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A product liability lawsuit filed by a California woman indicates that she suffered severe gastrointestinal bleeding from Eliquis side effects, as well as an ischemic stroke, which was allegedly caused by the drug makers failure to adequately warn about the risk of uncontrollable bleeding problems associated with the controversial new-generation anticoagulant.
The complaint (PDF) was filed earlier this month by Carmen Flores in Delaware Superior Court, indicating that Bristol-Myers Squibb and Pfizer, Inc. withheld important safety information from consumers and the medical community, which may have allowed Flores to avoid the severe gastrointestinal bleeding injury from Eliquis.
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 medication has been promoted as easier to use than warfarin, a large number of bleeding problems caused by Eliquis have been reported, since there was no safe and effective reversal agent available at the time the drug was introduced.
Flores indicates that her doctors prescribed Eliquis for the prevention of stroke due to atrial fibrillation. However, in February 2015, she suffered an ischemic stroke and severe gastrointestinal bleeding, which the lawsuit indicates was due to the side effects of Eliquis and the lack of a reversal agent.
Although the blood thinning effects of warfarin can be quickly reversed if hemorrhaging occurs, there was no antidote for Eliquis available for doctors treating Flores.
The case joins a growing number of similar Eliquis bleeding lawsuits being filed in courts nationwide, which raise common allegations that the drug makers knew or should have known about the risks associated with the medication, yet failed to provide the important safety information to users and doctors.
“The U.S. label approved when the drug was first marketed in the U.S. and at the time Plaintiff was using in 2014 it did not contain an adequate warning regarding the lack of antidote, and the significance of that problem for patients who began to bleed,” the lawsuit states. “After the drug was approved by the FDA, Defendants engaged in an aggressive marketing campaign for Eliquis, including extensive marketing directly to the public, via TV and print.”
Amid an increasing number of cases filed in courts nationwide, Bristol-Myers Squibb and Pfizer filed a request in October with the U.S. Judicial Panel on Multidistrict Litigation (JPML) last month, seeking to transfer all Eliquis failure to warn cases 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.
The JPML heard oral arguments on January 26, and last week decided that a multidistrict litigation (MDL) should be established for the Eliquis lawsuits.
Similar MDL proceedings have previously been established for all Pradaxa lawsuits and Xarelto lawsuits, which raised similar allegations about the same risks associated with these other new generation anticoagulants, which hit the market before Eliquis and were previously bigger sellers.
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 about 15,000 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 Eliquis lawsuit filed by Flores will be transferred to the recently established MDL, where it is expected that a similar bellwether program will be established to help the parties gauge the relative strengths and weaknesses of their cases, and potentially facilitate Eliquis settlements in the future.