Responsible Corporate Officer Doctrine: When is Falling Down on the Job a Crime?
Seton Hall School of Law; Seton Hall University - Center for Health & Pharmaceutical Law & Policy
November 9, 2012
St. Louis University Journal of Health Law & Policy, Vol. 6, 2012
Seton Hall Public Law Research Paper No. 2180098
The FDA's recent deployment of the Responsible Corporate Officer Doctrine (also known as the Park Doctrine), and HHS OIG's presumption of federal health program debarment following an RCO Doctrine conviction has been extremely controversial. This article defends strategic use of the Doctrine against officers and directors of entities such as New England Compounding Center, whose egregious behavior puts into commerce products that present serious public health risks. This article posits that the Doctrine is an option of necessity for successful enforcement against entities that are "too big to nail" because of the essential nature of their products which all but precludes their criminal conviction and exclusion from Federal healthcare programs. The article suggests that the toothlessness of fiduciary duties, as well as the theory of efficient breach potentially explain continued legal violations by life science companies, even in the face of enormous fines, which, according to HHS OIG, have become viewed as a cost of doing business.
Number of Pages in PDF File: 36
Keywords: Responsible Corporate Officer Doctrine, new england compounding center, FDA, Park Doctrine, debarment
Date posted: November 25, 2012