Johnson & Johnson and Bayer AG have agreed to settle more than 25,000 U.S. lawsuits over their blockbuster blood thinner Xarelto for a total of $775 million, court documents on Monday showed.
The amount will be shared equally between the two companies that jointly developed the drug. Bayer and J&J do not admit liability under the agreement.
The settlement will resolve all pending U.S. lawsuits over Xarelto, which plaintiffs claimed causes uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of plaintiffs.
Plaintiffs accused the drugmakers of having failed to warn about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information.
Bayer in a statement on Monday said it continues to believe the claims are without merit.
“However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation,” the company said.
J&J in a statement said it continued to believe in the safety of Xarelto, but that the settlement was the right thing to do for patients and their doctors.
Xarelto is Bayer’s best-selling drug. It contributed 3.6 billion euros ($4.07 billion) in revenue to the German group’s pharmaceutical business last year.
Bayer on Monday said its share of the settlement amount will be partially offset by product liability insurance.
Bayer jointly developed Xarelto with J&J’s Janssen Pharmaceuticals unit, which sells the blood clot preventer under a licensing agreement in the United States.
J&J reported 2018 Xarelto sales of $2.47 billion.