A motion has been filed to consolidate a cases alleging serious bleeding side effects from the blood thinner Xarelto into a multidistrict litigation (MDL). An MDL coordinates proceedings in complex litigation where a large number of lawsuits allege similar injuries associated with a medication or product.
At least 21 actions pending in 10 judicial districts make similar allegations against the manufacturers of Xarelto (rivaroxaban). Xarelto is prescribed to prevent or treat blood clots and reduce the risk of stroke.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 include patients with atrial fibrillation (a type of irregular heartbeat) and the treatment of deep vein thrombosis and pulmonary embolism. Xarelto has significant risk of severe, even fatal, internal bleeding.
Lawsuits against Bayer AG and Johnson & Johnson allege the drug makers failed to adequately warn about the bleeding risk or the lack of an effective agent to stop serious bleeding.
The new blood thinners, including Xarelto, Pradaxa (dabigatran), and Eliquis (apixaban). are designed to replace warfarin, which has bee 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 for uncontrolled bleeding.
Xarelto sales reached approximately $2 billion in 2013, with a reported one million prescriptions in the U.S. and seven million worldwide, making Xarelto the leading new anticoagulant globally. The Institute of Safe Medication Practices (ISMP), a watchdog group, says a significant number of serious bleeding side effects have been associated with Xarelto. In 2012, the FDA received 750 Xarelto side effects reports, including 58 deaths.