Government Not Using Park Doctrine Enough: Study

Harvard Medical School researchers say the federal government “has not exercised the full scope of its authority to prosecute corporate officials responsible for the illegal behavior of the drug and device companies they run.” Writing in JAMA Internal Medicine, the researchers say enforcement under a reinvigorated Responsible Corporate Officer doctrine (stated in United States v. Park) could better promote the doctrine’s goal of protecting patients.

The study’s literature review of several sources identified 13 cases of executives from six drug and medical device companies prosecuted under the Park doctrine since 2000. Of the six companies, the authors say, three were drug manufacturers, two were medical device manufacturers, and one was a compounding pharmacy.

All three drug manufacturers produced opioids, the study says, with two executives charged with unlawful promotion and one with manufacturing errors. Both device manufacturers were charged with unlawful promotion.

“All but three prosecutions alleged the defendants’ complicity or personal involvement in the misconduct, which Park does not require,” the researchers write. “By contrast, most large settlements with the Department of Justice over alleged misconduct in the past two decades did not result in individual liability for executives.”

The report says the threat of Park prosecutions may hang over industry behavior, deterring misconduct. However, it says, the relative frequency and severity of known unlawful industry conduct “suggest that the threat of Park deters violations insufficiently if it deters them at all.”

It also suggests that the threat of Park strengthens the department’s hand in negotiations with corporate defendants, leading to settlements more advantageous to the government. “However,” it adds, “Park should not be a factor in these settlement negotiations. The department policy prohibits releasing individuals from prosecution on the basis of a corporate settlement.”

The authors conclude that a reinvigoration of the Park doctrine could begin with the recognition that a higher standard of conduct should be expected from corporate officers of drug and medical device companies, as the Park doctrine suggests. To address that, they say, the president, FDA, or the Justice Department could take steps to prioritize Park prosecutions in appropriate cases of corporate negligence with medications and other healthcare products. Congress could also explicitly codify the doctrine through further legislation, they add, reaffirming prosecutors’ existing authority to bring Park cases in addition to any other legal intervention through a public mandate to deter harms caused by the negligent oversight of corporate officers.