FDA Black Box Warnings Fortify Xarelto Plaintiff’s Lawsuit Cases

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

A South Florida resident, whose husband died as a result of internal bleeding while taking Xarelto, has filed a lawsuit on his behalf against Janssen Pharmaceuticals, a subsidiary of the Johnson & Johnson Corporation and Bayer Healthcare.  The deceased’s wife alleges that the pharmaceutical companies did not adequately warn consumers about the potentially dangerous side effects related to taking Xarelto, in particular the potential for significant and uncontrollable bleeding.

The plaintiff in the aforementioned case claims that Janssen and Bayer are responsible for her husband’s death as they were unable to stop his excessive bleeding. He died from a subdural hemorrhage. The deceased had been taking Xarelto to decrease his risk of stroke that he was susceptible to as he had the heart condition, atrial fibrillation.

When Xarelto was first released, it was heralded as being more convenient than traditional blood thinners as patients did not have to be constantly monitored, nor did they have to stay with a strict diet. Xarelto’s popularity, though, was soon marred by the drug’s association with serious side effects of uncontrollable bleeding.

There are now approximately 2,800 lawsuits filed in federal courts across the United States focusing on Xarelto. Xarelto is also the subject of 550 more in a mass tort program in Philadelphia, Pennsylvania.

The U.S. Food and Drug Administration (FDA) has recently verified the alleged risks linked to Xarelto, with the issuance of two black box warnings for the drug. The black box warning is considered to be the strongest and harshest that can be given to a product before being ordered removed from the consumer market.