The daughter of a Kentucky woman claims Xarelto problems were the cause of her mother’s death.

Plaintiff Toni Q. is bringing this Xarelto lawsuit on behalf of herself and that of the estate of her late mother Joan. Toni alleges Joan took Xarelto as a treatment for deep vein thrombosis from February to March 2015.

At the end of that March, Joan suffered a lower gastrointestinal bleed that ultimately led to her death. Toni now claims her mother’s gastrointestinal bleed and ensuing death were the results of Xarelto problems that the drug’s manufacturers failed to adequately warn about.

In her Xarelto lawsuit, Toni names as defendants Janssen Pharmaceuticals, Johnson & Johnson, Bayer Pharmaceuticals, and their associated companies. All these pharmaceutical companies have had a hand in the development, promotion or manufacture of Xarelto.

Xarelto is an anticoagulant medication introduced in 2011. It’s now FDA-approved to reduce the risk of deep vein thrombosis and pulmonary embolism in patients who have recently undergone surgery for hip replacement or knee replacement.

It’s also frequently prescribed to reduce the risk of stroke and systemic embolism associated with non-valvular atrial fibrillation.

Thanks in part to a vigorous marketing effort, Xarelto has been a marked business success for the defendants. According to Toni’s Xarelto lawsuit, sales of Xarelto in its first year on the market reached $582 million and increased to approximately $2 billion by the end of fiscal 2013.

Plaintiff: Xarelto Problems Revealed in Clinical Trials

Toni cites several of the clinical trials that were used to earn FDA approval for Xarelto, many of which revealed the existence of particular Xarelto problems.

A group of studies known as the RECORD studies compared Xarelto to enoxaparin, another anticoagulant. Results of the RECORD studies showed Xarelto led to more frequent instances of bleeding that led to decreased hemoglobin levels and the need for blood transfusions.

In another clinical trial known as the ROCKET AF study, researchers reported that “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.”

A third set of studies known as the EINSTEIN studies revealed an increased risk of adverse events associated with Xarelto, some of which resulted in prolonged hospitalization.

Toni says the defendant pharmaceutical companies used results from all three of these studies to promote Xarelto. However, the promotional materials they published failed to mention the Xarelto problems revealed in these studies.

She also points out that to date, there is no drug available on the market that works as an antidote to Xarelto. This lack of an antidote potentially leaves Xareldo patients without a medical means of reversing Xarelto’s anticoagulant effect in cases of excessive bleeding.

The original label for Xarelto failed to include a warning about the lack of an antidote, instead mentioning that fact only in the label’s overdosage section, Toni says.

Toni’s Xarelto Lawsuit is Case No. 2:17-cv-00473 in the U.S. District Court for the Eastern District of Louisiana. It’s part of the Xarelto Multidistrict Litigation, In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, also in the U.S. District Court for the Eastern District of Louisiana.