The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine

October 8, 2010

In criminal prosecutions of corporate executives, ignorance of the law and the facts is often no defense. FDA’s application of the Park Doctrine has taken different forms in the decades since its inception. In the 1960’s through 1980’s, FDA frequently prosecuted company officials without any allegation that the defendant intended to violate the law. However, FDA has rarely brought these cases since that time. Recently, FDA announced it will resuscitate the so-called Park Doctrine under which FDA, through the U.S. Department of Justice (“DOJ”), can criminally prosecute food, drug, medical device, and cosmetic company executives and other employees when their company has allegedly violated the Federal Food, Drug, and Cosmetic Act, even though the government can’t prove the employee knew about or approved the alleged conduct.

This webinar features attorneys from Hyman, Phelps & McNamara, P.C. with decades of experience in FDA’s application of the Park Doctrine. You will hear from FDA’s Chief Counsel from the 1980’s when many of these cases were initiated and from DOJ officials who pursued such prosecutions. They:

  • Share their insights of the doctrine from their government days;
  • Make predictions as to the type of cases they believe are most likely to lead to a prosecution under the doctrine;
  • Provide tips on how companies and their executives can minimize their risk of being subject to one of these criminal prosecutions; and
  • Discuss potential career-ending consequences of misdemeanor convictions.

A copy of the slides from the webinar is available here