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UNITED STATES v. UNDETERMINED QUANTITIES OF AN ART

April 18, 1979

UNITED STATES of America, Plaintiff,
v.
Undetermined quantities of an article of device, labeled in part, DEPILATRON EPILATOR MODEL NO. DP-206 UNIVERSAL TECHNOLOGY, INC., WOODBRIDGE, CONN. or Depilatron, Inc., Woodbridge, Conn. Model No. DP-206 and including as accompanying labeling undetermined quantities of brochures and leaflets entitled: (brochure) depilatron What You Should Know About the Depilatron Method of Hair Removal and (leaflet) Harvey Glass, M.D. December 29, 1975, I have studied the Depilatron method of hair removal from both a theoretical and practical point of view, Defendant



The opinion of the court was delivered by: SAND

This action is an In rem proceeding pursuant to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 334(a)(2), for forfeiture and condemnation of a depilatory device. Claimant has moved to dismiss the complaint on the grounds that (1) 21 U.S.C. § 334(a)(2) "is unconstitutional on its face as a violation of the commerce clause of the United States Constitution" and (2) "that plaintiff is collaterally or equitably estopped from asserting this claim on the basis (of an action by the State of California) wherein the same issues as raised herein were conclusively resolved in favor of claimant after a full trial on the merits." For the reasons hereinafter set forth, the motion is denied.

I. The Commerce Clause

Section 334(a) of Title 21 of the United States Code provides for the seizure of, Inter alia, adulterated or misbranded devices. Prior to 1976, it was a requirement of such seizures that the device in question have been introduced into interstate commerce. Subsection 334(a) was amended in 1976, however, so as to include adulterated or misbranded devices in the class of articles which are "liable to be proceeded against at any time on libel of information" without regard to interstate commerce. 21 U.S.C. § 334(a)(2)(D) (1976).

 Claimant concedes that "Congress may regulate not only interstate commerce, but also those wholly intrastate activities which it concludes have an affect (sic) upon interstate commerce." Claimant's contention is, rather, that where Congress seeks to regulate intrastate activities, "a proper nexus to interstate commerce must be made by Congress in order to justify (the) departure from the Commerce Clause" (Claimant's Memo. at 4, 5), and that Congress has failed to make the required findings.

 The legislative history of the 1976 amendment contains no express consideration of the impact of the intrastate sale and distribution of medical devices on interstate commerce. It was, however, the clear intent of Congress

 
to authorize the seizure of devices which are distributed wholly in intrastate commerce. This provision will be applicable to all devices and will assist enforcement by doing away with the cumbersome and time consuming task of establishing interstate shipment. This provision will be particularly useful against quack devices.

 S.Rep.No. 94-33, 94th Cong.1st Sess. 14, Reprinted in (1976) U.S.Code Cong. & Admin.News, pp. 1070, 1083. Congress also expressly compared the Food and Drug Administration's extensive authority over prescription drugs with its "limited authority" over medical devices, and stated its intention "that the FDA has the proper authority to regulate (the development of medical devices) so that Americans are not put at risk from the use of unsafe and ineffective medical devices." Id. at 1071. Congress further noted:

 
a device which does not perform as promised may pose a risk to health as well as an economic detriment to the purchaser. Reliance on unwarranted claims made for a device, recommending use in serious disease conditions, may induce the purchaser to forego seeking timely and appropriate medical treatment. Fraudulent devices were a major concern of Congress in 1938 when it gave FDA authority to regulate devices.

 Id. at 1072.

 The Government argues that § 334(a)(2) is a valid exercise of Congress' power under the Commerce Clause, and that its legislative history "plainly implies (that) effective protection of the public health and safety would be sacrificed were Congress to have required that the source and destination of all allegedly adulterated or misbranded devices be determined in seizure cases." (Pl."s Memo. at 10). Moreover, the Government argues that

 
(w)ith respect to the absence of express legislative history regarding the impact of the intrastate sale and distribution of medical devices on interstate commerce, it is enough that this Court perceive a basis upon which Congress could have predicated a judgment that such a nexus exists.

 Id. at 11. It is the Government's position that it would be sufficient for Congress to have acted on the basis of "common experience . . . (and) the circumstances of life as we know them," quoting from Tot v. United States, 319 U.S. 463, 468, 63 S. Ct. 1241, 1245, 87 L. Ed. 1519 (1943).

 We agree that the absence of formal findings as to the nexus between intrastate sale and distribution of medical devices and interstate commerce is not fatal, as long as Congress had a rational basis for finding such a nexus. See Katzenbach v. McClung, 379 U.S. 294, 304, 85 S. Ct. 377, 13 L. Ed. 2d 290 (1964). Congress alluded to the proliferation of medical devices and to the danger posed by unsafe and ineffective devices to the public health and safety. In light of the extensive hearings held by Congress with respect to the 1976 legislation, we find that Congress did have a sufficient basis for ...


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