Drug giants Bayer and Janssen Pharmaceuticals are named as defendants in a recently filed lawsuit alleging that they concealed their knowledge from the public and medical community that the new generation blood thinner, Xarelto, can cause life-threatening, irreversible bleeds.

A Colorado resident has filed a lawsuit against the manufacturer Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson and the co-marketer of Xarelto) and Bayer Healthcare AG, alleging these companies failed to adequately warn about the lack of a Xarelto antidote to reverse uncontrolled bleeding caused by Xarelto.

According to the Xarelto lawsuit, plaintiff Lydia S. used Xarelto beginning in May 2012 to prevent deep vein thrombosis after undergoing hip replacement surgery. A week after initially taking Xarelto, Lydia was hospitalized for acute gastrointestinal bleeding as well as other severe injuries that were a direct result of Bayer and Janssen Pharmaceutical’s omissions relating to Xarelto side effects, the Xarelto lawsuit alleges.

Lydia claims the drug should not be sold and that Bayer and Janssen Pharmaceutical failed to provide warnings or other information that accurately reflected the symptoms, scope, and severity of Xarelto side effects and Xarelto bleeding risks. Lydia is also seeking for her case to be included in the Xarelto multidistrict litigation (MDL) currently pending in the U.S. District Court for the Eastern District of Louisiana.

What is Xarelto?

Xarelto (rivaroxaban) is one of the latest generation of anticoagulant drugs, designed to treat patients at risk of deep vein thrombosis (the formation of blood clots deep under the skin surface). Specifically, it is prescribed for those patients, like Lydia, who have undergone hip or knee replacements.

Xarelto, along with two similar medications (Pradaxa and Eliquis), was intended to replace warfarin, a a blood thinner medication that has been the standard treatment for this condition since the early 1950s. The purported advantage of Xarelto and similar medications is a reduced need for patient monitoring; these prescriptions have far fewer drug and food interactions than warfarin, though the cost per dose to the patient is substantially higher.

Xarelto Bleeding Issues

The most serious problem associated with Xarelto and similar medications is fatal hemorrhaging. When a patient on the medication starts bleeding from even a minor injury (including a bump on the head), there is virtually no way to stop it.

The reason for this lies in the drug’s mechanism of action. Blood coagulation is dependent on the action of Vitamin K (naturally occurring in leafy greens and vegetables) in order to produce the clotting agent, thrombin. Warfarin disables Vitamin K, so any serious bleeding can be halted with high dosages of this vitamin. Xarelto prevents the production of Vitamin K altogether; therefore, once a patient starts suffering from Xarelto bleeding, there is virtually no way to stop it.

Xarelto Injury Lawsuits

The Xarelto Injury lawsuit is seeking compensatory and punitive damages arising from ingestion of Xarelto as well as the defendants’ disregard in misleading the medical community and consumers in favor of increasing sales. The filed complaint indicates a demand for a jury trial for this case.

The Xarelto Lawsuit is Case No. 2:15-cv-01261 in the U.S. District Court for the Eastern District of Louisiana, and the Xarelto MDL is In re: Xarelto® (Rivaroxaban) Products Liability Litigation, Case No: 14-md-2592, MDL 2592, in the U.S. District Court for the Eastern District of Louisiana.