The pharmaceutical companies behind the widely advertised blood thinner Xarelto reached a $775 million settlement in 25,000 lawsuits alleging patients were not adequately warned about the risks of life-threatening complications, plaintiff attorneys and the manufacturers said Monday.
Bayer Healthcare and Janssen Pharmaceuticals had won six of the cases that went to trial. Bayer said in an emailed statement that the settlement "allows the company to avoid the distraction and significant cost of continued litigation."
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Xarelto is the brand name for the drug rivaroxaban. Among its uses is treatment and prevention of blood clots in the leg or lung and prevention of strokes in people with irregular heartbeats. Heavily advertised on television, it was hawked in a widely seen 2015 ad featuring comedian Kevin Nealon, golfer Arnold Palmer and NASCAR driver Brian Vickers.
Lawsuits dating back to 2014 had been consolidated in federal court in New Orleans. They involved claims that users of the medication marketed by Bayer Healthcare and Janssen pharmaceuticals were not adequately informed of risks of life-threatening complications including internal bleeding, strokes and deaths.
"There is no admission of liability, and we remain steadfast that the claims raised in the litigation contradict years of scientific data and the U.S. Food and Drug Administration's repeated confirmation of Xarelto's safety and efficacy," Sarah Freeman, a spokeswoman for Janssen Pharmaceuticals said in an emailed statement.
Attorneys for the plaintiffs called the settlement a "fair and just resolution" in a statement outlining its details. It said a court-appointed special master and a claims administrator will be appointed to manage claims and process any appeals.
"It may have taken more than four years and six separate trials but litigation like this is an important way for consumers to have a voice in matters of drug safety," lead plaintiff attorney Brian Barr said in the release.
U.S. District Judge Eldon Faldon presided over the cases. He issued a series of orders Monday regarding implementation of the settlement. A detailed settlement document had not been filed as of Monday midday.
The plaintiffs' statement said that in addition to addressing lawsuits that are already part of the multidistrict litigation, the agreement resolves newly filed claims by those who had retained a lawyer to investigate Xarelto-related personal injury claims before March 11 if they register their claim by March 28 and file suit by April 4.
Neither side had an estimate on how much an individual might get. Payments will be "substantially reduced" for people who filed on or after Dec. 1, 2015, or for those who first suffered an injury they attribute to the drug on or after March 1, 2016, the statement from the plaintiffs' lawyers said.