The anticipated personal representative of an estate has filed a Xarelto bleeding problems lawsuit alleging the anticoagulant’s side effects led to the death of Carmen D.

Plaintiff Francisco R. alleges Carmen took Xarelto in or about 2014 and suffered a gastrointestinal bleed that resulted in hospitalization in January 2015. Carmen is now deceased.

Xarelto is one of the NOACs (Novel Oral Anticoagulants) on the market. The drug class also includes Pradaxa and Eliquis. These three NOACs have been heavily marketed to replace warfarin (Coumadin), an older anticoagulant that has been used for nearly six decades.

Xarelto (rivaroxaban) was approved by the FDA in 2011. Johnson & Johnson and its subsidiary Janssen Pharmaceuticals teamed up with Bayer to create, produce, market and sell Xarelto, which acts by inhibiting Factor Xa in the blood’s coagulating action.

The NOACs entered the market with great fanfare because they were promoted as much easier to take than warfarin. Patients on warfarin have dietary restrictions, must take it twice daily, and have to have their blood monitored to ensure a therapeutic level of warfarin is maintained in their system.

Overview of Xarelto Bleeding Problems

According to the Xarelto bleeding problems complaint, the medication was approved for the prevention of DVT (deep vein thrombosis) and PE (pulmonary embolism) in patients undergoing hip or knee replacement surgeries based on a collection of clinical trials.

The RECORD (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism) studies allegedly indicated Xarelto was superior to enoxaparin for the prevention of thrombosis after total knee and hip replacement surgery.

“However, the studies also showed a greater bleeding incidence with Xarelto leading to decreased hemoglobin levels and transfusion of blood,” alleges the Xarelto GI bleed lawsuit.

The Food and Drug Administration’s Official Action Indicated-rated inspections purportedly found the RECORD studies were flawed and were conducted negligently. A 2009 inspection pointed to violations such as the “systemic discarding of medical records, alleged falsification, and “concerns regarding improprieties in randomization.”

The FDA eventually determined the RECORD 4 study results were not reliable.

Still, in November 2011, the FDA additionally approved Xarelto to be used in the reduction of stroke and systemic embolism in patients experiencing non-valvular atrial fibrillation. This additional approval was based on another clinical trial called the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) study.

The ROCKET AF study indicated Xarelto was not inferior to warfarin in preventing strokes or systemic embolisms in patients with non-valvular atrial fibrillation and they all had a similar risk of experiencing major bleeds.

However, “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,” according to M.R. Patel in an article in the New England Journal of Medicine in 2011.

According to the journal BMJ, concerns about the point of care device that researchers used to measure the amount of warfarin in the patients participating in the study was recalled because it could show levels that were “clinically significantly lower” than regular laboratory tests, said the FDA. The point of care device used in the ROCKET AF study was the subject of an FDA class I recall in December 2014.

The Xarelto Bleeding Problems Lawsuit is Case No. 2:19-cv-00497-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.