05/28/2014 10AM Source Forbes.com
Boehringer 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: