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A lawsuit alleges that a Pennsylvania man suffered a gastrointestinal hemorrhage as a direct result of taking Xarelto.

According to the lawsuit, the plaintiff was prescribed Xarelto from February 2016 to August 2016. The plaintiff alleges he suffered a gastrointestinal hemorrhage from taking the drug for less than one year. Ultimately, says the plaintiff, he was hospitalized and had to stop taking the drug.

“Specifically, Plaintiffs suffered various injuries, serious physical pain and suffering, medical, hospital and surgical expenses, loss of consortium, and/or death and funeral expenses as a direct result of their use of Xarelto,” alleges the lawsuit.

The plaintiff accuses Janssen, Johnson & Johnson, and Bayer of knowing about the risk of an gastrointestinal hemorrhage, but failing to warn physicians and their patients.

According to the lawsuit, the Food and Drug Administration (FDA) approved the use of Xarelto to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat DVT and PE, to reduce the risk of recurrence of DVT and/or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery in 2011.

The  lawsuit alleges that the drug makers relied on flawed research to obtain initial FDA approval of the drug. The lawsuit points to a 2009 review of the research drug makers used to urge FDA approval of the drug that states the studies were flawed. One study, says the review, had to be discarded because of research flaws.

The plaintiff claims that the drug makers aggressively marketed the drug, despite knowing about the risks of severe bleeding, including gastrointestinal hemorrhage.

Xarelto was touted as a more convenient alternative to warfarin. Drug makers highlighted the drug as a single daily dose pill that does not require blood monitoring or changes in diet, as required for patients taking warfarin. Contrary to these marketing claims, however, studies showed that Xarelto is safer and more effective if taken twice a day and while patients are undergoing blood monitoring, alleges the lawsuit.

“The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” argues the plaintiff. “The Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors and the FDA.”

medicationExacerbating the bleeding risks of the drug, including gastrointestinal hemorrhage, there is no antidote to stop the bleeding as there is with warfarin.

The plaintiff has joined others in a lawsuit against the drug makers.

The lawsuit seeks damages caused by the use of Xarelto, including additional medical expenses, lost wages, pain and suffering, and even wrongful death on behalf of family members who have lost loved ones due to severe bleeding from Xarelto.

The Xarelto Gastrointestinal Hemorrhage Lawsuit is Case No. 2:18-cv-00852-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.

If you or a loved one experienced an gastrointestinal hemorrhage or other injury from the drug Xarelto, contact the attorneys at McDonald Worley to evaluate your claim.

Disclaimer: McDonald Worley is not representing the plaintiff in this lawsuit.