Boehringer Ingelheim settles Pradaxa litigation

Boehringer Ingelheim today announced that the company has reached a comprehensive settlement of state and federal cases in the US litigation regarding dabigatran etexilate.

The settlement was closed at $650 million. There are approximately 4,000 claims that the company seeks to resolve with this settlement, including claims that dabigatran (Pradaxa) caused serious adverse events such as major bleeding. The company expects that most or all of the plaintiffs will accept the settlement terms, according to a press release.

This announcement comes in the wake of a reaffirmation from the FDA of the positive benefit-risk profile of Pradaxa, according to the release. In early May, the agency issued a Drug Safety Communication that included results from a Medicare study of more than 134,000 older adults with AF who were new users of Pradaxa and warfarin. Compared with warfarin, Pradaxa was associated with lower risk for ischemic stroke, intracranial hemorrhage and death, similar risk for MI and higher risk for gastrointestinal bleeding, according to the FDA announcement.

The drug is currently approved for the prevention of stroke/systemic embolism in patients with nonvalvular AF and a risk factor for stroke; primary prevention of venous thromboembolic events in patients undergoing elective total hip- or knee-replacement surgeries; treatment of deep vein thrombosis and pulmonary embolism; and prevention of recurrent deep vein thrombosis and pulmonary embolism.