Despite a setback last month in the first Xarelto bellwether trial, the future of the Xarelto multidistrict litigation (MDL) looks very bright. Currently, there are approximately 14,000 individual Xarelto cases consolidated before U.S. District Judge Eldon Fallon in the United States District Court for the Eastern District of Louisiana (the MDL court). As we have stated, Xarelto is an anticoagulant (blood thinner) initially approved in 2011 to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) following knee and hip replacement surgery. It was later approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation (A-fib) and for treatment of DVT and PE. Xarelto carries a significant risk of severe, uncontrolled internal bleeding and it has been linked to gastrointestinal bleeds, rectal bleeds, brain hemorrhages, and bleeding-related deaths.
Judge Fallon is presiding over four initial bellwether trials – the first of which began on April 24 and ended May 3 with a Defense verdict. The Plaintiff in that case, Joseph Boudreaux, started taking Xarelto in January 2014 to control his atrial fibrillation (irregular heartbeat) and that within a matter of weeks he was hospitalized for dangerous gastrointestinal bleeding that required multiple blood transfusions. Mr. Boudreaux contended that Janssen Pharmaceuticals, Johnson & Johnson and Bayer (the Defendants) defectively designed Xarelto by failing to develop a coagulation-monitoring test specifically calibrated to Xarelto that would allow doctors to assess the coagulation status of patients. He also said that the Defendants failed to warn and adequately instruct doctors about the ability to measure Xarelto’s anticoagulant effect on patient’s blood with currently available lab tests.
Ultimately, the jury decided that Mr. Boudreaux’s prescribing doctor received adequate instructions for the safe use of Xarelto. This is due in no small part because of the doctor’s testimony that he would have prescribed the drug for Mr. Boudreaux regardless of the warnings he was (or wasn’t) given. While this result was certainly disappointing for our client, it is hardly an indicator of future trial results, given the unique testimony of Mr. Boudreaux’s prescribing doctor.
Andy Birchfield, our Mass Tort Section Head and the Xarelto MDL Co-Lead Plaintiffs’ Counsel, is hard at work trying the second bellwether case in Judge Fallon’s court. This second trial, which started on May 30, involves Joseph Orr, Jr., a Louisiana resident who filed suit on behalf of his deceased wife, Sharyn Orr. Tragically, Sharyn Orr suffered a fatal brain bleed while taking Xarelto. She was just 67 years old at the time of her death.
Mrs. Orr started taking Xarelto in February 2014 for treatment of chronic atrial fibrilation. On April 24, 2015, Mrs. Orr suddenly became severely ill. She was transported to the hospital by ambulance, where her condition continued to deteriorate to the point that she became nonresponsive. CT-scans of her head revealed she was suffering from an extensive, acute hemorrhage in her brain.
Because of the unknown level of Xarelto in Mrs. Orr’s system and the lack of a reversal agent for the drug, her doctors were unable to “green light” surgery upon her arrival at the hospital. The next day, after any remaining Xarelto had cleared her system, her doctors performed a procedure to drain the excess blood from her brain. Unfortunately, the procedure came too late and Mrs. Orr’s neurologic condition continued to worsen until she passed away on May 4, 2015, with her family by her side. Hopefully, Mrs. Orr’s family will prevail in this case. Based on the facts and the science, I believe that will happen with justice being served.
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