A medical device manufacturer employee was sentenced to 1 year in prison for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance.
Peter Stoll III, 35, pleaded guilty last year to one felony count of violating the Federal Food, Drug and Cosmetic Act (FDCA) for faking FDA clearance for two medical devices that were sold illegally by his employer. U.S. District Judge Joseph F Leeson sentenced Stoll to 12 months in prison and one year of supervised release.
Stoll was a regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania and was responsible for making submissions to the FDA before the company could sell its medical devices. Stoll admitted that in 2017, he created two false letters showing that the FDA had granted clearance to sell two different medical devices. As a result, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.
“Individuals who subvert the FDA clearance process for medical devices put patients’ lives at risk,” said Brian M. Boynton, Principal Deputy Assistant Attorney General, head of the Justice Department’s Civil Division. “The Justice Department will work with its law enforcement partners to prosecute individuals who falsify documents and violate the law.”
According to court documents, Stoll was responsible for shepherding two of the company’s devices through the FDA’s 510(k) clearance process: the ELAN-4 Air Drill, a high-speed surgical drill used for bone cutting, sawing and drilling, and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments.
Stoll admitted that he never submitted any 510(k) documents to the FDA regarding either device. Instead, he forged a fraudulent letter using FDA letterhead and a forged digital signature of an FDA official falsely stating that the agency had cleared the ELAN-4 Air to be marketed. Stoll later created another, similarly fraudulent letter on FDA letterhead for the SterilContainer JS Series medical device.
“The FDA’s checks and balances exist for one reason: to protect the public,” said Jacqueline C. Romero, U.S. Attorney for the Eastern District of Pennsylvania. “One of the medical devices illegally sold in this case is meant to be used in invasive surgeries; the other, to sterilize instruments, preventing infection or contamination. Evading the prescribed FDA clearance process can literally be a matter of life and death, which is why we take these cases so seriously and work to hold perpetrators responsible for their actions.”
