United States Ninth Circuit

Conviction for conspiracy to commit adulteration in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section 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, is affirmed where: 1) a physician's use of a consumable, single-use device on a paying patient satisfies the 'held for sale' element under section 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 section 331(k); 2) there was sufficient evidence to support the conviction that the 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 Nevada State Medical Board; 3) 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; 4) 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; and 5) defendant waived any challenge to the jury instructions and special verdict form regarding how the jury distinguished between a misdemeanor and a felony conviction.

Appellate Information

• Published 2016/09/09

Judges

• TALLMAN

Court

• United States Ninth Circuit

Counsel