Our partners are preparing for the nation’s first trials involving the blood-thinning medication Xarelto. The two trials, set for April 24, 2017, and May 30, 2017, in New Orleans, will be the first “bellwether” trials in the multidistrict litigation (MDL). The MDL is pending before U.S. District Court Judge Eldon Fallon of the United States District Court for the Eastern District of Louisiana. The two trials in New Orleans will be followed by a third bellwether trial in the Southern District of Mississippi and a fourth trial in the Northern District of Texas.
Approximately 16,000 lawsuits have been filed in the U.S. against German drug manufacturer Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals. Of that number, approximately 14,000 are pending in the MDL, while another 2,000 cases are pending in state courts in California, Delaware, Missouri, and Pennsylvania.
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. Xarelto has been linked to gastrointestinal bleeds, rectal bleeds, brain bleeds, strokes, and bleeding-related deaths.
Louisiana native Joseph Boudreaux, Jr. is the Plaintiff in the first Xarelto trial. In January 2014, Mr. Boudreaux was diagnosed with atrial fibrillation (A-fib), and he was prescribed Xarelto to thin his blood to reduce the risk of stroke associated with A-fib. After taking Xarelto for less than a month, Mr. Boudreaux experienced severe, life-threatening gastrointestinal bleeding. Upon discovery of his severe internal bleeding, Mr. Boudreaux’s doctors discontinued Xarelto and admitted him to the intensive care unit of a local hospital. Mr. Boudreaux was hospitalized for six days, during which he received several blood transfusions, an Esophagogastroduodenoscopy (EGD), and a colonoscopy. Moreover, because of the gastrointestinal bleeding, he experienced while on Xarelto, Mr. Boudreaux subsequently underwent two invasive heart procedures to treat his recurrent A-fib condition.
The second Xarelto bellwether trial involves Joseph Orr, Jr., another Louisiana resident, who filed suit on behalf of his deceased wife, Sharyn Orr. Tragically, Mrs. 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 A-fib. On April 24, 2015, she 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.
A CT scan of her head revealed Mrs. Orr was suffering from an extensive, acute hemorrhage in her brain and a hemorrhagic stroke. Because of the Xarelto in her system and the lack of a reversal agent for Xarelto, Mrs. Orr was not a surgical candidate upon her arrival at the hospital. The next day, after Xarelto had the chance to clear 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.
In the upcoming trials, the Plaintiffs’ claims center on Bayer and Janssen developing and marketing Xarelto as a blood thinner that does not require coagulation monitoring, as well as the Defendants’ conduct surrounding Xarelto’s clinical trials. The Plaintiffs assert that 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. Further, Defendants failed to warn and adequately instruct doctors about the ability to measure Xarelto’s anticoagulant effect on patients’ blood through currently available tests.
The ability to measure Xarelto’s effect on a patient’s blood can identify patients at high risk of bleeding and allow for the risk of bleeding to be avoided by taking the patient off Xarelto. Further, in an emergent bleeding patient, the ability to measure Xarelto’s effect on the patient’s blood can identify whether that patient has been anti-coagulated with Xarelto and accelerate the time when it is known to be safe to initiate life-saving surgery. Of course, the ability to measure Xarelto’s effect on a patient’s blood is particularly important given the lack of an available antidote for Xarelto.
Our partners in the Mass Torts Section will continue to review and file cases involving serious injuries or death related to Xarelto's use. For more information, Jon C. Boesen at (303) 327-9988.