Lessons From Recent Medical Device Criminal Resolutions

Food and Drug Law Institute's Update

Maya P. Florence

Partners Jennifer Bragg and Maya Florence and associate Jessica Reese wrote an article for the Food and Drug Law Institute analyzing the FDA’s recent use of criminal actions against medical device manufacturers, even in the absence of intentional or willful FDCA violations. The fact that a company’s failure to comply with its obligations may have been the result of a misunderstanding or uncertainty will not shield the company from criminal liability, and enforcement agencies will pursue criminal components in response to a range of alleged culpability in order to address a perceived serious risk to public health.

Shared with the permission of FDLI and originally published in the Fall 2020 issue of Update.