’s chambers last week to provide a “full and detailed report of the status of settlement negotiations and why the case has not yet settled.”

On May 27, 2014, Judge Herndon issued another CMO, appointing a group of eight attorneys to serve on a Pradaxa Claimants’ Negotiating Committee (PCNC), whose job it is to negotiate the terms of a settlement agreement with Boehringer Ingelheim.

Pradadxa (dabigatran) was first approved by the FDA in October 2010, for prevention of strokes among patients with atrial fibrillation.

It was the first member of a new class of medications that have been promoted as superior alternatives to warfarin, also known by the brand name Coumadin, since they require less monitoring during treatment. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.

The first order came several days after the Food & Drug Administration (FDA) revealed that according to its analysis and studies, Pradaxa increased the risk of gastrointestinal bleeds compared to warfarin. It was also revealed that Boehringer Ingelheim had left a number of bleeding incidents out of the Phase III clinical trial results that it reported to the FDA.

If you or someone you love took Pradaxa and suffered a serious bleeding event, hemorrhage or hemorrhagic stroke, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Breaking News: Pradaxa Makers Admit Leaving Bleeding Incidents Out of Study

The makers of the anticoagulant Pradaxa admitted that the clinical trial data submitted to the FDA for approval for the controversial anticoagulant omitted at least two dozen reports of bleeding events.

Boehringer Ingelheim announced in a recent press release that it discovered the bleeding incidents during a review of the RE-LY study data, which was used as the basis to establish that Pradaxa is safe and effective for the prevention of strokes among patients with atrial fibrillation. The additional bleeding incidents were discovered during a reevaluation of the study, but Boehringer Ingelheim claims that they do not have any impact on the study’s conclusions.

Boehringer Ingelheim continues to face more than 2,000 lawsuits filed in federal court concerning bleeding events and hemorrhagic strokes associated with the drug. These lawsuits allege that Boehringer Ingelheim failed to provide adequate warnings about the risk of uncontrollable hemorrhages and the lack of a reversal agent for the relatively new blood thinner. The lawsuits are consolidated in a multi-district litigation or MDL, centered in the Southern District of Illinois.

RE-LY was an 18,000-patient study that pitted Pradaxa against warfarin, which is more commonly known by the brand name Coumadin. The clinical trial was conducted by researchers at the Population Health Research Institute in Hamilton, Ohio, comparing the safety and efficacy profile of the drugs when used to prevent strokes in atrial fibrillation patients.

At least 22 previously uncategorized bleeding incidents were identified during the re-evaluation of the data, including five involved patients taking a 110 mg Pradaxa dose, 11 among those who took a 150 mg dose of Pradaxa and six for patients who took warfarin.

Previously, in November 2010, the researchers issued a correction, admitting they had left out some bleeding events and other complications that had been overlooked. As many as 81 complications affecting 80 patients, including bleeding events, blood clots, heart attacks and at least one stroke, were found to have been omitted even before the recent revelation by Boehringer Ingelheim. –

If you or someone you love have suffered a major bleeding event, hemorrhage or hemorrhagic stroke as a result of taking Pradaxa, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Lipitor Bellwether Discovery Plan Outlined by Federal Judge

The U.S. District Judge presiding over the Lipitor multidistrict litigation (MDL) has approved a discovery plan that is designed to prepare a small group of lawsuits for early trial dates starting next summer.

There are currently about 500 product liability suits filed in federal court by women who claim they developed type 2 diabetes from the side effect of Lipitor and have brought claims against Pfizer, Lipitor’s manufacturer for failing to provide an adequate warning to consumers and the medical community.

In February 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established centralized proceedings for the Lipitor cases, consolidating all federal lawsuits before U.S. District Judge Richard Gergel in the District of South Carolina.

Judge Gergel issued a case management order on May 16, 2014 detailing the discovery plan for the MDL and selection of bellwether cases for trial, a small group of cases that will be prepared for early trial to help the parties gauge how juries may respond to evidence and testimony through the Lipitor MDL.

The plan calls for plaintiffs’ attorneys to submit a list of seven cases to be part discovery pool by June 20, and for Pfizer attorneys to submit a list of seven other cases by June 23. These “bellwether” cases will go through case-specific discovery over the remainder of this year.

The pool of 14 discovery cases will be reduced in December, with each side identifying three cases to be removed from consideration for the initial Lipitor trials in the MDL.

By December 15, Judge Gergel has indicated that he will randomly select one of the remaining cases to be scheduled the first trial date, which will be ready for trial to begin by July 1, 2015.

The plan calls for plaintiffs’ attorneys to submit a list of seven cases to be part discovery pool by June 20, and for Pfizer attorneys to submit a list of seven other cases by June 23. These “bellwether” cases will go through case-specific discovery over the remainder of this year.

The pool of 14 discovery cases will be reduced in December, with each side identifying three cases to be removed from consideration for the initial Lipitor trials in the MDL.

By December 15, Judge Gergel has indicated that he will randomly select one of the remaining cases to be scheduled the first trial date, which will be ready for trial to begin by July 1, 2015.

If you have developed type 2 diabetes from taking Lipitor and are a woman with a BMI under 30 and are otherwise in good health, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Vaginal Mesh Removal Surgery Often Fails to Correct Problems

The use of transvaginal mesh has been linked to reports of severe complications and new research suggests that even women who undergo surgery to remove the mesh also continue to experience problems.

More than 50,000 women nationwide have brought lawsuits concerning transvaginal mesh against the manufacturers of these products used for repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The lawsuits are currently pending in seven different multidistrict litigations (MDLs) in federal court in West Virginia.

These women allege that they have suffered various problems following vaginal mesh surgery, including erosion of the mesh through the vagina, infections and other complications. In many cases, plaintiffs indicate that they have required vaginal mesh removal surgery and continue to pursue claims for permanent injuries.

Researchers from the University of California – Los Angeles reviewed data on 214 women who had their vagina mesh explanted due to complications, surveying the women three years later to evaluate the outcomes. The findings suggest that about a third of women continue to suffer severe or moderate pain three years later, with half of the women reporting pain during sexual intercourse. About 28% of women continue to suffer urinary leakage at least once every day, according to the findings. The results of the study were presented at the American Urological Association’s annual meeting.

This study has not yet been peer reviewed or published and that additional women may still respond to the ongoing study.

If you have been injured by a vaginal mesh product used to repair pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Second Ethicon Vaginal Mesh Trial to Begin in August

The U.S. District Court Judge presiding over the seven multidistrict litigations (MDL) concerning vaginal mesh lawsuits, Judge Joseph R. Goodwin has scheduled a second bellwether or test trial to begin in August in the Johnson & Johnson Ethicon pelvic mesh MDL.

Johnson & Johnson’s Ethicon subsidiary currently faces more than 17,500 Ethicon pelvic mesh lawsuits in the MDL. All of the complaints allege that women who received the Ethicon Gtynecare mesh for pelvic organ prolapse or stress urinary incontinence suffered severe complications. The pelvic mesh and bladder sling products have been linked to serious and debilitating injuries where the mesh may erode through the vagina, cause infections or other complications.

In the federal court system the cases have been organized into se en different MDLs or multi-district litigations, organized by manufacturer.

In February, the first Ehticon bellwether trial ended in a defense verdict.

According to a pretrial order, issued by Judge Goodwin on May 6, jury selection in the second Ethicon pelvic mesh trial is now set to begin on August 22, with trial set to commence on August 25. A lawsuit filed by Jo Huskey is scheduled for this trial date, with a backup case filed by Tonya Edwards set to proceed to trial on that date if the Huskey case has settled or is otherwise not ready.

In addition to cases involving Ethicon mesh, Judge Goodwin is also presiding over six other consolidated proceedings involving similar pelvic mesh products manufactured by American Medical Systems (AMS), Boston Scientific, C.R. Bard, Coloplast Corp, Cook Medical and Neomedic.

If you have been injured by vaginal mesh used to treat stress urinary incontinence or pelvic organ prolapse contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

FDA: Lunesta May Cause Problems the Next Day

The FDA has indicated that the side effects of the sleeping aid Lunesta may cause users to experience impairments and other problems the next day, leading to recommendations that doses be cut in half.

On May 15, 2014, the FDA issued a drug safety communication that initial doses of Lunesta may be too powerful. The agency indicated that it will require Sunovion, the manufacturer of Lunesta to cut the starting recommended dose in half, from 2 mg to 1 mg.

The change comes following the findings of a new study that showed that Lunesta side effects may cause users to experience severe impairments the next day after taking the drug, which could increase the risk of automobile accidents or other injuries.

Lunesta (eszopicione) was first approved by the FDA in 2004 and comes in 1 mg and 3 mg pills, with a original recommended starting dose of 2 mg., which is being changed to 1 mg following the FDA’s recent announcement which requires a change to Sunovion’s prescribing information.

The FDA advised doctors to be aware that Lunesta can cause next-day impairment of driving and other activities that require full alertness. The agency also noted that the dosing can be raised to 2 mg or 3 mg if needed, but should not exceed 3 mg. The maximum recommended dose for elderly patients and those with liver impairments should be 2 mg, the agency recommended.

he warnings and dosing reduction are similar to actions the agency took almost exactly a year ago regarding sleeping drugs like Ambien, which contain the active ingredient zolpidem.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm 

Testosterone Black Box Warning Opposed by Doctors With Industry Ties

A group of doctors with apparent ties to the pharmaceutical industry are opposing potential new testosterone warnings about cardiovascular risks, suggesting that the popular testostoerne drugs sold for treatment of Low T actually help prevent heart attacks, despite numerous studies that have reached the opposite conclusion.

The Androgen Study Group is a group of doctors that are uriging the FDA to reject a petition filed by Public Citizen, a consumer watchdog group, which calls for a black box warning on all testosterone drugs, to provide for information about the increased risk of heart attack and stroke.

The Androgen Study Group was recently formed in response to what they consider “unnecessary” concerns surrounding the safety of testosterone replacement therapy. While the organization portrays itself as an independent group of professionals dedicated to the accurate and fair treatment of testosterone drugs in medical literature and to the public, it actually consists of several doctors and scientists with close ties to the pharmaceutical industry, including several different manufacturers of popular testosterone drugs.

Public Citizen is a well established and respected consumer advocacy organization which is known for raising awareness about potential risks with prescription medicine that may not be adequately disclosed in the drug label. In a petition filed in February with the FDA, the group called or a black box warning, the strongest type of warning available for a drug label, to raise awareness about the risk of heart attack and stroke with testosterone replacement therapies, including AndroGel, AndroDerm, Forestra, Testim and Axiron.

If you have been injured by a testosterone replacement therapies and suffered a heart attack, stroke or blood clot while taking Testim, AndroGel, AndroDerm, or Axiron, contact Cliff Rieders, Esq. of the Rieders Travis Firm 

Xarelto Adverse Evenets Now Outnumber Pradaxa

The blood thinner Xarelto, used to treat atrial fibrillation, has surpassed rival Pradaxa in both number of prescriptions and the number of severe adverse events reported by users, according the findings of a new analysis.

The latest issue of the Institute of Same Medication practices WuarterWatch Report indicates that increasing sales of Xarelto and falling sales of Pradaxa are likely behind the shift in adverse events reported.

According to the ISMP, there were 680 serious adverse event reports linked to Xarelto, compared to only 528 for Pradaxa over the last year. The reports involving Xarelto problems are climbing, while reported Pradaxa side effects are declining, researchers found.

Pradaxa and Xarelto are both part of a new family of anticoagulants known as direct factor Xa inhibitors. The blood thinners have been promoted as superior alternatives to warfarin, which is commonly known by the brand name Coumadin, for prevention of strokes among patients with atrial fibrillation.

While warfarin has been the go-to anticoagulant for decades, it is also known to be a risky drug that can cause bleeding problems, requiring careful monitoring during treatment to maintain the appropriate dose. Xarelto and Pradaxa are promoted as easier to use, but lack an approved reversal agent that can be used to stop bleeding problems that may develop.

However, warfarin has a known antidote to bleeding problems, Vitamin K. There are not any currently known FDA approved reversal agents for Xarelto or Pradaxa, leading doctors to be unable to control bleeding in many cases. This has resulted in a spike of adverse events involving severe hemorrhages and deaths associated with the medications.

Xarelto is manufactured and marketed by Bayer Pharmaceuticals and Johnson & Johnson, while Pradaxa is manufactured and marketed by Boehringer Ingelheim.

With Johnson & Johnson and Bayer’s Xarelto, however, some doctors have recently found off-label treatments to stop the bleeding, though there is no official reversal agent. Boehringer Ingelheim, the maker of Pradaxa, says it is on the verge of developing a reversal agent that would make that drug much safer as well. However, there are other safety measures that could make Pradaxa even safer, according to the ISMP.

At this time, nearly 2000 (and growing) Pradaxa lawsuits have been consolidated in a multidistrict litigation (MDL) which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.

In February, the first Xarelto lawsuit was field against Johnson& Johnson and Bayer in the Philadelphia Court of Common Pleas, but was removed to federal court for the Eastern District of Pennsylvania.

If you have suffered a hemorrhage, hemorrhagic stroke, GI bleed or other serious bleeding event while taking Pradaxa or Xarelto, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Transvaginal Mesh May Receive Warning From Health Canada

Amid mounting concerns worldwide about the risk of severe complications from transvaginal mesh implants, Canadian health officials indicated this week that they are reviewing whether women in Canada are being adequately warning of the risks associated with these products.

Health Canada indicated an information update on May 13, indicating that the agency continues to receive reports of problems experienced by women treated with transvaginal mesh for pelvic organ prolapse and stress urinary incontinence.

Health Canada states that it is reviewing the labeling on transvaginal mesh products to determine whether additional information should be provided. A number of recommendations have been made for women considering a transvaginal mesh implant, with the Canadian agnecy recommending that women:

• Ask their surgeon about all POP and SUI treatment options, including both surgical and non-surgical treatments

• Ask for, and then review, a copy of the mesh product’s patient information

• Discuss any questions or concerns with their health care professional

• Contact their doctor if they have been implanted with a mesh and start to suffer complications.

• Continue with routine follow-ups if they have had the mesh and suffered no complications to date.

If you have been injured by transvagianl mesh products used to treat pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Lawyers in Lipitor MDL to Review Discovery Plans

During a status conference today, May 16, 2014, parties in the Lipitor diabetes multidistrict litigation (MDL) are expected to review with the Judge their proposed plans for discovery and selected a small group of bellwether cases that will be selected for expedited discovery and prepared for early trial dates.

There are currently about 500 product liability lawsuits filed against Pfizer in U.S. District Courts throughout the country, which have been consolidated as part of an MDL, or Multidistrict Litigation, for coordinated handling during pretrial proceedings.

All of the complaints are brought by women alleging that the drug maker failed to adequately warn women about the risk of the potential side effect that Lipitor may cause them to develop Type 2 diabetes.

The cases in the MDL are centralized in the U.S> District Court for the District of South Carolina before Judge Richard K. Gergel.

If you are a woman with a BMI under 30 and otherwise in good health and took Lipitor for elevated cholesterol but developed Type 2 diabetes, contact Cliff Rieders, Esq. to determine whether you may have a claim. 

Settlement Reached in Bard Avaulta Mesh Bellwether Lawsuit

Only a few days before the last trial in the initial series of bellwether trials for Bard Avaulta vaginal mesh lawsuits was set to begin, the parties have reached an agreement to settle the lawsuit. The trial was set to begin on May 19 .The case was the last in a series of bellwether trials involving Bard mesh which is the subject of more than 7,000 lawsuits filed in the federal court system.

As part of coordinated handling in a federal Multidistrict Litigation (MDL) established for the cases, a series of three cases were scheduled for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

The first bellwether trial took place in July 2013 involving the Bard mesh and ended in a $2 million damages award against Bard for failure to warn. The verdict included $1.5 million in punitive damages. A second trial began in August 2013, but the parties reached a settlement during the first day of trial.

In the federal court system, seven different multidistrict litigations (MDLs) have been established for lawsuits against different manufacturers, with all pretrial proceedings centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia. In the Bard MDL, following the initial series of three bellwether trials, Judge Goodwin ordered the parties to prepare a second wave of 200 cases for trial last month in a pretrial order and ordered that the cases may be ready for trial to begin on January 30, 2015.

If you have been injured by a vaginal mesh product used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Pradaxa Stomach Bleed Risks Higher than Warfarin – FDA

After months of studies and mounting reports on bleeding problems, federal regulators issued an updated statement on the potential side effects of Pradaxa, suggesting that users of the anticoagulant may face an increased risk of stomach bleeds compared to warfarin.

In a drug safety communication issued on May 13, the FDA indicated that while Pradaxa was associated with lower risks of clot related strokes, brain bleeds and death, there was an increased risk of major gastrointestinal bleeding compared with the decades old competitor it was designed to replace, warfarin.

The new data comes from a recently-completed study that involved information on more than 134,000 Medicare patients, age 65 or older. The FDA study found that using Pradaxa increased the risk of gastrointestinal (GI) bleeding by 28%, with 34.2 GI bleeding incidents for every 1,000 person-years of use. That compares to only 26.5 incidents for users of warfarin. The study also found that Pradaxa carried only 80% of the risk of stroke when compared to warfarin, and only had about a third of the risk of brain bleeding. The risk of heart attacks was about the same for both drugs, and the mortality rate for Pradaxa patients was slightly lower.

Despite concerns about the risk of bleeds on Pradaxa, the FDA indicates that the benefits provided by the drug still appear to outweigh the risks, and determined that no label changes will be made.

There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced by Boehringer Ingelheim. Many doctors have expressed concerns about the lack of an effective reversal agent for Pradaxa. While doctors are able to reverse the blood thinning effects of warfarin with a dose of vitamin K, there is no such antidote available for Pradaxa users.

Pradaxa was first approved by the FDA in October 2010 for prevention of strokes among patients with atrial fibrillation. Pradaxa was the first member of a new class of medications that have been promoted as superior alternatives to warfarin, also known by the brand name Coumadin, since they require less monitoring during treatment. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.

Boehringer Ingelheim, the manufacturer of Pradaxa, currently faces more than 2000 Pradaxa lawsuits centralized in a multidistrict litigation (MDL) in the Soutern District of Illinois in federal court before U.S. District Court Judge David R. Herndon. A series of four bellwether cases, or test trials are set to be tried between September 2014 and March 2015.

If you or someone you loved suffered a serious bleeding event while taking Pradaxa, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Topamax Jury Verdict for Plaintiffs Upheld by Philadelphia Judge

A Philadelphia Judge has upheld a $11 million dollar verdict against defendant Janssen Pharmaceuticals awarded to the parents of a child born with a severely deformed cleft lip as a result of the anti-seizure drug Topamax, taken by the mother during pregnancy. The verdict was upheld by Philadelphia Court of Common Pleas judge George Overton, who denied Johnson & Johnson’s (the parent of Janssen) request for a new trial. The jury had issued its $11 million award in favor of the Plaintiffs on November 18, 2013. The verdict was divided into $335,000 for future health expenses and $10.6 million for economic damages. Delay damages were added on December 3, 2013 in the amount of $700,294, bringing the total to $11.6 million.

Last month, Defendant Janssen settled 76 Topamax cases. In each of these cases, the plaintiffs alleged that Topamx caused birth defects when taken during pregnancy. 59 cases are still pending in the Complex Litigation Center’s inventory in the Philadelphia Court of Common Pleas.

According to court papers, Janssen Pharmaceuticals knew of the risk of birth defects with Topamax but failed to provide an adequate warning to consumers and physicians. Janssen also claimed that the failure to warn claims were preempted by federal law, but Judge Overton rejected this argument.

If you or someone you love took Topamax during pregnancy and had a child with a severe cleft palate or other birth defect, contact Cliff Rieders, Esq. of the Rieders Travis Firm for the help you deserve.

Punitive Damages Excluded from Pennsylvania Risperdal Breast Growth Lawsuits

A Pennsylvania Judge has ruled that Plaintiffs pursuing Risperdal lawsuits will not be permitted to seek punitive damages against Defendant Johnson & Johnson. Punitive damages would have been intended to punish the drugmaker for failing to warn about the risk of breast growth associated by the use of the medication in young boys.

Johnson & Johnson currently faces about 500 product liability lawsuits in Pennsylvania state court, which all involve similar allegations that information was withheld from families and the medical community about the risk of gynecomastia associated with Risperdal.

In a recent ruling issued May 2, Philadelphia Court of Common Pleas Judge Arnold New indicated that plaintiffs can only go after compensatory damages from Johnson & Johnson, removing the possibility that the drug maker may face substantially higher punitive damages designed to punish reckless and grossly negligent behavior claimed in the lawsuits.

While plaintiffs argued that Pennsylvania law should be applied to the cases, allowing punitive damages, Judge New found that Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, which developed and sold Risperdal, is mainly a New Jersey defendant that falls under the New Jersey Product Liability Act. The drug maker argued that New Jersey law prohibits punitive damages in claims involving medications that had to undergo FDA premarket approval.

Gynecomastia is a medical condition associated with the abnormal development of breasts among males. The condition is typically associated with disease or metabolic disorders, but it is also known to occur as a side effect of certain medications, including the anti-psychotic drug Risperdal.

Settlements have been reached in at least six cases since 2012 by young men who had to have surgery to have their breasts removed as a result of taking Risperdal and underwent severe psychological trauma as a result.

Most of the litigation pending throughout the United States is filed in the Philadelphia Court of Common Pleas, but a number of cases are also consolidated in the New Jersey court system as part of an MCL, or multi-county litigation, which is centralized before Judge Jessica R. Mayer in Middlesex County.

If you or someone you loved took Rsiperdal as an adolescent and developed gynecomastia, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

First MDL Trial for Zoloft Litigation Delayed Until January 2015

The start of the first federal Zoloft birth defect trial has been pushed back from November 2014 until January 15 because defendant Pfizer indicated that it needs additional time to prepare the case to go to trial.

Pfizer currently faces more than 500 product liability lawsuits concerning Zoloft, which have been consolidated in a multidistrict litigation or MDL before U.S. District Court Judge Cynthia M. Rufe in the Eastern District of Pennsylvania.

All of the complaints involve similar allegations that the drug maker failed to provide adequate warnings about the risk of birth defects from Zoloft use during pregnancy.

On May 1, 2014, Judge Rufe issued a pretrial order that extended trial schedules, such that the first bellwether, or test trial in the MDL will commence on January 5, 2015. The parties have been directed to confer and propose a revised schedule for preparing the first cases in light of the new trial date. The delay was ordered following a motion by Pfizer that more time was needed to complete case-specific discovery.

The parties have not yet finalized the pool of cases that may be eligible for the first trial date, though the lists were originally due this week. Pfizer asked to be given until June 16 to submit selections, which would push the rest of the case schedule back a month and a half.

Zoloft (sertraline) is one of the most widely prescribed medications in the United States, and has been used by tens of millions of individuals. However, use of Zoloft by pregnant women has been linked to a potential increased risk of serious and potentially life-threatening birth defects and malformation for children.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis law firm to determine whether you have a claim. 

Proposed Trial Schedules Submitted for Fresenius Granuflo Lawsuits

Attorneys involved in the federal Fresenius Granuflo dialysis lawsuits are scheduled to meet with the presiding U.S. District Court Judge, Judge Douglas Woodlock, over the litigation, at which time the court is expected to review and rule on competing proposals submitted by the parties this week regarding preparations for the first bellwether trials.

Fresenius Medical Care currently faces more than 1,500 complaints filed in the federal court system on behalf of dialysis patients who suffered sudden cardiac arrest or death following dialysis treatments with GranuFlo or NaturaLyte acid concentrates.

All of the complaints involve similar allegations that Fresenius failed to provide adequate warnings about the importance of monitoring bicarbonate levels during hemodialysis, withholding information from doctors at their own clinics and other dialysis centers about the increased risk of severe and potentially life threatening heart problems that may surface during or shortly after treatments.

The multidistrict litigation or MDL is centralized in U.S District Court for the District of Massachusetts before Judge Woodlock.

If you or someone you loved suffered sudden cardiac arrest during dialysis with GranuFlo or NaturaLyte, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Pfizer Says MDL for Testosterone Should Be Limited to Gel Treatments

In response to a Plaintiffs’ motion seeking to centralize all testosterone drug lawsuits as part of one MDL or multidistrict litigation, Defendant Pfizer indicated that the consolidated pretrial proceedings in a proposed MDL should only include claims involving testosterone gel treatments such as AndroGel, Testim, Axiron and Forestra.

There are currently more than 85 product liability lawsuits filed in U.S. Disgtrict Courts on behalf of men who allegedly suffered heart attacks, strokes or blood clots allegedly caused by the side effects of testosterone treatments. So far, the majority of the cases involve AndroGel, which accounts for 60% of the testosterone replacement therapy market share.

In March 2014, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all federal AndroGel lawsuits into a MDL. Another group of plaintiffs filed a second motion several weeks later seeking to consolidate all testosterone lawsuits as part of an industry wide MDL, regardless of which specific medication the person took, noting that many plaintiffs took several different testosterone treatments and the cases involve common questions of law and fact.

Several drug manufacturers have filed responses supppoerting the inclusion of the lawsuits in a single MDL, including AbbVie, Inc, Abbott Laboratories, Eli Lilly and Endo Pharmaceuticals Inc. These companies manufacture AndroGel, Axiron and Forestra, respectively.

In a response in opposition filed last week, Pfizer asked that cases involving their Depo-Testosterone injection be excluded from the MDL, indicating that the drug has been named in four cases and there are important distinctions between these lawsuits and the rest of the litigation. For example, Pfizer maintains that it has not engaged in any direct to consumer marketing for the Depo-Testosterone injection. Auxilium Pharmaceuticals, the makers of Testim gel has also opposed the consolodation, indicating that an MDL should only be for AndroGel cases.

If you have taken the testosterone replacement therapies AndroGel, Axiron, Testim, EndoDerm or Forestra and suffered a heart attack, stroke or severe blood clot, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

Lipitor Bellwether Trials Set for July 2015

The federal Judge presiding over all of the Lipitor diabetes lawsuits filed by women throughout the United States has indicated that the first cases should be ready to go to trial as bellwether trials, or early test trials, next summer. The presiding Judge is Judge Richard Gergel of the U.S. District Court for the District of South Carolina where the MDL is located. All of the complaints involve similar allegations that women developed type 2 diabetes from side effects of Lipitor. In a recent case management order, Judge Gergel indicated that the first cases should be ready for trial by July 1, 2015.

If you are a woman with a body mass index under 30 who developed Type 2 diabetes while taking Lipitor, contact Cliff Rieders of the Rieders Travis Law Firm to determine whether you have a claim. 

Numbers of Mirena Lawsuits Continue to Grown

The number of product liability claims filed against Bayer concerning its intrauterine device Mirena continues to grown. The lawsuits allege that women experienced complications with the Mirena IUD after implant.

Mirena is a small T-shaped form of birth control, known as an intrauterine device or IUD, which is implanted in the uterus by doctors to provide long-term protection against pregnancy for up to five years. Many of the alleged complications involve perforation of the uterus by the device, infections and/or migration to other parts of the body.

Since 2000, More than 70,000 adverse event reports have been field with the Food & Drug Administration (FDA) concerning Mirena, including at least 5000 reports alleging that the device migrated out of place since 2008.

In federal court, Mirena lawsuits have been consolidated as part of a multi-district litigation (MDL) in the Southern District of New York before Judge Cathy Seibel. Nearly 500 cases have been filed in the MDL.

In state court, approximately 900 cases have been field in a multi country proceeding (MCL) in New Jersey before Judge Brian Martinotti in Bergen County.

In both proceedings, Mirena bellwether test trials are not expected to begin until the second half of 2015.

Bayer has previously maintained that it intends to defend the cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

If you have been injured by the IUD Mirena, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

Breaking News – Endo Will Pay $830 Million to Settle Most Vaginal Mesh Lawsuits Against It

Endo Health Solutions has agreed to pay $830 million to settle the majority of all of the vaginal mesh lawsuits filed against its American Medical Systems (AMS) subdivision.

There are currently about 22,000 AMS vaginal mesh lawsuits pending in courts throughout the country. All of the claims involve similar allegations that the surgical mesh used for transvaginal treatment of pelvic organ prolapse and stress urinary incontinence are dangerous and defective, carrying an unreasonable risk of infections, organ perforation, and erosion of the mesh into the vagina.

The majority of the AMS claims were field in federal court in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation or MDL. The presiding judge is Judge Joseph R. Goodwin.

Judge Goodwin is also presiding over six other vaginal mesh MDLs, which involve similar lawsuits against other manufacturers, including Ethicon, Boston Scientific, C.R. Bard, Cook Medical, Coloplast and Neomedic.

In the statement released this week, Endo estimates that the agreement to settle will resolve about 20,000 AMS mesh claims, but the company is not admitting liability or fault.

Even without the agreement to settle AMS mesh lawsuits, other manufacturers still face tens of thousands of claims brought by women nationwide.

If you were injured by vaginal mesh products used for pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

Testosterone Makers Split Over Motion for MDL For All Lawsuits

While the makers of most testosterone replacement drugs have filed a response supporting the creation of one federal multidistrict litigation (MDL) for all testosterone lawsuits, at least one manufacturer is opposing efforts to centralize cases involving various different products before one judge.

There are currently approximately 74 lawsuits filed against testoerone replacement manufacturers in the U.S. alleging that the drugs caused heart attack, stroke or pulmonary embolism in men who took them.

While most of the cases involve the use of Androgel, which accounts for about 60% of the market for testosterone replacement therapy, other cases have been filed against the makers of AndroDerm, Testim, Axiron, Foresta, Depo-Testosterone and other low T drugs.

Last month, a motion was filed with the Judicial Panel on Multidistrict Litigation (JPML) to consolidate all of the testosterone replacement therapy product liability lawsuits into a single MDL proceeding.

In a response filed by Auxilium Pharmaceuticals, Inc. on April 25, the maker of Testim and Testopel opposed an industry-wide MDL. Auxilium indicates that it has only been named in seven federal cases, arguing that given the small number of cases, an MDL for lawsuits involving all testosterone drugs is not warranted.

Other testosterone makers AbbVie, Abbott Laboratories, Eli Lilly & Co, Lilly USA and Endo Pharmaceuticals filed a joint response that they support centralization of all testosterone replacement therapy proceedings in a single MDL. AbbVie and Abbott Laboratories make AndroGel and Eli Lilly makes Axiron.

“If only the AndroGel cases are centralized, the co-Defendants who were also sued in some of those cases would find themselves litigating in both the AndroGel MDL and in the courts that have non-AndroGel cases,” wrote the drug makers in their response filed April 25. “The benefits and efficiencies of an MDL would be lost for those Defendants and plaintiffs in those cases.” -An earlier motion was filed by another Plaintiff to centralize only the AndroGel cases into a single MDL.

If you took AndroGel, Axiron, Testim, AndroDerm or another testoerone replacement therapy and suffered a heart attack, stroke or blood clot, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a case.

Testosterone Replacement Drug Heart Risks Being Reviewed by European Medicines Agency (EMA)

European regulators have followed U.S. regulators at the FDA and launched an investigation into the heart risks of low testosterone drugs, following recent studies that suggest certain men may faced increased risks of heart attack, stroke and death. The EMA announced its review of the safety of all drugs containing testosterone, such as Androgel, Testim, Androderm and other “Low T” treatments. The risk of heart attacks, strokes and other side effects is already under review at the FDA following the safety concerns raised by two recent scientific publications in the form of clinical studies.

Concerns about the potential Low T drug heart risks first gained widespread attention following a study published in the Journal of the American Medical Association (JAMA) in November 2013, which found that Low T gels, patches and other treatments may increase the risk of heart attacks, strokes and death among older men with certain pre-existing heart conditions. The JAMA study was followed by a second study published in the medical journal PlosONe in January 2014. This study found that the Low T drugs may double the risk of heart attack for younger men with heart disease as well as for men age 65 and older with no prior heart problems.

Amid concerns about the overuse of Low T drugs, the U.S. drug regulators indicated at that time that testosterone replacement therapy is only approved for use among men who have diagnosed low testosterone levels in conjunction with an associated medical condition, such as hypogonadism.

Over the past decade, use of testosterone replacement therapy among men in the United States has increased five fold, largely driven by the manufacturers’ aggressive marketing campaigns to encourage men with Low T to seek treatment if they experience generic symptoms often also associated with aging such as lack of energy, weight gain and/or muscle loss.

In the United States, a growing number of men have filed lawsuits against the manufacturers of AndroGel, Testim and Axiron, as well as other Low T drugs. Last month, a motion was field with the Joint Panel on Multidistrict Litigation seeking to centralize all AndroGel cases.

If you or someone you love took AndroGel, Axiron, Testim or AndroDerm for low testosterone and suffered a heart attack or stroke, contact Cliff Rieders, Esq. of the Rieders Travis Firm. 

Stryker MDL Judge Seeks Coordination with Stryker Hip Medication Program in NJ State Court

Judge Donavan Frank, the U.S. District Court Judge in Minnesota presiding over federal Stryker Rejuvenate hip lawsuits has ordered several attorneys representing Plaintiffs in the litigation to coordinate with peers litigating similar claims in New Jersey state court, where a number of cases have settled during court-ordered mediation efforts.

 

There are currently more than 1,700 cases filed throughout the country by individuals who allege they experienced problems with Stryker Rejuvenate or ABG II modular hip implants which were recalled in July 2012, due to increased risk of corrosion, loosening and failure within a few years.

 

Unlike traditional hip implants, which feature a single femoral component, the Stryker Rejuvenate and ABG II contains a modular neck-stem, which consists of two pieces that fit inside each other to allow the surgeon to customize the length of the femoral component based on the patient. However, the design has been linked to an increased risk of problems that may result from the release of microscopic metal debris as the chromium-cobalt neck rubs against the titanium femoral stem.

 

Approximately 700 cases are pending in a multidistrict litigation

(MDL) in federal court in the U.S. District Court for the District of Minnesota, while another 1000 cases are pending in a multi-county coordinated proceeding in New Jersey state court. The New Jersey litigation has been centralized as part of an MCL, or Multicounty Litigation, before Superior Court Judge Brian R. Martinotti in Bergen County.

 

Judge Frank issued a pretrial order on April 22 in which he appointed several members of the plaintiffs’ leadership group to serve on a sub-committee to confer with plaintiffs’ counsel in the New Jersey state court litigation to obtain information about a mediation program being pursued at the state court level. – A group of four lawyers have been directed to “explore what, if anything, can be learned from the New Jersey court’s Early Mediation Program that may be applied usefully in this MDL.”

 

If you had a Stryker Rejuvenate or ABG II hip implant that failed, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm to determine whether you have a claim.

Risperdal Plaintiffs’ Lawyers to Meet With Philadelphia Judge in Gynecomastia Cases

As a growing number of Risperdal lawsuits continues to be filed on behalf of boys and adolescents who were diagnosed with gynecomastia after taking the anti-psychonic drug Risperdal, the Pennsylvania Court of Common Pleas Judge presiding over several hundred such cases is scheduled to meet with lawyers involved in the litigation next month. The conference will be held on Tuesday May 13 at 10:30 am.

Risperdal (risperidone) is an atypical antipsychotic manufactured and sold by Johnson & Johnson, which has been associated with growth of breasts among boys receiving the medication.

There are currently about 430 product liability lawsuits pending against Johnson & Johnson, Risperdal’s manufacturer in the mass tort unit of the Philadelphia Court of Common Pleas that involve claims that inadequate warnings were provided about the link between Rsiperdal and gynecomastia.

Approximately six cases have settled, since September 2012, but the amounts of these settlements have not been disclosed.

Most of the pending lawsuits have been field in the Philadelphia Court of Common Pleas, but others are pending in the New Jersey court system as part of an MCL or multi-county litigation.

If you took Risperdal and developed gynecomastia, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim.

Lawsuits Grow Over Benicar Diarrhea Side Effects

Over the past two months, a growing number of product liability lawsuits have been field against Daiichi Sankyo by persons alleging that the side effects of Benicar caused them to suffer from chronic diarrhea.

All of the complaints involve allegations that the users and the medical community were unaware of the link between Benicar and diarrhea problems, leaving users with long-term damage and other health issues.

At least nine lawsuits have been field against the drugmaker in New Jersey Superior Court for Atlantic County.

Benicar is a widely prescribed blood pressure medicine in the U.S. , which is distributed by Daiichi Sankyo and Forest Laboratories.

Although the medication has been on the market for more than 10 years, it has only recently been disclosed that Benicar may cause sprue-like enteropathy, a medical condition that causes diarrhea, weight loss and other problems. As a result of the drug makers’ failure to warn about these Benicar diarrhea problems, many users have suffered these symptoms for years, and many individuals were misdiagnosed as having celiac disease.

In July 2013, the FDA issued a drug safety communication informing consumers and the medical community about the link between Benicar and sprue like enteropathy.

While the symptoms typically stop when the medication is no longer used, many users experience permanent intestinal damage, known as villous atrophy, where the microscopic tentacles that line the wall of the small intestine erode. Villous atrophy from Benicar can leave former users with reduced digestive capabilities, malnourishment and dehydration, according to allegations raised in the lawsuits.

It appears that the cases will be centralized in New Jersey Superior Court.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders. Esq. of the Rieders Travis Firm.

Breaking News: Motion Filed to Centralize All Testosterone Replacement Therapy Lawsuits into Multidistrict Litigation, Not Just Androgel Cases

Following a request filed last month to consolidate all federal Androgel litigations as part of a MDL or multidistrict litigation a second motion has been field by Plaintiffs with the U.S. Judicial Panel on Multidistrict Litigation (JPML) asking that all testosterone treatment lawsuits be consolidated in a single MDL.

There are currently more than 50 product liability lawsuits filed in federal court on behalf of men who allege that they suffered a heart attack, stroke or blood clot that was allegedly caused by the side effects of testosterone replacement therapy, including AndroGel, Axiron, Testim and Androderm.

While most of the current cases involve use of AndroGel, which is the most widely used testosterone treatment, other claims have been filed by users of different testosterone gels, creams and patches, including Testim, Axiron, Androderm and others.

The second motion to transfer was filed by Plaitniff Rafael Barrios and his wife Connie has he had used both AndroGel and Testim whcihb are made by different drug manufacturers. The request came little more than two weeks after another group of Plaintiffs filed a motion to consolidate all AndroGel lawsuits as part of a MDL.

Oral arguments on the first motion to establish an AndroGel MDL will be heard on May 29, 2014 in Chicago. t is unclear whether the second motion to include all testosterone lawsuits as part of a single MDL will also be considered at the same time, or whether that motion will be heard at a future session in July 2014.

Out of the 50 testosterone cases currently pending, at least 37 of the lawsuits involve Androgel injuries. However, all of the claims involve similar allegations that the manufacturers failed to adequately warn about the risk of heart attacks, strokes, blood clots and death associated with testosterone replacement therapy.

If you suffered a heart attack, stroke, or blood clot as a result of taking testosterone replacement therapies such as AndoGel, Axiron, Testim or AndroDerm, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

Fresenius Dialysis Treatment Cases to be Selected for Bellwether Trials in Multidistrict Litigation

The U.S District Court Judge presiding over all of the federal Fresenius dialysis treatment lawsuits concerning GranuFlo and NaturaLyte dialysis dialysate treatments has laid out a protocol for selecting a small group of cases to be prepared for early test trials that will help gauge how juries will respond to the hundreds of cases pending in the multidistrict litigation. Such test trials are known as bellwether trials.

Fresenius currently faces more than 1,500 complaints filed throughout the federal court system, all of which involve allegations that the patients suffered sudden cardiac arrest and/or death following treatment involving the use of GranuFlo or NaturaLyte during hemodialysis.

The cases were consolidated in a multidistrict litigation (MDL) in April 2013. The MDL is centralized in federal court for the District of Massachusetts before Judge Douglas P. Woodlock. On April 8, 2014, Judge Woodlock issued a case management order that outlined the procedure that would be followed for identifying bellwether cases and preparing those cases for trial.

The parties have been directed to each submit a list of ten potential bellwether cases by September 15, which will then go through case specific discovery. In March 2015, the parties will then narrow the original 20 selections down to ten, with five cases recommended by each side for further pretrial discovery and bellwether trials. Judge Woodlock has indicated that the final pool of 10 cases will include at least one case where the alleged injury occurred prior to November 4, 2011, one case where the injury occurred between November 4, 2011 and March 29, 2012, one case where the last dialysis treatment was provided at Fresenius clinic and one case where the last treatment was provided by another clinic that used the Fresenius products.

All of the complaints in the litigation involve nearly identical allegations, claiming that Fresenius Medical Care failed to provide proper warnings and instructions regarding their Granuflo and NaturaLyte acid concentrates, which are used during hemodialysis treatments. Plaitniffs allege that this resulted in an increased rate of sudden cardiac arrest and death among dialysis patients because the solutions convert to bicarbonate at higher levels than doctors were aware of.

Fresenius Medical Care not only manufactures the solutions, but also owns and operates many of the dialysis treatment centers in the United States where the injrueis occurred. oncerns about the link between NaturaLyte, Granuflo and heart problems surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA.

If you or a loved one experienced a sudden cardiac arrest from kidney dialysis with GranuFlo or NaturaLyte at a Fresenius Treatment Center, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm to determine if you have a claim. 

Pretrial Schedule Established for First Pradaxa Lawsuit in MDL

The U.S. District Court Judge presiding over all of the consolidated federal Pradaxa lawsuits established a pretrial schedule for the first bellwether trial in the multidistrict litigation (MDL). The first bellwether case is a wrongful dealth lawsuit and is scheduled to begin on September 8, 2014. The case is the Higgins case.

In the federal court system, all product liability lawsuits filed against Defendant Boehringer Ingelheim over Pradaxa have been consolidated as part of an MDL, or Multidistrict Litigation, which are centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.

There are currently more than 2,000 Pradaxa cases pending before Judge Herndon, which all involve similar allegations that Boehringer Ingelheim failed to adequately warn consumers and the medical community about the bleeding risk with Pradaxa, or the lack of an effective reversal agent to allow doctors to stop hemorrhages that develop among users.

Judge Herndon issued a case management order on April 9, 2014, that outlined the pretrial scheduile for the Higgins case. Plaintiffs have been directed to serve their witness list by July 2, with defendants submitting their witness list by July 9. Depositions for any witnesses not previously deposed must be completed by July 31, with any motions in limine seeking to exclude the mention of certain evidence or issues at trial filed by August 8. Jury selections in the case are set to begin on September 8, with opening statements expected to begin on September 15. Trial in the case is expected to last for several weeks.

Pradaxa (dabigatran) is a relatively new anticoagulant intorudced in the market in 2010 to treat atrial fibrillation. It was the first member of a new family of medicines that was alleged to act as an alternative to warfarin. Bayer’s Exilixis is also a member of this class. Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa, which has proved problematic.

If you or someone you love has suffered from a serious bleeding event, hemorrhage, or hemorrhagic stroke, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a case that can be filed in the MDL. 

J&J Vaginal Mesh Injuries Highlighted by Corporate Watchdog Group

A corporate watchdog group has launched a new campaign designed to warn women about the risks of transvaginal mesh surgery and implants, specifically targeting products made by Johnson & Johnson, whose Ethicon unit currently aces more than 20,000 product liability lawsuits brought by women who suffered injuries from vaginal mesh products that were sold and surgically implanted without adequate warnings.

