Top Food and Drug Cases 2015 and Cases to Watch 2016: United States v. Quality Egg, LLC

May 24, 2016By: Jennifer M. Thomas & Anne K. Walsh Download PDF

For years, the government has threatened to increase the number of criminal charges it brings against executives of companies that have violated the Federal Food, Drug, and Cosmetic Act (“FDC Act”), even in the absence of intent or even knowledge of the company’s wrongdoing. The “responsible corporate officer” doctrine operates on the principle that these officers are in positions of responsibility and authority over regulatory compliance, and thus can be held strictly liable for violations committed by their companies.

United States v. Quality Egg made the list this year because not only does it evidence the government’s trend toward prosecuting more individuals, it also serves as a high-water mark for a criminal sentence imposed on these individuals. Given the significant consequences of a conviction, up to $250,000 in penalties per violation, in addition to possible imprisonment (should the Quality Egg precedent stand), and disbarment from employment in the healthcare industry – the implications are frightening.