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Shifting Gears

BY Jonathan S. Feld
September 28, 2012

Recent news accounts have been replete with large corporate settlements for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Some corporate plea arrangements and deferred prosecution agreements require companies to accept responsibility and pay a large fine. However, their officers are not prosecuted. That is changing, especially in the healthcare and pharmaceutical context. Increasingly, the focus is on senior executives who, under 21 U.S.C.
” 331 and 333(a)(1), can be held strictly liable as “responsible corporate officers” for the actions of persons under their supervision. The responsible corporate officer (RCO) doctrine is now forming the basis for significant civil and administrative ramifications.

The Park Doctrine

The RCO doctrine stems from two decisions of the U.S. Supreme Court ' United States v. Dotterweich, 320 U.S. 277 (1943) and United States v. Park, 421 U.S. 658 (1975). In Park, the defendant was the Chief Executive Officer of a large national food chain that pleaded guilty to contamination of food stored in its warehouses. Park, 421 U.S. at 660-661. In his capacity as CEO, Park had received letters from FDA inspectors about unsanitary conditions at the company's warehouses. The CEO argued at trial that although he was CEO of the company and ultimately responsible for its actions, he had not personally done anything illegal. While Park had received letters from FDA inspectors about the sanitation problem, he emphasized that he operated “by delegating 'normal operating duties' including sanitation” to others in the company. Id. at 663. In other words, Park contended that he could not be held criminally responsible because any failures or wrongful acts were performed by others. Park admitted that, as CEO, he was responsible for the entire operation of the company, but that the company had an organizational structure that assigned this area to “'dependable subordinates.” Id. at 664. Notwithstanding his position, Park was convicted after a trial. The conviction was overturned by the US. Court of Appeals for the Fourth Circuit. It explained that Park could not be convicted without a finding of “wrongful action” by the CEO. Id.

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