An atrial fibrillation patient filed a Xarelto bleeding lawsuit, alleging the drug caused dangerous gastrointestinal bleeding.

Plaintiff Lloyd E. says he started taking Xarelto in May 2014 on his doctor’s advice as a treatment for atrial fibrillation and coronary artery disease. A few months later, he says, he developed an acute gastrointestinal bleed for which he had to be hospitalized.

Lloyd argues the bleeding was directly attributable to the Xarelto he took for his cardiovascular conditions. So he filed a lawsuit against Xarelto’s maker Janssen Pharmaceuticals, its parent company Johnson & Johnson, Bayer Corporation, and their related companies.

The lawsuit argues the companies failed to properly disclose the risks of Xarelto bleeding. If they had, he says, he never would have taken Xarelto.

Xarelto (rivaroxaban) is an anticoagulant medication that’s been on the market since earning FDA approval in July 2011. Xarelto is often used to prevent blood clots and strokes in patients with non-valvular atrial fibrillation.

Other approved uses of Xarelto include treatment of deep vein thrombosis and pulmonary embolism, prevention of both those conditions before they happen, and reducing the risk of blood clots and related complications in patients who recently had hip or knee replacement surgery.

The marketing for Xarelto touted it as an improvement over warfarin, which for years had been medicine’s go-to anticoagulant. Lloyd says the defendants’ marketed Xarelto as not requiring ongoing blood monitoring or dietary restrictions. However, Lloyd claims Xarelto is not actually safer than warfarin and may be only slightly easier to use and administer.

Lloyd argues the labeling for Xarelto should have included a warning about the risk of excessive bleeding. He cited the ROCKET AF clinical trial, in which patients taking Xarelto had more bleeding events and more need for blood transfusions.

A print advertisement for Xarelto in WebMD magazine earned the defendants some negative attention from the FDA. In a letter to the defendants, Lloyd says, the FDA said the advertisement understated the risks associated with Xarelto and incorrectly stated that no dosage adjustments were necessary, contrary to the language on the FDA-approved label.

The Xarelto lawsuit also cites hundreds reports of adverse events associated with Xarelto, including 72 cases in Germany that ended in death. He says that in 2012, the Institute for Safe Medication Practices “identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug.”

Lloyd says the defendants knew this information about Xarelto side effects but purposely concealed it from patients and doctors.

Lloyd is raising claims based on theories of failure to warn, design defect, negligence, misrepresentation, breach of warranty, and fraud. He seeks compensation for pain and suffering, past and future medical expenses, and past and future physical impairment.

Lloyd is also asking for an award of punitive damages, arguing that the defendants acted “willfully, intentionally, and with reckless disregard” for both Lloyd’s rights and those of the public.

Lloyd’s Xarelto lawsuit is Case No. 3:15-CV-00413in the U.S. District Court, in the Eastern District of Tennessee.