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Holding Pharmaceutical and Medical Device Executives Accountable as Responsible Corporate Officers

To identify the key insights or developments described in this article
1 Credit CME

Importance  When a drug or medical device company violates federal law, the government has a powerful tool to use: the Park doctrine. The aim of the doctrine is to protect patients from the harms of an unsafe or fraudulent medical marketplace by targeting the executives who run the companies that make revenues on these products while violating federal law, rather than have that risk borne by patients or impersonal corporate entities; however, public reports of drug and device company executives being prosecuted in Park doctrine cases are uncommon.

Objective  To identify Park prosecutions and characterize their role in US Department of Justice (DOJ) enforcement efforts related to misconduct in the drug and medical device industry.

Evidence Review  A systematic search of Westlaw, Google Scholar, DOJ press releases, and the legal literature was conducted.

Findings  Thirteen cases of executives from 6 drug and medical device companies prosecuted under the Park doctrine since 2000 were identified. The prosecutions resulted in 11 guilty pleas and 2 jury trials, leading to 2 convictions. Of the 6 companies, 3 were drug manufacturers, 2 were medical device manufacturers, and 1 was a compounding pharmacy. All 3 drug manufacturers were opioid manufacturers, of which 2 executives were charged for unlawful promotion, and 1 was charged for manufacturing errors. Both device manufacturer executives were charged with unlawful promotion. All but 3 prosecutions alleged the defendants’ complicity or personal involvement in the misconduct, which Park does not require. By contrast, most large settlements with the DOJ over alleged misconduct in the past 2 decades did not result in individual liability for executives.

Conclusions and Relevance  These findings suggest that the 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. Enforcement under a reinvigorated Park doctrine could better promote the doctrine’s goal of protecting patients.

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Article Information

Accepted for Publication: July 27, 2022.

Published Online: September 19, 2022. doi:10.1001/jamainternmed.2022.4138

Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1620 Tremont St, Ste 3030, Boston, MA 02120 (akesselheim@bwh.harvard.edu).

Author Contributions: Mr Daval had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Daval, Kesselheim.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Daval, Avorn.

Critical revision of the manuscript for important intellectual content: All authors.

Obtained funding: Kesselheim.

Administrative, technical, or material support: Avorn.

Supervision: Avorn, Kesselheim.

Conflict of Interest Disclosures: Dr Kesselheim reported personal fees from the state of West Virginia for having served as an expert witness in a case against various opioid manufacturers (2021-2022) outside the submitted work. No other disclosures were reported.

Funding/Support: This work was supported by grants from Arnold Ventures.

Role of the Funder/Sponsor: The funders had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication.

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