U.S. v. Travia

• Decision Date: 30 November 2001
• Docket Number: No. CRIM. 01-0372-01.,No. CRIM. 01-379M-02.,No. CRIM. 01-0375M-01.,No. CRIM. 01-374M-01.,No. CRIM. 01-375M-02.,No. CRIM. 01-377M-01.,No. CRIM. 01-374M-02.,CRIM. 01-0372-01.,CRIM. 01-374M-01.,CRIM. 01-374M-02.,CRIM. 01-0375M-01.,CRIM. 01-375M-02.,CRIM. 01-377M-01.,CRIM. 01-379M-02.
• Citation: 180 F.Supp.2d 115
• Parties: UNITED STATES of America, v. Anthony J. TRAVIA, et al., Defendants.
• Court: U.S. District Court — District of Columbia

180 F.Supp.2d 115

UNITED STATES of America, v. Anthony J. TRAVIA, et al., Defendants.

No. CRIM. 01-0372-01.

No. CRIM. 01-374M-01.

No. CRIM. 01-374M-02.

No. CRIM. 01-0375M-01.

No. CRIM. 01-375M-02.

No. CRIM. 01-377M-01.

No. CRIM. 01-379M-02.

United States District Court, District of Columbia.

November 30, 2001.

United States of America, for Plaintiff.

Stephen F. Brennald, Hyde & Brennwald, L.L.P., Silver Spring, MD, for Defendants.

MEMORANDUM OPINION

THOMAS F. HOGAN, Chief Judge.

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.

The government then filed one-count criminal informations against each of the defendants. The informations charge the defendants with unlawful distribution of misbranded prescription drugs, in violation of 21 U.S.C. §§ 331(a), 333(a)(1), 353(b)(1), and 352(f)(2).¹ On July 6, 2001, two of the defendants appeared before the Magistrate Judge to enter pleas of guilty. Rather than taking the guilty pleas, however, the Magistrate Judge sua sponte raised a question concerning whether nitrous oxide was a "drug" within the meaning of the FDCA. The Magistrate then continued the hearing until July 13 and requested briefing from the parties on the issue. On July 10, another defendant appeared before the Magistrate Judge on return of a bench warrant. At that time, the Magistrate raised another question in conjunction with these cases concerning whether the FDCA covered individuals who distribute misbranded drugs on the street, as opposed to medical practitioners, manufacturers, or other commercial entities that distribute drugs. She then directed further briefing on the issue.

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 FDCA is constitutional if applied against these defendants.²

A. Whether Nitrous Oxide is a "Drug"

The FDCA defines the term "drug" to mean "articles (other than food) intended to affect the structure or any function of the body of man or other animals." 21 U.S.C. § 321(g)(1)(C) (emphasis added).³ The intended use of an article thus determines whether it is classified as a "drug" for purposes of the FDCA. See, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 237-40 (D.C.Cir.1980) (upholding FDA's refusal to assert jurisdiction over cigarettes containing nicotine as a "drug" under 21 U.S.C. § 321(g)(1)(C) as not arbitrary, capricious, or contrary to law).

The parties' dispute how to properly discern the "intended use" of the nitrous oxide in this case. The government argues that the Court should look to the objective intent of the sellers in this case, which would permit the Court to view the totality of the circumstances — namely, the selling of balloons of laughing gas in the parking lot at a rock concert — surrounding the sale of the nitrous oxide here. See, e.g., 21 C.F.R. § 201.128 ("The words `intended uses' ... refer to the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article.").⁴

The defendants rejoin that "it is well established `that the intended use of a product, within the meaning of the [FDCA], is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source.'" Action on Smoking, 655 F.2d at 239 (quoting Hanson v. United States, 417 F.Supp. 30, 35 (D.Minn.), affirmed 540 F.2d 947 (8th Cir.1976)). But, contend the defendants, the gravamen of the charge against them here is that there was no labeling on the balloons they sold. By the defendants' logic, therefore, without at least an allegation that representations were made by them in labeling or advertising the balloons, the nitrous oxide they sold cannot be considered a "drug" for the purposes of the FDCA.

The Court can find no support for the defendants' position. Labeling is not exclusive evidence of the sellers' intent. Rather, as the very language quoted by the defendants themselves states, "it is well established `that the intended use of a product, within the meaning of the [FDCA], is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source.'" Action on Smoking, 655 F.2d at 239 (emphasis added). The court in Action on Smoking went on to acknowledge that even consumer intent could be relevant, so long as it was pertinent to demonstrating the seller's intent: "Whether evidence of consumer intent is a `relevant source' for these purposes depends upon whether such evidence is strong enough to justify an inference as to the vendors' intent." Id. Thus, while it may be true that "`[t]he vendors' intent in selling the product to the public is the key element in this statutory definition.'" id., nothing limits the attempt to discern that intent to labeling or advertising. Instead, "the crux of FDA jurisdiction over drugs lay in manufactures' representations as revelatory of their intent." Id. (emphasis added); United States v. 250 Jars, Etc., of U.S. Fancy Pure Honey, 218 F.Supp. 208, 211 (E.D.Mich.1963) ("In determining that a particular article was intended to be used as a drug, a court is not...