A Philadelphia state court ordered Bayer AG and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drugmakers' failure to warn of internal bleeding risks associated with their blood thinner rivaroxaban (Xarelto). The verdict marks the first trial loss in litigation over rivaroxaban. Bayer AG and Johnson & Johnson won three previous cases in federal court.
Both companies issued a statement saying they plan to appeal the verdict, adding that it contradicted years of scientific data and repeated confirmations of rivaroxaban's safety by the U.S. Food and Drug Administration (FDA).
"Xarelto is the worst in class of the new blood thinners," Michael Weinkowitz, the couple's lawyer, said in a statement. "The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks."
The trial was the first of approximately 1,400 rivaroxaban cases pending in the Philadelphia court. More than 18,500 cases are pending in federal court.
The FDA approved rivaroxaban in 2011 to treat patients with atrial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolism.
Source: Reuters, December 5, 2017.
