After three wins in cases over the risks of blockbuster blood thinner Xarelto, Bayer and Johnson & Johnson have encountered their first defeat. A jury in Philadelphia ordered the drugmakers to pay $28 million to plaintiff Lynn Hartman, but the companies plan to appeal.
In a statement to FiercePharma, Michael Weinkowitz, an attorney for the plaintiff, said his team is "grateful" for the jury's decision. Hartman argued that her Xarelto use—prescribed to prevent strokes associated with atrial fibrillation—caused severe gastrointestinal bleeding, according to Reuters.
"Xarelto is the worst in class of the new blood thinners," Weinkowitz said via email. "The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks."
But J&J and Bayer contend that Xarelto's label does disclose its risks. Sarah Freeman, a Janssen spokesperson, said the "verdict contradicts years of scientific data and the U.S. Food and Drug Administration’s repeated confirmation of XARELTO’s safety and efficacy."
Freeman said Xarelto's label "has always warned of bleeding events—a known risk associated with anticoagulation—and appropriately informs physicians of the information that they need to make treatment decisions with their patients."
A representative for Bayer added that his company "believes there is no basis in fact or law for the verdict, including the punitive award, and plans to appeal." He noted that Xarelto's "safety and efficacy is supported by both real-world experience with 31 million patients and expert health regulators in 130 countries, and its FDA-approved label provides accurate and science-based information on the medicine’s benefits and risks."
The case was the first to go to trial in state courts over Xarelto bleeding risks, according to Freeman. It follows several significant victories in federal court for the pharma partners as J&J and Bayer previously prevailed in three bellwether suits in Mississippi and New Orleans.
The company faces thousands more liability cases, 21,400 in fact, according to J&J's most recent quarterly filing. About 1,400 are pending in Philadelphia, Reuters reports.
First approved by the FDA in 2011, Xarelto was Bayer’s top-selling drug last year at $3.24 billion and ranked third for J&J at $2.5 billion in sales.