About 75 cases involving the blood-thinning drug Xarelto have been organized into a mass tort by Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas. The cases were transferred to the court’s Complex Litigation Center.
The lawsuits filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer HealthCare Pharmaceuticals allege that Xarelto (rivaroxaban) can cause uncontrollable and sometimes fatal bleeding, the Legal Intelligencer reports. An attorney who represents several plaintiffs said Xarelto can cause “bleeding that cannot be stopped because there’s no antidote. The person can bleed to death or sustain serious injuries which could have been controlled in another product.”
Xarelto received Food and Drug Administration (FDA) approval in 2011 to reduce deep vein thrombosis and pulmonary embolism after knee or hip replacement surgery. The approved uses were expanded to include treatment of atrial fibrillation—a type of irregular heartbeat—and the treatment of deep vein thrombosis and pulmonary embolism. Xarelto is one of a new generation of blood thinners developed to replace warfarin, which has been prescribed for more than 60 years. Patients taking warfarin must follow a number of dietary restrictions and they must have regular blood testing to ensure the proper dose, but there are antidotes available if serious internal bleeding occurs. The new anticoagulants have been marketed as superior to warfarin because they do not have dietary restrictions and testing requirements, but there is no known antidote for serious bleeding.
Xarelto quickly captured a significant share of the market, with $2 billion in sales nationwide and roughly 1 million prescriptions written by 2013. But court documents indicate that by the end of 2012, there had been 2,080 Xarelto-related injuries reported, including 151 deaths, according to the Legal Intelligencer. Because there is no antidote for bleeding, the petition said, “Xarelto treatment leaves trauma professionals without an effective means to treat and stabilize patients who experience uncontrolled or excessive bleeding while taking Xarelto.”
Another attorney noted that the mass tort program “benefits the court system and the parties by eliminating duplicative discovery, inconsistent rulings and promoting the efficient prosecution and resolutions of similar cases,” according to the Legal Intelligencer.