## F I L E D United States Court of Appeals Tenth Circuit 

### MAR 31 1998 

### PATRICK FISHER Clerk PUBLISH
UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

UNITED STATES OF AMERICA,

Plaintiff - Appellee,

v. TIM THEMY-KOTRONAKIS,

Defendant - Appellant. No. 96-4201

APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF UTAH (D. Ct. No. 86-486G)

Robert L. Booker, Booker & Associates, Salt Lake Ci ty, Utah, appearing for Defendant-Appellant. Andrew Clark, Attorney, U.S. Department of Justice, Washington, DC (Eugene M. Thirolf, Director, and Jacqueline H. Eagle, Atto rney, Office for Consumer Litigation, U.S. Department of Justice, Washington, DC, and David J. Horowitz, Associate Chief Counsel for Enforcement, Food and D rug Administration, Rockville, Maryland, on the brief), appearing for P laintiff-Appellee.

Before TACHA, BRISCOE, and LUCERO, Circuit Judges.
TACHA, Circuit Judge.
Defendant Tim Themy-Kotronakis (“Themy”) was convic ted in the United- 2 -

States District Court for the District of Utah of c riminal contempt under 18 U.S.C. § 401(3) for violating a permanent injunctio n. 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 “St er-O-Lizer” and the “AIDS Treating Machine,” which are subject to regul ation 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 againstthe Ster-O-Lizer devices, and later amended its complaint to seek injunctive reli ef as well. In 1989, the U.S. District Court for the District of Utah granted sum mary judgment for the government, finding that the seized Ster-O-Lizers w ere devices within the meaning of the FDCA, and further that they were adu lterated 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 cond emned the devices and issued a permanent injunction against T hemy. This 1989 injunction prohibits Themy from directly or indirectly “[i]ntr oducing or causing the introduction into interstate commerce of any device , or holding for sale any device after shipment of one or more of its compone nts in interstate commerce, unless and until,” among other things, the Food andDrug Administration (FDA) has notified Themy that he is in compliance with it s current good manufacturing- 3 -

practice regulations (CGMPs). United States v. 22 Rectangular [or] Cylindrical Finished Devices , No. C-86-0486G, Judgment and Decree of Condemnati on 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 sa le 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 De vices , No. C-86-0486G, Consent Decree of Injunction Pending Final Resoluti on 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 wa s in compliance with the FDA’s CGMPs, that he did not receive premarket appr oval for the AIDS Testing Machine or any other device, and that he never obta ined an investigational device exemption from the FDCA requirements for any of his products. In June 1995, the government submitted a contempt p etition alleging that Themy had violated the terms of the 1989 and 1994 O rders. After a bench trial,- 4 -

the district court concluded that Themy had committ ed criminal contempt by willfully disobeying the 1989 and 1994 Orders, in v iolation of 18 U.S.C. § 401(3). See United States v. 22 Rectangular or Cylindrical Fin ished Devices , 941 F. Supp. 1086, 1096 (D. Utah 1996).
DISCUSSION Themy contends that the evidence presented by the g overnment was insufficient to prove beyond a reasonable doubt that he had committed criminal contempt by violating the terms of the 1989 and 199 4 Orders. When a criminal defendant appeals on the basis of insufficient evid ence, 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 r easonable inferences to be drawn therefrom, convinces us that a reasonable fac tfinder could have found the appellant guilty of the crime charged beyond a reas onable doubt. See United
States v. Voss , 82 F.3d 1521, 1524 (10th Cir.) (citations omitted ), cert. denied , 117 S. Ct. 226 (1996). The record contains more th an sufficient evidence to allow a reasonable factfinder to find that Themy vi olated the terms of the 1989 and 1994 Orders. Moreover, we find that he had not ice 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 ord er are essential elements of- 5 -

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 byname. However, neither order is limited to just one product. The 1989 Order prohibits the shipping, sale, or off ering for sale of “the condemned articles [i.e., the Ster-O-Lizers] or anyother articles of device ” unless a Department of Health and Human Services represent ative 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 meanin g 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 himin 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,” T hemy’s contentions that it covers only the Ster-O-Lizer are without merit. Likewise, the terms of the 1994 Order are not limit ed to the AIDS Treating- 6 -

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]anufacturin g, processing, labeling, packing, promoting, distribut ing, or holding for sale the AIDS Treating Machine or any other article of devic e ” (emphasis added)). Moreover, the 1994 Order clearly states that it is intended to supplement but not supersede the 1989 Order. Thus, Themy’s contention s 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 ambigu ous. We disagree. Each order specifically refers to the statutory def inition 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 st ructure or function of the body- 7 -

of man.” 1994 Order at ¶ II, III.B.
II. Evidence of Acts in Violation of the 1989 and 19 94 Orders A. Promoting and Holding for Sale the AIDS Treating Machine and Ster-O-Lizer The injunction prohibits Themy from promoting or ho lding for sale the AIDS Treating Machine or any other article of devic e. The government introduced evidence that Themy had promoted the AID S Treating Machine and both promoted and held for sale the Ster-O-Lizer wi thin weeks of the entry of the 1994 Order. 1. Promotion of the AIDS Treating Machine Themy sent at least two letters to different indivi duals 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 Machi ne 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 themfrom the desease [sic].” Id. at 308 (letter dated 8/15/94).

