Janssen Pharmaceuticals has found itself the subject of a new Xarelto injuries lawsuit.

Plaintiff John B., a resident of Colorado, has filed a Xarelto injuries lawsuit against Janssen Pharmaceuticals as well as Johnson & Johnson and Bayer Healthcare.

He claims after he took Xarelto, he suffered various injuries including serious physical pain and suffering, medical, hospital and surgical expenses, and loss of consortium.

John began using Xarelto in January 2014 and continued using it until November of that year. Because of Xarelto, he claims, he experienced gastrointestinal bleeding and blood in his stool.

Because of these Xarelto injuries, John alleges, he underwent a life-threatening bleed that required blood transfusions and extensive hospitalization.

According to John’s Xarelto lawsuit, defendants Janssen Pharmaceuticals, Johnson & Johnson and Bayer were in the business of designing, researching, manufacturing, testing, advertising, promoting, marketing, selling and distributing Xarelto “to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrilation.”

It is also used to treat DVT (deep vein thrombosis) and PE (pulmonary embolism) for patients undergoing hip and knee replacement surgery.

Xarelto was introduced in the United States in 2011 and is part of a new class of drugs called New Oral Anticoagulants (NOACs).

NOACs have been marketed as the next generation of blood-thinning drugs with the intention to compete with the market leader, warfarin (Coumadin).

Warfarin has been an established treatment for stroke prevention and systemic embolism for 60 years.

Xarelto Injuries Linked to Flawed Studies

The approval of Xarelto was based on a series of clinical trials known as the RECORD studies.

The RECORD studies found that Xarelto was superior to other drugs in some regards but also showed an increased incidence of bleeding that led to decreased hemoglobin levels and transfusion of blood.

Critics believe that the RECORD studies were flawed in design and conducted in a negligent manner.

In fact, according to this Xarelto lawsuit, the Food and Drug Administration found rampant flaws including “systemic discarding of medical records,” unauthorized unblinding, falsification, and “concerns regarding improprieties in randomization.”

The FDA found four RECORD studies were so flawed that they had to be deemed unreliable.

In essence, the plaintiff believes that the clinical studies involved with the approval of Xarelto were flawed and Xarelto should never have been approved in the manner it was.

Another study, the ROCKET AF study, compared warfarin to Xarelto. However, according to this Xarelto lawsuit, this study was also flawed.

The plaintiff claims the warfarin group was not managed well making the data not adequate to determine the efficacy of Xarelto as compared to warfarin.

The plaintiff claims that the defendants used these two studies, plus other allegedly flawed studies, to promote Xarelto in their marketing materials.

However, those same promotional materials, John claims, do not make mention of serious injuries such as the increased risk of gastrointestinal bleeding and other various bleeding concerns.

Xarelto was even marketed as being superior to warfarin because patients need only take it once per day.

But, the clinical studies found that Xarelto is safer and more effective when there is close monitoring of the patient’s blood as well as dose adjustments.

What is even more concerning is that Xarelto, when it was approved for market, did not have a reversal agent in the case of a uncontrollable bleeding event.

In the first year after its release, Xarelto users reported over 1,000 serious adverse events as well as 65 deaths associated with the drug.

John is raising claims of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violation of consumer protection laws.

This Xarelto Injuries Lawsuit is Case No. 22:16-cv-15924 in the U.S. District Court for the Eastern District of Louisiana. It’s part of the Xarelto MDL, In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, also in the U.S. District Court for the Eastern District of Louisiana.