In a statement released by the company, senior vice president and general counsel of Boehringer Ingelheim USA Corporation, Desiree Ralls-Morrison, said that despite the settlement, "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," she continued.
Pradaxa was created to substitute warfarin to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The settlement is expected to take care of most or all of the 4,000 claims against the company.
In May 2014 the Food and Drug Administration issued a Drug Safety Communication with the results of a Medicare study that compared Pradaxa and warfarin. The results confirmed that Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin, but that it came with an increased risk of gastrointestinal bleeding.
Ralls-Morrison said the settlement didn't change Pradaxa's effectiveness or its importance to patients and added that 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."
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