This MDL will allow Pradaxa users who have filed lawsuits to consolidate their efforts
Birmingham,AL (PRWEB) May 31, 2012
A motion filed before the Judicial Panel on Multidistrict Litigation seeks to create a coordinated MDL docket for all pending and future federal product liability cases involving the drug Pradaxa, an anticoagulant.
“This MDL will allow Pradaxa users who have filed lawsuits to consolidate their efforts and hopefully hold the drug maker, Boehringer Ingelheim Pharmaceuticals, accountable for the inadequate warnings and negligent corporate conduct that are alleged in those lawsuits,“ said J.C. Conlin, an attorney with Cory Watson Crowder & DeGaris. Cory Watson is recognized nationally for its work in complex litigation involving pharmaceutical drugs, medical devices, and other products. Conlin says Cory Watson is working with Pradaxa users who believe they were injured by the drug.
Pradaxa (dabigatran) is a prescription blood-thinning medication that received Food and Drug Administration (FDA) approval in October 2010 and is intended specifically for use in reducing the risk of stroke of people with non-valvular atrial fibrillation (AFib). AFib is the most common type of arrhythmia or irregular heartbeat. Pradaxa is in a class of anticoagulant drugs called direct thrombin inhibitors, which attach to clotting agents in the blood to reduce the blood's ability to clot.
According to a December 7, 2011 Safety Communication issued by FDA, from the time Pradaxa was approved in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies. Pradaxa sales have topped $1 Billion dollars according to an article published April 24, 2012 in the Wall Street Journal. The billion dollar sales figure puts Pradaxa in the “blockbuster” category of pharmaceuticals.
The FDA is evaluating reports that serious bleeding is more common in patients using Pradaxa than in patients using other blood thinners. According to the FDA, Boehringer Ingelheim, the maker of Pradaxa, reported 260 fatal bleeding events related to Pradaxa between March 2008 and October 2011.
Pradaxa safety continues to come under closer scrutiny across the globe. Following required labeling changes in Europe, Japan, and New Zealand in 2011, on May 25, 2012, the European Medicines Agency (EMA) recommended updating the Pradaxa product information on how to reduce and manage the risk of bleeding associated with the anticoagulant medicine. The EMA concluded that while the benefits of Pradaxa continue to outweigh its risks, the adverse events need to be kept under close surveillance due to the number and severity of the reported complications.
The motion to consolidate the US Federal court Pradaxa cases was filed on behalf of Plaintiff Vera Lee Sellers (Vera Lee Sellers vs. Boehringer Ingelheim Pharmaceuticals, Inc., et al. in the Southern District of Illinois, East St. Louis Division, Case No.3:12-cv-00615) .
About Cory Watson Crowder & DeGaris
Cory Watson Crowder & DeGaris is a Birmingham, Alabama, personal injury law firm recognized nationally for its practice in complex litigation including multidistrict litigation, class actions, products liability, business and securities litigation, environmental litigation and mass torts litigation of defective medical devices and pharmaceutical drugs. Cory Watson has an extensive practice in consumer litigation, personal injury and wrongful death cases. Additional information is available on the Cory Watson website.