Xarelto Lawsuit Plaintiffs Await Results From Investigation Of European Regulators Into Xarelto Clinical Trials

April 19, 2016 – – BloodThinnerHelp.com comments on details of an investigation which is reportedly being conducted by European regulators in reference to clinical trial results conducted on Xarelto. The investigation is coming at a time when a surge of Xarelto-related lawsuits have been filed against Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson). Thousands of lawsuits have been filed against the blood-thinning drug by plaintiffs who similarly allege that use of the drug can place patients at heightened risk for sudden, dangerous bleeding episodes.

The clinical trial which is reportedly under investigation was conducted by researchers at the Duke Institute for Clinical Research. Details provided in the Project On Government Oversight (POGO) seem to indicate that the official issuing the 2011 FDA approval of Xarelto had expressed concerns over the safety of the anticoagulant, and that the approval was also met with some strong contention from members of the agency.

POGO stated, “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 reference to the possible objections, POGO also noted, “The official who issued the FDA’s decision to approve the drug expressed a series of misgivings about it.” It was reported that this official, named as FDA Deputy Division Director Stephen M. Grant,discussed the decision to approve Xarelto and several of his concerns, noting in a November 2011 memo, “The decision was made difficult by the limitations in the design and conduct” (during the clinical trial).

Since gaining this 2011 approval from the FDA, Xarelto has also been issued two ‘black box’ warnings from the organization. These are the most severe product warnings possible to be given before a product is instead fully removed from the market for public sale. The drug has also become the topic of more than 3,400 lawsuits filed by plaintiffs from across the country.

AllGov.org discussed Xarelto clinical trial controversies further by 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’.”

It was additionally noted that at this time, 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.” Those closely involved understandably are anxiously awaiting more answers as time goes on.

Attorney Joseph Osborne is working to help others who have used Xarelto and who believe that the drug caused them to experience adverse health events. Affected patients may be entitled to significant compensation, and are encouraged to take the opportunity to explore their legal rights in the matter fully. To better assist those wishing to learn more about their rights, Attorney Osborne is offering free legal consultations for qualified individuals at this time.

To request further information on Xarelto bleeding lawsuits, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.

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Joseph Osborne
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