A new lawsuit was filed in federal court as a result of the plaintiff’s alleged experience with a Xarelto gastrointestinal bleed.

The plaintiff, Patricia A., is a citizen and resident of Indiana who says she ingested the blood thinner from early May 2015 to early January 2017—a little over a year and a half. On Jan. 2, 2017, she alleges she suffered a Xarelto gastrointestinal bleed directly related to this prescription.

The defendants named in this case include Janssen Research and Development, its parent company, Johnson & Johnson Inc., Ortho-McNeil-Janssen Pharmaceuticals, and Bayer Healthcare Pharmaceuticals. It also names related subsidiaries.

Patricia is seeking a jury trial and a compensatory award for the pain and suffering she says she experienced as a result of her Xarelto induced gastrointestinal bleed. She believes the defendants misrepresented their defective product and needlessly endangered her and others in the process.

Xarelto’s History

These defendants received approval from the U.S. Food and Drug Administration (FDA) to market Xarelto on July 1, 2011. Its stated purpose was to prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in patients expected to undergo total knee or hip arthroscopies.

Within four months, that approval was extended to include reduction in risk for sufferers of non-valvular atrial fibrillation of having a stroke or embolism (blood clot) released in their system.

The initial FDA approval was based upon a clinical trial which has been referred to as the RECORD studies. The RECORD studies sought to contrast and compare the effectiveness of Xarelto against the tried and true blood-thinner called warfarin—in use for close to six decades.

All anticoagulants purportedly can bring on episodic problems with bleeding as a side effect. Data produced from the RECORD study revealed a similar rate with regard to this problem, but the blood clot prophylaxis was allegedly superior. Unfortunately, certain patients that experienced a Xarelto bleed were greater in number.

Because patients on the new blood thinner experienced these episodes of Xarelto gastrointestinal bleeding more often, blood lab work often revealed overall poorer results when hemoglobin tests were run. Blood transfusions were often necessary in the face of the test results.

According to the factual allegations section of this lawsuit, the FDA proceeded to approve Xarelto despite discovering during an inspection that appropriate protocol for the RECORD trials had not been upheld.

In fact, alleges Patricia in her lawsuit, data had likely been grossly skewed. She reports that evidence was found of medical record destruction, removal of blinding mechanisms for researchers delivering warfarin and Xarelto to patients, and outright falsification of data. Conclusions were ostensibly drawn that RECORD produced completely unreliable results.

A second study known as ROCKET AF revealed that Xarelto was on par with the performance of warfarin, notes the complaint, but that the experience of gastrointestinal bleeding occurred more often with Xarelto than with warfarin.

Nevertheless, the defendants over-promoted Xarelto and claimed that it was superior, alleges the lawsuit. It allegedly pursued an aggressive advertising campaign to the medical professional community and sold it on the basis of once a day dosing, limited dietary changes, and little to no needed monitoring.

The Janssen Research & Development Lawsuit is Case No. 2:18-cv-14158-EEF-MBN in U.S. District Court for the Eastern District of Louisiana.