Fourteen different plaintiffs have joined in a single Xarelto lawsuit, alleging that Xarelto wrongfully caused their relatives’ deaths.

The plaintiffs are the respective relatives of six different people who allegedly died after taking Xarelto. The plaintiffs all claim their relative’s deaths are due to their Xarelto use.

They are suing Janssen Pharmaceuticals, Johnson & Johnson Co., Bayer Pharmaceuticals, and their related companies, all of whom they allege are involved in the manufacture or sale of Xarelto.

Blood Thinner Xarelto

Xarelto is an anticoagulant medication approved by the FDA to reduce the risk of stroke and systemic embolism in persons with nonvalvular atrial fibrillation. It’s also known by the generic name rivaroxaban.

Xarelto is also used to treat pulmonary embolism and deep vein thrombosis, and to prevent their recurrence. It can also prevent those conditions from occurring after hip or knee replacement surgery.

Xarelto Safety Concerns

The plaintiffs say that when the defendants first introduced Xarelto to the market, they claimed that Xarelto patients would not need routine blood testing or dietary restrictions. They also promoted Xarelto as having a convenient once-daily dosing schedule.

The plaintiffs say these claims amounted to over-promotion regarding both the safety and effectiveness of Xarelto. They cite clinical studies like the ROCKET-AF clinical trial, which found that in comparison to the older anticoagulant warfarin, Xarelto was associated with more frequent gastrointestinal bleeds and need for transfusions.

The Xarelto lawsuit also cites a report by the Institute for Safe Medication Practices from October 2012 that found the primary adverse event related to Xarelto use was serious injury related to blood clot, which is exactly the type of condition Xarelto is intended to treat and prevent. The plaintiffs’ allege this is evidence of Xarelto’s lack of effectiveness contrary to the defendants’ promotional statements.

According to the Xarelto lawsuit, in June 2013 the defendants received a letter from the FDA admonishing them for statements in a print advertisement that the FDA said were “false or misleading.”

The agency said the advertisement minimized the risks associated with Xarelto. The ad also claimed that Xarelto does not require dosage adjustments, which statement is not consistent with its FDA-approved labeling.

Plaintiffs are also attacking the warning information distributed with Xarelto. They say the defendants failed to alert patients to the important fact that there has been no effective antidote to Xarelto bleeding – meaning, according to plaintiffs, that once excessive bleeding starts during Xarelto treatment, it is effectively “irreversible.”

Xarelto Bleeding Lawsuits

The plaintiffs note that they expect their claims will be transferred to the Xarelto multidistrict litigation now going on in federal court in New Orleans.

A multidistrict litigation, or MDL, is a consolidation of several individual yet similar claims into a single court. The federal court system uses the MDL procedure to conduct pretrial procedures more efficiently.

The Xarelto MDL began in December 2014 as a consolidation of several federal Xarelto lawsuits. The first few trials in this MDL are expected to begin in 2017.

The Xarelto Lawsuit is Case No. 5:15-cv-01669-HRL in the U.S. District Court for the Northern District of California. The Xarelto MDL is No. 2592 pending in the U.S. District Court for the Southern District of Louisiana.