A Philadelphia-area man pleaded guilty today for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance, the Department of Justice announced.
Peter Stoll III, 34, pleaded guilty 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, in violation of 21 United States Code, Section 331(a) and 331(a)(2).
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. In pleading guilty, Stoll admitted that in 2017 he created two false letters that purported to show that FDA had granted clearance to sell two different medical devices. As a result, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.
Stoll was responsible for 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, 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.
“Subverting the FDA clearance process for medical devices can put patients’ lives at risk,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will work with its law enforcement partners to prosecute anyone who ignores their obligations regarding consumer safety.”
“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. “Not obtaining this required clearance is bad enough, but impersonating FDA to cover up this failure is truly egregious and puts patients at risk. The FDA’s Office of Criminal Investigations (OCI) protects the American public by aggressively 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.”
Stoll pleaded guilty before U.S. District Judge Edward G. Smith. He is scheduled to be sentenced on Nov. 7. He faces a maximum penalty of three years’ in prison, a one-year period of supervised release, a $250,000 fine and $100 special assessment.
FDA’s Office of Criminal Investigations investigated the case.
