U.S. JPML Set to Hear Arguments Over Xarelto MDL Today in South Carolina

Oral arguments are scheduled to begin this afternoon before the U.S. Judicial Panel on Multidistrict Litigation (JPML) over whether to consolidate all federal Xarelto lawsuits filed on behalf of individuals nationwide who have experienced bleeding complications.

On October 15, a group of plaintiffs filed a motion requesting that the Xarelto litigation be centralized before one judge in the Southern District of Illinois to reduce the risk of duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and courts.

In complex pharmaceutical claims, where a large number of cases have been filed in U.S. District Courts nationwide involving similar injuries associated with the same medication, it is common for the courts to consolidate the pretrial proceedings as part of an MDL, or multidistrict litigation.

All of the complaints involve nearly identical allegations that Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary failed to adequately warn about the risk of uncontrollable bleeding from Xarelto side effects, indicating that the drug makers withheld important information about the importance of blood monitoring and the lack of a reversal agent that could be used to stop the blood thinning effects of the drug.

Bayer and Janssen have opposed the creation of a Xarelto MDL, arguing that each of the cases involve individualized facts and circumstances, and proposing that informal consolidation among the parties can achieve the same purposes.

In a supplemental response (PDF) filed last week, Bayer indicates that although the number of cases filed nationwide has now grown to 48, the drug maker continues to maintain that centralization is not appropriate.

“It remains Bayer’s position that the Panel should decline to consolidate,” states the drug maker in the latest filing on November 24. “Notably, Movants don’t dispute many of the ways in which each of the cases subject to their motion is unique – e.g., different plaintiffs used Xarelto for different indications and suffered different injuries. Nor do Movants meaningfully address Bayer’s good-faith offer to coordinate cases through the informal means that the Panel has said are preferable to MDL centralization. Movants simply have not shown that consolidation is necessary here.”

In the event that the U.S. JPML does establish a Xarelto MDL following the oral arguments today, Bayer indicates that the cases should be transferred to the District of New Jersey, which is where both manufacturers of the controversial drug have their U.S. headquarters located.

The panel of federal judges is expected to hear from interested parties during an afternoon session today in the U.S. District Court in Charleston, South Carolina.

Xarelto Bleeding Litigation

Xarelto (rivaroxoaban) was introduced by Bayer and Janssen in 2011, as part of a new generation of anticoagulants promoted as a superior alternative to Coumadin (warfarin), which has been the go-to blood thinner for prevention of strokes among patients with atrial fibrillation for decades.

While all blood thinners carry a bleeding risk, Xarelto has been linked to a number of problems involving uncontrollable bleeding injuries.

Unlike warfarin, for which the blood thinning effects of the medication can be quickly reversed in the case of an emergency, allowing blood to clot, there is no approved antidote available for users of Xarelto. As a result, many of the bleeding injuries have resulted in severe outcomes, after doctors were unable to control the bleeds.

Despite the reports of bleeding problems, 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.

As Xarelto injury lawyers continue to review potential claims for individuals who have suffered severe or fatal bleeds, the number of cases filed throughout the federal court system is expected to continue to grow over the coming months and years, with many expecting that there will eventually be several thousand similar claims brought against Bayer and Johnson & Johnson.

If the U.S. JPML, does decide to centralize the cases before one judge for coordinated discovery and pretrial proceedings, it is likely that a small group of cases will be prepared for early trial dates in the MDL to help the parties gauge how juries may respond to certain evidence and testimony that may be offered throughout the litigation. However, if Xarelto settlements are not reached following pretrial litigation, each case may ultimately be remanded back to the U.S. District Court where it was originally filed for a separate trial.