A New York couple has joined the Xarelto multidistrict litigation now pending in Louisiana federal court.

Plaintiffs Ann and Richard B. of Auburn, N.Y. filed their Xarelto lawsuit in August. They are joining other plaintiffs in pursuing legal action for the serious and dangerous bleeding complications that allegedly occurred as a result of the anticoagulant drug Xarelto.

These federal Xarelto lawsuits have been consolidated into a multidistrict litigation, or MDL, in federal court in New Orleans.

Plaintiffs in this MDL consist of former Xarelto patients, their close relatives, and estate representatives. Generally, these Xarelto lawsuits are seeking compensation for excessive gastrointestinal bleeding or other severe internal bleeding that they say was caused by the anticoagulant.

Defendants in the Xarelto MDL include several different pharmaceutical companies all of whom share some involvement in the development, manufacture, or marketing of Xarelto. These include Janssen Pharmaceuticals, Janssen’s parent company Johnson & Johnson, Bayer Healthcare Pharmaceuticals Inc., and their related companies.

What is Xarelto?

Xarelto, or rivaroxaban, first received FDA approval in July 2011. It’s now approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a common use for many anticoagulant medications.

Xarelto is also approved to treat pulmonary embolism and deep vein thrombosis (DVT), to prevent recurrence of those conditions, and to prevent DVT after hip or knee replacement surgery.

The blood thinner is one of a new class of anticoagulant drugs (along with Pradaxa and Eliquis) introduced to the market within the last few years. These new anticoagulant drugs have been the first in years to successfully compete with warfarin (Coumadin), which had been the go-to anticoagulant medication for decades.

Plaintiffs Allege Xarelto Bleeding Risks Understated

The newest joint complaint added to the Xarelto MDL claims that the defendants’ aggressive promotion of Xarelto benefits is misleading to consumers and the medical community. According to the Xarelto lawsuit, the defendants had promoted Xarelto as offering the benefits of a single daily dose, with no need for ongoing monitoring of blood levels or adjustment of dosage as is required with warfarin.

Ann and Richard are taking issue with this promotion in two ways. First, contending the defendants over-promoted Xarelto, overstating its efficacy while understating the risks associated with Xarelto bleeding. The plaintiffs claim that the clinical trials for Xarelto actually showed that the drug is safer and more effective when administered with twice-daily dosing and with ongoing blood level monitoring.

Second, Ann and Richard point out that Xarelto, unlike warfarin, has no antidote that can stop excessive bleeding once it starts. They say that the original FDA-approved label for Xarelto mentioned the lack of an antidote in the overdose section but did not actually contain a warning about that fact.

Furthermore, the plaintiffs state that with this promoted once-daily dosing and no monitoring, Xarelto puts the patient at a greater risk for major, life-threatening bleeding events.

Ann and Richard say in the Xarelto lawsuit that the new generation blood thinner creates an unacceptable risk of excessive bleeding that defendants failed to warn physicians or patients about these risks.

The Xarelto Bleeding MDL is In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.