Food and Drug Law Program Looks at Enforcement of Federal Acts
Web Editor - Published: March 18, 2012
Asked whether increased prosecution of responsible corporate officers under the Park Doctrine might result in more executives seeing prison time for violations of the Food, Drug, and Cosmetic Act (FDCA), Assistant United States Attorney in the Eastern District of Pennsylvania John J. Pease said, “I don’t see the flood gates opening any time soon,” although he acknowledge that more attention being paid to such violations could lead to more executives seeing jail time.

Pease’s remarks came as part of “FDA Matters: Crimes, Misdemeanors and More,” a continuing legal education program presented by Widener Law’s student run Food and Drug Law Association, which was held on Thursday, March 15th in the Ruby R. Vale Moot Courtroom.

Following a brief introduction from FDLA president Sarah Alsaleh, adjunct Professor Roseann Termini offered some background on the Food, Drug and Cosmetic Act, including a look at some of the seminal cases involving strict criminal liability and corporate accountability including United States v. Dotterweich and United States v. Park, from which the Park doctrine takes its name.

Mr. Pease spoke next, offering a look at the increase in Healthcare fraud prosecutions and a number of revealing statistics related to healthcare fraud. He noted that only two real defenses for an executive faced with violations under the Park doctrine, which are being “powerless” to prevent or correct the situation, or proving that it would be “objectively impossible” to do so. Mr. Pease spoke briefly about some of the more recent cases invoking the Park doctrine and prosecutorial discretion regarding charging considerations.

Assistant Dean for Business and Administration Verne Smith, who teaches animal law, then presented “From Piglet to Pork Chop: Factory Farming and Public Health.” He opened by paraphrasing Otto von Bismarck, joking, “It’s said that there are two things you should never see made – laws and sausages.”

Smith’s remarks included a look at the recent U.S. Supreme Court decision in National Meat Association v. Harris, in which the court reversed a Ninth Circuit opinion upholding California Section 599 (f), which mandated euthanasia for “downer” animals. The Supreme Court held that the laws requirements were “different than” the Federal Meat Inspection Act (FMIA) and “within the scope” of the FMIA.

The program closed with some remarks on ethics by Professor Termini, and then a brief question and answer session with the panelists.