A woman has filed a Xarelto wrongful death lawsuit after her mother died of internal bleeding in 2015.

Xarelto is a blood thinner that belongs to a class of drugs known as New Oral Anticoagulants (NOACs). Xarelto, made by Janssen Pharmaceuticals, Johnson & Johnson and Bayer Healthcare, was FDA-approved in July 2011.

Plaintiff Juanita T. allegedly was prescribed Xarelto in April 2015 for the prevention of atrial fibrillation, an irregular heartbeat that can cause patients to be at a higher risk of blood clots and strokes.

According to the Xarelto wrongful death lawsuit, Juanita suffered internal bleeding on June 25, 2015 and died July 6, 2015.

At the time of Juanita’s death, there was no antidote available to stop the anti-coagulating effects of Xarelto.

Xarelto Wrongful Death Lawsuit Allegations

The Xarelto wrongful death lawsuit alleges Xarelto was marketed as a better blood thinner than Coumadin (warfarin), a medication that has been used to prevent blood clots for 60 years. In the event of an accident or injury, Coumadin’s anticoagulating effects can be stemmed by an IV dose of vitamin K. Every ER in the country is trained to administer this antidote in emergency situations.

Xarelto was touted as a more convenient medication than Coumadin because the latter requires a periodic blood test to make sure a therapeutic level of the medication is maintained.

Xarelto was advertised as a “one dose fits all” blood thinner that every patient had to take only one time a day. Marketing and advertising materials directed at consumers called the ease of taking it once a day and not tracking the medication’s levels the “Xarelto Difference.”

The Institute for Safe Medication Practices questioned the Xarelto Difference when it noted in its initial 2012 QuarterWatch publication that during the reviewing process, the FDA “questioned the convenient once-a-day dosing cheme [of Xarelto], saying blood level studies had shown peaks and troughs that could be eliminated by twice-a-day dosing.”

The Xarelto wrongful death lawsuit alleges that Xarelto’s effectiveness was overstated and that the dangers of excessive, irreversible bleeding were not made clear.

Clinical studies conducted before Xarelto received FDA approval allegedly were mishandled to the extent that the FDA expressed concerns regarding the falsification of records and problems with randomization of samples, claims the Xarelto wrongful death lawsuit.

The FDA reported 1,080 Serious Adverse Event Medwatch reports regarding Xarelto in the year ending June 30, 2012, including 65 deaths.

By the end of 2012, Xarelto had 2,081 Serious Adverse Event reports, and 151 of those resulted in death. During that same time, 56 deaths were reported with warfarin.

The Xarelto wrongful death lawsuit says after learning of the Serious Adverse Event report data, Xarelto’s manufacturers failed to warn the public and failed to further investigate their drug’s safety profile.

The Xarelto Wrongful Death Lawsuit is Case No. 2:18-cv-05439-EEF-MBN 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.