The campaign is being run by the Corporate Action Network which highlights the Johnson & Johnson vaginal mesh products, many of which were discontinued in the face of mounting litigation and thousands of additional complaints involving complications concerning mesh erosion, infection and the need surgery to remove the mesh.

Corporate Action Network has launched a website, www.johnsonandjohnsonhurtswomen.org, with a countdown to April 24, when it promises to reveal new information involving alleged corporate abuses towards women. The website calls for an investigation into the company’s activities, and includes a link for whistleblowers within Johnson & Johnson to submit information involving inappropriate actions.

On March 26, 2014, the Corporate Action Network sent a letter to Attorney General Eric Holder calling for an investigation into two potential criminal violations for obstruction of a criminal investigation into healthcare offenses and destruction of documents. These claims followed a federal judge’s ruling in February that found that Ethicon had failed to properly preserve documents in the vaginal mesh litigation that were relevant to the case. As a sanction for the destruction of evidence, juries hearing cases may be told of the company’s transgressions.

Judge Joseph R. Goodwin, a federal judge for the U.S. District Court for the Southern District of West Virginia currently presides over seven different federal multidistrict litigations (MDLs) established for cases filed against different vaginal mesh and bladder sling manufacturers. The vaginal mesh and bladder sling products are commonly used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The complaints in the ongoing lawsuits allege that women face an unreasonable risk of vaginal mesh complications following surgery and that the manufacturers failed to adequately warn of these risks.

According to an updated case list, as of April 15, 2014, Judge Goodwin currently presides over 14,679 Ethicon lawsuits against Johnson & Johnson, as well as 16,515 AMS mesh lawsuits, 9,776 Boston Scientific mesh lawsuits, 7,096 Bard Avaulta mesh lawsuits, 1,267 Coloplast mesh lawsuits, 173 Cook Medical lawsuits and 25 Neomedic Pelvic mesh lawsuits.

Earlier this month a Texas jury awarded 1.2 million in compensatory damages to a woman who suffered complications after being implanted with the Ethicon TVT-O transvaginal mesh bladder sling for SUI.

If you have been injured by a vaginal mesh product used to treat pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm today. 

Mirena IUD Lawsuits to be Selected for Bellwether Early Trial Dates in MDL

The U.S. District Court Judge presiding over the Mirena multidistrict litigation (MDL) has determined the procedure for selecting a small group of cases for early trial dates in the litigation, known as bellwether trials.

Mirena is an intrauterine device (IUD) or long lasting form of birth control which is manufactured by Bayer Healthcare. More than 1100 women have filed lawsuits alleging that the Mirena IUD perforated their uterus or migrated to other parts of their body, resulting in serious injuries.

In the federal court system, cases have been consolidated in a multidistrict litigation or MDL. The cases are centralized before U.S. District Court Judge Cathy Seibel in the Southern District of New York.

As part of the coordinated pretrial proceedings, Judge Seibel has indicated that a small group of cases will be selected as early test cases, which will be scheduled for “bellwether” trials to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout other Mirena cases in the litigation.

On April 9, 2014, Judge Seibel issued an order that outlined the process for selecting a group of 24 cases that will be part of an initial disposition pool, that will later be reduced to a group of 12 cases which will be prepared for early trial dates.

Attorneys for the plaintiffs and the defendants have until June 3 to each submit a list of 12 cases, which may include any case in which a Plaintiff Fact Sheet and Defense Fact Sheet have been exchanged by the parties as of May 2. From these Initial Disposition Pool selections, the parties will then each strike six cases chosen by the other side on June 17. The first cases to be set for trial dates will later be selected from these remaining 12 lawsuits.

Judge Seibel said that the parties will discuss what types of cases should be excluded from the Mirena bellwether pool at a May 14 conference.

The Mirena IUD has been on the market in the United States since 2000. Since that time, more than 70,000 Mirena adverse event reports have been filed with the FDA.

Bayer has attempted to defend the cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs maintain that the previous warnings were vague and misleading.

Judge Seibel also said that the parties should be prepared to discuss at the May 14 conference, whether a second wave of early discovery cases should be selected in the litigation.

If you have suffered a severe injury from a Mirena IUD, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm to determine if you have a claim against Bayer. 

FDA Awaits New Over the Counter Drug Approval Process

The Food & Drug Administration (FDA) is looking to update its approval process for over-the-counter drugs, seeing to be able to more rapidly respond to the discovery of new side effects, the development of new active ingredients and to be able to get the drug to market faster.

Earlier this month, the director of the FDA’s Center for Drug Evaluation and Research published a blog post calling for public comment on how the agency can improve its OTC approval process.

The current process, known as the OTC monograph approval process, is responsible for the regulation of more than 300,000 OTC drugs currently on the market. Each drug is required to have a monograph that details the amount and types of active ingredients, permitted uses, and drug facts. However, the agency does not require that the drugs meet the monograph requirements before being marketed to consumers.

One example of where the FDA has struggled with OTC drug concerns is Johnson & Johnson’s popular pain reliever Tylenol and its active ingredient, acetaminophen.

The FDA has previously identified acetaminophen as the leading cause of liver injury in the United States. It has been suggested that more than 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths

In 2011, Johnson & Johnson agreed to lower the maximum recommended dosage for Tylenol from 4,000 mg per day to 3,000 mg per day, after the FDA announced the new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, concerns have been raised about the narrow margin between the recommended dose and the risk of liver failure if users take more than six Extra Strength tablets every 25 hours.

Plaintiffs’ Steering Committee Selected for Lipitor MDL

group of Plaintiffs’ lawyers have been appointed to serve in various leadership role sin the federal multidistrict litigation (MDL) established for all Lipitor diabetes lawsuits brought by women who developed Type 2 diabetes while taking the blockbuster cholesterol lowering agent. The MDL was established in February 2014 and is consolidated in the federal U.S. District Court for the District of South Carolina. The presiding federal Judge is Richard K. Gergel.

Pfizer currently faces several hundred Lipitor lawsuits, which all involve similar allegations that the drug maker failed to provide adequate warnings for women and the medical community about the risk of developing diabetes as a result of using the popular cholesterol drug. Thousands of cases are ultimately expected to be filed in the MDL.
Lawyers in the cases met with Judge Gergel on March 27, 2014 and a case management order was issued which appointed a group of 16 plaintiffs’ lawyers to a Plaintiffs Steering Committee and as Plaintiffs’ Liaison Counsel as well.

The PSC will be responsible for conducting common discovery in the litigation, presenting the position of all plaintiffs to the Court and Pfizer, as well as entering into any stipulations or settlement agreements as necessary during pretrial proceedings. The Lead Counsel and Plaintiffs’ Executive Committee will be responsible for coordinating and overseeing the activities of the Plaintiffs during the Lipitor Litigation, and the Plaintiffs Liaison Counsel will receive notices and orders of the Court on behalf of all Plaintiffs and make documents available to all attorneys involved in the Lipitor Litigation.

If you are a woman with a BMI under 30 who was otherwise in good health but developed Type 2 diabetes while taking the drug Lipitor to lower your cholesterol, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Amid Bleeding Safety Concerns, Pradaxa Expanded by FDA for New Indication

The Food & Drug Administration (FDA) has approved an expanded use of the blood thinner Pradaxa, despite safety concerns involving the risk of uncontrollable bleeding events, which have made the anticoagulant one of the most frequently cited drugs in adverse event reports submitted to regulatory authorities.

On April 7, 2014, Pradaxa’s manufacturer, Boehringer Ingelheim announced that the FDA has approved Pradaxa for the treatment of deep vein thrombosis and pulmonary embolisms. Deep vein thrombosis and pulmonary embolism are known as venous thromboembolisms, and are the side effects of blood clots. It is the third most common form of cardiovascular disease.

Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was introduced by Boehringer Ingelheim for stroke prevention in 2010 in patients with atrial fibrillation. The medication was the first member of a new class of drugs that are promoted as superior alternatives to warfarin, because they are easier to use and require less monitoring.

The drug has come under scrutiny because, unlike warfarin, it does not currently have an approved reversal agent that can be used by doctors to quickly stop its blood thinning effects. Patients who suffer bleeding events on warfarin can be given vitamin K to stop the drug’s effects, but no such antidote exists for Pradaxa. Some doctors say that lack of a reversal agent has led to bleeding injuries and death.

To date, over 2000 Pradaxa lawsuits have been filed in a consolidated multi-district litigation (MDL) in federal court. All of these federal complaints are centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois. A series of four bellwether trials are set to commence going before juries between September 2014 and March 2015.

If you or a loved one has suffered uncontrolled bleeding or a hemorrhagic stroke from taking Pradaxa or Xaerlto, contact Cliff Rieders, Esq. of the Rieders Travis Firm to see if you may have a claim. 

More Stryker Hip Settlements Reached

As a second round of Stryker Rejuvenate hip replacement lawsuits continue to be mediated in New Jersey State Court, additional settlements have been reached between plaintiffs and the manufacturer of the recalled modular hip implant, Howmedica Osteonics. The manufacturer currently faces more than 1,500 product liability lawsuits over the recalled Styker Rejuvenate and ABG II modular stems which were recalled in July 2012, due to reports that the device is prone to corrode, fret and fail within a few years after being implanted. Most hip implants are expected to last 15 to 20 years.

Approximately 600 cases are pending in federal court for the District of Minnesota before Judge Donavan Frank in a consolidated multi district litigation (MDL). Another 954 complaints are pending in New Jersey State Court in a consolidated multi county proceeding before Judge Brian Martinotti. Judge Martinotti has ordered a series of mediations to determine if cases can settle before trial, as part of coordinated pretrial proceedings. The first phase involved ten mediations. According to a case management order issued on April 1, 2014, all of the cases in the first phase of the mediations have settled. A second phase of mediations began in another group of cases earlier this year. According to the case management order, at least two of those cases have settled as well. The details of the settlements have not been disclosed.

While mediation efforts continue, so does the discovery process into generic issues that apply to all cases, with a discovery cut off set for March 31, 2015. Judge Martinotti has indicated that if the litigation is not settled, two “bellwether” trials will be held next summer in New Jersey state court to help gauge how juries may respond to certain evidence and testimony that is likely to be introduced throughout a number of other cases. One trial will begin on June 15, 2015 and the other on July 13, 2015.

In the federal MDL, between three and five bellwether trials will be held beginning in the summer of 2015.

If you have been injured by a Stryker Rejuvenate or ABG II modular hip implant, these devices have been recalled. Contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a case. 

Topamax Settlements Reached to Resolve Birth Defect Lawsuits

Jassen Pharmaceuticals, a subsidiary of Johnson & Johnson, has reached an agreement to resolve dozens of Topamax birth defect lawsuits alleging that side effects of the epilepsy drug caused pregnant women taking the drug to give birth to children suffering from cleft lips, cleft palettes and other malformations.

The Topamax lasuits were announced last week in Pennsylvania state court, indicating that agreements have been reached in 76 lawsuits. The drugmaker continues to face at least 60 additional Topamax cases that are centralized in the Philadelphia court of common pleas.

Specific details of the agreements were not disclosed by the court, and additional steps will be necessary to officially conclude most of the cases, since the claims involve minors, “Incompetent/Incapacitated Persons” or wrongful death claims.

The settlements come after three bellwether or test trials were held in the Philadelphia County Court of Common Pleas, which resulted in three multi-million dollar awards against Defendant Johnson & Johnson of $4 million in October 2013, $11 million in November 2013 and $3 million in March 2014.

Topamax was approved by the FDA in 1997 and has been available as a generic since 2006. It is approved for the treatment of epilepsy, migraines and to promote weight loss.

Johnson & Johnson has maintained that adequate warnings were provided with Topamax from the onset. However in March 2011 the FDA issued a warning about the Topamax oral birth defect among babies born to mothers who took the drug during the first trimester of pregnancy.

If you have been injured by a pharmaceutical or dangerous medical device, contact Cliff Rieders, Esq. of the Rieders Travis Firm

Ethicon Travsvaginal Mesh Lawsuit Results in Plaintiff’s Verdict Against Johnson & Johnson

A Texas state court jury has awarded $1.2 million in damages to a woman who has suffered severe injuries after receiving Ethicon TVY-O transvaginal mesh to treat stress urinary incontinence (SUI). The verdict was handed down in Dallas District Court on April 4, 2014, following a two week trial.

Allegations raised at trial were similar to claims raised in lawsuits brought by more than 50,000 women throughout the United States, who have experienced problems with pelvic mesh made by Johnson & Johnson’s Ethicon subsidiary, as well as other manufacturers, such as American Medical Systems (AMS), Boston Scientific, C.R. Bard, Coloplast Corp, Cook Medical and Neomedic.

All of the lawsuits involve allegatiosn that the transvaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) were defective, unreasonably dangerous and that the manufacturers failed to warn of the risks of these products.

In the Texas case, the jury awarded $1.2 million in compensatory damages, but declined to award punitive damages. Johnson & Johnson indicated that they plan to appeal the verdict.

Johnson & Johnson faces nearly 13,000 Ethicon mesh lawsuits in the federal court system, which have been centralized for pretrial proceedings before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, as part of an MDL, or multidistrict litigation. There are currently six MDLs in the Southern District of West Virginia concerning vaginal mesh lawsuits from different manufacturers.

In February 2014, another Ethicon mesh trial ended in a defense verdict in federal court before Judge Goodwin. At least two more federal trials before Judge Goodwin concerning Johnson & Johnson’s Ethicon vaginal mesh are expected to being later this year.

If you were injured by a transvaginal mesh product used to treat pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim that can be filed. 

Breaking News – Actos Lawsuit Result in Landmark $9 Billion Punitive Damages Verdict in Federal Court

Following a 12 week trial, it took a Louisiana federal jury only a few hours to return a verdict in the first federal case tried in the multi-district litigation (MDL) involving the development of bladder cancer from the side effects of the diabetes drug Actos (pioglitizone) awarding $1.5 million on compensatory damages and an additional $9 billion in punitive damages against Defendants Takeda Pharmaceuticals and Eli Lilly.

This is a landmark jury award which is the largest ever in a pharmaceutical product liability lawsuit, which came in a case brought by Terrance Allen who alleged that the makers of the diabetes drug Actos withheld information from consumers, the medical community and the FDA about the risk of users developing bladder cancer. The trial was the first bellwether trial in the Actos multi-district litigation in the U.S. District Court for the Western District of Louisiana.

Following closing arguments presented on Monday in the U.S. District Court for the Western District of Louisiana, the jury awarded $1.5 million in compensatory damages, which are designed to compensate Allen for his injuries. The jury also awarded additional damages designed to punish the drug makers for their actions, indicating that Takeda Pharmaceuticals should pay $6 billion in punitive damages and another $3 billion should be paid by Eli Lilly, which helped distribute the drug in the United States for several years.

The judge presiding over the MDL and the trial was U.S. District Judge Rebecca Doherty. She had found before the case began that Takeda acted in bad faith during pretrial discovery in accidentally or intentionally destroying evidence relevant to the case. As a result, she allowed evidence to be presented to the jury on spoliation of evidence. Testimony was also presented by the plaintiffs during trial that suggested that Takeda actively tried to hide the drug’s links to bladder cancer. The trial included internal memos and communications, as well as scientific studies that Allen’s attorneys argued the drug maker tried to keep the public unaware.

Following the award, Takeda’s stock dropped more than 8 percent.

If you took the drug Actos and developed bladder cancer, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if your case can be filed in the MDL.

Closing Arguments in First Federal Actos Trial Start Today

The first federal trial involving allegations that the Type 2 diabetes drug Actos (pioglitizone) causes bladder cancer is coming to a conclusion after 33 days of trial testimony, with the judge scheduled to hear closing arguments today before jury deliberations begin.

Trial began on February 3, 2014 in a case brought by Terrence Allen which was selected as the first bellwether case in the Actos federal multidistrict litigation (MDL) established fro all federal product liability lawsuits filed involving allegations that Plaintiffs developed bladder cancer from taking Actos.

There are currently about 3,000 case sin the Actos MDL which is centralized in federal court for the District of Louisiana before U.S. District Court Judge Rebecca Doherty.

Just days before the trial began, Judge Doherty ruled that Takeda Pharmaceuticals, the manufacturer of Actos, acted in bad faith during the discovery process, ordering that juries can be told that the drug maker hid or destroyed information that should have been preserved for the cases.

Takeda Pharmaceuticals has defended the case, claiming that Allen’s bladder cancer was not caused by his use of Actos. The last witness called by the drug maker this week was Dr. Lewis A. Chodosh, who testified that bladder cancer develops over the course of decades and that the risk increased dramatically with age. On cross-examination, Dr. Chodosh admitted never having published any papers on bladder cancer and having a focus primarily on breast cancer. Dr. Chodosh also said he had been paid $1 million to testify as a defense witness in breast cancer cases over the last nine years.

After the defense rested on Thursday, both sides called for summary judgment, and Takeda Pharmaceuticals also called for the judge to block attempts by the plaintiffs to seek punitive damages designed to punish the drug maker for failing to warn about the risk of bladder cancer from Actos. Judge Doherty denied all of those motions.

Closing arguments were schedule for 9 AM today.

If you have been injured by Actos or another pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Pradaxa Bleeding Side Effects May Be Stopped by Reversal Agent

The makers of the controversial anticoagulant Pradaxa, used to treat atrial fibrillation, may have finally discovered an effective reversal agent to stop bleeding, which could help doctors rapidly counteract the blood thinning effects of the drug and stop potentially life threatening bleeding problems among users.

A study on the new potential Pradaxa reversal agent was presented on Sunday at the American College of Cardiology’s annual scientific meeting by European researchers funded by Pradaxa’s manufacturer, Boehringer Ingelheim.

he potential reversal agent, idarucizumab, also known as aDabi-Fab, was tested on 24 male pigs who were given Pradaxa for three days and the results were compared to six pigs who were given a placebo. All of the pigs who suffered a bleeding event caused by trauma after receiving the placebo died. Those who were given aDabi-Fab as an antidote saw a significant and dose-dependent drop in bleeding. Mortality among those pigs was only 17%.

Pradaxa was approved by the FDA in 2010 as an anticoagulant to treat atrial fibrillation, as the first member of a new class of medicines marketed as alternatives to warfarin i(Coumidin) n ischemic stroke prevention. However, shortly after its introduction, Pradaxa began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events.

Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.

There are over 2000 lawsuits filed in federal court against Defendant Boehringer Ingelheim, Pradaxa’s manufacturer, alleging that the manufacturer failed to warn about the severe risk of uncontrolled bleeding

All federal complaints have been centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois for coordinated handling as part of an MDL, or multidistrict litigation. Pradaxa bellwether trials are set to commence later this year. In these lawsuits, Plaintiffs allege that Boehringer Ingelheim failed to warn about the bleeding risks associated with Pradaxa, as well as Boehringer Ingelhim’s failure to develop an antidote prior to bringing the drug to market.

If you or someone you loved suffered a serious bleeding event, hemorrhage or stroke from Pradaxa contact Cliff Rieders, Esq. of the Rieders Travis Firm to see if your case can be filed in the multidistrict litigation.

Parties in C.R. Bard Vaginal Mesh Multidistrict Litigation Ordered to Select Cases for Second Round of Bellwether Trials

A federal judge overseeing more than 6,000 lawsuits in the C.R. Bard transvaginal mesh multidistrict litigation (MDL) has asked the parties to choose 200 cases for case specific discovery in preparation for next year’s bellwether trials. An order to that effect was issued on March 25, 2014. The MDL is pending in federal district court for the Southern District of Virginia.

According to the March 25 order, the 200 cases selected initially will go into a pool that will be further narrowed down and chosen to serve in a second wave of bellwether trials.

According to complaints that have been filed in the Southern District of West Virginia, thousands of women who received C.R. Bard Avaulta implants for pelvic organ prolapse (POP) claim to have experienced chronic pain, pain during sexual intercourse, infection, mesh erosion and other complications caused by the implants.

The first C.R. Bard transvaginal mesh trial in the MDL ended in August 2013 where the plaintiff received a $2 million verdict in compensatory and punitive damages.

If you have been injured by a vaginal mesh product used to treat pelvic organ prolapse, contact Cliff Rieders, Esq. of the Rieders travis Firm to determine if you have a potential claim that can be field in the MDL. 

Lawsuits Over Fosamax Fractures Prior to September 2010 Dismissed

The U.S. District Court Judge presiding over all Fosamax lawsuits involving sudden femur fractures has entered an order dismissing all claims where plaintiffs indicate their injury was suffered prior to September 14, 2010.

There are currently more than 11,00 product liability lawsuits pending against Merck in federal court alleging that plaintiffs suffered an atypical femur fracture from Fosamax, a popular osteoporosis drug.

Since all of the claims involve similar allegations that Merck failed to provide users with adequate warnings, the federal litigation is consolidated as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Joel Pisano in the District of New Jersey.

Judge Pisano issued an Order on March 26, 2014 granting Summary Judgment to Merck, dismissing all claims of injuries prior to September 14, 2010 on preemption grounds, This decision comes prior to the dismissal of a bellwether lawsuit in the litigation. In that case, Judge Pisano found that the Plaintiff’s failure to warn claim was preempted by federal law because the FDA had decided against strengthening the label at that time. In March 2010, the FDA announced that it would review the link between Fosamax and femur fractures and ultimately agreeing that new warnings should be placed on Fosamax later that year.

Following the dismissal of the Glynn case, Merck filed a motion for summary judgment, seeking the dismissal of other cases on the same grounds, claiming that since the drug maker had offered to make the label change and the FDA rejected that attempt, Merck should not be held responsible for failure to warn claims involving fractures that occurred between that time and when the FDA finally allowed the label change to go through.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm

Biomet Cases Must be Filed in Two Weeks to Be Eligible For Settlement

Hip replacement patients who experienced problems with a Biomet Magnum metal-on-metal hip have two weeks to file their claim if they wish to participate in a $56 million settlement agreement reached with the manufacturer. Earlier this year, a Biomet settlement was reached to resolve these product liability lawsuits brought by individuals who have required revision surgery due to complications associated with a Magnum hip replacement.

There are currenbtly about 1,000 Biomet M2A Magnum hip lawsuits pending, which all involve similar allegations that the implants were defectively designed and unreasonably dangerous, carrying a high risk of early failure within a few years after implant.

Under the terms of the settlement agreement, each claimant will receive a base settlement payment of $200,000, with other factors impacting individual allocation in each case.

It is expected that most plaintiffs will agree to participate in the settlement, which should resolve the majority of the litigation. However, there are more than 250 cases pending that do not involve revision surgery, and a joint agreement reached by the parties may result in a stay on all proceedings in those cases until the plaintiffs require revision of the implant.

The majority of the Biomet hip cases are consolidated in a federal multidistrict litigation (MDL), centralized before U.S. District Judge Robert Miller in the Northern District of Indiana. The settlement agreement was reached before a series of bellwether trials that were expected to begin next year.

If you have been injured by a pharmaceutical or medical device, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Zimmer NexGen Kneww Cases Selected for Bellwether Trials in 2015

The first Zimmer NexGen knee replacement lawsuits are moving closer to trial, as the presiding judge identified six cases that will be eligible for early trial dates in the multidistrict litigation (MDL) as bellwether cases.

There are currently more than 1,300 product liability lawsuits filed throughout the country involving problems with the Zimmer NexGen knee implants, which involve allegations that certain components are defective and prone to fail.

The MDL is consolidated in federal U.S. District Court for the Northern District of Illinois before Judge Rebecca Pallmeyer. On Monday, plaintiffs’ attorneys and attorneys for Defendant Zimmer met before a Judge Pallmeyer to discuss competing proposals regarding bellwether case selections, which were submitted to the Court on February 7. In an order issued on March 24, 2014, Judge Pallmeyer identified six Zimmer NexGen bellwether trials which are expected to begin in 2015. Each side selected three cases for trial.

The Zimmer NexGen system was first introduced in 1995, with most components later approved without extensive trials or FDA investigation into their safety through the 510K fast-track approval program, which only requires that devices be “substantially equivalent” to medical devices already on the market to obtain marketing approval.

If you have been injured by a Zimmer NexGen knee replacement, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Fresenius Bellwether Trial Proposals Submitted

The parties in the Fresenius multi-district litigation (MDL) are moving forward with selecting a small group of cases to be prepared for early trial dates in the MDL, known as bellwether trials. There are currently more than 650 product liability lawsuits filed against Fresenius Medical Care in the federal MDL, all of which involve allegations that its GranuFlo /NaturaLyte dialysis patients suffered sudden cardiac arrest or death following treatments due to problems with the GranuFlo or NaturaLyte dialysate solutions. The lawsuits are consolidated in a MDL which is centralized in U.S. District Court for the District of Massachusetts before Judge Douglas Woodlock.

A status conference is scheduled for Friday March 28, when the parties are expected to review with the court competing proposals submitted for the bellwether trial program.

Fresenius Medical Care not only manufactures the solutions, but also owns and operates many of the dialysis treatment centers in the United States. Concerns about the link between NaturaLyte, Granuflo and heart problems surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA.

Granuflo and NaturaLyte have been linked to an increased risk rate of sudden cardiac arrest and death among dialysis patients, which may occur during or shortly after dialysis treatment. The lawsuits allege that the solutions convert to bicarbonate at higher levels than doctors were aware, which requires much closer monitoring of levels during treatment to avoid the risk of injury or death.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers on March 29 of that year, which the FDA determined constituted a recall.

If you or someone you love suffered a serious, sudden cardiac event from dialysis with GranuFlo or NaturaLyte, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

First Lipitor Status Conference in Multi-District Litigation (MDL) Set For This Week

The first status conference before the U.S. District Court Judge presiding over the federal Lipitor diabetes lawsuits consolidated in a multi-district litigation (MDL) is scheduled for March 27, at which time the organization and structure of the rapidly growing litigation will be discussed.

On February 18, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established centralized proceedings in the federal court system for all lawsuits filed against Defendant Pfizer concerning the drug Lipitor and the failure to warn about the risk of developing Type 2 diabetes from taking Lipitor to regulate blood cholesterol.

The federal Judge presiding over the MDL is Judge Richard Gergel in the U.S. District Court for the District of South Carolina.

About sixty cases were transferred into the Lipitor MDL when it was established, and over the past 45 days, more than 250 lawsuits have been transferred into the MDL. Plaintiffs’ attorneys estimate that thousands of lawsuits will ultimately be included in the litigation.

At the first status conference, Judge Gergel is expected to discuss the appointment of liaison counsel and a group of lawyers to serve in various leadership roles, including a Plaintiff Steering Committee. Other issues, including filing of new cases in the MDL, service of documents and coordination of discovery are also expected to be discussed.

Judge Gergel has also been asked to adopt certain pretrial discovery, Orders and agreements that were reached between Pfizer and plaintiffs in South Carolina before consolidated proceedings were established. While the organizational structure of the MDL is being set up, Judge Gergel has stayed all proceedings in the federally filed Lipitor cases.

All of the cases involve similar allegations brought by otherwise healthy women who have been diagnosed with diabetes after taking Lipitor to lower their cholesterol levels. Plaintiffs claim that Pfizer knew or reasonably should have known about the diabetes risk, yet placed their desire for profits before consumer safety by withholding information from patients and the medical community.

Lipitor (atorvastatin) is one of the most widely used brand-name medications in the United States, and it has been used by millions of Americans.

In Feburary 2012, the FDA required a new diabetes warning for Lipitor and other similar statin drugs, informing users that they may face increased risk of changes to their blood glucose levels. However, Plaintiffs allege that even this warning was grossly inadequate as it fails to warn about the risk of developing diabetes. Further, plaintiffs allege that Pfizer was aware of the possible risks of diabetes long before these warnings were issued, with some studies connecting statins to diabetes dating as far back as 2004. Plaintiffs maintain that if they had been provided proper warnings about the Lipitor risks, they could have avoided diabetes by choosing not to take the cholesterol drug or by diligently monitoring their blood glucose levels during treatment.

If you are a woman with a BMI under 30 who is otherwise healthy, but developed Type 2 diabetes while taking Lipitor, contact Cliff Rieders, Esq. to determine if you may have a claim in connection with the newly formed multi-district litigation. 

Stryker Rejuvenate Bellwether Trials to Begin in Summer 2015

The first cases in the federal multi-district litigation concerning the Stryker Rejuvenate hip recall lawsuits will be ready for trial in the summer of 2015, according to a new pretrial order, dated March 14, 2014.

Mediations are moving forward for a small group of cases set for early trial dates, called bellwether cases. There are currently more than 1,500 product liability lawsuits pending claiming that individuals experienced problems with the Stryker Rejuvenate or ABG II modular hip replacements which were recalled in July 2012 amid reports that the metal on metal implants may fret and corrode at the modular stem, causing early failure.

Unlike traditional hip implants, which feature a single femoral component, the Stryker Rejuvenate and ABG II contains a modular neck-stem, which consists of two pieces that fit inside each other to allow the surgeon to customize the length of the femoral component based on the patient. However, the design has been linked to an increased risk of problems that may result from the release of microscopic metal debris as the chromium-cobalt neck rubs against the titanium femoral stem.

In the federal court system, more than 600 of the cases have been centralized before U.S. District Judge Donovan Frank in the District of Minnesota as part of an MDL. Cases are also pending in a consolidated multi-county litigation centered in Bergen County in New Jersey state court before Judge Brian Martinotti. At least 873 cases are pending in the New Jersey litigation. Judge Martinotti established a mediation process last year and eight of the nine cases that have gone to mediation have settled. Additional rounds of mediation are being planned and scheduled.

If you have been injured by a recalled Stryker Rejuvenate or ABG II modular hip implant, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a case that can be filed in one of the above proceedings. 

Diabetes Risk Seen with Lipitor, Crestor and Other Statins According to New Study

The findings of a new clinical study provide further evidence that the side effects of Lipitor, Crestor and other statin drugs increase the risk of developing Type 2 diabetes, suggesting that one out of ever five cases of diabetes diagnosed among users of the popular medications may be caused by these cholesterol lowering drugs.

The study was published last week in the European Journal of Preventative Cardiology, showing that the class of drugs increases the risk of diabetes. Researchers looked at data from 14 prevention trials involving more than 46,000 subjects where people either took a statin agent or placebo.

Statins are among the best selling drugs in the United States with $14.5 biollion in combined sales in 2008. They work by using the liver to block the body’s creation of cholesterol, which is a key component to coronary artery disease.

In February 2012, the FDA required the manufacturers of Lipitor, Crestor and other statin drugs to add a new warning to the labels about the potential impact of the medications on blood glucose levels. However, many critics have indicated that these warning are not strong enough as they do not mention a link between the drugs and diabetes.

Pfizer, the manufacturer of Lipitor, currently faces hundreds of Lipitor diabetes lawsuits filed by women throughout the United States who allege that the medicine caused them to develop Type 2 diabetes. The cases are centralized in a multi-district litigation (MDL) in U.S. District Court for the District of South Carolina. AstraZeneca also faces some Crestor diabetes lawsuits in California state courty.

If you are a woman with a body mass index under 30 and you developed Type 2 diabetes while taking Lipitor contact Cliff Rieders of the Rieders Travis Firm to see if we may be able to file a lawsuit in the MDL on your behalf. 

New Study Shows Risperdal Increases Gynecomastia Risk In Young Boys

The findings of a new study appear to confirm the link between Johsnon & Johnson’s Risperdal and gynecomastia in young boys, a condition that has been found to cause the development of breasts.

Dr. Mahyar Etminan, lead author and a pharmacoepidemiologist at the University of British Columbia, presented the findings of a new study on March 15 at the American Association for Geriatric Psychiatry (AAGP) meeting. The findings indicate that males using Risperdal have a significantly higher risk of developing unnatural breast growth, known as gynecomastia, when compared to those who did not use the drug.

Researchers found an increased risk of gynecomastia among users of the antipsychotics Risperdal and Invega. Those who took the drugs had a 69% increased risk of developing breasts, compared to non-users. When compared to individuals who used other atypical antipsychotics that are part of the same class, researchers found that the risk was still 41% higher than seen among users of Seroquel, and 40% higher than users of Zyprexa.

In recent years, Johnson & Johnson has been facing a increasing number of Risperdal gynecomastia lawsuits which allege the drug maker failed to warn consumers about the medical risk that boys and young men could face about developing gynecompastia following Risperdal use. Many cases have been filed in Pennsylvania state court.

If you or someone you love took Risperdal and developed gynecomastia, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you may have a claim.

New Sanctions Imposed on Defendant in Pradaxa Multi-District Litigation

Boehringer Ingelheim, the manufacturer of Pradaxa and defendant in the ongoing multi-district litigation (MDL) has been ordered by a federal jduge to pay expenses associated with overseas depositions to Plaintiffs in the Pradaxa litigation for bad faith conduct during discovery and for withholding documents and destroying evidence.

More than 2000 Pradaxa lawsuits are currently filed and pending in federal court against Defendant Boehringer Ingelheim. These lawsuits allege that the drugmaker failed to warn about the serious risks assiociated with the risk of uncontrollable bleeding associated with Pradaxa.

All of the federal complaints have been centralized in U.S. District Court for the Southern District of Illinois before Judge David R. Herndon. The new sanctions were included in a new case management order issued by Judge Herndon on March 13, 2014. The order required the defendant to pay expenses incurred by plaintiff attorneys while they take depositions of employees of the drug maker.

In December, Judge Herndon had previously sanctioned Boehringer Ingelheim $1 million for prior bad faith actions during discovery.

Since attorneys representing plaintiffs in the litigation will now have to travel to Europe to conduct the depositions, Judge Herndon has ordered Boehringer Ingelheim to pick up the tab for those depositions, requiring the company to pay for plaintiff attorneys to rent sufficient office space in Amsterdam, the capital city of the Kingdom of the Netherlands. The order also requires the company to reimburse the costs of court reporters, videographers and interpreters the plaintiffs’ attorneys use while in Europe retroactively from December 9, 2013 until at least August.

The parties estimate that about 50 Boehringer Ingelheim employees will be deposed.

The judge rejected calls by plaintiffs’ attorneys to increase the previous fine to $20 million, but noted that Boehringer Ingelheim may face more sanctions in the course of the litigation. He also did not order the company to pay for the plaintiffs’ attorneys travel expenses.

Bellwether trials in the Pradaxa litigation are expected to begin in September of 2014.

If you or someone you loved suffered from an uncontrollable bleeding event, hemorrhage, or stroke from taking Pradaxa, call Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a case

Coordination Sought For Zimmer NexGen Knee Cases

Parties involved in the Zimmer NexGen knee cases seek to coordinate between state and federal court proceedings., asking the federal judge assigned to a coordinated proceeding to liase with various state court proceedings.

There are currently more than 1,250 product liability lawsuits pending in the federal court system involving claims for individuals who have experienced complications with a Zimmer NexGen knee. More than a dozen cases are pending in state court proceedings around the country.

In 2011, the U.S. Judicial Panel on Multidistrict Litigation established centralized proceedings for all Zimmer NexGen cases filed in federal courts nationwide, centralizing the litigation for pretrial proceedings before U.S. District Judge Rebecca Pallmeyer in the Northern District of Illinois.

In a joint update filed on March 10, attorneys for plaintiffs and Zimmer asked Judge Pallmeyer to send a letter to judges presiding over 15 cases pending at the state court level in Indiana, Delaware, New York, Illinois and California, to establish “a relationship of coordination” between the courts.

A status conference is scheduled for March 21, at which time the parties are expected to discuss the selection of Zimmer NexGen cases for early trial dates. Each side has identified three lawsuits for first case picks, and filed responses to the cases proposed by the opposition.

If you suffered a serious injury from a Zimmer NexGen knee implant that failed, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim that can be filed for relief. 

Actos Trial Begins in Nevada State Court

Another Actos (pioglitizone) trial began on March 10, 2014 in Nevada state court over Takeda Pharmaceuticals’ alleged failure to warn about the risks that its blockbuster diabetes drug Actos causes bladder cancer.

Both plaintiffs allege that Actos was responsible for their bladder cancer, after 14 months and two years of Actos use respectively. In 2011 the FDA had warned that use of Actos for more than one year could be associated with an increased risk of developing bladder cancer.

Opening statements began on Monday before a Los Vegas jury. The case is a consolidated trial of two separate cases. Attorneys for the women plan to ask for a multi-billion dollar damage award, including punitive damages designed to punish Takeda Pharmaceuticals in a way that would affect the drug maker’s bottom line.

In May 2013, a California jury awarded a plaintiff who developed bladder cancer while on Actos a $6.5 million verdict but the court reversed that verdict after the judge excluded plaintiff’s expert witness testimony.

In a second trial in Maryland state court in September 2013, a jury awarded another plaintiff $1.77 million in damages but the court reversed that verdict under Maryland contributory negligence law because the plaintiff failed to exercise reasonable care for his own health.

A third trial in Nevada state court resulted in a defense verdict where the jury determined that both Actos and the plaintiff’s history as a smoker contributed to his development of bladder cancer.

In the federal court system, all Actos cases filed in U.S. District Courts nationwide are centralized for coordinated pretrial proceedings in the Western District of Louisiana. The first federal bellwether trial is presently also underway.

If you or someone you love has been seriously injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

More Than 250 Lipitor Diabetes Cases Pending in MDL

During the first month of its existence, more than 250 Lipitor lawsuits hae been transferred to the newly formed multi-district litigation (MDL) in the U.S. District Court for the District of South Carolina.

On February 18, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated proceedings for all federal product liability lawsuits filed against Pfizer that involve allegations that women developed Type 2 diabetes from taking Lipitor to regulate their blood cholesterol. The cases in the MDl are centralized before U.S. District Judge Richard M. Gergel.

At the time that the MDL was established, there were 56 cases pending in U.S. District Courts concerning similar allegations, including 14 in the District of South Carolina. Since that time, more than 160 additional cases have already been moved into the MDL.

All of the lawsuits involve similar allegations that Pfizer failed to adequately research their blockbuster medication or provide adequate warnings for women about the risk of developing type 2 diabetes, especially among otherwise health women who did not have other risk factors that may lead to the development of the disease.

Lipitor (atorvastatin) is a widely used brand-name medication used to help individuals lower levels of blood cholesterol and reduce the risk of heart disease. The medication is part of a class of cholesterol lowering drugs known as statins. Another widely used statin is Astra Zeneca’s Crestor.

In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add a new warning about the potential impact of the medication on blood glucose levels.

If you are an otherwise healthy woman with a BMI under 30 but developed Type 2 diabetes while taking Lipitor, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you may have a claim. 

Breaking News: AndoGel MDL Motion Filed to Centralize Testosterone Gel Lawsuits

A request has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all AndroGel lawsuits filed throughout the federal court system, centralizing the cases before one judge for coordinated pretrial proceedings.

A Motion to Transfer was filed on March 28, 2014 which states that there are at least 38 product liability lawsuits that have already been filed in U.S. District Courts throughout the country involving similar allegations that the side effects of AndroGel testosterone caused plaintiffs to suffer heart attacks, strokes, blood clots and/or pulmonary embolisms, in some cases resulting in death.

A group of plaintiffs are now requesting that all cases be centralized in the U.S. District Court for the Northern District of Illinois as part of an AndroGel multidistrict litigation or MDL. The MDL request that all of the cases be centralized in the U.S. District Court for the Northern District of Illinois before Judge Matthew Kennelly, who is already presiding over AndroGel cases that have been filed in that judicial district. At least 36 cases have been field against AbbVie nationwide in Illinois, Colorado and Pennsylvania.

AndroGel is the leading testosterone replacement therapy on the market, and is manufactured and marketed by AbbVie, a division of Abbott Laboratories. All of the lawsuits involve similar allegations that AbbVie failed to warn men about the risk of heart problems from taking AndroGel.

It is expected that thousands of cases will ultimately be filed. The litigation comes after a series of clinical studies have raised concerns about the link between testosterone replacement therapies, including AndroGel, and heart attacks, including a January 2014 study in the medical journal PLOSOne and a November 2013 study in the Journal of the American Medical Association.

In response to the two clinical study reports, the FDA launched a safety review of AndroGel and other testosterone replacement therapies on January 31, 2014.

If you or someone you loved took the testosterone replacement therapies AndroGel, Axiron, Testim or AndroDerm, and suffered a heart attack, stroke, or blood clot, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a claim that can be filed in federal court. 

GranuFlo and NaturaLyte Use Identification Process Outlined by Judge

The federal judge presiding over the multi-district litigation (MDL) in the U.S. District Court for the District of Massachusetts, Judge Douglas Woodlock, has approved a process that allows plaintiffs to obtain identification of the acid concentrate used in their treatment.

In the pending lawsuits in the MDL, plaintiffs allege that the dialysis acid solutions GranuFlo and NaturaLyte caused them to suffer sudden cardiac arrest, heart attack and/or death. There are currently more than 500 cases centralized before Judge Douglas Woodlock in the MDL. As part of his management of the MDL, Judge Woodlock issued a case management order earlier this month that allows plaintiffs to seek conformation about whether GranuFlo or NaturaLyte were used during their last treatment at a Fresenius dialysis clinic prior to their cardiac arrest and/or death.

Granuflo and NaturaLyte are dry acid and liquid acid concentrates, respectively, which were used by Fresenius at their dialysis treatment clinics throughout the United States. The product identification process was established to facilitate the discovery of which solution was used during a specific patient’s treatment, as such information is often not included in medical records.

According to the process approved by Judge Woodlock on March 5, plaintiffs may issue a request for the release of information from a Fresenius “Data Warehouse.” Within 14 days after the first Friday following the receipt of the request, Fresenius has been ordered to identify the last “acetate value” or “concentrate identifier” for the patient prior to the injury or death. The order only applies to cases where the last treatment was provided at a Fresenius Medical Care dialysis clinic.

If someone you loved suffered a sudden heart attack or diet from cardiac arrest during or shortly after dialysis treatment at a Fresenius clinic with GranuFlo or NaturaLyte contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim. 

Coloplast Agrees to $16 Million Transvaginal Mesh Lawsuit Settlement

The Danish medical device company Coloplast has agreed to pay $16 million to resolve pending transvaginal mesh lawsuits alleging serious injuries caused by its pelvic lawsuits according to Bloomberg News.

Claimants eligible to participate in the settlement will receive about $40,000 each. Approximately 400 vaginal mesh lawsuits filed against Colopalst for complications such as vaginal scarring, bleeding, mesh erosion, chronic pain and pain during intercourse will be impacted by the agreement.

There are currently six different multi-district litigations (MDLs) pending in federal court in the U.S. District Court for the Southern District of West Virginia against various manufacturers of vaginal mesh products sued to treat stress urinary incontinence and pelvic organ prolapse. There are approximately 40,000 lawsuits filed in federal court in total against the various defendants.

If you have been injured by a vaginal mesh product used to treat pelvic organ prolapse, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

Topamax Lawsuit Over Birth Defect Results in $3 Million Verdict

A jury in Pennsylvania state court has awarded $3 million dollars in damages to the parents of a five year old boy born with birth defects following exposure to the drug Topamax during pregnancy. This represents the third Topamax lawsuit to result in a multi-million dollar verdict against Johson & Johsnon’s Janssen Pharmaceuticals subsidiary over the past six months.

