Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood thinner Pradaxa, which has been linked to more than 500 patient deaths.
Boehringer, slated to face the first U.S. 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 in a statement today. That would provide an average per-case payout of $162,500.
The settlement comes about week after the drugmaker, based in Ingelheim, Germany, 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, including Bristol-Myers Squibb Co.’s Coumadin. 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, who teaches product-liability law at the University of Richmond in Virginia, said in an interview today.
Patients and their families alleged Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought it to the U.S. market in October 2010. Researchers last year came up with an experimental antidote for the drug, which has generated more than $1 billion in sales worldwide for Boehringer, the world’s biggest family-owned drugmaker.
More than 2,500 Pradaxa suits have been consolidated before U.S. 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. Boehringer officials are seeking to resolve all those cases as part of today’s accord.
“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 Corp., said in the statement.
The U.S. Food and Drug Administration approved Pradaxa as a safe and effective alternative to 58-year-old Coumadin, a brand of warfarin, for preventing strokes caused by blood clots.
Concerns about Pradaxa’s safety surfaced soon after U.S. 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.
Boehringer officials continue to contend that Pradaxa is safe and point to an FDA finding this month that the drug had a lower risk of blood-clot-related strokes, bleeding in the brain and death compared to warfarin.
Documents made public as part of patients’ Pradaxa suits showed Boehringer officials didn’t disclose to U.S. regulators a data analysis that indicated the blood-thinning drug may have caused more fatal bleeding after it was cleared for sale than in a study used to win approval.
Herndon ordered Boehringer to pay a $931,000 fine in December for failing to preserve “countless” files on Pradaxa’s development and marketing. Patients’ lawyers say Boehringer should have placed an effective “litigation hold” on the documents, forcing employees to preserve them.
The judge’s sanction may have been a factor in prompting Boehringer officials to settle, Tobias said.
“They probably saw that similar document-destruction claims against Takeda and Lilly involving files about the Actos diabetes drug recently led to a $9 billion punitive award,” Tobias said.
The case is In re Pradaxa Products Liability Litigation, 12-MD-02385, U.S. District Court, Southern District of Illinois (East St. Louis).
(An earlier version of this story corrected the amount of the Boehringer fine.)