Xarelto Lawsuit Plaintiffs Continue Their Legal Battle As They Await Results Of Report Related To Duke Clinical Trials

June 22, 2016 – – TheProductLawyers.com reports on ongoing investigations related to the results of clinical trials for Xarelto, a blood-thinning drug approved by the U.S. Food and Drug Administration (FDA) in 2011. One such investigation is being undertaken by European regulators related to the clinical trial conducted at the Duke Institute for Clinical Research.

As per AllGov.org, the clinical trial that European regulators are looking into relied on blood testing devices that were the subject of FDA warnings prior to the start of the clinical trial, with an FDA recall notice being issued for the device after the trial was completed. The FDA warning notice stated that the blood testing devices had the potential of reporting false negatives and that the use of said devices could cause life-threatening risks, including death.

Another issue with the clinical trial in question, according to an article in the New York Times, is that the FDA representative that initially issued the approval for Xarelto, in fact, actually expressed serious concerns over the approval, as per reports by the Project on Government Oversight (POGO). POGO reports that the approval was granted regardless of objections expressed by the primary FDA scientist that was in charge of study the drug’s safety and effectiveness. The POGO report states that the reviewer’s assessment concluded that patients taking Xarelto could be at a higher risk for stroke and/or internal bleeding than if they took warfarin, a predecessor blood-thinning drug that has been on the market since the ’50’s.

Xarelto has been the subject of lawsuits now in excess of 3,300 filed against the manufacturers of the drug, Janssen Pharmaceuticals, a subsidiary company of the Johnson and Johnson Corporation, and Bayer AG. Plaintiffs in all of the cases generally allege that the blood thinner drug put them at serious risk for sudden and potentially life-threatening bleeding, which proved fatal in many cases, for whom some family members have filed suit on their behalf.

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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