United States District Court, D. Nevada
PHILIP M. PRO, District Judge.
Before the Court are Defendant Michael Stanley Kaplan's Motion to Dismiss Count One for "As Applied" Statutory Vagueness (Doc. #24), Motion to Dismiss Count One for Failure to State a Federal Offense or Invoke the Jurisdiction of the Court (Doc. #25), and Motion to Dismiss Count Two for Failure to State a Federal Offense or Invoke the Jurisdiction of the Court (Doc. #27). Magistrate Judge Hoffman issued a Report and Recommendation (Doc. #45), recommending the Court deny all three Motions. Defendant Kaplan filed Objections (Doc. #50) to the Report and Recommendation. The Court reviews de novo the Magistrate Judge's report and recommendation on dispositive motions. 28 U.S.C. § 636(b)(1)(B).
Defendant Kaplan is a physician who allegedly reused single-use needle guides during prostate needle biopsies he performed at Green Valley Urology. Kaplan is charged in a two-count Indictment with Conspiracy to Commit Adulteration (Count One) and False Statement to a Government Agency (Count Two). Count One alleges that from approximately December 2010 through March 2011, Kaplan obtained through interstate commerce single-use needle guides, and Kaplan used or directed others at Green Valley Urology to reuse single-use needle guides multiple times before disposing of them. According to the Indictment, because of the manner in which the needle guides are used during prostate needle biopsies, multiple uses of a single-use needle guide caused the guides to be held under unsanitary conditions, thereby threatening the health of Kaplan's patients. The Indictment alleges Kaplan did not advise his patients that a reused needle guide would be used during their procedures. Count Two alleges Kaplan made a materially false representation to an investigator for the Food and Drug Administration - Office of Criminal Investigations when Kaplan stated that Green Valley Urology ceased reusing needle guides in February 2011, when in fact Kaplan continued to direct his staff to reuse the needle guides in March 2011.
A. Motions to Dismiss Count One
Defendant Kaplan is charged in Count One with conspiracy to commit the crime of adulteration in violation of the Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. §§ 331(k), 333(a)(2), and 351(a)(2)(A). Section 331(k) prohibits:
The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
Section 333(a)(2) makes the offense a felony if the defendant commits the violation "with the intent to defraud or mislead." Section 351(a)(2)(A) provides that a device is adulterated "if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health."
Kaplan moves to dismiss Count One, arguing that the offense requires the allegedly adulterated medical device be "held for sale, " and there is no allegation in the Indictment that Kaplan sold the needle guides or held them for sale to patients. Rather, Kaplan used the devices during the conduct of his medical practice. Kaplan contends that given the ordinary meaning of "sale" to involve a transfer of title to another for a price, the statute is unconstitutionally vague to the extent the Government seeks to apply it to a physician's use of a medical device during a medical diagnostic procedure. Kaplan also argues that for the same reasons, the Indictment fails to allege the essential element of "held for sale." Alternatively, Kaplan contends that if the phrase "held for sale" includes a physician's use of a device during a medical procedure, the Indictment attempts to usurp State jurisdiction over the regulation of the practice of medicine and the prosecution of crimes related thereto. Finally, Kaplan argues the Indictment fails to allege a felony because the Indictment does not allege he acted with the intent to defraud or mislead.
The Government responds that the statute is not unconstitutionally vague because a reasonable person of ordinary intelligence would understand that the phrase "held for sale" includes a physician's use of a medical device during a procedure for which he charges the patient for his services. The Government argues this reflects the FFDCA's purpose of regulating the safety of medical devices up to the moment the device is delivered to the ultimate consumer. The Government also argues that reading the statute to apply to devices used during a physician's for-profit practice does not usurp the State's power to regulate the practice of medicine. Finally, the Government contends Count One alleges a felony because it alleges Kaplan concealed from his patients that a reused needle guide would be used in their procedures. The Government further contends that the Indictment alleges Kaplan took other steps, including lying to investigators, the public, and his patients, to conceal his activities, and he did so to enrich himself. The Government also notes that even if Kaplan were correct, that would not result in dismissal, it would merely limit Count One to a misdemeanor charge.
1. Held for Sale
Kaplan challenges § 331(k) as void for vagueness as applied to the facts in his case. Specifically, Kaplan contends that the statute requires the adulterated device to be "held for sale, " and the needle guides were not held for sale because Kaplan never transferred ownership to the patients; rather, he kept the needle guides after the procedures. Kaplan thus contends he did not hold the needle guides for sale, and the statute is unconstitutionally vague if it applies to this conduct.
"A criminal statute is void for vagueness if it is not sufficiently clear to provide guidance to citizens concerning how they can avoid violating it and to provide authorities with principles governing enforcement." United States v. Zhi Yong Guo, 634 F.3d 1119, 1121 (9th Cir. 2011) (quotation omitted). Where, as here, the defendant makes an as-applied challenge, "a statute is unconstitutionally vague if it fail[s] to put a defendant on notice that his conduct was criminal." United States v. Harris, 705 F.3d 929, 932 (9th Cir. 2013) (quotation omitted). "As a corollary to the vagueness doctrine, where the statute is ambiguous, the rule of lenity must ...