Janssen Research and Development, a subsidiary of Johnson & Johnson, faces a woman’s Xarelto bleeding risk lawsuit alleging serious adverse bleeding side effects that she says she was never warned about.

Plaintiff Shari H., a Kentucky resident, filed the Xarelto bleeding risk lawsuit, joining a growing multidistrict litigation (MDL) against the company in Louisiana federal court.

According to the Xarelto bleeding lawsuit, Shari says that she took Xarelto between approximately November 2016 and February 2017. It was on Feb. 14, 2017, when she suffered internal bleeding side effects because of Xarelto.

The Xarelto bleeding risk lawsuit was filed on multiple counts including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, and Violation of Consumer Protection Laws/Consumer Fraud Laws.

Shari demands a trial by jury.

Overview: Xarelto Bleeding Risk

Shari’s claim is filed as part of a large MDL centered on allegations that Xarelto causes patients to suffer serious internal bleeding complications more than what they were led to believe to occur.

There are currently more than 18,000 lawsuits pending over Xarelto bleeding risk side effects. Plaintiffs that have filed lawsuits allege that they suffered several severe side effects and complications including stroke, excessive blood loss, adrenal bleeding, epidural hematoma, and wound infection and complication.

Xarelto (rivaroxaban) was approved by the U.S. Food and Drug Administration (FDA) in 2011. Xarelto, which works by inhibiting specific proteins in the bloodstream that contribute to blood clotting, is prescribed to inhibit a range of conditions such as pulmonary embolism (PE), strokes, and deep vein thrombosis (DVT).

Deep vein thrombosis (DVT) is caused by a blood clot in a deep vein, usually in the legs. It can also be life-threatening. A pulmonary embolism (PE), in comparison, occurs when one or more arteries in the lungs become blocked by a blood clot. A PE occurs when there is a blockage in one part of the body which circulates to the lungs and prevents blood flow.

While symptoms of a DVT include pain, tenderness, and swelling, often in the legs, symptoms of a PE include chest pain, coughing, and shortness of breath.

The lawsuits against the manufacturers claim that the defendants were negligent in several ways. For one, patients state that the company failed to warn about Xarelto’s dangerous bleeding risks. They also claim that by manufacturing a drug without an antidote, such an action constitutes a design defect.

Although marketed, the lawsuits claim, to provide superior patient benefits, the issue with Xarelto is that unlike other anticoagulant medications, Xarelto does not carry with it an antidote to stop potential Xarelto bleeding risks. In comparison, warfarin allows patients to stop internal bleeding through the administration of Vitamin K.

The Xarelto Bleeding Risk Lawsuit is Case No. 2:18-cv-01353-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.