A man has filed a claim against the makers of Xarelto on behalf of his loved one who allegedly suffered a life-threatening bleed from taking the blood thinning drug.

Plaintiff Alvin A. filed his Xarelto lawsuit in Louisiana federal court as part of the multidistrict litigation currently in progress against Hanssen Pharmaceuticals, its parent company Johnson & Johnson, Bayer Healthcare Pharmaceuticals and their related companies.

Alvin is suing on behalf of Ernestine A. He alleges that the dangerous side effects from Xarelto caused Ernestine to suffer a dangerous bleeding injury.

Ernestine was prescribed Xarelto in May 2014 in order to prevent and treat deep vein thrombosis. Shortly after she began taking the drug, “as a direct and proximate result of the use of Defendants’ Xarelto, [Ernestine] experienced hemorrhagic effusion on or about May 14, 2014 and suffered a life-threatening, irreversible bleed from the use of Xarelto, as well as severe pain and suffering.”

In addition to the life-threatening bleed, Ernestine suffered other permanent and lasting personal dangerous side effects from Xarelto including “physical pain and mental anguish, including, but not limited to, diminished enjoyment of life, expenses for hospitalization and medical treatment, and loss of earnings.”

Xarelto is one of a new generation oral anticoagulant drugs to treat the blood of patients who are at risk of developing blood clots for a variety of reasons. While it has been useful for some patients, many others have suffered dangerous side effects from Xarelto.

The drug has been approved to prevent stroke and heart attack in patients suffering from atrial fibrillation, an abnormal heart rhythm. It is used to treat and prevent deep vein thrombosis and pulmonary embolism, and is also used prophylactically to prevent blood clots in patients undergoing major surgeries such as hip or knee replacement.

In order to receive market approval, Xarelto was required to conduct a number of clinical trials to demonstrate its safety and efficacy before receiving clearance by the FDA.

The Xarelto lawsuit states that several trials conducted with the purpose of receiving market approval were actually flawed and faulty in nature, and the results of the studies were not accurately reflected in the information presented to patients and the medical community.

One such study, the ROCKET AF study, found that Xarelto was not inferior to a previous oral anticoagulant, warfarin, and had a similar risk of major bleeding.

However, the study found that “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 Xarelto lawsuit states.

The EINSTEIN studies showed that Xarelto was noninferior to warfarin, but they also showed that there was an increased risk of adverse events that caused the users to permanently discontinue the use of the medication or caused them to need prolonged hospitalization.

The RECORD studies showed Xarelto was superior to another anticoagulant medication, but patients also reported a greater incidence of bleeding that resulted in decreased hemoglobin levels and the need for blood transfusions.

Alvin has alleged multiple counts against the defendants regarding the dangerous side effects from Xarelto. These counts include negligence, strict products liability, breaches of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and violation of consumer protection laws.

The plaintiff is seeking a jury trial and awards of compensatory, economic, punitive and/or exemplary damages, pre-and post-judgment interest, attorneys’ fees and costs, and any additional relief deemed just and proper by the Court.

The Dangerous Side Effects from Xarelto Lawsuit is Case No. 2:17-cv-02136-TEF-MBN, and is part of the Xarelto MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.