A lawsuit filed last week in state court in Philadelphia, Pennsylvania alleges that Xarelto’s recommended dosage doesn’t work for as long as is represented by the manufacturer, Janssen Pharmaceuticals and Bayer HealthCare. It is believed to be the first in the nation to allege that Xarelto does not prevent, and in some cases may actually contribute to, ischemic strokes in patients suffering from atrial fibrillation.
The lawsuit was filed on behalf of a Florida man who suffered an ischemic stroke while taking Xarelto, an anticoagulant prescribed to specifically prevent stroke. The case alleges that the indicated 20mg dose of Xarelto is insufficient to protect against stroke/systemic embolism for those who take the medication once a day. Xarelto is currently the only new anticoagulant that is recommended by the manufacturer for once-per-day dosing for those with atrial fibrillation. All other comparable anticoagulants are given on a twice-per-day basis.
Late in 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) announced that all nationwide Xarelto lawsuits filed in federal courts would be consolidated in the Eastern District of Louisiana before U.S. District Judge Eldon E. Fallon. Experts estimate that eventually several thousand cases will be transferred into the MDL.
According to court documents, all of the pending Xarelto lawsuits allege that the manufacturers of the drug:
- Failed to provide adequate warnings regarding the risk of uncontrollable internal bleeding associated with Xarelto, particularly the lack of an approved antidote to counteract bleeding incidents.
- Falsely marketed Xarelto as a superior alternative to warfarin, a blood thinner that has been on the market for decades, pointing out that warfarin bleeding can be reversed with the administration of vitamin K.
Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011, and is currently being prescribed to prevent strokes in people with atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and prevent deep vein thrombosis in patients undergoing hip or knee replacement surgery.