The estate of a Louisiana woman has filed a lawsuit against Bristol-Myers Squibb and Pfizer, Inc. alleging that the drug Eliquis was the cause of her death. The plaintiff states that Eliquis, “an anticoagulant designed to prevent blood clots and strokes, allegedly made the deceased suffer serious and dangerous side effects including brain bleeding, gastrointestinal bleeding and severe pain,” Top Class Actions reports.
Brisol-Myers Squibb and Pfizer joined forces to market Eliquis. They bragged that Eliquis was supported by Bristol-Myers Squibb’s “long-standing strengths in cardiovascular drug development and commercialization” with Pfizer’s “global scale and expertise in this field,” reports Top Class Actions.
The U.S. Food and Drug Administration (FDA) gave Eliquis approval in 2012 as an anticoagulant that was useful in the treatment of atrial fibrillation. The clinical trial that the approval was based on, known as Aristotle, was called by some, “dubious.”
The Aristotle studies were mentioned by the lawsuit because the defendants allegedly hired incompetent and untrustworthy people in China to run the studies as a money-saving ploy. Those testing agents are accused of fraud as they failed to report a death during the study, did not correctly dispense the drugs if at all to some subjects, falsified records, and exercised general poor quality control, wrote Top Class Actions.
What made Eliquis so attractive was that it did not have to be monitored strictly the way warfarin, its main competitor, requires with regular blood testing and a restrictive diet. However, warfarin has an antidote which can be administered to stop hemorrhaging if someone is bleeding excessively while on warfarin.
There is no such antidote for Eliquis. The lawsuit claims that the manufacturers knew of the serious risks of gastrointestinal bleeding and brain bleeding with possible fatal consequences and did not alert the public or the medical community, Top Class Actions reports.