Boehringer Ingelheim has reached a settlement of state and federal cases in US litigation regarding its oral anticoagulant Pradaxa (dabigatran etexilate) for $650 million.There are approximately 4,000 claims that the company seeks to resolve with this settlement.

Boehringer Ingelheim said that it expects most, if not all, of the plaintiffs to accept the terms of the settlement and it “will vigorously defend against those who do not,” the company said in a statement. Pradaxa is an oral anticoagulant approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.”The settlement enables Boehringer Ingelheim to focus solely on its mission of improving patients’ lives and allows the company to avoid the distraction and uncertainty of lengthy litigation,” said the company in the statement. 

“Time and again the benefits and safety of Pradaxa have been confirmed in many clinical trials and in real world data analyses. This settlement does not change the facts about Pradaxa or its importance to patients,” said Andreas Neumann, head of the Legal Department and general counsel, Boehringer Ingelheim worldwide, in a statement. “From the time Pradaxa launched, Boehringer Ingelheim properly advised healthcare professionals and patients about its benefits and safety, working closely with US, European, and many other regulators to ensure healthcare professionals and patients had the information they needed.”

Boehringer Ingelheim pointed to an FDA Drug Safety Communication issued in May 2014 that included results from a Medicare study comparing new users of Pradaxa and warfarin who had received a diagnosis of atrial fibrillation. This included more than 134,000 Medicare patients, who were 65 years of age or older. The new study found that, among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin, but no increased risk of myocardial infarction compared to warfarin.

Source: Boehringer Ingelheim

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