An Illinois couple has added their claim to the multidistrict litigation against Janssen Pharmaceuticals and related companies over the prescription drug Xarelto, which has been linked to fatal internal bleeding events.

Plaintiff John F. began taking Xarelto in April 2013. In early October of that year, John suffered from a life-threatening bleed with blood in his urine and low levels of hemoglobin and red blood cells. His complications required surgery and blood transfusions that necessitated an extended hospital stay.

John alleges Xarelto caused that excessive bleeding and is therefore defective. He also alleges Janssen failed to properly test Xarelto for safety, intentionally concealed knowledge of Xarelto’s defects, and misrepresented Xarelto as safe for its indicated use.

Xarelto and Gastrointestinal Bleeding

Xarelto is an anticoagulant medication used to treat and prevent certain circulatory conditions. The FDA first approved Xarelto in July 2011 for use to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. In November 2011, the FDA granted additional approval for use to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

In its relatively few years on the market, Xarelto has been a commercial success. Sales in its first year on the market were in the hundreds of millions of dollars, and by 2013 annual worldwide sales reached $2 billion.

However, studies of Xarelto showed it came with an increased risk of excessive and uncontrollable bleeding. The clinical trials for the 2011 FDA approvals consistently showed Xarelto (studied under its generic name rivaroxaban) led to more instances of bleeding, particularly gastrointestinal bleeding, that resulted in low hemoglobin levels and required blood transfusions. John’s Xarelto lawsuit says Janssen failed to address this increased risk of bleeding in their promotional materials.

Janssen’s marketing of Xarelto has also received negative attention.

Janssen spent at least $11 million in 2013 on marketing for Xarelto, much of it direct-to-consumer. In June of that year, the FDA ordered Janssen to stop distributing certain promotional material for Xarelto, saying that material minimized risks associated with Xarelto dose adjustments in a way that was false or misleading.

Much of Janssen’s marketing also portrayed Xarelto as an improvement over warfarin, an older anticoagulant considered relatively safe. However, while warfarin has a complementary medication, known as a “reversal agent,” that can stop excessive bleeding once it starts, there is no such reversal agent that can stop Xarelto bleeding.

Indeed, in the U.S. and Germany, government regulators have received reports of thousands of adverse events related to Xarelto bleeding, several dozens of which have resulted in death. John alleges that Janssen failed to warn of the lack of a reversal agent in its marketing.

John’s Xarelto lawsuit raises claims for negligence, defects in design and manufacture, breach of warranty, misrepresentation, withholding of important safety information, fraud, and violation of consumer protection laws.

John and his wife Mary G., also a plaintiff, both seek compensation for the effect of John’s Xarelto side effects on their marriage. They seek compensation for pain and suffering, medical and related expenses, punitive damages, and costs of the litigation including attorney’s fees.

This Xarelto lawsuit is pending in the U.S. District Court for the Eastern District of Louisiana under case no. 2:15-CV-01093-EEF-MBN. It’s part of the Xarelto multidistrict litigation titled In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL no. 2592.