The verdict was issued in the Philadelphia County Court of Common Pleas. his case was the third Topamax trial to go before a jury in Philadelphia, with combined verdicts of $17 million now awarded to three families. The opther two trials resulted in a $4 million jury verdict on October 2013 and an $11 million jury verdict in November 2013. Janssen has indicated it will appeal this latest verdict, maintaining that the plaintiff was repeatedly warned by her doctors not to take Topamax during her pregnancy. The company faces more than 130 similar lawsuits over Topamax birth defects filed by families throughout the country. –

Topamax (generic topiramate) was approved by the FDA in 1997, and it has been available as a generic since 2006. It is approved for the treatment of epilepsy, migraines and to promote weight loss. Johnson & Johnson has maintained that adequate Topamax warnings were provided. However, in March 2011, the FDA issued a warning about the Topamax oral cleft birth defect risk among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.

Help Filing a Topamax Lawsuit

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Pradaxa Trial Dates in MDL Pushed Back to September 2014

The first four Pradaxa lawsuits scheduled for early trial dates in federal court will now begin in September 2014 after the U.S. District Court Judge presiding over the litigation delayed the start of the trial about one month.

District Court Judge David R. Hedndon is currently presiding over more than 2000 lawsuits pending against Boehringer Ingelheim in federal court which involve similar allegations that the drug maker failed to provide adequate warnings about the risk of Pradaxa bleeding injuries.

As part of the coordinated pretrial proceedings in the cases, Judge Herndon previously selected four cases for early trial dates, which were expected to begin between August 2014 and February 2015 in the U.S. District Court for the Southern District of Illinois.

In a case management order issued on March 5, Judge Herndon issued a new order and schedule for the cases to go before juries.

Jury selections in for lawsuit filed by Suzanne Mackiewicz will now begin on September 8, 2014, with opening statements expected to begin on September 15. Her case involves a wrongful death claim on behalf of her father, Malachy Higgins. The second bellwether trial will address a claim filed by Georgia Primus and is scheduled to begin on December 1, 2014. The third bellwether trial involves a wrongful death lawsuit by Adalaine Nancy Kohn, whose husband died after a Pradax bleeding event. Originally it was the scheduled to be the second case to go to trial, but it will now go before a jury on February 17, 2015. The fourth and final bellwether trial will involve a case brought by Helen Jean and John Edwards Hawkins, which is scheduled to begin on March 23, 2015.

Each of the lawsuits allege that the manufacturer failed to warn the medical community about the potential bleeding side effects of Pradaxa as well as the lack of an antidote that would allow doctors to halt the blood thinning effects of the medication. As a result of this failure to warn, many doctors did not have any plan in place for counteracting the drug.

Pradadxa (dabigatran) is a relatively new anticoagulant therapy that was approved by the FDA in October 2010 -Since that time, it has seen an extremely high if not a record number of adverse events after patients experienced uncontrolled bleeding events that have been reported to the FDA.

If you have been injured by Pradaxa or Xarelto and experienced an uncontrolled bleeding event, hemorrhage or stroke, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

Mirena Federal Bellwether Trials Postponed By 60 Days

The U.S. District Court Judge presiding over the federal multi-district litigation (MDL) for Mirena has postponed deadlines regarding the preparation of a small group of cases for early trial dates, termed bellwether trials.

Mirena is a long-lasting form of birth control known as an intrauterine device, or IUD, which is manufactured by Bayer Healthcare. More than 1,000 women are now pursuing product liability lawsuits, alleging that the IUD caused them to severe injuries caused by the device migrating in their bodies and perforating their uterus.

In the federal court system, cases filed have been centralized before District Court Judge Cathy Seibel in the Southern District of New York as part of a MDL.

On February 26, 2014, Judge Seibel issued a case management order which extends to many deadlines impacting the bellwether cases. While the parties were originally expected to select cases for this bellwether pool by April 4, 2014 and complete all case-specific discovery by September 30, 2014, these deadlines have been pushed back 60 days. The first Mirena trial dates have not been scheduled yet, but the pretrial proceedings and challenges to expert witnesses are not expected to be completed until July 15, 2015.

Bayer introduced Mirena to market in 2000, and since that time more than 70,000 adverse event reports have between filed with the FDA, including at least 5000 instances where Mirena migrated out of place since 2008. Bayer has attempted to defend the cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

More than 1000 product liability lawsuits have been filed with Mirena.

If you have been injured by an Mirena IUD that resulted in uterine perforation or injury to other internal organs, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm.

New Testosterone Replacement Drug Approved by FDA Despite Heart Attack, Stroke Risk

Amid a growing chorus of concerns about the risk of heart attacks and strokes from testosterone replacement therapies, based on two new clinical studies, the FDA has nonetheless approved a new injectibale testosterone drug after previously rejected the drug three times in the past due to safety concerns.

On March 6, 2014, Endo Pharmaceuticals announced that the FDA has approved Aveed injections for the treatment of men with low testeosterone due to hypogonadism. The injections are designed to have long-term effects, only requiring men to get the testosterone shot once every few weeks.

Aveed is a 3 mL intramuscular injection that would be given at initiation of therapy and then a second short in four weeks. After that men would only receive the injection once every 10 weeks. Endo expects to release the drug later this month.

However, the FDA approval came after the agency rejected the drug three times previously. The injections contain both testosterone and castor oil, and during the last attempt at approval, in May 2013, the FDA said that it was concerned that the castor oil could cause pulmonary embolism and post-injection reactions.

The decision to approve Aveed was controversial only days after the consumer group Public Citizen filed a petition with the FDA urging the agency to delay approval of Aveed and require a black box warning on all testosterone therapies altering men to the increased risks of heat attack and strokes associated with the products.

While use of testosterone drugs, such as AndroGel, Androderm, Testim, Axiron and others already on the market, have increased dramatically over the past ten years, concerns have emerged in recent months about serious and potentially life-threatening adverse events, based on several new clinical studies. In November 2013, a study published in the Journal of the American Medical Association (JAMA) suggested that testosterone drugs may increase the risk of heat attack, stroke and death in older men with certain pre-exisitng concitions. A second study was published in the medical journal PLoSOne in January 2014, which found that testosterone treatments may double the risk of heart attack and stroke in young mean with heart disease as well as men over age 65 with no prior heart problems.

If you took testosterone replacement therapies AndroGel, AndroDerm, Testim or Axiron and suffered a heart attack, stroke or pulmonary embolism, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Medtronic Infuse Lawsuits Over Bone Growth Complications Reach 1,000

Medtronic presently faces about 1000 lawsuits involving complications with its Infuse bone graft device. Plaintiffs in these cases allege that they experienced complications with bone overgrowth after the device was implanted in their spines during procedures that were not approved by the U.S. Food & Drug Administration (“FDA”).

Medtronic Infuse is a newer type of bio-engineered bone graft product that has been promoted as an alternative to traditional spinal fusions, where bone is harvested from another area of the body or used from a cadaver.

The FDA approved Infuse recombinant human bone morphogenetic protein (rhBMP-2) for limited use during spinal fusion procedures where the lumbar spine is approached through the front and the product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae. However, Medtronic has been accused of illegally promoting the device for non-approved uses, with a vast majority of sales for Infuse involving applications that were never approved by the FDA.

Medtronic’s third quarter report for fiscal 2014 indicates that more than 1,000 lawsuits have been field in federal and state courts concerning Infuse, and that number is expected to grow significantly.

According to allegations plead in the various filed complaints, plaintiffs have suffered severe never damage, airway compression and other complications associated with uncontrollable bone growth after the device was used off-label, such as in the cervical spine, at multiple levels or through a non-anterior approach.

Medtronic’s litigation approach thus far has been to argue that the cases are federally preempted because the device was approved by the FDA, citing the Supreme Court’s decision in Riegel v. Medtronic. A federal judge rejected Medtronic’s preemption argument in August. The litigations have not been centralized in federal court in a multi-district litigation or MDL, despite the large number of complaints filed. This could lead to contradictory opinions from different federal judges on a variety of issues, including preemption.

If you have been injured by Medgtronic’s Infuse bone graft, contract Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a claim against Medtronic.

First Testim Lawsuit Filed Over Stroke from Low Testosterone Gel

Auxilium Pharmaceuticals faces its first product liability lawsuit concerning its Testim low testosterone gel, which allegedly caused the plaintiff to suffer a stroke. A growing number of product liability lawsuits are currently being filed against Abbott Pharmaceuticals, the manufacturer of the low testrosterone gel AndroGel, as well.

The Testim complaint was field in the U.S> District Court for the Central District of California alleging that Auxilium failed to adequately warn about the risk of heart attacks, strokes and other cardiovascular risks associated with Testim gel. Claims have been presented against Auxilium for failure to warn, negligence, breach of warranty, fraud and negligent misrepresentation, seeking both compensatory and punitive damages.

Plaintiffs allege that the drug makers have withheld important safety information while engaging in substantial direct-to-consumer marketing that has distorted the need for testosterone treatments. Manufacturers of the drugs have engaged in what some have called “disease mongering,” by convincing men of the existence of a condition known as “Low T,” which is actually a term that appears to have been developed for marketing purposes.

Testim and other testosterone replacement therapy medications were approved by the FDA specifically to treat low testosterone levels associated with a medical condition, such as hypogonadism, which can cause excessively low or no testosterone production. However, a recent study found that 25% of men prescribed the drugs never had their testosterone tested, and that doctors have often prescribed the drugs in recent years for “lifestyle reasons,” treating symptoms associated with the natural reduction of testosterone that all men experience as they age.

In November 2013, a study published in the Journal of the American Medical Association found that testosterone gels, patches and injections increased the risk of heart attack, stroke and death.

In a second study, published in the medical journal PLOSOne last month, the authors found that low testosterone may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions. Researchers estimated that for every 1,000 men over the age of 65 who take Androgel or another testosterone product, 11.52 may suffer a heart attack injury, which compares to 5.27 per 1,000 men who do not use testosterone replacement therapy.

On January 31, 2014, the FDA announced that an investigation was being launched into the safety of testosterone treatments, while looking into the new data.

If you have suffered a heart attack, pulmonary embolism or stroke as a result of taking testosterone replacement therapy including AndroGel, Axiron, Testim or AndroDerm, contact Cliff Rieders, Esq. of the Rieders Travis Firm today to determine if you have a claim. 

Public Citizen Calls For Black Box Warning for Testosterone Replacement Therapy Risks

The prominent consumer watchdog group Public Citizen is calling for the Food & Drug Administration (FDA) to require a “black box” warning, the strongest type of warning on a pharmaceutical label that federal drug regulators can provide, about the potential cardiac risks of testosterone replacement therapies. Such testosterone replacement therapies include AndroGel, Testim and Axiron, as well as other products.

Public Citizen filed a petition with the FDA on February 25 calling for the strong black box warning on labels for these medications, such as AndroGel. Public Citizen cited a number of studies that suggested that the side effects of testosterone replacement treatments may increase the risks of heart attacks, strokes, blood clots, pulmonary embolisms and death. Public Citizen is also urging the FDA to ussue a “Dear Doctor” letter to medical providers to wearn them of the potential risks of testosterone replacement therapies such as AndroGel, Axiron and Testim. The group also indicates that the FDA should delay approval of a new long-acting testosterone injection proposed by Endo Pharmaceuticals called Aveed.

On January 31, 2014, the FDA announced that it had launched an investigation into the heart safety of AndroGel and other testosterone therapies. This safety alert was in response to two studies that were published recently that found an increase in the risk of cardiovascular events among men prescribed testosterone gels, patches, injections and other treatments.

If you have taken testosterone therapies such as AndroGel, Axiron, Testim or AndroDerm and suffered a heart attack, stroke, or serious blood clot such as a pulmonary embolism, contact Cliff Rieders, Esq. of the Rieders Travis Firm to have your potential claim evaluated. 

FDA Refuses to Recognize Pancreatic Cancer Risk with Byetta, Januvia, Janumet and Victoza

In a recent report published by the New England Journal of Medicine on February 27, 2014, the FDA and European Medicines Agency (EMA) assessed the risk of pancreatic cancer associated with incretin mimetic diabetes drugs. Drug sin this class include Byetta, Victoza, Januvia and Janumet. Their assessment states that there is no evidence establishing a causal link to pancreatic cancer with this class of drugs. These findings are contrary to a number of recent studies that have suggested an increased risk of pancreatic and thyroid cancer among users of the drugs. However, the FDA and EMA indicate that they looked at the same data and gathered even more but were unable to come to the same conclusions.

The FDA and EMA say they looked at data from animal tests, post-marketing studies, pre-marketing clinical trials and adverse event reports before reaching their conclusions.

“Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data,” the assessment concludes. “The FDA and the EMA have not reached a final conclusion at this time regarding such a causal relationship. Although the totality of the data that have been reviewed provides reassurance, pancreatitis will continue to be considered a risk associated with these drugs until more data are available; both agencies continue to investigate this safety signal.”

If you or someone you love developed pancreatic cancer after taking Byetta, Januvia, Janumet or Victoza for more than four months, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you may have a claim that can be filed in conjunction with ongoing litigation

Stryker Rejuvenate Hip Case Numbers Continue to Rise

The number of Stryker Rejuvenate hip cases filed in federal and state courts continues to grow, with several thousand patients indicating that they have experienced problems after receiving the recalled hip implant.

On February 18, 2014, federal Judge Donavan Frank, who is overseeing the coordinated multi-district litigation in U.S. District Court for the District of Minnesota, wrote a letter to state court judges overseeing lawsuits involving the Stryker Rejuvenate and ABG II modular hip implants. Judge Frank’s letter sought to coordinate his MDL with the state court proceedings.

Judge Frank is presiding over all federal cases, which were centralized last year in the U.S. District Court for the District of Minnesota as part of an MDL, or Multidistrict Litigation. Judge Frank sent the letter to state court judges in Illinois, Michigan and Oregon, indicating that there are presently 573 cases filed in the federal MDL with plaintiffs indicating that another 1000 cases are expected to be filed in the coming months.

Nearly 900 cases have been filed in carious state courts, with at least 779 lawsuits filed in state court in New Jersey in a coordinated multi-county proceeding centered in Bergen County before Judge Brian Martinotti.

Unlike traditional hip implants, which feature a single femoral component, the Stryker Rejuvenate and ABG II contain a modular neck-stems, which consists of two pieces that fit inside each other to allow the surgeon to customize the length of the femoral component based on the patient. However, the design has been linked to an increased risk of problems that may result from the release of microscopic metal debris as the chromium-cobalt neck rubs against the titanium femoral stem.

A status conference was held in the MDL before Judge Frank on February 20. In New Jersey, the first phase of the litigation involved a mediation program in a group of ten cases. In December 2013, the court reported that six of these mediations had been completed, with agreements to settle four cases. One additional case settled last month.

If you have been injured by the recalled Stryker Rejuvenate or ABG II hip implants, contact Cliff Rieders, Esq. of the Rieders Travis Firm today to determine whether you may have a claim that can be filed in conjunction with the ongoing litigations.

Neomedic Cases Added to Vaginal Mesh MDL in West Virginia

A panel of federal judges have decided to establish a seventh multi-district litigation (MDL) for vaginal mesh lawsuits, centralizing all lawsuits involving pelvic repair products manufactured by Neomedic before the same judge presiding over more than 40,000 cases involving vaginal mesh products made by other manufacturers.

According to a new order issued by the U.S. Joint Panel on Multidistrict Litigation (JPML) on February 18, 2014, all Neomedic vaginal sling lawsuits will be consolidated in an MDL before U.S. District Court Judge Joseph R. Goodwin in the Southern District of West Virginia.

TRhere are currently 21 cases filed involving the Neomedic Needleless Sling and other Neomedic vaginal mesh products, with at least 14 of those cases already pending in federal court which will be transferred into the MDL.

Judge Goodwin is already presiding over six vaginal mesh MDLs that contain over 40,000 lawsuits against other vaginal mesh manufacturers, He is currently assigned to oversee 12,992 Ethicon (Johsnon & Johnson) lawsuits, 13,292 American Medical Systems lawsuits, 7,617 Boston Scientific lawsuits, 6,172 Bard Avaulta lawsuits, 1,155 Coloplast lawsuits and 152 Cook lawsuits.

All of the pending complaints involve similar allegatiosn that women experienced complications from vaginal mesh surgery with these products when used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Neomedic, the seventh defendant in the MDLs, had opposed the creation of an MDL, arguing that it would harm the progress already made in the pending cases against the manufacturer. However, the JPML felt that it would be better for all of the federally filed vaginal mesh lawsuits to be handled together under one federal judge.

Judge Goodwin has scheduled a series of bellwether trials against the other manufactures for this year. At least five vaginal mesh cases have gone before juries, primarily in state court. Ealier this week Judge Goodwin entered a defense verdict in the first bellwether case, an Ethicon bellwether trial. Throughout the year, additional bellwether trials are expected against various manufacturers.

If you have been injured by vaginal mesh implanted to treat pelvic organ prolapse (POP), contact Cliff Rieders, Esq. of the Rieders Travis Firm to have your potential claim evaluated. 

Xarelto Lawsuit Filed Over Uncontrollable Internal Bleeding

A Kentucky woman has filed a product liability lawsuit against Johnson & Johnson and Bayer, alleging that she nearly bed to death due to side effects of Xarelto (rivaroxaban), an anticoagulant that is similar to Boehringer Ingelheim’s Pradaxa, which has been linked to thousands of lawsuits over uncontrollable bleeding. The complaint was filed in the Philadelphia Court of Common Pleas , raising similar allegations to those brought in Pradaxa lawsuits.

The Xarelto lawsuit alleges that the drug makers sold an unreasonably dangerous and defective product, and failed to warn about the risk of bleeding events that might be irreversible. While bleeding risks are common with all blood thinners, Xarelto and Pradaxa are from a new generation of anticoagulants that

Are marketed as safer and requiring less monitoring. he new class of medications are marketed as a replacement for Coumadin, or warfarin, which has long been the standard anticoagulation therapy. The new class of treatments have been promoted as superior to warfarin because they are easier to take and require less frequent monitoring to maintain the correct dose. However, unlike older generic blood thinners such as warfarin, Xarelto and Pradaxa do not have a reversal agent that allow doctors to quickly stop the blood thinning effects. Pradaxa was the first drug in this class to go to market, introduced by Boehringer Ingelheim in 2010. It has become one of the most common prescription medications associated with adverse event reports submitted to the FDA, often associated with uncontrollable bleeding problems.

In the Xarelto lawsuit, like the Pradaxa plaintiffs, the plaintiff alleges that the manufacturers of Xarelto concealed their knowledge that the drug can cause life threatening, irreversible bleeding. Both the manufacturers of Pradaxa and Xarelto are currently working with pharmaceutical partners in hopes of developing a reversal agent.

Boehringer Ingelheim currently faces more than 2,000 Pradaxa personal injury lawsuits that have been filed on behalf of users who experienced severe bleeds, strokes and heart attacks. Bayer and Johnson & Johnson are working with a company called Portola Pharmaceuticals to develop a reversal agent to Xarelto.

If you or someone you love suffered from uncontrollable bleeding due to taking Pradaxa or Xarelto, contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Motion to Establish Byetta, Januvia and Victoza MDL for Thyroid Cancer Lawsuits Withdrawn By Plaintiffs

A recently filed request to add all Byetta thyroid cancer lawsuits to the consolidated federal multi-district litigation (MDL) being handled by the Southern District of California was withdrawn by plaintiffs by motion on February 18, 2014. The MDL is pending for pancreatic cancer lawsuits currently before Judge Anthony Battaglia in the U.S. District Court for the Southern District of California. Judge Battaglia is presiding before an established MDL for all Byetta, Januvia, Janumet and Victoza lawsuits filed in federal court that involve allegations that the plaintiffs developed pancreatic cancer after taking these drugs.

A motion filed by Plaintiffs last month had asked that all cases involving thyroid cancer and the above drugs also be centralized before Judge Battaglia. The motion was made to the Joint Panel on Multidistrict Litigation (JPML).

here are currently more than 300 cases pending before Judge Battaglia, but all of those cases involve individuals diagnosed with pancreatic cancer. Following a status conference on January 16, Judge Battaglia indicated that the Court will continue to monitor discussions between the parties regarding the Byetta thyroid cancer cases to ensure a plan for managing the cases is put in place –

At the time the request was filed to establish a second MDL before Judge Battaglia, there were at least 36 different lawsuits pending in three different U.S. District Courts involving plaintiffs who allege they developed thyroid cancer from Byetta. However, Judge Battaglia indicated last month that there is a potential for this number to grow into something in the hundreds.

Plaintiffs motion to withdraw its request states: “Movants are withdrawing their motion to consolidate in order to facilitate further discussions with Defendants related to this motion.” “Plaintiffs believe it is in the interests of justice and efficiency that further discussions are had among counsel prior to presenting this motion to consolidate to the Panel for resolution.”

If you took Januvia, Janumet, Byetta or Victoza and developed pancreatic or thyroid cancer, contact Cliff Rieders, Esq. of the Rieders travis Firm to determine whether you may have a claim. 

Mirena Birth Control Lawsuit Filings Approach 1000

The number of women pursuing personal injury product liability lawsuits over Mirena birth control continues to mount with more than 1,000 complaints already filed in New Jersey state court and New York federal court consolidated litigation proceedings.

irena is a long-lasting form of birth control known as an intrauterine device, or IUD. According to claims brought by women nationwide, Merck sold the product without providing adequate warnings about potential serious side effects associated with Mirena, particularly the risk that the device could move or migrate internally, causing severe internal injuries to other organs in the body.

A multi-district litigation (MDL) is pending in federal court for the Southern District of New York, before presiding district court Judge Cathy Seibel. There are at least 408 cases in this Mirena MDL.

Another centralized proceeding is established in state court in New Jersey before Judge Brian Martinotti, where at least 628 lawsuits are pending. Merck, the Defendant, has its headquarters in New Jersey.

he number of new cases filed is growing at a rapid rate in both New Jersey and the federal court system. The size of the federal Mirena litigation has increased nearly 20% over the past month, with the total number of cases increasing from 344 pending as of January 15.

Since 2000, more than 70,000 adverse events have been field with the FDA involving Mirena, including perforation and puncture of the uterus and other organs, infections and abscess and other serious complications.

If you have been seriously injured by the IUD Mirena, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim against Merck. 

Boston Scientific Obtryx Sling Lawsuits Consolidated for Trial

The judge presiding over more than 50,000 vaginal mesh lawsuits pending in federal court, U.S. District Judge Joseph R. Goodwin of the Southern District of West Virginia, has scheduled a combined trial date for October 14, 2014 which will involve 11 different cases brought by women who experienced problems stemming from a Boston Scientific Obtryx sling for stress urinary incontinence (SUI). The device is not used for pelvic organ prolapse (POP).

Judge Goodwin is currently overseeing eight different federal multidistrict litigations (MDLs), which have been centralized in the Southern District of West Virginia for product liability lawsuits brought against different manufacturers of vaginal mesh and bladder sling products, including Boston Scientific, Ethicon, American Medical Systems (AMS), C.R. Bard, Coloplast, Cook Medical and Neomedic.

These early trial dates, including the October 14, trials are known as bellwether trials that help test the strength of the claims brought in the lawsuits in the vaginal mesh multi-district litigations (MDLs).

According to a pretrial order in the MDL that was issued on February 19, 2014, a trial scheduled to begin on October 14, 2014 will include eleven lawsuits brought by different women against Defendant Boston Scientific involving the Obtryx Transobturator Mid-Urethral Sling System, used to treat stress urinary incontinence (SUI).

All of the complaints in the eight MDLs involve similar allegations that women experienced complications from baldder slings and vaginal mesh implants that were surgically implanted transvaginally for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Lawsuits claim that the surgical mesh was defectively designed and unreasonably dangerous, carrying a risk of the mesh eroding through the vagina, causing infections and other debilitating injuries.

If you have been seriously injured by a vaginal mesh or bladder sling used to treat pelvic organ prolapse or stress urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Breaking News – Lipitor Diabetes Lawsuits Centralized in Multi-District Litigation

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to consolidate all Lipitor (atorvastatin) diabetes lawsuits filed against Pfizer throughout the federal court system before one federal judge in the U.S. District Court for the District of South Caroline, granting Plaintiff’s request.

Several hundred product liability complaints have been filed by women throughout the United States, all involving similar allegations that Pfizer failed to provide adequate warnings for users or the medical community about the risk of developing Type 2 diabetes as a side effect of taking Lipitor for elevated blood cholesterol.

Oral arguments were heard earlier this month on a motion brought by plaintiffs to consolidate all of the Lipitor lawsuits in a MDL by a panel of federal judges. The JPML panel found that the rapidly increasing number of lawsuits filed through the country justified centralized management of the litigation in a MDL to avoid duplicative discovery, conflicting rulings and other problems concerning witnesses.

A court order was issued on February 18, 2014 to consolidate all of the federally filed Lipitor cases, transferring them to U.S. District Judge Richard M. Gergel in the District of South Carolina. At the time of the transfer request, there were 56 Lipitor cases pending, including 14 in the South Carolina federal court. However, the panel estimates that there are at least another 170 tag-along cases filed in recent weeks, which will also be transferred into the Lipitor MDL -In addition, plaintiffs attorneys continue to review potential cases from women who developed Type 2 diabetes while taking Lipitor and many more filings are expected.

The JPML agreed with the plaintiffs, finding that the number of lawsuits, plaintiffs, and law firms involved has grown considerably. The panel also rejected an argument by Pfizer that consolidation would draw an increased number of frivolous Lipitor lawsuits.

If you are a woman with a body mass index (BMI) under 30, but developed Type 2 diabetes while taking Lipitor to lower your blood cholesterol, contact Cliff Rieders, Esq. today to determine whether you may have a claimthat can be brought in the MDL against Pfizer.

First Ethicon Vaginal Mesh Bellwether Ends in Judgment for Defendant

The first federal bellwether trail for an Ethicon vaginal mesh lawsuit ended in a defense verdict on Tuesday after the Judge entered a judgment as a matter of law following the Plaintiff’s presentation of her case.

There are over 40,000 cases filed against several different manufacturers of products used during surgical repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI) including Ethicon (a division of Johnson & Johnson), American Medical Systems, Boston Scientific, C.R. Bard, Coloplast and Cook Medical.

All of the lawsuits involve similar allegations that transvaginal mesh and bladder sling products were defective and unreasonably dangerous, causing women to experience complications where the mesh eroded through the vagina, caused infections and other injuries. U.S. District Judge Joseph Goodwin is presiding over six separate federal MDLs, or Multidistrict Litigations, which have been centralized in the Southern District of West Virginia.

The trial against Ethicon began on February 10, 2014 before Judge Goodwin and stemmed from a complaint filed by Carolyn Lewis. The JNOV was issued by Judge Goodwin on February 18, 2014 when he found that the plaintiff failed to present sufficient evidence showing that the Ethicon TVT pelvic mesh was defectively designed or caused her to suffer any injury.

Attorneys for Johnson & Johnson and Ethicon filed a summary judgment motion at the conclusion of plaintiff’s presentation of her case, arguing that a reasonable jury could not find that the plaintiff met her burden of proof.

Lewis’s attorneys argued that she did not need to prove that defects in the vaginal mesh caused her injuries, maintaining that she should only be required to show that the injuries were caused by the product.

In this case, the plaintiff had been treated for stress urinary incontinence, not pelvic organ prolapse.

The plaintiffs also pointed out that Ethicon’s own worldwide medical director, Dr. Piet Hinoul, testified that Ethicon knew that it was theoretically possible that women would suffer life-long pain during intercourse due to nerve damage at the time they launched the product.

The lawsuit filed by Carolyn Lewis was the first in a series of ten test cases, or bellwether trials, expected to be held this year before Judge Goodwin, with about one case set to begin each month between February and December involving products manufactured by Ethicon, AMS, Boston Scientific and Bard.

Prior to this year, three other vaginal mesh cases have gone to trial, two in state court and one in federal court. In all three of those cases, plaintiffs prevailed and received multi-million dollar awards.

If you have been injured by a vaginal mesh product used to treat pelvic organ prolapse (POP) contact Cliff Rieders, Esq. of the Rieders Travis Fuirm today to determine whether you have a claim.

New Pulmonary Embolism Lawsuit Filed Against AbbVie Concerning AndroGel

North Carolina man has filed a product liability lawsuit against the makers of the testosterone replacement therapy AndroGel, alleging that the side effects of the testosterone gel caused him to suffer a pulmonary embolism, deep vein thrombosis and blood clot injuries. AbbVie, the defendant, is a division of Abbott Laboratories.

The complaint was field against AbbVie in U.S. District Court for the Northern District of Illinois on February 10. The case joins a growing number of testosterone replacement therapy lawsuits filed in the last few weeks by men who allege that testosterone replacement therapies AndroGel, Axiron and Testim caused them to suffer heart attack, stroke or sudden death.

Last month, the FDA launched an investigation into the potential testosterone therapy heart risks after two new clinical studies indicated that users of these pharmaceuticals may face an increased risk of cardiovascular events.

The North Carolina complaint alleges that AndroGel causes the levels of hematocrit to increase, thereby thickening the blood, and that this effect can lead to life threatening cardiac events, strokes and thrombolytic events. The complaint further alleges that AbbVie failed to warn about the risk of AndroGel problems, as well as presenting claims of negligence, breach of warranty, fraud, misrepresentation and loss of consortium on behalf of his wife, and seeks both compensatory and punitive damages.

AndroGel is a prescription topical gel applied to the upper arms as a testosterone replacement therapy, which is designed for men suffering from testosterone deficiency caused by medical conditions such as hypogonadism. The testosterone treatment is the most widely used replacement therapy, with various other products sold as gels, patches, injections, implants and pills.

If you have suffered a heart attack stroke, severe blood clot or pulmonary embolism while taking testosterone replacement therapies such as AndroGel, Axiron or Testim, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

FDA to Wait for Study Results Before Changing NSAID Safety Labeling

The U.S. Food & Drug Administration (FDA) will wait until a large clinical study currently underway is completed before deciding whether labeling for non steroidal anti inflammatory drugs (NSAIDs) including Celebrex and Naproxen should contain warnings for increased risk of cardiac events.

The FDA made the decision on the recommendation of an expert advisory panel that was convened following the Lancet’s publication of a retrospective analysis of multiple clinical trials (2013) which suggested naproxen was less dangerous to the heart than other NSAIDs.

The advisory panel said that the available evidence does not prove that the painkiller Naproxen carries lower cardiac risk than rival products. They advised the FDA to allow the Precision study, being led by Dr. Steve Nissen, chairman of the Cleveland Clinic’s Department of Cardiovascular Medicine and the lead investigator on the Precision Study to finish first. Precision has so far enrolled 27,000 patients and is expected to complete towards the end of 2015. The study has already been underway for seven years to test the safety of NSAIDs. The issue of cardiovascular safety associated with NSAIDs has been an issue for the FDA since Merck & Co.’s Vioxx was taken off the market when it was found to increase the risk for heart attack. The advisory panel stated they are looking to the Precision study to provide definitive answers to the question of cardiovascular safety with these drugs.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

Breaking News – J&J Prevails in First Ethicon Vaginal Mesh Trial With Directed Verdict

U.S. District Court Judge Charles Goodwin today granted a directed verdict for Defendant Johnson & Johnson’s Ethicon unit on Plaintiff Carolyn Lewis’s claims that a TVT Retropublic Sling implanted to treat urinary stress incontinence was improperly designed.

The Lewis case was the first TVT Retropublic case to go to trial as a bellwether trial. Johnson & Johnson, based in New Brunswick, NJ faces more than 12,000 lawsuits in federal court over the TVT Retropublic sling and its other vaginal mesh products that are the subject of the litigation. The majority of the lawsuits are consolidated in U.S. District Court in the Southern District of West Virginia before Judge Goodwin.

The Judge concluded that Plaintiff’s attorneys failed to present sufficient evidence to support her claim that the defect in the device caused her injury.

Last year the FDA ordered C.R. Bard, Ethicon and 230 other manufacturers of vaginal implants to study rates of organ damage and complications linked to the implants.

Patients have sued Johnson & Johnson (Ethicon), Endo Health Solutions, Boston Scientific and C.R. Bard in tens of thousands of vaginal mesh lawsuits, the majority of which are consolidated in six separate mutli-district litigations (MDLs) in West Virginia before Judge Goodwin.

J&J officials decided last year to stop selling some lines of vaginal-mesh implants after being hit with a wave of suits over the devices. J&J, the world’s biggest maker of medical products, contended in court filings that its Prolift and TVT Retropubic devices are safe and effective and that the company gave adequate warning of any risks associated with them.

If you have been injured by a vaginal mesh device used to treat pelvic organ prolapse or another condition, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

Fresenius Granuflo Lawsuit Statute of Limitations May Be Approaching

As the two year anniversary approaches for the NaturaLyte and GranuFlo recall issued by Fresenius Medical Care in March 2012, an influx of product liability lawsuits are likely to be filed on behalf of dialysis patients who suffered sudden death or sudden cardiac arrest in the dialysis chair during treatment.

Hundreds of Fresenius dialysis lawsuits are already pending in state and federal courts across the country, all involving similar allegations that Fresenius failed to adequately warn about the risks of heart problems from GranuFlo and NaturaLyte dialysis solutions from bicarbonate overload. The number of cases is expected to increase dramatically between now and March 2014 as the potential two year state statute of limitations may require that many cases be filed before the end of March. The statute of limitations in a case is the deadline by which a claim may be filed in court. States have different time limits for different types of claims. Many states have a two year statute of limitations that require an individual to file a claim for personal injury within two years of discovering the injury or the link between the product and the injury.

Although plaintiffs allege that Fresenius has known for years that a higher-than-expected number of patients were suffering sudden cardiac arrest or death during dialysis treatments, the first information about the risk became available on March 29, 2012, when the manufacturer sent a notice to its facilities using GranuFlo and NaturaLyte about the importance of patient monitoring of bicarbonate levels during treatment. The Food & Drug Administration (FDA) later classified this notice as a recall.

As a result of this first warning sent to clinics throughout the U.S., Fresenius Medical Care may argue that claims involving injuries that occurred prior to March 2012 in states with a two-year statute of limitations need to be filed by the end of next month. Plaintiffs are expected to allege that this warning was insufficient to trigger the statute of limitations from tolling.

In April 2013, a multi-district litigation (MDL) was established by the U.S. Panel on Multidistrict Litigation (JPML) to coordinate pretrial proceedings for all of the GranuFlo and NaturaLyte cases filed in federal court. All of these federally filed lawsuits are now consolidated in U.S. District Court for the District of Massachusetts before Judge Douglas Woodlock. A number of cases have also been filed against Fresenius involving similar allegations in Massachusetts state court.

If you or someone you love has been injured by GranuFlo or NaturaLyte and suffered a sudden heart attack or cardiac arrest dyring dialysis, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim that can be filed in federal court. 

Plaintiffs Allege J&J Trying to Renege on Risperdal Settlements

Plaintiffs’ lawyers involved in Risperdal side effects lawsuits allege that the makers of Risperdal, Johnson & Johnson have attempted to go back on an agreed upon settlement. As a result, in November 2013, plaintiffs in the Philadelphia state court litigation have filed a motion to enforce the settlements against the Defendant.

The motion was filed to have the Judge in the Philadelphia Court of Common Pleas litigation force settlement with 77 plaintiffs. The lawyers allege that Johnson & Johnson is trying to allege on a legally binding settlement that it entered into with these plaintiffs.

According to the motion, there were prior bellwether Risperdal cases that were settled, including Banks v. Janssen Pharmaceuticals, Inc., et al(January Term 2010, No. 00618) and Rolen v. Janssen Pharmaceuticals, Inc., et al., (January Term 2010, No. 00649). Both, along with four other bellwether cases in the same trial pool, were reportedly settled in late 2012 for confidential amounts. The Plaintiff lawyers argue that a settlement was reached in 78 Risperdal lawsuits on January 28, 2013 for a confidential amount, but that one plaintiff was ultimately withdrawn from the settlement. According to motin papers filed by the Plaintiffs, months later, Johnson & Johnson reportedly objected to the settlement, despite, according to plaintiff’s lawyers, several status conferences during which the settlement was discussed.

There are approximately 420 lawsuits pending between Johsnon & Johsnon and plaintiffs in the Pennsylvania litigation involving Risperdal, with about 130 of those suits claiming young males developed gynecomastia after taking the drug.

If you have been injured by a pharmaceutical drug contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

Xarelto Expanded Use Again Rejected by FDA

For the third time, the Food & Drug Administration (FDA) has rejected a joint request by Johnson & Johnson and Bayer Pharmaceuticals to expand the use of its blood thinner Xarelto (rivaroxaban) for prevention of heart attacks, cardiac arrests and strokes in patients with acute coronary syndrome. he makers of anticoagulant Xarelto, which is a joint effort between Johnson & Johnson and Bayer, also wanted the drug approved for prevention of coronary events due to stent thrombosis

Last month, the FDA’s Advisory Panel had recommended against the expanded use of Xarelto.

Xarelto is one of a new generation of anticoagulants used to decrease the risk of blood clots and trokes. These class also includes the first to market, Boehringer Ingelheim’s Pradaxa.

Potential side effects of Xarelto and other members of the same class of anticoagulants include a potential risk of uncontrollable bleeding, as the medications Xarelto and Pradaxa do not currently have an effective antidote to allow doctors to reverse the blood thinning effects of the drug when a hemorrhage begins. The treatments have been promoted as superior to generic warfarin, or Coumadin, (which has an antidote, Vitamin K), because they are allegedly easier to take and require less frequent blood monitoring.

Xarelto was first introduced in July 2011, as the second drug in this new class of “direct thrombin inhibitors.” It is currently approved for prevention of deep vein thrombosis (DVT) among individuals undergoing knee or hip replacement surgery, to reduce the risk of stroke among people suffering from atrial fibrillation and to reduce the risk of DVT or pulmonary embolism (PE).

Pradaxa (dabigatran) was the first drug in this class to hit the market, introduced by Boehringer Ingelheim in October 2010. While Pradaxa did gain an advantage by being first to market, concerns have surrounded the medication, as it quickly became one of the most common prescription medications associated with adverse event reports submitted to the FDA, often involving problems with uncontrollable bleeding.

While all blood thinners carry a risk of bleeding, Xarelto, Pradaxa and other direct thrombin inhibitors currently lack an effective reversal agent. While doctors are able to administer a dose of vitamin K and plasma to reverse any bleeding problems that develop with warfarin, no such antidote is available for the new class of medication.

Boehringer Ingelheim currently faces over 2000 Pradaxa lawsuits that have been field in federal court for the Southern District of Illinois in a multi-district litigation or MDL.

If you or someone you love took Pradaxa or Xarelto and suffered from an uncontrollable bleeding event, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim that can be filed in court.

Astra Zeneca Buys Bristol-Myers Squibb Diabetes Interests, Including Byetta Amid Mounting Lawsuits

Amid mounting Byetta lawsuits alleging that the drug caused plaintiffs taking the Type 2 diabetes drug to develop pancreatic cancer, Bristol Myers Squibb has chosen to sell off its entire diabetes division, including its interests in Byetta, to Astra Zeneca.

Last week, Astra Zeneca announced that it will pay $4.1 billion to acquire Bristol Myers Squibb’s diabetes drug line, including Nyetta, Bydureon and Onglyza. The acquisition comes as a number of product liability lawsuits including Byetta and other incretin mimetic injectable agents for Type 2 diabetes allege that such incretin mimetic drugs have caused patients to develop pancreatic cancer. The drugs involved in the pending incretin mimetic litigation include Byetta as well as Merck Sharp & Dohme’s Januvia and Janumet and Novo Nordisk’s Victoza.

Incretin mimetics work by work by mimicking the incretin hormones that the body usually produces to naturally stimulate the release of insulin in response to a meal. However, over the past year, concerns have been raised about the risk users may face of developing cancer following long-term use of the medications.

In March 2013, the risk of pancreatic cancer from Januvia, Byetta, Janumet and Victoza gained attention after a study published in the medical journal Diabetes found that pancreas tissue from organ donors found that those who took incretin mimetics were more likely to have increased pancreatic mass and precanecerous cells.

As the number of complaints began to spike throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated proceedings in the federal court system in August 2013. All pancreatic cancer lawsuits involving Januvia, Janumet, Byetta and Victoza are currently consolidated as part of an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Anthony J. Battalglia in the Southern District of California.

If you have taken Januvia, Janumet, Byetta or Victoza and developed pancreatic cancer, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim that can be filed in conjunction with ongoing litigation. 

Competing Case Management Proposals Submitted in Incretin Mimetic Litigation

Competing case management proposals have been submitted by leadership attorneys in the federal multidistrict litigation (MDL) established for Byetta, Januvia, Janumet and Victoza lawsuits filed by individuals diagnosed with pancreatic cancer after using the incretin mimetic injectible Type 2 diabetes drugs. The MDL is currently pending in federal District Court for the Southern District of California before Judge Anthony Battaglia. There are currently at least 262 cases centralized in the MDL.

As part of the coordinated proceedings, Judge Battaglia ordered the parties to submit a joint proposal regarding various deadlines for discovery in the litigation and the selection of a small group of cases to serve as “bellwether” trials, which are generally designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of cases.

Lawyers appointed to leadership roles for the plaintiffs and defendants failed to reach an agreement on a joint proposal so competing proposals were submitted earlier this week. These proposals will be reviewed by the court in advance of an upcoming status conference, scheduled for February 18, 2014.

Defendants’ proposal asks for submission of Plaintiff’s causation expert reports in less than 90 days, prior to completing fact discovery, which is a quite unusual discovery plan. This is because the manufacturers contend that the drugs at issue do not cause pancreatic cancer and this expert issue of causation should be reviewed by the court early in the litigation before conclusion of fact discovery.

Plaintiffs contend that this is inappropriate before they have been fully permitted discovery of records from the drug companies about what they knew of the pancreatic cancer risks from internal documents and data that have not been made public.

If you or someone you loved contracted pancreatic cancer from taking Byetta, Januvia, Janumet or Victoza, contact Cliff Rieders of the Rieders Travis Firm today to determine whether you have a claim. 

FDA to Review Heart Failure Risk With Diabetes Drug Onglyza

On February 11, 2014, the FDA announced that it requested clinical data from the manufacturer of Onglyza (saxagliptin) to investigate a possible association between use of the drug and heart failure. This request resulted from a recent study published in the New England Journal of Medicine (NEJM) which reported an increased rate of hospitalization and heart failure with use of saxagliptin compared with inactive treatment.

Onglyza is marketed by AstraZeneca to treat Type 2 diabetes. However, AstraZeneca just recently completed a deal to purchase all of Bristol Myers Squibb’s diabetes assets, which had included both Byetta and Onglyza. The manufacturer is expected to submit the requested data by early March 2014, at which point the FDA will conduct its analysis.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

Alloderm Hernia Patch Lawsuits to be Selected for Early Trial Dates in New Jersey

As several hundred product liability lawsuits continue to move forward in New Jersey state court involving individuals who experienced problems from an AlloDerm hernia patch, the parties are expected to select a small group of cases next week to be prepared for potential bellwether trials that will begin in September 2015.

