The Park Doctrine: All Bark And No Bite

For about two years the Government has threatened to revive the “Responsible Corporate Officer” (RCO) Doctrine, or as it is more commonly known, the “Park Doctrine.”  Based on the Supreme Court’s decision in United States v Park, 421 U.S. 658 (1975), the Park Doctrine stands for the proposition that a corporate officer who is in a position of authority to prevent or correct a violation of the Food Drug and Cosmetic Act (FDCA), but who fails to do so, may be convicted of a misdemeanor by virtue of such authority even if the officer was unaware of the violation.  Although the Government has made a lot of noise about going after high-profile C-suite executives for misconduct committed by their underlings, no convictions have been obtained and not much in the way of cases has been brought.  Given the absence of conscious wrongdoing by these so-called “head in the sand” executives and the low bar the Government has set for itself, what accounts for the Government’s lack of success in putting some bite into the Park Doctrine bark?  Quite simply, a sense of fair play. [Read more...]

Feds “Stryke[ ]” out Again

There is little argument that the Government has been very successful over the past 8 or so years in wringing billions in fines from pharmaceutical and medical device companies for paying kickbacks and promoting off-label.  But what about individuals?   After all, corporations are run by people.  Marketing plans are developed by people.  And sales, in one form or another, are made by people.  So, if the Government can fine and impose multi-year corporate integrity agreements (a.k.a. “CIA’s”) on companies, then the Feds should be able to hold the people responsible for those awful schemes accountable too, right?  Well, no, but not for lack of trying. [Read more...]