Direct Filing of Xarelto Lawsuits in MDL Permitted To Eliminate Delays

As a growing number of Xarelto lawsuits continue to be brought throughout the federal court system on behalf of individuals who suffered severe bleeding problems, the U.S. District Judge presiding over the litigation has approved the direct filing of new cases in the federal multidistrict litigation (MDL) established late last year.

Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary currently face more than 300 personal injury and wrongful death lawsuits over the failure to warn about the bleeding risk with Xarelto. However, it is ultimately expected that several thousand complaints will be filed nationwide over the coming months and years.

In December, the U.S. Judicial Panel on Multidistrict Litigation determined that all cases filed throughout the federal court system will be consolidated for pretrial proceedings as part of an MDL, which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges on the same pretrial matters and to serve the convenience of the parties.

To increase efficiency and avoid the delays involved in transferring cases from U.S. District Courts nationwide to the Eastern District of Louisiana, Judge Fallon issued a pretrial order (PDF) on March 24, which permits lawyers to file Xarelto cases directly into the MDL.

The makers of Xarelto have agreed that they will not assert any objection for improper venue in any lawsuits filed directly in the Eastern District of Louisiana. However, cases emanating from outside that district will only remain in the Eastern District of Louisiana for pretrial proceedings.

Following the coordinated discovery and any “bellwether” trials held in the MDL, if Bayer and Janssen fail to reach Xarelto settlements that resolve the litigation, each case pending in the MDL will be transferred back to the federal district where the plaintiff was injured or resided at the time of their injury for an individual trial date.

Xarelto Bleeding Litigation

Xarelto (rivaroxoaban) is a new-generation anticoagulant introduced in 2011 as a superior replacement for Coumadin (warfarin), which has been the “go-to” medication for prevention of blood clots and strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a risk of bleeding injury, Xarelto has been linked to a surprising number of problems as more and more patients are switched to the novel anticoagulant.

Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

In addition to failing to warn about the risk of bleeding and importance of blood monitoring, plaintiffs claim that drug makers withheld information about the lack of a Xarelto reversal agent, which doctors could use to stop hemorrhaging that may develop among users.

While warfarin’s blooding thinning effects can be quickly reversed in an emergency, there is no antidote for Xarelto.

Similar allegations were raised in the litigation over Pradaxa, which is another new-generation anticoagulant introduced by Boehringer Ingelheim in October 2010, one year before Xarelto hit the market. More than 4,000 Pradaxa lawsuits were filed by users of that drug who suffered bleeding injuries.

Following several years of litigation, Boehringer Ingelheim ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.