Concerns heighten over the prospect of ‘responsible corporate officer’ prosecutions against drug and device manufacturers
Westlaw article by Kim M. Schmid, Esq., and Molly J. Given, Esq., Bowman & Brooke, and Mark DuVal, J.D., and Mark Gardner J.D. DuVal & Associates
JANUARY 18, 2011-VOLUME 17, ISSUE 24
The recent announcement that the Department of Justice, Health and Human Services’ Office of Inspector General, and the Food and Drug Administration plan to aggressively pursue individual criminal charges against executives for illegal offlabel marketing deservedly caused a stir in the drug and medical device manufacturing community.
High-ranking employees of pharmaceutical and medical device manufacturers are taking notice as they analyze the prospect of facing a personal criminal investigation under the “responsible corporate officer” doctrine of the Food, Drug and Cosmetic Act. However, the concern over the government’s stated intent to use the RCO doctrine has implications greater than personal criminal liability because it may also provide fuel to the plaintiffs’ product liability tort bar.
The results for manufacturers should government agencies forge ahead with these aggressive RCO prosecutions could be farreaching, affecting not only manufacturers and their executives and managers, but also medical industry insurers, shareholders and, ultimately, the health care consumer.
This article outlines the contemplated enforcement actions and explores the impact that RCO prosecutions and convictions may have in the world of product liability lawsuits involving pharmaceuticals and medical devices. Industry must anticipate the likely increase in RCO prosecutions and plan accordingly.