Xarelto Bleeding Lawsuits in MDL Hit 2,400

According to a recent case list released by the U.S. Judicial Panel on Multidistrict Litigation (JPML), there are currently at least 2,400 Xarelto lawsuits pending throughout the federal court system, which all involve similar allegations that users of the controversial anticoagulant suffered uncontrollable bleeding or other problems.

Since December 2014, the Xarelto litigation pending throughout the federal court system has been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation.

Complaints filed nationwide are centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to reduce duplicative discovery into common issues in the cases, avoid contradictory pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

One year after the Xarelto MDL was established, the U.S. JPML reports (PDF) that the number of cases transferred from U.S. District Courts nationwide continues to climb, with many of the cases involving multiple plaintiffs who suffered bleeding injuries.

Thousands of Xarelto Bleeding Problems

Xarelto (rivaroxoaban) was introduced in 2011 as a replacement for Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades. The drug is part of a new-generation of treatments designed to avoid blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism, which has been promoted as easier to use than warfarin. However, it has been linked to a large number of bleeding problems.

Each of the lawsuits involved in the Xarelto MDL raise nearly identical allegations, indicating that users and the medical community were provided inadequate warnings about the potential bleeding side effects of Xarelto, as well as the fact that the new-generation anticoagulant lacked a safe and effective reversal agent to allow doctors to quickly stop the blood thinning effects of the drug.

One of the more recent lawsuits was filed earlier this week, involving claims for nine different plaintiffs, each involving allegations that severe injuries were caused by uncontrollable bleeding on Xarelto, including at least one wrongful death claim.

The complaint (PDF) was brought on behalf of individuals from across the U.S., including Alfred Klein, of New York; Beatrice McCall, of Alabama; Helen Maestas, of New Mexico; Perry Middleton, of Colorado; Richard Montigne, of Arizona; Tracy Patton, of North Carolina; Brenda Rogers, of Texas; David Vickery, also of Texas; and New York resident John Sturtevant, whose wife died of internal bleeding after using the drug.

“Plaintiffs bring this case against Defendants for damages associated with ingestion of the pharmaceutical drug Xarelto,” the lawsuit states. “Specifically, Plaintiffs suffered various injuries, serious pain and suffering, medical, hospital and surgical expenses, loss of consortium, and/or death and funeral expenses as a direct result of their use of Xarelto.”

The factual patterns provided by each of the nine plaintiffs are similar, indicating that uncontrollable bleeding occurred after taking Xarelto for periods ranging from five days to twelve months. Among the injuries suffered by plaintiffs are intracerebral hemorrhaging oral bleeding, gastrointestinal bleedings and other internal bleeds, as well as strokes and heart failure.

Lack of Reversal Agent with Xarelto

While all blood thinners carry a risk of bleeding injury, the side effects of warfarin can be quickly reversed with a widely known antidote of bleeding occurs. However, there was no Xarelto reversal agent when the drug was introduced. Plaintiffs allege that the drug makers failed to adequately warn doctors about the lack of an antidote.

“Importantly, Xarelto’s significant risk of severe, and sometimes fatal, internal bleeding has no antidote to reverse its effects, unlike warfarin,” the lawsuit (PDF) filed earlier this week states. “Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label, approved when the drug was first marketed, did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdose section.”

Similar claims were raised in the litigation over Pradaxa, which is another new-generation anticoagulant introduced in October 2010, one year before Xarelto hit the market.

More than 4,000 Pradaxa lawsuits were ultimately filed by users of that drug who suffered bleeding injuries. Following several years of litigation, the manufacturer of that medication ultimately agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.

As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, it is expected that this litigation will involve many more cases than the Pradaxa litigation, as the drug has become more widely used in recent years.