There are currently more that 330 AlloDerm lawsuits filed in New Jersey state court, which have been consolidated in a multi-county litigation, or mCL before Superior Court Judge Jessica R. Mayer in Middlesex County. All of the complaints involve complications from patients who received the AlloDerm Regenerative Tissue Matrix for hernia surgery or abdominal repair. AlloDerm is manufactured by LifeCell Corporation, a New Jersey company.

The complaints all involve similar reports that individuals experienced complications after AlloDerm hernia repair, where the patch began to stretch, sag or loosen once implanted. This has been linked to reports of severe abdominal pain, infection, inflammation, injury to nearby organs, adhesion failure, hernia recurrence and other problems.

Last month, Judge Mayer issued a case management order that outlines the bellwether trial selection process. Following the selection of 20 cases for an initial pool by December of last year, the parties are expected to further narrow the pool by February 18, with each side choosing four cases for a total of 8 cases.

If you have suffered an injury because of a recalled AlloDerm patch, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

Sales of AndroGel Drop with New Studies on Safety of Testosterone Replacement Therapies

Sales of Abbott’s AndroGel, the leading testosterone replacement therapy on the market, slipped in the fourth quarter of 2013 and are likely to continue to decrease amid concerns that the drug and other testosterone replacement therapies may be linked to higher rates of heart attacks and strokes according to two new clinical studies.

In the fourth quarter AbbVie, a division of Abbot Laboratories that makes AndroGel saw its sales 21% and 10% overall last year.’

Although a number of different testosterone injections, testosterone gels and other treatments are available, AndroGel has 60% of the testosterone replacement therapy market. That dominance has been expected to continue until at least 2015, when AbbVie loses patent protection and generic AndroGel equivalents may become available

AndroGel is a topical testosterone replacement therapy that is applied to the upper arms. It is approved by the FDA to treat low testosterone caused by a condition known as hypogonadism. However, critics say that it is being liberally prescribed to men who are seeking to reverse the effects associated with the natural decline in testosterone levels that occur as all men age. Critics suggest that the drug maker has created a market for low testosterone treatments, although most men receiving the medications have no real medical need.

On January 31, the FDA announced that it is invextigating the potential risks of testosterone replacement therapies, including AndroGel, Testim and AndroDerm. In a safety announcement issued by the agency, the FDA indicated that the products were never approved for any use other than to treat men who have a medical condition that’s causing them to have lower testosterone than normal, such as hypogonadism.

Two recent studies support an increase in heart attacks from using testosterone replacement therapies, including AndroGel. A November 2013 study published in the Journal of the American Medical Association and a study released last week that was published in the medical journal PLOSOne both found that testosterone replacement therapies increased the risks of heart attack, stroke and death.

If you have suffered a heart attack while taking testosterone replacement therapies, including AndroGel, Axiron or AndroDerm, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim that can be filed in court. 

Endocrine Society Calls for Long Term Testosterone Replacement Therapy Study

group of endocrinology experts are calling for large scale scientific studies to help doctors better determine the potential risk of heart attacks and stroke with testosterone replacement therapy (TRT), including the popular medicines AndroGel, Testim and AndroDerm.

On February 7, 2014, the Endocrine Society issued a statement warning about the serious concerns raised by two recent studies that suggest that users of testosterone treatments may face increased cardiovascular risks, urging doctors to follow the Society’s clinical practice guidelines on appropriate prescribing of these drugs.

“Large scale, prospective, randomized controlled trials are needed to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels,” the Society states. –

On January 31, the FDA announced that it is invextigating the potential risks of testosterone replacement therapies, including AndroGel, Testim and AndroDerm. In a safety announcement issued by the agency, the FDA indicated that the products were never approved for any use other than to treat men who have a medical condition that’s causing them to have lower testosterone than normal, such as hypogonadism.

If you suffered a heart attack or stroke while taking AndroGel, Testim or AndroDerm, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm to determine whether you might have a claim against the manufacturer for your devastating injuries. 

MDL Trial for Ethicon Gynecare Mesh Lawsuit to Begin This Week

Trial is set to begin this week against Johnson & Johnson subsidiary Ethicon in a case filed by a Texas woman who alleges that she suffered problems with the Gynecare TVT transvaginal mesh.. This is the first MDL trial to go before a jury concerning thousands of cases involving Ethicon Gynecare transvaginal mesh products.

There are currently more than 11,000 Ethicon Gynecare mesh cases filed throughout the federal court system which are currently consolidated before U.S. District Court Judge Joseph R. Goodwin in the Southern District of West Virginia as part of a multi-district litigation (MDL).

All of the lawsuits involve similar allegations that women suffered devastating injuries from transvaginal mesh products made by Ethicon, which were used for surgical treatment of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Plaintiffs allege that design defects led to the mesh to eroding through the vagina, causing infections and other painful injuries.

In the case at trial, the complaint filed by Carolyn Lewis, the plaintiff, was selected as the first in a series of test cases in the Ethicon litigation known as bellwether trials. Following the Lewis trial it is expected that nine other bellwether trials will be held against Ethicon over the course of the year, with about one case per month, involving claims against Ethicon, American Medical Systems, Boston Scientific and C.R.Bard.

In advance of the start of the Lewis case, Judge Goodwin issued an order (on February 4, finding that Ethicon failed to properly preserve documents relevant to the litigation. While Judge Goodwin did decline to issue a summary judgment in favor of the plaintiffs as punishment for the discovery violations, the Court determined that juries will be allowed to be told by plaintiffs that Ethicon destroyed and lost key evidence.

If you have been injured by faulty vaginal mesh products, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim that can be filed in the multi-district litigation. 

Bellwether Plan to be Proposed for Propecia Sexual Side Effects Litigation

As the litigation continues to progress, the parties are working on a proposed plan for completion of discovery in the multi-district litigation (MDL) concerning Propecia (finsasteride) and selecting a series of cases for early trial dates, known as bellwether cases.

There are currently more than 1100 Propecia lawsuits pending in federal and state concerning claims brought by men that they have suffered sexual problems after using Propecia to restore hair loss. The product liability complaints allege that Merck failed to adequately warn men about the risk of long-lasting and even permanent sexual dysfunction that can result from use of the medications.

There are at least 740 cases currently consolidated in a multi-district litigation or MDL in federal U.S. District Court for the Eastern District of New York before Judge John Gleeson. During a status conference held last week before U.S. Magistrate Judge Viktor V. Pohorelsky, lawyers involved in the federal litigation discussed the current status of discovery into general items that apply to all cases, including document production, depositions of Merck employees and the plan for collecting and maintaining medical records of the plaintiffs.

The Propecia label was updated in April 2012 listing a variety of permanent sexual adverse events that have been reported with Propecia. Information about the FDA’s label change can be found here. http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm299754.htm

If you took Propecia and suffered severe permanent sexual side effects, contact Cliff Rieders, Esq. to determine whether you may have a complaint. 

Breaking News – Merck Agrees to $100 Million Nuva Ring Settlement

Rather than face continued litigation and trial in several thousand lawsuits brought on behalf of women who allege they suffered serious blod cots due to NuvaRing birth control, Merck has agreed to pay $100 million to settle the litigation.

A global settlement was announced on February 7, 2014 during a hearing before New Jersey Superior Court Judge Brian Martinotti, which includes both cases pending in state court and in the federal court system as well as some cases that are qualifying but have not yet been filed.

Judge Martinotti noted that there are about 3,800 filed NuvaRing cases against Merck nationwide. The average payout of the settlement per case is expected to be $58,000 per plaintiff based on a report by Bloomberg News which can be found here: http://www.bloomberg.com/news/2014-02-06/merck-said-to-agree-to-100-million-nuvaring-settlement.html

Under the terms of the NuvaRing settlement, each participant must meet certain basic requirements to qualify for a payout. The settlement offer requires that 95% of all eligible plaintiffs agree to participate. If a sufficient number of plaintiffs do not agree to settle through this lump sum offer, Merck can walk away from the settlement and continue to defend the cases in litigation.

NuvaRing is a vaginal contraceptive ring which delivers a combination of ethinyl estradiol and etonogestrel to prevent pregnancy. It is manufactured and marketed by Organon Pharmaceuticals, a subsidiary of Merck. Several studies have found that women may face substantially higher risks of blood clots while using Nuva Ring compared with oral contraceptives.

Judge Martinotti is presiding over a coordinated proceeding in New Jersey superior (state) court. More than 2,012 cases are pending in that coordinated litigation, centralized in Bergen County. In federal court, more than 1,573 NuvaRing cases are centralized in a multi-district litigation (MDL) before Judge Rodney Sipple in the Eastern District of Missoiri.

If you have been injured by NuvaRing or another medical device or pharmaceutical, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim.

Biomet Settlement Reached

An agreement has been reached to settle pending Biomet M2a Magnum hip lawsuits brought in federal court.  The manufacturer has agreed to pay $56 million to resolve the cases alleging that design problems with the metal-on-metal hip implant  caused them to require hip revision surgery.

 

There are currently about 1000 Biomet hip product liability lawsuits pending in federal court.  The federal litigation is centralized in a multi-district litigation (MDL) pending before Judge Robert L. Miller in U.S. District Court for the Northern District of Indiana.  The cases were being prepared for a series of bellwether trials before the settlement was reached.  These trials had been expected to take place this year.

 

According to a February 3, 2014 court order, the settlement that was reached will resolve all pending Biomet cases in the MDL where individual plaintiffs have required hip revision surgery.  Biomet has agreed to pay a base amount of $200,000 for each claimant, with other factors impacting the individual amount for each case settlement. The amount paid to each plaintiff was similar as for the settlement that was reached in the DePuy ASR hip implant litigation, which was settled late last year.  Excluded from the settlement in the Biomet litigation are claims made by plaintiffs who have not undergone hip revision surgery.  There are approximately 237 such cases remaining in the MDL.

 

If you have been injured by a defective hip device such as the Biomet M2a or Stryker Rejuvenate hip implant, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim that can be brought in connection with the pending litigations.

New Androgel Lawsuits Filed Over Heart Attacks from Testosterone Gel

Following the release of two new studies strongly suggesting a link between the increased risk of heart attacks from testosterone replacement therapies like Androgel, at least four new complaints were filed by men in U.S. District Court for the Northern District of Illinois alleging that they suffered a heart attack after using Androgel for the treatment of low testosterone.

These complaints were brought in federal court in Illinois, which is the home state of Androgel’s manufacturer, AbbVie, which is a spin-off of Abbott Laboratories.

The FDA has approved Androgel for treatment of low testosterone for a medical condition known as hypogonadism.  However, AbbVie and other companies in the space have used direct-to-consumer marketing in attempt to convince men that they need treatment for low testosterone levels and various symptoms including lack of energy, weight loss and lack of sex drive, when the condition may not really require treatment at all as those symptoms may simply be attributable to the natural aging process.  Therefore, in their complaints, plaintiffs allege that AbbVie is trying to create a false market for Androgel, and that other companies that make similar testosterone replacement therapy gels are doing the same.

These new complaints come on the heels of two recent studies supporting an increase in heart attacks from using testosterone replacement therapies, including a November 2013 study published in the Journal of the American Medical Association and a study released last week that was published in the medical journal PLOSOne.  Both studies found that testosterone replacement therapies increased the risks of heart attack, stroke and death.

On January 31, 2014, the FDA announced that in response to these new studies, it is investigating the safety of testosterone therapies, including the potential for heart attack, stroke or even death.

Androgel Lawsuits

If you have suffered a heart attack or stroke while taking testosterone replacement therapies such as AbbVie’s Androgel, contact Cliff Rieders, Esq. of the Rieders Travis Firm today to determine whether you have a claim.

Pradaxa Manufacturer Boehringer Ingelheim May Have Suppressed Critical Report

The New York Times today reported that Boehringer Ingelheim, the German manufacturers of the anti-coagulant drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees pressured the authori to revise the paper and sought to quash it altogether.

The documents were made public last week in the pending multi-district litigation (MDL) in the Northern District of Illinois.  These lawsuits allege that the drug Pradaxa can cause fatal bleeding, hemorrhage, heart attack and stroke.  The drug has been linked to more than 1000 deaths since it was approved by the FDA in 2010.

Boehringer Ingelheim has stood by its drug, noting that the FDA has upheld its safety, and further touting its clinical trials.

Many of the documents released by Judge David Herndon in the pending litigation centered on whether a coming research paper would undercut one of Pradaxa’s main selling points compared to generic warfarin (Coumadin), that Pradaxa does not require regular blood monitoring to ensure that it is working.

The documents that were released by Judge Herndon showed that Boehringer Ingelheim openly fretted when it appeared that the results of a research paper written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from blood monitoring.  In emails, company executives wrote that the research if known, would undermine the company’s efforts to compete with other new anticoagulants coming to market such as Xarelto and Eliquis.

A link to the full New York Times article is available here.

If you or someone you loved took Pradaxa and suffered from hemorrhage or uncontrolled bleeding contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Another Stryker Rejuvenate Lawsuit Settles

As a result of mediation efforts in New Jersey State Court as part of Judge Brian Martinotti’s order in a consolidated multi-county proceeding, a fifth Stryker Rejuvenate hip replacement case has settled in the early stages of the litigation process, meaning that 5 of 8 cases tat went through the court-ordered mediate process have settled so far.

There are presently about 1200 Stryker Rejuvenate cases filed around the country. The majority of these are filed in the New Jersey state court multi-county proceeding based in Bergen county or in a federal multi-district litigation (MDL) in the District of Minnesota before Judge Donavan Frank. The cases are individually filed by persons who had problems with the Stryker Rejuvenate or ABG II modular hip implants, which were recalled in July 2012 amid reports that the design was prone to fail within a few years. About half of the filed cases are pending in the federal MDL in Minnesota and roughly another 660 or half of the cases are pending in New Jersey State Court. New Jersey is the location of Osteonics Corp., the parent company for Stryker.

In the New Jersey state proceeding in Bergen county, a group of ten cases were selected for early mediation and so far eight have gone through early mediation. Five of those cases have settled.

Unlike traditional hip implants, which feature a single femoral component, the Stryker Rejuvenate and ABG II contain a modular neck-stems, which consists of two pieces that fit inside each other to allow the surgeon to customize the length of the femoral component based on the patient. However, the design has been linked to an increased risk of problems that may result from the release of microscopic metal debris as the chromium-cobalt neck rubs against the titanium femoral stem.

If you have one of the recalled hip implants., Stryker Rejuvenate or ABG II and underwent removal surgery or will need to have the implant removed, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine if you have a claim as part of one of these ongoing litigations. 

Motion Filed to Centralize Incretin Mimetic Thyroid Cancer Cases with JPML

A motion has been filed with the U.S Judicial Panel on Multidistrict Litigation (JPML), seeking to consolidate and centralize all Byetta thyroid cancer lawsuits filed throughout the federal court system, asking that the cases be transferred to the same judge presiding over all lawsuits involving allegations that users of the diabetes drugs Byetta, Victoza, Januvia or Janumet developed pancreatic cancer.

In August 2013, the U.S. JPML established a federal multidistrict litigation (MDL) for all product liability lawsuits filed in U.S. District Courts against the makers of the incretin mimetic diabetes drugs, but limited the proceedings to just cases involving allegations that plaintiffs suffer pancreatic cancer.

There are currently at least 262 Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits consolidated as part of this incretin mimetic MDL, which are centralized before U.S. District Judge Anthony J. Battalglia in the Southern District of .

In a motion filed on January 28, plaintiff Elizabeth Childress asked that cases involving thyroid cancer from Byetta also be centralized before Judge Battaglia in California.

At this time there are at least 36 lawsuits pending in three different federal district courts alleging that the makers of Byetta failed to adequately warn about the risk of thyroid cancer, and it is ultimately expected that additional claims will be filed in the future.

The U.S. JPML will likely schedule oral arguments on the motion for an upcoming hearing session scheduled for March 24, in San Diego, California.

If you have developed pancreatic cancer or thyroid cancer from taking Januvia, Byetta, Janumet or Victoza contact Cliff Rieders, Esq. of the Rieders Travis Firm.

Breaking News: FDA Reviewing Heart Attack and Stroke Risks with Testosterone Gels Like Androgel After New Clinical Study

Amid mounting concerns about the increased risk of heart attack and stroke with testosterone replacement therapies, based on two new clinical studies, the Food & Drug Administration (FDA) has announced that they are investigating the findings of recent studies that suggest popular medications like AndroGel, Testim and other testosterone supplements may pose serious risks for men.

On January 31, the FDA announced it is investigating the risk of testosterone based therapies including the potential risk of stroke, heart attack or even death.

The agency said the decision to take a new look at the potential side effects of the popular hormone therapy came after two studies showed an increased risk of heart problems for certain men using the gels, creams, injections, pills and patches.

In recent years the use of AndroGel, Androderm, Testim, Axiron and similar testosterone treatments has increased more than a factor of five, with more than $1.9 billion in sales in 2012.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) showed that testosterone replacement drugs were linked to an increased link of heart attack, stroke and death in older men with pre-existing heart problems.

Last week, another study published in PLOSOne, another medical journal, found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and older men without pre-existing heart conditions.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the FDA stated in a statement released on Friday. “We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”

If you have taken AndroGel, Testim, Androderm or Axiron and have suffered a heart attack or stroke while undergoing treatment with such testosterone replacement therapy, contact Cliff Rieders, Esq. to determine whether you may have a claim against the manufacturer. 

Two Bellwether Cases Selected for Further Trials in AMS Vaginal Mesh Litigation

Two federal cases involving pelvic mesh manufactured by American Medical Systems (AMS) have been selected for a third round of bellwether trials in the transvaginal mesh multi-district litigation (MDL).

In a court order dated January 24, 2014 in the U.S. District Court for the Southern District of West Virginia, the court selected the first case for trial on August 19, 2014 and the second case as back up if the first is unable to proceed for any reason. There are over 14,000 individual lawsuits pending in the litigation against AMS alleging that the various plaintiffs suffered pain, vaginal scarring mesh erosion and other complications from the company’s pelvic implants.

If you have been injured by pelvic or vaginal mesh implants contact Clifford Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim

Breaking News: Judge Finds Takeda Acted in Bad Faith, Destroyed Documents in Actos Litigation

A federal Judge has ruled that Takeda Pharmaceuticals has “clearly breached its duty” to preserve documents relating to claims that the side effects of the diabetes drug Actos (pioglitizone) increase the risk of bladder cancer.

U.S. District Court Judge Rebecca Doherty issued a ruling (PDF) on January 27, finding that Takeda Pharmaceuticals has acted in bad faith in preserving evidence during the pretrial proceedings and discovery process in the federal Actos litigation.

While Judge Doherty indicated that a default judgment will not be entered against the drug maker, indicating that such a sanction would be too extreme, she has stated that information may be presented to juries in Actos bladder cancer trials about Takeda’s actions and a decision will be made following the first bellwether case about what jury instructions or other sanctions may be warranted. The motion for sanctions was a pretrial motion filed by Plaintiff.

While Takeda has attempted to argue that it was unaware of a reasonable risk of lawsuits over Actos until the summer of 2011, Judge Doherty agreed with plaintiffs, finding that the company knew about the litigation for nearly 10 years before that time and was under an obligation to preserve files of key employees involved in the development and marketing of Actos.

There are currently more than 2600 Actos bladder cancer cases pending in a MDL that is centralized in the Western District of Louisiana. The first trial in the MDL started this week with opening statements expected to begin next week.

If you have been injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

Master Complaint Approved for Stryker Rejuvenate Litigation

There are currently 512 product liability lawsuits concerning the Stryker Rejuvenate him replacement system pending in federal court before U.S. District Court Judge Donavan Frank in the District of Minnesota before Judge Donavan Frank as part of an MDL or multi-district litigation.

Before the Stryker Rejuvenate hip recall was issued in July 2012, an estimated 20,000 of the implants were sold by the manufacturer. As hip replacement lawyers continue to review and file new cases on behalf of individuals who have their implant fail, it is ultimately expected that several thousand complaints will be filed throughout the federal court system.

Judge Frank issued a case management order on January 23, 2014 which approved a master complaint and use of a short form complaint to standardize proceedings in the litigation.

The Master Complaint outlines all of the common allegations raised in the cases involving Stryker Rejuvenate and ABG II hip failures. Potential plaintiffs will now be able to bring a new case by adopting the claims raised in the Master Complaint through a Short Form complaint, which outlines the specific allegations of that individual, indicating which product was involved and case-specific information about their implant, problems experienced, revision procedures required and other injuries suffered.

In addition to the federal litigation, about 642 lawsuits are currently pending against Stryker in a coordinated multi-county proceeding in New Jersey state court where Styker’s parent company, Howmedica is based. The New Jersey cases are centralized before Judge Briaqn Martinotti.

Stryker is currently engaged in mediations with the Plaintiffs. In the first round of mediations, settlements were reached between Stryker and the plaintiffs in four separate cases. Negotiations continue in other cases.

If you have been injured by the recalled Stryker or ABG II hip implant, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim against the manufacturer.

Depakote Multi-District Litigation Moving Forward With Order to Produce Documents

A Court Order by a US Magistrate Judge on December 16, 2013, ordered Abbott to turn over about 4,000 copies of literature that relate to Depakote and birth defects “as soon as possible,” and to “exercise all avenues available” in the federal multi-district litigation (MDL) concerning the epilepsy drug Depakote. The documents were first ordered to be produced back in April 2013. The litigation is pending in U.S. District Court for the Southern District of Illinois, where all of the lawsuits allege that Depakote’s manufacturer, Abbott Laboratories, failed to warn about the risk of birth defects with Depakote.

The plaintiffs, whose mothers took Depakote during pregnancy, claim they were born with serious side effects including spina bifida, heart defects and neural tube defects, among other congenital malformations and birth defects.

If you or someone you love developed a serious injury from a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

First Actos Bellwether Trial Set to Commence in Federal Multi-District Litigation

Jury selection is scheduled to begin in the first Actos bellwether trial in the federal multi-district litigation. The lawsuits each allege that Actos caused the plaintiffs to develop bladder cancer.

The first Actos bellwether trial involves a lawsuit brought by Terrence Allen and his wife Susan, which will be the first of nearly 2,700 pending lawsuits in federal court to be heard before a jury. Jury selection is expected to begin today in the case. Opening statements are scheduled to begin on February 3. The presiding Judge is federal Judge Rebecca Doherty, who is presiding over all of the Actos lawsuits that are consolidated in the federal MDL which is centered in the Western District of Louisiana. Trial is expected to take about six weeks. The Plaintiffs are expected to take 20 days to present their case, with another 11 days for the defense to present their case.

All of the cases center around similar allegations that Takeda Pharmaceuticals failed to adequately warn consumers and physicians about the potential risk of bladder cancer associated with long-term use of the diabetes drug Actos.

According to the complaint, the Plaintiff took Actos from 2004 through 2011, when he was diagnosed with bladder cancer. The Plaintiffs allege that Takeda know about the link between Actos and bladder cancer in the early 2000s but withheld this information.

So far, there have been three Actos trials that have taken place in state court proceedings around the country. In May 2013, a California jury found that Takeda had failed to warn about the risk of bladder cancer with Actos awarded $6.5 million on damages to the Plaintiff. However, the presiding judge reversed the verdict after granting a post-trial motion to exclude the plaintiffs’ expert witness testimony. In a second trial in Maryland state court in September,. Another jury also found that Takeda had failed to warn about the risks of Actos and bladder cancer with $1.77 million in damages for the Plaintiff. However, that case resulted in a defense verdict for the drug maker under a Maryland contributory negligence law, as the jury also found that the plaintiff failed to exercise reasonable care for his own health, which nullified the negligence of the drug maker. Finally, in a third trial held in Nevada state court, the jury rendered a defense verdict because the jury determined that both Actos and the Plaintiff’s smoking contributed to his development of bladder cancer.

Following the Allen trial, it was previously expected that a second Actos bellwether trial would begin in the federal MDL on April 14, 2014. However, in an Order (PDF) issued by Judge Doherty on January 17, that second pilot trial was continued without a new date selected.

If you have been seriously injured by a pharmaceutical drug, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

Hearing Scheduled for Motion for Sanctions Filed by Plaintiffs in Ethicon Vaginal Mesh MDL

A hearing has been scheduled for later this week in response to a motion for sanctions filed by Plaintiffs in a large vaginal mesh multi-district litigation (MDL) filed against Johnson & Johnson subsidiary, Ethicon. The motion for sanctions alleged that Defendant Ethicon had destroyed large volumes of data that was relevant to the ongoing litigation.

There are currently approximately 11,000 vaginal mesh lawsuits pending against Ethicon in the multi-district litigation in federal court. All of the cases are pending in U.S. District Court for the Southern District of West Virginia as part of a centralized multi-district litigation before U.S. District Judge Joseph Goodwin.

All of the complaints involve similar allegations that women suffered devastating injuries from transvaginal mesh products made by Ethicon, which were used for surgical treatment of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI).

Last month, Plaintiffs had filed a motion for sanctions against Ethicon in the MDL, alleging that Ethicon had lost or destroyed thousands of crucial documents that should have been preserved. Thus, Plaintiffs allege that Defendant Ethicon engaged in spoiliation.

In a supplement to this motion, Plaintiffs further allege that in addition to the documents of more than a dozen corporate executives and marketing personnel, the company has also lost the files from John Clay, a regulatory affairs manager who was in charge of the company’s vaginal mesh products in 2006 and 2007; Kendra Munchel, a global marketing manager from 2005-2007 who was one of the employees in charge of professional education on the launch of some of the company’s vaginal mesh product lines, as well as several others who were involved at various points with the development and marketing of Ethicon vaginal mesh products.

If you have been injured as a result of a vaginal mesh product requiring surgery for removal and involving other painful symptoms, contact Cliff Rieders, Esq. at the Rieders Travis Firm. 

Pennsylvania Supreme Court Issues Ruling in Lance v. Wyeth

On January 21, 2014, in the case of Lance v. Wyeth, the Pennsylvania Supreme Court held that drug companies are not immune to products liability claims in Pennsylvania for defective drugs in a victor for the Plaintiff.

In this case, Plaintiff alleged that the drug company was negligent in testing, marketing and designing their prescription drug products, namely the diet drug Redux.

The majority opinion was authored by Justice Thomas Saylor, who was joined by Justices Max Baer, Debra Todd and Seamus McCaffery. JusticeJ. Micahel Eakin wrote a dissenting opinion, which was joined by Chief Justice Ronald Castille. A link to the opinion can be found here.

The majority opinion found that under Pennsylvania law, pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone. The court further held that There has been no supported presentation which would persuade us to immunize companies from the responsibility to respond in damages for such a lack of due care resulting in personal injury or death.

The court affirmed in relevant part the ruling of the intermediate appellate court and recognized the validity of claims for negligent design, negligent marketing, and negligent decision to continue to market against a drugmaker for continuing to sell an unreasonably dangerous drug. In this case, Plaintiff contends that Wyeth continued to sell Redux (a drug related to fen-phen) long after it knew or should have known that Redux was unreasonably dangerous and should not have been sold.

An amicus brief was submitted in the case by the American Association of Justice and the Pennsylvania Association of Justice.

Judge in Mirena Litigation Orders More Coordination Between State Court and Federal Court Discovery Proceedings

Judge Martinotti, the state court Judge overseeing the Mirena consolidated lawsuits in New Jersey state court has ordered that hat further steps be taken to encourage counsel in various state and federal proceedings involving the birth control IUD to coordinate depositions with the Bergen County court.

According to an Order issued on January 14, protocols for all depositions taken in the proceeding have been established to conserve the resources of the court, and avoid duplicative discovery.

A total of 488 IUD product liability lawsuits have been filed against Defendant Bayer concerning Mirena in New Jersey Superior Court on behalf of women who allege spontaneous migration of the device, uterine perforations, ectopic pregnancy and other complications. The lawsuits alleged that Mirena’s manufacturer, Bayer, failed to warn of these risks and that the product was defectively designed. A total of 344 Mirena products liability lawsuits have been filed in federal court in a multi-district litigation centered in U.S. District Court for the Southern District of New York, alleging similar claims.

If you have been seriously injured by a Mirena IUD, contact Cliff Rieders of the Rieders Travis Firm to determine whether you may have a claim that can be filed in conjunction with the ongoing litigation proceedings. 

FDA Panel Recommends Against Xarelto Expansion for Johnson & Johnson

A FDA advisory committee considering the issue has recommended that the agency reject Johnson & Johnson’s efforts to expand the approved use if its blood thinner Xarelto for prevention of heart attacks.

At a January 16 meeting, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously that Johnson & Johnson and Bayer have failed to show that the benefits outweigh the potential Xarelto risks when used for the prevention of thrombotic cardiovascular events in patients with recent acute coronary syndrome (ACS).

Xarelto (rivaroxaban) is one of a new generation of anticoagulants being marketed as an alternative to Coumadin (warfarin), which has long been the standard anticoagulant therapy, to reduce the risks of blood clots and strokes. This class of medications also includes Boehringer Ingelheim;’s Pradaxa (dabigatran). Potential side effects of Xarelto and Pradaxa anticoagulants include uncontrollable bleeding, as there is no known antidote to either Xarelto or Pradaxa to reverse the blood thinning effect when a hemorrhage begins. Warfarin or Coumadin has a known antidote, by comparison to reverse bleeding, Vitamin K.

The FDA has already turned down the drug makers’ requests to expand the use of Xarelto twice before. However, Johnson & Johnson and Bayer, distributing the drug jointly, continue to press for expanded use of the relatively new anticoagulant, based on the results of a clinical trial called Atlas. The committee and the FDA have questioned the analysis of the Atlas trial data, indicating that they do not see the proof, as well as other more comprehensive critiques of the Atlas trial which are highlighted in the Advisory Committee’s report.

Xarelto was first introduced in July 2011, as the second drug in this new class of “direct thrombin inhibitors.” It is currently approved for prevention of deep vein thrombosis (DVT) among individuals undergoing knee or hip replacement surgery, to reduce the risk of stroke among people suffering from atrial fibrillation and to reduce the risk of DVT or pulmonary embolism (PE). Pradaxa, the first drug in this new class, was approved in 2010.

Pradaxa has been the subject of numerous lawsuits filed alleging that Boehringer Ingelheim, its manufacturer failed to warn of the risk of uncontrollable bleeding and heart attacks with the drug. Pradaxa is associated with an extremely high number of adverse event reports to the FDA, one of the highest of any prescription medication on the market, due to concerns about uncontrolled bleeding events.

Bayer and Johnson & Johnson who control the rights to Xarelto, are jointly working with a company called Portola Pharmaceuticals to develop an antidote to Xarelto’s bleeding events, while Boehringer Ingelheim is also working with a partner to develop an antidote for Pradaxa. Xarelto is manufactured by Bayer and marketed by a subsidiary of Johnson & Johnson.

In addition to uncontrolled bleeding events, a study published in a January 2012 issue of Archives of Internal Medicine completed by researchers at the Cleveland Clinic based on data from seven clinical trials that enrolled 30,514 patients showed that patients taking Pradaxa had a 33% greater risk of having a heart attack or severe symptoms of heart disease than patients taking warfarin. Boehringer Ingelheim has disputed the results of this study.

If you took Pradaxa or Xarelto and developed uncontrollable bleeding, hemorrhage or suffered a heart attack., contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim. 

NuvaRing Lawsuits On Hold as Bellwether Trial Cancelled

The majority of the cases are centralized in federal court in a multi-district litigation (MDL) before U.S. District Judge Rodney W. Sipple in the Eastern District of Missouri.

A complaint filed by Marianne Prather was selected for the first bellwether trial in the MDL and was expected to begin on January 27, 2014. However, in October 2013, Judge Sipple put a hold on all discovery, motions and rulings until the end of last year and postponed the start of the trial until April 7, 2014.

In a new Court Order issued late last week, Judge Sipple indicated that the trial is now cancelled, and a new date has not been selected. In anotherOrder (PDF) issued January 9, Judge Sipple indicating that all “adversarial litigation” in the cases will remains on hold until at least May 31, 2014.

New Study Finds Small Increase in Development of Diabetes from Lipitor and Other Statins

A new study published in the medical journal Diabetes, Obesity and Metabolism, researchers from the University of Alabama and the Mid America Heart Institute at Saint Luke’s Hospital say they found a “definite but small” increase in the development of diabetes linked to Lipitor (atorvastatin) and other medications that are part of a popular class of cholesterol drugs known as statins. Lipitor is manufactured by Pfizer, although the drug went generic in the past couple of years. Astra Zeneca’s Crestor is a second popular statin drug used to lower blood cholesterol levels.

The new study was a meta-analysis which pools the results of different studies together in drawing its conclusions. Researchers looked at a wide variety of studies focused on a number of different cholesterol drugs

Researchers looked at a wide variety of studies focused on a number of different cholesterol drugs.

If you are a woman with a body mass index under 30 and are otherwise in good health but developed diabetes while taking Lipitor, contract Cliff Rieders, Esq. of the Rieders Travis firm today to determine whether you have a claim that can be filed.

Breaking News – Third Bard Avaulta Vaginal Mesh Bellwether Trial Postponed Indefinitely

The U.S. District Judge presiding over thousands of vaginal mesh lawsuits pending throughout the federal court system has indefinitely postponed the third bellwether trial scheduled in the Bard Avaulta litigation, after a key expert witness for the plaintiff became unavailable to appear. This trial was set to be the last in a series of bellwether trials against defendant Bard in the multi-district litigation centered in the U.S. District Court for the Southern District of Virginia. The cases in the MDL are all being presided over by Judge Joseph Goodwin.

The plaintiff in the postponed case is Carolyn Jones. Her lawyers filed a motion for continuance after learning that a key witness for the plaintiff was unable to attend the trial because he had been hospitalized. The request was granted by Judge Goodwin and the trial will be rescheduled at a later date.

If you have been injured by vaginal mesh implanted for pelvic organ prolapse or urinary incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

First Federal Actos Bladder Cancer Case Set for Trail on January 27

The first trial in the federal multi-district litigation (MDL) concerning the popular diabetes drug, Actos, (pioglitizone) will commence later this month, on January 27. The trial will involve a claim by a New York plaintiff who alleges that he developed bladder cancer from taking Actos. The plaintiffs are Terrence and Susan Allen.

Although three cases have been tired so far in state court, the upcoming trial is the first in the federal multi-district litigation, or MDL. The trial will take place in U.S. District Court for the Western District of Louisiana where the MDL is centralized. The presiding Judge is U.S. District Judge Rebecca Doherty. This case is the first in a series of early test trials, known as bellwether trials. Which will help the parties gage how juries may respond to evidence and testimony that may be repeated in similar cases in the MDL.

There are presently more than 2,600 Actos bladder cancer lawsuits pending against Defendant Takeda Pharmaceuticals.

The allegations raised by Terrence Allen and his wife are representative of other cases pending in the Actos MDL. According to the complaint filed more than two years ago, Allen used Actos from 2004 through May 2011, and was diagnosed with bladder cancer in January 2011. The lawsuit claims that the cancer was caused by Actos, and that Takeda Pharmaceutical failed to adequately warn consumers or the medical community about the potential risks associated with the diabetes drug.

Experts for plaintiff are expected to testify that Actos causes bladder cancer, and causes the disease to progress more quickly.

If you took Actos and developed bladder cancer, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether your claim can be filed in the multi-district litigation.

Bard Denied Motion to Exclude Evidence in Transvaginal Mesh Lawsuits; Trial Set for January 10

Defendant C.R. Bard Inc. has been denied a motion to exclude certain evidence pertaining to the company’s implants in a federally-filed transvaginal mesh lawsuit trial slated to begin this week.

The case, the last in a series of bellwether cases, is scheduled to go to trial this Friday January 10, 2014, in the multi-district litigation centered in the U.S. District Court for the Southern District of West Virginia. The Presiding Judge is Judge Joseph R. Goodwin. The Motion in Limine that was denied was one where Defendant Bard sought to exclude certain info about its Avaulta pelvic mesh product development.

mong other claims included in this litigation, plaintiffs allege that Defendant C.R. Bard failed to adequately warn about the risks associated with its pelvic mesh, which they say was defectively designed. Federal court records indicate that a total of 6,362 transvaginal mesh suits are pending against C.R. Bard concerning its Avaulta devices.

his proceeding’s upcoming trial follows an August 2013 decision to award $2 billion in damages to a woman implanted with C.R. Bard’s Avaulta mesh.

If you have been injured by a vaginal mesh product used to treat pelvic organ prolapse or urinary stress incontinence, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Statute of Limitations for Lipitor Diabetes Claims May be Approaching

Many female patients and potential plaintiffs who took the cholesterol-lowering drug Lipitor (atorvastatin) and subsequently developed Type 2 diabetes could be facing a deadline, or statute of limitations on their ability to pursue a product liability case against Pfizer for failure to provide adequate warnings about the potential side effects of Lipitor.

Pfizer is currently facing a growing number of Lipitor diabetes claimed filed by women in state an federal courts, all involving allegations that otherwise healthy women with BMI under 30 developed diabetes after using the medication to lower their cholesterol.

However, all lawsuits are subject to a statute of limitations, or deadline, for which a claim can be filed in court. For example, many states, such as Pennsylvania, have a two year statute of limitations after an individual discovers or could have discovered a link between a prescription medication and an injury.

For cases where women were diagnosed with diabetes more than two years ago, Pfizer may seek to argue that the statute of limitations for their claims began to run in February 2012 when warnings were added to the Lipitor warning label for the first time informing users about the potential impact the medication may have on blood sugar levels. Thus, the statute of limitations of two years would expire in February 2014. However, plaintiffs are likely to argue that Pfizer’s warning was inadequate to trigger the statute of limitations. However, this issue is likely to result in many new Lipitor complaint filings in the next several weeks so that plaintiffs can ensure that a subsequent interpretation of the Lipitor warning and statute of limitations does not result in their claims being time barred.

If you are a woman who developed Type 2 diabetes while taking Lipitor, and are otherwise healthy with a BMI under 30, contact Cliff Rieders, Esq. of the Rieders Travis firm to determine whether you may have a claim.

Pradaxa Bleeding Risk Safety Assessment Ordered by FDA

The FDA is launching an investigation into the bleeding risk associated with Pradaxa following reports of hundreds of deaths and thousands of severe injuries by patients who suffered uncontrollable bleeding and hemorrhages while taking the anti-coagulant.

On December 30, the FDA issued a call for public comments that will run until January 13. The comments are for a protocol that will be the guiding force behind a Pradaxa Safety Assessment.

The assessment will compare the safety of Pradaxa to generic warfarin, also known by the brand name Coumadin, for the treatment of patients with nonvalvular atrial fibrillation.

“The primary outcomes will be the occurrence of ischemic stroke, intracranial hemorrhage, all strokes (ischemic stroke + intracranial hemorrhage) as well as episodes of major bleeding,” the FDA announced. “This approach will provide the relevant information on outcomes that matter most to providers and patients with regards to the safety of each therapeutic approach.”

Pradaxa (dabigatran) was introduced to market by Boehringer Ingelheim in Octoebr 2010, and has been promoted as superior to warfarin in preventing stroke. However, unlike wafarin, there is no antidote agent to reverse excessive bleeding or hemorrhage that may occur with Pradaxa.

Boehringer Ingelheim currently faces more than 1500 Pradaxa lawsuits field in federal court for the Northern District of Illinois on behalf of patients who suffered severe and sometimes fatal bleeding injuries while taking Pradaxa. Early trial dates are expected to begin on are expected to begin on August 11, 2014, November 3, 2014, January 5, 2015 and February 16, 2014. Last month, the presiding Judge, Judge David Herndon levied nearly $1 million in fines on Boehringer Ingehleim for bad faith conduct during the ongoing litigation.

Last month, the results of a manufacturer-sponsored clinical trial were published in the medical journal Circulation, suggesting that Pradaxa was as effective as warfarin at the treatment of venous thromboembolism (VTE) and carried less of a risk of bleeding. Boehringer Ingelheim quickly issued press releases announcing the results of the study, known as RE-COVER II.

Have you suffered uncontrollable bleeding and suffered a severe bleeding injury due to Pradaxa? Contact Cliff Rieders, Esq. of the Rieders Travis Firm to have your claim evaluated. 

Bard Vaginal Mess Case Census Ordered by Federal Judge

The federal judge presiding over all of the federally filed vaginal mesh cases in six multi-district litigations has issued an order requiring a census of cases being presented by women nationwide involving products associated with one of the defendant manufacturers, C.R. Bard.

There are currently more than 6000 Bard Avaulta mesh lawsuits pending in federal court in one of the MDLs. The presiding Judge over all six MDLs, is Judge Joseph Goodwin in the Southern District of West Virginia.

A Pretrial Order was issued on December 31, 2013 by Judge Goodwin which orders that a census of the cases be performed in order to obtain more accurate information about all of the claims pending against C.R. Bard. All of the plaintiffs lawyers with cases filed in the MDL are required to register their cases by January 23, 2014 in a census spreadsheet. This order is expected to result in a list of all potential claims Bard is facing, including claims filed in various state courts, those not yet transferred into the MDL and claims that are not yet filed in any jurisdiction.

The litigation involving Bard mesh products are the furthest along of any of the vaginal mesh MDLs, with the third in a series of Avaulta bellwether trials scheduled to begin later this month, involving a lawsuit filed by Carolyn Jones.

If you had vaginal mesh implanted that resulted in severe injuries or complications, culminating in removal of the mesh, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you have a claim. 

Joint Panel on Multidistrict Litigation to Hear Neomedic Vaginal Mesh Consolidation Arguments on January 30

The JPML has scheduled to hear oral arguments on January 30 to consider a motion to consolidate and centralize all neomedic vaginal mesh lawsuits filed in U.S. federal District Courts across the United States. The lawsuits have been filed on behalf of women who suffered complications from implants that were designed to treat pelvic organ prolapse and stress urinary incontinence.

There are presently more than 35,000 product liability lawsuits pending throughout the federal court system involving problems with transvaginal mesh or bladder sling products made by various manufacturers. The JPML has established six different multi-district litigations (MDLs) organized by manufacturers, against C.R. Bard, American Medical Systems, Ethicon, Boston Scientific, Coloplast and Cook Medical, each of whom manufacture vaginal mesh products. All of the MDLs are centered in federal court for the Southen District of West Virginia and are presided over by Judge Joseph Goodwin.

Plaintiffs have requested creation of a seventh MDL before Judge Goodwin for all Neomedic needleless sling lawsuits. A Notice of Hearing was sissued last week in response to this request and the panel has scheduled to hear oral arguments on whether a seventh MDL should be created on January 30, 2014.

There are currently at least 21 complaints pending against Neomedic in eight different U.S. District Courts. The cases raise nearly identical allegations to claims made against the other manufacturers, indicating that the design of the pelvic repair products were not adequately researched and that inadequate warnings were provided about the risk of complications where the mesh may erode through the vagina, cause infections or other injuries.

According to currently updated case lists, there are 11,589 cases pending against Ethicon, 11,390 against American Medical Systems, 7,310 lawsuits against Boston Scientific, 5,505 against C.R. Bard , 1.099 against Coloplast and 133 against Cook Medical.

Cliff Rieders, Esq. of the Rieders Travis Firm is handling vaginal mesh cases. If you think you may have a claim against one of the manufacturers, contact him today.

