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According to allegations raised in a product liability lawsuit recently filed against Bristol-Myers Squibb and Pfizer, side effects of Eliquis caused cerebral bleeding that left a Texas man with severe and permanent injuries.
The complaint (PDF) was filed by Michael and Danna Watkins in Delaware Superior Court on January 9, indicating that the drug makers knew or should have known that Eliquis may cause dangerous and life-threatening bleeding problems, yet failed to adequately warn consumers or the medical community about the risks associated with the controversial anticoagulant.
Michael Watkins was prescribed Eliquis to reduce the risk of stroke and embolism associated with atrial fibrillation. However, in January 2015, he suffered a cerebral bleed, or hemorrhage.
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 caused by Eliquis, Xarelto and Pradaxa have been reported, since there was no safe and effective reversal agent available at the time the drugs were introduced.
Although 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 Watkins and other plaintiffs pursuing Eliquis bleeding lawsuits 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.
“Defendants concealed their knowledge of Eliquis’ defects, from Plaintiff, the FDA, the public in general and the medical community, including Plaintiff’s prescribing doctor,” Watkins’ complaint states. “These representations were made by Defendants with the intent of defrauding and deceiving Plaintiff, the public in general, and the medical and healthcare community including Plaintiff’s prescribing doctor, and were made with the intent of inducing the public in general, and the medical community in particular, to recommend, dispense and purchase Eliquis, all of which evinced a callous, reckless, willful, depraved indifference to health, safety and welfare of the Plaintiff herein.”
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 will hold oral arguments later this month to determine whether the creation of a multidistrict litigation (MDL) should be established for the Eliquis lawsuits. The Watkins complaint was filed in state court, so unless it is removed to the federal court system, it would not be included in any such consolidated proceedings.
Similar MDL 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 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.