Xarelto lawsuit plaintiffs are claiming that the manufacturers of the blood-thinning medication withheld some key lab data from an analysis recently published in The New England Journal of Medicine (NEJM). The analysis, which was included in a Letter to the Editor written by Duke University researchers, asserted that a recalled blood clotting device used during thea Xarlet clinical trial did not affect the study’s outcome.

The trial in question, entitled ROCKET-AF, was key to Xarelto’s regulatory approval in 2011. The study compared the number of strokes and bleeding events among more than 14,000 patients treated with either Xarelto or warfarin. The worldwide trial was funded by Bayer and Johnson & Johnson, and run by scientists at the Duke Clinical Research Institute.

Xarleto Plaintiffs Claim NEJM Reanalysis Omitted Critical Lab Data

Last year, the two drug companies disclosed that a device recalled in 2014 had been used to ensure warfarin patients enrolled in the study received the proper dose of the medication. If the testing instrument had malfunctioned during Rocket-AF, results would have been skewered in favor of Xarelto. In February, the Duke Clinical Research Institute published a letter in the NEJM stating that it stood by ROCKET-AF, after a re-analysis indicated that problems with the testing device “did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial.”

But according to a New York Times report dated March 1st, a legal brief filed on behalf of thousands of plaintiffs pursuing Xarelto lawsuits in the U.S. District Court, Eastern District of Louisiana, asserts that the re-analysis omitted “critical laboratory data.” The brief also claims that Bayer and Johnson & Johnson were “complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the U.S. and Europe.”

A spokesperson for Johnson & Johnson told The New York Times that the Duke re-analysis was conducted independently of the company. And while top NEJM editors said that they only learned of the omitted data when contacted by the Times, they dismissed its relevance and said they stood by the article’s analysis.

Xarelto Litigation

The manufacturers of Xarelto are currently facing more than 3,000 product liability lawsuits over uncontrollable bleeding and other complications allegedly related to use of the blood thinner. Among other things, plaintiffs claim that the companies wrongly marketed Xarelto as a superior alternative to warfarin, an anticoagulant that has been on the market for decades.

Bernstein Liebhard LLP is currently representing a number of plaintiffs in the Xarelto litigation. If you or a loved suffered complications that may be associated with this medication, please call 877-779-1414 to learn more about your legal rights.

Published March 9, 2016 by