U.S. v. Two Units, More or Less, of an Article or Device, Consisting of a Power Unit and a Chair, 93-16083

• Citation: 49 F.3d 479
• Decision Date: 14 November 1994
• Docket Number: No. 93-16083,93-16083
• 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.
• Court: United States Courts of Appeals. United States Court of Appeals (9th Circuit)

Page 479

49 F.3d 479

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.

Submitted Nov. 14, 1994. ^*

Memorandum Nov. 23, 1994.

Order and Opinion March 6, 1995.

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.

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 regulations promulgated pursuant to 21 U.S.C. Sec. 360j(f)(1)(A). These regulations require a manufacturer of medical devices to keep records of quality assurance procedures and information concerning the sources of critical component parts for review during FDA inspections. 21 C.F.R. Sec. 820.180-195. Because Kyttaron conceded that no such records existed, the district court granted summary judgment to the government.

Kyttaron argues that regulations governing manufacturers do not apply. According to Kyttaron, no manufacturing took place at the Las Vegas facility. Kyttaron's argument, however, is founded upon the misapprehension that FDA records requirements apply only to premises on which actual manufacturing occurs. To the contrary, 21 C.F.R. Sec. 820.3(k) defines a manufacturer as "any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, or processes a finished device." By Kyttaron's own admission, its purpose was "to manufacture and supply devices for use in designated clinics...." Moreover, during the October 16, 1991 inspection, Ms. Strojny observed "two complete BIS devices and numerous components of the BIS at the facility." According to Ms. Strojny's declaration, "[t]he BIS devices were present in various stages of completion."

In support of its contention, Kyttaron points to a declaration by Mr. Naydo, Kyttaron's Director of Manufacturing, which states that no manufacturing took place during his year at the Las Vegas facility. But neither Mr. Naydo's declaration nor Kyttaron's additional submissions contain evidence indicating that its Las Vegas facility did not process or repack BIS devices. At a minimum, Ms. Strojny's declaration establishes that Kyttaron assembled or repacked BIS devices at the Las Vegas facility. The district court properly granted summary judgment to the United States on this issue.

2. Misbranding

A medical device is misbranded if it does not bear adequate directions to enable a layperson to use it safely. See 21 U.S.C. Sec. 352(f)(1); 21 C.F.R. Sec. 801.5; cf. United States v. Articles of Drug, 625 F.2d 665, 672-75 (5th Cir.1980) (interpreting analogous provision applicable to drugs). Misbranded medical devices are subject to forfeiture without regard to whether they entered interstate commerce. 21 U.S.C. Sec. 334(a)(2)(D). The government relied upon Ms. Strojny's declaration, which states that during the October 16, 1991 inspection, she observed fully...