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2023: Guilty plea for falsifying documents
On July 20, 2023, the US Department of Justice announced that Peter Stoll, a former employee of the German medical and pharmaceutical company B. Braun, pleaded guilty to falsifying documents. The man forged several permits on behalf of the Food and Drug Administration (FDA).
Stoll, 34, who is a resident of Philadelphia, served as B. Braun's regulatory specialist and was responsible for filing filings with the FDA, among other things, according to court filings. Such permits are necessary to bring medical equipment to market. An investigation found that in 2017, the man drew up two false documents that allegedly confirmed that the FDA had granted permits to sell the products. As a result, B. Braun illegally put tens of thousands of dollars worth of medical devices on the market. These disapproved pieces were sold throughout the United States.
One of the products Stoll forged the permit for was the ELAN-4 Air Drill, a high-speed surgical drill. The second product is a reusable SterilContainer S2 container for sterilizing medical instruments. The man admitted that he never provided the FDA with any documents regarding the named products. Instead, he created fake letters using an FDA letterhead and a fake digital signature from a department official.
Violation of the FDA's procedure for certifying medical devices can endanger the lives of patients, the US Department of Justice said in a statement. |
Stoll fully admitted his guilt. The former B. Braun worker faces a maximum sentence of three years in prison, one year of supervised release and a fine of $250,000.[1]