2. Promotion and Holding for Sale of the Ster-O-Lize r At about the same time that he was promoting the AI DS Treating Machine, Themy solicited Steve Nielsen of the General Medica l Corporation in Richmond, Virginia, to act as the “exclusive sales agent” forthe Ster-O-Lizer. Id. at 309- 8 -

(letter dated 7/25/94). Themy also placed an ad in the Salt Lake Tribune seeking a salesman to work on commission and possibly becom e “national sales director.” Id. at 311 (ad dated 7/3/94). Joseph Cormier testifie d that he answered the ad, that Themy trained him to sell Ster-O-Lizers, and t hat Themy tried to sell him a Ster-O-Lizer. Cormier testified that he and Themy together visited the officers of several physicians in the Salt Lake City area, demo nstrating, promoting, and attempting to sell the Ster-O-Lizers. These facts constitute sufficient evidence that The my promoted the AIDS Treating Machine and promoted and held for sale the Ster-O-Lizers in violation of the 1994 Order. B. Sale and Shipment of Ster-O-Lizers in Interstate Commerce The 1989 Order prohibits Themy from “[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 compone nts in interstate commerce” until the FDA informed Themy that he was in compliance with the FDA’s
CGMPs. See 1989 Order at ¶ IX.A. It is undisputed that the F DA never notified Themy that he was in compliance with the CGMPs.

1. Sale and Shipment of the Ster-O-Lizer to Spain In May 1995, Themy had an air freight company pick up a package containing a Ster-O-Lizer for delivery to an intern ational freight forwarder. The- 9 -

package was marked for shipment to Barcelona, Spain . The package, which was called to the FDA’s attention by the international freight company and eventually seized by the U.S. Marshal, had an invoice showing a price of $7,000. This attempted shipment to Spain violated the injunction for two reasons. First, it meant that Themy introduced the Ster-O-Lizer into i nterstate commerce. Second, it meant that he held the device for sale after shi pment of one of its components in interstate commerce. (Themy concedes that gauge s used in the Ster-O-Lizer came from a company in Ohio.) Themy asserts that the shipment of the Ster-O-Lizerto Spain constituted foreign commerce, not interstate commerce, and thus does not violate the terms of the injunction. We agree with the district court t hat interstate commerce, for purposes of the FDCA, includes foreign commerce. T he FDCA defines “interstate commerce” as “commerce between any Stat e or Territory and any place outside thereof.” 21 U.S.C. § 321(b)(1) (emphasis added); see als o United States v. Food, 2,998 Cases , 64 F.3d 984, 992 (5th Cir. 1995) (“The plain word s of the statute expansively define ‘interstate commerce’ to effectively include foreign commerce.”). It is insignificant that the Ster-O-L izer did not actually reach Spain. It is sufficient that Themy introduced the package into interstate commerce by having the package delivered to the int ernational freight company, even though it did not reach its intended destinati on. Cf. Baltimore & O.S.W.R.- 10 -

Co. v. Settle , 260 U.S. 166 (1922) (focusing on the intent with which railroad lumber shipment was made in order to determine whether it was intrastate or interstate in nature). Even assuming that the injunction did not extend to shipments intended for foreign commerce, the shipment to Spain still wouldhave violated the terms of the injunction. The injunction not only prohibits the introduction of nonconforming devices into interstate commerce, butalso prohibits the sale of a nonconforming device whose components have been shi pped in interstate commerce. As noted above, Themy admitted that the gauges on the Ster-O-Lizers had originated in Ohio and had been shipped in inte rstate commerce. Themy next contends that his shipment to Spain was for research purposes and was not a sale. He points to a statutory provi sion permitting shipments of non-FDA approved devices to other countries. See 21 U.S.C. § 381(e). However, one must meet certain statutory prerequisites in or der to be allowed to export devices under this provision, see id. , and Themy has not demonstrated that his devices meet those prerequisites. Moreover, device s that fail to meet a requirement of section 360d or 360e (relating to pe rformance standards and premarket approval) are not eligible for export und er section 381(e), unless the FDA grants an exception. Themy has not shown that he has met the requirements of sections 360d and 360e, and the FDA has not granted him an exception.- 11 -

