Xarelto Lawsuit Plaintiffs Note New York Times Article Reporting Possible Error During Xarelto Clinical Studies

April 22, 2016 – – BloodThinnerHelp.com comments on reports from a New York Times article which announced the U.S. Food and Drug Administration’s current investigation into whether a recalled, potentially faulty blood-testing device may have impacted Xarelto clinical trial results and therefore led to Xarelto’s premature approval.

Xarelto is manufactured by Johnson & Johnson’s subsidiary company Janssen Pharmaceuticals and Bayer AG. The drug is a new-generation anticoagulant which gained FDA approval in 2011, and was released to the market for public use. Initially, Xarelto was very popular, offering users freedoms that traditional blood thinners had not been able to. The drug has reportedly made billions of dollars for the manufacturers. In just five years time, however, Xarelto has been linked to sudden, dangerous bleeding events among patients, and to over 3,400 lawsuits from across the nation.

These 3,400 lawsuits have been filed by plaintiffs who commonly allege that the blood thinner is significantly dangerous. Over 2,800 of the cases have been federally-filed and were transferred and consolidated to a single court in Eastern Louisiana by the U.S. Judicial Panel on Multidistrict Litigation. In addition, over 620 other Xarelto lawsuits have been consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas, forming a mass tort program.

New controversies have erupted surrounding the drug now that the New York Times has indicated that the FDA is now asking 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.”

Questions over the accuracy of clinical trial results have been discussed since last fall when both Johnson & Johnson (Janssen) and Bayer, were said to have “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 medical device in question is known as an INRatio, and is used to measure clotting rates, and help evaluate how many bleeding episodes or strokes were experienced by patients taking Xarelto compared to those who were taking warfarin, a traditional blood thinner.

The New York Times also indicated that at this time, “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.”

As those closely involved anxiously await the results of these investigations, Attorney Joseph Osborne is working to help other patients who have used Xarelto and who feel that it has negatively impacted their health. He hopes to ensure that all affected patients will be given the important opportunity to investigate their legal rights in the matter. Patients could be entitled to substantial compensation gained through legal action. To help those wishing to explore their legal options fully, Attorney Osborne is now offering complimentary Xarelto consultations to qualified parties.

To obtain more information, or to ask questions, please contact Joseph Osborne, Esq. at (866) 425-8902.

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Contact BloodThinnerHelp.com:

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

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