A former employee of a medical device manufacturing company was recently sentenced to 12 months in prison and one year of supervised release for his actions in distributing medical devices without clearance from the United States Food and Drug Administration (FDA). Peter Stoll, III, a former regulatory affairs specialist at a medical device manufacturer located in Pennsylvania was responsible for making submissions from the company to the FDA, submissions that were often required before the company could sell its medical devices.
Stoll had previously plead guilty to one felony count of violating the Federal Food, Drug and Cosmetic Act (FD&C Act) by “causing the introduction of misbranded and adulterated medical devices into interstate commerce.”
In his role as regulatory affairs specialist, Stoll was responsible for moving two of the company’s devices through the FDA’s 510(k) clearance process: the ELAN-4 Air Drill and the JS Series SterilContainer S2. The ELAN-4 Air Drill is a high-speed surgical drill that is used for bone cutting, sawing, and drilling, while the SterilContainer S2 is a reusable sterilization container for medical instruments.
By pleading guilty, Stoll admitted that he created two false letters in 2017 that purported to show that the FDA granted clearance to sell the two different medical devices. By creating those falsified letters, the company illegally sold tens of thousands of dollars’ worth of medical devices throughout the United States.
Stoll also admitted that he did not submit any 510(k) documents to the FDA for either device but instead created a falsified letter on FDA letterhead with the forged digital signature of an FDA official. The letter stated that the FDA cleared the relevant medical device (either the ELAN-4 Air or the SterilContainer JS Series medical device) for marketing and sale.
“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.”
“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.”
Stoll faced a maximum penalty of three years in prison, a one-year period of supervised release, a $250,000 fine, and $100 special assessment.
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According to a local news story that was published around the time of Stoll’s criminal information becoming public, the company “promptly notified the federal government when it learned of the fabricated documents” in August 2017 and terminated Stoll’s employment that day.
A company spokesperson was also quoted in the article as saying, “There have been no reports of patient harm related to the sale of those products,” and noting that “the products ultimately received FDA clearance. The company has fully cooperated with the government’s investigation into the incident and will continue to do so.”
Stoll’s attorney at the time did note that Stoll “regrets his conduct, has accepted responsibility, and is looking to put this matter further behind him once he is sentenced,” but blamed his actions on “merely trying to preserve his job when he got over his head both in the administrative complexity of what he was being asked to do.”