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Responsible Corporate Officer DoctrineThe Responsible Corporate Officer or Park doctrine allows corporate officers to be held criminally liable for violations of the Food, Drug, and Cosmetic Act without evidence of individual culpability based on a showing that their positions within the corporation gave them responsibility and authority to prevent or correct violations.  The government has suggested that it will increasingly use this theory to pursue executives at pharmaceutical and medical-device firms.  But critics say that such prosecutions, which may result in prison sentences and long-term exclusion of convicted executives from participation in Medicare and Medicaid, reflect government overreaching.  In this previously recorded conference call, two experts discuss the legal rationale for the doctrine, its current use in law enforcement, and its future.


  • Mr. Gerald Masoudi, Covington & Burling LLP
  • Mr. Rick Blumberg, Office of Chief Counsel, Food and Drug Administration
  • Moderator: Mr. Dean Reuter, Vice President & Director of Practice Groups, The Federalist Society

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