A woman has filed an Eliquis wrongful death lawsuit after her mother died following an irreversible bleeding episode.

Margaret S. began taking Eliquis on May 18, 2015 for treatment of atrial fibrillation, also known as an irregular heartbeat.

Margaret was staying in a skilled nursing facility while she recovered from pneumonia accompanied by atrial fibrillation. Staff found her in bed with blood coming from her mouth and nose on June 4, 2015.

A look into a nearby trash can revealed she had lost a large amount of blood.

Because she had gone into cardiac arrest, staff began administering CPR. Margaret was rushed to a hospital via ambulance, but doctors determined she had suffered irreversible brain damage from the cardiac arrest. Her family, including Plaintiff Catherine C., decided to stop life support, and Margaret died that same day.

Eliquis Wrongful Death Lawsuit Faults Drug’s Makers

In 2007, Bristol-Myers Squibb and Pfizer partnered to promote Eliquis. The pharmaceutical giants declared that Eliquis was backed by Bristol-Myers Squibb’s “long-standing strengths in cardiovascular drug development and commercialization” with Pfizer’s “global scale and expertise in this field.”

The FDA approved the marketing of Eliquis in 2012 as an anticoagulant that could be used in the treatment of atrial fibrillation. The FDA’s approval was based for the most part on what are now known to be questionably-handled clinical trials known as ARISTOTLE.

Plaintiff: Clinical Trials Full of Unreliable Data

The Eliquis wrongful death lawsuit alleges the ARISTOTLE clinical studies were overseen by incompetent and untrustworthy people in China in order to reduce the costs of clinical trials.

The testing agents are accused of fraud for failing to report a death during the study; not following up with subjects; making dispensing errors that resulted in some subjects not even receiving the drug at all; poor overall quality control; and falsifying records.

In one instance, records went missing – supposedly on the order of a Bristol-Myers Squibb employee – just before the FDA initiated a site visit.

The Eliquis wrongful death lawsuit claims that the FDA told Bristol-Myers Squibb and Pfizer executives that they were “showing a pattern of inadequate supervision.”

Eliquis Wrongful Death Lawsuit Points to Bleeding Issues

Eliquis was aggressively marketed to the public through television commercials and print advertisements. The main message conveyed was that Eliquis did not have to be monitored in the blood. Its main competitor, warfarin, does require monitoring blood levels.

However, warfarin has an antidote. If someone is bleeding excessively while on warfarin, vitamin K is a reversal medication that stops hemorrhaging.

Eliquis has no known reversal agent. The manufacturers omitted the fact that with no way to mitigate the drug’s effects, uncontrolled bleeding could have unavoidable, fatal consequences, the Eliquis lawsuit alleges.

Bristol-Myers Squibb and Pfizer are accused of knowing of the hemorrhaging issues with the drug, but never disclosing these dangers to the medical community, nor to the public.

The Eliquis wrongful death lawsuit says, “Before and after marketing Eliquis, Defendants became aware of many reports of serious hemorrhagic events in users of its drugs, both as reported to the FDA and to them directly. Yet Defendants have not fully disclosed the complete facts, findings, and complications/adverse events of the Aristotle study.”

In addition, Eliquis is not the one-size-fits-all medication that it was promoted to be, the suit states. Elderly patients with other medical issues could experience a variety of blood levels of Eliquis based on these co-morbidities.

“To this end, Defendants published a paper showing 43 percent more exposure to the drug for those with creatinine levels at 1.5 or above, yet failed to properly supply adjusted dosing information.”

The creatinine level is an indicator of kidney functionality.

The Eliquis Wrongful Death Lawsuit is Case No. 3:17-cv-00969-N, in the U.S. District Court for the Northern District of Texas, Dallas Division.