Responding To Recalls May Be a Walk in the Park for FDA

August 29, 2010

By Oisin A. Mulvihill* & Peter M. Jaensch

A recent string of high-profile pharmaceutical and medical device product recalls appears to be reigniting FDA’s interest in pressing misdemeanor charges against corporate executives under the Responsible Corporate Officer Doctrine, or Park Doctrine.

Lewis Grossman, professor of law at The American University Washington Colege of Law, says that there now seems to be a growing attitude within the FDA  that "working it out with the company and the company doing a voluntary recall is not enough."  This will surely cause concern in the leadership of food and drug companies because, under some circumstances, the Park doctrine permits the misdemeanor conviction of a corporate officer who fails to prevent or correct a company regulatory violation – regardless of whether or not the officer knew of the violation.

Indeed, the past few months have seen a number of FDA officials announce the agency’s intention to be more aggressive in their punishment of companies for manufacturing violations. Speaking at the annual Food and Drug Law Institute Conference on April 22, Eric Blumberg, FDA’s deputy chief counsel for litigation, revealed that “[v]ery soon, and I have no one particular in mind, some corporate executive is going to be the first in a long line…” The previous month, FDA Commissioner Margaret Hamburg wrote to Sen. Chuck Grassley, R-Iowa,  informing him that the agency intends to "increase the appropriate use of misdemeanor prosecutions … to hold responsible corporate officials accountable."

The Park Doctrine has rarely been employed since the 1980’s but its seemingly imminent revival is sure to have corporate executives ill at ease. See here for our previous blog post and FDLI article on this topic.   

* Intern

Categories: Enforcement