Regulatory: Unknowing company executives held responsible for FDCA violations

Corporate intergrity agreements from the Office of the Inspector General place senior executives accountable for companywide compliance.

 Recent focus on the Park Doctrine—an expansive theory of liability under which company executives can be held personally responsible for violations of the federal Food, Drug, and Cosmetic Act (FDCA) even without knowledge of or participation in the misconduct—has garnered much attention.

In 2007, three senior executives of Purdue Pharma pled guilty to misbranding violations of the FDCA and were subsequently excluded from federal health care programs, even though these executives were unaware of the actual illegal promotional activity. Similarly, four executives from Synthes, a spinal implant manufacturer, pled guilty as responsible corporate officers to misdemeanor charges and in 2011 were sentenced to five to nine months each, on the theory that they were in a position to prevent or correct misconduct but failed to do so. This focus illuminates a growing trend in government enforcement within the health care sector: an increased focus on senior executives.      

Contributing Author

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Michael Lampert

Michael Lampert is a health care partner with Ropes & Gray. He is based in the firm’s Boston office.

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Contributing Author

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Alison Fethke

Alison is counsel in Ropes & Gray’s health care practice. She is based in the firm’s Chicago office.

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