June 26, 2014 — Johnson & Johnson’s Janssen Pharmaceuticals unit has been hit with a lawsuit on behalf of a man who took Xarelto (rivaroxaban) and died of uncontrollable bleeding in the brain (subdural hemorrhage).
The plaintiff, Nancy Packard, filed the lawsuit (PDF) on behalf of her husband, William N. Packard, Jr. He started taking Xarelto in January 2012 because he had atrial fibrillation, a type of irregular heart rhythm that can cause strokes.
About six months after starting Xarelto, he suffered a subdural hemorrhage and was admitted to the hospital. Doctors tried to stop bleeding in his brain and even drilled a hole in his skull (right frontal burr hole), but the bleeding ultimately caused and/or contributed to his death on June 28, 2012.
According to the complaint:
“Defendants failed to adequately warn about the lack of an antidote to reverse uncontrolled bleeding caused by Xarelto®. Defendants merely indicated that there was a risk for bleeding and side-stepped the important issue of reversing the effects of Xarelto® should a bleed occur. Other safer alternatives to Xarelto® have an antidote that can reverse uncontrolled bleeding.”
The plaintiffs also pointed out that Xarelto lacks a “Black Box” warning informing patients and doctors that Xarelto can cause irreversible bleeding. The lawsuit accuses Janssen and Johnson & Johnson of failing to adequately warn about the “extreme risks” posed by ingestion of this drug.
The lawsuit was filed in the U.S. District Court for the Southern District of Florida. Bayer has reported less than 10 lawsuits are pending against the company, but these numbers could rise as more people who were injured decide to come forward. Since Xarelto was approved in the United States in 2011, hundreds of adverse events have been reported — many involving uncontrollable bleeding.
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