Xarelto Lawsuit Plaintiffs Await Results Of European Regulators Investigation Of Drug’s Clinical Trial Results

March 04, 2016 – – BloodThinnerHelp.com reports on news from European Regulators, who have announced that they are conducting an investigation into the clinical trial results of new-generation blood-thinning drug, Xarelto. The investigation may have been spurred by recent lawsuit numbers, which are in the thousands, and have been filed against the manufacturers of Xarelto: Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson corporation). Plaintiffs involved in these mounting lawsuits commonly allege that use of the anticoagulant drug caused them spontaneous and dangerous bleeding episodes, and that it puts all patients at increased risk for these occurrences.

The clinical trial which is the subject of this investigation was conducted at the Duke Institute for Clinical Research. Project on Government Oversight reports note that the official who issued the U.S. Food and Drug Administration’s (FDA) approval of Xarelto in 2011 had additionally expressed concerns regarding the drug. In a statement released by POGO, they noted that “The FDA approved Xarelto in 2011 over the objections of the primary FDA scientists assigned to study its safety and effectiveness. The report by the reviewers argued that patients could be ‘at greater risk of harm from stroke and/or bleeding’ if they took Xarelto than if they were treated skillfully with Warfarin, a blood thinner that has been on the market since the 1950’s.”

In addition, the POGO article stated, “The official who issued the FDA’s decision to approve the drug expressed a series of misgivings about it.” It was noted that this particular official, FDA Deputy Division Director Stephen M. Grant stated, “The decision was made difficult by the limitations in the design and conduct” of Xarelto clinical trials, and that this statement was written in a November 2011 memo.

Today, Xarelto is the topic of over 3,300 lawsuits filed both in a federal court in the Eastern District of Louisiana, and in Philadelphia, Pennsylvania. The Louisiana federally-filed cases are being presided over by Judge Eldon Fallon, and continue to grow in number as they await further preparations for trial. These lawsuits have been consolidated by the U.S. Judicial Panel for Multidistrict Litigation to form MDL No. 2592. The Philadelphia lawsuits were consolidated by the Court of Common Pleas to form a mass tort group. Xarelto has additionally received two ‘black box’ warnings from the FDA. These types of warnings are the most serious warnings possible for a product to receive before being fully removed from the market.

AllGov.org further discussed the EMA’s clinical trial investigation, noting, “The clinical trial relied on blood testing devices that were the subject of two FDA warning letters before the trial began and an FDA recall notice after the trial ended, according to the Project on Government Oversight (POGO). Certain devices in the INRatio product line, the warning notice read, could deliver false test results and that use of those devices may “cause severe or life-threatening injuries, including death.”

The most recent reports on the investigation indicate that the EMA “is currently investigating whether the data generated from the INRatio device could have had any impact on the trial results and the extent of this impact, if applicable.” POGO additionally reported that an FDA staff review of Xarelto clinical trials noted that results appeared to be biased in Xarelto’s favor. As investigations regarding these details progress further, lawsuits filed against Xarelto manufacturers Bayer AG and Janssen Pharmaceuticals continue to appear from across the country.

At this time as well, Attorney Joseph Osborne is working to help ensure that anyone who used Xarelto and believes that they were negatively affected by the drug will be given the important opportunity of investigating their legal rights in full. It is likely that patients who have used Xarelto and have also suffered from dangerous side effects could be entitled to substantial compensation. To help those deserving seek justice, Attorney Osborne is offering complimentary Xarelto consultations to affected parties at this time.

To learn more about Xarelto lawsuits, or to ask questions, contact Joseph Osborne, Esq. by calling (866) 425-8902.

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Joseph Osborne
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