July 24, 2015 — A widow has filed a lawsuit against Pfizer Inc. and Bristol-Myers Squibb Co. claiming the blood-thinning drug Eliquis caused her husband’s death.
The lawsuit (PDF) was filed today in the U.S. District Court for the Southern District of New York (Case No. 1:15-cv-05808) by Deborah J. Herschell.
Her husband, Donald, was prescribed Eliquis in August 2014 for the treatment of atrial fibrillation, a common type of irregular heart rhythm that can cause blood clots and strokes. In October 2014, he experienced a gastrointestinal hemorrhage and irreversible bleeding that caused his death.
The lawsuit accuses drug-makers of cutting costs by choosing “incompetent and untrustworthy agents in China” to conduct clinical trials to gain FDA approval, and then hiding unfavorable results.
For example, at least one death went unreported, although the purpose of the study was to investigate the rate of death in Eliquis users compared to warfarin. The lawsuit also accuses drug-makers of poor quality control, changing and falsifying records, and “missing” records just before the FDA made a site visit.
Pfizer and Bristol-Myers Squibb are also accused of failure to warn about the risk of uncontrollable bleeding or the lack of an effective reversal agent:
“Unlike generally known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Eliquis, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Eliquis.”
Similar accusations have been made in thousands of lawsuits involving Xarelto (rivaroxaban) and Pradaxa (dabigatran), two other new blood-thinners. Last year, over 4,000 lawsuits involving Pradaxa settled for $650 million.
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