Plaintiffs Shirley and Allan S. have filed a products liability lawsuit against the manufacturers of Xarelto in Louisiana federal court.

According to the lawsuit, Shirley was prescribed Xarelto, also known as rivaroxaban, to reduce her risk of stroke and systemic embolism. The medication is prescribed to defer the risks of these conditions in patients who suffer and possess non-valvular atrial fibrillation, a type of cardiac arrhythmia.

Shirley S. a resident of Kansas, was prescribed Xarelto on May 1, 2017, upon her physician’s request to treat deep vein thrombosis; the formation of a blood clot rising within the body’s lower extremity. She had continued to take the medication until May 14, 2017.

Moreover, allegedly because of the prescription medication, she suffered a hematoma in her left leg and irreversible life-threatening bleeding.

The lawsuit maintains that due to the prescribed Xarelto medication, Shirley was caused to suffer Xarelto bleeding side effects including “serious and dangerous side effects including inter alia life threatening bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain, and mental anguish, including diminished enjoyment of life.”

This Xarelto lawsuit is part of the multidistrict litigation, or MDL, currently in progress against Janssen Pharmaceuticals, its parent company Johnson & Johnson, Bayer Healthcare Pharmaceuticals and other companies in relation.

Xarelto is a new anticoagulant medication currently being prescribed to patients to treat or at risks of developing blood clots. Although it has been reported to be of some use in patients, other patients have complained and suffered serious Xarelto bleeding side effects and other dangerous side effects.

The drug was approved in prevent stroke and heart attacks in patients with the condition of an abnormal heart rhythm or, atrial fibrillation. It was approved to treat conditions such as pulmonary embolism and deep vein thrombosis. It is also prescribed to patients undergoing knee replacement surgeries, for example, to prevent them from forming blood clots.

To receive its approval from the U.S. Food and Drug Administration, it had to conduct several clinical trials to prove and safety and efficacy in patients.

However, claims and reports have been made that the clinical trials were allegedly flawed and faulty in nature. Moreover, the results and conclusions of the study were not properly presented to the medical community and patients at large.

The ROCKET AF study, is one such study that was allegedly found to be faulty and flawed in nature. Purportedly, the study had concluded that Xarelto was noninferior to warfarin for the “prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation, with a similar risk of major bleeding.”

However, what was found, according to the Xarelto bleeding side effects lawsuit, was that in the Xarelto group in comparison with its competitor warfarin, “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

The plaintiff has alleged multiple accounts against the defendant including: negligence, fraudulent concealment, negligent misrepresentation, and fraud, among many others.

The Xarelto Bleeding Side Effects Lawsuit is Case No. 2:17-cv-06963-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana. The Xarelto MDL is In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.