United States v. Kaplan, ___ F.3d ___, No. 15-10241, 2016 WL 4709870 (9th Cir. Sep. 9, 2016).
Dr. Michael Kaplan, a urologist, reused single-use needle guides on patients undergoing prostate biopsies, despite clear packaging statements that the guides were appropriate only for a single use, as well as verbal warnings from a colleague and medical staff to stop this unsafe practice. Kaplan never informed his patients that he was reusing the single-use guides. During an FDA investigation, Kaplan made inconsistent statements about how long he had been reusing the guides. He also assembled a public relations team that published a newspaper advertisement explaining his conduct; the ad claimed he reused guides for less than three weeks, even though the practice actually took place over three months. Kaplan was charged with conspiracy to commit adulteration under 18 U.S.C. § 371 in violation of the Federal Food Drug and Cosmetic Act, 21 U.S.C. §§ 331(k), 333(a)(2), and 351(a)(2)(A). A device, like a needle guide, is adulterated if “held under insanitary conditions whereby it may have been contaminated with filth, or . . . rendered injurious to health.” Here, the government was required to prove that Kaplan’s guides were “held for sale . . . after shipment in interstate commerce.” A jury found that Kaplan was guilty and that he acted with intent to defraud or mislead, making the conviction a felony.
The Ninth Circuit affirmed. Deciding an issue of first impression, the court held that Kaplan’s reuse of the single-use needle guides was considered a “sale” under § 331(k) because the guides were “consumed” in the course of treating patients. The court rejected Kaplan’s arguments regarding the “practice of medicine exemption” and that his conduct was protected off-label use of the needle guides, holding that neither defense applied to the use of adulterated products. The court found there was sufficient evidence to support the conviction because “Kaplan was repeatedly made aware of the problems with reusing the guides, knew that the guides should not be reused, and persisted in reusing the guides anyway for several weeks thereafter.” Finally, the Ninth Circuit determined there was sufficient evidence Kaplan intended to defraud or mislead, and thus committed a felony, by not disclosing his reuse to his patients, and by misrepresenting his conduct to the FDA and the public.
Thomas Watson
htwatson@horvitzlevy.com
Horvitz & Levy LLP
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