Ex-B. Braun Regulatory Specialist pleads guilty to forging FDA clearance documents

According to court documents, Peter Stoll III created counterfeit letters that copied the FDA’s letterhead and the digital signature of an agency official.  He said two products developed by his employer Aesculap, a B. Braun company, had received 510(k) clearances — when, in fact, they had never been submitted for review in the first place.  They included the ELAN-4 Air Drill, a power cutter designed for sawing through bone during surgery, and a model of the company’s SterilContainer, used to store sterilized equipment.

In one case, he copied over the FDA product reference code, also known as a K number, from an entirely different product:  plastic connectors for enteral nutrition tubing sets, developed by an Italian manufacturer.

In early 2017, Stoll e-mailed those documents to senior management at the Pennsylvania-based Aesculap and its German parent B. Braun, saying the devices had been cleared — while also providing them to FDA Investigators during inspection leading one to believe it was an official document, according to charges filed by U.S. attorneys at the Department of Justice (DOJ).

Aesculap then went on to sell the drills and containers, without knowing they were illegal, for months — collecting about $138,000 in revenue between the two — before the dozens of devices were recalled and pulled from the market and hospital shelves.  The two products eventually collected official regulatory clearances.  “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 Agency’s Assistant Commissioner for Criminal Investigations, Justin Green, said in a DOJ announcement.

Stoll pleaded guilty to one felony count under the Federal Food, Drug, and Cosmetic Act (FD&C Act), for causing the introduction of misbranded and adulterated medical devices into interstate commerce.  According to the DOJ, he faces a maximum of three (3) years in prison and a $250,000 fine and is scheduled to be sentenced in Eastern Pennsylvania federal court 07 NOV 2023.\

And, by the way, if any readers are curious about the state of their own 510(k) numbers, the FDA’s database is searchable here.

REFERENCE:  Fierce Biotech; 21 JUL 2023; Conor Hale