United States v. Palazzo
United States Court of Appeals for the Fifth Circuit
558 F.3d 400 (2009)
- Written by Mary Phelan D'Isa, JD
Facts
Dr. Maria Carmen Palazzo (defendant) was indicted on multiple counts of fraud in connection with her failure to maintain proper records during clinical studies to evaluate the efficacy and safety of Paxil in children and adolescents with obsessive-compulsive disorder. The district court dismissed those indictments based on the nondelegation doctrine, and the government appealed. Palazzo argued that neither 21 U.S.C. § 355(i), the statute that authorized the promulgation of the record-keeping regulations, nor the record-keeping regulations themselves authorized the imposition of criminal liability on clinical investigators. Rather, Palazzo argued that § 355(i) only provided for criminal sanctions and exemptions therefrom for manufacturers and sponsors of clinical studies.
Rule of Law
Issue
Holding and Reasoning (Stewart, J.)
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