United States v. Hodges X-Ray, Inc., Civ. A. No. C 81-0610 L(A).

• Court: United States District Courts. 6th Circuit. United States District Court of Western District of Kentucky
• Writing for the Court: Weick
• Citation: 582 F. Supp. 35
• Parties: UNITED STATES of America, Plaintiff, v. HODGES X-RAY, INC., et al., Defendants.
• Docket Number: Civ. A. No. C 81-0610 L(A).
• Decision Date: 21 February 1984

582 F. Supp. 35

UNITED STATES of America, Plaintiff,
v.
HODGES X-RAY, INC., et al., Defendants.

Civ. A. No. C 81-0610 L(A).

United States District Court, W.D. Kentucky, Louisville Division.

December 6, 1983.

As Amended February 21, 1984.

582 F. Supp. 36

Michael Spalding, Louisville, Ky., for plaintiff.

Ackerson, Ackerson & Blandford, Louisville, Ky., for defendants.

MEMORANDUM OPINION

ALLEN, Chief Judge.

This action is submitted to the Court for decision upon cross-motions of plaintiff United States of America and defendants Hodges X-Ray, Inc. and James J. Hodges for summary judgment. The action is entitled "COMPLAINT FOR CIVIL PENALTIES" and arises under 42 U.S.C. § 263k(a) and 42 U.S.C. § 263k(b)(1) in accordance with 28 U.S.C. § 1355. Those statutory provisions were enacted under the Public Health Service Act, as amended by the Radiation Control for Health and Safety Act of 1968, hereinafter the "Act."

Defendant Hodges X-Ray, Inc., hereinafter the "Corporation," is a Kentucky corporation which was engaged in the manufacturing, certifying and selling of diagnostic x-ray systems. Its President at all times pertinent was defendant James J. Hodges, hereinafter "Hodges."

The defendants, during the years 1976 and 1977, sold their Traceray III diagnostic x-ray systems to chiropractors, doctors and veterinarians located in many different states of the United States. The plaintiff alleges that thirteen of the machines sold by the Corporation failed to comply with 21 CFR § 1020.31(a)(2) by failing to terminate x-ray exposure at the preselected time interval.

The complaint alleges that twenty-two of the machines sold by the Corporation during the period March 3, 1977 to August 4, 1977 failed to comply with 21 CFR § 1020.31(a)(1) by failing to visibly indicate at the operator's position the selected exposure time in seconds or pulses. The complaint also alleges that ten units sold by the defendants failed to comply with both 21 CFR § 1020.31(a)(1) and 21 CFR 1020.31(a)(2). The complaint further alleges that the defendants violated 42 U.S.C. § 263j(a)(1) by delivering for introduction into interstate commerce the forty-four Traceray III diagnostic x-ray units which bear numbers 1-9 and 11-45.

It is also alleged that the defendants violated 42 U.S.C. § 263j(a)(5) by issuing

582 F. Supp. 37

certification for twenty-two Traceray III diagnostic x-ray systems shown in the complaint as items 8-13, 25-35 and 41-45, when, in the exercise of due care, the defendants had reason to know that the certification was false or misleading because it implied to the purchaser that the system complied with and would continue to comply with all applicable standards for a reasonable period of time

The United States introduced the declarations of all the personnel who had examined the machines which are the subject-matter of the complaint. There are a total of fifty-five inspectors who inspected the forty-five machines. The evidence of the inspectors contained in their declarations, which under applicable law may be received in lieu of affidavits in support of the motion for summary judgment, see 28 U.S.C. § 1746 and Ceja v. United States, 710 F.2d 812, 813 (Fed.Cir.1983), is to the effect that the violations, which the Government contends have occurred, did in fact occur, with the exception of four machines which the United States now concedes are no longer subject to penalty.

The defendants have not introduced any expert testimony to contradict the statements made in the declarations of the Government inspectors. However, they raise many contentions in opposition to the plaintiff's motion for summary judgment and in support of their own motions.

The Corporation, whose assets were sold in October 1977, contends...