An Arkansas woman has filed a Xarelto lawsuit against the makers of Xarelto on behalf of her mother’s estate, claiming compensation for Xarelto side effects her mother suffered while she was still alive.

Plaintiff Debbie W. brings this Xarelto lawsuit as administrator of the estate of her late mother Mary W. Mary began taking Xarelto in February 2013 as a treatment for atrial fibrillation.

While taking Xarelto, she had two episodes of internal bleeding and anemia, in April and June 2013. Both episodes required hospitalization and blood transfusions. Debbie now alleges these episodes of excessive bleeding led to “severe and permanent personal injuries, pain, suffering, and emotional distress,” all of which she attributes to Mary’s Xarelto treatment.

Debbie names as defendants Janssen Pharmaceuticals, its parent company Johnson & Johnson, and Bayer Corp., as well as their related companies, all of which were involved in manufacturing, distributing, or promoting Xarelto.

Xarelto is an oral anticoagulant used to prevent stroke in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism and prevent their recurrence, and to prevent deep vein thrombosis in patients undergoing hip or knee replacement surgery.

Xarelto is one of a new generation of anticoagulant medications that entered the market in September 2010, beginning then with Pradaxa. Xarelto itself was first approved by the FDA in July 2011.

The main selling point for Xarelto, as well as for the other new-generation anticoagulants, has been that it does not require continuous monitoring of blood levels with as-needed dosage adjustment, as is necessary with the older and more established anticoagulant warfarin.

However, Xarelto has a major drawback in its lack of an antidote, or reversal agent. While all anticoagulants create some risk of excessive bleeding, warfarin bleeding can be slowed by administering vitamin K.

There is no such reversal agent for Xarelto. Once Xarelto bleeding starts, it could continue until the body finishes metabolizing the drug and in some cases can be life-threatening. According to Debbie’s Xarelto lawsuit, neither the original label for Xarelto nor Janssen’s subsequent Xarelto marketing mentioned the lack of a reversal agent.

Initial clinical trials of Xarelto found it had some advantages over other medications but also caused decreased hemoglobin levels and need for a blood transfusion. Later trials found Xarelto comparable to warfarin except for the fact that gastrointestinal bleeding “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.”

According to Debbie’s Xarelto lawsuit, both U.S. and German regulatory authorities have received thousands of reports of adverse events related to Xarelto, hundreds of which resulted in death.

Despite its drawbacks, Xarelto has been a considerable business success. Sales in fiscal 2013 reached about $2 billion. According to Debbie, Xarelto is now the leading anticoagulant medication in the world in terms of sales.

Debbie’s Xarelto lawsuit alleges Janssen and the other defendants failed to properly warn physicians and their patients about the risk of excessive Xarelto bleeding or the lack of a reversal agent. She raises claims for negligence, strict liability for a defective product, breach of warranty, fraudulent misrepresentation, fraudulent concealment (the withholding of essential safety information), negligent misrepresentation, fraud and deceit, and violation of Arkansas’ Deceptive Trade Practices Act.

This Xarelto Lawsuit is part of the Xarelto multidistrict litigation now pending in the U.S. District Court for the Eastern District of Louisiana under the title In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL no. 2592.