A new claim by a Texas couple accuses Janssen Pharmaceuticals and Johnson & Johnson of overpromoting their blood thiner Xarelto.

Plaintiffs Walter and Sue P. of Texas are bringing claims against Janssen Pharmaceuticals Inc., Johnson & Johnson, Bayer Healthcare Pharmaceuticals Inc., and their related companies, all of whom are involved in the development, manufacture or sale of the anticoagulant medication Xarelto.

Walter says he began taking Xarelto around May 2013. According to his Xarelto lawsuit, Walter suffered two internal bleeding events in May and November of that year. Both bleeding events were life-threatening and required hospitalization and blood transfusions, he says.

Walter now says these two bleeding events were caused by the Xarelto he took. He argues that the defendants made certain misstatements in their promotional material for Xarelto and concealed certain important information about the risk of Xarelto bleeding.

Had Walter known otherwise, he says, he would have taken extra precautions during his Xarelto treatment or would not have used Xarelto at all.

Xarelto Bleeding Risks

At issue in this and other Xarelto lawsuits is the risk of excessive bleeding that comes with Xarelto treatment. Xarelto, or rivaroxaban, is a product of Janssen Pharmaceuticals and its parent company Johnson & Johnson.

It’s commonly used to prevent stroke and systemic embolism in persons with non-valvular atrial fibrillation. It’s also approved by the FDA to treat deep vein thrombosis and pulmonary embolism, and to prevent their recurrence. It also reduces the risk of deep vein thrombosis in patients undergoing hip and knee replacement surgery.

Along with Pradaxa and Eliquis, Xarelto is one of a new generation of anticoagulants that recently entered a market that had been dominated for decades by the anticoagulant warfarin, also sold under the brand name Coumadin.

Though Coumadin is still the most frequently prescribed drug for treatment of atrial fibrillation, Xarelto is in second place. Sales of Xarelto reached $2 billion dollars in 2013.

Excessive, Misleading Xarelto Advertising

Walter and Sue argue that the defendants over-promoted Xarelto’s efficacy and understated its risks. They say the defendants spent at least $11 million in 2013 alone on advertisements in medical journals and on direct-to-consumer advertising.

This campaign touted what the defendants called the “Xarelto Difference,” which referred to the fact that unlike warfarin, Xarelto used an easier once-daily dosage and did not require ongoing blood monitoring.

However, the plaintiffs also cite research that suggests both dosage adjustments and blood monitoring might be warranted in the course of Xarelto treatment. The advertising also does not mention the fact that, unlike with warfarin, there is no antidote to the anticoagulation effects of Xarelto. Once excessive Xarelto bleeding starts, there is no complimentary medication or “reversal agent” that can get it under control.

They also cite a June 2013 letter from the FDA asking the defendants to cease production of a particular print ad that the agency described as “false or misleading because it minimizes the risks associated with Xarelto” and could mislead consumers about the necessity of dose adjustments.

Sue, Walter’s spouse, is bringing her own claim for loss of consortium. Loss of consortium is a legal claim that the spouse of a victim can bring to seek compensation for the harm done to the marital relationship. It can cover more concrete losses like loss of services and financial support, and it can also compensate for losses not as easily quantified, such as loss of affection and emotional support.

The Xarelto Lawsuit is Case No. 2:15-cv-01693 in the U.S. District Court for the Eastern District of Louisiana.