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A Texas man filed a new lawsuit against Bristol-Myers Squibb and Pfizer, Inc., manufacturers of the blood-thinning drug Eliquis. He filed as Personal Representative of his wife’s Estate, whom he claims passed away as a result of taking Eliquis.

The case was filed on March 2, 2017, in the Superior Court of the State of Delaware. The plaintiff seeks both compensatory and punitive damages.

Plaintiff Suffers Gastrointestinal Bleed and Dies

According to the complaint, the decedent first started taking Eliquis (apixaban) on February 26, 2015. She took it at the direction of her physician for the treatment of atrial fibrillation.

The FDA first approved Eliquis on December 28, 2012, to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. It later approved the drug to help reduce the risk of blood clots following knee or hip replacement surgery and for the treatment of deep vein thrombosis and pulmonary embolism.

The plaintiff alleges that his wife suffered a gastrointestinal bleed (or excessive bleeding in the digestive tract) in March 2015, shortly after she started taking Eliquis. She also suffered other complications including anemia and related injuries. She was initially treated at a hospital but later died as a result of her injuries.

The plaintiff claims that the defendants failed to provide adequate warnings as to Eliquis’ risks and failed to conduct appropriate clinical trials to ensure its safety and efficacy.

Eliquis Clinical Trial Contained with Fraud and Errors

The FDA’s approval of Eliquis was based in large part on a clinical trial known as the ARISTOTLE trial. The plaintiff claims that the study was conducted in various countries, including China, and that the defendants chose “incompetent and untrustworthy agents in China” to conduct the study.

Indeed, reports have indicated that the manufacturers of Eliquis concealed information from the ARISTOTLE study, including side effects in test users, major dispensing errors, falsified records, and one death. According to an article in Pharmaceutical Approvals Monthly, based on documents posted by the FDA, the administration delayed approving the drug because of its investigation into evidence of fraud and dispensing errors in this clinical trial. The FDA ultimately questioned data from 24 of the 35 sites in China, according to Forbes.

The plaintiff claims that instead of admitting to these errors, the defendants never publically acknowledged the missing and incorrect data, thus misleading prescribing physicians and the public.

Plaintiff Claims Defendants Overstated Benefits of Eliquis

The plaintiff also claimed that after the FDA finally approved the drug, the defendants aggressively marketed it, stating that it was superior to warfarin—the leading anticoagulant for decades—because it didn’t require blood monitoring and because it was more effective at preventing stroke and blood clots.

According to the complaint, the defendants also failed to warn healthcare professionals and patients that there was no way to reverse the effects of the drug if they develop a bleed. Patients taking warfarin can have the effects reversed with vitamin K injections, but those taking Eliquis have no such option, leading to more serious and even life-threatening possibilities.

The plaintiff brings counts of negligence, strict products liability, breach of warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, fraud, and violation of consumer protection laws.

All federally-filed Eliquis lawsuits were recently consolidated in the Southern District of New York for pre-trial proceedings.

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