FDA Releases Criteria For Criminal Prosecution Under Park Doctrine

Feb 08, 2011   

The FDA has released “criteria” it developed for consideration of which cases would be appropriate for misdemeanor criminal prosecution under the Park Doctrine, named after a Supreme Court case called United States v. Park, 421 U.S. 658 (1975).

Under the Park Doctrine, an executive may be criminally prosecuted for violations of the Food, Drug & Cosmetic Act, if he or she had, by reason of his or her position in the corporation, responsibility and authority either to prevent in the first instance, or to promptly correct the violation of the law. This is known as the “responsible corporate officer doctrine,” which does not require that the corporate officer be aware of wrongdoing within the company. Use of this doctrine is limited to misdemeanor offenses involving regulatory or public safety crimes that do not have an intent requirement.

The new criteria released by the FDA is not binding on the agency, and creates no rights or benefits on the behalf of a putative defendant who is potentially subject to Park responsible corporate officer liability. In addition to the individuals 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:

  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 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.

The announcement regarding the new criteria may be found here.

The FDA has expressly stated that it will seek to increase the amount of Park Doctrine criminal prosecutions of corporate executives whose companies are involved in Food, Drug & Cosmetic Act violations. This increase in enforcement is part of the FDAs aggressive stance in a variety of investigations, one of which has recently resulted in the prosecution of a companys lawyer for obstruction of justice, as we previously blogged here. Compliance reviews, and if necessary, a strong defense team in the face of such potential jeopardy to ones liberty is advisable, necessary and prudent in todays regulatory environment. In addition, when facing a potential Park Doctrine prosecution, executives should consider obtaining separate counsel from their employers, free of any potential conflicts of interest with the company.

Fuerst Ittleman attorneys have represented clients in a variety of FDA-related criminal investigations and prosecutions. For more information, please contact us at contact@fidjlaw.com.