The daughter of a California woman who suffered a fatal hemorrhagic brain bleed while taking the anticoagulant (blood thinner) Xarelto (rivaroxaban), is suing Janssen Pharmaceuticals and Bayer for failing to provide adequate warnings about the risk of severe bleeding and the lack of an approved reversal agent.

In August 2012, a doctor prescribed Donna Y.’s mother Xarelto for the treatment of atrial fibrillation, a common abnormal heart rhythm manifested by heart palpitations, fainting, chest pain, or congestive heart failure, the Xarelto lawsuit explains.

On Oct. 27, 2014, Donna’s mother suffered hemorrhagic bleeding on the brain, resulting in her death, which she alleges was caused by Xarelto in the uncontrollable bleeding lawsuit.

Xarelto is manufactured and marketed by Janssen Pharmaceutical and Bayer and has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (arrhythmia of the heart); deep vein thrombosis (blood clots deep within the body); pulmonary embolism (blood clots in the lungs); stroke; and in patients who have recently undergone a knee or hip replacement surgery.

Severe internal bleeding and death are Xarelto’s most commonly reported side effects, but others include thrombosis (blood clots); decreased hemoglobin (a substance that carries oxygen in red blood cells); cerebrovascular accidents (an event that leads to a cerebral hemorrhage); hematoma (a semisolid mass in the blood); peripheral edema (swelling of the lower limbs); and dyspnea (difficulty breathing).

Johnson & Johnson and Bayer have marketed Xarelto as a superior blood thinner alternative to Coumadin for anticoagulant therapy.

Many doctors have begun prescribing Xarelto instead of warfarin (Coumadin), a blood thinner that has been used in the United States since the 1950s. However, unlike warfarin, there’s no antidote to Xarelto and if a hemorrhagic complication occurs, there is no reversal agent.

According to Donna’s Xarelto lawsuit and hundreds of others, the Xarelto medication guide failed to warn patients of the lack of reversal agent for anticoagulation effects of Xarelto.

On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved Xarelto for prophylaxis of deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. Four months later the agency approved its use for stroke prophylaxis in patients with non-valvular atrial fibrillation.

In the year leading up to June 30, 2012, the agency received 1,080 reports of Xarelto-associated serious adverse events, 65 of them deaths, according to Donna’s Xarelto lawsuit.

At the close of the fiscal year 2012, 2,081 new Xarelto-associated adverse events from uncontrollable bleeding were reported, with 151 of those being deaths. During that same time period, there were 56 deaths reported from warfarin.

A federal judicial panel in December 2014 established a multidistrict litigation consolidating proceedings for hundreds of Xarelto bleeding lawsuits. The number of Xarelto lawsuits is expected to grow substantially.

Xarelto is in the same class of drugs as Pradaxa, an anticoagulant that is the subject of more than 4,000 Pradaxa lawsuits where plaintiffs allege bleeding complications. To resolve some 4,000 uncontrollable bleeding lawsuits brought by Pradaxa (dabigatran) patients, Boehringer Ingelheim GmbH agreed to pay $650 million in a comprehensive settlement. Researchers linked Pradaxa to more than 500 deaths.

The Xarelto Bleeding Lawsuit is Case No. 3:15-cv-00084-H-BGS, in the U.S. District Court for the Southern District of California.