Misdemeanor FDCA Violations and the Park Doctrine

The FDA can, and oftentimes does, prosecute cases criminally even when it does not believe that the violation was committed intentionally. Even though such violations may only be pursued as misdemeanors, the prosecution itself – as well as its collateral consequences – can be life altering, and the targets of these prosecutions should take them as seriously as felony prosecutions.

The Park Doctrine, which is named after a 1975 Supreme Court case called United States v. Park, provides that a “responsible corporate official” can be held liable for a first-time misdemeanor (and possible subsequent felony) under the FDCA without proof of intent or negligence, and even if the official did not have any actual knowledge of, or participation in, the specific offense.

Misdemeanor prosecution under the Act can be a valuable enforcement tool. Once a person has been convicted of an FDCA misdemeanor, any subsequent violation becomes a felony, even without proof that the defendant acted with the intent to defraud or mislead. Additionally, in many cases, a misdemeanor Park Doctrine conviction has served as the basis for debarment by FDA, meaning that the responsible corporate official was excluded from any participation in federal health care programs for as many as 12 years.

In addition to the individual’s position in the company and whether he or she had the authority to prevent or correct the violation, the FDA will also consider, when determining whether to bring a Park Doctrine indictment, the following list of relevant factors:

  1. Whether the violation involves actual or potential harm to the public;
  2. Whether the violation is obvious;
  3. Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings;
  4. Whether the violation is widespread;
  5. Whether the violation is serious;
  6. The quality of the legal and factual support for the proposed prosecution; and
  7. Whether the proposed prosecution is a prudent use of agency resources.

Our FDA criminal defense lawyers have an in-depth understanding of the FDCA and its implementing regulations governing the operation of FDA-regulated companies, as well as extensive experience litigating white collar criminal cases in federal court. If you have been charged with a misdemeanor Park Doctrine violation, contact us now for a free consultation by emailing us at contact@fuerstlaw.com or by calling us at 305.350.5690.