The second bellwether trial of a Xarelto lawsuit has hit an important milestone, as Plaintiffs have concluded their case. Defendants have now motioned the Court for a judgment as a matter of law, asserting that Plaintiffs’ failed to prove that Xarelto was the cause of brain hemorrhage that ultimately resulted in the death of a Louisiana woman.
The Xarelto trial began May 31st in the U.S. District Court, Eastern District of Louisiana, where more than 16,000 similar cases have been centralized before a single judge for the purposes of coordinated pretrial proceedings. The litigation’s first bellwether trial concluded in March, with a verdict in favor of the drug’s makers.
Xarelto is a blood thinning medication approved by the U.S. Food & Drug Administration (FDA) in 2011. It is one of several novel anticoagulants positioned as superior alternatives to warfarin, a blood thinner that has been in use for decades. However, while internal bleeding related to warfarin can be stopped via the administration of vitamin K , there is no comparable agent to reverse a Xarelto-bleeding incident.
This trial is focused on the case of Sharyn Orr, who was prescribed Xarelto in February 2014. She was rushed to the hospital via ambulance in April 2015, after she suddenly became severely ill with a headache and nausea. Her condition continued to deteriorate until she was nonresponsive. A CT scan subsequently revealed that Mrs. Orr was suffering from an extensive, acute hemorrhage in her brain and a hemorrhagic stroke.
Mrs. Orr’s doctors had to wait until Xarelto cleared her system before they could perform procedure to drain the excess blood from her brain, due to the lack of a reversal agent. While the procedure was performed a day later, it came too late to save her life. During opening statements, the attorney representing Mrs. Orr’s family asserted that her chance of survival would have been about 60% had her doctors been able to operate immediately.
In their June 8th Motion for Judgment, Bayer and Johnson & Johnson’s Janssen Pharmaceuticals unit argued that the evidence presented by the Plaintiffs did not establish that Xarelto was the cause of Mrs. Orr’s injury. They further argued the lawsuit’s failure-to-warn claims were barred by the learned intermediary doctrine. This legal concept holds that a manufacturer’s duty to warn has been fulfilled so long as an “intermediary” medical professional has been adequately apprised of a drug’s risks.