Pharmaceutical Litigation Re Pradaxa Net $650 Million Settlement

May 28, 2014. By Larry Husten via forbes.comBoehringer Ingelheim said today that it will pay $650 million in a “comprehensive settlement” of lawsuits over Pradaxa (dabigatran), the company’s novel anticoagulant. The company said that it expects the settlement will resolve about 4,000 current cases against the company in the US. Since its approval, Pradaxa has been bedeviled by reports of excessive bleeding complications. Although there have been numerous investigations, including lengthy investigations by the FDA, no definitive conclusion has been reached, though the FDA recently stated that it continues to believe that dabigatran has “a favorable benefit to risk profile.” The issue is difficult to resolve because some bleeding complications are inevitable with any anticoagulant, including warfarin, which for many years was the only available oral anticoagulant. Following the approval of Pradaxa by the FDA in 2010, two other anticoagulants have been approved, Johnson & Johnson’s Xarelto (rivaroxaban) and Pfizer and BristolMyers Squibb’s Eliquis (apixaban). Although these drugs can also cause bleeding complications, they have not so far engendered the same degree of criticism and concern. In its statement the company denied wrongdoing and said that it had settled the lawsuit to avoid lengthy litigation: “We continue to stand resolutely behind Pradaxa® and believed from the outset that the plaintiffs’ claims lacked any merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years,” said Andreas Neumann, Head of the Legal Department and General Counsel, Boehringer Ingelheim worldwide.. “The US litigation system is described by some as a business where lawyers run advertising campaigns to find clients. Furthermore we have to consider that juries composed of lay people have to decide about very difficult scientific matters. All this does not allow reliable predictions for the outcome of a huge number of individual trials and that is why we came to the tough decision to settle.”