by John R. Fischer
, Senior Reporter | July 27, 2023
A former regulatory affairs specialist has pleaded guilty to fabricating 510(k) clearance documents for two medical devices, leading the company where he was employed to illegally sell nearly $140,000 in technologies without knowing they were not properly regulated.
Peter Stoll III, 34, confessed to Judge Edward Smith, in the Eastern District of Pennsylvania, on July 20 that he violated the Federal Food, Drug, and Cosmetic Act by misbranding and creating two false letters that said Aesculap Implant Systems, in Upper Saucon Township, could sell its ELAN-4 Air Drill, a high-speed surgical device for bone cutting, sawing, and drilling, and JS Series SterilContainer S2, a reusable sterilization container for medical instruments, according to Lehigh Valley Live
Aesculap, a wholly-owned subsidiary of B. Braun, sold $78,840 worth of unapproved ELAN drills between March and June 2017, and $59,781 of SterilContainers between July and August 2017.
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“Not obtaining this required clearance is bad enough, but impersonating the FDA to cover up this failure is truly egregious and puts patients at risk,” said FDA Assistant Commissioner for Criminal Investigations Justin Green in a statement.
Stoll, who was hired by Aesculap in 2015, never submitted applications for either device, instead creating false letters on FDA letterhead and forging the digital signature of an FDA official.
B. Braun Medical spokesperson Allison Longenhagen said that the company terminated Stoll in August 2017 upon learning of his deceit and notified the federal government.
“There have been no reports of patient harm related to the sale of those products. The products ultimately received FDA clearance. The company has fully cooperated with the government’s investigation into the incident and will continue to do so,” said Longenhagen.
His lawyer, Rocco Cipparone, Jr., says that Stoll committed the acts to “preserve his job” after realizing the administrative complexity of seeking 510(k) clearance. He also said that the drill had previously been approved and that the only difference was that it was powered by air instead of electricity.
“Stoll regrets his conduct, has accepted his responsibility, and is looking to put this matter further behind him once he is sentenced,” he told Lehigh Valley Live.
Stoll will be sentenced on November 7 and faces a maximum penalty of three years in prison, one year of supervised release, a $250,000 fine, and a $100 special assessment.Back to HCB News