Xarelto Lawsuit Alleges Drug Isn’t Effective, Even When Taken as Directed

A lawsuit filed last week in Pennsylvania state court against Janssen Pharmaceuticals alleges that the company’s recommended once a day dosage for the blockbuster drug Xarelto isn’t effective for a full 24 hours.

A plaintiff with non-valvular atrial fibrillation who suffered a stroke four days after starting on Xarelto filed the lawsuit in Philadelphia on October 8. The suit alleges that the indicated 20mg dose of the medication is insufficient to protect against stroke/systemic embolism for those who take the medication once a day.

The Pennsylvania case is believed to be the first in the nation to make the allegation that Xarelto is not effective in preventing, and in some cases actually contributing to, ischemic strokes in patients suffering from atrial fibrillation.

What is Xarelto?

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.

Xarelto is currently the only new anticoagulant that is recommended by the manufacturer for once-a-day dosing for patients with atrial fibrillation. Rival anticoagulants require users to take multiple doses per day and in some situations, to undergo monitoring.

Xarelto MDL

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. Plaintiffs in those cases claim that Xarelto caused uncontrollable and sometimes fatal bleeding in patients.

Recent numbers show that there are more than 400 Xarelto-related cases currently pending, and experts estimate that eventually several thousand cases will be transferred into the MDL.