Johnson & Johnson and Bayer said Monday that they had agreed to pay $775 million to settle about 25,000 lawsuits involving the blood thinner Xarelto, which they jointly sell.
The settlement, which will be split evenly between the two companies, resolves state and federal cases in which patients sued the companies for failing to warn about potentially fatal bleeding episodes when patients took the drug.
Neither company admitted liability, and each noted that the companies had prevailed in the six lawsuits that went to trial. In a statement, Janssen, the pharmaceutical division of Johnson & Johnson, said it was settling because such complex litigation "demands an enormous amount of time and resources." It added: "What's the bottom line? We stand behind Xarelto and are eager and excited to move forward."
In a separate statement, Bayer said, "We remain committed to the more than 45 million patients who have been prescribed Xarelto worldwide."
"This is a fair and just resolution for thousands of consumers who have substantial claims," Andy Birchfield of Beasley Allen, the co-lead counsel of the plaintiff's steering committee for the federal litigation, said in a statement.
"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.
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.
It is one of a new group of blood thinners intended to replace warfarin, a widely used and decades-old drug that required frequent blood tests and a strict diet. Xarelto, along with similar drugs like Eliquis and Pradaxa, did not require such tests.
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.
Lawyers for the patients had argued that the companies failed to warn patients that Xarelto, which thins the blood to prevent clots that lead to strokes, could trigger significant bleeding in some people, leading to deaths and serious injury. The bleeding episodes didn't always respond to standard treatments and, for years, there was no specific antidote to bleeding caused by Xarelto and the other new drugs.
Last year, the Food and Drug Administration approved such an antidote, Andexxa, that can help stop the bleeding in patients who take Xarelto and Eliquis, which is sold by Pfizer and Bristol-Myers Squibb.
But Bayer and Johnson & Johnson stood by Xarelto, citing large-scale clinical trials that showed the drug was safe and effective.
Lawyers for the plaintiffs in the Xarelto lawsuits had previously raised questions about whether the clinical trial that led to the drug's approval was flawed because a blood-testing monitor that was used in the study was later found to be faulty, possibly skewing the results. The FDA later concluded that the problems with the monitor did not affect the trial's outcome.
Neither side had an estimate on how much money 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.
Xarelto was among Johnson & Johnson's top-selling products in 2018, bringing in nearly $2.5 billion in revenue, although its sales fell slightly last year compared with 2017, according to its annual filings.
In 2014, the German drugmaker Boehringer Ingelheim agreed to pay $650 million to settle about 4,000 lawsuits over a similar drug, Pradaxa, which was also blamed in bleeding deaths and injuries.
Information for this article was contributed by Katie Thomas of The New York Times and by Kevin McGill of The Associated Press.
Business on 03/26/2019