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UNITED STATES v. ARTICLES OF DEVICE

January 25, 1977

UNITED STATES OF AMERICA, Plaintiff
v.
ARTICLES OF DEVICE (ACUFLEX; PRO-MED), consisting of the following: One device, more or less, labeled in part: (front panel) "ACUFLEX DUAL MODEL CA-110 * * * MODULATION * * * RATE * * * VOLTAGE * * * MODE * * * SENSITIVITY * * * AUDIO * * * RANGE * * *" (rear panel) "JAESTIC INDUSTRIAL CO., INC. 29830 BECK ROAD, WIXOM, MICHIGAN 48096 2195-D" including as accompanying labeling, one, more or less, of each of the following items of written, printed, and graphic matter relating to the device: leaflet entitled: "Acuflex Neur-Metron Modules * * *" leaflet entitled: "ACUFLEX INSTRUCTION GUIDE * * *" booklet entitled: "What Electric Acupuncture (E.A.P.) is * * *" leaflet entitled: "TECHNICAL DATA MODEL CZ-110 * * *" One device, more or less, labeled in part: "PRO-MED 1100 * * * FREQUENCY * * * POLARITY * * * TIMER * * * INTENSITY * * * SENSITIVITY * * * VOLUME * * *" including as accompanying labeling one, more or less, of each of the following items of written, printed and graphic matter relating to the device: leaflet entitled: "P.M.D., Inc. is pleased to announce * * * 'PRO-MED-1100' * * *" booklet entitled: "PRO-MED 100 INSTRUCTIONS * * *", Defendants and PROFESSIONAL MEDICAL DISTRIBUTORS, INC., and CONSTANCE HABER, D.C., Claimants



The opinion of the court was delivered by: SNYDER

The Government has brought an in rem action under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., to condemn two electric acupuncture devices, Acuflex Dual Model CZ-110 and Pro Med 1100, and their accompanying pamphlets. It contends that the devices are misbranded in violation of 21 U.S.C. § 352(a)&(f) *fn1" and therefore subject to seizure under 21 U.S.C. § 334(a). *fn2" After seizure by the U.S. Marshal and commencement of this suit, Dr. Constance Haber (who was in possession of the devices in the Western District of Pennsylvania) and Professional Medical Distributors (distributors of the devices located in Wixom, Michigan) intervened as claimants. The parties have now cross-moved for summary judgment.

 The court's review of materials accompanying *fn4" the devices revealed that the labeling failed to include directions adequate for safe use by the laity. The labels contain no directions on what diseases may be diagnosed by use of these devices and the diagnostic procedure for each disease, much less a specific list of diseases or conditions which may be treated with adequate directions on proper duration, frequency, or location of application sufficient for self-treatment of the specific conditions or diseases. *fn5" Moreover, the court determines that laymen cannot be expected to possess the skill and knowledge necessary to operate these devices safely; *fn6" therefore adequate directions cannot be devised for these devices.

 The mere fact that the devices were intended to be sold only to licensed operators for use in their practices does not in itself exempt the devices from the requirement that the labeling include adequate directions for use by the laity. United States v. Article of Device . . . Cameron Spitler, supra; United States v. Articles of Drug . . . Alberty Instant Food, supra. See 38 Fed. Reg. 6419. However, recognizing the value to medical practice and research of devices which cannot be safely used by laymen and for which adequate directions for use therefore cannot be written, Congress has authorized the promulgation of regulations for exemption from § 352(f)(1). Pursuant to this authority, the FDA has promulgated regulations which exempt a device from the labeling requirement of adequate directions for use if:

 
"(a) The device is: . . . .
 
(2) [To] be sold only to or on the prescription or other order of [a licensed] practitioner for use in the course of his professional practice.
 
(2) The method of its application or use.
 
(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contra-indication, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package, if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. . . .
 
(d) Any labeling, as defined in section 201(m) of the act, whether or not within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnished or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contra-indication, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented. . . .

 21 C.F.R. 801.109.

 The record reveals that these requirements for exemption have not been met. Part 801.109(b)(2) requires that the label bear the method of application or use of the device. The materials accompanying the device give insufficient directions for a licensed operator to approach diagnosis or treatment safely for any specific disease. *fn7"

 The labeling also fails to conform to the Part 801.109(c) requirement that on or within the package must appear information for use including methods, frequency and duration of application or administration, hazards, side effects, precautions, etc. *fn8" This information is clearly lacking. The regulations provide that only when this information is commonly known to practitioners licensed to use the device may it be omitted from the packaging. The Government has supplied affidavits of two medical experts who attest that few physicians use acupuncture devices in their practices and they do not commonly know the uses, frequency, pulse and wattage settings, duration of treatment and other such information. Although claimants' experts attest that the directions are adequate that physicians may use the devices safely, they do not assert that all physicians commonly know the directions, uses, hazards, etc., for the devices. Thus, the absence of detailed directions on or within the package is not in accord with Part 801.109(c).

 Finally, Part 801.109(d) requires that to be exempted from § 352(f)(1), all labeling that furnishes information about the device must state indications, side effects, routes, methods, frequency and duration of administration, hazards, precautions and other information needed by the practitioner to employ the device safely for its intended purpose. Even if all pamphlets specifically referring to these devices are considered as one label, they fail to conform to this requirement. *fn9" They contain only general specifications and directions for the devices, with no mention of what conditions or diseases may be treated or ...


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