A woman from New York is suing on behalf of a patient who allegedly died due to side effects of the drug Xarelto.

Plaintiffs Vivian R. is bringing this Xarelto lawsuit on behalf of the late Belen H., who died in September 2014.

Vivian claims Belen suffered a wrongful death caused by Xarelto.

According to this Xarelto lawsuit, Belen started taking Xarelto around February 2014 to reduce the risk of antiphospholipid antibody syndrome.

On September 24, 2014, she allegedly was diagnosed with a subdural hemorrhage.

She died two days later, according to Vivian. Vivian now alleges Belen’s hemorrhage was a wrongful death caused by Xarelto.

Vivian names as defendants Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals and their related companies, all of whom she alleges have been involved in the development, manufacture, marketing or sale of Xarelto.

Also known by its generic name rivaroxaban, Xarelto is an oral anticoagulant used by many patients who have atrial fibrillation to reduce their risk of suffering blood clot-related injuries like stroke or systemic embolism.

It’s also used to treat pulmonary embolism and deep vein thrombosis and to reduce the risk of their recurrence, and to prevent deep vein thrombosis in patients undergoing hip or knee replacement surgery.

Vivian quotes information from the defendants’ websites that says over seven million people have been prescribed Xarelto worldwide.

Sales revenues for Xarelto have been substantial, reaching almost $2 billion for the 2013 fiscal year, Vivian says.

Plaintiff Alleges Wrongful Death Caused by Xarelto

Vivian alleges the results of clinical trials used to get FDA approval for Xarelto show the drug creates an increased risk of excessive bleeding.

She says one set of studies known as the EINSTEIN studies showed Xarelto created an “obvious increased risk of bleeding events as compared to placebo.”

Another study known as the ROCKET study showed that gastrointestinal bleeding occurred more frequently in patients taking Xarelto than in those taking warfarin, an older anticoagulant medication.

Vivian argues the defendants knew about the danger of excessive bleeding associated with Xarelto but failed to adequately warn the medical community or the general public about that risk.

The defendants also failed to disclose the fact that, unlike with warfarin, there is no antidote for Xarelto’s anticoagulant effect, Vivian says.

The lack of an antidote puts patients at risk for “permanently disabling, life-threatening and fatal consequences,” Vivian claims.

In addition to the claim for wrongful death caused by Xarelto, Vivian is also raising claims for negligence, strict products liability, breaches of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud and deceit.

Vivian seeks an award of compensatory damages to cover the harm Belen suffered and the associated expenses, punitive damages to punish the defendants for their allegedly “wanton, willful, fraudulent, [and] reckless acts,” court costs and attorneys’ fees, and whatever other relief the court deems fitting.

The Xarelto Wrongful Death Lawsuit is part of the Xarelto Multidistrict Litigation In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.