B. Braun Aesculap Employee Guilty of Forging FDA Device Clearance Letters

A Philadelphia, PA man pleaded guilty last week to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) for causing the introduction of non-FDA approved medical device products into interstate commerce through falsification of two clearance letters. Peter Stoll III, a regulatory affairs specialist at a medical device company, was responsible in his role for the submission of 510(k)’s required before medical devices can be sold on the market.

The US Department of Justice (DOJ) press release did not name the company responsible for the devices. MD+DI reached out to the DOJ Office of Public Affairs to confirm the company involved in the prosecution but did not obtain a response. Medtech Dive, however, reported the company as B. Braun’s Aesculap division. In a statement from Aesculap, the company confirmed to Medtech Dive that it informed FDA of the fabricated documents in August 2017, initiated a recall of the devices, and terminated Stoll’s employment.

While working at the company in 2017, he oversaw the FDA submission of 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. However, instead of actually submitting any 510(k) documents to the administration for the two devices, he created fraudulent letters of clearance using FDA letterhead and bearing the forged digital signature of an FDA official.

As a result of the false documents, the company illegally sold tens of thousands of dollars’ worth of the two medical devices throughout the US, putting many patient lives at risk.

“FDA must be notified and given the opportunity to clear certain medical devices before they are distributed into interstate commerce,” said Justin D. Green, FDA assistant commissioner for criminal investigations, in a Department of Justice press release. “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 FDA’s Office of Criminal Investigations (OCI) protects the American public by aggressively investigating allegations involving FDA-regulated products and violations of the FDCA. In this case, OCI worked with the Justice Department to ensure a just resolution, and we applaud the exceptional work done by the team.”

Pleading guilty before US district judge Edward G. Smith, Stoll is scheduled to be sentenced on Nov. 7 and faces a maximum of three years in prison, one year of supervised release, a $250,000 fine, and $100 special assessment.

“Subverting the FDA clearance process for medical devices can put patients’ lives at risk,” said Brian M. Boynton, principal deputy assistant attorney general and head of the Justice Department’s civil division. “The Department of Justice will work with its law enforcement partners to prosecute anyone who ignores their obligations regarding consumer safety.”