The nation’s second bellwether trial involving the blood-thinner Xarelto got underway on Friday, with the plaintiffs’ attorney arguing that a Louisiana woman’s death would have been “completely avoidable,” had Bayer and Johnson & Johnson not concealed important safety information from doctors and patients.
“Hypertension and diabetes, they did not slow Mrs. Orr down. What slowed her down, what took her life was Xarelto, a pill that she was taking to reduce her risk of stroke,” the lawyer asserted during his opening statement in the U.S. District Court, Eastern District of Louisiana. “Sharyn should have never been put on the drug Xarelto.”
“Defendants learned that for every million people who take Xarelto for one year, 36,000 of those people will have a major bleeding event. 5,000 of those bleeding events will be brain bleeds like Ms. Orr had, and 2,000 of those events will be fatal,” he continued.
More than 16,000 Xarelto lawsuits have been filed in the federal multidistrict litigation now underway in the Eastern District of Louisiana. According to her family’s lawsuit, Mrs. Orr was prescribed Xarelto in February 2014. She suddenly became severely ill with a headache and nausea on April 24, 2015, and was rushed to the hospital by ambulance. Her condition continued to deteriorate to the point that she became nonresponsive. A CT scan subsequently revealed that Mrs. Orr was suffering from an extensive, acute hemorrhage in her brain and a hemorrhagic stroke.
Because there is no approved antidote for reversing Xarelto’s anticoagulant effects, Mrs. Orr’s doctors had to wait until the drug cleared her system before they could perform procedure to drain the excess blood from her brain.
“Her chance of survival would have been about 60 percent had Dr. Bui been able to immediately operate. You will hear that Ms. Orr could have been saved had these companies told her doctors the truth,” The Orrs’ attorney told jurors assembled to hear the case.
The U.S. Food & Drug Administration (FDA) initially approved Xarelto in October 2011, and it has since become a big-seller for both Bayer and Johnson & Johnson. Mrs. Orr’s family and other Xarelto plaintiffs claim that the companies wrongly marketed the drug as a superior alternative to warfarin, a blood thinner that has been in use for decades. Among other things, they point out that internal bleeding associated with warfarin can be stopped via the administration of vitamin K. They also argue that Xarelto patients would benefit from a routine blood testing program to ensure proper testing. Warfarin patients are subjected to blood monitoring, but marketing materials for Xarelto claim that regular testing is unnecessary.
The federal Xarelto litigation has scheduled a total of four bellwether trials. The first concluded last month, with a win for the defense. Two other trials will be convened this summer in Texas and Mississippi federal courts.