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Xarelto Litigation Raises Safety Questions

Jul 14, 2016

Lawsuits filed over the anticoagulant drug Xarelto continue to draw attention. Bayer AG and Janssen Pharmaceuticals are facing over 3,000 lawsuits alleging that the companies failed to warn about the risk of irreversible bleeding. According to court documents, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated 2,800 cases in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana. Similarly, 550 cases were centralized in state court, in a mass tort program, by the Philadelphia Court of Common Pleas.

The lawsuits are being combined because they have similar claims, and consolidating these cases is intended to make the litigation more efficient. In the Xarelto litigation, plaintiffs allege that Xarelto caused serious, sometimes fatal, bleeding. The lawsuits allege that Bayer and Janssen failed to warn both the patient and their physicians about the risk of irreversible bleeding.

Xarelto was approved in 2011 to prevent blood clots and deep vein thrombosis in patients recovering from hip or knee surgery. Deep vein thrombosis is a condition where a blood clot forms in the deep veins of the leg. If a piece of the clot breaks off, it can become lodged in the lungs, resulting in a life-threatening condition known as pulmonary embolism. The drug was later approved for patients with atrial fibrillation, an abnormal heart rhythm that could lead to blood clots.

Plaintiffs point out that Xarelto is part of a new generation of blood thinners marketed as a replacement to warfarin, which has been on the market for decades. Warfarin, sold under the brand name Coumadin, requires patients to undergo blood monitoring and avoid certain foods. Although Xarelto patients do not have these limitations, the lawsuits emphasize that the drug lacks a reversal agent if patients suffer internal bleeding. This means that bleeding in Xarelto patients is essentially untreatable. Warfarin, on the other hand, can be reversed with vitamin K. The lawsuits accuse Bayer and Janssen of failing to warn about the lack of an antidote.

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