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Boehringer Ingelheim has agreed to pay $650 million to settle Pradaxa lawsuits filed by about 4,000 people who allege the drug maker failed to adequately warn about the risk of severe and potentially life-threatening bleeding problems associated with the controversial anticoagulant.
The agreement was announced one day after the U.S. District Judge presiding over the litigation appointed a committee of lawyers to negotiate terms of a global Pradaxa settlement. Reports suggest that the deal will result in an average payment of about $165,000 per claim.
Most, if not all of the plaintiffs are expected to agree to the settlement, Boehringer Ingelheim said in a press release announcing the deal.
Pradaxa (dabigatran) was first approved by the FDA in October 2010 for the prevention of strokes among patients with atrial fibrillation. It was the first in a new class of blood thinners designed to compete with warfarin, also known by the brand name Coumadin, which had dominated that market for decades.
However, shortly after its release, Pradaxa racked up a large number of adverse event complaints by doctors and patients who saw incidents of Pradaxa bleeding that could not be stopped. Unlike warfarin, whose anticoagulant effects can be reversed using vitamin K, Pradaxa had no reversal agent. That meant that doctors did not have a go-to technique to stop Pradaxa bleeding events.
There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced by Boehringer Ingelheim.
About 4,000 product liability lawsuits over Pradaxa have been filed in both state and federal courts nationwide. In the federal court system, more than 2,350 of the Pradaxa cases have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.
All of the complaints involve similar allegations that Boehringer Ingelheim failed to provide adequate warnings for consumers and the medical community about the risk of serious Pradaxa bleeding events, as well as the lack of an effective reversal agent to allow doctors to control hemorrhaging that develops among users.
The settlement comes about six months before the first trials were set to begin and only a few weeks after the FDA announced that it has concluded a review of the medication, determining that additional warnings are not necessary. However, the drug regulatory agency indicated that Pradaxa was found to increase the risk of certain bleeding events when compared to its older competitor, warfarin. Even though the drug decreased the risk of stroke and brain bleeds, the FDA said evidence indicated Pradaxa increased the risk of gastrointestinal bleeding.
Gastrointestinal bleeding complaints form the core of Pradaxa injury claims.
Boehringer Ingelheim officials said that the settlement is not an admission of guilt or that Pradaxa is unsafe.
“We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” Andreas Neumann, head of the company’s legal department, said in the press release. “Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years.”