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A wrongful death lawsuit alleges that the side effects of Eliquis, a new-generation anticoagulant, caused a North Carolina woman to experience a bleeding event that turned fatal.
The complaint (PDF) was filed by Roy Green in the U.S. District Court for the Southern District of New York on April 7, on behalf of himself and his late wife, Mary Ann Green. Bristol-Myers Squibb and Pfizer are named as the defendants, for failing to warn consumers and the medical community about the risk of uncontrollable bleeding while taking the blood thinner.
Eliquis is part of a new crop of oral anticoagulants introduced in recent years, which also includes the 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, where the blood thinning effects of the medication can be reversed in an emergency to stop bleeding problems, there was no approved reversal agent when Eliquis, Pradaxa or Xarelto were introduced.
Since the medication hit the market, a large number of fatal bleeding events on Eliquis have been reported, since doctors were left unable to stop or control gastrointestinal bleeds, brain bleeds and other complications.
According to the lawsuit, Green was first prescribed Eliquis in March 2015. About three months later, she suffered a severe bleeding event, which ultimately led to her sudden death on June 25, 2015.
The case joins a growing number of similar Eliquis bleeding event lawsuits being filed in courts nationwide, many of which involve wrongful death claims. Each of the cases raise similar allegations that the drug makers knew or should have known about the risk of uncontrollable bleeding, yet failed to warn physicians or disclose the lack of an available reversal agent.
“During the years since first marketing Eliquis in the U.S., Defendants modified the U.S. labeling and prescribing information for Eliquis,” the lawsuit states. “Despite being aware of: (1) serious, and sometimes fatal, irreversible bleeding events associated with the use of Eliquis; and (2) 1,014 SAE Medwatch reports filed with the FDA in 2014 alone, including at least 108 deaths, Defendants nonetheless failed to provide adequate disclosures or warnings in their label…”
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), 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 decided a month later that a multidistrict litigation (MDL) should be established for the Eliquis cases, transferring all lawsuits pending throughout the federal court system to U.S. District Judge Denise L. Cote in the Southern District of New York for coordinated pretrial proceedings.
Similar MDL proceedings have previously been established for all Pradaxa lawsuits and Xarelto lawsuits, which raised 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 enter 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, with a series of early “bellwether” trials are expected to begin early next year.