A Xarelto lawsuit was filed in Louisiana in December that claimed the blood thinner designed to help atrial fibrillation patients caused severe internal bleeding.

Defendants Janssen, Johnson & Johnson, and Bayer, who were responsible for designing, testing, promoting and selling Xarelto, have faced a number of Xarelto uncontrollable bleeding lawsuits that list severe bleeding as a Xarelto side effect. 

Plaintiff Joseph B. began taking Xarelto in January 2014 and stopped on Feb. 3, 2014 when he was hospitalized for “a severe gastrointestinal bleed, dizziness, weakness, and fatigue accompanied by black, tarry stools,” according to the Xarelto lawsuit.

Joseph claims that needed several blood transfusions in order to recover, and he still requires follow-up treatment.

The defendants were accused of “negligently and/or fraudulently” claiming that Xarelto was safe to use and concealing alleged Xarelto side effects from the public and medical community, according to the Xarelto lawsuit.

Xarelto was approved in 2011 to treat atrial fibrillation and to help prevent clotting in patients undergoing knee or hip replacement surgery. It was introduced as an alternative to warfarin, which was the leading anticoagulant for decades. Xarelto was introduced to the market a year after Pradaxa, the first generation in this new wave of medicine. Eliquis followed after Xarelto.

Xarelto was heavily promoted as a treatment that did not require blood monitoring and did not limit a patient’s diet, like warfarin.

It was the most advertised drug. However, “the Defendants’ promotional materials fail to … highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns,” says the Xarelto lawsuit.

Although allegedly the defendants claimed the drug was safer than warfarin, many have experienced Xarelto bleeding side effects which have resulted in hospitalization.

Furthermore, warfarin has an antidote if bleeding side effects arise. There is no Xarelto antidote, making is especially dangerous if a patient, like Joseph, experiences severe Xarelto side effects.

In June 2013, the U.S. Food and Drug Administration, or FDA, required Xarelto makers to cease publishing their promotional materials based on the fact that “the print ad is false or misleading because it minimizes the risks associated with Xarelto.”

Even though the promotional materials stopped, physicians were allegedly not adequately informed about Xarelto side effects, that Xarelto was not as safe and/or effective as warfarin, and that there is no Xarelto antidote.

Millions have been prescribed Xarelto since its introduction to the American market.

In the fist six months of 2012, over 1,000 adverse events were reported to the FDA. Several of these cases involved death.

By the end of the 2012 fiscal year, an additional 2,000 reports were filed with the FDA. Out of these adverse reports, 151 of these reports were Xarelto deaths. Warfarin only had 56 deaths reported during the same time frame.

Many adverse events are not reported to the FDA. Patients may also not be aware of the source of their medical condition.

Joseph sought compensatory damages for the pain and suffering, emotional distress, medical bills, and several other limitations mentioned in the Xarelto lawsuit. He also asked for damages for loss of care and comfort, loss of earnings and impaired earning capacity, all present and future medical bills caused by Xarelto, attorney fees, and exemplary damages.

Joseph is one of many individuals who have filed a Xarelto lawsuit against these defendants. A Xarelto class action lawsuit investigation has been launched.

This Xarelto Uncontrollable Bleeding Lawsuit is Case No. 2:14-cv-02720 filed in the U.S. District Court of the Eastern District of Louisiana.