49 F.3d 479 (9th Cir. 1994), 93-16083, United States v. Two Units, More or Less, of an Article or Device, Consisting of a Power Unit and a Chair

• Docket Nº: 93-16083.
• Citation: 49 F.3d 479
• Party Name: UNITED STATES of America, Plaintiff-Appellee, v. TWO UNITS, MORE OR LESS, OF AN ARTICLE OR DEVICE, CONSISTING OF A POWER UNIT AND A CHAIR, etc., Defendant, and Kyttaron Energy Corporation, Claimant-Appellant.
• Case Date: November 14, 1994
• Court: United States Courts of Appeals, Court of Appeals for the Ninth Circuit

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Page 479

49 F.3d 479 (9th Cir. 1994)

UNITED STATES of America, Plaintiff-Appellee,

v.

TWO UNITS, MORE OR LESS, OF AN ARTICLE OR DEVICE, CONSISTING

OF A POWER UNIT AND A CHAIR, etc., Defendant,

and

Kyttaron Energy Corporation, Claimant-Appellant.

No. 93-16083.

United States Court of Appeals, Ninth Circuit

November 14, 1994

*

Memorandum Nov. 23, 1994.

Order and Opinion March 6, 1995.

Page 480

Richard J. Merritt, Lido Beach, NY, for claimant-appellant.

Greg Addington, Asst. U.S. Atty., and James S. Cohen, Associate Chief Counsel for Enforcement, U.S. Food and Drug Admin., Reno, NV, for plaintiff-appellee.

Appeal from the United States District Court for the District of Nevada.

Before: CHOY, FARRIS, and BRUNETTI, Circuit Judges.

ORDER

The memorandum disposition filed November 23, 1994, is redesignated as an authored opinion by Judge Farris.

OPINION

FARRIS, Circuit Judge:

Kyttaron Energy Corporation appeals from the district court's summary judgment for the United States. Kyttaron contends that the district court erred in ruling that the seized medical devices were subject to forfeiture under the Food, Drug, and Cosmetic Act for failure to maintain adequate records and for mislabeling. We have jurisdiction under 28 U.S.C. Sec. 1291. We affirm.

Page 481

I. BACKGROUND

Evans Rapsomanikis is the founder and CEO of Kyttaron Energy Corporation, which is licensed to conduct business in California and Nevada. Kyttaron manufactures a device known as a Bio-Ionic System. The BIS device is an electrical machine and accompanying reclining chair that applies electromagnetic currents to the human body through adhesive electrode pads and coils. Kyttaron maintains that the Bio-Ionic System produces "free electrons" within the body, thereby stimulating and enhancing the body's natural healing processes.

The FDA received several reports that Kyttaron was promoting the device as a cure for cancer, AIDS, paraplegia, heart disease, muscular dystrophy, and other diseases. In October 1991, FDA investigators obtained administrative inspection warrants and conducted an administrative inspection of Kyttaron's Las Vegas facilities pursuant to 21 U.S.C. Sec. 374. During the search, two violations of the FDCA were discovered: 1) Kyttaron's manufacturing director told investigators that Kyttaron did not maintain manufacturing records and 2) Kyttaron did not label the BIS devices.

U.S. Marshals seized two of the BIS devices after the district court issued a Warrant of Arrest in Rem. Kyttaron filed a claim for the two devices. At the close of discovery, the...