(Reuters) – A Pennsylvania state court judge on Tuesday overturned a $27.8 million jury award to an Indiana couple who accused Bayer AG (BAYGn.DE) and Johnson & Johnson (JNJ.N) of failing to warn of internal bleeding risks of their drug Xarelto, the companies said.
Judge Michael Erdos, in the Philadelphia County Court of Common Pleas, ruled following a hearing on the drugmakers’ motion to reverse the December verdict, which was their first trial loss in litigation over the blood thinner, the companies said.
J&J’s Janssen Pharmaceuticals Inc unit and Bayer, which jointly developed Xarelto, in separate statements welcomed the decision and said they will continue to defend against the allegations in related litigation.
“Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it,” Bayer said in a statement.
Michael Weinkowitz, a lawyer for the couple, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia.
The U.S. Food and Drug Administration approved Xarelto in 2011. It is prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.
Bayer and J&J contend Xarelto’s label adequately warns of bleeding risks.
Federal juries have cleared the companies of liability in three previous trials. The latest verdict in the federal litigation came in August in the case of a Mississippi woman.
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