New York, NYFollowing in the footsteps of other anticoagulant drugs, Eliquis reportedly now faces its own side effects lawsuit. The Eliquis lawsuit was filed in June 2015, and claims the patient in question was given Eliquis but not warned of the lack of an antidote or the risks associated with Eliquis side effects.
According to court documents, Donald Bruce Herschell was 60 years old and had been prescribed Eliquis because of his atrial fibrillation. After being on Eliquis a short time, Herschell developed a massive gastrointestinal bleed. Although he was admitted to the hospital, doctors were unable to stop the bleeding and he died.
Newer anticoagulant medications have come under fire because of their lack of an antidote. Anticoagulants are used to prevent strokes by inhibiting the blood’s ability to clot - but that can cause serious problems if the patient develops an uncontrolled bleeding event. Warfarin - long the standard in anticoagulant medication - has a risk of uncontrolled bleeding but comes with an antidote in the form of vitamin K. Newer anticoagulants do not yet have a widely accepted antidote.
Plaintiffs who have filed lawsuits against the makers of newer anticoagulant medications allege they were told the medications were just as effective as warfarin in preventing strokes and did not require blood monitoring to ensure the blood stayed within therapeutic ranges. They also allege they were not warned that there was no antidote if the patient developed uncontrolled bleeding.
Herschell’s widow, Deborah J. Herschell, filed the lawsuit against Bristol-Myers Squibb, alleging the drugmaker misrepresented Eliquis as having been proven in tests to be safe and effective.
Included in the lawsuit are allegations that Bristol-Myers Squibb cut costs and hired incompetent agents to conduct the ARISTOTLE study, on which the approval of Eliquis was reportedly largely made. Among issues that allegedly came from the study were an unreported death, the loss of subjects for follow-up, dispensing errors and “changing and falsifying records, including records disappearing just before the FDA made a site visit, reportedly on the order of an employee of BMS.”
According to the lawsuit, an FDA physician objected to data from the ARISTOTLE study that was reportedly not included with the application for approval.
“Despite life-threatening bleeding findings in a clinical trial and other clinical evidence, Defendants failed to adequately conduct complete and proper testing of Eliquis prior to filing their New Drug Application for Eliquis,” the lawsuit argues.
The lawsuit is Herschell v. Bristol-Myers Squibb et al, case number 1:15-cv-04621, in the Southern District of New York.
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