No Walk in the Park: JAMA Editorial Calls for More Park Prosecutions; We Disagree

September 22, 2022By Jeffrey N. Wasserstein & JP Ellison

In a recent JAMA editorial (unfortunately behind a paywall), three authors called for increased use of the Park Responsible Corporate Officer doctrine, under which senior level officials at a company can be held liable under a strict liability theory even if they were not involved in, or even knew about, the alleged violations of the Federal Food, Drug, and Cosmetic Act (United States v. Park, 421 U.S. 658 (1975)).  While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree.  We note our prior writings on the subject, which extend to five pages of posts,.  We note further that the JAMA editorial cites our own John Fleder, which makes sense since John is one of the foremost experts on Park liability from his time at the Department of Justice’s Office of Consumer Litigation as well as private practice with our firm.  An interesting historical sidenote is that if one looks at the official Park decision from the Supreme Court, one will find our own Paul Hyman who was one co-author of the amicus curiae briefs.  Our own reactions to the decision when it came out was somewhat muted, given that we were in our low single digits at the time of the decision.

The JAMA editorial notes that there are few Park cases for two primary reasons:

[The government] may lead . . . favor cases of clear intentional wrongdoing over cases of mere negligent oversight. Others may be uncomfortable with the strict liability premise of the Park doctrine, adhering to the value that punishment should not be inflicted without proof that the defendant intended to commit wrongdoing. The public may harbor similar doubts, leading prosecutors to avoid putting Park cases before juries.

These intuitions about fairness weigh against policy interests designed to protect the public health. The logic of the Park doctrine in its special applicability to medical products is to bring special legal vulnerability for problematic products to the executives who participate in the lucrative marketplaces of human health and illness, rather than have that risk borne by the patients who depend on the products or only by impersonal corporate entities less responsive to sanctions. The drug and medical device industries present particularly compelling arenas in which to pursue deterrence through such prosecution because misconduct can carry high levels of public risk.

The editorial conflates a number of distinct but related principles of law and federal prosecution.  First, regardless of Park, under the FDC Act, any individual who commits an FDC Act violation can be held liable for a strict liability misdemeanor, regardless of whether the individual is a responsible corporate officer.   Second, because of this strict liability exposure, an individual can be charged with an FDC Act misdemeanor as a lesser included offense any time DOJ charges an FDC Act felony.  Therefore, as a matter of proof, DOJ can obtain a misdemeanor conviction even when a jury acquits on a felony.  Third, while the sanction in the original Park case was a $50 fine, DOJ can seek terms of imprisonment for misdemeanor violations and when multiple counts are involved, seek consecutive sentences.  Last, because of the tremendous power given government prosecutors under this strict liability misdemeanor statutory framework, it is critical that those prosecutors exercise prosecutorial discretion, which is why the Justice Manual identifies a host of factors that prosecutors should consider before bringing any criminal charge.  A Park case should be no different.  It’s one thing to prosecute a corporation for the actions of employees since a corporation, while a legal entity, can only act through the individuals that make up that entity.  And if the corporation lacks the regulatory and compliance functions necessary to ensure safe products, then it makes sense to punish that corporation.  It’s another thing entirely to prosecute individuals who were not involved in the misfeasance and were unaware of the alleged violations.  It’s a bedrock principle of criminal law that crimes require an actus reus (the prohibited act) and the requisite mens rea (mental state).  While strict liability criminal statutory schemes are an exception to that rule, we don’t agree that the government should bring a Park case just because it can.

Categories: Enforcement