A wrongful death lawsuit was filed last month against Janssen Research and Development and Bayer Healthcare Pharmaceuticals, the manufacturers of the blood thinning medication Xarelto.

This Xarelto lawsuit, like many other lawsuits against Janssen and Bayer, claims the anti-coagulant drug that was supposed to reduce the risk of stroke instead led to severe gastrointestinal bleeding, causing the death of the plaintiff-decedent.

Plaintiff Joann B., the wife of the deceased, and her three sons filed the wrongful death Xarelto lawsuit on behalf of Louisiana resident David B., who allegedly died from Xarelto bleeding on Jan. 12, 2014, at the age of 75. His wife and children allege that Xarelto side effects not only caused David to die prematurely, but also caused, “severe and personal injuries…physical pain, and mental anguish” before his untimely death.

Xarelto Bleeding Warnings

The Xarelto injury lawsuit claims, “Defendants negligently and improperly failed to preform sufficient tests, if any, on humans using Xarelto during clinical trials,” which led to the FDA, medical professionals, and patients to, “rely on safety information” on drugs that were similar to Xarelto.

FDA approval of Janssen and Bayer’s blood thinning medication was granted based on clinical trials for rivaroxaban. However, Xarelto side effects have demonstrated that this similarity was false and has led to the injury and death of many individuals, according to a growing number of lawsuits. 

Xarelto was approved by the FDA in 2011 as a drug that could reduce the risk of stroke in patients undergoing hip replacement or knee replacement surgeries. It was later approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

Xarelto was promoted as an alternative to warfarin, the leading anticoagulant preferred by doctors and patients for decades. While warfarin sometimes led to gastrointestinal bleeding or pulmonary bleeding, there was an antidote that could be used to stop the uncontrollable bleeding side effects. In the case of Xarelto bleeding, there is no such antidote to remedy Xarelto side effects. 

Joann B.’s wrongful death Xarelto lawsuit noted that the original warning label, “did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section,” an oversight that could mean legal trouble for Xarelto’s manufacturers. 

In 2013, the FDA required the defendants to stop their drug’s promotional materials because they were over-stating the efficacy of Xarelto, while simultaneously withholding potential Xarelto side effects and the lack of an available reversal agent. While Xarelto promotional material ceased to be circulated, the defendants issued no other communication that warned against patients and prescribers of Xarelto side effects, including the increased risk of death. 

Xarelto is now “the leading anticoagulant on a global scale in terms of sale,” according to the Xarelto lawsuit, which means that millions of people may be at risk for Xarelto bleeding side effects.

Xarelto is one of three Factor XA inhibitors that have all appeared to have serious internal bleeding side effects. Currently, researchers are working on an antidote that will make Xarelto use safe for individuals undergoing certain surgeries.

This Xarelto Lawsuit is Case No. 2:15-cv-00041 filed in the U.S. District Court of the Eastern District of Louisiana.