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Makers of Xarelto Accused of Deceiving Medical Journal on Results of Clinical Trials

Posted on in Xarelto Claims

Xarelto lawsuit, Chicago personal injury lawyersWith nearly two billion dollars in sales in the United States last year, Xarelto is now considered a best seller among the category of drugs meant to replace the age-old anticoagulant, warfarin. And why not? After all, Xarelto users are not forced to follow the same diet restrictions and monitoring needed as their warfarin counterparts. Plus, patients only have to take Xarelto once daily. But, then again (as is often the case) not everything is quite as it seems.

Bayer and Johnson & Johnson, the manufacturers of Xarelto, are currently facing more than 5,000 lawsuits from patients and their families; 500 of those involve Xarelto patient deaths. Their attorneys say that the company knew their drug was dangerous, and that the company intentionally deceived doctors, patients, and even medical journals. Of course, the manufacturers continue to defend their drug, saying it is safer than its competitor, but recent documents suggest that the claims against them may actually hold some truth.

Clinical Trials Under Fire

Prior to releasing their drug to the public, the two manufacturers hired Duke Clinical Research Institute for a three-year clinical trial. That trial, which involved more than 14,000 patients and ultimately led to the FDA approval of Xarelto, came under fire in September of 2015 for the malfunction of a blood-testing device. The concern was that, because of the malfunction, doctors may have provided wrong dosing of warfarin to patients. Ultimately, this could have favored Xarelto in terms of clotting times, bleeding events, and the number of strokes experienced by participants.

Once the information came out, Duke researchers published an analysis in The New England Journal of Medicine and concluded that the malfunctions would not have impacted the results. However, those findings were questioned by the medical community, with some saying that the methods required the researchers to simply guess which patient results would have most likely been affected.

Another Set of Data Recently Revealed

Months after releasing the report to the prestigious medical journal, The New York Times reportedly asked Duke researchers about the presence of additional data – data that experts say provides a better indication of just how much the malfunction may have altered the clinical trial results. Only then did they admit to having such data.

The data in question are results from blood tests taken on more than 5,000 of the study participants at 12 and 24 weeks. On one hand, the Duke researchers claimed not to have known about the data until this past week. But they also allegedly said they felt the information was irrelevant. And still others accuse the researchers of rephrasing questions related to the data so that they did not have to fully admit to having it. Regardless of the reason, experts in the medical community are angered and feel like they were deceived.

Nothing to Hide?

Although an analysis of the missing data indicates that the malfunctioning equipment did not alter the test results, one must wonder why they covered it. After all, why would they keep the information a secret if they have nothing to hide? Some say it is because, despite the data and analysis, there will never be a way to truly know what happened during the trials. And, as a result, we may never know if the manufacturers lied and deceived their way into approval. Regardless, there are patients – thousands of them – that have been injured or killed. And they deserve justice.

Hurley McKenna & Mertz, P.C. have extensive experience with defective drug claims, and we are currently assisting Xarelto victims to help them receive the compensation they deserve. Backed by more than 75 years of combined experience, our firm will work hard to build your case and will ensure your rights are protected every step of the way. Get your claim started by scheduling your free initial consultation with a skilled Chicago defective drug attorney. Call 312-553-4900 today.

Source:

http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html

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