COMPANY FAILED TO UNDERTAKE APPROPRIATE INVESTIGATIONAL STUDIES
In mid-October, MW (67), the former CEO of Dolor Technologies, Inc., pleaded guilty to misdemeanor charges for selling “misbranded and adulterated devices into interstate commerce.”
Apparently, the company sold a device, called the “SphenoCath,” that was intended to treat migraine headaches. But no approvals were reportedly sought from the Food and Drug Administration. While the latter recommended that Dolor undertake appropriate investigational studies, the company never did so, which thus rendered the “SphenoCath,” “adulterated and misbranded under the Federal Food, Drug and Cosmetic Act.”
In a written statement, Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, noted that, “Patients must be able to trust that they are being treated with medical devices that have been shown to be safe and effective …. The Department of Justice will continue to take action against companies and individuals that put public health at risk by not complying with the law.”
That sure had to hurt Dolor.
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