Xarelto Manufacturers Settle Lawsuits Over Bleeding Risks

Johnson & Johnson and Bayer, the manufacturers of rivaroxaban (sold as Xarelto), have agreed to pay $775 million to settle thousands of lawsuits over failure to warn consumers about the risk of potentially fatal internal bleeding. The settlement will be split evenly between the two companies, which jointly sell Xarelto.

Plaintiffs were suing the drug manufacturers for failing to warn patients about the bleeding risks associated with this newer class of direct oral anticoagulants. Until May 2018, when the U.S. Food and Drug Administration approved andexanet alfa, there was no specific reversal agent available for managing bleeding associated with these agents.

“This is a fair and just resolution for thousands of consumers who have substantial claims,” said Andy Birchfield of Beasley Allen, the co-lead counsel of the plaintiff’s steering committee for the federal legislation.

In 2017, the companies faced a similar lawsuit, and agreed to pay $28 million to an Indiana couple; that verdict marked the first trial loss in litigation over rivaroxaban, after the drugmakers won three previous cases in federal court.

Neither company admitted liability in the cases, citing large-scale clinical trials data demonstrating rivaroxaban’s safety and efficacy. Instead, Johnson & Johnson said that it chose to settle because such complex litigation “demands an enormous amount of time and resources. … What’s the bottom line? We stand behind Xarelto and are eager and excited to move forward.”

Representatives from Bayer added: “We remain committed to the more than 45 million patients who have been prescribed Xarelto worldwide.”

Source: The New York Times, March 25, 2019.