Xarelto Lawsuit Report: Legal Brief Contends Xareltos Makers Misled Medical Journal Editors

Xarelto Lawsuits Allege Bayer and Johnson Johnson Failed To Warn Doctors And Their Patients About The Severe Or Fatal Bleeding Risks Associated With Their Blood Thinner.

Xarelto Lawsuit Information: A legal brief filed in a federal Xarelto lawsuit accuses Bayer and Johnson Johnson of misleading editors of an international medical journal by withholding important laboratory data obtained during the clinical trial of the blockbuster blood thinner, according to The New York Times. Plaintiffs attorneys in the Xarelto bleeding lawsuit contend in their brief that the companies had more than 5,000 blood samples taken from patients and sent to a central laboratory but did not mention the tests to Duke University researchers who oversaw Xareltos clinical trial called, ROCKET AF. Researchers recently published a letter about the clinical trial in The New England Journal of Medicine (NEJM) without mentioning the laboratory data. The NEJM editors said in an interview that they did not know about the companies laboratory data until asked about it by a New York Times reporter, but they stood by the researchers analysis.

[http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?_r=1, The New York Times, March 1, 2016]

Duke University researchers wrote in their letter that problems that occurred with a blood-monitoring device used in ROCKET AF did not affect the trial results, according to The New York Times. The device that tested for blood clotting malfunctioned during the trial and was later recalled. Bayer and Johnson Johnson took separate blood samples and compared them to results provided by the faulty device, and then submitted the laboratory data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Xarelto was approved by both regulatory agencies.

Since last fall, questions have been raised about whether the recalled device affected the trial results. ROCKET AF, which involved 14,264 patients, compared the number of strokes and bleeding events suffered by patients who took Xarelto and patients who took warfarin, a rival blood thinner. The questions focused on whether results due to the malfunctioning blood-monitoring device may have lead doctors to give patients an incorrect dose of warfarin, which could have favored Xarelto, The New York Times reported.

[http://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0, The New York Times, February 22, 2016]

Xarelto (rivaroxaban) is an oral blood thinner prescribed to reduce the risk of blood clots and strokes in patients with atrial fibrillation (irregular heart rhythms) and to treat blood clots in the leg and lungs. Xarelto, approved in 2011, is considered a new generation blood thinner compared to warfarin (Coumadin), an anticoagulant that has been sold for 60 years. Xarelto is more convenient to use because it does not require patients to have regular blood monitoring as does warfarin. However, Xarelto does not have an antidote to reverse its effects should internal bleeding occur in patients whereas warfarin uses vitamin K as a reversal agent.

[http://www.fda.gov/Drugs/NewsEvents/ucm405148.htm, July 17, 2014]

Bayer, Johnson Johnson, and its Janssen Pharmaceuticals Inc., unit, which markets Xarelto, are facing more than 4,600 Xarelto lawsuits nationwide that allege the anti-clotting medication causes dangerous side that include internal bleeding, gastrointestinal hemorrhages, brain bleeds, and blood clots. The Xarelto lawsuit complaints also contend the defendants failed to warn that Xarelto does not have an antidote to reverse bleeding side effects. (Xarelto Lawsuit: In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592) Plaintiffs attorneys have asked U.S. District Judge Eldon Fallon, who is overseeing the federal Xarelto litigation in New Orleans, to unseal documents in the case that would show actions the defendants took during the ROCKET AF clinical trial, according to The New York Times.

[http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?_r=1, The New York Times, March 1, 2016]

About Alonso Krangle LLP and filing a Xarelto lawsuit

Alonso Krangle LLP is investigating Xarelto lawsuits. If you or someone you love suffered serious side effects, such as severe bleeding, internal bleeding, blood clots, stroke or heart attack from taking Xarelto, you may be eligible to file a Xarelto lawsuit against the manufacturer of the blood thinner. For more information on the legal options available to you or to file a Xarelto lawsuit, please contact Alonso Krangle LLP by filling out our online form or by calling us at 888-836-3050.

 

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