140 F.3d 858 (10th Cir. 1998), 96-4201, United States v. Themy-Kotronakis

Docket Nº:96-4201.
Citation:140 F.3d 858
Party Name:UNITED STATES of America, Plaintiff--Appellee, v. Tim THEMY-KOTRONAKIS, Defendant--Appellant.
Case Date:March 31, 1998
Court:United States Courts of Appeals, Court of Appeals for the Tenth Circuit
 
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Page 858

140 F.3d 858 (10th Cir. 1998)

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

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[Copyrighted Material Omitted]

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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.

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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...

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