Bertha Bivens has filed a wrongful death lawsuit on behalf of her mother Nancy Brummett in U.S. District Court for the Eastern District of Tennessee against Boehringer Ingelheim alleging that Brummett died from gastrointestinal bleeding caused by the new blood thinner Pradaxa.
According to the lawsuit, Brummett began taking Pradaxa in January 2011, as prescribed to treat her atrial fibrillation, and was hospitalized with gastrointestinal bleeding two months later. Brummett was released from hospital under the care of hospice and died shortly after.
Pradaxa hit the market in 2010 as an alternative to the blood thinner Coumadin in the prevention of strokes for people who have atrial fibrillation. Pradaxa (dabigatran) is a direct thrombin inhibitor which is being questioned in relation to hemorrhages and bleeding events and hundreds of deaths.
According to the lawsuit, Boehringer Ingelheim created a defective product that is no safer than older blood thinners like Coumadin. Whereas bleeding events associated with drugs like Coumadin can be reversed with doses of Vitamin K, Pradaxa does not have a reversal agent. The lawsuit also says that the warning label for the drug failed to adequately warn physicians and their patients about the risks of gastrointestinal bleed, and failed to instruct doctors on how to handle bleed events. Bivens states in the lawsuit that Pradaxa is defective and the manufacturer should recall the drug.
In 2011, Boehringer Ingelheim reported 260 Pradaxa deaths worldwide, with 120 death reported in the United States. The FDA, as well as the Canadian and European health agencies are investigating the safety risks of Pradaxa.