Motion Filed to Modify Zoloft Lawsuit Trail Pool in Federal MDL

As a result of delays in the discovery process while preparing for early scheduled trial dates in the federal multi-district litigation concerning the psychiatric drug Zoloft (sertraline), plaintiffs have filed to ask the Judge to rethink the selection process for the first cases that will go to trial as bellwether cases in the litigation

There are currently more than 400 product liability lawsuits in the MDL filed against the manufacturers of Zoloft in the federal court system. In each of these cases, plaintiffs allege that they took Zoloft while pregnant, resulting in birth defects and malformations to their unborn children from exposure to Zoloft during the pregnancy. The plaintiffs allege that the defendant, Zoloft’s manufacturer, Pfizer, failed to warn of the risks to unborn children of taking the drug during pregnancy.

All cases filed in U.S. District Courts throughout the country are centralized for coordinated proceedings before U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania for pretrial discovery and a series of “bellwether” trials. In early 2013, Judge Rufe established a bellwether trial selection process for the Zoloft MDL. These cases are then to be narrowed down to a pool of six trial cases by May 2014.

According to a motion filed on December 27, plaintiffs indicate that the current plan is unmanageable and they are asking the judge to reduce the number of cases in the discovery pool.

Plaintiffs indicate that they would have to take 125 to 175 depositions over the next few months to meet that deadline, with depositions of every treating physician in all 25 pool cases needing to be completed by January 24. They claim that the problem has been exacerbated because of delays in the deposition process, which plaintiff attorneys argue have been caused by Pfizer’s actions and delays that have frustrated the discovery process.

According to the motion filed last week, Plaintiffs claim that Pfizer has been intentionally selecting cases for the discovery pool that are inappropriate and non-representative of the issues that will arise throughout the remainder of the litigation. As a result, after plaintiffs voluntarily dismiss those cases rather than moving those non-representative cases closer to trial, the drug maker gets to strike an equal number of the “representative” cases selected by plaintiffs. Plaintiffs have requested that Judge Rufe reduce the discovery pool to 8 picks by each side, or a small number as the Court deems appropriate. Further, they request that no strikes be permitted and that Judge Rufe select the actual cases that will go to trial first.

The parties are scheduled to meet with Judge Rufe during a status conference on January 17, 2014. Plaintiffs have requested that the Court hear this motion to alter the trial selection process at that time.

Zoloft is one of the most widely prescribed anti-depressants and is manufactured by the pharmaceutical giant Pfizer. In 2006, the Food & Drug Administration (FDA) added warnings about potential risk of persistent pulmonary hypertension in newborns (PPHN) from Zoloft and other newer antidepressants when taken after the 20th week of pregnancy. Plaintiffs allege that this warning is inadequate. Other studies came out in 2007 and 2009 that found associations between Zoloft and other antidepressants and skull development, gastrointestinal abnormalities, brain development and risks of heart defects during the first trimester of pregnancy, a time that many pregnant women do not know that they are even pregnant.

The Rieders Travis Firm handles a wide variety of pharmaceutical cases. If you have been injured by Zoloft or another pharmaceutical drug, contract Cliff Rieders, Esq. today.

Fresenius Dialysis Lawsuits May be Delayed

An increasing number of lawsuits have been filed against defendant Fresenius Medical Care, concerning its dialysis products GranuFlo and NaturaLyte by or on behalf of individuals who suffered a sudden cardiac arrest or heart attack following dialysis treatment. The parties involved in the litigation have asked the court for additional time to establish the bellwether trial process.

In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a coordinated multi-district litigation (MDL) procedure for all Fresenius lawsuits filed in federal court. There are now 443 lawsuits that are consolidated in federal court in an MDL that is centralized in federal court for the District of Massachusetts before Judge Douglas Woodlock, the presiding Judge. All of the lawsuits allege that Fresenius, the defendant manufacturer, failed to adequately warn about the risk of sudden heart problems that may result following dialysis treatment with GranuFlo and NaturaLyte.

Judge Woodlock is presiding over the exchange of discovery in the cases and has indicated that a small group of representative cases will be set for early trial dates, known as “bellwether” cases. In October, Judge Woodlock had issued a Case Management Order which had ordered the parties to submit proposals concerning the bellwether trial process by January 6, 2014. he preparation and outcome of these cases are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.

However, on December 16, the parties filed a joint motion to ask the court for additional time to submit proposals for a bellwether case management order until the next Status Conference on February 3, 2014.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate, which are not only used during hemodialysis treatments at Fresenius clinics, but were also sold to other dialysis centers throughout the country. Both products contain sodium acetate that converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the complaints.

In November 2011, Fresenius conducted an internal review involving the use of Granuflo and NaturaLyte at their own clinics, identifying at least 941 instances where patients suffered cardia arrest during dialysis treatments in 2010. While the company issued a memo to doctors in their own clinics in late 2011, they failed to provide the same information or warnings to other clinics that used Granuflo and NaturaLyte.

After an internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a recall of the two products.

If you or someone you loved had dialysis treatments with GranuFlo or NaturaLyte at a Fresenius or DaVita clinic and suffered a heart attack or other severe cardiac problems right after dialysis treatment, contact Cliff Rieders, Esq. of the Rieders Travis Firm today to determine whether you can bring a lawsuit to recover for these devastating injuries.

Boehringer Ingelheim May Face Additional Sanctions in Pradaxa Litigation

After noting that Boehringer Ingelheim may have withheld negative information about Pradaxa during discovery, the federal judge presiding over hundreds of lawsuits in the federal multi-district litigation (MDL), is threatening to sanction the drug maker again for acting in bad faith during the litigation.

Last week, Judge David Herndon, the presiding Judge in federal court for the Southern District of Illinois hit Boehringer Ingelheim with over $900,000 in sanctions for withholding documents during the discovery process with regard to the files of Professor Thorstein Lehr; a former company employee and scientist who worked on the development of Pradaxa. ccording to the order entered by Judge Herndon on December 18, the drug maker failed to keep crucial files and claims it cannot provide them as the court has required, leaving it open for more fines and other sanctions.

There are currently 1700 lawsuits field in the Pradaxa MDL that is being presided over by Judge Herndon. All of the lawsuits allege that the plaintiffs suffered severe bleeding problems that their doctors were unable to stop or control while they were on Pradaxa. The complaints in these litigations allege that the manufacturer, defendant Boehringer Ingelheim, failed to warn about the potential bleeding risk associated with Pradaxa as well as the lack of an antidote that could allow doctors to reverse the blood thinning caused by the anti-coagulant.

Under the aggressive discovery schedule set in place by Judge Herndon, the first bellwether trials in the litigation are scheduled to begin in the second half of 2014. hese early Pradaxa trials, known as “bellwether” cases, are designed to help the parties gauge how juries may respond to certain facts and testimony that may be offered throughout a large number of similar cases.

On December 9, Judge Herndon hit the company with $931,500 in sanctions for failing to produce or preserve documents important to the litigation. Judge Herndon accused the company of acting in bad faith throughout the litigation and for giving poor excuses for not preserving or turning over the files.

Judge Herndon said the sanctions will be decided at the end of the bellwether discovery process and those being considered in relation to Professor Lehr’s files include the striking of certain affirmative defenses, preventing the company from making certain arguments at trial, deeming certain facts admitted at trial or providing an adverse inference jury instruction, which would mean that the jury will be that the failure to preserve documents may be considered as evidence that the drug maker was protecting itself from legal repercussions.

If you or someone you loved suffered severe bleeding while taking Pradaxa, contact Cliff Rieders, Esq. of the Rieders Travis Firm today to determine whether you may have a claim against the manufacturer.

MDL Consolidation Hearing for Lipitor Cases Scheduled for January 30

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to reconsider whether the consolidate and centralize all of the Lipitor diabetes suits filed in federal court by women who allege they were first diagnosed with Type 2 diabetes as a result of taking the cholesterol lowering drug Lipitor. Oral argument is scheduled for January 30, 2014.

There are currently more than 100 lawsuits pending against Lipitor’s manufacturer, Pfizer, in the federal court system. In each of these cases, a female plaintiff alleges that the drug maker failed to adequately warn women of the risk of developing Type 2 diabetes.

Lipitor has generated more than $125 billion in sales since 1996, so thousands or even tens of thousands of cases are expected to be filed in the coming months and years.

Plaintiffs counsel filed a second motion to establish a federal MDL in October 2013. uch centralization is designed to reduce duplicative discovery across a large number of cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts. The U.S. JPML had denied a similar request made by plaintiffs in July 2013, due to the insufficient number of Lipitor lawsuits field at the time.

If you developed Type 2 Diabetes while taking Lipitor and are a woman with a BMI (body mass index) under 30, contact Cliff Rieders, Esq. of the Rieders Travis Firm today to determine whether you have a case.

Second Component of Da Vinci Robot Flagged for Potential Complications by FDA

A second component to a surgery robot named in numerous da Vinci lawsuit filings has been flagged for potential complications by the U.S. Food and Drug Administration (FDA), according to recent reports.

According to a December 16 announcement, the da Vinci Surgical System’s EndoWrist instrument may detach during surgery. The FDA issued a Class II recall to call attention to the potential problem. In addition, on December 3, regulators similarly ordered that Intuitive Surgical inspect the robot’s Patient Side Manipulator component for possible repair and replacement after it was found to stall during surgery. That component was also issued in a prior recall by the FDA on November 11, 2013, also a class II recall.

Class II recalls involve “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA said in a public report.

Between the two Class II recalls, approximately 11,000 da Vinci robot components have been impacted.

If you have been injured by one of the above-mentioned parts failing during a da Vinci robotic surgery, contact Cliff Rieders, Esq. of the Rieders Travis law firm today to determine whether you have a claim.

Biomet Hip Trials to Begin In June 2015

A series of five bellwether trials will be held in the federal multi-district litigation (MDL) established for all Biomet hip replacement lawsuits with the first trial expected to commence in June 2015. To date, there are approximately 900 lawsuits pending against Biomet that are consolidated in the federal MDL, which is centered in the U.S. District Court for the Northern District of Indiana. The presiding Judge over all of the cases is federal U.S. District Judge Robert L. Miller.

All of the complaints against Biomet that are pending in the MDL involve allegations that the plaintiffs experienced complications after receiving Biomet’s metal on metal hip implants, including the M2A Magnum and similar configurations. Plaintiffs allege that the implants failed due to their defective and dangerous design, which allows for corrosion and for debris to be released into the body.

In a December 10, 2013 Scheduling Order, Judge Miller set a schedule for discovery and for the bellwether trial selection process. The first four trials are scheduled for June, August and December 2015 with a fifth trial set to begin in January 2016. The bellwether cases have not been selected yet, but the order outlines a process for the parties to select the bellwether cases for a total of six. The identification of these bellwether cases will be made by February 7, 2014 with core discovery completed by April 18, 2014 and the selection of the five of the six cases for the first trial dates made by July 2014. Three cases will be selected by plaintiffs attorneys and three by defense attorneys.

The Biomet M2a Magnum is a metal-on-metal artificial hip replacement system. According to the lawsuits, the design causes excessive amounts of cobalt and chromium to corrode and wear from the surfaces of the acetabular cup, femoral head and taper sleeve as the metal parts rub against each other. This excessive wear makes the Biomet M2a Hip system prone to fail, leading to problems walking, pain, and frequently resulted in plaintiffs having to undergo revision surgery to have the device removed or replaced. The company reportedly received hundreds of reports of failures not long after the implant was launched, and plaintiffs say that should have resulted in a Biomet Magnum recall.

If you received a Biomet hip implant such as the Biomet Magnum and have been injured by the implant, contact Cliff Rieders, Esq. of the Rieders Travis firm today to determine whether you have a claim that can be filed in the litigation.

Nuva Ring Bellwether Trials Set for January 2014

U.S. District Judge Rodney Sippel, who is overseeing the Niva Ring multi-district litigation (MDL), has scheduled the first trial to start on January 27, 2014. The latest court records show the number of cases filed has grown over 4% in less than a month from 1,358 claims on August 15th to 1,419 as of September 11, 2013. The cases are consolidated in a federal MDL centered in U.S. District Court for the Eastern District of Missouri. The formal case is known as In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri. Plaitniffs in the cases allege that they suffered blood clots, strokes, DVT or pulmonary embolisms while using the Nuva Ring contraceptive impant.

The defendant in the Nuva Ring cases is pharmaceutical giant Merck and its subsidiary Organon.

The NuvaRing is a flexible ring that is inserted in the vagina, where it releases fertility suppressing hormones over the course of three weeks. It is then removed for a week to stimulate a menstrual period. he FDA approved the device in 2001. Its sale continues despite the impending lawsuits.

If you were injured by the Nuva Ring contraceptive device, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Master Complaint Approved for GranuFlo Lawsuits Against Fresenius

There are currently more than 433 product liability lawsuits filed in U.S. District Courts throughout the United States against Fresenius Medical Care, all involving nearly identical allegations that the company failed to adequately warn about the cardiac risks of their Granuflo and NaturaLyte dialysis products.

In April 2013, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for all Fresenius cases filed throughout the federal court system, centralizing all lawsuits before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.

As part of the coordinated management of the Fresenius litigation, Judge Woodlock just issued a case management order approving the use of a master complaint and short form complaint to standardize the process of filing addition lawsuits against Fresenius.

Following adoption of the master complaint, plaintiffs are now able to utilize the short form compliant to bring future lawsuits, outlining the specific allegations of that plaintiff’s claim, indicating the portions of the master complaint they are adopting, which product was used and case-specific information about their heart attack, cardiac arrest or other alleged injury.

If you or someone you loved suffered a serious or fatal heart attack from GranuFlo or NaturaLyte during kidney dialysis, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether your claim can be filed as a lawsuit for recovery as part of the federal multi-district litigation.

Pfizer Again Opposes Centralization of Lipitor Cases for Diabetic Women in Multi-District Litigation

Despite the growing number of cases filed by women alleging they developed Type 2 diabetes while taking Pfizer’s blockbuster cholesterol lowering drug, Lipitor (atorvastatin), Pfizer is, for the second time, asking a panel of federal judges to deny plaintiffs request for centralization of the litigation into a multi-district litigation (MDL).

In October 2013, Plaintiffs filed a second request with the U.S. Judicial Panel on Multidistrict Litigation (JPML) asking that a federal Lipitor MDL be created involving allegations that the drug caused women to develop Type 2 diabetes.

On November 1, 2013, Pfizer opposed the request indicating that even though there have now been more than 100 lawsuits filed, the Lipitor litigation does not require centralization.

The U.S. JPML previously requested a prior request brought by plaintiffs to centralize all of the Lipitor diabetes lawsuits in August 2013, but at that time there were only about two dozen cases filed, which the panel deemed to be an insufficient number. Since that time, the number of Lipitor cases filed has increased dramatically and cases are now pending in at least 20 different federal courts.

According to the response filed by Pfizer, the MDL process would delay the litigation. The drug maker indicates that discovery and other pretrial proceedings are already underway in a number of cases, with early Lipitor trial dates set for late 2013 and early 2015 in at least seven different jurisdictions.

If you are a woman in otherwise reasonably good health with a BMI under 30 and you developed Type 2 diabetes while taking Lipitor, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm to determine whether you may have a claim against Pfizer.

Plaintiffs Push for Seventh Vaginal Mesh MDL

Plaintiffs groups are pushing for the addition of a seventh vaginal mesh MDL in federal court for the Southern District of West Virginia involving Neomedic Needleless Slings.

There are currently 35,000 vaginal mesh litigations pending in the federal court system involving vaginal mesh and bladder sling products. These products are made by six different manufacturers, Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast and Cook Medical.

These cases have been consolidated into six different multi-district litigations (MLDs), organized by manufacturer defendants. All of the cases are assigned to federal District Court Judge Joseph Goodwin in the Southern District of West Virginia.

Last month, plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting the addition of a seventh MDL centralized before Judge Goodwin for complaints against Neomedic Needleless bladder slings. Neomedic makes three bladder slings that are at issue: Needleless sling, the Contasure Needleless sling and the Remeex. According to this motion, there are at least 22 different federal cases pending against Neomedic in eight different federal courts, on behalf of 42 different women. All of these cases involve SUI products for urinary stree incontinence, rather than products for pelvic organ prolapse (POP).

All of the complaints include nearly identical allegations raised in the other MDLs, bringing injury lawsuits on behalf of women who have experienced vaginal mesh or bladder sling complications after the mesh eroded through the vagina, punctured or damaged other organs, caused infections or other painful health problems.

If you have been injured by a vaginal mesh or bladder sling product, contact Cliff Rieders of the Rieders Travis firm to determine whether you have a claim that can be brought in one of the federal litigations.

Breaking News – Ethicon Unit of Johnson & Johnson Faces Possible Sanctions in Vaginal Mesh MDL

Plaintiffs in the federal transvaginal mesh multi-district litigation (MDL) have moved for sanctions, alleging that the Ethicon unit of Johnson & Johnson, one of the defendants, has lost or destroyed crucial evidence. There are six transvaginal mesh MDLs, all pending in the Southern District of West Virginia before the same federal judge, each involving a different mesh manufacturer. Bellwether trials are scheduled to commence in the MDL against Ethicon in two months.

In the documents filed in U.S. District Court for the Southern District of West Virginia by plaintiffs, the plaintiffs allege that Ethicon lost or destroyed tens of thousands of documents that are likely relevant to their claims against Ethicon, and maybe more. Plaintiffs argue that this loss of evidence “severely prejudiced” them for the looming bellwether trials involving Ethicon’s Gynecare TVT and Gynecare Prolift mesh products.

The plaintiffs allege that Ethicon did not honor its own litigation hold. As early as May 2003, Ethicon issued notices instructing employees to keep files for litigation purposes. The notices covered all of the products that eventually became the subjects of MDL 2327. But plaintiffs complain that during discovery, Ethicon has “produced numerous important witnesses who worked there for several years and have few, if any, documents in their custodial files.” For esxample, plaintiffs allege that while Renee Selman was the president of Ethicon from 2005 through 2010, defendant has only produced 25 documents from Ms. Selman during discovery, Plaintiffs further allege that Ethicon has produced “shockingly few documents” from other important corporate officials during discovery in its motion papers.

In Plaintiffs motion, Plaintiffs urge the court to impose sanctions to punish Ethicon. Federal court rules allow judges to impose sanctions on a party that “destroys, alters or fails to preserve property for use as evidence in reasonably foreseeable litigation such that the judicial process is disrupted.” Defendant Ethicon has not yet filed papers in opposition to Plaintiff’s motion.

Ethicon has manufactured various products that are the subject of the vaginal mesh lawsuits, including the Gynecare TVT and Gynecare Prolift mesh products. The products at issue in the various lawsuits are used to treat pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). Ethicon discontinued its Prolift product in 2012 after the FDA issued warnings about complications and added that these complications “were not rare” for the Prolift and other POP mesh products. The FDA issued its warning in 2011.

More than 11,000 lawsuits have been field to date against Johnson & Johnson concerning its mesh products.

If you have been injured by trasvaginal mesh products and required surgery to remove the mesh, contact Cliff Rieders, Esq. of the Rieders Travis Law Firm to determine whether you might have a claim against the mesh manufacturer.

Abbott Ordered to Produce Overdue Documents in Depakote Litigation

Abbott Laboratories, the defendant, must produce medical literature and documents related to potential side effects of Depakote as soon as possible, according to an order issued by a federal magistrate Judge handling the cases.

On December 16, U.S. Magistrate Judge Stephen C. Williams, of the Southern District of Illinois, issued an order requiring Abbott to produce these “long overdue” Depakote birth defect documents. He also ordered Abbott to produce custodial files that were also late in the company’s document production. These documents were required to be produced as part of the discovery process in the ongoing Depakote lawsuits filed by parents who claim their children suffered birth defects caused by exposure to the epilepsy drug while in the womb. The plaintiffs accuse Abbott of failing to adequately warn pregnant women or their doctors that the antiseizure medication carried a risk of causing birth defects if taken during pregnancy.

The order notes that Abbott was asked to produce the documents months ago, but has apparently failed to meet the order’s requirements. The company says there is no centralized database to pull all the information from and that it will begin going through about 215 boxes of medical literature in a warehouse this week. The last deadline had ordered Abbott to produce the requested documents in April. The current order requires that Abbott produce the documents as soon as possible. The Magistrate’s order warns that Abbott could face other relief judgments if they continue to fail to produce the documents necessary to move the case forward.

Depakote was first approved by the FDA in 1978. In 2006, the FDA added a black box warning to Depakote about the potential risks of taking the drug during pregnancy after a study found that 20% of women who took Depakote during pregnancy gave birth to children with a birth defect. Earlier this year, the FDA put new restrictions on Depakote use during pregnancy, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines. In addition to Depakote and Depacon, other drugs that are affected by the warning include Depakene, Stavzor and generic equivalents.

Contact Cliff Rieders, Esq. of the Rieders Travis Firm today if you have been injured by a pharmaceutical drug.

Stryker Settles Some Rejuvenate Hip Cases During Mediation

An agreement has been reached to settle four Stryker Rejuvenate hip implant products liability cases as part of early mediation efforts, of the approximately 1000 cases pending against Stryker’s parent, Howmedica Osteonics Corp. The cases concern problems with Styker’s Rejuvenate and ABG II hip implants which were recalled in July 2012.
Unlike traditional hip implants, which feature a single femoral component, the Stryker Rejuvenate and ABG II are modular neck-stems, consist of two pieces that fit inside each other to allow the surgeon to customize the length of the femoral component based on the patient. However, the design has been linked to an increased risk of problems that may result from the release of microscopic metal debris as the chromium-cobalt neck rubs against the titanium femoral stem.

About half of the cases currently filed against Stryker have been filed in New Jersey state court in a consolidated multi-county proceeding before Judge Brian Martinotti. The other half of the cases have been field in federal court as part of a multi-district litigation in the District of Minnesota. These cases are being presided over by Judge Donavan Frank.

According to an order issued on December 16 in the New Jersey multi-county litigation, the four cases that settled were mediated last week in the state court proceeding. A pool of ten cases had previously been selected for early negotiations. Four of the original ten cases still need to be mediated, and those mediations will resume in January. Details of the four settlements have not been disclosed.

If you were injured by a recalled Stryker Rejuvenate or ABG II hip implant and had or will need to have the defective device surgically removed, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Pradaxa Manufacturer Boehringer Ingehleim Fined Nearly $1 Million in Federal Litigation

U.S. District Court Judge David Herndon, who is presiding over nearly 1,700 lawsuits against Boehringer Ingelheim in a federal multi-district litigation concerning the blockbuster drug Pradaxa has ordered Boehringer Ingelheim, the drug’s manufacturer to pay a sanction of $931,000, for inadequate record keeping in a recent ruling.

Judge Herndon issued this ruling because pharmaceutical executives acted in “bad faith” allowing 500,000 or more documents to mysteriously disappear and then failing to produce these documents during discovery in the ongoing multi-district litigation (MDL) which is pending in federal court for the Southern District of Illinois. “The wrongs here are egregious,” Herndon said in the ruling. He scolded the company, calling its lack of safeguarding documents a “gross inadequacy.”

Plaintiffs attorneys sought records concerning Pradaxa’s clinical development and marketing during discovery in the ongoing litigation. Plaintiffs’ claims allege that Pradaxa causes serious bleeding risks which have been linked to over 500 deaths and thousands of complications since the drug went to market in October 2010.

According to documents filed in the litigation, Boehringer Ingelheim blames a series of technology errors for the missing information they were asked to present to prosecuting attorneys. In one instance, the pharmaceutical company blames a Microsoft Windows 7 update for erasing a hard drive that contained some of the requested files. Boehringer could possibly face additional sanctions from the judge if it fails to turn over the missing files. If Boehringer can’t produce them, the company must tell the court it is “unable to comply with the order.”

If you have suffered uncontrolled bleeding or hemorrhage as a result of taking Pradaxa, contact Cliff Rieders, Esq. today to determine whether you may have a legal claim that can be filed as part of the multi-district litigation.

AMS Transvaginal Mesh Lawsuits Set For First Two Bellwether Trials

The federal judge presiding over tens of thousands of products liability lawsuits concerning transvaginal surgical mesh products has established the priority order for four AMS mesh lawsuits, that have been selected for two bellwether trials. The trials are scheduled to go forward on April 7, 2014 and May 5, 2014. Judge Joseph R. Goodwin is the presiding judge over all of the vaginal mesh cases pending in federal court in the Southern District of West Virginia.

Judge Goodwin is presiding over six vaginal mesh multi-district litigations (MDLs) in the Southern District of West Virginia, which includes more than 36,000 lawsuits filed against various vaginal mesh manufacturers, C.R. Bard, American Medical Sytstems (AMS), Boston Scientific, Ethicon (a unit of Johnson & Johnson), Colorplast and Cook Medical.

Plaintiffs in all of the lawsuits allege that the manufacturers failed to adequately warn about the risk of complications following use of a the products for transvaginal repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). –

In addition to the recently selected AMS bellwether trials, bellwether trials are already scheduled to proceed in January 2014 for the Bard Avaulta mesh lawsuit, and in February 2014 for Ethicon Gynecare and in March 2014 for Boston Scientific. Back to back trials are scheduled to begin in April 2014 for the AMS mesh lawsuits.

In a pretrial order issued by Judge Goodwin on December 12, the priority was established for four cases prepared for these first two AMS trial dates. The first case to go before a jury will involve a complaint filed by Joann Serrano, followed by cases brought by Debbie Jilovec of Iowa, Mary Weiler of Montana, and Lisa Marie Fontes of Rhode Island. Judge Goodwin indicates that the cases will be tried “seriatim”, such that if any of the cases settle or otherwise resolve, the next case on the list will go forward on the next assigned trial date.

Judge Goodwin is currently presiding over 11,390 cases involving AMS mesh, 11,589 cases involving Ethicon mesh, 7,310 cases involving Boston Scientific mesh, 5,505 cases involving Bard mesh, 1,099 cases involving Coloplast mesh and 133 cases involving products manufactured by Cook Medical.

If you have been injured by a vaginal mesh product which required surgical removal of the device, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you may have a claim.

Master Complaint Approved for Byetta, Januvia, Victoza Multi-District Litigation

The master complaint has been approved by the court in the federal multi-district litigation (MDL) for the incretin mimetic diabetes drugs Byetta, Januvia, Janumet and Victoza. In August of this year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a centralized MDL proceeding before U.S. District Court Judge Anthony Battaglia for all of the Byetta, Januvia, Janumet and Victoza lawsuits filed in federal court. The plaintiffs in these lawsuits allege that they developed pancreatic cancer from taking these injectable Type II diabetes drugs. The cases in the coordinated proceeding are centralized in federal court for the Southern District of California.

On December 2, 2013, Judge Battaglia issued a new Order approving the use of a master complaint and short form complaints to standardize the process of filing lawsuits against the makers of the four incretin mimetic diabetes drugs.

The master complaint outlines the common allegations raised in all of the individual complaints filed with the court to date. The master complaint claims that the drug makers failed to adequately research the medications or provide proper warnings to consumers and the medical community about the risk of developing pancreatic cancer.

Following the court’s adoption of the master complaint, plaintiffs are now able to utilize a short form complaint to file future lawsuits as part of the MDL, outlining the specific allegations of that plaintiff’s claim, indicating which portions of the master complaint they are adopting, which medications were used and information about their pancreatic cancer diagnosis or other alleged injury.

There are currently only about 150 cases filed in the MDL, but thousands are expected.

If you took Byetta, Januvia, Janumet or Victoza and developed pancreatic cancer while on one of these drugs, contact Cliff Rieders, Esq. of the Rieders Travis Firm to determine whether you might have a claim against the manufacturer.

Breaking News – Defendant Boehringer Ingelheim Fined $1 Million Over Bad Faith Conduct in Pradaxa Litigation

The federal Judge presiding over the Pradaxa (dabigatran) multi-district litigation (MDL) has fined Defendant Boehringer Ingelheim $1 million over bad faith conduct in the ongoing litigation. There are currently approximately 1700 lawsuits filed against Boehringer Ingelheim concerning the safety of its anti-coagulant drug Pradaxa. The plaintiffs in these lawsuits allege that they suffered severe bleeding side effects and/or hemorrhage as a result of taking Pradaxa. The plaintiffs in these lawsuits allege that the drugmaker failed to adequately warn of these side effects and failed to adequately warn that there was no reversal agent on the market that physicians could use to stop the blood thinning effect of Pradaxa like there is the widely used generic blood thinner, warfarin.

Judge David Herndon is presiding over the Pradaxa multi-district litigation (MDL) which is located in federal court for the Southern District of Illinois. On December 9, Judge Herndon issued a case management order in the litigation that outlines several discovery violations alleged by the plaintiffs and fines Boehringer Ingelheim $931,500.00, which comes to approximately $500 per case pending in the MDL.

Plaintiff filed a Motion for Sanctions last month against Boehringer Ingelheim, indicating that the drug maker failed to preserve key documents for the litigation. According to allegations raised, Boehringer failed to preserve the files of a high-ranking scientist involved in Pradaxa development; failed to preserve evidence relating to materials used by sales representatives, clinical science consultants, and medical science liaisons; caused production issues related to a shared network; and failed to preserve business related text messages on some employees’ cell phones.

The text of Judge Herndon’s recent order is very favorable to plaintiffs’ arguments. The Judge specifically wrote, for example, “Almost since its inception, this litigation has been plagued with discovery problems primarily associated with misconduct on the part of the defendants.”

Bellwether trials in the Pradaxa litigation are scheduled to begin in the second half of 2014, according to the current schedule set by Judge Herndon. Judge Herndon has indicated that the Court will identify the four cases that will be set for the first trial dates before January 23, 2014.

If you are someone you loved suffered severe bleeding from taking Pradaxa, contact Cliff Rieders, Esq. of the Rieders Travis firm today to determine whether you may have a claim to file in conjunction with the MDL.

Fosamax Settlement Reached for Jaw Injuries

Merck has agreed to pay $27.7 million to settle more than 1,100 Fosamax jaw lawsuits, which may bring the eight year old litigation to a close. Merck announced the settlement agreement on Monday December 10, 2013.

Plaintiffs will have until March 31 to opt-out of the agreement, at which time Merck will have until May 15 to decide whether to go forward with the settlement if any claims are excluded.

The settlement agreement only applies to plaintiffs who took Fosamax and suffered certain jaw injuries, namely ostenecrosis of the jaw, and does not impact approximately 4,000 Fosamax lawsuits concerning femur fractures.

The majority of the cases impacted by the settlement announcement are pending in a multi-district litigation (MDL), which is centered in federal court for the Southern District of New York before Judge John Keenan. A series of Fosamax bellwether trials was previously held in this MDL, with some cases going for plaintiffs and some for defendants.

If you have been injured by a pharmaceutical drug, call Cliff Rieders of the Rieders Travis Law Firm to determine whether you may have a case against the pharmaceutical manufacturer for failure to warn.

Plaintiffs File Motion for Sanctions Against Ethicon in Transvaginal Mesh MDL

In the transvaginal mesh multi-district litigation against defendant Ethicon, plaintiffs allege that the Johnson & Johnson subsidiary destroyed or lost tens of thousands, or even hundreds of thousands, of key documents that should have been preserved due to the pending litigation.

On December 2, 2013, plaintiffs filed a motion for sanctions, indicating that few, if any, documents have been produced from custodial files of important witnesses in the litigation who worked at Ethicon for years. Plaintiffs claim that Ethicon failed to implement and monitor the required litigation hold on documents, leaving it to individual employees to preserve documents. However, when employees left, documents were destroyed unless that outgoing employee took specific measures to prevent that from happening.

As a result of the extent of the spoliation of evidence by Ethicon, plaintiffs have requested that a default judgement be entered in the bellwether cases scheduled for early trial dates next year, indicating that the Court should strike Ethicon’s learned intermediary defense and give the jury an instruction regarding the presumption to be inferred from the failure to preserve the evidence.

Ethicon is one of at least six manufacturers that face lawsuits over injuries caused by transvaginal mesh, with similar claims pending against C.R. Bard, American Medical Systems (AMS), Boston Scientific, Coloplast Corp. and Cook Medical. Six MDLs are pending in federal court for the Southern District of West Virginia. Judge Joseph Goodwin is the presiding Judge over all six MDLs, with nearly 15,000 individual lawsuits filed to date.

Actos Trial Underway in Nevada State Court

A third Actos trial is underway in Nevada state court against defendant Takeda Pharmaceuticals. A second week of testimony continues in the ongoing trial where the plaintiff alleges that he developed bladder cancer from taking Takeda’s type 2 diabetes drug, Actos. The trial is expected to continue until the middle of the month before jury deliberations begin.

The case is only the third to reach a jury out of more than 3,000 complaints filed nationwide against Takeda, which all involve similar claims that plaintiffs developed bladder cancer following the long-term use of the popular diabetes drug.

In the first two previous trials for Actos lawsuits, both in state courts, juries have found that Takeda failed to adequately warn about the risk and returned multi-million dollar damage awards for plaintiffs. However, in both cases, the jury awards were set aside by the presiding judges. In the first case, a $6.5 million verdict was set aside after excluding plaintiff’s expert testimony, while in the second case a $1.7 million award was set aside due to plaintiff’s contributory negligence as a smoker.

In federal court, all Actos cases are centralized before U.S. District Judge Rebecca H. Doherty in the Western District of Louisiana as part of an MDL or Multidistrict Litigation. A small group of cases in the federal Actos litigation are being prepared for early trial dates, which are expected to begin early next year.

Class II Recall Issued for DaVinci Robot by FDA

The Food & Drug Administration (FDA) has issued a Class II recall for the Da Vinci Robot, after the manufacturer, Intuitive Surgical, issued a voluntary product correction for Da Vinci Patient Side Manipulators (PSMs) due to an issue where the mechanical arms could stall during robotic surgery.

Intuitive Surgical warned hospitals and other medical providers that the Da Vinci robot instrument arms need to be replaced. A Class II recall from the FDA suggests that the agency believes ould typically result in temporary or medically reversible health problems, but could pose a risk of serious injury in rare cases. –

The FDA’s Class II recall impacts 1386 Patient Side Manipulators on Da Vinci surgical systems.

Intuitive Surgical says it is addressing the problem by inspecting affected robots and repairing or replacing the arms if necessary. The company said in its November statement that nearly 70% of the inspections had been completed and the large majority of the arms did not need adjustment. However the company does not indicate how many robot arms were affected by the problem.

In May of this year, Intuitive Surgical also issued a warning to health care providers about problems with the Da Vinci Robot’s cauterizing scissors, also known as “hot shears.” The company indicated that these components may develop micro-cracks that allow electrosurgical energy to “leak” to nearby tissue and cause thermal injury or burns to internal organs.

In July of 2013, the FDA issued a prior Class II recall impacting the Da Vinci Robot after it was discovered that about 30 of the surgical systems were not properly tested before being distributed. However, no further problems were revealed. The FDA also issued a warning letter to Intuitive Surgical, complaining that the company was not adequately reporting Da Vinci robot problems.

Johnson & Johnson Will Pay Insurers in DePuy ASR Cases

Johnson & Johnson will pay $1 billion to insurers who covered the costs of removal surgery for DePuy ASR hip implants impacted by the 2010 DePuy ASR hip recall, according to details of the recent settlement in the litigation in Ohio federal court.

The settlement could impact as many as 8,000 claims against DePuy Orthopedics, a division of Johnson & Johnson, amounting to a total of $2.47 in damages paid by DePuy. However, the agreement must be ratified by 94% of plaintiffs before it takes effect. This agreement may resolve the majority of 12,000 claims that have been filed over the ASR metal-on-metal hip in the U.S.

Under the terms of the proposed settlement agreement, plaintiffs who underwent revision surgery to remove the faulty metal on metal DePuy ASR hip implant will be eligible to receive funds from the settlement. These plaintiffs may receive a base award of $250,000, but that amount could be reduced based on certain factors including prior medical history, multiple revision surgeries and certain extraordinary injuries sustained in the future.

Documents for the settlement were filed in the multi district litigation (MDL) in Ohio federal court on November 22, 2013. Claims Administrator and Special Masters were recently appointed to oversee the settlement process.

FDA Eases Warning for Avandia

Earlier this week, the Food & Drug Administration (FDA) announced that it will ease certain restrictions on prescribing and using the type 2 diabetes drug Avandia, a move that is designed to reflect current cardiovascular risks and recommendations of expert advisory committees regarding use of Avandia.

Most concerning is Avandia’s risk of myocardial infarction, or heart attack, together with the risk of death. The drug first went to market in 1999 and thousands of Avanida lawsuits were subsequently filed in a multi district litigation (MDL) in federal court for the Eastern District of Pennsylvania. This, and other factors, such as findings from the landmark study by Dr. Steven Nissen in the New England Journal of Medicine, (2007), resulted in the FDA requiring strengthened safety warnings on Avandia’s prescribing information. Plaintiffs were largely successful in many of the lawsuits in the MDL.

Just last week, the FDA issued a statement easing the warning on Avandia. The agency stated “The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on our review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).” The statement was issued on November 25.

Update on Transvaginal Mesh Litigations

So far approximately 35,000 transvaginal mesh lawsuits have been filed against six different device manufacturers alleging that the mesh products are defective and resulted in severe injuries due to erosion of the mesh.

Vaginal mesh products are surgically implanted for treatment or pelvic organ prolapse (POP) or urinary stress incontinence (SUI). Many women have undergone surgery to have both mesh types removed.

In federal court, the vaginal mesh lawsuits have been consolidated into six different multidistrict litigations (MDLs) organized by manufacturer. All of the MDLs are in the federal court for the Southern District of West Virginia. The MDLs are presided over by district court Judge Robert Goodwin.

US District Judge Robert Goodwin, who is overseeing the MDLs, had originally suggested individual trials of bellwether cases, which would be those most representative of all the lawsuits against the four manufacturers with the oldest and largest number of cases.

This year, CR Bard, the manufacturer of Avaulta, Faslata, Pelvicol and PelviSoft Products was the first to have trials heard as bellwethers. On August 15, a jury awarded $2 million including punitive damages in the first bellwether case against CR Bard. Bard settled the second bellwether case out of court. The third lawsuit was withdrawn by plaintiffs. The fourth bellwether case against CR Bard is scheduled to go to trial on December 3, 2013.

Bellwether trials in the MDLs against American Medical Systems, Inc., Ethicon Inc. (a division of Johnson & Johnson) and Boston Scientific Corp. are scheduled to be tried next year.

On June 14, American Medical Systems agreed to pay $54.5 million to settle some cases. However, the settlement didn’t resolve the majority of the more than 10,000 pending against American Medical’s subsidiary Endo Health Solutions Inc. Because a broad settlement of outstanding cases could take a long time, Judge Goodwin has indicated he wishes to speed up the process, and has asked attorneys to suggest a way to consolidate the remaining cases for trial.

Additional lawsuits continued to be filed against the defendants, with as many as 60,000 lawsuits expected to be filed.

New Study Warns of Pancreatitis Risk with Byetta

A new study examining the results of incretin mimetics on the pancreas looked at 1,169 complaints found on the Italian Spontaneous ADR Reporting Database, which were published online at Informa Healthcare on November 13th. Of those adverse event reports, 90 alleged pancreatitis or elevated levels of the pancreatic enzyme, leading authors to conclude that individuals taking Byetta should be monitored for these types of injury.

The new study is the most recent to illustrate the dangers alleged to be associated with incretin mimetic drugs used to treat Type 2 Diabetes, which include Merck’s Januvia and Janumet, Amylin Pharmaceuticals’ and Bristol Myers Squibb’s Byetta and Novo Nordisk’s Victoza. A multi-district litigation (MDL) alleging that these incretin mimetic drugs cause pancreatic cancer and pancreatitis in users is organized and pending in the Southern District of California, in federal court. The first status conference in this MDL was held on November 21, 2013. There are currently 150 lawsuits filed as part of the MDL, but that number is expected to grow in the federal proceeding. These lawsuits were brought on behalf of individuals who allegedly developed Byetta pancreatic cancer, pancreatitis and other injuries, and now similarly allege that its manufacturer failed to adequately warn diabetics and their doctors about the serious risks associated with its product. The MDL is No. 2452.

The Rieders Travis law firm is currently screening cases of Byetta, Januvia, Janumet and Victoza users who developed pancreatic cancer or pancreatitis while on these drugs. If you or someone you loved took these drugs and developed pancreatic cancer or pancreatitis, contact us today for a consultation.

Breaking News: Link Between Byetta, Januvia, Janumet, Victoza and Pancreatic Cancer Confirmed by New Italian Study

Italian researchers have just published a new study that adds fuel to recent concerns over the link between incretin mimetic drugs that treat Type II diabetes and pancreatic cancer, including Byetta, Januvia, Janumet and Victoza.

The study was published in early November in the medical journal Expert Opinion on Drug Safety where researchers claim to confirm U.S. studies linking the incretin mimetic drugs to pancreatic cancer by looking at 1,169 adverse drug reaction reports concerning this class of drugs. Among those reports they found 90 instances of pancreatitis and elevated pancreatic enzymes that may lead to development of pancreatic cancer. In the text of the publication, the researchers concluded “[o]ur data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients.”

In March 2013, the journal Diabetes published another study that found that pancreas tissue from organ donors who used incretin mimetic drugs was more likely to have increased pancreatic mass and precancerous cells.

In addition, a new investigation by the British Medical Journal (BMJ) concluded that the pancreatic risks associated with incretin mimetics like Byetta may have been downplayed by the drugs’ manufacturers. The BMJ investigation consisted of a review of regulatory documents that discovered unpublished data pointing to “unwanted proliferative or inflammatory pancreatic effects” associated with incretin mimetics. The authors of the report also faulted the U.S. Food & Drug Administration (FDA) and European regulators for failing to aggressively address these concerns.

According to a 2011 publication the journal Gastroenterology from a study based on a clinical study done at the University of California at Los Angeles (UCLA) people taking Byetta, Januvia, Janumet and Victoza and for type 2 diabetes are significantly more likely to develop pancreatic cancer, while people taking Januvia are also significantly more likely to develop thyroid cancer.

In addition, new research published in 2013 in the Journal of the American Medical Assocviation (JAMA) showed that patients taking incretin mimetic drugs such as Januvia and Janumet are significantly more likely to develop pancreatic ailments and be hospitalized for acute pancreatitis, often a precurser to pancreatic cancer.

Earlier this year, the FDA had launched an investigation into the pancreatic cancer risks associated with the incretin mimetic class of drugs. So far, the agency has indicated that the current data does not show any heightened risk of pancreatic cancer and has resisted requests to add a warning to the drugs.

The Rieders Travis Law Firm is screening cases from users of Byetta, Januvia, Janumet and Victoza who developed severe pancreatitis or pancreatic cancer from these drugs. If you or someone you love took one of these drugs and developed pancreatic cancer, contact the Rieders Travis Law Firm today for a confidential evaluation to determine whether you may have a claim.

New Statin Guidelines Could Increase Use – And Risks

A new update to the heart guidelines from the American Heart Association and the American College of Cardiology recommends that statin medications prescribed to lower blood cholesterol, could also be administered to patients with a high risk of stroke, regardless of their cholesterol levels.

This change in guidelines could lead to a large increase in the numbers of people who take statin drugs, which could increase the risks for elevated blood sugar levels and developing of diabetes in women taking statin drugs.

