Boehringer Ingelheim announced today that it has reached a comprehensive settlement of state and federal cases in the U.S. litigation regarding Pradaxa (dabigatran etexilate mesylate) in the amount of $650 million.
"Time and again, the benefits and safety of PRADAXA have been confirmed," said Desiree Ralls-Morrison, senior vice president and general counsel, Boehringer Ingelheim USA Corporation. "BI stands resolutely behind PRADAXA and believed from the outset that the plaintiffs' claims lacked merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows BI to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients' lives." BI is proud of its employees who have worked for years to research, develop and offer to patients such an important medication as PRADAXA.
PRADAXA was the first oral anticoagulant approved by FDA in more than 50 years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).
"This settlement does not change the facts about PRADAXA or its importance to patients. From the time PRADAXA launched, BI properly advised doctors and patients about its benefits and safety, working closely with FDA, European Medicines Agency (EMA) and other regulators to ensure doctors and patients had the information they needed," said Desiree Ralls-Morrison.
There are approximately 4,000 claims that the company seeks to resolve with this settlement. BI expects most, if not all, of the plaintiffs to accept the terms of the settlement and BI will vigorously defend against those who do not.