Health lawyers should note the aggressive re-emergence of a decades-old strict liability theory that targets corporate officers and other individuals for corporate noncompliance. The responsible corporate officer doctrine (RCOD) is a U.S. Supreme-Court based theory increasingly used by the Food and Drug Administration (FDA) and other federal agencies to attribute responsibility to corporate officers for public welfare-based crimes, without any evidence that they may have been aware of, or participated in, the underlying problematic conduct.
The renewed application of the RCOD reflects the interest of the Obama administration in holding individuals accountable for allegedly illegal conduct when the facts and the law allow. Use of RCOD theories — usually applied in the context of “public welfare”-type laws — has been prevalent of late in the health care sector. For example, RCOD has been used in several high-profile prosecutions involving officers of medical device and pharmaceutical companies. What is particularly noteworthy is that FDA officials have recently (and publicly) acknowledged their interest in its application.
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