Recent Developments in the Responsible Corporate Office Doctrine

The Food, Drug, and Cosmetic Act (FDCA) has historically allowed prosecutors to charge corporate employees with misdemeanors without having to prove personal participation or wrongful intent. But, as the use of the statute has become more frequent and penalties have gotten more severe, the constitutionality of such an application of the FDCA has come under heightened scrutiny. Until recently, the typical FDCA case has involved an executive who pleaded guilty to one or more misdemeanors in the face of Department of Justice (DOJ) allegations of felony misconduct. These negotiated resolutions did not raise the same due process concerns posed by cases today, where defendants are facing these charges at trial and challenging the constitutionality of their sentences. Until the Supreme Court clarifies the bounds of the FDCA, district courts will struggle with identifying the necessary elements of individual criminal liability.