Regulatory: Individual liability for corporate FDCA violations—What you don’t know can hurt you
03 October 2012InsideCounsel
“There are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns–the ones we don’t know we don’t know.”
–Donald Rumsfeld, 2002 press briefing
“Whoever said what you don't know can't hurt you was a complete and total moron.”
–Dr. Meredith Grey (actress Ellen Pompeo, in “Grey’s Anatomy”), 2005 episode
They both have it right. The then-Defense Secretary was speaking to the lack of evidence that Iraq was supplying weapons of mass destruction to terrorists, and the TV character was talking about ... well, it doesn’t matter, because it’s a TV character. Taken together, though, these quotations could be a good summary of the state of affairs regarding the liability individual officers can face for corporate violations of the Food, Drug, and Cosmetic Act (FDCA).