Xarelto Stomach Bleed Lawsuit Claims Manufacturers Failed To Recommend Blood Monitoring

A lawsuit recently filed against Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary suggests that individuals nationwide may have been severely injured or died from the bleeding side effects of Xarelto due to the drug makers’ failure to provide adequate warnings about the importance of blood monitoring.

In a complaint (PDF) filed in the U.S. District Court for the Eastern District of Louisiana, Sharon McNamee indicates that she suffered a severe stomach bleed on Xarelto because the drug makers failed to adequately warn consumers and the medical community about the dangers, including the importance of blood monitoring, making dose adjustments and taking twice daily doses.

McNamee began taking the new-generation anti-coagulant Xarelto in November 2013, but on March 11, 2014 and again on April 2, 2014, she suffered gastrointestinal bleeding events that she indicates were life-threatening and left her with permanent injuries. As a result of the bleeding problems, McNamee indicates that she stopped using the drug in April 2014.

Xarelto Blood Monitoring Should Have Been Recommended

Xarelto (rivaroxoaban) was introduced in 2011 as a superior replacement for Coumadin (warfarin), which has been the go-to-anticoagulant treatment for prevention of deep vein thrombosis and pulmonary embolism for decades.

The medication quickly became one of the top-selling drugs in the United States, as the drug makers aggressively marketed Xarelto as easier to use than warfarin, indicating that it did not require close blood monitoring to maintain the appropriate and safe dose.

McNamee points out in the complaint that Xarelto was promoted as a single dose pill that does not require measuring patient’s blood plasma levels or any diet limitations, marketing that as the “Xarelto Difference.” However, the lawsuit alleges that clinical studies have shown that Xarelto is safer and more effective when there is blood monitoring, dose adjustment and twice a day dosing.

“The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events,” the lawsuit states. “Physicians using Xarelto have to be able to balance the dose so that the blood is thinned enough to reduce the risk of stroke, but not thinned so much as to increase the risk for a major bleeding event. The Defendants were aware of this risk and the need for blood monitoring but have failed to disclose this vital health information to patients, doctors and the FDA.”

Xarelto also lacked a safe and effective antidote at the time it was introduced, which McNamee indicates was not adequately disclosed to doctors. While the blood thinning effects of warfarin can be quickly reversed, there was no Xarelto reversal agent available to allow doctors to stop severe bleeds that may develop among users.

During the first full year Xarelto was on the market, McNamee’s complaint notes that the drug generated more than 2,000 severe adverse event reports submitted to the FDA, including 151 deaths. Those numbers continued to climb in 2013, when Xarelto passed its competitor Pradaxa as the drug most associated in the U.S. with severe adverse health events.

“Despite the clear signal generated by the SAE data, Defendants did not tell consumers, health care professionals and the scientific community about the dangers of Xarelto, nor did Defendants perform further investigation into the safety of Xarelto,” the lawsuit states.

Status of Xarelto Litigation

McNamee’s case joins hundreds of similar Xarelto bleeding lawsuits filed by individuals throughout the U.S., which each raise similar allegations that inadequate warnings were provided for consumers and the medical community.

There are currently more than 2,400 related claims pending in the federal court system, which have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation

The cases are centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated discovery and a series of bellwether trials to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

A series of Xarelto bellwether trials are expected to begin during the first half of 2017. While the outcomes of these trials will not be binding on other cases, they will be closely watched by those involved in the litigation and may help facilitate eventual Xarelto settlements to resolve large numbers of claims without the need for several thousand individual jury trials nationwide.