The New Era of Responsible Corporate Officer Doctrine Enforcement

For the most part, investigative subpoenas and inquiries from the Department of Justice (DOJ) and the Food and Drug Administration (FDA) are aimed at companies. But criminal and regulatory penalties for product misbranding or adulteration are by no means limited to corporate defendants. Federal officials are increasingly deploying an old but potent weapon against executives in FDA-regulated industries. Dating from a 1943 Supreme Court case, the responsible corporate officer (RCO) doctrine is being used to impose strict criminal liability on managers for corporate misconduct carried out on their watch, regardless of their prior knowledge or individual intent.

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