A Xarelto lawsuit was filed against Bayer and Jansen Pharmaceuticals by the daughter of a Florida woman who allegedly bled to death after taking the medication.

Like millions of Americans, Tara H.’s mother had been prescribed Xarelto to treat her atrial fibrillation and to ultimately prevent stroke. The lawsuit says the plaintiff and her mother were unaware of the potentially fatal bleeding associated with Xarelto.

Her mother was prescribed Xarelto in July 2012, and stayed on it for several months without experiencing complications. However, on Nov. 26, 2012, she suffered uncontrollable gastrointestinal bleeding and was hospitalized. She died three days later.

The Xarelto lawsuit accused Jansen and Bayer of failure to warn about the possibility of such bleeding episodes. The plaintiff insists that her mother never would have used Xarelto if she had known about the possible side effect of uncontrollable bleeding, especially when Xarelto has no reversal agent.

As the manufacturing companies, Tara’s lawyers state that Janssen and Bayer had the responsibility to warn their client and other Xarelto patients of any potential side effects that could occur when using their product.

Among the allegations made in the Xarelto lawsuit are negligence, false advertising, concealing information, and misrepresenting a product.

This Xarelto Lawsuit is Case No. 2:15-cv-00189-EEF-MBN, in the U.S. District Court for the Middle District of Florida, Tampa Division.

Overview of Xarelto Bleeding Complications

Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011 to treat atrial fibrillation in high-risk stroke patients, and has become the most popular new-generation anticoagulant. It was released as a joint effort by Bayer Pharmaceuticals and Johnson & Johnson’s subsidiary, Jansen Pharmaceuticals, and has proven to be successful.

Due to aggressive marketing by these companies, Xarelto propelled its way to the top of the blood-thinner market. Unlike their predecessor Warfarin, Pradaxa and Xarelto allegedly have the same design defects that cause bleeding injuries and no stopping agent.

Essentially, if a Xarelto or Pradaxa patient were to suffer internal bleeding, there would be no way to stop the bleeding without medical intervention. This differs greatly from Warfarin, which has vitamin K as its stopping agent, and had various requirements for the patient to follow such as frequent doctor visits, blood monitoring, and dose adjustment.

Xarelto and Pradaxa have no such requirements, which had been a main advertising point. With no need for maintaining dose regulation and frequent doctor appoints, as well as having a reportedly faster-acting mechanism than Warfarin, patients found the prospect of these new anticoagulants very appealing.

Unfortunately, Xarelto now faces the same intense litigation pressure as Pradaxa, with experts expecting lawsuits to continue.