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 legislation, said in a statement.
Xarelto 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.
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 massive 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 F.D.A. later concluded that the problems with the monitor did not affect the trial’s outcome.
In 2014 the German drug maker 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.
Xarelto, which is also known as rivaroxaban, was among Johnson & Johnson’s top-selling products in 2018, bringing in nearly $2.5 billion in revenues, although its sales fell slightly last year compared with 2017, according to its annual filings.