In less than two years on the market, Boehringer Ingelheim’s controversial anticoagulant drug Pradaxa (generic: dabigatran) has been the subject of numerous reports of injuries including severe bleeding events, gastrointestinal bleeding, and death.
In December 2011, the U.S. Food & Drug Administration (FDA) issued a press release announcing that it was investigating these reports in an attempt to determine whether the adverse events linked to Pradaxa are occurring more often than would be expected, based on the clinical trials submitted to the FDA for the drug’s initial approval.
Since the FDA issued its warning, more patients have filed Pradaxa lawsuits, all making similar allegations against Boehringer. To date, 21 such complaints have been filed in federal courthouses around the country, and industry insiders have predicted that this number will grow much larger in the near future.
Last month, Vera Lee Sellers filed a Pradaxa bleeding side effect lawsuit in the U.S. District Court for the Southern District of Illinois. Sellers subsequently filed a motion to transfer all other Pradaxa cases filed in U.S. federal courts to the same jurisdiction for pretrial proceedings under Chief Judge David R. Herndon. According to the motion, consolidation in the Pradaxa cases is warranted because all of the claims involve similar allegations against the manufacturer, including failure to warn and defective design. Additionally, each of the lawsuits pose similar questions of fact and law, and none have yet entered the discovery phase of litigation. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has scheduled a hearing session to be held next month during which they will consider the proposal to consolidate the federal Pradaxa lawsuits.
As Pradaxa lawsuits continue to be filed in courthouses around the country, many critics feel that the medications’ warning label still does not adequately warn users about the risk of severe bleeding events. In a report published earlier this month in the Philadelphia Inquirer, it was noted that Pradaxa led all other drugs in 2011 with more than 500 deaths reported to the FDA, while Coumadin (generic: warfarin), a mainstay anticoagulant that has been in use for over a half century, was only associated with 72 deaths.
Pradaxa is manufactured by Boehringer to be a replacement for warfarin, and is supposed to require less patient monitoring and be easier to use. However, warfarin can be quickly counteracted by a single dose of Vitamin K when an internal bleeding problem occurs. This does not work with Pradaxa or any of the other newer generation of blood thinners such as Xarelto (generic: rivaroxaban).
Pradaxa bleeding events have been reported to come on quickly, shortly after initiating a regimen of the drug, sometimes with catastrophic consequences. Many former users’ family members have come forward to join the Pradaxa litigation, filing claims on behalf of deceased loved ones who fell victim to irreversible internal bleeding complications. If the JPML decides to consolidate the Pradaxa lawsuits - and in all likelihood it will - legal claims against Boehringer will almost certainly continue to be filed indefinitely. Additionally, the results of the ongoing FDA investigation are likely to have a significant impact on how the Pradaxa litigation plays out.
Michael E. Schmidt is recognized as one of Americaʼs most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP is currently accepting Pradaxa lawsuits in all 50 states. To learn more about this topic, please visit his website: http://www.schmidtandclark.com/pradaxa.