The judicial panel’s decision comes after lawsuits were filed alleging Bayer AG and Johnson & Johnson minimized the risk of bleeding associated with Xarelto. Patients involved in the lawsuits filed a motion that the lawsuits be consolidated in a multidistrict litigation before US District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings. According to Bloomberg (12/4/14), as many as 65 deaths have allegedly been linked to the use of Xarelto, and 21 lawsuits have been filed in 10 federal courts.
Bayer and Johnson & Johnson have fought the move to multidistrict litigation. A spokesperson for Bayer said the company stands behind Xarelto, while a spokesperson for Johnson & Johnson said the “benefit-risk profile of Xarelto remains favorable.” But the judicial panel found that the plaintiffs raised common issues of fact, including concerns about Xarelto’s warning label and the alleged risk of severe bleeding.
Xarelto is a blood thinner used to reduce the risk of blood clots and strokes. Like other drugs in its class - including Pradaxa and Coumadin - Xarelto comes with an increased risk of uncontrolled bleeding events. Unlike Coumadin, however, neither Xarelto nor Pradaxa has a currently approved antidote. Patients who take Coumadin and suffer a bleeding event can be given vitamin K to reverse the anti-blood clotting effects of Coumadin. Patients on Xarelto or Pradaxa have no such antidote.
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Plaintiffs in the Xarelto litigation argue that Xarelto was not properly tested before it was approved for the market in 2011.
Bloomberg notes that by 2013, Xarelto made more than $2 billion in sales.
The case is Xarelto Products Liability Litigation, MDL No. 2592, U.S. Judicial Panel on Multidistrict Litigation. The Pradaxa Lawsuits are In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, case number 3:12-md-02385, in the U.S. District Court for the Southern District of Illinois.