Last summer, FDA management warned industry the Agency was planning to find ways to use an old court decision, U.S. vs. Park, 421 U.S. 658 (Sup. Ct. 1975), to increase its enforcement arsenal. In that case, an executive at a food company had relied on subordinates to make sure best practices were employed to keep food in its warehouses in sanitary conditions. When that food became significantly rodent-invested, the FDA proceeded with criminal charges. The company pled guilty to five (5) misdemeanor counts of adulteration, but Mr. Park, the CEO, pled not guilty to those same counts. He was found guilty, the matter went up on appeal, and the U.S. Supreme Court was eventually asked to address the jury instructions that were given so as to make clear the level of knowledge and intent the CEO needed to have before he could be found guilty for the failings of his subordinates and for his company’s procedures, about which he had no direct knowledge. The verdict was overturned and case returned to the lower court for the admission of additional evidence on several key issues. However, the Supreme Court’s holding set the standard for the principle that a company executive can be found guilty for one or more misdemeanor violations, even where he has no direct knowledge of the actual FDA violations.
The FDA has since updated its Regulatory Procedures Manual (RPM) at 6-5-3 to include guidance on proceeding with such cases. Specifically, the FDA states: "The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (‘the Act’) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense. A Park Doctrine prosecution, for the purposes of this section, refers to a recommended prosecution of a responsible corporate official for a misdemeanor violation of the Act."
The RPM goes on to state:
"When considering whether to recommend a misdemeanor prosecution against a corporate official, consider the individual’s position in the company and relationship to the violation, and whether the official had the authority to correct or prevent the violation. Knowledge of and actual participation in the violation are not a prerequisite to a misdemeanor prosecution but are factors that may be relevant when deciding whether to recommend charging a misdemeanor violation.
Other factors to consider include but are not limited to:
- Whether the violation involves actual or potential harm to the public;
- Whether the violation is obvious;
- Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings;
- Whether the violation is widespread;
- Whether the violation is serious;
- The quality of the legal and factual support for the proposed prosecution; and
- Whether the proposed prosecution is a prudent use of agency resources."
It makes one wonder if/when other agencies will tweak the context a bit and then seek to expand Park’s reach beyond FDA rules and regulations.