The daughter of a man who allegedly died of bleeding from Xarelto has filed suit against the drug’s manufacturer Janssen Pharmaceuticals.

Plaintiff Annie K. is suing on behalf of the estate of her father Hurtis W., a former Alabama resident. Annie says Hurtis took Xarelto from roughly May 2013 to May 2015. He had experienced two episodes of severe bleeding from Xarelto, the last of which required hospitalization. He died in January 2016.

Annie files this lawsuit against the defendants seeking damages associated with her father’s use of Xarelto.

She alleges that not only had her father suffered from bleeding from Xarelto, but that he had, “suffered various injuries, serious physical pain and suffering, medical, hospital and surgical expenses, and loss of consortium, as a direct result of his use of Xarelto.”

Patients are typically prescribed Xarelto for treatment of reducing strokes in patients with non-valvular atrial fibrillation. It is also prescribed to prevent DVT, or deep vein thrombosis, and PE, or pulmonary embolism.

Pulmonary embolism is a condition when one or more arteries in the lungs is blocked by a blood clot. Deep vein thrombosis is also a blood clot but one that typically occurs in the body’s lower extremity. Most of these blood clots will occur in the leg or thigh. But sometimes, a deep vein thrombosis can break free and lead to a pulmonary embolism.

Annie accuses the defendants of having fraudulently represented to her father and the public the safety of Xarelto. She adds that that misrepresentation is despite clinical trials conducted that showed evidence of life-threatening bleeding from Xarelto that can occur due to taking the blood thinning medication. The lawsuit accuses the defendants of failing to conduct additional and proper testing before filing an FDA New Drug Application for Xarelto.

Reports of Life-Threatening Bleeding From Xarelto

Xarelto currently does not have an available antidote to reverse the life-threatening bleeding from Xarelto that can occur as a result of taking the medication. Physicians who prescribe the medication must be careful to allot the proper dosage amount; too much and there is an increased risk for a major bleeding event; too little and the dosage amount does not protect the patient against the risk of strokes.

Additionally, the Xarelto lawsuit alleges that in the year leading up to June 30,2012, there were 1,080 serious adverse even reports filed with the FDA over Xarelto side effects, including at least 65 deaths.

“Of the reported hemorrhage events associated with Xarelto, 8% resulted in death, which was approximately twofold the risk of a hemorrhage-related death with warfarin,” the complaint states.

Additionally, the lawsuit maintains that by the end of fiscal 2012, “2,081 new Xarelto- asscociated SAE reports were filed with the FDA … Of those reports, 151 resulted in death, as compared to only 56 deaths associated with warfarin.”

The Xarelto Lawsuit is Case No. 2:17-cv-05164-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.