Brief Filed in Xarelto Lawsuit Litigation Claims Drug Makers Remained Silent Regarding Omission of Lab Data Published in The New England Journal of Medicine
A brief filed on behalf of thousands of plaintiffs who have Xarelto lawsuits pending in a federal multidistrict litigation has made some alarming claims regarding the conduct of Johnson & Johnson and Bayer. The brief, which was filed in the U.S. District Court, Eastern District of Louisiana, contends that the companies were aware that important lab data had been omitted from an analysis published last month in The New England Journal of Medicine (NEJM). According to The New York Times, plaintiffs assert that the drug makers 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 United States and Europe.”
[nytimes.com/claims-drug-makers-deceived-a-top-medical-journal.html, New York Times]
“The report published by the Times is disturbing, and raises serious questions about the data used to obtain regulatory approval for Xarelto,” says Dr. François Blaudeau, the founder of Southern Med Law. As both an attorney and a practicing physician, Dr. Blaudeau possesses unique insight into the various legal and medical issues at the center of the growing Xarelto litigation.
Xarelto was approved by the U.S. Food & Drug Administration (FDA) in 2011, largely based on the Rocket-AF study. According to the times, that trial compared the number of strokes and bleeding events experienced by patients taking Xarelto with those using warfarin. However, last year it was discovered that a testing device used to make sure warfarin patients enrolled in the study received the correct dose of the drug had been recalled in 2014. If the device malfunctioned during Rocket-AF, the results would have suggested that Xarelto was superior to warfarin.
Rocket-AF was overseen by the Duke Clinical Research Institute, which last month published a re-analysis of the study in the NEJM. They concluded that the faulty testing device didn’t impact the trial’s results. But according to the Times, it now appears that some lab data might have been withheld which should have been published in the follow-up analysis. The data in question compared test results of the recalled device’s readings at a central laboratory, taking blood samples at the 12 and 24 month mark of the trial.
The editor at the NEJM acknowledged that they were unaware of the omitted data until a reporter from the Times asked them about it. However, “they dismissed its relevance and said they stood by the article’s analysis,” the report said.
More than 3,000 Xarelto lawsuits are now pending in the Eastern District of Louisiana, all of which were filed on behalf of patients who suffered dangerous internal bleeding and other problems allegedly associated with the blood thinning medication. Among other things, plaintiffs charge that the manufacturers of the drug wrongly marketed it as an improvement over warfarin. (In Re: Xarelto Litigation, Case ID 150102349)
Southern Med Law continues to review product liability claims on behalf of patients who may have been harmed by Xarelto. If you or a loved one experienced life-threatening internal bleeding or other complications while using this medication, please contact the Firm as soon as possible to learn more about your legal rights. You can arrange for a free, no obligation Xarelto lawsuit review by calling Southern Med Law today, at 205-547-5525.
About Southern Med Law and Filing A Xarelto Bleeding Lawsuit: Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective attorney and advocate for those who were harmed due to negligent pharmaceutical companies. If you or a loved one where harmed by Xarelto, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation Xarelto lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
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