Pradaxa lawsuits allege patients suffered from a serious Pradaxa side effect and were not sufficiently warned about the risk of that effect. Specifically, lawsuits allege patients were put at risk of uncontrollable bleeding with no possibility of an antidote. Plaintiffs also allege Pradaxa was marketed as being a suitable replacement for an older drug, warfarin, even though warfarin has an antidote that can be used in cases of uncontrollable bleeding.
In May, Boehringer Ingelheim agreed to settle around 4,000 claims regarding Pradaxa for a total of approximately $650 million. The settlement covers claims in both state and federal courts. In agreeing to the settlement, Boehringer Ingelheim did not admit to any liability.
According to reports, Pradaxa lawsuits have also been filed in Canada. Those lawsuits are not covered by the U.S. settlement.
Articles published in BMJ (7/23/14) reportedly suggest Boehringer Ingelheim knew about the risks associated with Pradaxa but failed to disclose those risks to regulatory authorities.
Similar to Pradaxa, a lawsuit has reportedly been filed against the maker of Xarelto, a drug similar to Pradaxa. That lawsuit also alleges patients suffered irreversible bleeding events after using the anticoagulant. The lawsuit is McGowan v. Janssen Research and Development, et al, case number. 2:14-cv-00159-cr.
Xarelto is in the early stages of litigation, with fewer than 10 lawsuits reportedly filed so far.
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