A Kentucky plaintiff recently filed a lawsuit against Bristol-Myers, alleging that she suffered major Eliquis side effects such as internal bleeding because of the company’s negligence.

According to the lawsuit, plaintiff Patsy R. was prescribed Eliquis after being diagnosed with blood clots in the brain. Patsy’s physician prescribed Eliquis to treat blood clots, as well as to prevent stroke from atrial fibrillation.

The lawsuit claims that the blood thinner drug has been linked in reports and studies with some potentially serious Eliquis side effects, including internal bleeding, and that Patsy’s internal bleeding was caused by the drug’s defectiveness.

Patsy alleges in her Eliquis side effects lawsuit that Bristol-Myers misrepresented Eliquis as safe and effective in comparison with other blood thinner drugs, and actively concealed their knowledge of the serious risks linked with the drug.

Eliquis Background

Eliquis, part of a class of drugs called Factor Xa Inhibitors, was first approved as a blood thinner by the FDA in 2012. This class also includes Pradaxa and Xarelto, two other popular blood thinning drugs.

Eliquis and other Factor Xa Inhibitors were created to help prevent strokes and blood clotting. As Eliquis and similar drugs have become more popular, warfarin (the traditional blood thinner) has begun to fall by the wayside.

Warfarin requires consistent blood monitoring, which many patients would like to avoid; Eliquis and other Factor Xa Inhibitors claim to not require this kind of blood monitoring. However, warfarin has a major advantage: it comes with an antidote to reduce the blood thinning effects during major internal bleeding emergencies.

Without an antidote, blood thinners like Eliquis may result in some extreme bleeding problems.

The Eliquis side effects lawsuit also claims that the major study that contributed to the drug’s approval was actually riddled with errors and fraud.

The study, known as the ARISTOTLE study, was conducted in China. The Eliquis lawsuit claims that Bristol-Myers intended to cut costs, but by outsourcing the study, the company allowed fraud and inadequacy to negatively impact the study’s results.

When Bristol-Myers initially applied for the FDA approval of Eliquis, an FDA physician involved in the review process noted important missing data from the ARISTOTLE study. The physician, Dr. Thomas Marcinak, recommended that Bristol-Myers adjust the drug’s labeling to note the quality control problems from the ARISTOTLE study.

The Eliquis lawsuit claims, however, that Bristol-Myers chose to keep this information from consumers and the medical community. Instead, the company misleadingly stated that they had submitted “additional data” to the FDA, without indicating that this data would be of concern to the public and prescribing physicians alike.

Eliquis Side Effects Lawsuits

Because of the severity of Eliquis side effects, some patients have begun filing lawsuits against Bristol-Myers and Pfizer, the drug’s manufacturers. The lawsuits allege that the manufacturers acted negligently, and failed to adequately warn the public and the medical community about the dangers associated with the drug.

Eliquis side effects lawsuits claim that, had patients been fully aware of the drug’s risks and the inadequate testing, they may have chosen a safer alternative and avoided these Eliquis side effects altogether.

While an Eliquis lawsuit cannot reverse injuries or bring back a loved one, a lawsuit can help with the financial expenses that these complications incur through medical expenses and lost wages.

If you or someone you know has taken Eliquis or a similar blood thinner and suffered from Eliquis side effects like internal bleeding, you may be able to file an Eliquis lawsuit.

The Eliquis Lawsuit is Case No. 5:16-cv-00127 in the U.S. District Court for the Eastern District of Kentucky, Central Division-Lexington Docket.