United States v. Kaplan, No. 15-10241 (9th Cir. 2016)
Annotate this CaseDefendant, a urologist, appeals his felony conviction for conspiracy to commit adulteration in violation of 21 U.S.C. 331(k) with the intent to defraud or mislead. Defendant's conviction stemmed from his reuse of single-use plastic needle guides during prostate biopsy exams. The court concluded that the district court did not err in determining that a physician's use of a consumable, single-use device on a paying patient satisfies the "held for sale" element under section 331(k) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(k); in this case, defendant's use of the guides in the course of treating his urology patients constituted a "sale" under section 331(k); and thus the district court did not err in denying the motion to dismiss the indictment. The court also concluded that there was sufficient evidence to support the conviction that defendant conspired to commit adulteration in violation of section 331(k) and to support the special finding that he intended to defraud his patients, the public, the FDA, and the Medical Board; the district court properly rejected defendant's proposed jury instructions because his proposed “theory of the case” instructions merely duplicated what the jury was already told, and there was no plain error in the district court’s refusal to give the “practice of medicine” instruction; the district court did not err in refusing to dismiss the indictment where it contained the elements of defendant's fraud in adequate detail and any error in omitting the materiality element was harmless; and defendant waived challenges to the jury instructions and special verdict form as they relate to the felony conviction. Accordingly, the court affirmed the judgment.
Court Description: Criminal Law. The panel affirmed a conviction for conspiracy to commit adulteration in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(k), with the intent to defraud or mislead, in a case in which the defendant, a urologist, reused single-use plastic needle guides during prostate biopsy exams. The panel held that a physician’s use of a consumable, single-use device on a paying patient satisfies the “held for sale” element under § 331(k), and that the district court, in denying the defendant’s motion to dismiss the indictment, did not err in determining that the defendant’s use of the needle guides in the course of treating his urology patients constituted a “sale” under § 331(k). The panel held that there was sufficient evidence to support the conviction that the defendant conspired to commit adulteration in violation of § 331(k) and to support the special finding that he intended to defraud his patients, the public, the FDA, and the Nevada State Medical Board. The panel held that the district court did not err in rejecting the defendant’s requested jury instruction stating that off-label use of an unadulterated device is not unlawful, where the theory was already covered by the instructions. The panel held that the district court did not plainly err in UNITED STATES V. KAPLAN 3 refusing to give a “practice of medicine” exemption instruction. The panel held that because the indictment contained the elements of the defendant’s fraud in adequate detail, he was fairly informed of the charges against him, and that any error in omitting the materiality element from the indictment was, on this record, harmless. The panel held that the defendant waived any challenge to the jury instructions and special verdict form regarding how the jury distinguished between a misdemeanor and a felony conviction.
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