Xarelto Litigation Grows

Xarelto lawsuits continue to build against Bayer and Janssen Pharmaceuticals, with thousands of cases pending in the multidistrict litigation (MDL) centralized to the U.S. District Court for the Eastern District of Louisiana and over 600 in a mass tort program in the Court of Common Pleas in Philadelphia. Plaintiffs accuse the companies of failing to warn about the lack of an antidote, or reversal agent, leading to uncontrollable bleeding in some patients.

Xarelto was approved in 2011. The anticoagulant is used to prevent blood clots in patients with atrial fibrillation, pulmonary embolism, deep vein thrombosis, and those recovering from knee and hip surgery. The lawsuits point to two black box warnings on the drug, which are the most serious type of warning.

Allegedly, Bayer and Janssen marketed Xarelto without fully disclosing its dangers. The lawsuits allege that the companies touted Xarelto as a superior alternative to Coumadin (warfarin), a decades-old blood thinner that requires blood monitoring and dietary restrictions. Xarelto patients do not have to undergo these restrictions, but lawsuits allege that the drug carries a risk of irreversible bleeding due to the lack of a reversal agent. In patients taking warfarin, however, bleeding can be reversed with vitamin K infusion.

Plaintiffs’ attorneys say they expect litigation to grow. When there are numerous lawsuits sharing common allegations, they are sometimes consolidated into a federal MDL, which centralizes these cases into a federal court before one judge and makes proceedings more efficient.

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