An investigation is underway into a clinical trial that the makers of Xarelto hired Duke University to undertake. Scientific trials for Xarelto, a blood-thinning drug, began in 2006 and reviewed the effects in a sample of 14,000 patients of a Xarelto compared to warfarin, a more traditional blood thinner, according to a new announcement.
Xarelto is manufactured by Janssen Pharmaceuticals, a subsidiary of the Johnson and Johnson Corporation, and Bayer AG.
Investigators are questioning the use of a defective testing device during the trials that would have influenced the results that ultimately indicated that Xarelto was more effective since the defective device in question allegedly gave patients the wrong dosage of warfarin.
Xarelto has become the focus of more than 5,000 lawsuits, as well as 500 allegations of fatalities. Plaintiffs in these cases and others now question whether the data would have made a difference in assessing the safety of the drug.
Intentional deception by J&J
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Duke Researchers may have failed to provide all the requisite data of the trial for publishing in the New England Journal of Medicine (NEJM). As a result, the manufacturers, Janssen Pharmaceuticals, a subsidiary of the Johnson and Johnson Corporation, and Bayer AG, are being accused of intentional deception by not giving the NEJM all the necessary data for its assessment, which most likely led to FDA approval of the drug and its subsequent release on the market.
Lawyers in a legal briefing recently filed allege that the makers of Xarelto did not say anything after noticing Duke’s omitted data related to a recalled blood testing device used in the trial, as well as remaining quiet as the information about the drug was sent to US and European regulators. By doing so, Janssen and Bayer in effect misled the NEJM and the many readers who rely on the journal’s information, as well at the patients who would eventually use the drug.