Jury selection is slated to begin today in the second bellwether trial involving Xarelto and its alleged association with serious internal bleeding. The case selected for trial was filed on behalf of a woman who suffered a fatal hemorrhagic stroke while she was taking Xarelto to treat atrial fibrillation.
More than 16,000 Xarelto lawsuits have been filed in the federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. According to her husband’s complaint, Sharyn Orr was prescribed Xarelto in February 2014 for treatment of chronic atrial fibrillation. She suddenly became severely ill on April 24, 2015, and was transported 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. While the procedure was performed the following day, it came too late. Mrs. Orr’s neurologic condition continued to worsen until she passed away on May 4, 2015.
Like other plaintiffs who have filed Xarelto lawsuits, Mr. Orr accuses the drug’s manufacturers of failing to provide doctors and patients with adequate warnings regarding its potential risks, especially the lack of an approved agent to reverse internal bleeding that sometimes occurs with its use.
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.
The U.S. Food & Drug Administration (FDA) initially approved Xarelto in October 2011. The blood-thinner now has the distinction of being Bayer’s top-selling product, generating $3.24 billion in sales last year. It ranked number three for Johnson & Johnson, which recorded $2.29 billion in Xarelto sales in 2016. Its approved indications now include:
Xarelto lawsuit plaintiffs claim that Bayer and Johnson & Johnson marketed the medication as a superior alternative to warfarin, a blood thinner that has been on the market 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 regular blood testing program to ensure proper testing. Warfarin patients are subjected to blood monitoring, but marketing materials for Xarelto promised that such a regimen was unnecessary.