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In a product liability lawsuit recently filed against Bristol-Myers Squibb Company and Pfizer Inc., the drug makers are accused of failing to adequately warn about the bleeding injury risk with Eliquis, a popular new-generation blood thinner that allegedly caused a New York man to suffer anemia, a hematoma and severe internal bleeding following vascular surgery.
The complaint (PDF) was filed by David O. Reed in Delaware Superior Court on February 27, indicating that Bristol-Myers Squibb and Pfizer negligently and fraudulently represented that Eliquis was safe and effective, concealing information about the risk that users may experience uncontrollable bleeding.
Reed indicates that he was prescribed Eliquis in January 2015, following vascular surgery. Less than three weeks later he developed bleeding complications, which resulted in the need for hospitalization. About one month after discharge, Reed indicates that he developed a gastrointestinal bleed, and had to be hospitalized again.
As a result of the Eliquis bleeding injury, Reed states that he has suffered severe pain and been left with permanent damages, which could have been avoided if the drug makers had provided adequate warnings and information about their blockbuster medication.
Eliquis is part of a controversial new crop of oral anticoagulants introduced in recent years, known as factor xa medications, which also includes the controversial 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.
Since the medication hit the market, 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.
“Before and after marketing Eliquis, Defendants became aware of many reports of serious hemorrhaging in users of its drugs, both as reported to the FDA and to it directly. Yet Defendants have never disclosed to the medical profession or patients what the incidence of such adverse reactions are,” the lawsuit states. “Despite the clear signal generated by the side effect data, Defendants failed to either alert the public and the scientific community, or perform further investigation into the safety of Eliquis.”
The case joins a growing number of similar Eliquis bleeding injury 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.
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 month decided that a multidistrict litigation (MDL) should be established for the Eliquis lawsuits, transferring cases 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. 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.