A woman from Pennsylvania is bringing a claim on behalf of her late husband’s estate, alleging his death was caused by the anticoagulant drug Eliquis.

Plaintiff Tommasina B. is suing on behalf of the estate of her late husband Edward, with claims also brought on her own behalf and on that of four listed dependents of Edward.

Tommasina alleges that before Edwards death, he was prescribed Eliquis as part of his treatment for atrial fibrillation. He later suffered an intracerebral hemorrhage, the Eliquis lawsuit states.

Tommasina says Edward died from his injuries on June 17, 2014.

Tommasina now argues Edward’s intracerebral hemorrhage was a “direct and proximate result” of his use of Eliquis. She is bringing this Eliquis lawsuit against Bristol-Myers Squibb and Pfizer Inc., the companies behind the development, manufacture and sale of Eliquis.

Eliquis, also known as apixaban, is an anticoagulant medication used to reduce the risk of stroke in patients with atrial fibrillation. Tommasina says the defendants market Eliquis as an alternative to the older medication, warfarin.

She says the defendant’s selling points include the fact that, unlike warfarin, Eliquis does not require regular blood testing or dietary restrictions.

Eliquis Lawsuit Says Drug Was Over-Promoted

In her Eliquis lawsuit, Tommasina says the defendants aggressively over-promoted Eliquis, overstating its efficacy in preventing stroke and systemic embolism.

She says that both before and after marketing Eliquis, reports made to the FDA and to the defendants themselves put them on notice that some patients had experienced severe hemorrhaging while on Eliquis.

Yet the defendants never disclosed information about those adverse events to the medical profession or to the public, the lawsuit alleges.

Tommasina also takes issue with some of the clinical trials on which FDA approval of Eliquis was based. She alleges the defendants tried to cut costs by contracting with “incompetent and untrustworthy agents in China” to conduct one set of trials known as the ARISTOTLE study.

These agents allegedly failed to provide reliable data on the side effects of Eliquis. One trial participant’s death allegedly went unreported.

Researchers refrained from reporting side effects of Eliquis in other subjects, the plaintiff claims, and dispensing errors resulted in some subjects receiving no dose of Eliquis at all.

One set of records allegedly disappeared just before an FDA site visit, purportedly on orders from an employee of Bristol-Myers Squibb.

Tommasina says the defendants knowingly submitted the suspect study results to the FDA for approval. When questioned about them, the defendants failed to withdraw or correct them but instead only offered to submit additional data, according to Tommasina.

The Eliquis lawsuit includes a claim for wrongful death under Pennsylvania’s Wrongful Death Act. This claim seeks compensation for Tomassina’s own losses and those of Edward’s other dependents.

These include losses like medical bills, funeral and burial expenses and the cost of administrating Edward’s estate.

Tommasina also makes a claim under Pennsylvania’s Survival Act that seeks compensation for losses to the estate like lost earnings, retirement income and Social Security benefits.

Her survival claim also seeks compensation for the physical and mental pain and suffering Edward experienced as a result of his intracerebral hemorrhage.

Other claims in Tommasina’s Eliquis lawsuit are based on theories of negligence, strict liability for a defective product, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation and violation of state consumer protection laws.

The Eliquis Wrongful Death Lawsuit is filed in the U.S. District Court for the Eastern District of Pennsylvania.