U.S. v. Themy-Kotronakis, 96-4201.

• Citation: 140 F.3d 858
• Decision Date: 31 March 1998
• Docket Number: No. 96-4201.,96-4201.
• Parties: UNITED STATES of America, Plaintiff-Appellee, v. Tim THEMY-KOTRONAKIS, Defendant-Appellant.
• Court: United States Courts of Appeals. United States Court of Appeals (10th Circuit)

140 F.3d 858

UNITED STATES of America, Plaintiff-Appellee, v. Tim THEMY-KOTRONAKIS, Defendant-Appellant.

No. 96-4201.

United States Court of Appeals, Tenth Circuit.

March 31, 1998.

Robert L. Booker, Booker & Associates, Salt Lake City, UT, for Defendant-Appellant.

Andrew Clark, Attorney, U.S. Department of Justice, Washington, DC (Eugene M. Thirolf, Director, and Jacqueline H. Eagle, Attorney, Office for Consumer Litigation, U.S. Department of Justice, Washington, DC, and David J. Horowitz, Associate Chief Counsel for Enforcement, Food and Drug Administration, Rockville, MD, on the brief), for Plaintiff-Appellee.

Before TACHA, BRISCOE, and LUCERO, Circuit Judges.

TACHA, Circuit Judge.

Defendant Tim Themy-Kotronakis ("Themy") was convicted in the United States District Court for the District of Utah of criminal contempt under 18 U.S.C. § 401(3) for violating a permanent injunction. Defendant now appeals that conviction. We exercise jurisdiction under 28 U.S.C. § 1291 and affirm.

BACKGROUND

Themy is a manufacturer of medical devices, the "Ster-O-Lizer" and the "AIDS Treating Machine," which are subject to regulation under the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. In 1986, the United States filed a civil seizure action under the FDCA against the Ster-O-Lizer devices, and later amended its complaint to seek injunctive relief as well. In 1989, the U.S. District Court for the District of Utah granted summary judgment for the government, finding that the seized Ster-O-Lizers were devices within the meaning of the FDCA, and further that they were adulterated and misbranded in violation of the FDCA. See United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F.Supp. 1159 (D.Utah 1989). The court condemned the devices and issued a permanent injunction against Themy. This 1989 injunction prohibits Themy from directly or indirectly "[i]ntroducing or causing the introduction into interstate commerce of any device, or holding for sale any device after shipment of one or more of its components in interstate commerce, unless and until," among other things, the Food and Drug Administration (FDA) has notified Themy that he is in compliance with its current good manufacturing practice regulations (CGMPs). United States v. 22 Rectangular [or] Cylindrical Finished Devices, No. C-86-0486G, Judgment and Decree of Condemnation and Injunction at ¶ IX.A (D.Utah Mar. 16, 1989) ("1989 Order"). The 1989 Order refers to the "Ster-O-Lizer" by name. In 1994, by consent of the parties, the court entered a new order that "supplements but does not supersede" the 1989 Order. The 1994 Order prohibits Themy from "manufacturing, processing, labeling, packing, promoting, distributing, or holding for sale the AIDS Treating Machine or any other article of device intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease ... as set forth in 21 U.S.C. § 321(h), unless and until" Themy has obtained from the FDA either premarket approval or an investigational device exemption. United States v. 22 Rectangular or Cylindrical Finished Devices, No. C-86-0486G, Consent Decree of Injunction Pending Final Resolution of Reserved Issues at ¶ III.B (D.Utah July 5, 1994) ("1994 Order"). It is undisputed that the defendant never received notification from the FDA that he was in compliance with the FDA's CGMPs, that he did not receive premarket approval for the AIDS Testing Machine or any other device, and that he never obtained an investigational device exemption from the FDCA requirements for any of his products.

In June 1995, the government submitted a contempt petition alleging that Themy had violated the terms of the 1989 and 1994 Orders. After a bench trial, the district court concluded that Themy had committed criminal contempt by willfully disobeying the 1989 and 1994 Orders, in violation of 18 U.S.C. § 401(3). See United States v. 22 Rectangular or Cylindrical Finished Devices, 941 F.Supp. 1086, 1096 (D.Utah 1996).

DISCUSSION

Themy contends that the evidence presented by the government was insufficient to prove beyond a reasonable doubt that he had committed criminal contempt by violating the terms of the 1989 and 1994 Orders. When a criminal defendant appeals on the basis of insufficient evidence, we review the evidence de novo, viewing the facts in the light most favorable to the government to determine whether the evidence, together with the reasonable inferences to be drawn therefrom, convinces us that a reasonable factfinder could have found the appellant guilty of the crime charged beyond a reasonable doubt. See United States v. Voss, 82 F.3d 1521, 1524 (10th Cir.) (citations omitted), cert. denied, ___ U.S. ___, 117 S.Ct. 226, 136 L.Ed.2d 158 (1996). The record contains more than sufficient evidence to allow a reasonable factfinder to find that Themy violated the terms of the 1989 and 1994 Orders. Moreover, we find that he had notice of the orders and that his disobedience of the orders was willful. See Yates v. United States, 316 F.2d 718, 723 (10th Cir.1963) ("[K]nowledge or notice of the order in question on the part of appellant and a willful disobedience of that order are essential elements of criminal contempt.").

