Xarelto Lawsuit Plaintiffs See Clinical Trial Results Investigated After Discovery Of Potentially Defective Device
April 26, 2016 – – BloodThinnerHelp.com comments on reports from Reuters with more details on current Xarelto lawsuits. Currently, it has been indicated that both U.S. and European drug regulators are investigating to determine whether a defective blood clotting medical device used during Xarelto clinical trials could have impacted the outcome of the results gathered. It has been indicated that the results may have been impacted in Xarelto’s favor, and could have led to a premature FDA-approval of the new-generation blood thinner, manufactured by Bayer AG and Johnson & Johnson subsidiary Janssen Pharmaceuticals.
Since its release in 2011, Xarelto has become the topic of more than 3,400 lawsuit filings. The plaintiffs filing the complaints share strikingly similar allegations that use of the blood thinner places patients at increased risk of the development of severe and dangerous bleeding episodes. Lawsuits referencing Xarelto have been formed into two major groupings: over 2,800 cases which were federally-filed have been transferred and consolidated to form MDL number 2592 in Eastern Louisiana. These lawsuits are joined by another group of over 620 complaints which were formed into a mass tort program in Philadelphia, Pennsylvania by the Court of Common Pleas.
The clinical study in question was conducted with the purpose of comparing new-generation Xarelto to a traditional blood thinner (warfarin) in terms of overall effectiveness for preventing strokes among those suffering from atrial fibrillation. It has been learned, however, that the study results could have been affected due to a defect in one of the medical devices used.
The European Medicines Agency commented on this possibility, stating, “Due to the defect, it is now thought that the INR (international normalized ration) device may have impacted the clotting results in some patients in the warfarin group.” They also stated that the study’s results would be published following the completion of their new investigation into this device. INR devices are used to measure how quickly blood is able to clot. It was reported that the system used to conduct this study had been recalled in December 2014 after researchers noted some significantly low results which were deemed false.
As the involved plaintiffs anxiously await trial dates, Attorney Joseph Osborne is working to assist other patients who have taken Xarelto and who feel that the blood-thinning drug negatively impacted their health in some way. He wants to help ensure that all affected patients will be provided with the important opportunity to investigate their legal rights in full. Affected parties could be entitled to significant compensation gained through legal action. To better assist those wishing to further explore their legal options, Attorney Osborne is now offering free legal consultations to qualified parties.
To request additional Xarelto bleeding lawsuit information, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
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