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U.S. v. TRAVIA

November 30, 2001

UNITED STATES OF AMERICA,
V.
ANTHONY J. TRAVIA, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Thomas F. Hogan, Chief Judge.

MEMORANDUM OPINION

Pending before the Court is the government's appeal from the Magistrate Judge's bench ruling of July 31, 2001, dismissing with prejudice the criminal informations and complaints filed in these cases. In each information, the government charged the defendants with distributing nitrous oxide, commonly known as laughing gas, at a rock concert at RFK Stadium on June 9, 2001. The government specifically charged the defendants with unlawful distribution of misbranded prescription drugs, in violation of the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 331(a), 333(a)(1), 353(b)(1), and 352(f)(2). The Magistrate Judge dismissed the criminal complaints and informations after opining that the FDCA did not cover these individual defendants. The issues raised in this appeal are whether nitrous oxide may be deemed to be a "drug" for the purposes of the FDCA, whether criminal liability under the FDCA may attach to these particular defendants, and whether the FDCA is constitutional if applied against these defendants. After careful consideration of the government's memorandum in support of its appeal, the defendants' consolidated opposition and the government's reply thereto, the hearing held in open court on November 14, 2001, the transcript of proceedings before the Magistrate on July 31, 2001, and the entire record herein, the Court will reverse the Magistrate Judge's ruling and reinstate these cases.

I. BACKGROUND

According to the government, members of the D.C. Metropolitan Police Department ("MPD") and Special Agents from the Food and Drug Administration ("FDA") engaged in a joint investigation of illegal distribution of nitrous oxide at a rock concert at RFK Stadium on June 9, 2001. An undercover officer approached the defendants in the parking lot, handed them pre-recorded MPD funds, and in exchange received balloons containing nitrous oxide gas. The undercover officer then left the area and signaled arrest teams. The arrest teams moved into the area and arrested the defendants, who were subsequently identified by the undercover officer.

At a hearing held on July 31, 2001, the Magistrate Judge issued a bench ruling in which she specifically answered her second question in the negative and dismissed the complaints and informations filed in these cases. 7/31/01 Tr. at 4-7.

II. DISCUSSION

Section 331 of the FDCA prohibits, inter alia, "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded." 21 U.S.C. § 331(a). The FDCA creates criminal liability for violations of such prohibitions. Section 333, for example, states that "[a]ny person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both." Id. § 333(a). In turn, the FDCA clarifies that "[t]he term `person' includes individual, partnership, corporation, and association." 21 U.S.C. § 321(e). In the context of this case, the FDCA deems a drug to be "misbranded"

[u]nless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.

Id. § 352(f). The FDCA further deems misbranded a prescription drug dispensed without a proper prescription:

A drug intended for use by man which — (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; . . . shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

Id. § 353(b)(1).

The issues raised in this appeal are (A) whether nitrous oxide may be deemed to be a "drug" for the purposes of the FDCA, (B) whether criminal liability under the FDCA may attach to these particular defendants, and (C) whether the ...


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