Events
Duane Morris Special Counsel Michael Clark to Discuss "Emerging Threats from the Responsible Corporate Officer Doctrine"
April 3, 2012 | Webinar
Duane Morris special counsel Michael Clark will be part of a panel discussing "Emerging Threats from the Responsible Corporate Officer Doctrine" at a West LegalEdcenter webinar on Tuesday, April 3, 2012 at noon.
The FDA has fairly recently issued a Guidance about factors the agency will consider when determining whether to recommend prosecutions using the Responsible Corporate Officer doctrine. Likewise, the Office of the Inspector General for the U.S. Department of Health & Human Services issued a Guidance about factors that agency will consider when seeking permissive exclusions of individuals from participation in federal health care programs, which includes individuals convicted of misdemeanors under the Federal Food Drug & Cosmetic Act for so-called "misbranding" violations based on applying the responsible corporate officer doctrine (or Park Doctrine).
Soon after issuing its guidance, the FDA has brought charges against corporate officers in pharmaceutical companies for violation the FDCA based on their status alone as "responsible corporate officers." The OIG for HHS subsequently has excluded corporate officers from government-wide participation in healthcare programs, including a general counsel for one pharmaceutical company, based solely on his status as a "responsible corporate officer." This program will examine how the responsible corporate officer doctrine has evolved over the years from a procedural device first used by the FDA in misdemeanor cases to being used by federal and state agencies in administrative, civil, and criminal proceedings—including felony prosecutions in environmental cases that carry with them long prison sentences.
The speakers will examine cases where the doctrine has been used to assist in proving up liability under the FCPA, in clawback actions under Sarbanes-Oxley, and in other agency proceedings, and will explain how courts are reluctant to allow individuals to claim that they had effectively delegated the responsibility for preventing such violations to others. The speakers will address how the RCO doctrine may impact the corporate compliance activities of companies who offer goods and services to the public which could potentially lead to an assertion of liability under this effectively strict liability theory.
For more information, or to register, please visit the West LegalEdcenter's website.
