Lawyers Seek Leadership Roles in Xarelto Litigation

In advance of a status conference later this week, a growing number of attorneys are filing petitions to serve in various leadership roles in the federal Xarelto litigation. 

Last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings for all product liability lawsuits filed throughout the U.S. that involve allegations that side effects of Xarelto caused users to suffer severe and often fatal bleeding injuries.

The cases have been centralized as part of a federal MDL, or multidistrict litigation, before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties.

While an initial status conference in the Xarelto MDL is set for January 29, plaintiffs’ attorneys have until February 5 to apply for various leadership roles in the litigation, including requests to serve as lead counsel or on a plaintiffs steering committee, which will take certain actions during discovery and pretrial proceedings that benefit all individuals who are pursuing a Xarelto bleeding lawsuit.

More than a dozen applications have already been filed by Xarelto attorneys, including many of the same lawyers who previously served in leadership roles in the federal Pradaxa litigation, which involved similar injuries associated with another new-generation anticoagulant from the same class of medications.

At the time the Xarelto MDL was established, there were at least 21 complaints pending in 10 different U.S. District Courts. However, according to the latest case list (PDF) released by the U.S. JPML on January 15, there are already at least 86 cases centralized before Judge Fallon.

As Xarelto injury lawyers continue to review and file cases for individuals who experienced injuries as a result of uncontrollable bleeding problems while using the drug, it is ultimately expected that several thousand cases will be included in the MDL.

Xarelto Bleeding Risks

All of the cases involved in the Xarelto MDL raise similar allegations, claiming that Bayer and Johnson & Johnson’s Janssen subsidiary failed to adequately warn consumers and the medical community about the potential bleeding risks with Xarelto, as well as the lack of an effective reversal agent to allow doctors to control hemorrhaging that may develop while using the drug.

Xarelto (rivaroxoaban) was the second member of a new-generation of anticoagulants introduced in recent years 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 years.

Pradaxa (dabigatran) was the first member of this class, introduced by Boehringer Ingelheim in late 2010. Shortly after the drug hit the market, it was rapidly adopted within the medical community. However, Pradaxa also quickly earned the dubious distinction as one of the medications most commonly associated with adverse event reports submitted to the FDA.

Unlike warfarin, for which the blood thinning effects of the drug can be quickly reversed with a dose of vitamin K and fresh frozen plasma, no antidotes are yet available for the new-generation anticoagulants. This has left doctors unable to control or reverse bleeding problems that may occur among users.

As thousands of reports began to surface involving users who suffered uncontrollable bleeding problems on Pradaxa, Boehringer Ingelheim faced over 4,000 injury lawsuits, which involve similar allegations to those now being brought in the Xarelto litigation.

Shortly before the first Pradaxa trials were set to begin last year, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements to resolve the litigation, with an average of about $150,000 to be awarded to former users who experienced injuries associated with uncontrollable bleeds.

Amid the mounting concerns and lawsuits over Pradaxa bleeding problems, Xarelto was introduced in 2011, and grew to overtake the top spot among the new medications in 2013, with sales exceeding those of Pradaxa. Due to the lack of a Xarelto reversal agent, similar reports involving uncontrollable bleeding have been received among users of the drug and a growing number of product liability lawsuits have been filed throughout the federal court system.

During the coordinated pretrial proceedings in the Xarelto MDL before Judge Fallon, it is ultimately expected that a small group of cases will be selected as “bellwether” claims, which will then be prepared for early trial dates. While the outcomes of these early test cases are not binding on other claims in the litigation, they are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Following coordinated pretrial proceedings and any bellwether trials, if Bayer and Johnson & Johnson’s Janssen unit fail to reach Xarelto settlements, they may face hundreds of individual trials in courts throughout the U.S.