Former Employee of Medical Device Firm Admits Forging FDA Clearance Letters

A Philadelphia-area man has pleaded guilty for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance, the U.S. 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 Pennsylvania and was responsible for making the FDA submissions necessary for the company to sell its products. In pleading guilty, Stoll admitted he created two false letters in 2017 that purported to show the FDA 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.

The Justice Department did not name the company, but lehighvalleylive.com reports that Stoll worked for B. Braun of America Inc. subsidiary Aesculap Implant Systems LLC of Upper Saucon Township. The news source quotes B. Braun spokesperson Allison Longenhagen in confirming the timing of the false FDA clearances; she told lehighvalleylive.com that Stoll was fired on Aug. 23, 2017, the day the company learned of the fabricated FDA documents. No patients were harmed as a result of Stoll’s actions, and the products ultimately received FDA clearance, Longenhagen said. 

Stoll was responsible for shepherding two of the Aesculap’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, he created a fraudulent letter using FDA letterhead and bearing the forged digital signature of an FDA official that falsely indicated the FDA 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.”

Stoll’s attorney, Rocco C. Cipparone, Jr., told lehighvalley.com that his client acted inappropriately “merely to preserve his job when he got over his head both in the administrative complexity of what he was being asked to do.”
 
“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 and faces a maximum three-year prison term, one-year supervised release period, a $250,000 fine, and $100 special assessment.
 
FDA’s Office of Criminal Investigations investigated the case.
 
Trial Attorney Max J. Goldman and Assistant Director Ross S. Goldstein of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney M. Beth Leahy for the Eastern District of Pennsylvania prosecuted the case.