A former regulatory affairs specialist at B. Braun’s Aesculap division pleaded guilty last week to distributing medical devices without Food and Drug Administration clearance, according to a statement from the Justice Department.
Peter Stoll, 34, who was responsible for shepherding two of the company’s devices through the FDA’s 510(k) process, admitted creating fraudulent letters stating the agency had granted clearance to sell the products — a high-speed surgical drill and a sterilization container, the DOJ said.
Stoll used FDA letterhead and forged an agency official’s digital signature on letters falsely indicating clearance for the ELAN-4 Air Drill, used in bone cutting, sawing and drilling, and the JS Series SterilContainer S2 system, a reusable sterilization container for medical instruments. But Stoll never submitted any 510(k) documents to the FDA for either device.
His actions resulted in the illegal sale of tens of thousands of dollars’ worth of medical devices, the DOJ said.
Aesculap, in an emailed statement, said there have been no reports of patient harm related to the sale of the products. When it learned of the fabricated documents in August 2017, the company promptly notified the FDA, initiated a recall of the devices and ended Stoll’s employment, a company spokesperson said.
“The Company has fully cooperated with the Government’s investigation into the incident and will continue to do so,” the spokesperson said.
The two devices ultimately received FDA clearance.
Stoll pleaded guilty in federal district court in eastern Pennsylvania to one felony count of violating the Federal Food, Drug and Cosmetic Act by causing the introduction of misbranded and adulterated medical devices into interstate commerce. He is scheduled to be sentenced on Nov. 7 and faces up to three years in prison and a $250,000 fine.
B. Braun Medical, a U.S. subsidiary of Germany’s B. Braun, makes products for infusion therapy, dialysis and IV sets.