A Philadelphia jury awarded an Indiana woman $29 million after finding that Johnson & Johnson’s Janssen Pharmaceuticals and Bayer did not adequately warn about bleeding risks with their blood thinner Xarelto.
The case was brought by Lynn Hartman, who was prescribed Xarelto to treat a common heart rhythm abnormality called atrial fibrillation. In June 2014, she was hospitalized for suspected gastrointestinal bleeding. During her four-day hospital stay, she underwent multiple blood transfusions and was taken off Xarelto.
Hartman’s attorneys presented studies showing the rate of major bleeding in U.S. patients taking Xarelto is 8.1 per year. The rate of major bleeding among all patients worldwide is 3.6 percent annually. Yet, Janssen and Bayer did not make this distinction among the subgroup of U.S. Xarelto users on the drug’s safety label until September 2016.
Hartman’s attorneys also accused the companies of failing to warn that the risk of bleeding increases when Xarelto is combined with aspirin, and for not informing doctors that levels of the drug can be significantly higher in some patients, putting them at greater risk of major bleeding.
Attorneys also argued that bleeding risks with Xarelto were significantly higher than other drugs in the same class, like Eliquis or Pradaxa.
Jurors ultimately sided with Hartman, handing down the $29 million verdict.
Hartman’s case is the first to go to trial of more than 1,500 Xarelto lawsuits pending in a mass tort program in the Philadelphia Country Court of Common Pleas. Another 18,000 Xarelto lawsuits are pending in a multidistrict litigation in the Eastern District of Louisiana.