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

May 15th, 2015 by Rieders Travis in Dangerous Drugs

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…

Xarelto Cases To Be Selected for Early Trial Dates

May 12th, 2015 by Rieders Travis in Dangerous Drugs

As a growing number Xarelto bleeding lawsuits continue to be filed nationwide, the U.S. District Judge presiding over the federal multidistrict litigation (MDL) has ordered the parties to identify between 40 and 60 plaintiffs to go through case-specific discovery and possible early test trials. There are currently more than 400 product liability lawsuits filed against Bayer and Johnson & Johnson's Janssen unit in the federal court system, which all involve similar allegations that the drug makers failed to adequately warn about the potential of serious adverse events, mainly uncontrollable bleeding and hemorrhagic stroke. In addition, numerous Xarelto cases have also been filed in the Philadelphia Court of Common Pleas, where a mass tort proceeding has been organized. In December 2014, the federally filed Xarelto cases have been organized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of a multidistrict litigation (MDL). A May 4, 2015 case management order was issued in the federal MDL by Judge Fallon, ordering both parties to meet and confer before June 15, to propose a process for identifying between 40 and 60 cases to be part of a "bellwether"…

Actos Bladder Cancer Settlement Reached

April 30th, 2015 by Rieders Travis in Dangerous Drugs

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…

Pradaxa Reversal Agent Gets Expedited FDA Review

April 28th, 2015 by Rieders Travis in Dangerous Drugs

The FDA has agreed to a fast-track review process for a potential reversal agent for the blood thinner Pradaxa, which has been linked to thousands of serious and sometimes fatal injuries due to uncontrollable bleeding events. Boehringer Ingelheim, the makers of Pradaxa, announced on April 23 that the FDA has announced expedited review for a drug which may be able to rapidly reverse the blood thinning effects of the anticoagulant. The decision means that the drug's review will be accelerated and, if approved, could get to patients faster than normal for new drugs. If approved by the FDA, idarucizumab, the name of the reversal agent, would be the first reversal agent to hit the market for a new generation of oral anticoagulants used to prevent strokes in patients with atrial fibrillation. The class, which includes the blockbuster drugs Pradaxa, Xarelto, and Eliquis, has been linked to uncontrollable bleeding events because they were released without antidotes that doctors can use in the event patients suffer hemorrhages or other bleeding events. The drugs have been promoted as superior replacements for generic warfarin, which has been on the market for many years, with…

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

April 22nd, 2015 by Rieders Travis in Dangerous Drugs

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…

Benicar Cases Consolidated In New Jersey MDL

April 7th, 2015 by Rieders Travis in Dangerous Drugs

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…

First Lipitor Bellwether Trial Scheduled

March 31st, 2015 by Rieders Travis in Dangerous Drugs

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…

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

March 31st, 2015 by Rieders Travis in Dangerous Drugs

New research raises more concerns about the potential side effects of Xarelto, a new generation anticoagulant used to reduce the risks of blood clots, particularly in patients diagnosed with atrial fibrillation. The research indicated that certain patients at risk for suffering a pulmonary embolism may be more likely to experience major and uncontrollable bleeding on Xarelto. In a new study published in the March Issue in the Journal, Academic Emergency Medicine, researchers found that while use of Xarelto to treat pulmonary embolism was relatively safe for patients facing a low to moderate risk of blood clots traveling to the lungs, those with a high risk for pulmonary embolism face a higher risk of Xarelto bleeding than normally associated with the blood thinner. The research was sponsored by the two companies manufacturing and marketing the drug, Bayer HealthCare and Janssen Pharmaceuticals, looking at data on about 5,000 patients at risk of pulmonary embolism. Researchers assigned patients simplified Pulmonary Embolism Severity Index (PESI) scores, with 0 meaning low risk, 1 meaning intermediate risk and 2 or greater meaning a patient faced high risk of pulmonary embolism. The score was based on a…

Arguments Over Benicar Multi-District Litigation Centralization

March 30th, 2015 by Rieders Travis in Dangerous Drugs

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…

Settlement Reached in Ethicon Vaginal Mesh Lawsuit During Trial

March 13th, 2015 by Rieders Travis in Dangerous Drugs

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…