One of the known side effects of being treated with Xarelto is uncontrollable internal bleeding. Lawyers suing on behalf of their clients who were treated with Xarelto and who were injured by the drug say that they injured parties were not appropriately warned about the risk this medication posed.

But, according to a recent article in the New York Times the FDA  is investigating whether a faulty blood-testing device may have compromised the results of the clinical trial that led to the FDA approval.

According to the Times article, lawyers in the suit cited internal company documents received during the normal discovery process, alleging that study doctors were complaining that the blood testing device they were using was malfunctioning during the approval trials leading to false findings.

In a follow up article several days later the Times questions whether the companies intentionally mislead editors of the New England Journal of Medicine as to the test results.

According to the Times, “Lawyers for patients suing Johnson & Johnson and Bayer, over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.”

The Times article goes on to say that the Plaintiff’s attorney’s are claiming that an analysis of the tests by Duke University researchers that was published in the Journal, stated that the malfunctioning device used in the test did not change the trial’s results, when, in fact, these researchers left out key information that might well have affected the clinical trial results when comparing it to Warfarin an older competitor in this market. The device in question was later recalled.

The stakes for Bayer are astronomical, in 2015 Xarelto made $1.8 billion dollars in sales in the United States. The drug is also the focus of more than 5000 lawsuits, at least 500 of these involve patient deaths.

What should I do if I am taking Xarelto?

I would suggest that you speak to your doctor, show her these articles and ask whether you should continue taking this medication. Also inquire what symptoms you should look out for.

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