Bayer and Johnson & Johnson Pharmaceuticals are facing a wrongful death lawsuit, alleging that their blood thinner Xarelto (also known as rivaroxaban) is dangerous and should not be sold.

The surviving granddaughter of a Louisiana woman filed a Xarelto wrongful death lawsuit in November on behalf of her deceased grandmother, Hattie G.

Her Xarelto lawsuit is against Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, and the co-marketer of Xarelto, and Bayer Healthcare AG, alleging these companies failed to warn patients and physicians of the increased risks of irreversible and fatal internal bleeding when using Xarelto.

Plaintiff Ashlie F. alleges in the Xarelto lawsuit that her grandmother Hattie used Xarelto in September 2014 to treat her deep vein thrombosis and subsequently, on Nov. 10, 2014, suffered a fatal intracranial bleed that was allegedly a direct result of the drug.

The Xarelto lawsuit claims that Bayer and Janssen Pharmaceuticals knew of the Xarelto side effects and continued to sell it despite the dangerous risks.

Serious Side Effects of Xarelto

Xarelto (rivaroxaban) is an oral anti-clotting medication or “blood thinner,” which is prescribed to prevent and to treat deep vein thrombosis (blood clots in the legs) and pulmonary embolism (blood clots in the lungs), and to reduce the risk of stroke in some patients with a common heart arrhythmia known as atrial fibrillation.

It may also be prescribed to patients undergoing knee or hip replacement surgery to prevent clots from forming in the legs and traveling to the lungs.

The FDA approved Xarelto to reduce the risk of deep vein thrombosis and pulmonary embolism in July 2011. The FDA also approved Xarelto for reduction of stroke risk in certain patients with atrial fibrillation in November 2011. The FDA then expanded its approval to the ongoing treatment and prevention of deep vein thrombosis and pulmonary embolism in November 2012.

In 2013, the Institute for Safe Medication’s Practice QuarterWatch reported a steady increase in adverse events reported to the FDA for Xarelto.

In January 2014, the FDA’s safety surveillance agency announced a plan to monitor and study Xarelto for serious events such as ischemic strokes, intracranial hemorrhages, and gastrointestinal bleeding. There is currently no reversal agent for Xarelto bleeds.

Injuries that can occur when using Xarelto include:

• Stroke
• Gastrointestinal bleeding
• Cerebral hemorrhage
• Uncontrolled hemorrhage
• Internal bleeding
• Death

Signs and symptoms of a Xarelto injury may include:

• Stroke (bleeding into the brain)
• Unusual bleeding
• Discolored urine (blood in the urine)
• Red or black-colored stool (blood in bowel movements)
• Coughing up blood
• Vomiting blood that looks like “coffee grounds” or is bright red
• Frequent nose bleed or gum bleeding
• Weakness and swelling in the extremities
• Neurological injury (bleeding around spinal cord)

Xarelto Lawsuits

The Xarelto lawsuit is seeking compensatory, economic, and punitive damages for Bayer’s and Janssen Pharmaceutical’s alleged deceptive and reckless practices in misrepresenting and omitting numerous facts about the dangers of taking Xarelto and causing the death of Hattie G. in part by their gross negligence.

The Xarelto Wrongful Death Lawsuit is Case No. No. 2:15-cv-05874 in the U.S. District Court, Eastern District of Louisiana. It will join about 1,700 claims pending in a federal multidistrict litigation (MDL), which is currently centralized for pretrial proceedings before U.S. District Judge Eldon Fallon.