Lawsuit Says Boehringer Ingelheim Ignored Pradaxa Risks

Thomas E. Cochran of Arkansas has filed a lawsuit against Boehringer Ingelheim, the manufacturers of Pradaxa, alleging that the drug not only caused the death of Emma Cochran, but also that the manufacturers were aware of the risk yet actively downplayed the danger to the public.

Cochran’s lawsuit first asserts that Boehringer Ingelheim reasonably should have been aware of the risk of uncontrollable bleeding associated with the drug. The Pradaxa lawsuit cites post-market surveillance – the process that regulatory agencies like the U.S. Food & Drug Administration (FDA), as well as drug companies like the defendant, maintain and utilize to sort through reports of adverse reactions to drugs. Per the lawsuit, the FDA received 1,800 MedWatch reports involving complications from Pradaxa for 2011 alone. Pradaxa was only released in the last few months of that year. These reports included 1,000 reports of life-threatening bleeding events and 237 deaths associated with Pradaxa use. 

Additionally, the Pradaxa lawsuit cites peer-reviewed journal articles that outline concerns related to Pradaxa, including a 2011 article in the Achieves of Internal Medicine. This article stated that the drug carried with it a substantial difficulty in assessing its function. Since Pradaxa thins the blood, it can actually prevent clotting if an individual is given too much of the medication. Older anticoagulants like Warfarin are easier to assess, preventing accidental overdose. Additionally, the article points out that unlike older anticoagulants, there is no reversal agent for Pradaxa. Again, older anticoagulants have these agents, which can reverse the effects of the drug should uncontrollable bleeding take place. 

The Pradaxa lawsuit further asserts that not only was Boehringer Ingelheim aware of the risks, but that it actively downplayed the risks, preventing patients like the deceased and their health care professionals from having all of the information they needed to make informed medical decisions. To support this assertion, the Pradaxa lawsuit points out that the initial prescribing information made no mention of the fact that there was no reversal agent, that there was no means of assessing anticoagulation, or the risk of impaired renal function associated with Pradaxa. Additionally, the manufacturers conducted more than 1.5 million promotional visits to cardiologists, primary care physicians and other health care workers and engaged in several direct-to-consumer marketing programs. According to the Pradaxa lawsuit, Emma Cochran received promotional material from one such campaign. 

The Pradaxa lawsuit holds that these factors leave the manufacturers of Pradaxa liable for the death of Emma Cochran. The case seeks more than $75,000 in various types of damages. 

The Pradaxa lawsuit is formally titled Thomas E. Cochran, as Administrator of the Estate of Emma Louise Cochran, v. Boehringer Ingelheim Pharmaceuticals Inc., et al., Case No. 3:13-cv-51581-DRH-SCW, in the U.S. District Court for the Southern District of Illinois. It has been added to ongoing multidistrict litigation, In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois. 

If you or someone you care about took Pradaxa and went on to suffer from serious health problems, you’ve almost certainly found yourself in a challenging situation. But you need to remember that you still have rights. You can start to explore your options by visiting the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. Here, you can enter information about your situation for a free review by a legal expert with a background in this type of litigation.