An new Eliquis lawsuit has been filed against Bristol-Myers Squibb and Pfizer, Inc. by the estate of a Louisiana woman, claiming the drug allegedly led to her death.

Plaintiff Karen M., as the personal representative of the estate of the late Josephine G., states that Eliquis, an anticoagulant designed to prevent blood clots and strokes, allegedly made Josephine suffer serious and dangerous Eliquis side effects, including brain bleeding, gastrointestinal bleeding and severe pain.

Her physical deterioration led to mental anguish and death.

The Marketing Machine Behind Eliquis

In 2007, Bristol-Myers Squibb and Pfizer combined forces to “commercialize” Eliquis. The pharmaceutical giants boasted 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. This approval was based for the most part on what some call “dubious” clinical trials known as Aristotle.

The Potentially Flawed Aristotle Studies

The Eliquis lawsuit mentions the Aristotle clinical studies because the defendants are accused of hiring incompetent and untrustworthy people in China to conduct the studies in order to save money.

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 made a site visit.

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

When one FDA physician objected to the Aristotle data, Bristol-Myers Squibb and Pfizer simply responded that “additional data” would be forthcoming, and have never acknowledged the missing and wrong data was submitted to the FDA.

Eliquis Lawsuit Targets Bleeding Issues

One of the main selling points of Eliquis was that it 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, a reversal medication can be given to stop the hemorrhaging.

No such antidote exists for Eliquis. The manufacturers omitted the fact that with no way to mitigate the drug’s effects, gastrointestinal bleeding and brain bleeding could have unavoidable, fatal consequences, the lawsuit claims.

The Eliquis lawsuit says that Bristol-Myers Squibb and Pfizer knew of the hemorrhaging issues with the drug, but never disclosed these dangers to the medical community, nor to the public.

In addition, the manufacturers have not disclosed any data on the number of severe adverse reactions.

Critics Wonder: Why Aggressively Market Eliquis?

With the safety of an aging population at risk, why market this improperly tested drug that has no antidote?

Even with the risk of uncontrollable gastrointestinal bleeding and brain bleeding, Eliquis had sales of $774 million in 2014.

The medication was not only marketed to the public via television commercials, but also to the medical community. According to ProPublica/NY Times, Bristol-Myers Squibb and Pfizer paid more than $8 million to physicians in 2013 alone.

The Eliquis Lawsuit is Case No. 2:16-cv-03673, in the U.S. District Court for the Eastern District of Louisiana.