Plaintiffs who allege they were injured by the blood thinner Xarelto have filed a motion to have their cases consolidated as part of a multidistrict litigation (MDL).
At least 21 actions pending in 10 judicial districts make similar allegations against the manufacturers of Xarelto (rivaroxaban), a medicine prescribed to prevent or treat blood clots and reduce the risk of stroke. An MDL coordinates proceedings in complex litigation where a large number of lawsuits allege similar injuries associated with a medication or product. The motion requests the U.S. Joint Panel of Multidistrict Litigation (JPML) to assign the MDL to the Southern Illinois District, which handled the recent MDL involving another new anticoagulant, Pradaxa.Xarelto was approved by the Food and Drug Administration (FDA) in 2011 to reduce deep vein thrombosis and pulmonary embolism after knee or hip replacement surgery. Its approved uses have since expanded to include patients with atrial fibrillation – a type of irregular heartbeat – and to treat deep vein thrombosis and pulmonary embolism. Xarelto has a significant risk of severe, even fatal, internal bleeding and numerous lawsuits over Xarelto bleeding have been filed against the drug makers Bayer AG and Johnson & Johnson. The lawsuits allege the drug makers failed to adequately warn about the bleeding risk or the lack of an effective reversal agent.
Xarelto is one of a new class blood thinners that also includes Pradaxa (dabigatran) and Eliquis (apixaban). The new blood thinners are designed to replace warfarin, a drug in use for more than 60 years. People taking warfarin must follow certain dietary restrictions and must have regular blood testing, but there are antidotes if serious bleeding occurs. The new anticoagulants have been marketed as being superior to warfarin because they do not have dietary and testing restrictions, but there is no known antidote available for serious bleeding occurs.
According to the Institute of Safe Medication Practices (ISMP), 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.