A resident of the U.S. Virgin Islands has filed a lawsuit against Janssen Pharmaceuticals, claiming the Xarelto bleeding risk associated with the medication caused him to suffer severe internal bleeding.

Plaintiff Hermino R. says he began taking Xarelto on Feb. 4, 2015 and continued taking it until Sept. 30, 2015. He claims that he suffered from gastrointestinal bleeding on Sept. 30, 2015 at which point he stopped taking the blood thinning medication.

In July 2011, Xarelto was approved by the U.S. Food and Drug Administration to prevent deep vein thrombosis and pulmonary embolism. Later it was approved to reduce the risk of stroke or systemic embolism in patients and it began to be used as a blood thinner.

It, along with Pradaxa and Eliquis, set out to replace warfarin, the standard medication doctors usually prescribed to those patients needing blood thinners.

Warfarin had been used widely for many years but patients often needed constant blood monitoring and changes in diet. Xarelto was marketed as a drug superior to this without side effects.

However, reports of a Xarelto bleeding risk began to grow . As a result, many plaintiffs, including Hermino, have filed lawsuits against the drug manufacturers.

This Xarelto bleeding risk lawsuit claims that a series of clinical trials performed with Xarelto, the RECORD studies found that Xarelto was superior to other available medication. However, it also showed that with Xarelto came with a Xarelto bleeding risk.

Even so, plaintiffs like Hermino allege that the “RECORD studies were flawed in design and conducted in a negligent manner” including the “systematic discarding of medical records” and “unauthorized unblinding, falsification, and concerns regarding improprieties in randomization.”

Additional studies were performed regarding Xarelto including the ROCKET AF study. The ROCKET AF study compared Xarelto to warfarin. The FDA noted that in this study, the warfarin group was not managed well which means the data was “not adequate to determine if Xarelto is as effective for its proposed indication in comparison to warfarin when the latter is used skillfully.”

Hermino claims that he suffered from life-threatening bleeding because of a Xarelto bleeding risk and has suffered from other severe and personal injuries which are permanent and lasting in nature. These include loss of earnings, physical pain and mental anguish, diminished enjoyment of life, and expenses for hospital and medical treatment.

He believes that Janssen failed to conduct proper safety tests prior to releasing Xarelto for use in the public market and they did not adequately test for life threatening side effects including Xarelto bleeding risk.

He also asserts that Janssen made, distributed, marketed and sold Xarelto without adequate warning of the Xarelto bleeding risk to his doctors or any other person in the medical community.

Hermino’s Xarelto bleeding risk lawsuit brings forth counts of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation and fraud.

This Xarelto Bleeding Risk Lawsuit is Case No. 2:17-cv-09021-EEF-MBN in the United States District Court for the Eastern District of Louisiana.