Eliquis Internal Bleeding Lawsuit Filed Against Bristol-Myers Squibb and Pfizer

Bristol-Myers Squibb and Pfizer face a growing number of Eliquis lawsuits, which claim that users suffered severe injuries due to uncontrollable bleeding caused by side effects of the new-generation anticoagulant.

In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Louisiana, Dixie Walker indicates that she she experienced internal bleeding after taking Eliquis to prevent blood clots following a hip fracture, alleging that inadequate safety warnings were provided for consumers and the medical community.

Eliquis is part of a controversial 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.

While the medications have been promoted as easier to use than warfarin, a large number of bleeding problems with Eliquis, Xarelto and Pradaxa have been reported, since there was no safe and effective reversal agent available at the time the drugs were introduced. While the blood thinning effects of warfarin can be quickly reversed if hemorrhaging occurs, there was no antidote for Eliquis available for doctors treating Walker.

According to allegations raised by Walker and other plaintiffs pursuing Eliquis internal bleeding cases in courts nationwide, Bristol-Myers Squibb and Pfizer knew or should have known that their new-generation drug was not sufficiently tested and withheld important safety warnings.

“In written information about the safety and risks of Eliquis, Defendants negligently and fraudulently represented to the medical and healthcare community, including Plaintiff’s prescribing doctor, the Food and Drug Administration, to Plaintiff and the public in general, that Eliquis had been tested and was found to be safe and effective for its indicated uses,” the complaint filed by Walker states. “Defendants concealed their knowledge of Eliquis’ defects from Plaintiff, the FDA, and the public in general, and the medical community, including Plaintiff’s prescribing physicians.”

Amid an increasing number of cases filed in courts nationwide, Bristol-Myers Squibb and Pfizer filed a request last month with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to transfer the Eliquis litigation to one judge for coordinated discovery and pretrial proceedings, suggesting that the number of complaints is likely to continue to increase over the coming weeks and months.

Similar centralized proceedings have previously been established for all Pradaxa lawsuits and Xarelto lawsuits, which raised similar allegations that the new generation of anticoagulants are unreasonably dangerous and defective.

Following several years of litigation over the failure to warn about the bleeding risk with Pradaxa, which was the first member of this class of drugs to hit the market, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements to resolve about 4,000 cases in 2014.

The Xarelto litigation is currently centralized in the federal court system, where more than 11,000 complaints are pending before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana. A series of early “bellwether” trials are expected to begin early next year, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be offered throughout the cases filed against Bayer Healthcare and Janssen Pharmaceuticals over their anticoagulant.

The U.S. JPML is likely to consider oral arguments over in January 2017, over whether to establish a new Eliquis MDL for cases filed against Bristol-Myers Squibb and Pfizer.