A federal judge has sentenced a Philadelphia-area man to prison for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance.
 
Peter N. Stoll III, 35, pleaded guilty last year to one felony count of violating the Federal Food, Drug and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce. U.S. District Judge Joseph F. Leeson sentenced Stoll to 12 months in prison and one year of supervised release.
 
According to court documents, 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 that were required before the company could sell its medical devices. Although the U.S. Justice Department did not identify the company for which Stoll worked, a spokesperson for B. Braun of America Inc. acknowledged last summer that Stoll worked for Aesculap Implant Systems LLC, the surgical division of B. Braun. Aesculap is based in Upper Saucon Township, which is located in the Eastern District of Pennsylvania (federal court). 

Stoll admitted creating two false letters in 2017 that reportedly showed the FDA had granted Aesculap clearance to sell two different medical devices. As a result, the company illegally sold $139,000 worth of the devices throughout the United States between March and August 2017.
 
According to court documents, Stoll was responsible for shepherding two 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 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. Stoll later created another, similarly fraudulent letter on FDA letterhead for the SterilContainer JS Series medical device.
 
“Individuals who subvert the FDA clearance process for medical devices put patients’ lives at risk,” said Principal Deputy Assistant Attorney General Brian M. Boynton, 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.”

A spokesperson told lehighvalleylive.com last summer that Aesculap “promptly notified” the federal government upon learning of the falsified documents and cooperated with the ensuing investigation. The spokesperson also said the illegally sold device did not result in any patient harm. Stoll’s employment at Aesculap ended the day the company discovered he had created the fraudulent letters.  
 
“The FDA’s checks and balances exist for one reason: to protect the public,” said U.S. Attorney Jacqueline C. Romero 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.”

During his guilty plea last year, Stoll’s attorney said the air-powered drill that received the false FDA clearance was the same as a previously approved electric device (the air-powered version was eventually properly cleared by the FDA). Stoll’s attorney also insisted he did not intend to harm anyone.  
 
“The FDA must be notified and given the opportunity to clear certain medical devices before they are distributed into interstate commerce,” said Assistant Commissioner for Criminal Investigations Justin D. Green of the FDA. “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. In this case, OCI worked with the Justice Department to ensure a just resolution, and we applaud the exceptional work done by the team.”
 
FDA’s OCI investigated the case.
 
Trial Attorney Max Goldman and Assistant Director Ross S. Goldstein of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney and Health Care and Government Fraud Chief Mary Mary Beth Leahy for the Eastern District of Pennsylvania are prosecuting the case.