Xarelto Lawsuit Plaintiffs Await Results Of Investigation Into Xarelto Clinical Trial By European Regulators

April 01, 2016 – – BloodThinnerHelp.com reports on an investigation currently underway to evaluate Xarelto clinical trials. The investigation is being conducted by European regulators, and it follows the steady increase of Xarelto-related lawsuits filed against manufacturers Bayer AG and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson corporation) which similarly claim that use of the anticoagulant can place patients at increased risk for the development of sudden and dangerous bleeding episodes.

The clinical trial currently being investigated was conducted at the Duke Institute for Clinical Research. Reports provided by the Project on Government Oversight show that the official issuing the U.S. Food and Drug Administration’s 2011 approval of Xarelto had actually expressed reservations regarding this approval. 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 addition, POGO noted, “The official who issued the FDA’s decision to approve the drug expressed a series of misgivings about it.” They reported that this official, FDA Deputy Division Director Stephen M. Grant had said, “The decision was made difficult by the limitations in the design and conduct” of the clinical trial, within a comment from a November 2011 memo.

Today, Xarelto is the topic of over 3,400 lawsuits making up two major groupings: federally-filed lawsuits were transferred and consolidated to Eastern Louisiana and number over 2,800. They are being overseen by Judge Eldon Fallon, and continue to grow in number as time passes. This consolidation formed multidistrict litigation No. 2592. In addition, they are joined by more than 600 other Xarelto lawsuits which were consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas to form a mass tort program.

Further details regarding the European investigation on Xarelto clinical trials is available on AllGov.org, which indicates, “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 details also show 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 also reported that an FDA staff review of the clinical trial showed that the results may be biased in favor of Xarelto. As these investigations look for additional answers, plaintiffs involved in lawsuits against Xarelto manufacturers anxiously await bellwether trials scheduled for early 2017.

As these plaintiffs await further action, Attorney Joseph Osborne is working to help others who used Xarelto and feel that they were negatively affected by the drug. He wants to ensure that these patients will be given the opportunity to investigate their legal rights in the matter. Affected patients may be entitled to significant compensation attained through legal action. To help those interested, Attorney Osborne is now offering complimentary legal consultations to qualified parties.

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

###

Contact BloodThinnerHelp.com:

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

ReleaseID: 60009027