Approximately 30 million Americans currently take statin drugs, but since 2012, the labels have contained a warning about the potential to cause elevations in blood glucose levels, which is thought to correlate with type 2 diabetes. Pfizer’s Lipitor and AstraZeneca’s Crestor are two are the most common statin drugs on the market.

Some female users of Lipitor who allege that they developed type 2 diabetes while taking Lipitor to control their cholesterol have filed lawsuits against Pfizer in federal court in Virginia, Louisiana, Illinois and South Carolina, but no multi district litigation (MDL) has been formed to date.

First Zoloft Trial in MDL Set for November 2014

The first Zoloft trial in a federal multi district litigation (MDL) will go before a jury in November 2014 in Pennsylvania. There are currently more than 420 Zoloft birth defect cases pending in the MDL, centered in the Eastern District of Pennsylvania. The cases are pending before Judge Cynthia Rufe, who previously presided over the Avandia MDL.

All of the plaintiffs in these cases allege that that their children siffered serious birth defects from taking Zoloft during pregnancy. They allege that Pfizer, Zoloft’s manufacturers, failed to adequately warn of the risks associated with Zoloft.

In the MDL, a group of 25 cases (some elected by defendants and some my plaintiffs) where chosen for an initial discovery pool. These cases are currently going through pretrial discovery, including depositions and the exchange of documents and medical records relevant to each complaint.

On November 18, 2013, Judge Rufe issued a pretrial order that amended the time table for selecting the specific cases that would be presented to juries first at trial, pushing back the first trial by about three weeks. The first Zoloft trial in the MDL is now scheduled to begin on November 3, 2014. The pretrial order states that testimony will go for about three weeks, with each side allotted a total of 25 hours to present its case. Jury instructions and the start of deliberations are expected to begin on Monday, November 24, 2013.

In November 2006, the Food & Drug Administration (FDA) added a warning to Zoloft about the potential risk of persistent pulmonary hypertension in newborns when taking Zoloft and similar newer antidepressants after week 20 of pregnancy. In June 2007, studies found an association between the use of antidepressants like Zoloft early in the pregnancy and a risk of abnormal skull development, gastrointestinal abnormality and brain defects. In September 2009, a study published in the British Medical Journal found that SSRI antidepressants like Zoloft increase the risk of heart defects when taken during the first trimester, a time when many women do not even know they are pregnant.

The plaintiffs in the individual cases are pursuing a failure to warn theory against Pfizer. It is expected that there may ultimately be several thousand cases brought as part of the MDL.

Byetta, Januvia, Janumet and Victoza Users Nearing Death From Pancreatic Cancer Will Be Allowed to Testify Early in MDL Proceeding

In the federal multi-district litigation (MDL) for pancreatic cancer lawsuits filed by plaintiffs who took Byetta, Januvia, Janumet or Victoza, a process has been established that will allow plaintiffs approaching death to schedule an In Extremis deposition to preserve their testimony for use at trial. This would allow those plaintiffs to testify early in the litigation.

In the litigation, In re Incretin Mimetics Products Liability Litigation, plaintiffs allege that the type 2 diabetes drugs Byetta, Januvia, Janumet and Victoza caused them to develop pancreatic cancer. The cases, about 150 filed so far, have been centralized or pretrial proceedings as part of an MDL in federal court for the Southern District of California. All of the complaints involve similar allegations that the makers of the popular diabetes drugs failed to adequately research the medications or provide sufficient warnings for users and the medical community about the risk of pancreatic cancer.

The order was used on November 5, 2013 by Magistrate Judge Mitchell Dembin which outlines a protocol for plaintiffs who are “reasonably near the end of their lives” to testify early, as it will likely be several years before the first bellwether trials are held in the MDL.

The Rieders Travis law firm is currently reviewing cases from users of Byetta, Januvia, Janumet and Victoza who developed pancreatic cancer while on these drugs. If you or someone you loved took one of these drugs and developed pancreatic cancer, contact us today.

New Study Shows that Pradaxa Reversal Agent in Development May Reduce Bleeding Risk Associated with Pradaxa

According to results from an early presentation at the American Heart Association annual scientific meeting in Dallas, Texas, Boehringer Ingelheim indicated that an antidote currently in development for their blockbuster anti-coagualnt medication provided “immediate and complete reversal” of Pradaxa among a small group of healthy men. According to data presented on Monday, the Pradaxa reversal agent under development involves the use of a fragment of protein that prevents the medication from attaching to the blood enzyme thrombin. This disrupts the blood thinning effects of the medication, allowing blood to clot again.

Although Pradaxa has gained widespread use as an anti-coagulant, there have been thousands of complaints to the FDA about uncontrollable bleeding events by those taking the drug and concerns have risen about bleeding events. Unlike generic warfarin, Pradaxa was put on the market without a reversal agent. Warfarin’s anticoagulant effect can be reversed with Vitamin K.

During 2011, the first full year Pradaxa was on the market, the Institute for Safe Medicines found that adverse event reports involving Pradaxa surpassed all other regularly monitored medications and the FDA received about 3,781 reports including 2,367 of hemorrhage and 542 deaths. In 2012, the FDA recived 3,292 reports involving Pradaxa side effects, including 582 deaths.

Currently approximately 1500 Pradaxa lawsuits are pending in a multi-district litigation (MDL) pending in federal court for the Southern District of Illinois before Judge David Herndon. In those cases, plaintiffs allege that they suffered severe injuries after doctors were unable to reverse Pradaxa’s bleeding effects. The complaints allege that the drug maker failed to adequately warn about the risk of uncontrollable bleeding or the lack of an antidote to reverse the side effects of Pradaxa. Plaintiffs in the lawsuit allege that Pradaxa was rushed to market by Boehringer Ingehleim without first developing an anticoagulant and the fact that the company is presently working to develop an anti-coagulant is an admission that the drug as presently marketed poses an unsafe risk of bleeding events.

According to the current case management plan, a group of bellwether cases are being prepared for early trial dates in August 2014, November 2014, January 2015 and February 2015.

Pradaxa is a blockbuster, as the drug reached $1.43 billion in sales in 2012.

The Rieders Travis lawfirm is currently reviewing Pradaxa cases from users of this drug who suffered serious bleeding injuries from taking Pradaxa. If you or someone you loved suffered an uncontrollable bleeding event while on Pradaxa, please contact our firm today.

Bellwether Selection Process Ongoing In Biomet Hip MDL

The process for selecting bellwether trials in the federal multi district litigation (MDL) for the Biomet hip litigation is currently taking place. Court documents reveal that Plaintiffs’ counsel recently submitted a proposal for bellwether cases where the first cases would not go to trial until March 2016. However, the proposal submitted by Defense counsel would start bellwether trial in the litigation in late 2014. The MDL is In re: Biomet M2a Magnum Hip Implant Products Liability Litigation – MDL No. 2391l

The litigation is currently pending in a MDL in federal court for the Northern District of Indiana. The lawsuits involve the Biomet M2a Magnum hip replacement, which is a metal on metal hip implant,. Associated with high rates of premature failure and complications necessitating revision surgery to remove the implant, as well as fretting and corroding at the metal on metal interface. As of mid November, 2013, there were a total of 718 lawsuits pending in the Biomet hip replacement MDL. In the litigation, Plaintiffs have plead defective design by the manufacturer.

In early 2013, the U.S. Food & Drug Administration (FDA) proposed new federal regulations that would restructure the approval process for devices like the Biomet M2a Magnum hip implant. Under the terms of this proposal, new metal hips would be required to undergo more rigorous safety testing before entering the market. In addition, ongoing safety data reports would be required for submission by manufacturers of these devices to the FDA in order for their products to remain on the market. These changes would make this class of medical devices ineligible to receive clearance through the FDA’s 510(k) process.

Philadelphia Jury Awards $11 Million to Topamax Plaintiff Over Birth Defect

A Philadelphia jury ordered Janssen Pharmaceuticals, a unit of Johnson & Johnson, to pay $11 million dollars in a lawsuit alleging that its anti-seizure drug Topamax causes birth defects. This was the second such Topamax jury loss for Johnson & Johnson in the past month.

The jury in the Philadelphai Court of Common Pleas found that Johnson & Johnson failed to warn the plaintiff of the risks associated with taking Topamax while pregnant, before she gave birth to a son with a cleft lip. According to plaitniffs’ counsel, this case was actually one of the cases selected by defense counsel to go to trial as a bellwether case in the Topamax litigation.

There are approximately 134 cases pending in the Philadelphia state court mass tort proceeding concerning the epilepsy drug Topamax, where the recent trial took place. In another case in state court in Virginia, Janssen lost a $4.02 million jury verdict on October 30, 2013. Janssen told the press that it would be appealing both jury verdicts.

Topamax was first approved by the U.S. Food & Drug Administration (FDA) in 1996. The drug came of patent protection and went generic in 2009, but before that it was one of Johnson & Johnson’s best selling drugs. It is generally used to treat epilepsy. Plaintiffs argued that Janssen knew as early as 1997 from animal studies that it conducted that Topamax showed an increased risk of birth defects, especially oral clefts, but decided against warning patients and doctors of these risks.

In the recent trial, plaintiffs argued that Johnson & Johnson intentionally concealed safety reports in 2003 and 2005 and did not tell doctors the information it knew in 1997 about the in increased risk of birth defects. Defense counsel argued that the label as it appeared in 2006 was adequate and reflected what the company knew at the time. Defense counsel further argued that the company tried to add a more robust warning in 2005 about birth defects in women taking Topamax but the FDA rejected that warning.

As it turns out, the FDA did not require Janssen to change the label for Topamax until 2011, when it said that Topamax might contribute to cleft lips and cleft palates in infants born to women who took Topamax during pregnancy. The FDA then required the label to be updated to reflect a stronger classification and warning.

Settlement Announced in DePuy ASR Hip Litigation

Johnson & Johnson and lawyers for plaintiffs both announced a $4.5 billion dollar settlement agreement in the DePuy ASR hip implant mass tort litigation. However, according to news reports, it was still not clear if the agreement would satisfy enough of the claimants in the litigations.

Under the terms of the settlement agreement , which was announced on Tuesday, Johnson & Johnson would pay $2.5 billion to approximately 8000 patients whose all metal hip implant had failed and we had to undergo revision surgery to have the hip implant removed and replaced with another device. In a separate agreement, Johnson & Johnson also agreed to pay all medical costs related to these revision surgery procedures. According to a New York Times report, this could raise the settlement’s total cost to Johnson & Johnson to closer to $3 billion.

Under the plan, the typical plaintiff who underwent revision surgery to have the hip implant removed would receive approximately $250,000 in compensation before legal fees. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, according to the New York Times.

The proposed settlement was submitted to a federal judge in the ongoing multi-district litigation (MDL) in the DePuy ASR hip litigation in Toledo, Ohio on Tuesday. It must receive the support of 94% of eligible claimants to go forward. Some patients would receive relatively small payouts and others would see payments reduced because the plan imposes a user’s fee on awards based on how long a patient had the implant. According to the New York Times, it is unclear if the plan will receive that level of support.

The ASR hip device was implanted in approximately 93,000 patients, about 1/3 of them in the United States, beginning in 2003.

The remaining 4000 plaintiffs in the litigation would not receive any compensation because they did not undergo replacement surgery at this time. However, there is a provision in the settlement agreement that adds $250,000 for each plaintiff who undergoes a subsequent replacement surgery before the agreement is complete.

So far, only two DePuy ASR cases have gone to trial. In March, a Los Angeles jury ordered DePuy to pay $8 million in damages to a Montana man after finding that the A.S.R. was defectively designed. In August, a Chicago jury sided with DePuy and rejected claims that it had inappropriately marketed the implant.

Under the plan that was announced on Tuesday, $2

billion would be set aside to cover basic awards, while $475 million would be set aside to cover more severe injuries. In addition, patients who had the device longer would also see reductions.

If the deal is approved, the group of plaintiffs attorneys who negotiated the payment would receive 6% or $150 million.

Risperdal Plaintiffs in Pennsylvania Ask Judge to Enforce Settlements

A total of 77 plaintiffs in a consolidated mass tort action in Pennsylavnia state court concerning the drug Risperdal alleging that the drug caused gynecomastia or male breast growth have asked the Judge overseeing the claims to enforce settlement agreements reached earlier this year by the drug’s manufacturer. The motion was field by the plaintiffs on November 5th.

The plaintiffs’ motion states that the Defendant, Johnson & Johnson, is refusing to stick to Risperdal settlement agreements reached on January 28, 2013, stating that the agreements should include certain co-defendants. The 77 cases are all pending in the Philadelphia Court of Common Pleas. As stated above, all of the plaintiffs are teenage boys who allege that the anti-psychotic drug Risperdal caused them to develop breasts. There are a total of 250 cases in the ongoing litigation.

Although some of the cases have settled, most of the cases are still pending in the mass tort litigation.

Risperdal is known as an atypical antipsychotic and is currently approved for the treatment of schizophrenia in adults and adolescents, as well as bipolar disorder in adults and children.

Recent studies indicate that this complication may stem from Risperdal’s potential to overproduce prolactin, a hormone associated with lactation and breast development in women The association between Risperdal and male breast growth was first revealed in 1999 when the journal Psychopharmacology published a study linking Risperdal to gynecomastia when used with the antidepressant Prozac. In 2006, the Journal of Clinical Psychopharmacology published a study showing that prolactin levels can increase significantly when Risperdal is given to adolescents. Finally, in 2009, a study was published in the Journal of Child and Adolescent Psychopharmacology that found that elevated prolactin levels associated with Risperdal persisted in the body for up to two years.

Discovery Schedule Set in GranuFlo / NaturaLyte MDL

An order has issued from the federal Judge presiding over the GranuFlo/ NaturaLyte MDL pending in federal court for the District of Massachusetts with a timeline of discovery deadlines in the mass tort litigation.

A status conference was held in the MDL, No 2428 on September 27, 2013 before the presiding Judge, Douglas Woodlock between plaintiffs and defendant Fresenius Medical Care. The Judge ordered the following deadlines for each party in the litigation.

By October 28, 2013, each party was required to serve initial requests for production and interrogatories, while plaintiff and defendant fact sheets are due to be submitted and agreed upon by both parties.

By November 27, 2013, the plaintiff fact sheets will be submitted, showing relevant, non-privileged medical records in the plaintiff’s possession, and authorizations for additional records by the plaintiff. Defendant fact sheets are due on January 31, 2014.

By January 6, 2014, both parties must submit a proposed Case Management Order addressing the bellwether process in which both parties will agree as to which cases will be tried first by the court.

By March 31, 2014, the defendant must serve a Production Certification of completion, indicating that they are ready for the upcoming trials. The defendant has the option of requesting an extension on the deadline.

The first of the GranuFlo/NaturaLyte bellwether trials will be announced sometime after March 31, 2014.

The MDL is In Re: Fresenius GranuFlo and NaturaLyte Dialysate Products Liability Litigation, MDL No.l:13-md-2428-DPW, in the United States District Court of Massachusetts. As of early November, at least 312 dialysis lawsuits have been filed in the MDL in the District of Massachusetts against Fresenius. Additional claims are also pending in state court in Massachusetts in Middlesex County Superior Court in consolidated litigation.

Boehringer Ingelheim Tries to Stop Depositions from Going Forward in Pradaxa MDL

More than 1500 lawsuits have been field to date against the manufacture of Pradaxa, Boehringer Ingelheim alleging that the company failed to warn about the risk of excessive bleeding and hemorrhage associated with its blockbuster anti-coagulant medication which first came to market in 2010.

According to FDA adverse event reports, in the short time that Pradaxa has been on the market, there have been 582 deaths associated with Pradaxa.

A multi-district litigation (MDL) is currently pending for consolidated Pradaxa lawsuits against Boehringer Ingelheim in the U.S. District Court for the Southern District of Illinois, before federal Judge David Herndon. The MDL is No. 2385.

The litigation is presently in the discovery phase, but in a recently filed motion, attorneys for Boehringer Ingelheim asked Judge Herndon to bar plaintiffs from proceeding with taking the depositions of two high ranking company executives, by filing a Motion for a Protective Order. They claim that these two depositons will place two great of a burden on the company as a whole because they have tremendous oversight responsibilities at Boehringer Ingelheim. The company’s lawyers had previously attempted to negotiate with plaintiffs’ counsel by offering one of the proposed individuals for deposition on the condition that plaintiffs did not try to depose the other individual. However, plaintiffs’ legal counsel rejected this offer. As a result, defendants currently seek a protective order that the depositions sought by plaintiffs would be too disruptive to the company as a whole. Defendants claim in the motion papers that plaintiffs have already deposed or will soon depose at least 40 other senior corporate officials who have just as much information on the side effects associated with Pradaxa and its clinical development.

According to data compiled by the Institute for Safe Medication practices, 3,292 reports of severe or fatal Pradaxa side effects were logged in 2012. The majority of these adverse events involved excessive bleeding. There is currently no antidote on the market to stop these life threatening bleeding events with Pradaxa. However, due to the number of adverse events, Boehringer Ingelheim is currently working with a partner to develop an antidote. Pradaxa came to the market in 2010 as an allegedly safer alternative to generic warfarin, which has a known antidote, Vitamin K.
The first Pradaxa bellewether cases in the MDL are expected to go to trial sometime in late 2014.

FDA Issues Warning Over Some Medtronic Guidewires

Food & Drug Administration (FDA) officials say that defects in some Medtronic devices used in heart procedures are severe enough to cause serious injury or death in patients and has issued a new warning.

The FDA’s warning covers about 15,000 recalled guidewires which are inserted through an artery and used to guide other devices into place, such as stents used to hold open blocked arteries.

The recall of the Medtronic guidewires mentioned above, commenced on October 21, 2013 after Medtronic received reports of four complaints from patients. Medtronic then issued a recall notice to hospitals and distributors worldwide, warning that the coating on the guidewires could break off, which could result in blocking a blood vessel. The wires are coated by Medtronic so that they can slide through blood vessels with greater ease.

The FDA classified the recall as a Class I recall, which is reserved for products with a reasonable potential to result in serious injury or death. The recall only impacts some newer lots of Medtronic guidewires that have been made since April, according to the company.

First Federal Nuva Ring Trial Scheduled for January

Federal Court officials, as of September, report that the number of Nuva Ring cases from across the country that have been consolidated into a federal multi-district litigation (MDL) before a U.S. District Court Judge in Missouri has risen to 1279 pending lawsuits. The cases are being overseen by Judge Robert Sippel in the Eastern District of Missouri.

The first bellwether trial was scheduled to begin in October 2013, but trial has been pushed back in that case until January .27, 2014 according to a recent court order. In the Nuva Ring cases, Plaintiffs allege that the prescription Nuva Ring contraceptive device puts them at greater risk of suffering blood clots and that the manufacture of Nuva Ring failed to inform FDA regulators and consumers. Plaintiffs further allege that the Nuva Ring device is defective and unreasonably dangerous.

Judge Sippel recently made an important ruling in the litigation, finding that the woman seeking damages in the bellwether trial will be able to seek punitive damages under the provisions of Missouri law, according to a July 12, 2013 opinion in the court file. The defendants had sought to have the case tried under more restrictive New Jersey law.

The cases name Merck and Organon USA, Inc. as the defendants. Nuva Ring was approved by the FDA in 2001 after being created by Organon as a flexible IUD. The IUD releases a low dose of etonogestrel and estrogen over three weeks, providing women the flexibility of a monthly contraceptive. On October 27, 2011, the Food & Drug Administration (FDA) released findings of government research that put women who used Nuva Ring and other IUDs with a similar mix of hormones at a 56% higher risk of suffering blood clots that led to deep vein thrombosis and pulmonary embolism than women who took birth control pills.

The federal MDL is In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, U.S. District Court, Eastern District of Missouri. The MDL is No. 1964. In addition to the federal MDL, over 200 Nuva Ring state court lawsuits are also pending in a coordinated state court proceeding in New Jersey Superior Court in Bergen County. The first bellwether trial in the consolidated New Jersey state court proceeding is scheduled to begin . The New Jersey litigation is being presided over by Judge Brian Martinotti.

Pennsylvania Lawmakers Push for False Claims Legislation Over Risperdal Settlement

Lawmakers in Pennsylvania are pushing for new state-level false claims laws in the aftermath of a $2.2 billion dollar settlement against Johnson & Johnson for improper promotion of its drug Risperdal, which is also involved in pending mass tort litigation. The settlement came on the heels of a government probe against J&J after a government investigation into the company’s off-label marketing practices for the drug which violated FDA guidelines.

In the settlement, Johnson & Johnson is required to pay $2.2 billion to resolve criminal charges involving Risperdal which the government said was improperly promoted by the company in nursing homes as well as to children with mental disabilities.

According to a November 6th report, a state version of a False Claims Act to reduce healthcare fraud, waste and abuse was introduced by a representative from Washington County in Pennsylvania, as well as a Democratic legislator in June.

In addition, the number of lawsuits against Johnson & Johnson filed in Pennsylvania state court in a mass tort action by teenage boys who allege that they developed gynecomastia, or male breast growth, from the drug continues to grow.

Pennsylvania lawmakers say that new false claims regulations would recover the “maximum amount possible from those who cheat or attempt to cheat the government.”

Mirena Lawsuits Increase

The number of Mirena lawsuits filed in a multi-district litigation (MDL) in New York has increased to 211 lawsuits as of October 17. The MDL is no. 2434 and is consolidated in federal court for the Southern District of New York. Judge Cathy Seibel is presiding over the litigation. The next conference in the federal Mirena MDL is scheduled for November 20, 2013. The litigation’s first bellwether trials are currentluy planned for late 2015.

FDA records show the agency has already received 70,072 reports of Mirena side effects, with as many as 6,000 involving device dislocation or uterus perforation.

Mirena is an IUD device manufactured by Bayer Pharmaceuticals. Mirena has been linked to uterine perforation and other serious side effects. These serious side effects have been reported to include device expulsion, device dislocation (migration into the abdomen or other organs) and vaginal hemorrhage.

In addition, numerous lawsuits have also been filed in New Jersey state court in a multi-county coordinated proceeding centered in Bergen County Superior Court before Judge Brian Martinotti.

When cases are consolidated, like in New Jersey state court, each plaintiff retains her independent claim against Bayer, unlike in a class action where all plaintiffs who suffered similar harm file one case together. However, the judge is able to more easily decide issues relevant to the individual cases because the judge is familiar with the facts.

Mirena was approved by the FDA in 2000 as a contraceptive device. In 2009 it was approved for treatment of heavy menstrual bleeding for women who prefer and IUD as their method of birth control. The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic “hormone” to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combined oral contraceptives.

In 2009, the FDA first issued a warning to Bayer for overstating the effectiveness of Mirena, while minimizing the risks associated with it. However, this warning has been viewed as entirely inadequate to preclude litigation against Bayer by most plaintiffs.

If you or someone you love was injured by Mirena, please call the Rieders Travis law firm to have your claim investigated.

Tentative Settlement Reached in DePuy ASR Hip Litigation According to NY Times Report

Johnson & Johnson has tentatively agreed to a $4 billion dollar settlement in the DePuy ASR hip litigation to resolve thousands of lawsuits according to a New York Times report dated November 13, 2013. The plan must win approval of the presiding Judge before it can be implemented.

The proposed settlement agreement will impact those plaintiffs who had the DePuy hip replacement implanted and were required to have the implant removed. Under the proposed agreement, each plaintiff would receive approximately $350,000 in compensation from the manufacturer on average, although the amount received by each plaintiff would vary based on other factors.

The settlement’s values remain undetermined because the parties are trying to determine how many of the plaintiffs were required to have the ASR hip implant replaced, as the settlement would only apply to those plaintiffs. According to the NYT article, lawyers believe that number could be 7000 to 8000 of the total of 12,000 cases.

The ASR hip was sold by DePuy, a unit of Johnson & Johsnon until mid-2010 when it was recalled due to rising rates of early failure of the impant. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.

Trials are currently scheduled in the federal multi-district litigation for January in federal court for the District of Ohio.

Schedule Set for Pradaxa MDL Bellwether Trials

Chief Judge David Herndon who is presiding over the Pradaxa multi-district litigation (MDL) in the Southern District of Illinois has set a schedule for four bellwether trials in the litigation to start in August 2014 and end in early 2015. In addition, Judge Herndon’s order provided guidelines for depositions, expert witnesses and filing procedures in the ongoing MDL over Boehringer Ingelheim’s anti-coagulant drug Pradaxa. The Pradaxa MDL was just created in August of this year by the Joint Panel on Multidistrict Litigation (JPML).

Plaintiffs bringing claims in the litigation allege that the blood thinner Pradaxa, which was rushed to market by Boehringer Ingelheim without first developing an antidote, caused severe bleeding and/or hemorrhage, resulting in serious injury and in some cases death. These lawsuits allege that Pradaxa’s manufacturer, Boehringer Ingelheim failed to warn users of the drug’s risks, including the potential for bleeding and the lack of an antidote or reversal agent to this bleeding.

As of early October, the Pradaxa MDL contained a total of 120 filed cases, while a handful of additional cases involving Pradaxa have been field in state courts in California, Connecticut and Illinois.

Judge Herndon is also presiding over the Yasmin/Yaz birth control MDL, which is also centralized in the Southern District of Illinois. In his order with respect to the Pradaxa bellwether trial, he asked that each trial occur six weeks apart.

The Rieders Travis law firm is currently evaluating claims of users of Pradaxa for potential inclusion in the MDL. If you or someone you loved suffered a serious bleeding event or hemorrhage from taking Pradaxa, contact the Rieders Travis firm today for a confidential evaluation to determine whether you may be able to bring a claim for your injuries.

Actos Federal MDL Set to Begin Bellwether Trials in January

Lawsuits against Takeda Pharmaceuticals, manufacturer of the oral Type 2 diabetes drug Actos (pioglitizone), continue to advance in federal court. A large number of Actos cases are pending in a federal multi-district litigation in the U.S. District Court for the Western District of Louisiana. The litigation is MDL No. 2299. The monthly status conference in the action scheduled for November 21, 2013 has been cancelled and the court will instead hold a telephone conference concerning motions in limine that have been filed in anticipation of upcoming trials in January.

In June 2011, the FDA warned that use of Actos for more than a year had been linked to development of bladder cancer. Since that warning, more than 2850 lawsuits have been filed against Takeda, Actos’ manufacturer in the MDL in the Western District of Louisiana. All of the claims allege that Takeda Pharmaceuticals and other defendants concealed knowledge that Actos could increase a person’s chances of developing bladder cancer, and failed to provide adequate warnings about that risk to the public and medical community. The first Actos bladder cancer trials in the MD, the bellwether trials, are scheduled to take place in January 2014.

Two state court lawsuits involving Actos have already gone to trial. In September, a Maryland state court awarded the family of a man who took Actos and died from bladder cancer $1.7 million. However, according to court records, the judge presiding over the trial set aside the verdict in accordance with Maryland law because the jury also found that the decedent’s decades-long smoking habit contributed to the development of the disease, as smoking has been found to have a casual relationship with bladder cancer. In April, a Los Angeles, California state court awarded a plaintiff who was diagnosed with bladder cancer $6.5 million, but that verdict was also set aside. Appeals are pending in both cases.

FDA Moves to Make Generic Drug Manufacturers More Accountable

Unlike patients who took brand name drugs, many patients who were injured by generic drugs are unable to bring lawsuits. Such claims against generic drugmakers have ordinary been thrown out by federal and state courts in the wake of the Supreme Court’s decisions in Pliva v. Mensing (2011) and Bartlett v. Mutual (2013). In Mensing, for example, the Supreme Court held that generic drug manufacturers cannot be held liable under a failure to warn theory because under current FDA rules, only brand name drug manufacturers, and not generics are responsible for safety warnings. Thus, holding generic manufactures liable in federal court would contradict the requirements set forth under federal generic drug law and trigger preemption with the federal laws. Generics are required to copy the label from the name brand and have no control over what’s on it, so as a result, they can’t be held liable.

However, on Friday November 8, the federal Food & Drug Administration (“FDA) announced a new proposed rule that would allow generic manufacturers to update labels with new information, just like brand manufacturers. This new federal requirement may open up generic manufacturers to the same liability for tortuous injuries as brand manufactures. This new proposed rule would be an attempt by the FDA to close what has been called a “dangerous safety gap” by consumer watchdog groups like Public Citizen.

With more than 80 percent of the prescriptions in the United States filled with generic drugs, rather than branded pharmaceuticals, the FDA said it is important for generic manufacturers to be actively involved in making sure drug labels are up-to-date and accurate.

However, generic manufacturers currently are opposed to this new proposed rule, and are lobbying against it. It had been reported by news sources that the Generic Pharmaceutical Association said that such a change in the rules could create “unnecessary confusion” and “drive up costs.” Currently, when generic drugs are approved by the FDA through an expedited ANDA process, they are already required by the FDA to have the same label as the brand drug once they are proven through testing to be scientifically equivalent to the brand in terms of safety, efficacy and quality. The Supreme Court has repeatedly held that generic manufacturers must duplicate the language on brand labels and cannot make changes to a label without FDA approval.

Stryker Rejuvenate Hip Implant Litigations Continue to Grow

Court records indicate that the number of Stryker Rejuvenate and ABG II hip implant cases continues to grow at a rapid pace following last year’s Stryker recall. n a consolidated multi-county litigation established in New Jersey’s Bergen County Superior Court, approximately 433 cases have been filed since the recall, which affected 20,000 Rejuvenate and ABG II modular-neck hip stems. The litigation is being presided over by Judge Brian Martinotti. In addition, 346 cases have been filed in Minnesota federal court in a multi-district litigation (MDL) which is being presided over by Judge Donavan Frank.

The Stryker hip recall, which impacted Styker Rejuvenate and ABG II modular metal-on-metal hip stems was issued on July 6, 2012 after the manufacturer became aware of post-market surveillance data that indicated the Rejuvenate and ABG II metal hip replacement’s potential to fret and corrode at the modular-neck junction. The pending lawsuits allege that the implant failure results in pain, swelling, metallosis (metal ion poisoning) and other side effects, as well as the need to have painful and invasive surgery to remove the hip implants.

Patients who received the Stryker Rejuvenate and/or ABG II modular-neck hip stems are advised to seek medical attention whether or not they are experiencing symptoms that indicate premature failure, due to the recall. Stryker Corp. has recommended that all hip implant recipients undergo routine blood testing and cross-sectional imaging to monitor for elevated metal ion levels, which may be caused by the accumulation of metallic debris in the body.

The Rieders Travis Law Firm is currently reviewing cases from patients with the recalled Stryker Rejuvenate and ABG II hip implants. If you received one of these recalled implants, contact us today for a consultation concerning your legal rights.

Joint Panel on Multidistrict Litigation Received Second Request for Consolidated Lipitor Litigation in South Carolina Federal Court

The Joint Panel on Multidistrict Litigation (JPML) has received a second request to establish a multidistrict litigation (MDL) for federally filed Lipitor claims, as lawsuits continue to mount in numerous federal courts.

The pending Lipitor lawsuits at issue have been filed by women who allege that they developed Type 2 diabetes from taking the statin drug Lipitor, manufactured and marketed by the pharmaceutical giant Pfizer. The new motion requesting an MDL for these cases was filed with the JMPL on October 10, 2013. A previous motion requesting a MDL in the District of South Carolina for federally filed Lipitor cases was denied by the JPML earlier this year. According to the current motion that was filed with the JPML there are currently 62 Lipitor cases filed by women in 21 federal courts. Plaintiffs’ assert that the increase in Lipitor claims should prompt the Panel to take another look at consolidating the lawsuits in a single federal court. (In re Lipitor (Atorvastatin) Litigation, MDL No. 2502 (JPML)).

When the JPML denied Plaintiffs’ request for an MDL earlier this year, they did so because there were not enough Lipitor claims yet filed, just 24 federal claims. The new Motion for a multidistrict litigation once again proposes that the proceeding be established in U.S. District Court, District of South Carolina, where 14 Lipitor lawsuits have already been filed and are being coordinated in an informal manner. Court records also indicate that a number of similar Lipitor lawsuits have also been consolidated in U.S. District Court, Southern District of Illinois, for the purposes of discovery and other pretrial proceedings. (Hines v.Pfizer Inc., No. 13-404, S.D. Ill.)

The number of federally filed Lipitor lawsuits has been growing since February 2012, when the Food & Drug Administration (“FDA”) ordered Pfizer, Lipitor’s manufacturer, and manufacturers of other statin cholesterol lowering drugs across the board to add new warnings to the Lipitor label regarding an increased risk of new-onset diabetes in patients who took the cholesterol-lowering statin. Plaintiffs in the federally filed lawsuits allege this warning is entirely insufficient. The label modifications were ordered after research that appeared in JAMA: Internal Medicine reported that post-menopausal women treated with drugs like Lipitor were more likely to develop the disease.*

In May 2013, the British Medical Journal also reported an association between Lipitor and diabetes, finding that patients who took the drug had a 22 percent increased risk of new-onset diabetes.

The Rieders Travis law firm is currently screening cases from women who developed Type 2 diabetes while taking Lipitor. If you are a woman with a BMI under 30 and are in otherwise reasonably good health, but developed Type II diabetes while taking Lipitor, contact the Rieders Travis law firm for a consultation to determine whether you may have a claim against Pfizer, Lipitor’s manufacturer.

Propecia Sexual Dysfunction Lawsuits Press Forward

Propecia has been prescribed to more than 1 million men in the United States as an effective treatment for male pattern hair loss. The drug, manufactured and marketed by Merck, was first approved as a hair loss treatment in 1997.

However, in June 2011, the Food & Drug Administration (“FDA”) announced new labeling requirements for Propectia because of new findings that finasteride, and active ingredient in Propecia had been linked to development of prostate cancer.

In April 2012, the FDA announced another label change for Propecia. This time, the FDA required that Propecia labels include warnings about “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.” This was in the United States. However, in Sweden researchers had been investigating claims of sexual dysfunction with Propecia as far back as 2006 and Merck had added warnings about persistent erectile dysfunction after discontinuing use of Propecia to its labels in Sweden in 2008. However, despite Merck’s awareness of this information, Merck didn’t add this warning to the label in the United States until the FDA required it to, four years later.

By the time the FDA took action with the label in 2012, many lawsuits had already been filed against Merck, alleging that Propecia caused development of sexual dysfunction.

In April of 2012, a federal Judicial Panel transferred lawsuits pending in federal courts to the U.S District Court for the Eastern District of New York creating a multi-district litigation (MDL). The MDL is No. 2331. By January 2013, the MDL contained 139 cases alleging persistent sexual dysfunction as a result of taking Propecia. The cases in the MDL are assigned to Judge John Gleeson.

In addition, more than 200 lawsuits have similarly been filed in state court in New Jersey. These cases are being centrally managed in Middlesex County by Judge Jessica Mayer

JAMA Study Raises Red Flag About Risks of Testosterone Drugs

A new research study published in the Journal of the American Medical Association (JAMA) raises questions about the safety of testosterone booting drugs that have increasingly become popular. Such testosterone boosting therapies include Eli Lilly’s Axiron, AbbVie’s AndroGel, and GlaxoSmithKline’s Testim.

IMS Health says sales of testosterone drugs grew by 90% over 5 years, reaching $1.9 billion in 2011. By 2017, the entire testosterone market is expected to hit $5 billion.

According to the study published in JAMA, the rate of death, heart attack and stroke was $25.7 percent in the group of male patients with low testosterone who took testosterone drug after a coronary angiogram procedure. That rate was only 19.9% on the group of patients who did not use testosterone drugs. After controlling for various factors, the researchers calculated a 29% increase in risk for the men who used testosterone

The researchers in the published study specifically note that the rate of risk was the same in men with coronary artery disease as men who didn’t, and that the testosterone group had a lower risk profile to begin with.

Lipitor Plaintiffs File Second Request for Federal Consolidated Multidistrict Litigation

Thirty-six cases alleging that Pfizer’s blockbuster cholesterol lowering drug Lipitor caused them to develop Type II diabetes have been removed and are no pending in federal court for the Southern District of West Virginia. These lawsuits, which allege the association between Lipitor and diabetes, were filed in McDowell County Civil Court between October 10th and October 14th. Court documents indicate that 14 similar actions were filed in September by plaintiffs from West Virginia, New York and North Carolina. According to their complaint, “Lipitor is associated with, and cases, an increased risk of type 2 diabetes and/or blood glucose levels diagnostic for type 2 diabetes. –

Lipitor claims have not yet been consolidated in a federal multi-district litigation (MDL) like with many mass torts. On October 10, 2013, a motion to create a single consolidated federal MDL proceeding was filed with the U.S. Judicial Panel on Multidistrict Litigation.

In the request, the plaintiff noted that 62 Lipitor lawsuits were pending in 21 federal courts. Earlier this year, a separate group of plaintiffs requested that a single federal proceeding be created, but was denied by the Panel. At the time, 24 Lipitor lawsuits had been filed in the U.S., which they said was not enough to establish a multidistrict litigation.

In February 2012, Pfizer was ordered by the U.S. Food and Drug Administration (FDA) to adjust the medication’s labeling to include the risk for new-onset Type 2 diabetes after it was found that post-menopausal women may run an increased risk for developing the disease. The FDA did not just impose this requirement on Pfizer, but on the manufacturers of all statin drugs in Lipitor’s class, including for example, Crestor.

Johnson & Johnson to Pay $2.2 Billion in Settlement for Improper Promotion of Risperdal

The United States Justice Department announced on November 4 that the pharmaceutical company Johnson & Johnson has agreed to pay more than $2.2 billion in civil and criminal fines that it improperly promoted its antipsychotic drug Risperdal to older adults, children and people with developmental disabilities.

Johnson & Johnson also has agreed to settle civil and criminal claims that it paid kickbacks to a large pharmacy, Omnicare, which caters to nursing homes.

In announcing the settlement, Attorney General Eric Holder said, “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust. This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health-care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

The settlement agreement is the third largest pharmaceutical settlement in United States history. It was part of a decade long effort on behalf of the federal government to hold pharmaceutical companies responsible for illegal marketing practices involved with using psychiatric drugs to control dementia patients in nursing homes, and to children with behavioral disabilities.

The conduct alleged in the case concerning Risperdal goes back to 1999 and extends until 2005. As part of the settlement, J&J was required to plead guilty to a criminal misdemeanor alleging that it improperly marketed Risperdal to older adults, children and people with developmental disabilities for unapproved uses, but the company did not admit to wrongdoing in the civil portion of the settlement which involves claims that the company promoted the drug’s use in children and the developmentally disabled, as well as accusations that it paid kickbacks to doctors and pharmacists in exchange for writing more prescriptions. The civil settlement involves accusations raised by 45 different states in separate proceedings.

Johnson & Johnson officials tried to expand the market for Risperdal to older dementia patients soon after the drug was approved in 1993 to treat symptoms of psychiatric disorders, court filings in the case stated. However, the drug was only primarily tested for FDA approval in schizophrenia patients. The FDA repeatedly rejected efforts by the company to expand the drug’s use to older dementia patients, according to court filings.

Plaintiffs’ Seek Special Master in Biomet Hip Litigation MDL

Plaintiffs’ counsel has endorsed appointing a special master in the federally filed Biomet hip litigation. A special master would likely help in facilitating the resolution of certain discovery issues related to the proceeding currently underway in the U.S. District Court, Northern District of Indiana, plaintiffs added in an October 25, 2013 court filing.

There are currently 725 cases pending in the proceeding in the Northern District of Indiana over the Biomet M2a Magnum metal on metal hip replacement in a multi-district litigation (MDL) entitled In re: Biomet M2a Magnum Hip Implant Products Liability Litigation – MDL No. 2391. The hip consists of a consists of a cobalt-chromium ball and cup that can be prone to wear and tear.

According to the complaints filed in the lawsuit, the hip replacement is faulty and may result in metallic debris that may shed into the plaintiffs’ blood stream and cause pain, swelling, metallosis (metal ion poisoning) and other complications. The defective design of the implant may then require revision surgery to correct complications allegedly caused by the device, the lawsuits allege.

While there has been no recall of the Biomet M2a hip implants that are at the center of this lawsuit like with the Stryker Rejuvenate hip replacements, in January 2013, the Food & Drug Administration (FDA) proposed new regulations that would require all new hip implant devices to receive premarket approval.

Defendant Boehringer Ingelheim Fined for Discovery Violations in Pradaxa Litigation; MDL Continues to Build Momentum

The blood thinner Pradaxa continues to be the target of mass tort litigation. Numerous claims continued to be filed against manufacturer Boehringer Ingelheim in a federal multi-district litigation (MDL) mass tort case in federal court for the Southern District of Illinois before Chief Judge David Herndon.

Throughout the course of the litigation to date, Defendant Boehringer Ingelheim has allegedly engaged in tactics of withholding documents and failing to timely produce documents involving Pradaxa to Plaintiffs’ attorneys. In doing so, Boehinger Ingelheim has allegedly violated multiple Court Orders issued by the Honorable Judge Herndon which set forth requirements governing the production of documents and other discovery matters. Accordingly, Plaintiffs’ counsel filed a motion for sanctions against Boehringer Ingehleim in September to address the ongoing discovery violations. At the subsequent hearing before Judge Herdon, the Judge agreed that Boehringer Ingelheim’s conduct amounted to disregarding many of the Court’s Orders governing discovery. Consequently, the Court imposed a $29,540.00 fine on Boehringer Ingelheim and issued a Mandatory Injunction requiring Boehringer Ingelheim to follow a series of Court Orders that are designed to remedy the discovery abuses and prevent them from occurring in the future.

Pradaxa is an oral anticoagulant medication which was launched to market in the United States by the German Defendant Boehringer Ingelheim in 2010. The drug was marketed as an alternative to generic warfarin, which had been in use for over fifty years, as a purportedly safer alternative. However, unlike warfarin which has an antidote in Vitamin K, Pradaxa was rushed to market by Boehringer Ingelheim without first developing a safe antidote.

According to the Judicial Panel on Multidistrict Litigation, over 1300 Pradaxa lawsuits were pending in the MDL as of late September, 2013. The number of cases in the MDL before Judge Herndon in the Southern District of Illinois is expected to grow significantly. Plaintiffs bringing cases in the MDL allege that the manufacturer failed to warn about severe bleeding risks and lack of an antidote when marketing the drug and allege that they have developed severe and often fatal injuries as a result. The lawsuit is titled In re:

Pradaxa (Dabigatran Etexilate) Products Liability Litigation (MDL 2385). The first bellwether trial in the Pradaxa MDL is currently scheduled for August 2014.

Pradaxa has been under scrutiny by physicians groups and patient advocates since 4,781 adverse effects and 542 deaths associated with the drug were reported to the Food & Drug Administration last year in 2012. Pradaxa’s adverse reports and deaths surpassed all other monitored drugs with respect to the 2012 FDA report. The FDA is currently conducting a safety review of Pradaxa.

Boehringer Ingelheim spent $464 million in 2011 to promote Pradaxa, including direct-to consumer advertising. During 2011 the company’s sales topped $1 billion.

The Rieders Travis Law Firm is currently screening cases from users of Pradaxa who suffered internal bleeding and hemorrhage complications from taking Pradaxa. If you or someone you loved think you may have been injured by Pradaxa, contact the Rieders Travis law firm today for a consultation as to whether you may have a claim against Boehringer Ingelheim for your injuries.

