Xarelto Lawsuit Plaintiffs Note Defective Device Used In Clinical Trials Of Drug
May 30, 2016 – – TheProductLawyers.com reports on a 3-year long clinical trial that the makers of Xarelto hired Duke University to undertake for Xarelto, a then newly developed blood-thinning drug. Xarelto trials began in 2006 and reviewed the blood-thinning effects in a sample of 14,000 patients of a Xarelto compared to warfarin, a more traditional blood thinner. There is currently an investigation underway about this particular clinical trial. Many 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.
A recent Business Insider article has stated that 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.
It is also being reported that 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.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
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