A Xarelto lawsuit has been filed by a Louisiana woman following her own life-threatening Xarelto bleeding symptoms.

Plaintiff Dawn G. accuses Xarelto manufacturers Janssen Research & Development LLC, Ortho-McNeil-Janssen Pharmaceuticals Inc, Bayer Pharma Ag, and others of negligence and misrepresentation regarding their product Xarelto.

Dawn alleges she suffered life-threatening Xarelto bleeding symptoms in November 2013, after taking Xarelto for over a month. She claims that Xarelto has a risk of bleeding symptoms that was not disclosed to consumers, physicians, or the FDA.

Dawn was first prescribed Xarelto in October 2013 for treatment of atrial fibrillation, a heart rhythm abnormality with the potential for blood clotting. In November 2013, Dawn suffered a life-threatening bleed and severe anemia.

Dawn alleges that her bleeding and its severity was caused by Xarelto.  The life-threatening bleed resulted in severe medical conditions, pain, and expenses related to medical care.

Xarelto is a blood thinning medication used to reduce the risk of stroke and blood clots via anticoagulation, or thinning, of the blood. Such medications are often prescribed to patients with blood clots or who are at risk for blood clots.

Although bleeding is common with any blood thinner, most have a reversing agent to be administered in case of severe bleeding. Allegedly, Xarelto manufacturers did not develop a reversing agent for Xarelto, significantly increasing the risks associated with Xarelto bleeding symptoms. Without a reversing agent, consumers are allegedly at higher risk should bleeding occur since the anticoagulation caused by Xarelto could not be reversed in an emergency medical environment.

Despite the appearance of Xarelto bleeding symptoms in initial clinical trials, Dawn alleges Xarelto manufacturers allegedly failed to conduct sufficient clinical testing while seeking FDA approval for Xarelto.

“Despite life-threatening bleeding findings in a clinical trial and other clinical evidence, Defendants failed to adequately conduct complete and proper testing of Xarelto prior to filing their New Drug Application for Xarelto” the lawsuit states.

Additionally, Xarelto manufacturers allegedly failed to disclose clinical information showing a trend in Xarelto bleeding symptoms.  As stated in the lawsuit, “Defendants concealed and failed to completely disclose its knowledge that Xarelto was associated with or could cause life-threatening bleeding as well as its knowledge that they had failed to fully test or study said risk”.

The lawsuit also accuses Xarelto manufacturers of breaching warranties, both express and implied. “The Defendants expressly warranted that Xarelto was safe and well accepted by users” the lawsuit states.  Additionally, Xarelto manufacturers implied and warranted that Xarelto was safe and fit for use. The alleged defects resulting in Xarelto bleeding symptoms would void both the express and implied warranties set forth by Xarelto manufacturers.

Xarelto manufacturers are also accused of misrepresenting their product as safe in the media and in medical communities. “They knew those representations to be false and they willfully, wantonly and recklessly disregarded whether the representations were true” states the lawsuit. The misrepresentation of Xarelto bleeding symptoms allegedly deceived Dawn and her physician into believing Xarelto was a safe treatment option.

Dawn is seeking a jury trial for counts of negligence, liability, breach of warranties, misrepresentation, concealment, fraud and deceit, and violation of consumer protection laws. She also seeks compensation for emotional damages, medical expenses, attorneys’ fees, and court costs.

The Xarelto Bleeding Lawsuit is Case No. 2:18-cv-00901-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.