A Xarelto death lawsuit has been filed by the husband of a woman who died of uncontrollable bleeding injuries after taking the drug.

Plaintiff Carl W. alleges his deceased wife Carol “suffered gastrointestinal and rectal bleeding as well as anemia as a direct result of Xarelto.”

Carol ultimately succumbed to her injuries on Dec. 6, 2015.

Xarelto (rivaroxaban) belongs to a new class of blood thinners known as New Oral Anticoagulants (NOACs). Xarelto has been marketed as “the next generation of blood-thinning drugs to replace warfarin (Coumadin), an established safe treatment for preventing stroke and systemic embolism for the past 60 years.”

Xarelto is a product of drug powerhouses Johnson & Johnson, Janssen, and Bayer.

Xarelto Death Complaint Points to Poorly Managed Research

Xarelto became available in the U.S. in July 2011 when it received FDA approval for the prevention of DVT (deep vein thrombosis) and PE (pulmonary embolism) in patients undergoing hip or knee replacement surgeries.

That approval was based on a series of clinical trials known as the RECORD studies (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism).

According to the Xarelto death lawsuit, the FDA determined the RECORD studies were not reliable because FDA inspections “disclosed rampant violations including ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’”

Even so, Xarelto received additional approval to reduce the risk of stroke in patients with no-valvular atrial fibrillation in November 2011. This approval was based on a clinical trial called Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study (ROCKET AF).

While the Rocket AF study indicated Xarelto was not inferior to warfarin for stroke in such patients with a similar risk of major bleeding, something else stood apart in the data. The Rocket AF study indicated “’bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.’”

The Xarelto death complaint says in order to prove Xarelto’s superiority, the warfarin study group would have needed to have been closely managed. The FDA claimed the warfarin study group in the Rocket AF study was the “worse managed warfarin study group in any previously reported clinical trial involving warfarin.”

The FDA also determined that blood levels of Xarelto were more likely to be maintained with twice daily dosing. At least one FDA reviewer said the once-a-day dosing was more of a marketing decision rather than one based on scientific evidence.

The Xarelto death lawsuit alleges the drug’s makers knew or should have known that the risk of life-threatening bleeding “needed further testing and studies prior to its introduction to the market.”

The Xarelto Death Lawsuit is Case No. 2:17-cv-05661-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.