Xarelto Lawsuit Plaintiffs Note New Evidence Of Possible Withheld Clinical Trial Data

June 22, 2016 – – TheProductLawyers.com reports on a recently published article from Business Insider (BI) that details both lawsuits against and controversies surrounding the anticoagulant drug, Xarelto. In 2011, the FDA granted approval to Xarelto. However, according to BI, a deluge of public concern has recently swamped the courts. The outcry was largely prompted by the release of a document claiming that Bayer AG and Janssen Pharmaceuticals intentionally failed to disclose crucial data to a medical journal during clinical trials of the drug.

At first, physicians and patients embraced the new generation anticoagulant, since it required little monitoring or dosage alteration and no dietary restrictions. Doctors frequently prescribed it to individuals who had deep vein thrombosis or were at risk of pulmonary embolism. It was also approved as a preventative therapy for those with increased risk for stroke and individuals recovering from hip or knee surgery because Xarelto is designed to prevent the development of blood clots and related complications.

This warm welcome translated into more than $1.8 billion in sales for the U.S. division. However, as the article from BI indicates, prospects are now distinctly less rosy for the manufacturers of the anticoagulant. To date, lawsuits alleging grievous harm as a direct result of using Xarelto have mounted to more than 5,000. Of these, ten percent claim patient fatality.

Business Insider also cited work by Katie Thomas of the New York Times. Drawn from a footnote of a federal legal brief, there is evidence that critical data may have been intentionally withheld from a peer-reviewed article in the New England Journal of Medicine. Public concern has been compounded by the results of a clinical trial of the drug.

It was revealed that the findings were based upon a monitoring device that has since been recalled, and that this flawed blood testing device may have skewed the results in favor of Xarelto’s efficacy. Such findings have prompted both the FDA and the European Medicine Agency to conduct investigations into the legitimacy of the FDA’s initial approval.

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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