Xarelto Bleeding Lawsuits Continue to Mount as MDL Hearing Approaches

As the U.S. Judicial Panel on Multidistrict Litigation (JPML) prepares to hear oral arguments next week over whether to consolidate all federal Xarelto lawsuits before one judge, a growing number of new complaints continue to be filed in U.S. District Courts nationwide.

Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary now face at least 50 product liability lawsuits over their new-generation anticoagulant, which are pending in nearly two dozen different federal courts.

All of the complaints involve nearly identical allegations, claiming that the drug makers failed to adequately warn about the potential side effects of Xarelto, which caused users to suffer uncontrollable bleeding that resulted in hospitalizations, the need for blood transfusions and sometimes death.

Plaintiffs claim that many severe injuries and deaths may have been prevented if the drug makers had not provided misleading information about the need for blood monitoring on Xarelto, and if stronger warnings had been provided about the lack of a Xarelto reversal agent.

MDL Panel Hearing

The U.S. JPML is scheduled to hear oral arguments on Thursday next week, in response to a motion filed last month by a group of plaintiffs that are seeking to centralize the complaints as part of a federal multidistrict litigation (MDL).

Such coordinated pretrial proceedings are typically established in complex pharmaceutical claims, where a large number of lawsuits are filed over injuries allegedly caused by same or similar drugs. Plaintiffs maintain that centralizing the Xarelto litigation will reduce duplicative discovery into common issues, avoid the risk of conflicting pretrial rulings from different judges and serve the convenience of the parties, witnesses and the courts.

At the time the original motion was filed on October 15, there were at least 21 Xarelto bleeding lawsuits pending in 10 different U.S. District Courts. However, that number has more than doubled over the past month and the rate of new cases is expected to increase dramatically once the panel decides whether to establish a Xarelto MDL and where the cases should be transferred.

Several responses filed in support of the motion (PDF) by different plaintiffs’ lawyers have suggested that hundreds of additional lawsuits are likely to be filed in the coming months, each involving very similar, if not identical, allegations of Xarelto bleeding injuries.

One of the most recently filed complaints (PDF) was brought by Harriet Ibanez in the U.S. District Court for the Eastern District of Louisiana on Friday, which presents a typical factual pattern seen in many of the lawsuits. Ibanez indicates that she was prescribed Xarelto for treatment of atrial fibrillation in October 2013, but was hospitalized with severe bleeding about four months later, which resulted in the need for a blood transfusion and has left her with permanent injuries.

Another complaint (PDF) filed the same day in the U.S. District Court for the Central District of Illinois describes a nearly identical fact pattern, indicating that Ann Hartman suffered severe rectal bleeding after being prescribed the anticoagulant for treatment of deep vein thrombosis (DVT) and pulmonary embolism, also resulting in hospitalization and the need for blood transfusions.

Xarelto Lawsuit Allegations

Xarelto (rivaroxoaban) was introduced by Bayer and 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 has been linked to an increasing number of adverse event reports 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.

While Bayer and Janssen have opposed the plaintiffs’ request to establish a Xarelto MDL, arguing that the cases will be dominated by individual facts of each case, it is widely expected that the U.S. JPML will establish centralized proceedings for coordinated discovery and a series of bellwether trials to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.