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Validity of Xarelto Clinical Trials as a Point of Contention

Aug 31, 2016

Currently, there are more than 800 Xarelto lawsuits pending in Philadelphia, with plaintiffs who claim they took the anticoagulant and then suffered serious injuries, such as gastrointestinal bleeding or stroke. Drug manufacturers, Janssen Pharmaceuticals, parent company of Johnson & Johnson, and Bayer AG are accused by the plaintiffs of allegedly failing to provide adequate warnings concerning the risks linked to the drug and for failing to conduct proper safety studies before they put Xarelto on the market.

The first trial in the Xarelto multidistrict litigation (MDL) in Louisiana, where over 6,000 cases are pending, is expected to begin in February 2017. The first Philadelphia bellwether trial is scheduled to begin in summer, 2017.

The British Medical Journal (BMJ) published a report in December 2015 warning that during the ROCKET-AF clinical trials, comparing the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin), the scientists used a defective device. The device allegedly, returned results that were falsely low. Alere, the company that made the device, recalled the device in December 2014 due to this defect, after the company had received 19,000 reports of malfunctions.

BMJ remarked that data from the trial “is being reanalyzed because of the use of a faulty device,” and that the European Medicines Agency had launched an investigation into the trial. The faulty readings could have resulted in patients receiving a dose that was too high, which would increase their risk of bleeding, making it appear like warfarin was linked to more excessive bleeding events than perhaps was actually the case.

False results could have also been created for Xarelto, which according to the study, was similarly effective to warfarin for the prevention of blood clots and stroke in patients with atrial fibrillation. This was the main clinical trial used to achieve FDA approval for Xarelto for the treatment of non-valvular atrial fibrillation.

A lead investigator for ROCKET-AF concluded that any potential malfunctions in the Alere device did not have any significant effect on the overall findings in the trial. The author of the BMJ report, Dr. Harlan Krumholz, stated that the new data didn’t alleviate his concerns and wished they had done further studies.

There is no doubt, whatever the eventual outcome of the situation, the quality of the Xarelto clinical studies will be a major topic of contention in the upcoming Xarelto litigation.

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