A woman has filed a Xarelto lawsuit on behalf of herself and her deceased mother’s estate, alleging the mother suffered and died from life-threatening bleeding after using the blood thinner Xarelto.

Plaintiff Bertha H. filed the lawsuit after her mother Helen C. suffered a life-threatening bleeding injury in February 2015, after allegedly having used Xarelto since 2013.

“As a result of using Defendants’ Xarelto, Plaintiff-decedent Helen … was caused to suffer from life-threatening bleeding in or about February 2015, and was caused to sustain severe and permanent personal injuries, pain, suffering, and emotional distress,” according to the Xarelto lawsuit.

Bertha says Helen suffered from sudden death caused by Xarelto in April 2015.

Xarelto is a product of Bayer Healthcare Pharmaceuticals and Janssen Pharmaceuticals, a division of Johnson & Johnson. The blood thinner Xarelto is used to reduce the risk of stroke and systemic embolism in patients suffering from non-valvular atrial fibrillation.

It is also used to treat and reduce the risk of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of DVT in patients undergoing major surgery, such as knee replacement or hip replacement surgery.

Plaintiff: Studies Showed Problems with Blood Thinner Xarelto

Xarelto was approved by the FDA in 2011 after several studies were performed to determine its efficacy and safety. However, Bertha alleges that the full results of the clinical trials were not adequately publicized to the medical community and to patients receiving the drug.

In one particular study, the ROCKET AF study, Xarelto was shown to be noninferior to another blood thinner, warfarin, that had been used for six decades prior.

Results showed that both drugs had a risk of major bleeding. However, “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban [the generic name for Xarelto] group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

Bertha’s Xarelto lawsuit argues that although warfarin may have had a similar risk of bleeding, the main difference that makes blood thinner Xarelto a less safe option was the fact that it did not have a way to reverse excessive bleeding like printed.

With warfarin, intravenous vitamin K or fresh frozen plasma could be administered as a reversal agent in order to restore the body’s natural clotting mechanisms, and thus stop the excess bleeding. Bertha further alleges that the manufacturers failed to provide adequate information about the lack of an antidote on its product labels.

On behalf of herself and her mother, Bertha has brought forth a number of claims against the defendants including negligence, strict products liability, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit and wrongful death.

Bertha is seeking compensatory damages for healthcare costs, medical monitoring and pain and suffering for severe and permanent personal injuries sustained by her mother.

She is also seeking punitive and/or exemplary damages “for the wanton, willful, fraudulent, reckless acts of the Defendants who demonstrated a complete disregard and reckless indifference for the safety and welfare of the general public and to the Plaintiffs in an amount sufficient to punish Defendants and deter future similar conduct.”

The Blood Thinner Xarelto Lawsuit is Case No. 2:17-cv-00706. It is part of the Xarelto MDL In re: Xarelto (rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.