A Pennsylvania man has been sentenced to prison for his role in distributing medical devices without FDA clearance, according to a statement from the Justice Department.
Peter Stoll III, 35, pleaded guilty last year to one felony count of violating the Federal Food, Drug and Cosmetic Act by causing the introduction of misbranded and adulterated medical devices into interstate commerce, the DOJ said.
Court documents said 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.
Stoll admitted in 2017 that he created two false letters that appeared to show that the FDA had granted clearance to sell two different medical devices, according to court documents. The company ended up selling tens of thousands of dollars of illegal medical devices throughout the U.S.
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Court documents stated that Stoll was in charge of 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 and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments.
Stoll admitted that he never submitted the 510(k) documents to the FDA but he instead created fraudulent letters using the FDA letterhead and bearing the forged digital signature of an FDA official, according to court documents.
“The FDA’s checks and balances exist for one reason: to protect the public,” U.S. Attorney Jacqueline C. Romero for the Eastern District of Pennsylvania said in a statement. “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.”
U.S. District Judge Joseph F. Leeson sentenced Stoll to 12 months in prison and one year of supervised release, according to the DOJ.
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