Pharma firm agrees $650m deal to settle lawsuits
Boehringer Ingelheim, slated to face the first US trial in September of claims there was no antidote to stop bleed-out deaths among Pradaxa patients, is seeking to resolve about 4,000 suits, company officials said yesterday. That would provide an average per-case payout of $162,500.
The settlement comes about a week after the firm said a new analysis of a company-funded study used to win approval of the Pradaxa found 22 serious bleeding events that weren’t included in the original report.
Researchers contend Pradaxa is more effective at preventing strokes than older competitors. Consumer lawyers counter Boehringer marketed the drug as superior to existing blood thinners while knowing its performance wasn’t better.
“Boehringer may have been reluctant to take any of these cases to trial because the causation evidence that Pradaxa can cause bleed-outs was pretty clear,” Carl Tobias, of the University of Richmond in Virginia, said.
Patients and their families alleged Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought it to the US market in October 2010.
Researchers last year came up with an experimental antidote for the drug, which has generated more than $1bn in sales worldwide for Boehringer.
Over 2,500 Pradaxa suits have been consolidated before US District Judge David Herndon in East St Louis, Illinois, for pre-trial information exchanges. An additional 1,500 cases are in state courts in Illinois, Connecticut, California and Delaware.
“This settlement allows BI to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives,” Desiree Ralls-Morrison, general counsel for Boehringer Ingelheim USA, said.
Concerns about Pradaxa’s safety surfaced soon after US doctors began prescribing it.
FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011.
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