An Ohio couple recently filed a lawsuit against Xarelto’s manufacturers, Bayer AG and Janssen Pharmaceutical (a subdivision of Johnson & Johnson), after the wife suffered a near fatal bleeding event.
The woman began taking Xarelto to help manage her risk of suffering a stroke from her atrial fibrillation. Atrial fibrillation is an irregular and often rapid heartbeat causing poor blood flow. After two months of taking the medication, the woman began to experience complications. Her intestinal blood vessels ruptured, causing uncontrollable bleeding. She also experienced anemia and other significant health complications.
What Is Xarelto?
Xarelto is a prescription medication used to prevent blood clots from forming by blocking specific clotting proteins in the patient’s blood. Also called Rivaroxaban, Xarelto is given to patients who have a higher risk of developing blood clots such as patients who have undergone surgery or patients who are suffering from deep vein thrombosis (DVT) or pulmonary embolism (PE).
Unlike its predecessor, Warfarin, Xarelto was approved without an antidote, so patients who suffer uncontrollable bleeding while taking the blood thinning medication have no consistent way to reverse the drug’s effect. Many patients who have suffered Xarelto bleeding events allege the manufacturers downplayed the risks in advertisements and labeling, which has prompted the filing of a significant number of defective drug lawsuits.
The consolidated multidistrict litigation has grown to more than 5,300 cases and isn’t showing any signs of slowing down. The first federal lawsuit will go to trial in early 2017 in the Eastern District of Louisiana.
While plaintiffs wait for their day in court, evidence in the case against the manufacturers is quickly mounting. Plaintiffs are questioning the validity of the Xarelto’s clinical trial data after it was learned the trials used a blood monitoring device that was recalled in 2014 for providing erroneous readings. In addition to compromised trial data, a recent study found that Xarelto readmission rates were slightly higher than an alternative anticoagulant, Lovenox.
Plaintiffs in the Xarelto mass tort litigation allege that the medication should never have been approved, but they will have to wait until 2017 to see if jury agrees.