D.C. Circuit's July 27 decision in Friedman v. Sebelius upholds HHS order excluding three ex-Purdue Pharma executives--including ex-General Counsel--from federal healthcare programs.
Client Alert highlights legal dangers -- and what should be done to reduce those risks -- for life sciences executives posed by the D.C. Circuit Court's July 27 decision upholding HHS's decision to exclude the three former Purdue Frederick executives even though the exclusions were misdemeanors based on convictions under the Responsible Corporate Official (RCO) Doctrine known in the FDA realm as the "Park Doctrine."
Under the RCO Doctrine, a corporate official can be convicted of a misdemeanor violation of the Federal Food, Drug, and Cosmetic Act even though the official did not intend for a violation to occur or even know about the circumstances constituting the violation so long as that person held a position of responsibility in the corporation that would have allowed him or her to prevent the violation from occurring or correct it upon learning of the violation.
To read the detailed alert I penned on this decision, visit:
http://www.duanemorris.com/alerts/dc_circuit_affirms_hhs_power_disqualify_corp_officials_convicted_misdemeanors_rco_doctrine_4559.html?goback=%2Egde_48201_member_144102235
Best,
Michael Swit
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
San Diego
maswit@duanemorris.com
619-744-2215 (direct)
760-815-4762 (cell)