Earlier this year, Boehringer Ingelheim, the manufacturer of Pradaxa (dabigatran), agreed to pay $650 million in a comprehensive settlement related to lawsuits issued by users of the drug. Reports of death, bleeding and stroke among individuals taking the blood-thinning medication have been ongoing since its introduction to the market in October, 2010.
Numerous studies have focused on the link between Pradaxa and serious side effects. In December 2011, U.S. regulators issued a safety announcement regarding the post-market reports of serious bleeding events among Pradaxa users. More than 260 fatal bleeding incidents have been confirmed by Boehringer Ingelheim.
The comprehensive settlement decision comes from the knowledge that the blood thinner manufacturer may have failed in its duty to adequately warn consumers about the frequency of bleeding events compared to traditional anticoagulants. Warfin, the long-standing blood-thinning medication has a reversal agent or antidote for dangerous side effects, while Pradaxa does not.
The settlement agreement comes less than a year after Boehringer Ingelheim filed for additional marketing approvals for Pradaxa, according to the NY Times. The additional marketing would present the drug as a treatment for deep vein thrombosis and pulmonary embolism.
Simmons Hanly Conly Pradaxa lawyers are no longer accepting clients in this area. However, the firm is pleased to have helped its clients harmed by Pradaxa receive the justice they deserve.