Plaintiff Genevieve P. of New York began taking Xarelto in 2012 under her physician’s supervision and continued to take it until the summer of 2014. During that time, Genevieve says she suffered two life-threatening bleeds requiring hospitalization and blood transfusions, once in May 2013 and again in March 2014. She attributes both these bleeds to the Xarelto she was taking at the time.

Genevieve now says that defendants Janssen Pharmaceuticals, Johnson & Johnson, and their related companies knew about the risks of Xarelto bleeding, yet failed to properly warn patients and their physicians of that risk. She also says the defendants failed to conduct proper studies of the risks of Xarelto bleeding.

She further alleges the defendants’ concealment of information about Xarelto was purposeful, demonstrating a “flagrant, willful, and depraved indifference to health, safety, and welfare.”

What is Xarelto?

Xarelto, or rivaroxaban, is an anticoagulant medication made by Janssen Pharmaceuticals. It’s approved by the FDA to reduce the risk of stroke in patients with non-valvular atrial fibrillation. It’s also approved as both a treatment and preventive for pulmonary embolism and deep vein thrombosis.

When Xarelto was first introduced to the market in July 2011, it was the second of a new generation of anticoagulants offered to supplant warfarin, which had been the dominant anticoagulant since the 1950s.

 Clinical Trials Indicated Xarelto Bleeding Risks

However, as Genevieve’s Xarelto lawsuit points out, the clinical trials for Xarelto revealed evidence of a risk of associated excessive bleeding. A series of trials known as the RECORD studies showed a greater incidence of bleeding with Xarelto.

Other trials known as the ROCKET AF studies reported that “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban [Xarelto] group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

In the defendants’ marketing for Xarelto, they highlighted the fact that Xarelto does not require ongoing blood testing and dosage adjustment, as is necessary with warfarin. But Genevieve argues that the clinical studies for Xarelto show that the drug is safer and more effective with ongoing monitoring of blood levels and dosage adjustment.

Genevieve notes that Xarelto has been implicated in many reports to the FDA of adverse events. In its first year on the market, 2,081 serious adverse events involving Xarelto were reported to the FDA, 151 of which resulted in death.

Genevieve’s Xarelto lawsuit raises claims for defective manufacturing and design, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraud, violation of various states’ consumer protection laws.

She seeks compensation for pain, suffering, emotional distress, medical expenses, and lost earnings. She is also asking the court for an award of punitive damages, based on the allegedly “wanton, willful, fraudulent” and “reckless” nature of the defendants’ actions.

Genevieve’s Xarelto Lawsuit is part of the larger Xarelto Multidistrict Litigation, MDL no. 2592, in the U.S. District Court for the Southern District of Louisiana.