Xarelto could be the next medication involved in a large, federal products liability litigation. According to a Motion filed earlier this month with the U.S. Judicial Panel on Multidistrict Litigation (JPML), six plaintiffs who have cases pending against the manufacturers of the blood thinner have asked the Panel to create a Xarelto multidistrict litigation in the U.S. District Court, Northern District of Illinois.
All of the plaintiffs have filed Xarelto cases that claim the drug caused uncontrollable internal bleeding and related side effects, including deep vein thrombosis and pulmonary embolism. They point out that at least a dozen such claims have already been filed so far, and assert that thousands of additional filings are likely. Among other things, the Motion notes that Xarelto has been named in hundreds of adverse event reports since it was first approved by the U.S. Food & Drug Administration (FDA) in July 2011.
According to Xarelto lawsuits, the blood thinner was the subject of more than 1,000 FDA adverse event reports, including 65 that had fatal outcomes, during its first year on the market. By the end of 2012, that number had grown to more than 2,000. And during the first quarter of 2013, the FDA received 680 reports of Xarelto-associated complications.
Among other things, the complaints accuse Johnson & Johnson and Bayer AG of failing to provide adequate warnings about the drug’s association with uncontrollable bleeding, especially the lack of an approved antidote to reverse this potentially deadly complication. They also claim that the companies’ assertions that Xarelto was a superior alternative to warfarin were misleading, as the bleeding that sometimes occurs with that decades-old anticoagulant can be stopped via the administration of vitamin K.
Federal multidistrict litigations are established when it is anticipated that a large number of product liability claims will be filed on behalf of individuals who are alleged to have suffered similar injuries and damages due to the same product. These types of proceedings preserve the resources of the court, parties and witnesses by allowing the lawsuits to undergo coordinated pretrial proceedings, including discovery and motions practice.
In proposing the Northern District of Illinois as the venue for the Xarelto litigation, plaintiffs point out that it also served as the locale for a multidistrict litigation involving Pradaxa, another blood thinner in the same class. A global settlement was reached in the Pradaxa proceeding within just 22 months of its establishment. U.S. Judge David R. Herndon, who presided over those claims, is one of two judges the plaintiffs have proposed to oversee the Xarelto cases.