Brenda Fulmer of Searcy Denney’s Mass Tort Unit filed yet another individual lawsuit against Boehringer Ingelheim this week on behalf of a South Florida man who died within months of ingesting Pradaxa and suffering a Pradaxa-induced GI bleed. This wrongful death claim is one of nearly 2,000 lawsuits that have been filed against the German parent company and U.S. subsidiary of Boehringer Ingelheim, which developed Pradaxa as an alternative to Coumadin or warfarin in patients with atrial fibrillation.
The first jury trials for Pradaxa victims will begin in the federal court MDL proceedings in East St. Louis, Illinois in August of 2014, with additional trials to follow through the end of 2014 and early 2015 in the MDL as well as state court venues. The lawyers at Searcy Denney have been involved in the Pradaxa litigation since its inception and have been involved in the national discovery efforts and coordination of the litigation.
Pradaxa, also known as dabigatran etexilate mesylate) was approved by the FDA in October of 2010 based primarily on the results of a single study known as the RE-LY trial. Within merely a year of approval, however, there were hundreds of reports of patients suffering bleeding events in their stomachs and brains. For many patients, these GI bleeds resulted in the patients bleeding to death, as there is no reversal agent for the anti-clotting effects of Pradaxa. However, the blood thinning effects of Coumadin, which has been on the market for decades and is an alternative to Pradaxa, can be reversed within a few hours for a patient who suffers a GI bleed or trauma. Patients and prescribing physicians were not given adequate information about the lack of a reversal agent for Pradaxa as well as the potential for Pradaxa to cause a GI bleed.