Xarelto Lawsuit Plaintiffs Note New York Times Article Detailing Controversies Behind Xarelto Clinical Trials
March 22, 2016 – – BloodThinnerHelp.com reports on an article recently published by the New York Times which stated that the U.S. Food and Drug Administration will begin to investigate whether a recalled testing device may have affected the results of clinical trials conducted on new-generation blood-thinning drug Xarelto, ultimately leading to its FDA approval.
Since its 2011 release to market in just five year’s time, Xarelto has become the topic of over 3,400 lawsuits– 2,800 of which were federally-filed, transferred, and consolidated in Eastern Louisiana by the U.S. JPML, and over 600 of which were consolidated to form a mass tort program in Philadelphia, Pennsylvania by the Court of Common Pleas.
Thousands of Xarelto plaintiffs filing lawsuits from across the nation share remarkably similar complaints which allege that the anticoagulant causes elevated risk of the development of sudden, dangerous, and even fatal bleeding episodes among patients taking it. The lawsuits concerning these allegations were filed against Xarelto manufacturers Bayer AG and Johnson & Johnson subsidiary Janssen Pharmaceuticals.
According to the New York Times article, the FDA has started to ask Johnson & Johnson, “…detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.”
Much controversy has been stirred up over the accuracy of the clinical trial study and over what information was provided from that study to a prestigious medical journal. It has been reported that questions surrounding the trial results have been growing since last fall when it was reported that Johnson & Johnson and Bayer, “…notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding.”
The New York Times additionally mentioned that, “Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.”
Attorney Joseph Osborne is working to help anyone who has taken Xarelto and who has also suffered from health complications that they feel were caused by the drug. He feels that it is important to help ensure that all affected individuals will be provided an opportunity to explore their legal rights in full. Affected patients could be entitled to substantial compensation through legal action. In an effort to better assist those who wish to pursue justice, Attorney Osborne is currently offering complimentary Xarelto consultations for affected individuals.
To obtain additional Xarelto lawsuit information, or to ask questions, please contact Joseph Osborne, Esq. at (866) 425-8902
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