Xarelto Lawsuit Plaintiffs Await Results Of European Regulator Investigation Into Xarelto Clinical Trial Results

April 26, 2016 – – BloodThinnerHelp.com reports on an ongoing investigation conducted by European regulators concerning the results of Xarelto clinical trials. The investigation comes after increasing controversial claims surrounding the new-generation blood thinner, and its 2011 approval by the U.S. Food and Drug Administration. Xarelto manufacturers Bayer AG and Janssen Pharmaceuticals are also facing thousands of lawsuits concerning the drug at this time, involving plaintiffs from across the nation who similarly allege that use of the anticoagulant drug can place patients at increased risk for the development of severe and dangerous bleeding events.

The clinical trial which is currently under investigation was conducted at the Duke Institute for Clinical Research in Durham, North Carolina. Detailed information sourced from the Project on Government Oversight shows that the issuing official who provided the U.S. Food and Drug Administration’s 2011 approval of Xarelto has actually expressed concerns over the decision. POGO noted, “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.”

POGO also stated, “The official who issued the FDA’s decision to approve the drug expressed a series of misgivings about it.” They name this official as FDA Deputy Division Director Stephen M. Grant, and note that in a November 2011 memo, the official commented, “The decision was made difficult by the limitations in the design and conduct” [of the clinical trial].

At this time, Xarelto has become the topic of over 3,400 lawsuits which have been formed into two major groupings. Lawsuits filed in federal court, which now number over 2,800 have been consolidated and transferred to a single court in the Eastern District of Louisiana, forming MDL number 2592. These cases are being overseen by Judge Eldon Fallon, and continue to rise in number. They are also joined by over 620 other Xarelto lawsuits which have been consolidated by the Court of Common Pleas in Philadelphia, Pennsylvania, forming a mass tort program.

The European investigation into Xarelto clinical trials was additionally discussed by AllGov.org, which reported, “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.”

Recent information concerning the investigation shows only that the European Medicines Agency, “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 also noted that an FDA staff review of the trial showed that results seemed to be biased in favor of Xarelto. As the investigations continue and those involved await new information, plaintiffs anxiously await their trial dates.

At this time, Attorney Joseph Osborne is working to help others who may be able to join the current lawsuit filings. Those who have used Xarelto and feel that they have been negatively affected by the drug may be eligible for significant compensation. They are greatly encouraged to take the opportunity to explore their legal rights in the matter. For those who are looking to further investigate their legal options, Attorney Osborne is currently offering complimentary 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.

###

Contact BloodThinnerHelp.com:

Joseph Osborne
866-425-8902
Mizner Park
433 Plaza Real Blvd., Ste. 271
Boca Raton, FL 33432

ReleaseID: 60009613