Peter Stoll III, Medical Device Forgery, Pennsylvania 2017

Philadelphia-area man Peter Stoll III pleaded guilty today for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance, according to a recent investigation.

A 34-year-old regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania, Stoll was responsible for making submissions to the FDA that were required before the company could sell its medical devices. However, in 2017, Stoll created two false letters that purported to show that FDA had granted clearance to sell two different medical devices.

The company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States as a result of Stoll’s actions. The medical devices in question include 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 FDA regarding either device. Instead, Stoll created a fraudulent letter using FDA letterhead and bearing the forged digital signature of an FDA official that falsely stated that FDA had cleared the ELAN-4 Air to be marketed. He later created another, similarly fraudulent letter on FDA letterhead for the SterilContainer JS Series medical device.

“Subverting the FDA clearance process for medical devices can put patients’ lives at risk,” said Principal Deputy Assistant Attorney General Brian M. Boynton. “The Justice Department will work with its law enforcement partners to prosecute anyone who ignores their obligations regarding consumer safety.”

Peter Stoll III is scheduled to be sentenced on November 7. He faces a maximum penalty of three years in prison, a one-year period of supervised release, a $250,000 fine and a $100 special assessment.

The FBI’s Office of Criminal Investigations investigated the case. Trial Attorney Max J. Goldman and Assistant U.S. Attorney M. Beth Leahy for the Eastern District of Pennsylvania prosecuted the case.

A total of tens of thousands of dollars’ worth of medical devices were sold illegally throughout the United States as a result of Stoll’s actions.

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