A Kansas widow filed a Xarelto bleeding lawsuit, claiming Xarelto caused her husband’s death.

Plaintiff Evelyn B. says her husband Donald took Xarelto in February and March 2013 as a treatment for his atrial fibrillation. On March 17 of that year, Donald began to suffer a severe gastrointestinal bleed, which Evelyn alleges led to his death that November.

Her Xarelto bleeding lawsuit names as defendants Janssen Pharmaceuticals, parent company Johnson & Johnson, Bayer Healthcare Pharmaceuticals, and several of their related companies, all of which are involved in the manufacture or distribution of Xarelto.

Xarelto and Gastrointestinal Bleeding

Xarelto, also known under the generic name rivaroxaban, is an anticoagulant medication used to lower the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat pulmonary embolism and deep vein thrombosis and reduce their risk of recurrence, and to prevent deep vein thrombosis for recipients of hip or knee replacement.

Xarelto has been on the market since its initial approval by the FDA in July 2011. Since then it has been a huge success for its manufacturers, with sales reaching about $2 billion in fiscal 2013.

Xarelto is one of a new generation of anticoagulant medications introduced around the same time as alternatives to warfarin, the dominant anticoagulant for over 50 years. These medications were touted as an improvement over warfarin in that they did not require constant blood testing and dosage adjustment.

But they also have one significant drawback that warfarin does not: the new medications do not have any antidote, or reversal agent, that can make them stop excessive bleeding once it starts. Excessive bleeding caused by warfarin can be resolved by administering vitamin K.

Several clinical trials of Xarelto showed it creates an increased risk of bleeding. One set of clinical trials on which the FDA’s approval was based, known as the RECORD studies, found that compared to the alternative medication enoxaparin, Xarelto had a higher incidence of bleeding that led to decreased hemoglobin and need for blood transfusions.

Other studies, known as the ROCKET AF studies, found that Xarelto, while not inferior to warfarin in preventing stroke or systemic embolism in non-valvular atrial fibrillation patients, did result in more frequent instances of gastrointestinal bleeding and other bleeding that resulted in lowered hemoglobin or need for transfusion.

A third group of studies, grouped under the EINSTEIN classification and directed at evaluating Xarelto’s effectiveness in treating deep vein thrombosis and pulmonary embolism, found Xarelto presented obvious greater risks of bleeding events compared to a placebo.

Despite the bad news revealed in these clinical trials, Evelyn alleges, the defendants improperly represented Xarelto as being safe for its indicated use while concealing vital information about Xarelto side effects from the public and the medical profession. She alleges the defendants used the positive results from these studies to promote Xarelto while ignoring the results that show the increased risk of Xarelto bleeding.

The defendants’ Xarelto promotional materials have received similar negative attention from the FDA, which in June 2013 ordered them to stop using a print ad that the FDA determined was false or misleading because it minimized the risks associated with Xarelto.

Evelyn’s wrongful death Xarelto lawsuit seeks compensation for her late husband’s pain and suffering, medical expenses, and lost earnings. Evelyn is also seeking punitive damages based on the allegedly intentional nature of defendants’ conduct.