Boehringer Ingelheim Settles Dabigatran (Pradaxa) Lawsuits for $650 Million

May 28, 2014

RIDGEFIELD, CT — A settlement has been reached between Boehringer Ingelheim and approximately 4000 individuals involved in state and federal lawsuits who claimed dabigatran etexilate (Pradaxa) caused serious adverse events, the vast majority of which were bleeding-related events, including fatal bleeding.[1].

The settlement amount is $650 million, and the company expects that most of the plaintiffs will accept its terms.

In a statement issued by the company, Desiree Ralls-Morrison, a senior vice president and general counsel, says the company "believed from the outset that the plaintiffs' claims lacked merit," but the settlement allows the company to avoid lengthy litigation, which would be a distraction. "This settlement does not change the facts about [dabigatran] or its importance to patients," states Ralls-Morrison.

As part of an ongoing safety review, the US Food and Drug Administration (FDA) announced earlier this month that it observed no signal of increased MI risk with dabigatran compared with warfarin in more than 134 000 Medicare patients. As previously reported by heartwire , the risk of MI was slightly increased in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) patients randomized to receive the newer drug compared with those on warfarin. The difference in MI risk reached statistical significance only at the 150-mg dose.

In addition, the FDA review of Medicare patients showed there was a reduced risk of ischemic stroke, intracranial bleeding, and death with dabigatran compared with warfarin, although the risk of major gastrointestinal bleeding was higher with the newer oral anticoagulant. The agency recently stated it believes dabigatran has a "favorable benefit-to-risk profile."

Dabigatran was approved in 2010 for the prevention of stroke in patients with atrial fibrillation on the basis of the RE-LY trial. It was recently approved for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

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