A man has filed a lawsuit against the makers of Xarelto after he allegedly suffered unexpected and life threatening bleeding from taking the blood thinning medication.

Plaintiff Samuel H., a Texas resident, says he began taking the medication in May 2015 and soon after suffered from life-threatening bleeding from Xarelto. He also alleges he suffered serious physical pain and medical expenses, all because of his Xarelto bleeding.

Samuel names as defendants Janssen Pharmaceuticals, its parent company Johnson & Johnson, and Bayer Healthcare Pharmaceuticals, along with several of their related companies.

Samuel accuses the defendants of having fraudulently represented to the plaintiff and public that the blood thinner had been effectively tested and found to be safe and effective for its indicated use.

“Despite life-threatening bleeding findings in a clinical trial and other clinical evidence, defendants failed to adequately conduct complete and proper testing of Xarelto prior to filing their New Drug Application for Xarelto,” Samuel contends.

Samuel says Janssen failed to adequately test Xarelto in clinical trials. He believes he could have avoided suffering life-threatening bleeding from Xarelto had Janssen given him adequate safety information.

According to the Xarelto lawsuit, “the use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events.”

“Physicians using Xarelto have to be able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event,” Samuel contends.

Moreover, “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,” Samuel alleges.

Importantly, there is no antidote available that can slow or reverse life-threatening bleeding from Xarelto. The severe, and sometimes fatal internal bleeding, or hemorrhagic complication that can occur has no reversal agent.

The U.S. Food and Drug Administration had originally approved the drug when first marketed and represented. But the warning section on the original U.S. label did not alert doctors and patients to the the lack of an antidote. Instead, the lawsuit alleges that, the label had only mentioned the potential adverse effect in the overdose section.

Samuel cites a Medwatch report stating that as of June 30,2012, the FDA had received up to 1,080 reports of serious adverse events related to Xarelto.

The report says that among those reported incidents, 65 deaths occurred. And in the reported hemorrhage events, or cases of life-threatening bleeding from Xarelto, 8% resulted in death. These cases were two-fold in contrast to Xarelto’s competitor blood thinner medication, warfarin.

The plaintiff alleges that the defendants ignored the association between the use of the blood thinner medication and its effects of life-threatening bleeding from Xarelto.

The Xarelto Lawsuit is Case Number. 2:17-cv-03703, in the U.S. District Court for the Eastern District of Louisiana.