{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T05:37:44Z","timestamp":1778045864236,"version":"3.51.4"},"reference-count":47,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"published-print":{"date-parts":[[2022,11,1]]},"abstract":"<jats:sec id=\"ab-isc220001-1\"><jats:title>Importance<\/jats:title><jats:p>When a drug or medical device company violates federal law, the government has a powerful tool to use: the <jats:italic>Park<\/jats:italic> 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 <jats:italic>Park<\/jats:italic> doctrine cases are uncommon.<\/jats:p><\/jats:sec><jats:sec id=\"ab-isc220001-2\"><jats:title>Objective<\/jats:title><jats:p>To identify <jats:italic>Park<\/jats:italic> prosecutions and characterize their role in US Department of Justice (DOJ) enforcement efforts related to misconduct in the drug and medical device industry.<\/jats:p><\/jats:sec><jats:sec id=\"ab-isc220001-3\"><jats:title>Evidence Review<\/jats:title><jats:p>A systematic search of Westlaw, Google Scholar, DOJ press releases, and the legal literature was conducted.<\/jats:p><\/jats:sec><jats:sec id=\"ab-isc220001-4\"><jats:title>Findings<\/jats:title><jats:p>Thirteen cases of executives from 6 drug and medical device companies prosecuted under the <jats:italic>Park<\/jats:italic> 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\u2019 complicity or personal involvement in the misconduct, which <jats:italic>Park<\/jats:italic> 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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-isc220001-5\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>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 <jats:italic>Park<\/jats:italic> doctrine could better promote the doctrine\u2019s goal of protecting patients.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamainternmed.2022.4138","type":"journal-article","created":{"date-parts":[[2022,9,19]],"date-time":"2022-09-19T15:32:04Z","timestamp":1663601524000},"page":"1199","source":"Crossref","is-referenced-by-count":7,"title":["Holding Pharmaceutical and Medical Device Executives Accountable as Responsible Corporate Officers"],"prefix":"10.1001","volume":"182","author":[{"given":"C. Joseph Ross","family":"Daval","sequence":"first","affiliation":[{"name":"Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry","family":"Avorn","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"10","reference":[{"issue":"2","key":"isc220001r4","first-page":"137","article-title":"Credible deterrence: FDA and the Park Doctrine in the 21st century.","volume":"68","author":"O\u2019Leary","year":"2013","journal-title":"Food Drug Law J"},{"issue":"3","key":"isc220001r9","first-page":"435","article-title":"Do we need stronger sanctions to ensure legal compliance by pharmaceutical firms?","volume":"70","author":"Rodwin","year":"2015","journal-title":"Food Drug Law J"},{"issue":"4","key":"isc220001r13","first-page":"799","article-title":"The crime of being in charge: executive culpability and collateral consequences.","volume":"51","author":"Copeland","year":"2014","journal-title":"Am Crim Law Rev"},{"issue":"12","key":"isc220001r45","doi-asserted-by":"publisher","first-page":"2318","DOI":"10.1377\/hlthaff.2011.0370","article-title":"False Claims Act prosecution did not deter off-label drug use in the case of Neurontin.","volume":"30","author":"Kesselheim","year":"2011","journal-title":"Health Aff (Millwood)"},{"key":"isc220001r2","author":"Randazzo","year":"2022"},{"key":"isc220001r3"},{"key":"isc220001r15"},{"key":"isc220001r19"},{"key":"isc220001r20"},{"key":"isc220001r21"},{"key":"isc220001r24"},{"key":"isc220001r27"},{"key":"isc220001r31"},{"key":"isc220001r33"},{"key":"isc220001r34"},{"key":"isc220001r1","unstructured":"United States District Court. 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