Janssen Research & Development, LLC., formerly known as Johnson and Johnson Pharmaceutical Research and Development, LLC. faces a lawsuit over its Xarelto product, also known as rivaroxaban.

Plaintiff George S., a Florida resident, filed this Xarelto lawsuit alleging that the “defendants concealed their knowledge of the defects in their products from the plaintiff, and plaintiff’s physicians, hospitals, pharmacists, the FDA, and the public in general,” the complaint explains.

George seeks relief from damages resulting from his use of Xarelto. The nature of the case is that George used Xarelto to reduce his risk of stroke and systemic embolism, and to treat deep vein thrombosis, or “DVT,” and pulmonary embolism, or “PE.”

However, as alleged in the Xarelto lawsuit, the defendants failed to accurately inform the plaintiff and consumers about the safety and risks of Xarelto.

The complaint contends that “when warning of safety and risks of Xarelto, defendants negligently and/or fraudulently represented to the medical and healthcare community, the Food and Drug Administration, to plaintiff and the public in general, that Xarelto had been tested and was found to be safe and/or effective for its indicated use.”

The Xarelto lawsuit alleges that sufficient tests had not been completed on human beings in any clinical trial. George claims that, because of the alleged lack of appropriate safety information and accurate representations, the plaintiff was “caused to suffer serious and dangerous side effects including, inter alia, life threatening bleeding, as well as other severe and personal injuries, which are permanent and lasting in nature.”

According to the complaint, “physical pain and mental anguish, including diminished enjoyment of life” was also endured, per the plaintiffs’ statement.

In March 2013, George was prescribed to use Xarelto as directed, for treatment of his atrial fibrillation, by his physician. He continued to use the drug through May 2014.

However, after its use and as an alleged direct result, George suffered a hemorrhagic stroke in May and a “life-threatening, irreversible bleed from the use of Xarelto, as well as severe pain and suffering,” the Xarelto lawsuit explains.

Before the plaintiffs’ use of the Xarelto drug, his physician was marketed and informed by sales representatives that Xarelto was an effective drug in, “reducing strokes in patients with non-valvular atrial fibrillation, as well as preventing DVT/PE in patients with prior history of DVT/PE or undergoing hip or knee replacement surgery.”

What was not relayed in the marketing information, however, was that, “there was no reversal agent that could stop or control bleeding in patients taking Xarelto,” the complaint states.

“At all times relevant hereto, defendants also failed to warn emergency room doctors, surgeons, and other critical care medical professionals that … there is no effective agent to reverse the anticoagulation effects of Xarelto, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Xarelto,” the Xarelto lawsuit states.

According to the complaint, there have been “1,080 Xarelto- associated “Serious Adverse Event” (“SAE”) Medwatch reports filed with the FDA.” Of those, 65 deaths have occurred.

Additionally, 8% of hemorrhage events have resulted in a death.

The Xarelto lawsuit alleges that the defendants are liable for negligence, strict products liability, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud and deceit.

The Xarelto Lawsuit is Case No. 2:17-cv-02671-EEF-MBN, in the U.S. District Court for the Eastern District of Louisiana.