August 12, 2014 — Janssen Pharmaceuticals and Bayer HealthCare have been hit with a lawsuit from a woman who took Xarelto (rivaroxaban), a popular new blood-thinning medication, and developed severe bleeding.
The lawsuit (PDF) was filed on July 29 in the U.S. District Court for the Eastern District of New York.
The plaintiff, Jeanne Jeffcoat, is a 71 year-old woman from Texas who started using Xarelto in March 2012. In July 2012, she developed severe bleeding and stopped using Xarelto.
Janssen Pharmaceuticals is accused of fraudulently claiming that Xarelto had been tested and was safe and effective for its intended use, while concealing their knowledge of its defects.
Unlike other blood-thinning medications, Xarelto cannot be reversed with dialysis because it binds too tightly to proteins in a patient’s blood. Unlike warfarin, Xarelto cannot be reversed with a dose of Vitamin K. If a bleeding emergency, doctors might struggle to de-activate Xarelto so a patient can form life-saving clots necessary to stop bleeding.
The lawsuit also accuses Janssen of failing to provide adequate warnings about safety risks, including its lack of a reversal agent or its increased risk of gastrointestinal bleeding. Doctors were not provided with adequate instructions on how to intervene and/or stabilize a patient who starts bleeding.
As a result of these failures, the plaintiff suffered life-threatening bleeding that caused her severe pain and suffering, permanent injuries, diminished quality of life, and ongoing medical problems.
This is not the first time Janssen has been accused of failing to warn about Xarelto side effects. In June 2013, the U.S. Food and Drug Administration (FDA) issued a warning letter (PDF) for Xarelto ads that were “false or misleading” because they minimize risk information and made misleading claims about the need for dosage adjustments.
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