Ariad’s Leukemia Drug Inclusig Pulled From Market

Sales of Ariad’s leukemia drug Inclusig (ponatinib) are being suspended by the Food & Drug Administration (FDA) because of a life-threatening risk of blood clots and severe narrowing of blood vessels. The FDA issued its announcement on Thursday October 31, 2013.

Inclusig has been linked in ongoing post-approval clinical trials to severe and sometimes fatal heart attacks and strokes, blindness and loss of blood flow in extremities, serious enough to require amputation. In some cases, the problems or deaths occurred as soon as two weeks after patients began taking the drug, according to the FDA. The FDA also said some of the people affected had no risk factors for heart disease, and some were in their 20s.

Inclusig was first approved by the FDA less than a year ago to treat chronic myeloid leukemia. At that time, the risk of blood clots was already known about the drug from earlier clinical studies and the label had a warning for this risk. However, in practice, problems with blood clots for patients taking the drug were much worse than in pre-approval clinical studies.

In earlier pre-approval studies, 8 percent of people taking the drug had serious blood clots in their arteries, and 3 percent had blood clots in veins. Now, the FDA reports, 24 percent of patients studied a median of 1.3 years and 48 percent studied a median of 2.7 years had “serious adverse vascular events.”

The FDA told the New York Times that the drug was not being permanently withdrawn from the market and patients with severe CML who wish to continue taking the drug can do so as the condition can be fatal. Iclusig was meant for patients with a mutation that made their cancerresistant to Gleevec and related drugs.

J&J’s Risperdal Gynecomastia Suits Continue to Grow

An increasing number of lawsuits are being filed in a consolidated Pennsylvania state court litigation alleging that the anti-psychotic drug Risperdal has caused gynecomastia (breast development) in young boys. The cases are filed in the Philadelphia Court of Common Pleas.

Risperdal is commonly used to treat schizophrenia and bipolar disorder, as well as autism in adults and children. The drug is also often prescribed off-label to treat ADHD. The lawsuits have been brought on behalf of young boys aged 12 through 17.

Research published over the past several years has lent evidence to the association been Risperdal and gynecomastia, which may be caused by the potential for the medication to produce excessive amounts of prolactin, a hormone known to stimulate milk production and breast growth in women. According to a study published in the Journal of Clinical Psychopharmacology in 2006, elevated levels of prolactin may cause gynecomastia in boys and men, and lactation in girls

The following symptoms are associated with gynecomastia in men: pain, swelling, tenderness, nipple discharge from one or both breasts. In the worst case scenario, mastectomies or liposuction may be required to reverse Risperdal gynecomastia complications.

So far, Johnson & Johnson has agreed to settle five of the cases filed in the Philadelphia Court of Common Pleas, alleging that Risperdal caused gynecomastia. The first settlement occurred in September 2012, on the opening day of trial in one of the cases. There are over 200 pending cases in the litigation according to court records.

This is not the first litigation involving Risperdal that Johsnon & Johnson has been party to. April 2012, a judge in Arkansas ordered Johnson & Johnson pay $1.2 billion in fines over Risperdal marketing. That verdict came three months after J&J decided to end a trial in Texas over the drug’s sales with a $158 million settlement. The Texas case included claims that the company marketed the drug for children while lacking approval by regulators for such use.

In June 2011, a judge in South Carolina ordered Johnson & Johnson to pay $327 million in penalties for deceptively marketing the medicine. The company on Aug. 31, 2012 also lost a bid to have a Louisiana appeals court throw out an award of almost $258 million that a jury ordered it to pay over Risperdal marketing in that state.

Earlier in October 2013, Johnson & Johnson announced that it had set aside $600 million to deal with litigation, much of it concerning Risperdal. In addition, the company set aside $1.1 billion to handle cots relating to a justice department investigation concerning Risperdal. The federal investigation involves Risperdal, another antipsychotic drug Invega, a heart-failure drug Natrecor and allegations of kickbacks to Omnicare, Inc. Omnicare is a nursing home pharmacy company and J&J is alleged to have paid Omnicare to prescribe Risperdal to nursing home patients.

FDA Puts Black Box Warning on GSK’s Potiga

The Food & Drug Administration (FDA) has added a black box warning to GlaxoSmithKline’s anti-seizure drug Potiga, (ezogabine) the strictest type of warning that the FDA can put on the label of a marketed pharmaceutical.

The warning included risks of potential vision loss. The warning “underscores risks of abnormalities in the eye, vision loss and skin discoloration, all of which may become permanent, the FDA said in a statement today. The revised label with the black box warning comes after risks were flagged by the FDA in April.

Patients should have eye exams before starting Potiga and every six months during treatment, the FDA said. The drug accounted for $11 million dollars in sales in 2012. Potiga was first approved by the FDA in 2010 for partial seizures in adults. he medication works by opening potassium channels in neurons, which is unique among anti-seizure medications. It was demonstrated to reduce seizures by 25-50% or more in a substantial percentage of patients.

Further studies post approval have indicated that approximately 33% of patients who took Potiga for four years were found to have retinal damage. It is unknown if discontinuing Potiga will reverse this effect on the retina.

According to the FDA, between April 2012 and February 2013, roughly 2,900 people purchased 10,900 Potiga prescriptions at retail pharmacies in the United States.

If you took Potiga and experienced vision loss, contact the Rieders Travis Law Firm today for a consultation to determine whether you have a claim against the manufacturer of this drug, GlaxoSmithKline.

Bellwether Litigations Selected for Vaginal Mesh Cases Against Boston Scientific

According to a Pretrial Order issued by a federal court for the Southern District of West Virginia, four vaginal mesh lawsuits have been selected for the multi-district litigation’s first round of bellwether trials for the MDL against Boston Scientific. The first round of bellwether trials is scheduled to begin on February 11, 2014 and will involve lawsuits over injuries allegedly related to the use of Boston Scientifics’ Pinnacle mesh products. The second round of bellwether trials will start on June 17, 2014 and will involve cases concerning the Obtyrx pelvic mesh. The MDL is In re: Boston Scientific Corp, Pelvic Repair System Products Liability Litigation. The MDL is No. 2326. Bellwether trials are the first trials of thousands of cases in the MDL which may set the stage for how other juries might weigh claims in transvaginal mesh lawsuits involving Boston Scientifics’ products.

There are a total of six MDLs, all pending in the Southern District of West Virginia, concerning vaginal mesh products for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Each of the six MDLs is for a different manufacturer of transvaginal mesh products.

Court documents indicate that Boston scientific has been named in more than 5,800 lawsuits on behalf of women who claim that the company’s pelvic mesh products caused them to suffer mesh erosion, chronic pain, infections and other serious complications. Plaintiffs in these litigations allege that Boston Scientific failed to provide adequate warnings regarding the risks associated with surgical mesh it marketed for the transvaginal repair of pelvic organ prolapse and stress urinary incontinence.

In October 2008, the U.S. Food & Drug Administration (FDA) warned the public that it had received more than 1,000 reports of serious complications associated with vaginal mesh products over a three year period. Less than 3 years later, in July 2011, the FDA warned that complaints associated with transvaginal prolapse repair had grown five-fold since the 2008 alert, and stated that it no longer considered these types of injuries to be rare.

Other manufacturers of vaginal mesh POP and SUI products involved in the six multi-district litigations pending in the Southern District of West Virginia include C.R. Bard (MDL No. 2326), Ethicon (a division of Johnson & Johnson) (MDL No. 2327) and American Medical Systems (MDL No. 2325).

The first bellwether trial in the federal C.R. Bard MDL concluded in August with a jury awarding the plaintiff $2 million dollars in compensatory and punitive damages concerning C.R. Bard’s Avaulta Plus Device.

In addition the first bellwether trail in the Ethicon MDL concluded in March 2013 with an $11 million dollar verdict for the plaintiff.

If you suffered serious vaginal mesh complications and needed to have mesh removed, you may be able to obtain compensation for your injuries. The Rieders Travis Law Firm is currently handling complex vaginal mesh cases. For a consultation on your potential vaginal mesh claim, contact the Rieders Travis law firm today.

Discovery Extending in DePuy ASR Hip Recall Litigation in New Jersey; First Federal Trial in Ohio MDL Delayed 90 Days

A new order has been issued in a consolidated DePuy ASR lawsuit litigation currently underway in Bergen County Superior Court in New Jersey as of Otober 17 which extends discovery to January 2014. Further discussion of the discovery deadlines will take place at the next status conference for the consolidated proceedings on November 21, 2013.

Court records indicate that over 650 DePuy ASR recall lawsuits have been filed in the New Jersey litigation, and similarly allege that the metal-on-metal hip, which was taken off the market in August 2010 after it became associated with excessively high early failure rates, may cause serious complications in recipients.

Court records show than more than 8,200 DePuy ASR lawsuits are currently pending in a federal multidistrict litigation (MDL) established in the Northern District of Ohio. The first bellwether trial in that litigation in scheduled to begin within 90 days. Trail was scheduled to begin in September of this year in the first bellwether trial in the Ohio MDL but has been delayed until December due to scheduling conflicts with expert witnesses on both sides of the litigation. However, with the trial currently scheduled for December 24, 2013, it is likely that due to holiday recess that the trial will not actually begin until January 2014. Plaintiffs’ lawyers have accused DePuy of drawing out the litigation. The first bellwether case that was selected to go to trial in the MDL is McCracken v. DePuy.

In addition, approximately 2,000 DePuy ASR recall claims have been filed in a consolidated litigation established in San Francisco Superior Court. In that proceeding, the first bellwether trial case has already settled for an undisclosed amount.

The Rieders Travis law firm is handling DePuy ASR Hip Recall cases. For a confidential consultation, please contact us today to determine if you have a claim.

GranuFlo and NaturaLyte MDL Enters Discovery Phase

GranuFlo lawsuits pending in a federal multi-district litigation (MDL) in the District of Massachusetts, before Judge Douglas Woodlock have entered the discovery phase, according to court documents.

Requests for production of documents and two interrogatories are both due by October 28. Responses to the document requests and interrogatories are due by January 6, 2015, at which time document production will begin, as well as the process for selecting specific GranuFlo and NaturaLyte lawsuits for the litigation’s first bellwether trials. Bellwether trials are intended to weigh the strength of plaintiffs’ claims, and could provide clues as to the outcomes of similar Granuflo and NaturaLyte lawsuits. The MDL in the District of Massachusetts is MDL No. 2428.

GranuFlo is a powder and NaturaLyte is a liquid and both are dialysis concentrates that neutralize acid in the blood as part of dialysis treatment at dialysis treatment centers. Both products were marketed by Fresenius Medical Care.

According to court papers filed in GranuFlo lawsuits, many physicians administering GranuFlo and NaturaLyte were not aware until the GranuFlo recall that the drugs contain more of an ingredient the body converts to bicarbonate than other products used for this purpose. If this difference wasn’t accounted for when the drugs were prescribed, dialysis patients were at risk of suffering a condition called metabolic alkalosis, which is associated with the occurrence of sudden, serious heart problems.

In March 2012, Fresenius reported the serious risk associated with its products in a notification that was sent to its dialysis clinics around the United States, By June 2012, the U.S. Food & Drug Administration had issued an urgent safety warning and the earlier Fresenius warning was given Class I status Recall. According to the FDA,’s communication, inappropriate dosing of GranuFlo or NaturaLyte can cause bicarbonate in the blood to rise to dangerous levels, resulting in metabolic alkalosis, and can lead to heart attack, stroke, cardiopulmonary arrest, dangerously low blood pressure and sudden cardiac death.

GranuFlo lawsuits allege that Fresenius Medical Care had been investigating the heart problems associated with GranuFlo and NaturaLyte long before the GranuFlo recall was announced. The lawsuit highlights that Fresenius sent a memo interall;y to its own dialysis clinics in November 2011 warning doctors to adjust the dosage of the products to avoid metabolic alkalosis and other associated side effects. This memo noted that 941 patients treated at Fresenius dialysis centers had experienced cardiac arrest during 2010, and further stated that elevated bicarbonate levels were associated with a significant increased risk of cardiac arrest.

A recent court update shows that the number of lawsuits filed alleging that the anticoagulant drug Pradaxa caused internal bleeding injuries and/or death has risen nearly 30% in recent months according to the DrugRisk Center.

Pradaxa is a blood thinner approved by the FDA in 2010 as a stroke preventative for patients with atrial fibrillation. Experts disagree, however, about its risks for internal bleeding. The FDA has advised Pradaxa is no more dangerous than traditional blood thinner warfarin. However, unlike warfarin, which has been on the market for years and has a known quick-acting antidote, Vitamin K. There is no known antidote that can reverse Pradaxa associated bleeding, and the drug was put on the market by Boehringer Ingelheim, its manufacturer, without first developing an antidote. However, Boehringer Ingelheim is presently working with a partner to develop an antidote to Pradaxa.

The Institute for Safe Medication Practices, have warned that patients may be nearly 5 times as likely to die from Pradaxa bleeding than from bleeding with warfarin. A study this year from the Netherlands also suggests patients taking newer blood thinners like Pradaxa may be 55% more likely to suffer internal bleeding.

A federal multi-district litigation is currently pending for Pradaxa in Illinois, as MDL No. 2385. DrugRisk has uncovered the latest court records, which show the number of cases filed has increased from 1,133 on July 10th to 1,470 by September 11th, a rise of nearly 30% in two months.

Januvia/Byetta/Victoza Multi-District Litigation Moving Forward

The federal litigation concerning products liability claims brought by users of Janvuia, Byetta, Janumet and Victoza is moving forward in a multi-district litigation (MDL) established in U.S. District Court for the Southern District of California. Attorneys for Plaintiffs submitted a Joint Status Report to the Court on October 7, 2013 which, among other things, proposes a Plaintiff Steering Committee leadership structure for the ongoing proceedings. The initial conference on the litigation will be held on October 17, 2103. The litigation is called In Re: Incretin Products Liability Sales and Marketing Litigation, MDL 2452.

The lawsuits filed allege that plaintiffs developed pancreatic cancer, pancreatitis and thyroid cancer while taking Januvia, Byetta, Janumet and Victoza to regulate blood sugar to control Type 2 diabetes. There are approximately 60 lawsuits that have been consolidated into the California MDL involving the incretin mimetic class of drugs.

In 2009, for example, the manufacturer of Januvia was ordered to add new warnings to the Januvia label about a possible association with pancreatitis, after the U.S. Food & Drug Administration (FDA) became aware of 88 cases of Januvia patients developing acute pancreatitis. However, there is no warning concerning development of pancreatic or thyroid cancer.

A 2014 study published in the Journal of the American Medical Association (JAMA) showed that patients taking incretin mimetic drugs such as Januvia and Janumet are significantly more likely to develop pancreatic ailments and be hospitalized for acute pancreatitis, often a precurser to pancreatic cancer. A 2011 study published in the Journal of Gastroenterology showed that the incretin mimetic class of drugs increased the risk of pancreatic and thyroid cancer, as well as pancreatitis.

This past March, the FDA announced a new review of the entire incretin mimetics class after a small study indicated that the drugs could cause dangerous changes in the cells of the pancreas. While the FDA recently announced it was unable to confirm this risk, the agency’s review of the drugs is ongoing.

The Rieders Travis Lawfirm is currently evaluating potential cases against the manufactures of Januvia, Byetta, Victoza and Janumet. If you, or someone you loved, took one of these drugs and developed pancreatic cancer, thyroid cancer or pancreatitis, contact the Rieders Travis firm today to determine if you may have a claim.

Bayer settling $1.4 billion In Safyral Contraceptive Claims

Bayer has settled about 6,760 claims with regard to drospirenone side effects for Safyral as of July 2013, which cost Bayer a total of approximately $1.4 billion. Another 5,400 lawsuits are currently pending in the United States. However, so far blood clots stemming from the contraceptive Safyral have taken a back seat to the more high profile contraceptive litigation involving similar drospirenone products Yasmin, Yaz and Ocella.

However, the website for Safryal and for the Food & Drug Administration (FDA) indicates that the contraceptive if very similar, in fact almost identical to Yasmin. For example, according to the FDA’s website, the formulation for Yasmin is described as “Drospirenone 3 mg and ethinyl estradiol 0.03 mg.” Safyral is “Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg.” In other words, the contraceptive is simply Yasmin with a B vitamin added. The website for Safryal gives no indication that the addition of Vitamin B to the product from Yasmin would lessen the risk of dangerous blood clots. The FDA has allowed these products to remain on the market.

However, in announcing an update to product labeling for drospirenone-based contraceptives in December 2011, an FDA advisory panel found that based on a review of observational (epidemiological) studies on the relationship and potential association of blood clots and drospirenone-based birth control pills, “FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” However, In a 15 to 11 vote, the panel found that the benefits still outweigh the risks, although it is notable that the vote only barely passed. Meanwhile, the panel voted overwhelmingly, 21 to 5, that the birth control labels should be updated to provide clearer warnings about the risk of blood clots.

Yasmin, Yaz, Safyral and Beyaz are all made by Bayer AG.

FDA Investigating Blood Clots with Ariad’s Inclusig Leukemia Drug

The Food & Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib).

According to the FDA’s October 11, 2013 Drug Safety Communication, patient taking Inclusig should seek immediate medical attention if they experience symptoms suggesting a heart attack such as chest pain or pressure, pain in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.

Inclusig is a prescription medication used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) who are no longer benefiting from previous treatment or did not tolerate other treatment.

Inclusig was first approved by the FDA in December 2012. At that time, the drug’s prescribing information contained information about the risks of blood clots, both in the boxed warnings and warnings & precautions sections of the label. In clinical trials conducted before approval, serious arterial blood clots occurred in 8 percent of Iclusig-treated patients, and blood clots in the veins occurred in 3 percent of Iclusig-treated patients. However, in the most recent clinical trial data submitted by the manufacturer to FDA, at least 20 percent of all participants treated with Iclusig have developed blood clots or narrowing of blood vessels.

The drug is manufactured by Ariad Pharmaceuticals. After investigators tracked a rising rate of blood clots among leukemia patients in ongoing clinical studies, Ariad halted enrolling a new clinical trial and rolled out a lower dosing schedule for current participants in its other ongoing clinical trials. According to Ariad’s website there are currently 8 different trials underway for ponatinib, including the pivotal PACE study for newly diagnosed patients with chronic myeloid leukemia.

Settlement Negotiations Ongoing in Large Vaginal Mesh MDLs

Pennsylvania-based Endo Health Systems now faces a total of approximately 13,500 transvaginal mesh lawsuits, between those that have been filed in a federal multi-district litigation (MDL) centered in West Virginia, and in state court. In addition, numerous vaginal mesh cases have been filed in separate MDLs in West Virginia as well as state court proceedings against other manufacturers of vaginal mesh products.

Earlier this year, Endo paid a total of $54.5 million to settle a number of cases alleging the company’s vaginal mesh inserts, specificially AMS transvaginal mesh products Perigree, Apogee and Elevate, were defective.

Another 30,000 lawsuits have been filed before Judge Joseph R. Goodwin in six federal multi-district litigations (MDLs) in West Virginia. The large number of lawsuits makes the transvaginal mesh cases the largest pending litigation in the United States.

Transvaginal mesh attorneys representing women suing over more than 50 different implants manufactured by six different companies, including AMS, have recommended that Judge Goodwin tap a group of transvaginal mesh (TVM) plaintiff lawyers, to take the lead in ongoing settlement negotiations. According to the a recent September 18, 2013 hearing, Judge Goodwin said on the record “I know you all are considering settlement protocols and the possibility of resolutions,” He noted that the talks were going on “behind the scenes.”

Several bellwether trials are continuing into 2013 for Bard Avaulta mesh. Additional bellwether trials are scheduled and continuing into 2014 for lawsuits involving transvaginal mesh products manufactured by AMS, Boston Scientific and Ethicon.

Stryker Rejuvenate and ABG II Hip Recall Cases Move Forward, as Minnesota Judge to Appoint Plaintiffs Steering Committee

As the consolidated multi-district litigation for the recalled Stryker Rejuvenate and ABG II modular hip implants rolls forward through pretrial proceedings in federal court for the District of Minnesota, Judge Donavan W Frank has ordered the appropriate of plaintiffs’ counsel; to leadership roles on a Plaintiff’s Steering Committee (PSC) to further assist in the coordination of the cases as they press towards trial or settlement.

The newly formed MDL was established recently, in June 2013, when a group of federal Stryker Rejuvenate, and ABG II lawsuits were transferred from federal courts around the country, to Judge Frank’s court in Minnesota. The MDL is No. 2441.

The Stryker MDL consisted of about 40 cases when it was established. Now, the number has grown significantly to include hundreds of lawsuits brought by plaintiffs alleging that they have suffered injuries caused by the manufacturer’s recalled Rejuvenate and ABG II hip replacement implants. As of late September, 2013, recipients of defective implants have filed more than 600 cases in state court and federal court. The total number of cases is expected to climb even higher as more than 20,000 of these devices were sold in the U.S. before the recall was issued. In addition to the Minnesota MDL, a coordinated multi-county proceeding involving the Stryker Rejuvenate and ABG II products is also pending in Bergen County, New Jersey. There were 382 cases pending in the New Jersey Action as of late September, 2013.

Patients who have he Stryker Rejuvenate and ABG II hip implants should be on alert for symptoms of failure that require the devices to be surgically removed. Symptoms of failure might include pain, swelling, decreased mobility, and elevated levels of metals in the bloodstream.

If you or someone you love has experienced failure with the Stryker Rejuvenate or ABG II modular hip implant, these devices have been recalled. Contact the Rieders Travis law firm today to determine if you have a claim.

GranuFlo Lawsuits Continue to Increase

Sudden death from GranuFlo and NaturaLyte kidney dialysis treatments, manufactured by Fresenius Medical Care, has been alleged in numerous lawsuits filed in state and federal court.

A multi-district litigation (MDL) is pending in the district of Massachusetts before Judge Douglas Woodlock in MDL No. 2428. In addition, a consolidated litigation is also pending in Middlesex County, New Jersey, in state court. More than 200 lawsuits have been filed in the consolidated New Jersey litigation. Other class action litigations are also pending in California state court, New York state court and Missouri state court, as well as several other state and federal courts.

The lawsuits allege problems involving alkali dosing errors inherent with the two products manufactured within a four year time span, ending in early June 2012, that lead to biocarbonate overdose that can result in a sudden heart attack , often resulting in sudden death, in patients receiving kidney dialysis.

Fresenius issued an urgent communication to employees in its own Fresenius-branded clinics urging caution with regard to the possibility of such dosing errors and the potential for dire consequences, but failed to issue a wider alert to non-Fresenius clinics such as those operated by DaVita Healthcare Partners. Many a DaVita lawsuit has been filed by plaintiffs alleging that DaVita Heart Attack could have been prevented had DaVita been aware of the problem with alkali dosing errors with the GranuFlo and NaturaLyte products. Fresenius chose not to issue a blanket alert concerning the dosing error issue with its products, but was eventually forced to do so after its initial communication to its clinics was leaked to the Food & Drug Administration (FDA). The FDA eventually issued a Class 1 GranuFlo recall and similar recall for NaturaLyte, at which point Fresenius issued an urgent alert to all clinics using its GranuFlo and NaturaLyte products.

The FDA, in its communication to Fresenius, referenced three previous warnings as to the company’s manufacturing practices and noted that it had found Fresenius responses to be inadequate.

C.R. Bard Settles Second Transvaginal Mesh Lawsuit

C.R. Bard has agreed to a settlement with the plaintiff in a second transvaginal mesh litigation. The case had been scheduled for trial concerning products from its line of Avaulta implants underway in a federal litigation in the Southern District of West Virginia. The terms of the settlement have not been made public.

The litigation that settled was to serve as one of four bellwether cases in the West Virginia MDL. The first bellwether trial took place in August and ended with a $2 million dollar jury verdict in the plaintiff’s favor.

C.R. Bard is currently facing over 5000 transvaginal mesh lawsuits, and that number is expected to increase significantly. Many of the cases have been field in the federal multi-district litigation (MDL) that is underway in West Virginia.

Plaintiffs are arguing that Bard has failed to warn plaintiffs about the risks associated with implanting the vaginal mesh, but Bard claimed it adequately informed physicians implanting the mesh and that plaintiffs’ failure to warn claim is barred by the learned intermediary doctrine. Plaintiffs are also raising negligence claims and manufacturing defect claims in the litigation. In addition, plaintiffs are seeking punitive damages.

In July 2011, the Food and Drug Administration (FDA) issued its second notification in three years to doctors and patients about the risks of surgical mesh products. The notification from the FDA said that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare. The FDA received more than 1,000 reports of adverse events involving the mesh to treat POP and stress urinary incontinence (SUI) between 2005 and 2007. In the three year period from January 1, 2008 until December 31, 2010, the FDA received more than 2,800 reports of complications with transvaginal mesh surgeries, including 1,503 reports of adverse effects of surgical mesh used to repair pelvic organ prolapse, and 2,371 reports of adverse effects of transvaginal mesh used to repair stress urinary incontinence. In addition, seven deaths associated with pelvic organ prolapse were reported during this three-year period.

Stryker Rejuvenate and ABG III Hip Replacement Lawsuits Gathering Steam

As of August 2013, more than 300 Stryker hip replacement lawsuits were pending in a consolidated litigation underway in New Jersey Superior Court, Bergen County, according to court documents. The litigation, which is before Judge Brian Martinotti, involves two recalled Stryker metal-on-metal hip implant devices, the Stryker Rejuvenate and ABG II Modular Hip Stem. In addition, another 200 Stryker hip replacement recall lawsuits are pending in federal multidistrict litigation (MDL), No. 2441 in federal district court for the District of Minnesota, before Judge Donavan Frank. All lawsuits allege that plaintiffs have suffered metallosis, necrosis, osteolysis and other serious complications, which have led many patients to revision surgery. It is not known, however, how many (if any) patients with Stryker hips had another Stryker implanted in revision surgery.

At the beginning of 2013, Stryker told shareholders that it expects between $190 million and $390 million in costs stemming from the recall. However, those costs are expected to go up because an FDA Advisory Panel found several months later that there is “almost no good reason” to use metal-on-metal (MOM) hip implants, including two the two recalled Stryker hips after reviewing 17,000 reports of problems in about 500,000 patients with metal balls and sockets. Since July 2013, Stryker has spent $570 million to cover hip replacement lawsuits and revision surgeries due to its recalled Rejuvenate and ABG II hip implants.

The Stryker Rejuvenate and ABG II hip implants were recalled in June 2012. Many more litigations are expected in both the multi-county litigation in New Jersey and the Minnesota MDL, as more than 20,000 devices were implanted in the three year window that they devices were on the market and are directly impacted by the recall.

Bayer Settles 7000 Yasmin/Yaz Cases for Close to $1.4 Billion

Bayer Pharmaceuticals recently announced that it has settled close to 7,000 Yamin and/or Yaz lawsuits for close to $1.4 billion. An adverse event report from the FDA shows that between November 1, 1997 and December 31, 2012, 274 women died from blood clots associated from Yasmin/Yaz birth control.

More than 3200 blood clot claims involving Yasmin/Yaz remain unsettled and many more lawsuits were anticipated according to Bayer’s 2012 annual report.

As of March 2012, a total of 12,000 lawsuits had been brought in the United States against Bayer alleging increased risk of blood clots (deep vein thrombosis), pulmonary embolism and gall bladder problems. The lawsuits allege that Bayer failed to adequately warn patients and physicians of the increased risk of serious side effects associated with the use of Yasmin and Yaz compared to safer oral contraceptives.

Most of the lawsuits filed to date have been consolidated in a federal multi-district litigation (MDL) in Illinois under MDL No. 2100, with Judge David Herndon as the presiding Judge. The first trials were set to begin in the fall of 2011, but litigation was postponed indefinitely and both sides were encouraged by Judge Herndon to try to settle the cases.

Despite the settlements, to date Bayer has not admitted liability in any of the lawsuits.

Roche Escapes Liability in Accutane MDL, but New Jersey State Litigations Continue

Hoffman La Roche inched closer to defeat of cases brought by plaintiffs in a Florida multi-district litigation (MDL) alleging that the acne treatment Accutane caused them to develop inflammatory bowel disorder.

In March, 2013 , U.S. District Judge James Moody Jr. granted summary judgment to Roche in an Accutane lawsuit where the plaintiff claimed he had part of his bowel removed after taking Accutane. The ruling came two weeks after Roche defeated 40 other lawsuits in the Accutane case due to lack of experts, leaving only once case remaining in the Florida MDL. The Judge cited that the plaintiffs had no legitimate reason for failing to name an expert who could testify that Accutane causes inflammatory bowel disorder by the deadline in the discovery schedule.

In June 2012, Judge Moody ruled that Roche had adequately warned Accutane users of the risks of developing inflammatory bower disorder, a decision that could impact the much large state court Accutane class action pending in New Jersey.

A recent study published in February in JAMA Dermatology found no link between the acne drug Accutane (isotretinoin) and inflammatory bowel disease in women, which comprises both Crohn’s Disease and colitis.

So far, Roche has paid more than $53 million to resolve various Accutane-related lawsuits in settlements and court verdicts. Plaintiffs have had several successes in state court trials in New Jersey, where the litigations are ongoing. In 2008, a jury awarded $10.5 million to the plaintiff in a state court trial, and was required to pay $25 million in a second state court trial in 2010 in New Jersey state court. In June 2012, a New Jersey state court ordered Roche to may $18 million to two Accutane patients, while dismissing two other cases. All of these cases alleged that Accutane caused the plaintiffs to suffer from inflammatory bowel disorder.

As of August, 2013, Roche continued to defend approximately 7,700 Accutane cases pending in New Jersey State court before Judge Carol Higbee. Defendants have renewed efforts to get the New Jersey Supreme Court to remove Judge Higbee from the litigation citing several of her decisions as allegedly improper. Such efforts were most recently made in August of this year.

In 2009, Roche removed Accutane from the United States market, citing sluggish sales due to competition from generics, since the patent expired in 2002. Generic equivalents include Amnesteen, Claravis and Sotret, but plaintiffs are largely barred from bringing products liability or mass tort cases against the manufactures of the generic versions of Accutane under two recent Supreme Court decisions.

Bellwether Trials Scheduled To Begin In October 2014 in Zoloft Antidepressant MDL

So far, approximately 92 cases have been field in a Pennsylvania multi-district litigation (MDL) concerning the antidepressant drug Zoloft (sertaline hydrochloride), alleging that used of Zoloft during pregnancy caused birth defects. The claims made by plaintiffs about Zoloft are similar to the claims of birth defects in the Paxil antidepressant litigation, which has largely settled.

The MDL is pending in the U.S. District Court for the Eastern District of Pennsylvania. District Court Judge Cynthia M. Rufe is presiding over the litigation. On April 17, 2012, the U.S. Judicial Panel on Multi-District Litigation entered its Transfer Order consolidating all pending Zoloft lawsuits filed around the country in the Eastern District of Pennsylvania. On July 13, 2012, Judge Rufe issued Pretrial Order No. 6, appointing 16 attorneys to the Plaintiffs’ Steering Committee (PSC). Attorneys Mark Robinson and Diane Nast have been appointed as Co-Lead Counsel and serve on the PSC’s Executive Committee. Attorney Stephen Corr serves as Plaintiffs’ Liason Counsel and was also named an ex-officio member of the Executive Committee. Attorney Bryan Aylstock was appointed as the Multi-District Coordinator and is also a PSC member.

Plaintiffs counsel had argued against centralization of the MDL because they expected that there would be hundreds of Zoloft claims rather than thousands of claims and that the cases do not share a common question of fact, as the injuries very significantly. However, these arguments were rejected.

According to the discovery plan for the MDL, Judge Rufe plans to start trying bellwether cases by October 2014.

Judge Rufe was the same Judge who had presided over the Avandia MDL in Pennsylvania.

So far, approximately 92 cases have been field in a Pennsylvania multi-district litigation (MDL) concerning the antidepressant drug Zoloft (sertaline hydrochloride), alleging that used of Zoloft during pregnancy caused birth defects. The claims made by plaintiffs about Zoloft are similar to the claims of birth defects in the Paxil antidepressant litigation, which has largely settled.

The MDL is pending in the U.S. District Court for the Eastern District of Pennsylvania. District Court Judge Cynthia M. Rufe is presiding over the litigation. On April 17, 2012, the U.S. Judicial Panel on Multi-District Litigation entered its Transfer Order consolidating all pending Zoloft lawsuits filed around the country in the Eastern District of Pennsylvania. On July 13, 2012, Judge Rufe issued Pretrial Order No. 6, appointing 16 attorneys to the Plaintiffs’ Steering Committee (PSC). Attorneys Mark Robinson and Diane Nast have been appointed as Co-Lead Counsel and serve on the PSC’s Executive Committee. Attorney Stephen Corr serves as Plaintiffs’ Liason Counsel and was also named an ex-officio member of the Executive Committee. Attorney Bryan Aylstock was appointed as the Multi-District Coordinator and is also a PSC member.

Plaintiffs counsel had argued against centralization of the MDL because they expected that there would be hundreds of Zoloft claims rather than thousands of claims and that the cases do not share a common question of fact, as the injuries very significantly. However, these arguments were rejected.

According to the discovery plan for the MDL, Judge Rufe plans to start trying bellwether cases by October 2014.

Judge Rufe was the same Judge who had presided over the Avandia MDL in Pennsylvania.

Canadian Court Certifies DePuy ASR Hip Replacement Class Action; Bellwether Trials in Ohio MDL Begin This Month

A court in Ontario, Canada has certified a DePuy ASR hip replacement class action lawsuit brought by citizens of Canada who were impacted by the DePuy ASR recall. DePuy Orthopedics issued a global recall of its ASR XL Acetabular metal-on-metal hip replacement on August 24, 2010. 93,000 implants were recalled in total as part of the global recall, including 37,000 in the United States, after a 12% failure rate of the implants in five years.

The ASR hip replacement is a metal-on-metal device believed to have a design flaw that has resulted in many patients needing follow-up hip revision surgery to replace the device soon after implant. Plaintiffs in the lawsuits both in the United States and Canada allege that the ASR hip replacement is a defective product.

Currently, in the United States there are more than 11,500 DePuy ASR lawsuits pending. All of these lawsuits allege that the hip replacement is a defective product, early device failure, or other serious complications due to the design of the product. The majority of these cases are pending in federal court as part of a multi-district litigation (MDL) centered in the Northern District of Ohio.

The first bellwether trial in the federal MDL is presently scheduled to commence on September 24, 2013. The litigation is titled In re: DePuy Orthopedics, Inc. ASR Hip Implant Products Liability Litigation MDL 2197. Currently seven bellwether trials are scheduled to take place in the litigation between September 2013 and January 2014. U.S. District Judge David Katz is overseeing that lawsuit by Ann McCracken, 58, a resident of Rochester, New York, who needed two replacement surgeries known as revisions after her ASR implant. Judge Katz is overseeing about 8000 DePuy ASR hip replacement cases that are consolidated into the MDL.

In addition, about 2,000 cases are pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.

Trials are also scheduled in state court in San Francisco in October 2013, in New Jersey in October 2013 and January 2014, in Florida in November, in Los Angeles in January 2014 and in Chicago in December 2013.

Two DePuy ASR lawsuits have already been heard by juries in state court. In March, a Los Angeles Superior Court jury found that the hip implant was defectively designed and granted an $8 million dollar award to plaintiffs. At the first trial in Los Angeles, lawyers for plaintiff argued DePuy failed to test the device adequately before selling it in the U.S. in 2005, buried surgeon complaints of mounting failures, and studied a redesign of the ASR before scrapping that effort in 2008. In the case, lawyers for the plaintiff further claimed that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels.

DePuy is a division of Johnson & Johnson, as Depuy was acquired by Johnson & Johnson in 1998.

According to an August 21, 2013 report by Bloomberg News, the parent company, Johnson & Johnson has discussed paying more than $3 billion to settle lawsuits pending in the United States in the Ohio MDL over the recalled hip implant. According to the Bloomberg report, J&J is pushing to resolve the lawsuits by early next year.

Fosamax Cases To Be Transferred Out Of NY MDL To Original Courts

In the ongoing litigation with Merck concerning the osteoporosis drug Fosamax, U.S. District Court Judge John Keegan in Manhattan (Southern District of New York) ordered that 200 cases a month be returned to the courts where they were originally filed, thereby transferring the cases out of the New York MDL. The plaintiffs in the MDL claim that Fosamax users developed osteonecrosis of the jaw, also known as jaw death. Judge Keegan’s order came after mediation efforts in some of the cases failed.

The cases, which Judge Keegan has been considering since 2006 account for about 20% of the more than 5000 calls alleging injuries from Fosamax. In November, Keegan tossed out 430 cases for not being able to provide evidence from their experts that their claims against Merck were valid. Nearly 1000 cases are pending in the MDL before Judge Keegan presently. The Judge’s Order, which transfers the cases even more swiftly than proposed by plaintiffs, states: “The court has tried five cases as bellwether, and general expert discovery has taken place,” the judge said in an order. “In this court’s view, all that is left for each of the cases in this MDL is case-specific discovery and trial.” Attorneys for plaintiffs said they supported this decision.

In February of this year, Merck lost a bellwether Fosamax trial when a New York jury awarded the plaintiff $285,000 and said that Merck was not up front about the risks of Fosamax. Thus far, Merck has prevailed in five of the seven Fosamax cases that have been tried, while more than 5000 cases are currently pending in federal and state courts.

In 2005, Merck added a warning about osteonecrosis of the jaw to the label of Fosamax, a drug that was reaping about $3 billion annually until it lost its patent in 2008.

Earlier in August, Judge Keenan refused Merck’s request for a so-called Lone Pine order that would have forced hundreds of plaintiffs to substantiate their injuries or else face dismissal from the litigation, saying the process would devolve into a fight on the merits of each case.

Motion to Consolidate Lipitor Cases Into MDL Denied by Federal Judicial Panel

plaintiff’s motion to consolidate federal litigations against Pfizer, the manufacturer if the cholesterol statin drug Lipitor was denied on August 8, with the Judge citing too few Lipitor lawsuit claims as the reason for the denial. The federal judicial panel ruled that the Lipitor lawsuit claims in the MDL request could be voluntarily handled with Lipitor’s manufacturer.

Despite the denial of the motion to consolidate the Lipitor cases into an MDL, numerous plaintiffs first are continuing to pursue individual claims against Pfizer alleging a link between the drug Lipitor (atorastatin), an anti-cholesterol medication, and type 2 diabetes.

In 2012, Yunsheng Ma and his team of researchers at the University of Massachusetts Medical School conducted a studythat included the collection of data from approximately 150,000 women who were taking Lipitor or another statin drug, with the average age of the women being 63. The study concluded that individuals taking Lipitor or other statin drugs, and particularly postmenopausal women, were more likely to develop type-2 diabetes compared to those not taking a statin drug.

There were five cases fending in the proposed MDL, which the federal judicial panel ruled as too few. All of the cases alleged that Lipitor caused type 2 diabetes in women.

Second Actos State Court Trial Underway in Maryland State Court

The second Actos trial is currently underway in Maryland state court, of the more than 3000 Actos lawsuits alleging that the type 2 diabetes drug Actos caused them to develop bladder cancer.

According to court filings for the plaintiff, Actos knew in 2005 that studies had revealed links between Actos and bladder cancer, as well as Actos heart failure. In their opening remarks, lawyers for the plaintiff contend that in spite of this knowledge Actos manufacturer Takeda waited six years before issuing a warning about the possible cancer risk.

In 2011, a Takeda (the company that manufactures and markets Actos) sponsored clinical study identified a link between Actos and bladder cancer. The FDA subsequently in 2011 issued a warning that use of Actos for more than one year had been linked to development of bladder cancer. However, the FDA stopped short of pulling Actos from the market, which was demanded by regulatory authorities in France. Germany mandated that Actos be removed from its reimbursed list of drugs.

In the Baltimore trial, Takeda maintained that the plaintiff’s bladder cancer was triggered by his 30-year smoking habit. Plaintiff lawyers countered that An was not a heavy smoker, and quit his half-pack-a-day habit in 1996, fifteen years prior to his diagnosis.

Earlier in 2013, the first Actos state court trial resulted in a $6.5 million dollar plaintiffs verdict against Takeda in Los Angeles Superior Court, before the judgment was vacated by the presiding Judge. The ruling is currently on appeal. Court documents indicate that more than 3,000 Actos bladder cancer claims are currently pending in courts throughout the U.S., the majority of which have been filed in a federal multidistrict litigation (MDL) underway in U.S. District Court, Western District of Louisiana. That litigation’s first bellwether trial will begin on January 27, 2014, while the second will commence on April 14, 2014. (In re: Actos Product Liability Litigation, MDL No. 2299).

Actos Litigations continue to Move Forward in Federal and State Court

Actos lawsuits alleging that many patients who took the drug for their type 2 diabetes developed bladder cancer due to prolonged use continue to move forward in a multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. According to an August 26, 2013 Court order, the parties have been directed to meet and confer in person prior to the filing of certain motions in order to attempt to resolve matters before bringing them before the court.

It has been more than two years since the FDA warned of the potential for bladder cancer with Actos. In June 2011, the FDA specifically warned that use of Actos for one year or more has been linked to bladder cancer. Court documents indicate that there are presently more than 2500 Actos lawsuits in the MDL underway in Louisiana. All of the claims pending in the proceeding allege that long-term users of Actos are at a higher risk for bladder cancer, and accuse Takeda Pharmaceuticals, the manufacturer of Actos, of concealing their knowledge of that risk and failing to provide adequate warnings to the public and to physicians in the medical community.

The federal litigations first bellwether trial will begin on January 27, 2014, while its second Actos bladder cancer trial will commence on April 14, 2014.

Although the federal bellwether trials have not yet commenced for the Actos litigations in the MDL, there have been several Actos trials in state court. The second Actos trial in the United States is currently underway in state court in Maryland, with opening arguments earlier this week. During opening arguments in that case, an attorney for the Plaintiff claimed that Takeda knew as early as 2005 that research had linked prolonged Actos use to bladder cancer, but waited six years to issue a public warning. The attorney further alleged that by delaying this warning, Takeda was able to increase its sales of Actos and profit financially.

On April 26, 2013, the first verdict was awarded in the California Actos trial of 6.5m USD for the plaintiff against the manufacturer of Actos, Takeda Pharmaceuticals. However, this jury verdict was vacated by the Court and the Plaintiffs are filing an appeal and attempting to have the jury verdict reinstated.

If you or someone you love took Actos and developed bladder cancer, please call the Rieders Travis law firm to investigate whether you may have a case against Takeda, the manufacturer of the drug.

Breaking News – Byetta, Januvia, Janumet and Victoza Cases Consolidated Into California MDL

On August 26, a panel of federal judges entered an order consolidating all future Byetta, Januvia, Janumet and Victoza cases in one courtroom in a multidistrict litigation (MDL) centered in the Southern District of California under the title In re: Incretin Mimentics-Based Therapies Products Liability Litigation.  According to the transfer Order, the 53 cases currently pending in seven federal judicial districts will be transferred into the litigation.

