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US JPML Will Hear Oral Arguments Regarding Xarelto MDL

xarelto pill bottleA motion to establish a multidistrict litigation (MDL) encompassing a growing number of Xarelto bleeding injury lawsuits will be heard on December 4 before the U.S. Judicial Panel on Multidistrict Litigation. The judges who are part of the panel will consider the merits of forming the MDL as a response to a motion put forward by a group of Xarelto plaintiffs on October 15. The motion requests that all of the lawsuits be consolidated under U.S. District Judge David R. Herndon of the Southern District of Illinois.

Currently, there are 21 Xarelto lawsuits that have been filed in 10 different districts across the country. Establishing an MDL would provide a more efficient way of carrying out all the lawsuits by carrying out the pretrial discovery process that would normally take place for each complaint as part of a collective process. Additionally, if an MDL were to be established, Judge Herndon would preside over a process to select one or more “bellwether” cases which would set a precedent for further trials. One goal of such trials would be to encourage agreement on a large scale settlement that would preclude protracted legal wrangling in the courts.

Xarelto bleeding injury lawsuits

Xarelto is part of a new generation of anticoagulants (blood thinners) touted as more effective and convenient than older varieties, chiefly warfarin, which required more monitoring and control of diet. Unfortunately, a high number of incidents involving bleeding deaths and injuries have been reported in connection with Xarelto. Although both warfarin and Xarelto can pose bleeding risks, only warfarin has a reversal agent: vitamin K. Doctors have been left with few options to stem a hemorrhage related to Xarelto, however.

The growing number of Xarelto lawsuits concern the risk of hemorrhage that the blood thinner can pose and the lack of reversal agent available to halt excessive bleeding, should such an incident occur. The FDA has censured the drug’s manufacturer, Bayer Pharmaceuticals, for providing inadequate warning about the lack of reversal agent to treat this dangerous side effect.

Lawsuits allege that Bayer should be held accountable for failure to warn the public and health care professionals that this problem exists. They also allege that while Xarelto has been marketed as a more convenient option than warfarin due to the lack of need for monitoring, Bayer suppressed studies suggesting that such monitoring may in fact be a desired safety precaution to guard against Xarelto internal bleeding.

Xarelto joins Pradaxa as the focus of litigation

In addition to Xarelto, other next-generation blood thinners are also marred by a lack of reversal agent and have also been the subject of lawsuits regarding inadequate testing, fraudulent marketing, and failure to warn. The first such drug introduced to the market was Pradaxa, introduced in 2010 by Boehringer Ingelheim.

Over 2,000 lawsuits have been filed over Pradaxa-related bleeding complaints, and have been consolidated as part of their own MDL. Judge Herndon is already the presiding judge in this MDL.

  1. JPML, Notice of Hearing Session
  2. Reuters, Bayer faces lawsuits in United States over Xarelto
  3. Reuters, Reports of side-effects from Bayer's Xarelto grow: Spiegel