I. Proper Construction of the Orders

Before addressing the sufficiency of the evidence, we must determine how the orders should be construed. Themy contends that the 1989 Order applies only to the Ster-O-Lizer and that the 1994 Order applies only to the AIDS Treating Machine. It is true that the first order refers to the Ster-O-Lizer by name and the second order refers to the AIDS Treating Machine by name. However, neither order is limited to just one product.

The 1989 Order prohibits the shipping, sale, or offering for sale of "the condemned articles [i.e., the Ster-O-Lizers] or any other articles of device" unless a Department of Health and Human Services representative releases them for sale. 1989 Order at ¶ VII.B.4 (emphasis added); see also id. at ¶ II (finding specifically that the Ster-O-Lizer is a device within the meaning of the FDCA). That order also prohibits Themy from introducing "any device" into interstate commerce, or holding for sale "any device" after shipment of one or more of its components in interstate commerce, until the FDA has informed him in writing that he is compliance with the FDA's CGMP. Id. at IX. A.4. Because the 1989 Order repeatedly specifies that it covers "any device," Themy's contentions that it covers only the Ster-O-Lizer are without merit.

Likewise, the terms of the 1994 Order are not limited to the AIDS Treating Machine, but also cover any "device." See 1994 Order at ¶ III.A (prohibiting Themy from conducting a clinical investigation of "the AIDS Treating Machine or any other article of device" without obtaining an exemption from the FDA (emphasis added)); id. at ¶ III.B (prohibiting Themy from "[m]anufacturing, processing, labeling, packing, promoting, distributing, or holding for sale the AIDS Treating Machine or any other article of device" (emphasis added)). Moreover, the 1994 Order clearly states that it is intended to supplement but not supersede the 1989 Order. Thus, Themy's contentions that the 1994 Order is limited to the AIDS Treating Machine also is without merit. In short, the language of each order is broad enough to cover both the Ster-O-Lizer and the AIDS Treating Machine, regardless of whether those products are mentioned by name.

Themy also asserts that the term "device" is ambiguous. We disagree. Each order specifically refers to the statutory definition of "device" contained at 21 U.S.C. § 321. See 1989 Order at ¶ II (referring to 21 U.S.C. § 321(h)); 1994 Order at ¶ II (referring to 21 U.S.C. §§ 321(g), (h) and also to the regulatory definitions found at 21 C.F.R §§ 201.128 and 801.4). Further, the 1994 Order specifically sets forth a definition of device, i.e., articles "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body of man." 1994 Order at ¶ II, III.B.

II. Evidence of Acts in Violation of the 1989 and 1994 Orders

A. Promoting and Holding for Sale the AIDS Treating Machine and Ster-O-Lizer

The injunction prohibits Themy from promoting or holding for sale the AIDS Treating Machine or any other article of device. The government introduced evidence that Themy had promoted the AIDS Treating Machine and both promoted and held for sale the Ster-O-Lizer within weeks of the entry of the 1994 Order.

1. Promotion of the AIDS Treating Machine

Themy sent at least two letters to different individuals promoting the AIDS Treating Machine. First, Themy sent a letter to Mr. Edward Cerullo in New York in which Themy claimed that the AIDS Treating Machine was a "multi-billion dollar making opportunity." Appellee's App. at 307 (letter dated 7/25/94). Second, in a letter to Fidel Castro of Cuba, Themy promised that his machine "will treat all the HIV-AIDS carriers and free them from the desease [sic]." Id. at 308 (letter dated 8/15/94).

2. Promotion and Holding for Sale of the Ster-O-Lizer

At about the same time that he was promoting the AIDS Treating Machine, Themy solicited Steve Nielsen of the General Medical Corporation in Richmond, Virginia, to act as the "exclusive sales agent" for the Ster-O-Lizer. Id. at 309 (letter dated 7/25/94). Themy also placed an ad in the Salt Lake Tribune seeking a salesman to work on commission and possibly become "national sales director." Id. at 311 (ad dated 7/3/94). Joseph Cormier testified that he answered the ad, that Themy trained him to sell Ster-O-Lizers, and that Themy tried to sell him a Ster-O-Lizer. Cormier testified that he and Themy together visited the offices of several physicians in the Salt Lake City area, demonstrating, promoting, and attempting to sell the...