A woman who has suffered a severe Xarelto GI bleed has joined her lawsuit against Janssen with the Xarelto MDL.

Plaintiff Tina B. is suing the makers of blood thinning medication, Xarelto, claiming that she experienced a Xarelto GI bleed.

According to her Xarelto GI bleed lawsuit, she experienced a “life-threatening, irreversible bleed” and “severe injury from the use of Xarelto, as well as severe pain and suffering, other severe and personal injuries which are permanent and lasting in nature, mental anguish, diminished enjoyment of life, medical expenses, and other economic and non economic damages.”

She believes that Janssen is responsible for her “damages and harm, including, but not limited to, personal injury, medical expenses, other economic harm, as well as, where alleged, loss of consortium, services, society, companionship, love and comfort.”

According to her Xarelto GI bleed lawsuit, Janssen failed to adequately test their drug for severe side effects including life-threatening bleeding before they filed their application for approval with the FDA.

Tina also believes that Janssen is responsible for not warning physicians or herself that Xarelto could in fact be the cause of irreversible, fatal bleeding events.

She also alleges in this Xarelto GI bleed lawsuit that Janssen concealed and failed to completely disclose their knowledge that Xarelto could possibly cause fatal bleeding events.

Additionally, Tina claims that Janssen did not warn her that she would require constant blood monitoring and dose adjustments. She did not know, she claims, that this risk of serious bleeding might be irreversible, permanently damaging and permanently disabling.

This Xarelto GI bleed lawsuit states that the drug maker’s fraudulent representations and concealment show that they acted in “flagrant, willful, and depraved indifference to health, safety, and welfare.” Also, she claims their behavior showed willful misconduct, malice, fraud, wantonness and oppression.

Overview of Xarelto

Xarelto, known generically as rivaroxaban, was only recently approved by the U.S. Food and Drug Administration in 2011. It is a blood thinning medication that is an active direct factor Xa inhibitor.

It was developed, along with Pradaxa and Eliquis, to directly compete with the longstanding blood thinner of choice, warfarin. Xarelto has been marketed as a drug that is better equipped to deal with blood clotting dangers than warfarin, needing less monitoring and less change in patient lifestyle.

Xarelto is approved to treat deep vein thrombosis and to prevent stroke in patients with atrial fibrillation.

However, just one year after its approval, there were over one thousand serious bleeding event reports reported to the FDA. This included 65 fatalities because of Xarelto bleeding.

Inherent to the nature of a blood thinning medication, patients may experience bleeding when it is not intended. For example, when a patient who is on a blood thinner experiences and accident or emergency, the blood may not clot as it is supposed to. For warfarin patients, vitamin K could be administered to combat unintended bleeding.

However, Xarelto does not have a reversal agent. If a Xarelto patient experiences a Xarelto GI bleed or some other kind of bleeding event, there is no reversal agent that can be administered for that patient.

This Xarelto GI Bleed Lawsuit is Case No. 2:17-cv-07397-EEF-MBN in the United States District Court for the Eastern District of Louisiana.