United States v. Hodges X-Ray, Inc.

582 F. Supp. 35, 1983 U.S. Dist. LEXIS 11086
CourtDistrict Court, W.D. Kentucky
DecidedDecember 6, 1983
DocketCiv. A. No. C 81-0610 L(A)
StatusPublished
Cited by1 cases

This text of 582 F. Supp. 35 (United States v. Hodges X-Ray, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Kentucky primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Hodges X-Ray, Inc., 582 F. Supp. 35, 1983 U.S. Dist. LEXIS 11086 (W.D. Ky. 1983).

Opinion

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)(l) 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)(l) 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 [37]*37certification 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 that it is no longer liable for any penalties that might be assessed as a result of the alleged violations. It contends that the purchaser of its assets took over the obligation to correct any violations that had occurred with respect to the machines. It develops that the corporation to which it sold the machines is also defunct. The Corporation cites no authority for its contention that it is relieved of liability for the civil penalties simply because it sold the allegedly offending machines after the alleged violations had occurred.

Since the Act specifies that a 'manufacturer is liable for penalties for machines manufactured by it, and since the machines were manufactured by the Corporation, it is apparent that the Corporation is still liable for any penalties which might be assessed. Hodges contends that he is not liable for any penalties which might be assessed because he did not manufacture the machines.

The Act defines a manufacturer to be any person engaged in the business of manufacturing, assembling or importing of electronic products. 42 U.S.C. § 263(c)(3). Neither plaintiff nor defendants have cited the Court to any discussion by Congress with reference to the enactment of this provision. The Act does not define what it meant by the use of the word “person.”

Plaintiff contends that the cases of United States v. Park, 421 U.S. 658, 95 S.Ct. 1903, 44 L.Ed.2d 489 (1975) and United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48 (1943) are analogous to the case at bar and require a finding that corporate officials be held civilly liable. Those cases hold that corporate officials could be held criminally liable for violations of the FFDCA without a showing of mens rea. The rationale for these decisions is that, where Congress has enacted laws pertaining to the health of the general public, corporate officials who are responsible corporate agents must suffer punishment if they fail to implement measures that will insure that violations of the law do not occur. See United States v. Park, 421 U.S. at 672, 95 S.Ct. at 1911.

In United States v. CGR Medical Corp., et al., Civil Action No. 80-2592-z (D.Mass. Sept. 13, 1982), the district court held, in a case arising under the identical Act as is involved here, that an individual defendant is not entitled to summary judgment on the ground that he was not the manufacturer or assembler as defined by 42 U.S.C. § 263(c)(3).

While there are no cases strictly in point, we start with the proposition that legislation designed to protect the public health must be given a broad and expansive reading. See United States v. Park, supra, [38]*38and United States v. Dotterweich, supra.

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Related

United States v. Hodges X-Ray, Inc.
759 F.2d 557 (Sixth Circuit, 1985)

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Bluebook (online)
582 F. Supp. 35, 1983 U.S. Dist. LEXIS 11086, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-hodges-x-ray-inc-kywd-1983.