Clues To The Future Of The Park Doctrine

Introduction – Responsible Corporate Officer

This article examines three recent cases brought under the controversial Park doctrine in search of clues to the doctrine's future. The responsible corporate officer (RCO) doctrine, also known as the Park doctrine, allows for criminal prosecution of individuals, typically high-ranking corporate executives of pharmaceutical companies, for violations of the Food, Drug, and Cosmetic Act (FDCA), even absent any proof of the individual defendant's knowledge of or participation in the violation.

The seminal U.S. Supreme Court cases of United States v. Dotterweich1 (1943) and United States v. Park2 (reaffirming Dotterweich in 1975) established the RCO/Park doctrine, providing that a corporate agent who stands in a "responsible relation" to misconduct may be held criminally liable even without having played any direct role in the misconduct.3 Standing in such a "responsible relation" means the corporate agent must have "had, by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so."4 In essence, Park liability provides a mechanism for holding corporate executives vicariously responsible for violations occurring under their watch, even if they did not know of or personally participate in those violations. The first occurrence is a misdemeanor, albeit one that is often accompanied by the career-ending consequence of exclusion from participation in federal health care programs by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), with subsequent felony liability for recidivists.

Although this doctrine originated in the food and drug context, it also has been applied in the context of other public health and welfare statutes. For example, the Clean Water Act provides that a "responsible corporate officer" may be held liable for violations of the Act.5 The same is true of the Clean Air Act6 and the Radiation Control for Health and Safety Act.7

The FDA's View of the Park Doctrine

In recent years, the Food and Drug Administration (FDA) has demonstrated an increasingly aggressive view of the Park doctrine. In March 2010, FDA Commissioner Margaret Hamburg wrote a public letter to Senator Charles Grassley advising him that the FDA recommended "increas[ing] the appropriate use of misdemeanor prosecutions, a valuable enforcement tool, to hold responsible corporate officers accountable."8 Hamburg's letter also informed Grassley that the FDA had developed criteria for recommending Park doctrine prosecutions, but did not specify what those criteria were.9

In October 2010, FDA Deputy Chief for Litigation Eric Blumberg echoed Hamburg's sentiment about a planned increase in Park doctrine prosecutions, remarking at the Food and Drug Law Institute's Enforcement Conference in Washington, D.C. that pharmaceutical executives whose companies promoted off-label uses of their products could be targeted for misdemeanor prosecutions.10 Blumberg further stated his view that large monetary settlements, such as a record-breaking $2.3 billion settlement with Pfizer the previous year to settle charges of the company's illegal promotion of the painkiller Bextra, were "not getting the job done" to deter FDCA violations, and he urged federal prosecutors to "show[] more resolve to criminally charge individuals at all levels in the company."11 In response, the Washington Legal Foundation (WLF) wrote a letter to Blumberg calling these comments "irresponsible" and urging the FDA not to seek criminal liability under the Park doctrine where the individual in question did not participate in or have knowledge of the alleged violations.12

In January 2011, the FDA published its non-binding criteria for recommending Park doctrine prosecutions, nearly a year after first alluding to the development of these criteria.13 They provide, contrary to the WLF's view, that "[k] nowledge of and actual participation in the violation...