Boehringer Ingelheim said Wednesday that it agreed to pay $650 million as part of a "comprehensive settlement" to resolve approximately 4000 state and federal cases in the US claiming that its oral direct thrombin inhibitor Pradaxa (dabigatran) caused severe and fatal bleeding in patients. The company noted that it "expects most, if not all, of the plaintiffs to accept the terms of the settlement," and that it will "vigorously defend against those who do not."
In the lawsuits, plaintiffs argued that Boehringer Ingelheim had failed to provide sufficient warnings about the risks associated with Pradaxa, adding that the company marketed the therapy as being superior to existing anticoagulants while knowing its performance was not better. "We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs' claims lacked any merit," said the drugmaker's general counsel Andreas Neumann, adding that "the benefits and safety of Pradaxa have been confirmed in many clinical trials and in real world data analyses." Boehringer Ingelheim, which did not specify whether the company admitted to any wrongdoing in the matter, said it agreed to the settlement in order "to avoid the distraction and uncertainty of lengthy litigation."
The settlement comes about a week after an analysis by Boehringer Ingelheim acknowledged there might be "previously uncategorised major bleeding events" that were not included in the original report of the company's RE-LY study on Pradaxa. Meanwhile, a recent analysis by the FDA concluded that the therapy was associated with reduced risks of stroke and death versus warfarin, although the drug was linked to an increased risk of gastrointestinal bleeding.
Pradaxa, which the FDA initially approved in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, generated approximately 1.2 billion euros ($1.6 billion) in revenue last year. The drug's indication was expanded in April when the US agency cleared it to treat and reduce the risk of deep venous thrombosis and pulmonary embolism in certain patients.
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