The Judge presiding over the federal litigation is the Honorable Anthony J. Battaglia.  The MDL is MDL No. 2452.  It is expected that now that an MDL is established, the number of product liability mass tort cases filed alleging injuries caused by the drugs Byetta, Januvia, Janumet and Victoza will increase substantially as part of the MDL.  The litigation involves a group of defendants, Merck, Amylin, Eli Lilly and Novo Nordisk.

All of the cases involve a common question of fact, that the class of incretin mimetic drugs for treatment of type 2 diabetes caused the plaintiffs to develop pancreatic cancer.  Thus, all of the cases in the MDL involve several different drugs and defendants, but all involve pancreatic cancer with incretin mimetic diabetes drugs.

The plaintiffs in the suits allege that use of one or more of four popular diabetes drugs Januvia, Byetta, Janumet or Victoza caused them or a loved one to develop pancreatic cancer, the transfer order notes. The suits were prompted by research that revealed a possible link between a class of diabetes drugs known as incretin mimetics and pre-cancerous cell changes in the pancreas, a potential risk outlined in a March 2013 FDA drug safety communication.

Several studies have supported the link between the incretin mimentic class of drugs and pancreatic cancer as well pancreatitis.  One study, published online in the Journal of the American Medical Association (JAMA) in February 2013 found that diabetes patients with pancreatitis were more likely to be on Byetta, another type 2 diabetes agent with a similar mechanism of action, or Januvia than patients with diabetes who did not have pancreatitis.

 

According to a second, 2011 study in the Journal Gastroenterology, which is based on clinical research done at the University of California at Los Angeles (UCLA) people taking Byetta and Januvia for type 2 diabetes are significantly more likely to develop pancreatic cancer, while people taking Januvia are also significantly more likely to develop thyroid cancer. The abstract for this study is available here.

 

The Rieders Travis law firm is currently reviewing cases on behalf of users of Byetta, Januvia, Janumet and Victoza for filing in the California MDL.  If you or a loved one was injured by one of these drugs, please contact the Rieders Travis law firm to explore whether you might have a claim.

$2M Awarded by Jury in First Transvaginal Mesh Case

A Georgia jury hearing the first transvaginal mesh case awarded the plaintiff $2 million dollars in damages. Donna Cisson in her lawsuit alleged that the Avaulta transvaginal mesh made by C.R. Bard which she had surgically implanted caused bleeding and pain.

With some 20,000 transvaginal mesh lawsuits pending in a multi-district litigation (MDL) in West Virginia, Cission’s case is a bellweather. The jury found that Bard failed to issue warnings regarding the transvaginal mesh design defect. The jury awarded Cisson $250,000 in compensatory damages and $1,750,000 in punitive damages. A second bellwether trial against C.R. Bard is expected to go to court shortly.

There is also a coordinated state court proceeding of cases pending involving the same transvaginal mesh in state court in Atlantic City, NJ.

The FDA has received over a thousand reports of Bard Avaulta complications associated with surgical mesh since 2005. In October 2008, the FDA issued an alert about complications associated with transvaginal placement of surgical mesh to treat POP and Stress Urinary Incontinence (SUI). On July 13, 2011, the FDA issued a public notice regarding the use of transvaginal mesh (TVM) for the treatment of POP and Stress Urinary Incontinence (SUI). Doctors and their patients are now advised to consider alternatives to TVM.

FDA gives New Warning for Fluoroquinolone Drugs, Including Levaquin; Levaquin Tendon Rupture MDL Advances

The FDA has issued a notice that requires the drug labels and medication guides for all fluoroquinolone antibacterial drugs to be updated to describe the serious side effect of peripheral neuropathy, a severe condition involving nerve damage that can occur with this class of drugs and may be permanent. Approved drugs in this class include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin) and gemifloxacin (Factive). The risk is only an issue for oral and injectible formulations of these drugs and not for topical formulations.

Fluoroquinolones including Levaquin, Acelox and Cirpo are associated with tendon rupture.

In 2012 the FDA announced that it was evaluating the risk of peripheral sensorimotor neuropathy that may arise from the use of fluoroquinolone antibiotics, with a view to changing the labeling if necessary, which it now deems it is. Presently, The FDA has also notified healthcare professionals that a boxed warning and Medication Guide are to be added to the prescribing information for the above listed drugs in this class to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. The FDA had issued a black box warning for Levaquin in 2008 for an increased likelihood of tendon problems.

There are presently over 1800 Levaquin tendon rupture cases pending in a multi-district litigation (MDL) in the U.S. District Court for the District of Minnesota. The cases are being presided over by Judge John R. Tunheim. No trial dates have been set yet for any of the pending Levaquin MDL lawsuits. Lawsuits in the Levaquin MDL allege that the plaintiffs suffered ruptured tendons after being prescribed Levaquin by licensed medical professionals. Plaintiffs accuse the drug manufacturers of failing to give them any warning about this possible side effect of Levaquin. The defendant companies being sued in the Levaquin tendon rupture MDL are: Johnson & Johnson, Ortho-McNeil Pharmaceutical Inc., and Johnson & Johnson Pharmaceutical Research & Development, LLC. A status conference was held in the Levaquin MDL in early June, 2013.

In November 2012, J&J settled 845 Levaquin lawsuits involving tendon ruptures. They were in Minneapolis in federal court. Four Levaquin cases went to trial already. J&J won three of those cases, but a fourth case resulted in a Plaintiffs verdict of 1.8m in 2010.

According to information provided by the Defendants at the status conference, there are currently 1000 Levaquin cases pending in the MDL that are “in the process of settling and soon will be dismissed.”

There is also a mass tort litigation in New Jersey state court with 1400 cases that remain open.

FDA Won’t Increase Januvia or Byetta Warnings Based on Current Risks

FDA will not update Januvia or Byetta Warning The Food & Drug Administration has stated that it will not update its warning label for the type 2 diabetes drug Januvia, or other drugs in the incretic class of diabetes drugs, despite the risks of pancreatic cancer and pancreatitis that have emerged in scientific data.

One study, published online in the Jounral of the American Medical Association (JAMA) in February 2013 found that diabetes patients with pancreatitis were more likely to be on Byetta, another type 2 diabetes agent with a similar mechanism of action, or Januvia than patients with diabetes who did not have pancreatitis.

According to a second, 2011 study in the Journal Gastroenterology, which is based on clinical research done at the University of California at Los Angeles (UCLA) people taking Byetta and Januvia for type 2 diabetes are significantly more likely to develop pancreatic cancer, while people taking Januvia are also significantly more likely to develop thyroid cancer. The abstract for this study is available here.

Yet, the FDA claims that the evidence is not sufficient at this time to support a link between Januvia (or Byetta) and pancreatic cancer. Byetta is manufactured by Bristol Myers Squibb and Amylin Pharmaceuticals, while Januvia is manufactured by Merck.

The American Diabetes Association released a statement on June 28, 2013, noting that there currently is “insufficient information to modify current treatment recommendations.” That said, the organization also wrote that people taking Januvia and other drugs in its class should be informed of all that is known about the potential for risks and advantages, so they can make an informed decision.

Patients who have developed pancreatic cancer after using Januvia have filed lawsuits against the maker of the diabetes medication, alleging they were not properly warned about the risks associated with the drug. There are reportedly more than 100 lawsuits filed across the US alleging patients were harmed by the use of incretin mimetic drugs such as Januvia and Byetta. The multidistrict litigation number is MDL 2452. There is currently a motion pending after a hearing was held concerning consolidation of the MDL in the Southern District of California.

Conflicting Rulings on Preemption Issue in Medtronic Infuse Spinal Device Cases

Just this week, a Minneapolis Judge ruled that federal law does not permit the court to hear the cases of dozens of people who claim to be injured by Medtronic’s Infuse Spinal device, due to preemption.

On August 9, the District of Minnesota, specifically, Judge Laurie Miller, granted the Defendant’s motion to dismiss based on Supreme Court rulings that have found that medical device makers are preemepted from being sued under tort law if the US FDA had already approved their products.

This new ruling in Minnesota came in the aftermath of a lower court judge in Cook County, Illinois, who allowed a Medtronic Infuse lawsuit to go forward, only a few weeks ago. That lawsuit alleged that Medtronic promoted unapproved uses of its Infuse Bone Graft product and it also alleged faulty labeling. These claims were similar to those brought in Minnesota.

In that case, the state court Judge, Eileen M. Brewer, denied a motion to dismiss based on preemption of state law by federal law. Based on the assumption that the plaintiff’s claims are federally preempted by the FDCA, Medtronic had also filed a motion to dismiss the lawsuit in the Illinois case. Judge Brewer, however, ruled that the claims are not preempted, since the off-label use violated FDA regulations for the device.

Lipitor Studies Show Wealth of Conflicting Information on Diabetes

Lawsuits have been filed by the makers of some statin drugs, including Lipitor, alleging that the drugs cause type 2 diabetes, specifically in women. However, the medical literature on the issue is currently divided. Pfizer is currently opposing an early stage MDL in federal court for the District of South Carolina.

The most recent study was published online on July 9, 2013, in the journal Circulation, and that study concludes that though the use of statin drugs was associated with an increased risk of developing diabetes mellitus, statins could be used to not only lower cholesterol but also decrease inflammation throughout the patient’s body. They also found that adverse events linked to the class of statin drugs were not common. A study published in the journal the Lancet on August 11, 2012 also found that the risk of developing diabetes was outweighed by the benefits of lowering cholesterol with statin drugs, including Lipitor. However, the Lancet study was funded by AstraZeneca which manufactures and sells the statin drug Crestor, one of Lipitor’s chief competitors.

By comparison, a study published in the British Medical Journal on May 23, 2013 found that statins that were at a higher potency may place patients at an increased risk for developing Type 2 diabetes. In that study, researchers found an increased risk of diabetes with patients given atorvastatin (Lipitor) and with simvastatin, but no increased risk with lower potency statin drugs. In addition, a fourth study, published in January 2012 in the Archives of Internal Medicine found that women aged 50-70 who took Lipitor were 48% more likely to develop diabetes. In addition on March 28, 2011 , a meta analysis from three clinical trials was published supporting increase in type 2 diabetes with Lipitor particularly in patients who have other risk factors. The stiudy was published in the Journal of American Cardiology, and showed that the risk of developing diabetes with Lipitor was much greater when certain other risk factors were present for developing Type 2 diabetes.

In August 2011, a change in Pfizer’s label and makers of other statins was requested by the FDA. PFzier did not change its label until February 26, 2012 with a labeling change that added that Lipitor and other statins may increase 1HbA1c and fasting glucose as a HMC-Co reductase. The label now specifically states the change as “increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lipitor.

Number of Mirena IUD Lawsuits Continue To Grow

Numerous lawsuits have been filed against Bayer Pharmaceuticals, the manufacturer of intrauterine contraceptive device Mirena. Mirena has been linked to uterine perforation and other serious side effects. These serious side effects have been reported to include device expulsion, device dislocation (migration into the abdomen or other organs)and vaginal hemorrhage. In addition, other side effects that have been linked to Mirena include sepsis, pelvic inflammatory disease, ovarian cysts in 12% of Mirena users and infertility.

Thus far, numerous lawsuits have been field in New Jersey, in state court. However, the Supreme Court of New Jersey denied a request to have the cases consolidated in January 2013. However, in June 2013, 60 Mirena lawsuits were in fact consolidated in the In re Mirena litigation (case 297 Superior Court in Bergen County) because they had common cause for suit. According to the court documents, the plaintiffs allege that their Mirena hormonal implants have caused them several serious adverse events, including uterine perforation, device migration and pelvic pain. A case management conference was scheduled for July 1 in the consolidated actions. Many Mirena lawsuits were also consolidated in the Southern District of New York, in federal court. These cases are assigned to district court judge Cathy Seibel to preside over. The number of Mirena lawsuits in both courts continues to grow.

Mirena was approved by the FDA in 2000 as a contraceptive device. In 2009 it was approved for treatment of heavy menstrual bleeding for women who prefer and IUD as their method of birth control. The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic “hormone” to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combined oral contraceptives.

In 2009, the FDA first issued a warning to Bayer for overstating the effectiveness of Mirena, while minimizing the risks associated with it. This was considered an FDA reprimand of Bayer for deceptive marketing practices. In its reprimand letter to Bayer, FDA noted that the company’s “Simply Style” marketing materials and scripts for sales representatives included a variety of false, misleading, and scientifically unsupportable statements.

As of June 30, 2012, the FDA has received 45,697 reports of a serious Mirena birth control side effect. More than two million women in the United States have used Mirena. However, to date the FDA has not issued a Mirena recall.

If you or someone you love was injured by Mirena, please call the Rieders Travis law firm to have your claim investigated.

Bayer Set Aide $1.5 Billion to Cover Yasmin/Yaz Lawsuits

Court data updated as of March 5th 2013 indicates that there are presently 9566 cases pending on the MDL for the birth control pills Yasmin and Yaz with respect to the dangerous adverse side effects associated with these drugs. The MDL is currently pending in the U.S. District Court for the Southern District of Illinois. As of early 2013 a total of 15,000 Yazmin/Yaz litigation are pending inclusive of the MDL and other cases filed in federal and state court.

Yasmin was approved by the FDA in 2001, and its sister drug Yaz was approved by the FDA in 2006. Both drugs are oral contraceptives that hat combine estrogen and a fourth generation progestin, drospirenone, to prevent pregnancy. Yasmin and Yaz are manufactured by Bayer Healthcare Pharmaceuticals.

It has been previously reported by Thompson Reuters in March 2013 that Mayer set aside $1.5 billion in 2012 to cover the lawsuits. In the lawsuits the plaintiffs claim that both Yasmin and Yaz pills caused blood clots that resulted in heart attacks, strokes, pulmonary embolisms, deep vein thrombosis and deaths.

The cases are pending at 3:2012cv11630 in the Southern District of Illinois, while the cases are being presided over by Judge David Herndon. In October 2010, a case management order was established in the federal MDL scheduling three Yasmin and one Yaz bellwether trials which would be used to gage how juries would respond to testimony in the litigations in the MDL and set the tone for the rest of the cases in the MDL. However, the bellweather trials have been postponed since December 31, 2011 by the Judge while the parties engage in mediation and settlement of the Yasmin and Yaz cases. The bellwether trials remain stayed.

As of January 2013, Bayer had agreed to pay more than $1 billion to settle lawsuits brought on behalf of more than 4,800 women who suffered a pulmonary embolism or deep vein thrombosis. Additional claims will continue to be settled throughout 2013 on a case-by-case basis, following negotiations.

Request for MDL In Eastern District of Pennsylvania Made for Effexor Litigations

A request has been field with the U.S. Judicial Panel on Multidistrict Litigation to consolidate all Effexor (venlafaxine) birth defect lawsuits filed in federal court to date. The request was filed in May, 2013. At that time, there were 14 lawsuits involving Effexor pending in U.S. district courts, although lawyers have suggested that the scope of the litigation is likely to increase in the coming months.

All of the lawsuits allege that use of the antidepressant during pregnancy resulted in birth defects, primarily heart defects and malformations. The plaintiffs are seeking damages from Pfizer, the manufacturer of Effexor for failing to warn about the risk of heart birth defects.

In Boyer & Boyer v. Wyeth Pharmaecuticals, et al., plaintiffs Glenn and Lauren Boyer had a baby girl named Adelaide. Shortly after taking her first breath on February 11, 2010, it was discovered that their baby suffered lethal cardiac anomalies, including severe left hypoplastic heart, a malformed aorta, no aortic value, a malformed mitral valve, and other related conditions. The Boyers allege that the fatal heart anomalies were caused by Mrs. Boyer’s use of Effexor. A motion filed on April 24 by the Boyers sought that the Effexor litigations be transferred and consolidated before Judge Cynthia M. Rufe in the Eastern District of Pennsylvania because Judge Rufe is already presiding over the MDL for all of the Zoloft birth defect lawsuits pending against Pfizer, the same drug manufacturer.

Effexor (venlafaxine) belongs to a class of antidepressants known as serotonin-norepinephrine reuptake inhibitors (SNRIs), which are very similar to the more popular selective serotonin reuptake inhibitors (SSRIs) such as Zoloft. SNRIs are known to have many of the same side effects as SSRIs.

Research now indicates that women using the Selective Serotonin Re-uptake Inhibitors (SSRIs) (which are similar to Effexor but not identical) in the first 12 weeks of gestation–when many may not know they are pregnant–have a 40 percent greater risk of their baby suffering malformations. Heart defects are 60 percent more likely, according to research.

A Danish study reported a link between SSRIs and major congenital malformations, including cardiac malformations. The risk was increased among women who had prescriptions for SSRIs filled in the 30 days prior to conception through the end of the first trimester, compared with those who had no SSRI prescriptions filled during the same period.

In March 2006, Health Canada issued a warning to all pregnant women and women considering becoming pregnant that SSRI drugs similar to Effexor may pose life-threatening risks to their babies. Nursing mothers are also warned that SSRIs could be secreted in milk and could have an effect on nursing infants.

Babies who are exposed to SSRI’s during late pregnancy are also at an increased risk for developing persistent pulmonary hypertension of the newborn, known as PPHN which is a life-threatening disorder in which the newborn’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream.

Effexor is in FDA Pregnancy Category C, meaning that there could be a risk to the unborn baby if exposed to Effexor prior to birth.

According to allegations raised in many of the Effexor lawsuits, plaintiffs claim that there were signs of the potential birth defect risk during clinical trials on animals and that there were signs of pregnancy problems with Effexor in post-marketing data as well. The lawsuits indicate that Wyeth, now owned by Pfizer, aggressively marketed the drug as safe for pregnant women, when no such assertion could be justified when looking at the scientific data.

Effexor generated USD 2.1 billion in sales in 2004, making it Wyeth (now Pfizer’s) biggest selling drug at the time.

MDL Approved for Pfizer Products Liability Diabetes Lawsuits

A multidistrict litigation (MDL) has been approved for the initial product liability lawsuits filed against the manufacturer of Lipitor (atorvastatin) Pfizer. The lawsuits against Lipitor allege that Pfizer failed to warn of the risk of developing Type 2 diabetes from taking Lipitor. Pfizer alleges that the plaintiffs at these lawsuits were already at high risk of developing Type 2 diabetes, which often correlates with high cholesterol. In 2012, Pfizer updated its label for Lipitor to include an increased risk of developing diabetes, but the lawsuits contend that this labeling change was insufficient. According to research studies, including one published in JAMA: Internal Medicine on January 23, 2012,* there is a potential link between statins such as Lipitor and a Type 2 diabetes risk in women.*

Lipitor is the best known of a class of drugs called statins, which are used to lower cholesterol in patients with elevated blood cholesterol levels. Lipitor works by decreasing low density lipoprotein (LDL), so called “Bad cholesterol” in the bloodstream.

Pfizer opposes the MDL, saying on record that as past experience in similar litigations has confirmed, the creation of a products liability MDL, particularly where the product at issue –” Lipitor –“is one of the most-prescribed medicines in history, would inevitably invite the filing of numerous copycat actions with questionable merit by counsel hoping to avoid diligent prosecution of their claims and to leverage volume to coerce settlement.”

The MDL is No. 2459 and is pending in the U.S. District Court for the District of South Carolina.

Zyprexa Relprevv Deaths Lead to FDA Investigation

The FDA is currently investigating two unexplained deaths in patients on the antipsychotic drug Zyprexa Relprevv. Both patients died 3-4 days after receiving an appropriate dose of the drug, well after the three hour post-injection monitoring period required by the Risk Evaluation and Mitigation Strategy (REMS). Clinical studies previously conducted with the drug show that high doses of olanzapine, the active ingredient, can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.

According to the FDA’s web page, the FDA is continuing to evaluate both deaths and will provide an additional update after it gathers more information.

The Medication Guide for the drug notes that this dangerous drug, Zyprexa Relprevv, can cause post-injection delirium sedation syndrome (PDSS), increased risk of death in elderly people who are confused and have memory loss (dementia-related psychosis) and can cause high fat levels in the blood, weight gain and high blood sugar.  The stated goal of the REMS program is to mitigate the risk of negative outcomes associated with PDSS. The Zyprexa Relprevv label also contains warnings about the risk of post-injection delirium sedation syndrome (PDSS), which is a serious condition caused when the drug enters the blood too fast following an intramuscular injection.  In the clinical trials supporting the FDA approval of Zyprexa Relprevv, there were cases of PDSS were observed within 3 hours after administration of Zyprexa Relprevv, but there were no deaths due to PDSS that were reported in the clinical trials.

Zyprexa Relprevv is an antipsychotic drug manufactured by Eli Lilly & Company. It is approved by the FDA for treatment of schizophrenia and bipolar disorder. The drug went generic in 2011. Sales of Zyprexa in 2008 (prior to going generic) were $2.2B in the US alone, and $4.7B in total.  In the fourth quarter of 2011, Lilly’s sales from Zyprexa were $794.6 million, a decrease of 40% from the fourth quarter of 2010. Zyprexa Relprevv is a long-acting intra-muscular injection form of the drug Zyprexa, which is a tablet form drug and went generic in 2011. Zyprexa Replevv was first approved in 2009 and was part of Lilly’s effort to counteract Zyprexa going generic by mitigating the numbers of lost sales.  However, it the risks prove to be more significant with the drug following the FDA’s investigation, this strategy could backfire.  Stay tuned . . .

J&J Currently Settling Levaquin Drug Cases With Injured Plaintiffs

In November 2012, Johnson & Johnson settled 845 Levaquin lawsuits involving tendon ruptures. They were in Minneapolis in federal court. A federal Judge in Minneapolis is overseeing about 1900 Levaquin lawsuits. In addition, there are (as of the end of 2012) about 3400 total levaquin lawsuits, including about 1500 in New Jersey state court. Four Levaquin cases went to trial already. J&J won three of those cases, but a fourth case resulted in a Plaintiffs verdict of 1.8m in 2010. Settlements were underway with about 180 other plaintiffs by the end of last year.

The plaintiffs claim that Johnson & Johnson and its Ortho- McNeil Pharmaceutical unit failed to sufficiently warn that Levaquin was linked to an increased risk of tendon damage in elderly patients. The plaintiffs say Johnson & Johnson downplayed the risks to boost sales.

Levaquin is a fluoroqinolone antibiotic used to treat bacterial infections. People who take levaquin are at risk for tendon ruptures. The risk is greater for tendon ruptures for people who engage in physical activity, are over 60 or who had kidney, heart or lung transplants. The most commonly ruptured tendons with levaquin are the Achilles tendon near the ankle and the rotator cuff of the shoulder. FDA issued a black box warning for Levaquin in 2008 warning of an increased likelihood of tendon problems.

If you have taken Levaquin and suffered from a ruptured tendon, call Cliff Rieders, Esquire, of Rieders, Travis, Humphrey, Harris, Waters, Waffenschmidt & Dohrmannn, (570) 323-8711, to see whether your claim would be appropriate for filing as a new case. If you or a loved one has taken Levaquin, contact us today to learn about your legal rights and the potential for recovery.

New Black Box Warning Added for Pradaxa in April 2013 – Lawsuits on the Horizon

Pradaxa (dabigatran etexilate) is a drug that has been on the market since 2010, when it was approved by the FDA as a supposed alternative to Coumadin (warfarin). The drug is manufactured and marketed by a European pharmaceutical giant, Boehringer Ingleheim. Pradaxa is an anti-coagulant or blood thinner, used to reduce the increased risk of blood clot or stroke in heart patients with non-valvular atrial fibrillation, a very common type of heart arrhythmia. Allegedly, Phase III clinical trials (known as the RE-LY) trials, done with guidance from the FDA by the pharmaceutical company, showed a reduced risk of stroke with Pradaxa in this group of patients. The results from this trial can be found here. The majority of the study authors had, problematically, as is the case with most late-stage clinical trials, received consulting fees from the drug company. The publication of the clinical study concluded:

“In conclusion, we compared two doses of dabigatran with warfarin in patients who had atrial fibrillation and who were at risk for stroke. As compared with warfarin, the 110-mg dose of dabigatran was associated with similar rates of stroke and systemic embolism and lower rates of major hemorrhage; the 150-mg dose of dabigatran was associated with lower rates of stroke and systemic embolism but with a similar rate of major hemorrhage.”

However, many on the FDA advisory board were skeptical that the risk of stroke was the same, if not higher, while the bleeding risk was actually greater given Pradaxa’s mechanism (discussed below). Any excellent article discussing the this issue and the skepticism among members of the FDA panel that reviewed the drug for approval can be found here.

The problem with Pradaxa is its mechanism and the fact that there is no antidote to the drug, like there is with warfarin. Pradaxa works as an anti-coagulant. The drug’s mechanism works to stop a series of interactions that lead to blood clotting to prevent but unlike other anti-coagulants, has no antidote, which creates the bleeding risk. However, this risk was minimized by the FDA in the label and warning information that was provided to the public when the drug was first approved, stating only: “Pradaxa can cause serious and, sometimes, fatal bleeding.” Critically, the label did not mention Pradaxa’s key flaw, that the Pradaxa is an anti-coagulant and that there is no antidote to its mechanism of stopping blood clotting, therefore, and overdose of Pradaxa, unlike an overdose of warfarin, cannot be reversed by any known medical means. It is because of this reason that many suspect that Pradaxa may actually have an increased risk of bleeding compared to warfarin, which has over fifty years of known, regulated use on the market. Because of these issues, Pradaxa lawsuits are beginning to emerge challenging that the drug has an unusually dangerous risk of bleeding which was concealed in the RE-LY trial, and hidden by the FDA as a means of quickly bringing Pradaxa to market.

Even worse in the label, it notes in tiny print (as the article hyperlinked above noted) that “risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs),” which a large number of the target patients, heart patients are taking concurrently.

On November 2, 2011, a drug safety communication was issued noting the numbers of serious bleeding events with Pradaxa, including gastrointestinal bleeding and intracranial hemorrhage. The FDA noted that “following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users,” and therefore conducted an investigation into these events. In fact, there were more reports of side effects to the FDA with Pradaxa in 2011 than with any other drug on the market. At the time, FDA claimed the results of its study of bleeding events was similar to the data from the RE-LY trial conducted for clinical drug approval but that the FDA was continuing to evaluate multiple sources of data.

At the time, FDA stated as follows about Pradaxa: “Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly. Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes. The risk of bleeding is a well-recognized risk of anticoagulant drugs. ” However, the FDA did NOT change its recommendation for Pradaxa, nor did it change the label, or add information noting that unlike warfarin, there is no antidote to Pradaxa.

On April 30, 2013, just recently, the Boehringer Ingleheim announced that Pradaxa would carry a black box warning for the first time, the most serious type of warning that the FDA employs on prescribing information. A copy of the drug company’s announcement can be found here. The Pradaxa prescribing information now contains a black box warning, altering patients that discontinuing Pradaxa without adequate anti-coagulation increases the risk of stroke. A similar warning had previously been present in small print in the prescribing information, as well as in the Pradaxa medication guide from the FDA, but had not been present in a black box form. In addition, the postmarketing section of the label will now include a risk of thrombocytopenia (low platelets). This black box is still not adequate to show the postmarketing experience of bleeding with the drug. Incredibly, the company continues to deny bleeding is unmanageable and poses no greater a risk with Pradaxa than with warfarin.

If you have taken Pradaxa and suffered from serious bleeding side effects, hemorrhage or stroke, call Cliff Rieders, Esquire, of Rieders, Travis, Humphrey, Harris, Waters, Waffenschmidt & Dohrmannn, (570) 323-8711, to see whether your claim would be appropriate for filing as a new case. If you or a loved one has taken Pradaxa, contact us today to learn about your legal rights and the potential for recovery.

More Studies Link Merck’s Januvia to Pancreatic Cancer; Reports Indicate Unpublished Data Shows Risk

Three recent studies now indicate an increased risk of pancreatic cancer with Merck’s Type 2 diabetes drug Januvia. The most recent study was published in the British Medical Journal (BMJ(found growing safety concerns associated with Januvia. hat data included a review of health insurance claims, which showed a higher risk of hospital admission for acute pancreatitis in patients taking Januvia when compared to other diabetes medications. It also revealed a review of FDA data showing increased pancreatitis and pancreatic cancer risks in patients taking incretin mimetics – Januvia is included in this class of drugs, as is Amylin/Bristol Myers Squibb’s Byetta and Novo Nordisk’s Victoza and Merck’s Janumet (a mixture of Januvia and metformin). According to reports, the BMJ was able to obtain thousand of regulatory documents under the Freedom of Information Act and rules. The Journal was able to locate unpublished data indicating “unwanted proliferative or inflammatory pancreatic effects.” The BJM article is available here.

As of July 14, 2013, there have been 43 Januvia pancreatic cancer lawsuits filed, according to Merck, the manufacturer. Court records indicate that the US Judicial Panel on Multidistrict Litigation (JPML) is now considering consolidation of all federal Januvia lawsuits, including claims involving similar diabetes drugs in the same incretin mimetics class, in a single federal court for pretrial proceedings. The cases are presently filed in the same MDL as the Byetta cases, in the Southern District of California. The JPML will hear Oral Arguments on the possible consolidation of those claims on July 25. In a filing on 4/29/13, Merck, maker of Januvia, agreed to move the Januvia product liability lawsuits to federal court; the drug manufacturer requested that the claims be consolidated in United States District Court for the Southern District of California (San Diego), by Judge Battaglia. In its filing, Merck also stated that the MDL should be limited to pancreatic cancer cases.

The FDA is currently reviewing the scientific data on Januvia, Janumet, Byetta and Victoza, a type of type 2 diabetes medication known as incretin mimetics, as a result of the reported adverse events related to these medications.

Actos Trials Scheduled to Move Forward in Louisiana MDL on Accelerated Schedule

The first bellweather trials in the Actos (pioglitazone) MDL litigation have been moved up. Actos ins an oral agent used to treat Type II diabetes. An Actos multidistrict litigation (MDL) is currently pending in the Western District of Louisiana before Judge Rebecca Doherty. The first trial in the Actos MDL is now scheduled for January 27, 2014, with the second trial in the MDL scheduled for April 14, 2014. The Judge’s order scheduling the two trials is reflecting of a new accelerated scheduled for the Actos MDL cases. The bellweather trials had previously been scheduled to begin in November 2014. he updated program establishes a “streamlined trial preparation schedule for a minimum of two Pilot Bellwether trials,” and is imposed “so as to serve the very important goal of moving these proceedings toward completion of this court’s responsibilities in a reasonable time,” according to the Court’s Order.

The first Actos lawsuit has already been tried outside of the MDL in Los Angeles, California, with plaintiff Jack Cooper alleging that manufacturer Takeda failed to warn about the serious risk of bladder cancer associated with long-term Actos use. Over 3,000 other plaintiffs have made similar claims against the company, with all federal cases consolidated into the Western District of Louisiana on December 29, 2011 (MDL No. 2299).

On June 11, 2011, the FDA put out a warning concerning the link between Actos and bladder cancer. The agency reviewed the five-year results of a 10-year ongoing epidemiological study, and reported that patients taking the type 2 diabetes drug for more than 12 months may be at a 40 percent increased risk of bladder cancer. In August 2011, the FDA approved updated drug labels that contained the new information concerning an increased risk of bladder cancer associated with Actos. This resulted in a large influx of cases in the Actos litigation, with now over 3000 cases filed in the MDL.

On April 26, 2013, the first verdict was awarded in the California Actos trial of 6.5m USD for the plaintiff against the manufacturer of Actos, Takeda Pharmaceuticals. However, this jury verdict was vacated by the Court and the Plaintiffs are filing an appeal. Rather than paying just compensation to the Coopers, California Superior Court filing records show that Takeda filed motions to keep the jurors from hearing expert testimony that Actos caused Mr. Cooper’s bladder cancer. On May 1, 2013, the Court granted Takeda’s motion and dismissed the Coopers’ case despite the jury’s finding that Takeda was responsible for Jack Cooper’s injuries. The Plaintiffs in this case are currently appealing the Court’s decision to vacate the jury verdict, in attempt the reinstate the jury’s verdict.

Momentum Continues to Build For Newly Filed Pradaxa Litigation

A multidistrict litigation over the blood thinner drug Pradaxa continue to move forward. A multidistrict litigation has been filed concerning Pradaxa before Chief Judge David Herdon of the United States District Court for the Southern District of Illinois. Herdon has been presiding over the Pradaxa MDL since August of 2012.

New cases continue to be filed in the MDL as well as other courts concerning the anti-coagulant medication Pradaxa. At total of 177 Pradaxa cases are currently pending in the MDL, which is presently in the discovery phase. Depositions of defendant Boehringer Ingelheim are scheduled to begin in the near future.

In its first two years on the market, Pradaxa garnered nearly $1.5 billion in worldwide sales. But in that same time frame, the drug was linked to more than 500 deaths in the United States. In 2011 alone, Pradaxa use accounted for 3,781 adverse events in patients, including reports of stroke, hemorrhage, acute kidney failure and about a dozen cases of liver failure.

However, Boehringer Ingehlheim still alleges that Pradaxa is not dangerous and is more effective than the alternative warfarin which has been on the market for years, despite the large number of adverse events comparatively in its time on the market. However, the company attempts to bolster its position with its own self-sponsored clinical study. Post-hoc analysis of the RE-LY clinical trial, a clinical trial sponsored by Boehringer Ingelheim, recently showed (published in June, 2013) that 110mg and 150mg doses of dagigatran (Pradaxa) had a net clinical benefit compared with warfarin in patients with atrial fibrillation. The company sponsored trial showed a reduction of about one ischemic stroke equivalent, which was the endpoint looked at in the trial. This endpoint took into account both ischemic and bleeding events. The study was published in the Journal of the American College of Cardiology.

Pradaxa has been on the market since 2010, when it was approved by the FDA as a supposed alternative to Coumadin (warfarin). The drug is manufactured and marketed by a European pharmaceutical giant, Boehringer Ingleheim. Pradaxa is an anti-coagulant or blood thinner, used to reduce the increased risk of blood clot or stroke in heart patients with non-valvular atrial fibrillation, a very common type of heart arrhythmia.

On April 30, 2013, just recently, the Boehringer Ingleheim announced that Pradaxa would carry a black box warning for the first time, the most serious type of warning that the FDA employs on prescribing information. A copy of the drug company’s announcement can be found here. The Pradaxa prescribing information now contains a black box warning, altering patients that discontinuing Pradaxa without adequate anti-coagulation increases the risk of stroke. A similar warning had previously been present in small print in the prescribing information, as well as in the Pradaxa medication guide from the FDA, but had not been present in a black box form. In addition, the postmarketing section of the label will now include a risk of thrombocytopenia (low platelets). This black box is still not adequate to show the postmarketing experience of bleeding with the drug. Incredibly, the company continues to deny bleeding is unmanageable and poses no greater a risk with Pradaxa than with warfarin.

If you have taken Pradaxa and suffered from serious bleeding side effects, hemorrhage or stroke, call Cliff Rieders, Esquire, of Rieders, Travis, Humphrey, Harris, Waters, Waffenschmidt & Dohrmannn, (570) 323-8711, to see whether your claim would be appropriate for filing as a new case. If you or a loved one has taken Pradaxa, contact us today to learn about your legal rights and the potential for recovery.

Hearing Scheduled for Proposed MDL for Byetta, Januvia and Victoza Diabetes Drugs

A multidistrict litigation for Byetta, Victoza and Januvia may move forward after a Judicial Panel on Multidistrict Litigation (JMDL) hears oral argument on July 25, 2013 in Portland, Maine.

The proposed MDL and known as In RE: Incretin Mimetics Products Liability Litigation (MDL No. 2452) would include lawsuits filed against Amylin Pharmaceuticals over Byetta, Merck over its own incretin mimetic diabetes treatment drug, Januvia, and Novo Nordisk over Victoza. – The plaintiffs behind the MDL and the largest number of cases filed in the litigation are presently pending in California. However, cases have also been filed in six other federal courts.

In addition, a new investigation by the British Medical Journal (BMJ) has concluded that the pancreatic risks associated with incretin mimetics like Byetta may have been downplayed by the drugs’ manufacturers. The BMJ investigation consisted of a review of regulatory documents that discovered unpublished data pointing to “unwanted proliferative or inflammatory pancreatic effects” associated with incretin mimetics. The authors of the report also faulted the U.S. Food & Drug Administration (FDA) and European regulators for failing to aggressively address these concerns. “On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” Deborah Cohen, Investigative Editor for BMJ, wrote in the piece, published online.

The Rieders Travis firm is currently reviewing cases whether Januvia Byetta and Victoza may have caused pancreatic cancer. If you or someone you loved took one of these drugs and developed pancreatic cancer, please feel free to contact the Rieders Travis firm to determine whether you have a case.

Supreme Court Follows PLIVA, Abandons Consumers in Recent Court Decision Exempting Generic Drug Manufacturers From Defective Design Drug Cases

The Supreme Court’s decision this week in Mutual Pharmaceutical Co. v. Bartlett, once again leaves consumers high and dry. In this case, the Supreme Court held in a 5-4 split decision authored by Justice Samuel Alito that state law design defect claims that turn under adequacy of drug’s warnings are pre-empted under federal law by PLIVA v. Mensing. The case was therefore decided under the Supremacy Clause, which says that when state and federal law come into conflict, federal law prevails.

In PLIVA Inc. v. Mensing, the Supreme Court previously held that federal generic drug law preempts state failure-to-warn claims. In its new decision in Mutual, the Court applied PLIVA as precedent to hold that federal law also preempts certain state design defect claims.

Both cases are a blow to consumers, because they eliminate all types of pharmaceutical mass tort cases against generic drug manufacturers. The effect of PLIVA and Mutual are that a consumer can suffer devastating injuries from a dangerous drug and have legitimate state law failure to warn (PLIVA) or defective design (Mutual) claims. But if the consumer, by chance, took a generic form of the drug rather than the non-generic form of the drug, the consumer’s lawsuit against generic manufacturers are pre-empted due to federal generic drug laws. However, if the plaintiff had taken a brand drug rather than a less expensive generic form of the identical drug, then she would have been able to sue and recover against the brand manufacturer. This seems to be an arbitrary result which hurts consumers over something they have no control over – whether they took a branded form or generic form of a drug. In fact, that is usually determined by insurance companies.

Both the majority opinion, as well as both dissenting opinions acknowledge that the facts underlying this case are tragic. The plaintiff in this case, Karen Bartlett suffered horrific injuries as a side effect of the generic drug sulindac, a non-steroidal anti-inflammatory drug. Yet, Justice Alito explains in the majority opinion that New Hampshire’s design defect statute imposes affirmative duties on manufacturers, including a “duty to design [their products] reasonably safely for uses which [they] can foresee.” Here, redesign of the drug was not possible for two reasons. First, federal law, specifically the Food Drug & Cosmetics Act (FDCA) requires a generic drug to have the same active ingredients, route of administration, dosage form, strength and labeling as its branded-equivalent. Secondly, because of the drug at issue, sulindac’s simple composition, the drug is chemically incapable of being redesigned. Thus, because redesign is impossible under the federal statute, which governs generic drugs, this comes into conflict with the state statute, and thus imposes a conflict between state and federal law which the court resolved by holding that the federal generic drug law pre-empts the state law defective design claim under the New Hampshire Statute. Thus, the court reached the same result as in the PLIVA case, reversing the decision of the Court of Appeals for the First Circuit.

The decision drew two dissenting opinions, which argued that the stop-selling theory is valid – the generic company simply could have stopped selling the drug, and also that Congress would have wanted to preserve a role for state law in drug regulation. Justice Sonia Sotomayor’s dissent concludes that “the Court has left a seriously injured customer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.” Mark it down as a another win for corporations and big business at the expense of consumers from the High Court.

AMA: Obesity is a Disease

Earlier this week, the American Medical Association (AMA) declared that obesity is a disease. What does this mean for the pharmaceutical industry? It likely paves the way for a large number of drugs that target obesity which have the potential for dangerous side effects, given the large spectrum of associated diseases that come along with obesity and its unhealthy lifestyle. “Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans,” says AMA board member Patrice Harris in a statement. “The AMA is committed to improving health outcomes and is working to reduce the incidence of cardiovascular disease and Type 2 diabetes, which are often linked to obesity.”

The FDA recently approved the first new diet drugs in over a decade after much scrutiny and debate at the FDA over the drugs’ safety profiles and/or potential for abuse as a controlled substance (the latter was the concern for Arena’s drug, belviq). The drugs are Arena Pharmaceuticals’ Belviq and Vivus Pharmaceuticals’ Qsymia. AMA’s announcement that obesity is a disease may result in an increase in prescriptions for these two new drugs, which were approved just last year. Potential Medicare coverage for these drugs could also mean an increase in prescriptions. Such Medicare coverage may be more likely following the AMA’s recent pronouncement about obesity. A third prescription diet drug, Contrave, which is being developed by Orexigen Therapeutics has not yet been approved because the FDA asked the manufacturer to run a large cardiovascular study that is not expected to be completed until next year, due to safety concerns pending approval.

Colchicine Gout Drug

Oral colchicine has been used to prevent and treat gout (a form of arthritis) for decades.  There are several drugs currently in Phase II and III clinical development for gout, which , while promising, are significantly more expensive and show at best, similar efficacy in treatment of gout.

So why did FDA, after sixty years make the decision to pull oral colchicine from the market? Because the generic forms on the market had never received mandatory FDA approval in any form, such as through the traditional process for FDA approval of generics.  The FDA determined that because these inexpensive colchicine products did not contain important safety data about drug interactions, dosing and safety data, that they should not be on the market.  This action was part of FDA’s broader campaign to get marketed but unapproved drugs off the market.  Of course, this is routine with medical devices under the pre-market approval process where devices can make it to market without full approval when similar to a marketed device.

This policy of pulling colchicine off the market raises prices for consumers on a drug that has nearly sixty years of safety data from market experience and actual use by rheumatologists and patients.  It also is worthy to note that pulling this cheap alternative from the market creates a bigger market for companies like Ardea and Regeneron with close to market clinical candidates in gout that will be significantly more expensive.  Colcrys is the only single ingredient FDA approved colchicine prodocut remaining on the market today in the U.S., as it was approved by the FDA in 2009.   The manufacturer has promised to maintain a patient assistance program and a co-pay program. In attempt to allow most patients to have affordable access to a form of colchicine until the FDA approves generic competition through the typical pathways.

FDA Adds Black Box Warning to Tigecycline

After sitting for two years on a Public Citizen petition calling for the addition of a black box warning to the label of the risky antibiotic tigecycline, the Food and Drug Administration (FDA) finally agreed with the organization’s Health Research Group. On September 27, the agency announced that this antibiotic – approved for use intravenously to treat a wide range of serious infections and sold by Pfizer under the brand name Tygacil – would now have to carry a black box warning, the strongest measure the FDA can take short of banning a drug altogether.

It alerted health care professionals to the danger and asked Pfizer to modify tigecycline’s label to include data about the increased mortality risk.

Even when clinical evidence points to significantly higher risks between similar drugs, manufacturers of the higher-risk drugs can still profit. In this case, tigecycline – the higher-risk, lower-success-rate antibiotic – generated sales for Pfizer of $334 million in 2012, two years after the FDA announced that it was less safe than other antibiotics.

If you have a medical, hospital or pharmaceutical issue, be sure to contact Cliff Rieders at (570) 323-8711; crieders@riederstravis.com;www.riederstravis.com.

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