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.

h2>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 Pradax, 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 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.

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

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.

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.

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).

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,

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.

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.

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.

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.

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

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.

PRODUCTS LIABILITY-PHARMACEUTICALS-PREEMPTION

In re Fosamax (Alendronate Sodium), 751 F.3d 150 (3^rd 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.

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.

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

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 LitigationUnlike 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.