A former B.Braun-Aesculap employee that pleaded guilty to distributing medical devices without U.S. Food and Drug Administration (FDA) clearance has been sentenced to 12 months in prison.
In July of 2023, Peter Stoll III, pleaded guilty to one felony count of violating the Federal Food, Drug and Cosmetic Act (FDCA) after he created two false letters that purported to show that the FDA had granted clearance for Aesculap to sell its ELAN-4 Air Drill and SterilContainer JS Series devices.
On Tuesday 23 January, an Eastern District of Pennsylvania court sentenced Stoll to a 12-month custodial sentence, with an additional year of supervised release.
The US Department of Justice (DOJ) detailed how, in 2017, Stoll had been a regulatory affairs specialist for medical device manufacturer, Aesculap, where he was responsible for ensuring that Aesculap’s ELAN-4 Air Drill and SterilContainer JS Series made it through the FDA 510(k) clearance process.
Instead, Stoll forged two letters that appeared to show that both devices had been granted clearance. He also falsified a K number in one instance. As a result, the company, and by extension its parent firm B Braun, illegally sold tens of thousands of dollars’ worth of medical devices.
Stoll admitted to the court that he had never submitted applications for either the ELAN-4 high speed surgical drill, or the SterilContainer device, which is designed to be used as a reusable sterilisation container for medical instruments.
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Assistant commissioner for criminal investigations at the FDA, Justin Green, said: “A medical device distributed without FDA clearance can put patients at risk. Our office will aggressively pursue those who place patients at risk by failing to follow the law.
“The FDA’s Office of Criminal Investigations (OCI) protects the American public by rigorously investigating allegations involving FDA-regulated products and violations of the FDCA.”
Stoll was arrested following an OCI investigation and proscecuted by lawyer, Max Goldman as well as Ross Goldstein of the Justice Department’s Consumer Protection Branch.
Green added: “Not obtaining this required clearance is bad enough, but impersonating FDA to cover up this failure is truly egregious and puts patients at risk.”