Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas ordered the creation of a mass tort, transferring roughly 75 cases involving the blood thinner Xarelto to the court’s Complex Litigation Center.
The lawsuits are filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer HealthCare Pharmaceuticals. The lawsuits allege that Xarelto (rivaroxaban) causes uncontrollable and sometimes fatal bleeding, the Legal Intelligencer reports. An attorney representing 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. Approved uses have expanded to 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 dietary restrictions and must have regular blood testing to ensure the proper dose, but there are antidotes available if serious bleeding occurs. The new anticoagulants have been marketed as being superior to warfarin because they do not have dietary and testing requirements, but there is no known antidote if serious bleeding occurs.
Since its introduction, Xarelto has garnered $2 billion in sales nationwide with roughly 1 million prescriptions written by 2013. Court documents indicate that by the end of 2012, there had been 2,080 Xarelto-related injuries, including 151 deaths. The legal petition emphasized Xarelto has no reversal agent to counteract its effects, the Legal Intelligencer reports. 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 involved in the petition said, “The creation of a 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. The defendants (Bayer and Janssen) have strong ties to Pennsylvania making this an appropriate and convenient forum,” according to the Legal Intelligencer.