Xarelto Wrongful Death Lawsuit Says Janssen Ignored FDA Marketing Warning

In a wrongful death lawsuit that names Janssen Pharmaceuticals and Bayer AG as defendants, the families of 10 people say their loved ones who died of excessive bleeding caused by the blood-thinning drug Xarelto.

The 10 plaintiffs live in different states but they filed the lawsuit together in St. Clair County (Illinois) Circuit Court on November 20, 2015. The plaintiffs are seeking compensatory damages for each of the deceased family members in the amount of $50,000. This amount is to help cover medical bills, funeral expenses, and for the pain and suffering for those left behind.

The plaintiffs allege misconduct on the part of Janssen and Bayer. They claim the drug makers failed to inform the public about Xarelto’s possibly serious side effects.

Xarelto (rivaroxaban) received Food and Drug Administration approval in 2011 to treat patients at increased risk of blood clots or stroke because of atrial fibrillation, deep vein thrombosis, and pulmonary embolism. Xarelto is also prescribed for people who have had hip or knee replacement surgery and are at risk for blood clots during recuperation.

Xarelto has been heavily advertised as being a more convenient alternative to the older medication warfarin, a blood-thinner that has been in use for more than 60 years. Warfarin users need regular blood monitoring to ensure the proper level of warfarin in their blood and they must follow a set of dietary restrictions to prevent possible harmful interactions. Xarelto does not have either of these requirements but Xarelto has a significant drawback: there is no known antidote in the event of a serious bleeding episode. Warfarin has a readily available antidote that can restore the body’s clotting ability and control bleeding. Xarelto lawsuits allege that television ads with celebrity Xarelto users happily touting its convenience omit the important risk created by the lack of an antidote. A number of people who have filed Xarelto side effects lawsuits say they would have chosen a different treatment if they had been aware of Xarelto’s bleeding risks.

Court documents in the wrongful death lawsuit say the FDA notified Janssen and Bayer that marketing claims about Xarelto were misleading and did not sufficiently identify the potentially fatal bleeding risks for Xarelto users. The lawsuit claims that Bayer and Janssen did not heed the warning, did not respond to the FDA’s letter, and did not change their marketing strategy for Xarelto.

More than 3,000 Xarelto side effects lawsuits have been filed; 2,800 of these are part of a federal multidistrict litigation (MDL) and 550 additional cases are part of a mass tort program in Pennsylvania state court. The first trials in the MDL are scheduled for early 2017.

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