The evidence, when viewed in the light most favorab le to the government, also rebuts Themy’s assertion that his shipment of the Ster-O-Lizer to Spain was for research purposes. The box containing the Ster -O-Lizer had an invoice for $7,000, indicating that it was a sale, not a loan f or research purposes. Moreover, Themy wrote a letter to his contact in Spain before the shipment was sent, explaining that he could buy a Ster-O-Lizer “by wir ing directly to our Bank the sum of $7,000.00.” Appellee’s App. at 318 (letter dated 5/4/95). Themy has produced no evidence supporting his assertion that the shipment was for research
purposes. 2. Sale and Shipment of Ster-O-Lizer to Greece Themy also sent a “reconditioned” Ster-O-Lizer to ahospital in Greece. This action, like the shipment of the Ster-O-Lizer to Spain, violates the 1989 Order’s prohibition of the shipment of the Ster-O-L izer or any other device in interstate commerce. The action also appears to be a sale in violation of the 1989 Order’s prohibition after the shipment of a compone nt in interstate commerce. Although Themy claimed on the invoice that the ship ment was a donation, the invoice indicated a price of $1,000. In sum, we find that Themy’s activities promoting b oth the AIDS Treating Machine and the Ster-O-Lizer, and his two sales andshipments of Ster-O-Lizers to foreign countries, violated the explicit terms o f the 1989 and 1994 Orders.- 12 -

III. Notice Knowledge or notice of the relevant court order is an essential element of the crime of contempt. See Yates , 316 F.2d at 723. We find that Themy had the requisite knowledge or notice. On two occasions, Themy received copies of the inju nction from FDA inspectors and had the terms of the injunction expl ained to him. On each occasion, he signed an affidavit indicating his awa reness and understanding of the terms of the 1989 and 1994 Orders. FDA investigato rs first visited his facilities in September, 1993, after the entry of the original 1989 Order but before the 1994 Order. At that time, Themy signed an affidavit that stated that FDA investigators provided me with a copy of the Judgement and Decree of Condemnation and Injunction [i.e., the 1989 Order] which states that I have been perpetually restrained and enjoined fro m directly or indirectly doing any introducing or causing the int roduction into interstate commerce of any device, or holding for s ale any device after shipment of one or more of its components in interstate commerce. Investigator Moore explained this judgme nt to me. I understand the Judgment and Decree of Condemnation and Injunction for which I am named. I further understand that until I comply with the requirements of the Judgment and Decree (sect. IX A & B), I may not manufacture, sell or distribute any medical dev ice as defined. Appellee’s App. at 303. In November, 1994, FDA inspectors again visited andprovided Themy with a copy of the injunction, this time including the 1 994 Order, and explained the injunction to him. Themy again signed an affidavit , affirming that he had been- 13 -

provided with copies of the 1989 and 1994 Orders. In this affidavit, Themy stated:I understand that the injunction restrains and enjo ins me from manufacturing, selling or distributing any medical devices until I have complied with the Food, Drug and Cosmetic Act and until I have complied with the requirements as stated in th e injunction. Id. at 310 (affidavit dated 11/18/94). Each typed affidavit contains handwritten changes, indicating that Themy read the affidavits carefully before signing them. These affidavits demonstrate that Themy understood the restrictions placed upon him by the orders. Therefore, we reject his claim of lack of notice.
IV. Willfulness Finally, Themy argues that if he did violate the or ders, his violation was not willful. See Yates , 316 F.2d at 723 (noting that willfulness is an es sential element of criminal contempt). We reject his claim

. In the context of criminal contempt, willfulness is defined “as a volitional act done by one who knows or should reasonably be aware that his conduct is wrongful.” United States v. Greyhound Corp. , 508 F.2d 529, 531-32 (7th Cir. 1974). Themy knew of both the 1989 and the 1994 Or ders, and he twice affirmed to FDA inspectors that he understood what the order s required. The terms of both orders are clear, and they refer to the Ster-O-Lize r and AIDS Treating Machine by name. The orders clearly prohibit Themy from manuf acturing, promoting,- 14 -

distributing, introducing into interstate commerce, or holding for sale the Ster-OLizers, the AIDS Treating Machine, or any other dev ice unless certain conditions were met. It is undisputed that none of those cond itions was met. Yet, Themy repeatedly undertook to promote, sell, and ship his products. He even told Mr. Cormier that the injunction did not pertain to him, and he boasted to a potential customer that he could commence human trials of the AIDS Treating Machine “without the FDA being able to stop me.” Under the se circumstances, a rational factfinder reasonably could infer that Themy’s viol ation of the injunction was willful. Viewing these facts and the reasonable in ferences to be drawn therefrom in the light most favorable to the government, Themy’s claims that he did not intend to violate the orders are unpersuasive.
CONCLUSION We find that there was sufficient evidence to prove beyond a reasonable doubt that Themy repeatedly violated the terms of t he 1989 and 1994 Orders, and that he did so wilfully and with notice of the orde rs. We AFFIRM his conviction for criminal contempt and DENY the motion for leave to file an additional opening brief.