A Kansas man has filed a Xarelto bleeding symptoms lawsuit against Janssen, the makers of the blood thinner, claiming he suffered serious injuries as a result of taking Xarelto.

Plaintiff William C. began taking Xarelto in September 2012 for a period of only six weeks for his atrial fibrillation. However, according to his Xarelto bleeding symptoms lawsuit, he suffered “serious and severe injuries, including gastrointestinal bleeding on approximately October 29, 2012.”

His severe Xarelto bleeding symptoms forced him to have a blood transfusion as well as undergo hospitalization. His physician instructed him to stop his use of the drug because of his Xarelto bleeding symptoms.

Xarelto Bleeding Symptoms

Xarelto is a newer anticoagulant drug that has only been available in the United States market since 2011. It, along with Pradaxa and Eliquis, were designed to be superior to warfarin (coumadin), the blood thinning medication that had been on the market previously.

Xarelto acts as a Factor Xa inhibitor and is used to treat deep vein thrombosis and pulmonary embolism in patients who have had lower body joint replacement surgeries such as hip or knee replacements.

Warfarin treats the same symptoms, and is the blood thinner that doctors prescribed to patients for years. Xarelto’s drug makers, however, claimed that Xarelto patients would not need as much careful monitoring as patients who took other blood thinners.

The approval for Xarelto relied on a series of clinical trials known as the RECORD studies. While the studies showed that Xarelto was successful in preventing blood clots, it also carried with it a greater incidence of bleeding events, decreased hemoglobin and need of blood transfusions in some patients.

William’s Xarelto bleeding symptoms lawsuit claims, “Despite these findings, the RECORD studies were flawed in design and conducted in a negligent manner.”

In fact, the Xarelto bleeding symptoms lawsuit alleges the FDA Official Action Indicated (OAI)-rated inspections discovered “rampant violations” including the “systematic discarding of medical records,” unauthorized unblinding, falsification and problems with randomization. Because of this, the RECORD studies were so “flawed” that the results were unreliable, the complaint says.

Essentially, the lawsuit claims that the studies that Xarelto’s approval was based on were deemed flawed and unreliable by the FDA. Regardless, the FDA had also approved Xarelto to treat patients suffering from atrial fibrillation, like William.

A subsequent study known as the ROCKET AF study compared warfarin to Xarelto for its treatment of atrial fibrillation. It was determined that the warfarin group was poorly managed and that the study was full of other problems.

In the year after Xarelto was approved, there were over 1,000 serious adverse event reports filed with the FDA, most of them due to Xarelto bleeding symptoms. By the end of that fiscal year, there were over 2,000 Xarelto bleeding symptoms reports filed, including about 150 fatalities.

This Xarelto bleeding symptoms lawsuit additionally claims that Xarelto was overpromoted. William claims that Janssen’s fraudulent concealment and misrepresentations were designed to prevent him and the medical community from understanding the full risks associated with the blood thinning medication.

This Xarelto Bleeding Symptoms Lawsuit is Case No.2:17-cv-17567 in United States District Court for the Eastern District of Lousiana.