On Monday, Bayer and Johnson & Johnson said that they had agreed to settle about 25,000 lawsuits by paying $775 million over the blood thinner Xarelto (rivaroxaban), which they sell together.
This settles about 25,000 lawsuits that claimed the pharma companies did not warn about life-threatening bleeding episodes caused by the blood thinner.
The settlement will be split equally between the two pharma giants, which will resolve state and federal cases in which patients sued both the companies for not warning about potentially life-threatening bleeding episodes when patients use the drug.
According to a statement by Janssen Pharmaceutica, the division of Johnson & Johnson, “The companies are settling because such complex litigation ‘demands an enormous amount of time and resources.’” It also added, “What’s the bottom line? We stand behind Xarelto and are eager and excited to move forward.”
Bayer stated, “We remain committed to the more than 45 million patients who have been prescribed Xarelto worldwide.”
Andy Birchfield of Beasley Allen, a law firm, said, “This is a fair and just resolution for thousands of consumers who have substantial claims.”
Xarelto contains rivaroxaban, a new drug that belongs to the group of anticoagulants (blood thinners), which is intended to replace Coumadin (warfarin), which is a widely prescribed blood thinner that requires frequent lab tests and a strict diet. On the other hand, Xarelto does not require lab tests. The drug thins the blood to prevent clots, which can lead to strokes and heart attacks.
Attorneys for the patients had argued that Bayer and Johnson & Johnson failed to warn patients that Xarelto could trigger massive bleeding in some people, resulting in serious injury and even death. The bleeding episodes did not always respond to conventional treatments. There was no specific antidote to bleeding episodes that could be caused by Xarelto and other new drugs for years.
In 2018, the U.S. FDA approved an antidote called Andexxa (andexanet alfa), which can help stop bleeding caused by Xarelto and Eliquis (apixaban), a drug sold by Bristol-Myers Squibb and Pfizer. Nevertheless, Johnson & Johnson and Bayer stood by their drug Xarelto, mentioning that large-scale clinical studies have shown it was safe and effective.
