Opinion ID: 64717
Heading Depth: 3
Heading Rank: 1

Heading: Ninth Circuit's Smith Opinion

Text: The Ninth Circuit based its analysis on prior circuit caselaw which states that [e]xecutive agencies have the authority to establish regulations which are enforced by criminal penalties only when Congress has provided `sufficient guidelines and standards for the exercise of the authority.' Smith, 740 F.2d at 738 (citation omitted). The court found that the statute placed the burden for record-keeping and reporting requirements on only manufacturers and sponsors. The court stated that the general authorization language contained in the statute to be insufficient legislative guidance for the issuance of regulations which, if violated, would furnish the basis for criminal liability. Id. at 738. Ultimately, the court found § 355(i) to be ambiguous as applied to clinical investigators, invoked the rule of lenity, [2] and affirmed the district court's dismissal of the indictment against the defendant-clinical investigator.