A woman from California is bringing a Xarelto lawsuit, seeking compensation for the loss of her husband due to an intracranial hemorrhage.

Plaintiff Leatrice O. is suing on her own behalf and as the executrix of the estate of her late husband Melvin. Leatrice alleges that in June 2014, Melvin fell asleep and could not be woken. She checked his blood pressure and found that it was abnormally high, she says.

Paramedics brought Melvin to the hospital, where imaging studies revealed he had severe bleeding on the brain. Doctors drained the blood from Melvin’s head, but he nevertheless fell into a coma. Melvin was taken off life support and later died.

Leatrice says that at the time of Melvin’s intracranial hemorrhage and subsequent death, he had been taking Xarelto since May 2013. She now claims that his hemorrhage was a direct result of his Xarelto treatment.

Bringing a Xarelto Lawsuit for Wrongful Death

Xarelto is a blood thinner medication introduced to the U.S. market in July 2011. Xarelto is specifically approved by the FDA to reduce the risk of stroke and embolism in patients with non-valvular atrial fibrillation.

It’s also approved to treat and prevent pulmonary embolism and deep venous thrombosis.

The Xarelto lawsuit also says Xarelto is one of a group of anticoagulant drugs known as New Oral Anticoagulants. These drugs were recently developed to replace the older blood thinner warfarin, which had been known for decades as a safe way to prevent stroke and systemic embolism, she alleges.

Among other arguments in the Xarelto lawsuit, Leatrice claims the defendants failed to properly warn the public about the dangers of Xarelto side effects despite ample available evidence of the risks involved.

She cites several of the clinical trials used to earn FDA approval for Xarelto, many of which found that Xarelto side effects included instances of excessive bleeding severe enough to require blood transfusions.

Leatrice also argues the defendants never should have marketed Xarelto as being safe for once-daily dosing. She says the defendants aggressively promoted Xarelto as having something they called the “Xarelto Difference.”

Part of that difference included once-daily dosing.

But Leatrice says recommending once-daily dosing for Xarelto was purely “a marketing campaign based on flawed science.” She quotes FDA medical reviewers who found that “the sponsor’s rationale for evaluating only once daily dosing during Phase 3 is not strong.”

The reviewers commented that twice-daily dosing would help smooth out the peaks and dips in blood levels and could be associated with more efficacy and possibly a better safety profile.

One reviewer expressed concern that the once-daily dosing was selected more for marketing advantage than on the basis of available scientific data, Leatrice says.

She also cites a letter from the FDA to the defendants ordering them to correct a print ad for Xarelto, saying the ad was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim” regarding dose adjustments.

Leatrice’s Xarelto lawsuit raises claims for strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraud and violation of consumer protection laws.

Leatrice seeks an award of damages to cover the expenses related to Melvin’s final illness and death, as well as the loss of all benefits that Leatrice could have expected from her relationship with Melvin had he remained alive.

She is also asking for an award of punitive damages to deter the defendants from continuing their allegedly culpable behavior.

The Xarelto Lawsuit is Case No. 3:16-cv-02965 in the U.S. District Court for the Northern District of California.