Will We See More Strict Liability Prosecutions?

The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Jamie K. Wolszon and John R. Fleder explores the so-called “strict liability” criminal prosecution doctrine in FDA cases that largely derives from the 1975 U.S. Supreme Court case of United States v. Park. 

FDA believes that the Park doctrine allows the government to obtain a misdemeanor criminal conviction against a company official for violations of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) – even if the corporate official was unaware of the existence of the violation – if the official was in a position of authority to prevent or correct the violation and did not do so.  Despite the doctrine’s extensive use in the 1960’s and 1970’s, prosecutors thereafter instead favored “intent to defraud or mislead” felonies under the FDC Act, and other criminal offenses under Title 18 of the U.S. Code, prompting some within FDA-regulated industries to speculate that the Park doctrine is dead.  Recent events, however, may suggest a reemergence of the doctrine.  The article explains the genesis of the Park doctrine, its early use, the shift towards prosecution of FDC Act intent to defraud or mislead felony or Title 18 offenses, and the recent events that may indicate a possible reawakening of the doctrine.