Opinion ID: 712827
Heading Depth: 2
Heading Rank: 5

Heading: Failing to Instruct on the Federal Regulatory Requirements

Text: 74 Thierman contends that the district court erred when it instructed the jury on the crime of selling adulterated drugs by failing to maintain current good manufacturing processes, (CGMPs) but failed to then further instruct them on the federal regulations which define what constitutes CGMPs. The government responds that the court properly instructed the jury on the basic elements, and the jury had sufficient guidance from testimony to determine whether Thierman employed CGMPs or not. We review for plain error a failure to give an unrequested instruction. U.S. v. Whitmore, 24 F.3d 32, 34 (9th Cir.1994). 75 Thierman's claim that this case falls within the parameters of U.S. v. Kostoff, 585 F.2d 378 (9th Cir.1978), while impressive, is insufficient. As here, the Kostoff court reviewed a situation where the defendant was charged with a two prong conspiracy. Unlike the present case however, the court in Kostoff failed to give any instructions on one of the two alleged object offenses. The court found this total lack of instructions on an object offense (an element of the crime) constituted plain error. Id. 76 In contrast, the district court in this case instructed the jury on the crime of selling adulterated drugs, and the definition of adulterated drugs. These instructions, matched with the testimony on CGMPs, should have provided sufficient direction for the jury. 77 In the event of a re-trial, the district court may wish to re-visit the issue, particularly if the government insists on making use of the burn evidence (Sec. III(E) & (F)) and its arguments that this evidence shows bad manufacturing practices on the part of defendant.