Cross-posted by at On the Docket

The FDA has just released its long-awaited criteria for criminal prosecutions under the Park doctrine, which allows the government to seek a misdemeanor conviction against a corporate officer for alleged violations of the FDCA—even if the officer was neither involved in or even aware of the statutory violation.  We’ve discussed the Park doctrine before here and here.

One point from these criteria is especially worth highlighting:  the FDA apparently concedes that a Park doctrine conviction is obtained “without proof that the corporate official acted with intent or even negligence.”  This is unquestionably a true statement of the law.  But then why is HHS attempting to use a mere Park doctrine conviction as a basis for excluding three pharmaceutical executives from participation in federal health care programs?  

In Friedman v. Sebelius, a case currently on appeal to the U.S. Court of Appeals for the D.C. Circuit, the OIG based HHS’s decision to exclude three Purdue Pharma executives on 42 U.S.C. § 1320a-7(b)(1), which permits exclusion of an individual who has been convicted of a misdemeanor “relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct.”  But, quite naturally, the stipulated statement of facts accompanying the executives’ pleas to a Park doctrine violation included no facts that could support a finding that they participated in or knew of the misconduct, or that they were negligent in any way for not knowing.  To the contrary, as the FDA’s latest criteria only reinforces, a Park doctrine conviction by definition lacks proof of wrongdoing or even negligence.

Unfortunately, the FDA’s latest “guidance” offers nothing to solve this mystery, nor does it even attempt to clarify the legal basis for bootstrapping a strict-liability Park doctrine plea into a career-ending exclusion for alleged negligent wrongdoing.    

As others have correctly observed, the FDA’s non-binding criteria is full of sound and fury, signifying nothing.