Did Xarelto Makers Withhold Data from Medical Journal?

Did Xarelto Makers Withhold Data from Medical Journal?

Almost everyone has heard of the prescription blood thinner, Xarelto; however, most people have not heard about the lawsuits being filed against the two companies that produce Xarelto.  A footnote in a recently filed legal briefing claims that the companies, Johnson & Johnson and Bayer, withheld information from researchers in relation to a letter published in the New England Journal of Medicine about the effects of Xarelto. 

Although it’s unclear what exactly happened during the course of these trials, any passive or active acts meant to conceal risks or overstate the effectiveness of any drug could lead to liability on behalf of the producer.

Following the revelation that some of the equipment that had originally been used in the clinical trial that led to Xarelto’s FDA approval could have been faulty, Duke’s Clinical Research Institute was asked to do further research into the effects of Xarelto. The focal point of the present issue is that Johnson & Johnson and Bayer withheld key information from Duke’s researchers that might have affected the results of the follow-up study. Furthermore, the lawsuit suggests that the data that was withheld demonstrated that Xarelto was not as effective as warfarin, a cheaper and older blood thinner.

Data Related to Xarelto and Warfarin

The withheld data could have been damning to the producers of Xarelto. During the initial trial, about 5,000 blood samples were taken from a random sample of patients and sent to a central laboratory. Experts say that these samples would have been best used in order to reevaluate the effects of Xarelto compared to warfarin. However, when it came to the follow-up analysis, Duke’s researchers based their findings off of much less concrete research methods. That is not to say that Duke’s research team is at fault. There is evidence that suggests that Duke’s researchers asked the Xarelto producers whether such data existed. The lawyers who filed the legal brief claim that the two Xarelto producers purposefully withheld the fact that those 5,000 samples existed in order to lead the researchers to find the result that the companies desired.

This issue could become very important throughout the course of the lawsuit against the producers of Xarelto. Although it’s unclear what exactly happened during the course of these trials, any passive or active acts meant to conceal risks or overstate the effectiveness of any drug could lead to liability on behalf of the producer.

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If you or someone you love has suffered a bleeding incident as a result of Xarelto, please contact our mass tort attorneys immediately for a free consultation to discuss your legal rights.

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