Xarelto dangerous side effects have prompted a new lawsuit regarding the blood thinner, alleging that the drug can cause uncontrolled bleeding.

Plaintiff Ora Mae M. recently filed a lawsuit against Janssen, Johnson & Johnson, and Bayer, alleging that Xarelto dangerous side effects caused her to suffer from a serious bleeding event.

According to her complaint, Ora Mae was prescribed Xarelto and took the drug from December 2015 to October 2016. In October 2016, she allegedly experienced a serious bleeding event caused by Xarelto dangerous side effects. In addition to the life threatening bleed, Ora Mae also allegedly experienced severe anemia.

Xarelto (rivaroxaban) is a blood thinning drug often prescribed to patients prone to blood clots or stroke, or patients undergoing hip or knee surgery, which may increase the risk of dangerous clots. Xarelto is part of a class of modern blood thinners designed to replace the industry standard warfarin, which has been used for over 60 years.

In attempt to prove that Xarelto was as good as warfarin, manufacturers conducted the ROCKET AF study. The study compared outcomes between Xarelto patients and warfarin patients. Although the study found that Xarelto was as effective in preventing stroke or embolism, the study also allegedly found that “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

Manufactures have allegedly pushed Xarelto’s benefits by marketing the “Xarelto Difference” – once a day dosing, no dietary restrictions, and no blood testing requirement. However, the lawsuit claims that Xarelto is more effective when implementing blood monitoring, dose adjustments, and twice a day dosing. Despite clinical evidence that Xarelto is more effective and safer with these constraints, the defendants allegedly continue to market the “Xarelto Difference”. Ora Mae argues that this persistence in over-marketing Xarelto shows that the drug manufacturers care more about selling their product than combating Xarelto dangerous side effects.

“Defendants’ fraudulent representations and concealment evidence flagrant, willful, and depraved indifference to health, safety, and welfare,” the Xarelto dangerous side effects lawsuit states. “Defendants’ conduct showed willful misconduct, malice, fraud, wantonness, oppression, and that entire want of care that raises the presumption of conscious indifference to the consequences of said conduct.”

Additionally, Xarelto dangerous side effects are compounded by the lack of antidote available should a severe bleeding event occur. In the event of a severe hemorrhage, no reversal agent is available and patients must be instead treated with transfusions until the drug is out of their system. However, this practice can be extremely difficult on the body, leading to a mortality rate of around 8 percent, according to reported received by the FDA’s Serious Adverse Event Medwatch.

Ora Mae accuses the defendants of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, fraud, and violation of consumer protection laws. The Xarelto dangerous side effects lawsuit seeks compensatory damages, economic damages, punitive damages, court costs, and attorneys’ fees.

The Xarelto Lawsuit is Case No. 2:18-cv-06498-EEF-MBN in the United States District Court for the Eastern District of Louisiana.