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# DoJ Views on ‘Responsible Executive’ Prosecutions
- URL: https://www.fdaweb.com/doj-views-on-responsible-executive-prosecutions/
- Published: 2017-07-18T12:00:00.000Z
- Updated: 2026-09-14T22:34:44.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5139165

Attorney **Michael Blume** (Venable) says that even though the Supreme Court declined to hear the appeal of Quality Egg owners **Jack** and **Peter DeCoster** from their three-month sentence after pleading guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Justice Department briefs submitted in that case tell a lot about how the government views criminal liability under the FFDCA. Writing in an online blog post, Blume says the fact that the government got a win in the DeCoster sentencing is likely to strengthen enforcement efforts in this area, meaning more prosecutions of responsible corporate officers.

In fact, he writes, there is likely to be pressure from Justice Department leadership to step up those efforts. He notes that the memo from then DoJ official **Sally Yates** encouraging prosecutors to use all resources available to them to identify and prosecute individual executives in corporate fraud cases remains in force. While Yates did not mention strict criminal liability, Blume writes, some of the language in the DeCoster briefs describes criminal liability under the FFDCA as meeting the challenges described in the Yates memo.

“Under the FFDCA,” he says, “no matter how difficult the decision-making may be, if you are in a position with the authority to prevent the unlawful conduct, then you are potentially liable for that conduct. And in its papers before the Court of Appeals, the government noted that the responsible corporate officer doctrine gives executives ‘a robust incentive’ to seek out information about unlawful activity in their companies so that they do not ‘insulate themselves’ from that conduct.”

According to the post, the government emphasized in its filings that the DeCosters had actual knowledge of Salmonella contamination in their facilities, knew what steps to take to eradicate it, but chose not to take those steps. “The government endeavored to make clear that it viewed \[the Park doctrine\] as imposing liability directly — not vicariously — on the DeCosters for what they themselves did and did not do,” Blume concludes. “In that same vein, the government sounded an important note at the very end of its papers before the Supreme Court. It stated that the ‘fear that *Park* … will lead to widespread incarceration of innocent executives with no personal involvement in FFDCA violations is unsubstantiated.’ That sentence is telling, and worthy of special attention. Fairly read, the government seems to be saying that, as past is prologue, it will bring *Park* prosecutions only against executives who had ‘personal involvement’ in the unlawful conduct. Of course, there are no promises here. But the government is not signaling that it intends to push the boundaries of *Park* liability.”