A man has filed a Xarelto gastrointestinal bleeding lawsuit against Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and Bayer Healthcare following the death of a loved one.

Plaintiff John S. filed this Xarelto gastrointestinal bleeding lawsuit on behalf of Shirley S., the deceased, as her personal representative.

Shirley was a Georgia resident and was prescribed Xarelto in October 2014 to treat her atrial fibrillation.

She took the medication approximately one month and suffered from a lower gastrointestinal bleed which ultimately led to her death on November 6, 2014.

Xarelto Gastrointestinal Bleeding Lawsuit Allegations

“As a direct and proximate result of the use of defendants’ Xarelto, [Shirley] suffered serious and dangerous side effects including, life-threatening bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including, but not limited to, diminished enjoyment of life, expenses for hospitalization and medical treatment, and loss of earnings,” the Xarelto gastrointestinal bleeding lawsuit states.

Xarelto (rivaroxaban) is an anticoagulant medication used to treat patients to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation.

It is also used to treat (DVT) and pulmonary embolism (PE) and is also used prophylactically to reduce the risk of DVT in patients undergoing major surgeries such as hip and knee replacements.

According to the Xarelto gastrointestinal bleeding lawsuit, Xarelto was approved for reducing the risk of stroke and systemic embolism in patients with atrial fibrillation based on a trial known as the ROCKET AF study.

The results of the study showed Xarelto to be “non-inferior to warfarin,” the industry standard for oral anticoagulant therapy.

However, the study also showed “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the Riva Roxanne group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”

Other studies were performed to support Xarelto’s use for the prevention and treatment of DVT and PE, and these studies are included in Xarelto’s promotional materials.

The Xarelto gastrointestinal bleeding lawsuit states, however, that these materials “failed to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns.”

Additionally, the Xarelto gastrointestinal bleeding lawsuit highlights the fact that Xarelto does not have an antidote, unlike its predecessor warfarin. With warfarin, fresh frozen plasma along with intravenous vitamin K could be administered to reduce the anticoagulant effects of the drug.

Xarelto has no such reversal agent, and there is no way currently for medical personnel to stop Xarelto-induced bleeding once it starts.

John brought forth multiple counts against Janssen and Bayer including negligence, strict products liability, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, violation of consumer protection laws and wrongful death.

The plaintiff is seeking compensatory damages for pain, suffering, emotional distress, loss of enjoyment of life, and other non-economic damages, economic damages for medical expenses, out of pocket expenses, lost earnings and other economic damages, punitive and or exemplary damages as well as pre-and post-judgment interest, attorneys’ fees and costs and other relief deemed proper by the court.

The Xarelto Gastrointestinal Bleeding Lawsuit is Case No. 2:16-cv-13926, in the U.S. District Court for the Eastern District of Louisiana.