Steven A. Johnson*

Why It Made the List

In what is becoming more common, the U.S. Food and Drug Administration (FDA) successfully brought a criminal prosecution through the Department of Justice (DOJ) against a lower-level company individual instead of a responsible company executive in a life science company for violations of the Federal Food, Drug and Cosmetic Act (FDCA). This is significant case in that it was a successful prosecution not of a regulated company corporately, but individually of a lower-level non-executive of a medical device company, and it involved the unique criminal acts of an employee fraudulently creating an agency clearance letter with a forged FDA official’s digital signature on the document.

Discussion

A. Legal Background

This case involved the government charging under its authority, a regulatory affairs specialist, Peter Stoll, with misbranding and adulterating a medical device under 21 U.S.C. 331(a) and 331(a)(2) of the Federal Food, Drug and Cosmetic Act (FDCA). Specifically, the FDCA makes it a criminal violation for any individual to do any act which results in the misbranding or adulteration of a medical device that is introduced into interstate commerce.

B. Factual Background

This case initiated when the government charged a regulatory affairs specialist, Peter Stoll, with misbranding and adulterating a medical device. The devices were the ELAN 4 device used for drilling and cutting bone during surgery and the JS series sterilization container used to store instruments in a sterile environment.
B. Braun division, Aesculap Medical Systems of Central Valley, PA was the manufacturer of the devices and Mr. Stoll’s employer.

As part of his illegal activities, Mr. Stoll created the false clearance letters using FDA letterhead and forged a digital signature of an FDA approving official. Stoll was responsible for shepherding two of the company’s devices through 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 additionally admitted that he never submitted any 510(k) clearance documents to FDA regarding either device.
The acts by Mr. Stoll eventually resulted in the company selling and distributing many of these medical devices throughout the United States as officially cleared by FDA.

Once the fake FDA clearance letters were discovered, the company was required to issue urgent device recalls in 2017. The recall lasted two years and resulted in thousands of these devices being recalled from surgery centers.

C. Court Decision

Mr. Stoll entered his guilty plea on July 20, 2023, to one felony count of causing the introduction of misbranded and adulterated medical device into interstate commerce under 21 U.S.C. Sections 331(a) and 331(a)(2).

Mr. Stoll admitted through his plea in the Eastern District of Pennsylvania to on or about 2017 creating two false letters showing FDA clearance of two medical devices used in surgery. The sentencing was originally scheduled for November 7, 2023, and continued when, on January 24, 2024, DOJ announced as a result of his earlier plea Mr. Stoll was sentenced by U.S. District Judge Joseph Leeson to twelve months in prison and one year of supervised release.

Stoll had faced up to three years imprisonment and a fine of $250,000.

III. Future Impact of the Case

FDA’s Office of Criminal Investigations (OCI) aggressively investigated this case against Mr. Stoll for his egregious intentional and fraudulent conduct as another example of the FDA and DOJ being willing to bring criminal prosecutions and hold lower-level life science company officials such as regulatory affairs specialists liable under the FDCA.

This case, which resulted in prison time, will likely further encourage FDA/OCI to pursue other lower-level individuals when this kind of fraudulent behavior is uncovered involving the sacred FDA approval and clearance process that patients and healthcare providers rely upon to ensure products are safe and effective prior to their use.

 

[*] Steven A. Johnson is a former FDA Associate Chief Counsel for Enforcement and Founder of the Consulting Firm FDACOUNSELS.COM who regularly counsel Life Science companies on regulatory and compliance issues.