A new lawsuit has been filed in the Xarelto multidistrict litigation currently under way in federal court in Louisiana against the manufacturers against Xarelto, a popular blood thinner medication.

Janssen Pharmaceuticals, its parent company Johnson & Johnson and Bayer Corporation, along with their related companies, are the named defendants in the Xarelto lawsuit alleging the pharmaceutical companies participated in over-promotion of Xarelto.

Plaintiff Frances C. Began taking Xarelto in May 2013 and used it through November 2014 under the advice of her physician.

“Upon information and belief, as a direct and proximate result of the use of Defendants’ Xarelto, Plaintiff experienced rectal bleeding, acute post hemorrhaging anemia on or about November 25, 2014 and was caused to suffer a life-threatening bleed requiring blood transfusions and extensive hospitalization from the use of Xarelto,” her lawsuit alleges.

Xarelto is the second most prescribed drug used to treat atrial fibrillation, second only to warfarin, the industry standard for the last six decades.

It works by blocking the body’s natural clotting mechanisms, thereby preventing blood clots. In patients with atrial fibrillation, a blood clot can cause fatal consequences, such as heart attack or stroke.

Over-Promotion of Xarelto Lawsuit Allegations

Frances’ lawsuit states that the makers of Xarelto spent $11 million just in 2013 alone to advertise their products in journals targeted to those who would prescribe the medication and to consumers in the United States.

Xarelto took the number one spot for advertising in the third quarter of fiscal year 2013 based on the total number of pages about Xarelto in journals and the total amount of money spent on product promotion.

While its advertising appeared to pay off, the lawsuit states that the over-promotion of Xarelto led to many personal injuries and even deaths sustained by patients.

The marketing materials referred to a “Xarelto Difference” which highlighted the drug’s requirement for easy once-a-day dosing without the need for blood monitoring.

“In fact, the’ Xarelto Difference’ was nothing more than a marketing campaign based on flawed science,” the Xarelto lawsuit states.

A great deal of marketing was done as direct-to-consumer, known as DTC.

“In the course of these DTC advertisements, Defendants overstated the efficacy of Xarelto with respect to preventing stroke and systemic embolism, failed to disclose the need for dose adjustments, failed to disclose the need for blood monitoring, and failed to adequately disclose to patients that there is no drug, agent, or a means to reverse the anticoagulation effects of Xarelto, and, that such irreversibility could have permanently disabling, life-threatening and fatal consequences.”

In June 2013, at the height of the drug’s popularity, the FDA sent the pharmaceutical companies a letter regarding their over-promotion of Xarelto.

It stated “the print ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim” with respect to dose adjustments that were necessary with the drug, according to the Xarelto lawsuit.

Unlike warfarin, Xarelto does not have a way to reverse the effects of blood thinning to promptly restore the body’s natural clotting mechanisms.

This has led to severe bleeding complications in some patients who have taken Xarelto. Gastrointestinal bleeds and brain bleeds, some which have proven fatal, are common complications of Xarelto use.

Frances has brought forth a number of counts against the pharmaceutical company including strict liability, manufacturing defect, design defect, failure to warn, negligence, breaches of express and implied warranties, negligent this representation, fraudulent misrepresentation and violation of consumer protection laws.

The Over-Promotion of Xarelto Lawsuit is Case No. 2:16-cv-15925, and is part of the Xarelto MDL, In re: Xarelto (rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.