Xarelto Bleeding Lawsuit Filed Over Wrongful Death

A wrongful death lawsuit has been filed by the family of a Vermont man who suffered irreversible brain bleeding that was allegedly caused by side effects of Xarelto, a new generation anticoagulant that has been linked to a growing number of similar reports.

The complaint (PDF) was filed by the daughter of Thomas C. Dunkley against Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary on July 25, in the U.S. District Court for the District of Vermont.

According to allegations raised in the Xarelto lawsuit, Dunkley was prescribed the anticoagulant in July 2012, for treatment of atrial fibrillation to reduce the risk of a deep vein thrombosis (DVT) or pulmonary embolism.

After using the medication for less than ten days, Dunkley suffered irreversible bleeding from Xarelto, which ultimately led to his death on August 1, 2012.

The case joins a growing number of Xarelto bleeding lawsuits being filed throughout the U.S., raising similar claims that individuals suffered severe and often fatal injuries as a result of uncontrollable hemorrhaging while taking the controversial anticoagulant, which does not have an approved reversal agent to allow doctors to stop the drug’s blood thinning effects.

Xarelto (Rivaroxaban) is part of a new generation of anticoagulants, known as “direct thrombin inhibitors,” which are used to reduce the risk of blood clots and strokes. The medication was jointly developed by Bayer and Janssen, and was introduced in late 2011.

While Bayer and Janssen have indicated that they are now working with a company called Portola Pharmaceuticals to develop an Xarelto reversal agent, plaintiffs allege that the drug makers withheld information from consumers and the medical community about the lack of an antidote and about the severe bleeding risks with Xarelto.

Dunkley’s daughter, Ruth McGowen, claims that the drug manufacturers placed their desire for profits before patient safety, pointing out that Bayer and Janssen spent $11 million promoting the drug in 2013 in medical journals alone.

As a result of aggressive marketing that suggested Xarelto is a superior alternative to warfarin, which has been the standard anticoagulation treatment for decades, the medication was quickly adopted and generated $582 million in worldwide sales during the first year on the market and total sales reached about $2 billion last year.

While the drug makers promoted that Xarelto is easier to use than warfarin, which requires blood monitoring during treatment, they withheld information that there is no Xarelto antidote like there is for warfarin, where doctors can quickly reverse the blood thinning effects of the medication if hemorrhaging develops.

“As part of their marketing of Xarelto, Defendants widely disseminated direct-to-consumer advertising campaigns that were designed to influence patients, including Decedent, to make inquiries to their prescribing physician about Xarelto and/or request prescriptions for Xarelto,” the complaint filed by McGowen states. “In the course of these direct-to-consumer advertisements, Defendants overstated the efficacy of Xarelto with respect to preventing stroke and systematic embolism, failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and that such irreversibility could have permanently disabling, life-threatening and fatal consequences.”

The lawsuit notes that on June 6, 2013, the manufacturers were cited by the FDA for putting out promotional material for Xarelto that was false or misleading because it minimized the risks associated with the drug.

The lawsuit charges Bayer, Janssen and Johnson & Johnson with negligence, strict product liability, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and violating consumer protection laws.

McGowan is seeking compensatory and survivor’s damages, as well as punitive damages against the manufacturers for “wanton, willful, fraudulent, reckless acts” in selling and promoting Xarelto.