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A new lawsuit alleges that a man from Maryland took Xarelto and developed a severe gastrointestinal bleed.

According to the lawsuit, Lloyd M., took Xarelto from July 2013 to March 2015. The plaintiff says he developed and suffered a gastrointestinal bleed from Xarelto in late March 2015 as a direct result from taking the drug.

According to the lawsuit, Janssen, Johnson & Johnson, and Bayer were “in the business of and did design, research, manufacture, test, advertise, promote, market, sell, and distribute the drug for use as an oral anticoagulant, the primary purposes of which are 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.”

The lawsuit alleges that the plaintiff “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.” The plaintiff claims that he suffered a severe gastrointestinal bleed from Xarelto.

According to the lawsuit, after the Food and Drug Administration approved use of the drug numerous complaints were filed. The FDA ended up reviewing the studies Janssen and other drug makers used to support the agency’s approval of Xarelto. According to the lawsuit, the FDA found “rampant violations.” Violations included discarding medical records, unauthorized unblinding, and even falsification of research records, according to the complaint.

In addition, alleges the plaintiff, the risk of a gastrointestinal bleed from Xarelto and other problems were not properly disclosed to doctors and patients before the drug hit the market.

“Xarelto is the second most prescribed drug for treatment of atrial fibrillation, behind only Coumadin (warfarin), and achieved blockbuster status with sales of approximately $2 billion dollars in 2013,” says the lawsuit.

side-effectsFurther, alleges the plaintiff, Coumadin, also known as warfarin, is a known, safe treatment for preventing the problems is meant to treat.

Although warfarin is supposedly more labor intensive for the patient, requiring blood monitoring and limitations to patients’ diets, it presents less risk of a gastrointestinal bleed than Xarelto.

Janssen and other drug makers aggressively marketed the drug after obtaining FDA approval, alleges the lawsuit; however, they failed to properly identify and warn doctors and patients about the risk of a gastrointestinal bleed from Xarelto.

“Defendants’ aggressive and misrepresentative marketing of a ‘Xarelto Difference’ lead to an explosion in sales. The ‘Xarelto Difference,’ i.e., was once a day dosing without blood monitoring. In fact, the ‘Xarelto Difference’ was nothing more than a marketing campaign based on flawed science,” further alleges the plaintiff.

According to the lawsuit, even the drug makers’ own studies acknowledge that is safer and more effective if taken twice a day and when there is blood monitoring. Further there is no antidote to a gastrointestinal bleed from Xarelto or other problems.

The Severe Gastrointestinal Bleed Lawsuit is Case No. 2:18-cv-00683-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.

If you or a loved one has suffered a gastrointestinal bleed from Xarelto or any other side effect, contact the experienced attorneys at McDonald Worley to help evaluate your claim.

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