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

• Court: United States Courts of Appeals. United States Court of Appeals (9th Circuit)
• Citation: 49 F.3d 479
• Docket Number: 93-16083.
• Parties: 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.
• Date: 14 November 1994

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 government's motion for summary judgment on two of three alternative grounds was granted. Kyttaron appeals.

II. DISCUSSION

A district court's grant of summary judgment is reviewed de novo. Jesinger v. Nevada Fed. Credit Union, 24 F.3d 1127, 1130 (9th Cir.1994).

A.

Kyttaron argues that the district court erred in granting summary judgment to the United States because it failed to make a finding that the seized devices had entered interstate commerce. Prior to 1976, the government could not seize and condemn misbranded medical devices under the Act without a showing of interstate commerce. In 1976, Congress eliminated the interstate commerce requirement, thereby permitting seizure and condemnation of any adulterated or misbranded medical device found within the United States. 21 U.S.C. Sec. 334(a)(2)(D); see also United States v. Depilatron Epilator, Etc., 473 F.Supp. 913 (S.D.N.Y.1979). Congress amended the Act because it found that defective medical devices pose significant risks to the health and safety of the public. In so doing Congress articulated a rational basis "necessary to the protection of commerce." Katzenbach v. McClung, 379 U.S. 294, 304, 85 S.Ct. 377, 383, 13 L.Ed.2d 290 (1964). The Act is valid and Congress need not provide an independent case-by-case inquiry regarding the effect on commerce. Id. at 303, 85 S.Ct. at 383. The district court was therefore not required under 21 U.S.C. Sec. 334(a)(2)(D) to find that the seized BIS devices had entered interstate commerce.

B.

Kyttaron next contends that genuine issues of fact exist that preclude summary judgment on the United States' claims under the Food, Drug, and Cosmetic Act.

1. Failure to Maintain Adequate Records

   The district court concluded that Kyttaron had not complied with record-keeping requirements under the FDCA. Pursuant to 21 U.S.C. Sec. 351(h), a medical device is deemed adulterated if it fails to conform with all applicable...