Xarelto Lawsuit MDL Consolidation Opposed By Drug Manufacturers

Despite a growing number of injury and wrongful death lawsuits filed by individuals throughout the U.S., raising nearly identical allegations that side effects of Xarelto caused uncontrollable bleeding, the manufacturers of the controversial blood thinner are urging a panel of federal judges not to centralize the cases before one judge for coordinated pretrial proceedings.

On December 4, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to hear oral arguments on a motion filed last month by a group of plaintiffs, which seeks to consolidate all Xarelto lawsuits filed throughout the federal court system as part of an MDL, or multi-district litigation.

In responses filed by Bayer Healthcare (PDF) and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary (PDF) on Friday, the two companies that jointly manufacture and distribute Xarelto indicate that the JPML should reject the request, arguing that the cases will be too individualized for consolidation and that informal coordination among the parties would achieve the same purposes.

There are currently at least 30 different product liability lawsuits filed in 14 separate U.S. District Courts, all involving nearly identical allegations that the drug makers failed to adequately warn about the bleeding risk with Xarelto, or the lack of a reversal agent that doctors could use to stop the blood thinning effects of the medication if a hemorrhage develops during treatment.

In addition to claims for severe and permanent injuries that resulted from bleeding events while using the medication, the drug makers also face a number of Xarelto wrongful death lawsuits brought by families of individuals who died after doctors were unable to control bleeds.

On October 15, a group of plaintiffs filed a motion to consolidate the Xarelto litigation to reduce the risk of duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

The original request proposed that the litigation be centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois, who was previously assigned to preside over the MDL for all Pradaxa lawsuits, which raised similar allegations.

In the responses filed October 31, Bayer and Janssen maintain that the Xarelto cases are without merit, and suggested that official coordination through an MDL is unnecessary since most of the compaints filed to-date have been brought by a small number of law firms. Therefore, the drug makers indicate that the panel should recommend informal coordination.

In the event that the JPML does decide to establish a Xarelto MDL, the drug makers indicate that the cases should not be transferred to the Southern District of Illinois, but rather indicate that the most appropriate venue is the District of New Jersey, where both drug makers’ U.S. headquarters are located and where a large number of witnesses and documents are located.

Xarelto Lawsuit Allegations

Xarelto (rivaroxoaban) was introduced by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals 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 risk of bleeding problems, Xarelto lacks an approved antidote that doctors can use to stop bleeding that may develop. While doctors can quickly stop the blood thinning effects of warfarin, users of Xarelto have reported experiencing uncontrollable bleeding that physicians were unable to control, often leading to severe injury or death.

Plaintiffs maintain that the drug makers provided false and misleading information about the bleeding risks, burying information about the lack of a reversal agent on the drug label. In addition, many of the claims allege that Xarelto was marketed in a reckless manner.

While the drug makers have promoted that users do not need regular blood monitoring, recent studies have suggested that Xarelto monitoring may actually help doctors identify patients at risk of bleeding.

In complex pharmaceutical litigation, where a large number of claims have been brought by individuals nationwide involving similar injuries caused by the same or similar medications, the U.S. JPML has generally opted to centralize the pretrial proceedings before one judge. While the discovery and litigation process is often similar to how a Xarelto class action lawsuit would be handled, each case would still remains an individual claim, where the plaintiffs must establish that the injury or death was caused by the drug maker’s failure to warn.

Following the pretrial proceedings in an MDL, if the parties fail to reach agreements to settle Xarelto lawsuits, each individual case may ultimately be remanded back to the U.S. District Court where it was originally filed for an individual trial date.

It is ultimately expected that several thousands lawsuits will be filed over the coming months and years, as individuals contact Xarelto injury lawyers about potential claims for themselves or their loved ones. Therefore, plaintiffs maintain that informal coordination in the cases is likely to become unwieldy very quickly.