Opinion ID: 156153
Heading Depth: 3
Heading Rank: 1

Heading: Promotion of the AIDS Treating Machine

Text: 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 -7- (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 officers of several physicians in the Salt Lake City area, demonstrating, promoting, and attempting to sell the Ster-O-Lizers. These facts constitute sufficient evidence that Themy 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 components 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 FDA 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 international freight forwarder. The -8- 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 interstate commerce. Second, it meant that he held the device for sale after shipment of one of its components in interstate commerce. (Themy concedes that gauges used in the Ster-O-Lizer came from a company in Ohio.) Themy asserts that the shipment of the Ster-O-Lizer to Spain constituted foreign commerce, not interstate commerce, and thus does not violate the terms of the injunction. We agree with the district court that interstate commerce, for purposes of the FDCA, includes foreign commerce. The FDCA defines “interstate commerce” as “commerce between any State or Territory and any place outside thereof.” 21 U.S.C. § 321(b)(1) (emphasis added); see also United States v. Food, 2,998 Cases, 64 F.3d 984, 992 (5th Cir. 1995) (“The plain words of the statute expansively define ‘interstate commerce’ to effectively include foreign commerce.”). It is insignificant that the Ster-O-Lizer did not actually reach Spain. It is sufficient that Themy introduced the package into interstate commerce by having the package delivered to the international freight company, even though it did not reach its intended destination. Cf. Baltimore & O.S.W.R. -9- 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 would have violated the terms of the injunction. The injunction not only prohibits the introduction of nonconforming devices into interstate commerce, but also prohibits the sale of a nonconforming device whose components have been shipped 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 interstate commerce. Themy next contends that his shipment to Spain was for research purposes and was not a sale. He points to a statutory provision 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 order to be allowed to export devices under this provision, see id., and Themy has not demonstrated that his devices meet those prerequisites. Moreover, devices that fail to meet a requirement of section 360d or 360e (relating to performance standards and premarket approval) are not eligible for export under 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. - 10 - The evidence, when viewed in the light most favorable 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 for 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 wiring 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.