Twelve people treated with Xarelto blood thinner have filed a lawsuit in California federal court claiming that they were not sufficiently warned that the drug could cause them to bleed uncontrollably. They all claim the medication caused them gastrointestinal bleeding, rectal bleeding and, in one case, a stroke.

The latest lawsuit joins hundreds of others around the country popping up in both state and federal court. In December, the U.S. Judicial Panel on Multidistrict Litigation consolidated nearly two dozen suits in Louisiana federal court involving bleeding events with the anticoagulant. A month later, a new mass tort program was created in Philadelphia County Court of Common Pleas to consolidate 73 similar lawsuits involving the Xarelto blood thinner.

Xarelto is in a new class of blood thinners designed to be an alternative to the long-used warfarin for the treatment and prevention of blood clots in patients undergoing knee or hip replacement surgery, and to reduce the risk of blood clots and strokes in some heart patients. Clinical trials showed the drug was effective, but its safety was called into question after the medication was linked to serious bleeding events, including gastrointestinal bleeds, brain hemorrhages and bleeding deaths. Unlike warfarin, there is no antidote to reverse the blood thinning effects of Xarelto.

The lawsuits target Xarelto makers Bayer Healthcare and Johnson & Johnson unit Janssen Pharmaceuticals.

Plaintiffs in the lawsuit claim they would have never used Xarelto had they been sufficiently warned of the bleeding risks. They also claim that the drugs’ makers misinformed patients and doctors when they said patients using the drugs did not need to be monitored.

The Xarelto lawsuits come on the heels of the recent $650 million Pradaxa settlement. Researchers linked Pradaxa, also a blood thinning medication, to more than 500 deaths. Xarelto blood thinner litigation has been consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, who presided over suits against Merck & Co. over its medication Vioxx. The Vioxx litigation resulted in a $4.85 billion settlement in 2007.

Beasley Allen lawyers are looking at claims related to uncontrolled bleeding events in patients taking Xarelto. For more information, contact David Byrne at David.Byrne@BeasleyAllen.com.

Source: Law 360



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