MDL Sought for Eliquis Lawsuits Over Bleeding Problems

As a growing number of Eliquis lawsuits continue to be filed in federal courts nationwide, alleging that Bristol -Myers Squibb and Pfizer Inc. failed to disclose the risk of bleeding problems associated with their new generation anticoagulant, a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation, seeking to centralize the cases before one judge for coordinated pretrial proceedings.

There are currently at least 34 complaints pending in 13 different U.S. District Courts nationwide, each involving similar claims that the drug makers failed to adequately warn consumers and the medical community about the side effects of Eliquis, and the lack of an effective reversal agent that would allow doctors to stop bleeding that may develop among users.

Eliquis is part of a new crop of oral anticoagulants introduced in recent years, known as factor xa medications, which also include the blockbuster treatments Xarelto and Pradaxa. The drugs have been aggressively marketed as a replacement for Coumadin (warfarin), which has been the go-to anticoagulation treatment for decades. However, unlike warfarin, these new drugs had no safe and effective antidote available when they were introduced, and a large number of bleeding problems with Eliquis, Xarelto and Pradaxa have been reported in recent years.

Thousands of Xarelto lawsuits and Pradaxa lawsuits have already been filed against the makers of these competing, and more popular, anticoagulants. While a relatively small number of Eliquis cases have been filed to date, it is expected that the number of complaints will continue to increase in the coming weeks and months, likely involving hundreds, or even thousands, of cases involving severe bleeds or wrongful death.

In a motion to transfer (PDF) filed with the JPML on October 13, Bristol -Myers Squibb and Pfizer Inc. requested that all Eliquis lawsuits filed in U.S. District Courts nationwide be consolidated before one judge to prevent duplicative discovery into common issues in the cases, avoid contradictory rulings from different judges, and to serve the convenience of the parties, witnesses and the judicial system.

“While there is some variation in each complaint, the core of the allegations is the same; indeed, many of the allegations are copied verbatim across complaints,” wrote the drug makers in the request. “Plaintiffs claim that Defendants should be held liable for Plaintiffs’ bleeding-related injuries under a variety of theories, including that (1) Defendants failed to warn adequately about the risk of bleeding; and (2) Defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect.”

Eliquis was the third member of this new class of medications to hit the market, coming after Xarelto and Pradaxa were aggressively marketed as a superior alternative to warfarin.

Following several years of litigation over Pradaxa, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements in 2012, resolving about 4,000 cases brought on behalf of individuals who experienced severe bleeding problems. In addition, since a Pradaxa reversal agent was just recently approved and introduced, additional cases have continued to be filed over the past few years, and may result in additional settlements.

There are also currently more than 7,200 product liability lawsuits pending in the federal court system over side effects of Xarelto, which has been the most popular of this new generation of anticoagulants. Bater Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary face a series of early trial dates that are expected to begin next year in the Xarelto litigation, which has already been centralized as part of a federal MDL U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.

The motion filed by Bristol -Myers Squibb and Pfizer Inc. proposes that an Eliquis MDL be established in the U.S. District Court for the Southern District of New York, as the drug makers’ headquarters are located there and about half of the cases are currently pending in that district. The U.S. JPML is expected to hear oral arguments on the motion during an upcoming hearing set for either December 1 in Charlotte, North Carolina or January 26 in Miami, Florida.