Controversy Mounts Over Omitted Data From Clinical Trial As Xarelto Plaintiffs Await Their Day In Court
September 28, 2016 – – TheProductLawyers.com reports on the mounting controversy over a 3-year long Xarelto clinical testing conducted by Duke University researchers for the manufacturers of the blood-thinning drug, Janssen Pharmaceuticals, a subsidiary of the Johnson and Johnson Corporation, and Bayer AG. The clinical trial is now under investigation and the results of the trial are being questioned due to the use of a recalled blood testing device. It is also being alleged that the manufacturers purposefully kept quiet after noticing the omission of the data related to the device. Because of this silence, incomplete drug information was sent to US and European regulators and to the New England Journal of Medicine (NEJM), whose assessment of Xarelto based on this faulty testing data most likely led to FDA approval of the drug.
As per a Business Insider article, Xarelto is now the focus of more than 5,000 lawsuits with 500 claims of patients dying from using the drug. Plaintiffs and lawyers representing them question whether the omitted data would have helped to prevent such a large number of lawsuits and unnecessary deaths allegedly resulting from use of the anticoagulant.
The Duke University clinical trial involved the review of 14,000 patients and the effects of the blood-thinning drug on them compared to warfarin, a predecessor blood-thinning drug. Many believe the faulty testing device led to the appearance that Xarelto was more effective because the device failed to give patients the right dosage of warfarin.
While the controversy continues to build over this particular clinical test, plaintiffs who have filed lawsuits against the manufacturers of Xarelto await their day in court. The first bellwether trials are set to begin in the spring of 2017. It is also anticipated that more cases will be filed as bellwether trials approach.
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 888-478-9711.
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