Metallic Flowers, Inc. v. City of New York

4 A.D.2d 292, 164 N.Y.S.2d 227, 1957 N.Y. App. Div. LEXIS 4915
CourtAppellate Division of the Supreme Court of the State of New York
DecidedJune 25, 1957
StatusPublished
Cited by4 cases

This text of 4 A.D.2d 292 (Metallic Flowers, Inc. v. City of New York) is published on Counsel Stack Legal Research, covering Appellate Division of the Supreme Court of the State of New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Metallic Flowers, Inc. v. City of New York, 4 A.D.2d 292, 164 N.Y.S.2d 227, 1957 N.Y. App. Div. LEXIS 4915 (N.Y. Ct. App. 1957).

Opinions

Frank, J.

This is an appeal by the defendants from a judgment granted the plaintiff, after trial. The judgment restrains the defendants from interfering with the advertising, manufacture, distribution and sale of certain metal bracelets seized by the defendants, and directs the return of the bracelets and advertising matter used in connection therewith.

The issues involve the recurrent conflict between property rights and State police power in respect to public health.

In March, 1955, the defendant city, through its Department of Health, seized the above-mentioned property pursuant to section 135 of the Sanitary Code of the City of New York empowering the Department of Health to take such action “where * * * there is probable cause to believe that the article is * * * misbranded ’ ’. The defendants contend that the plaintiff’s bracelets were misbranded because their labeling was “false and misleading (in any particular) ” (Sanitary Code, § 116, subd. 2, par. [a]) in that they did not transmit the electro-therapeutic qualities claimed and had no medical or therapeutic effect whatsoever.

The plaintiff marketed the metal device claiming it utilized a thermopile principle which generates a very low electric current, because of the various metallic elements used in the bracelet and the temperature differential between the human body and the air. The plaintiff asserts that the bracelet is a new method of ambulatory treatment for the relief of symptoms arising from a variety of unrelated diseases, On the box in which it is enclosed appear the words “ Electro-Therapeutic Bracelet, NEW! Relieves aches and pains by simple external application only.” The package includes a detailed pamphlet purporting [295]*295to explain the manner in which the bracelet is to be used, states that quick relief is possible, often overnight, that there are permanent benefits, and that no toxicity, burns or overdose are possible from its use. The printed blurb asserts that the device has high therapeutic efficiency and may be used in conjunction with short-wave diathermy, infra-red radiation and heating pads, which are called supplementary forms of treatment. In bold type, the bracelet is recommended for use in fractures and dislocations, joint sprains, myositis, bursitis, neuritis, sciatica, arthritis, acute and chronic sinusitis, and for respiratory diseases like bronchitis and pleuritis. These ailments, it is claimed, are cured or alleviated by the simple method of wearing the bracelet on the wrist. In further explanation, the brochure states, “ the E. T. B. should be worn on the left wrist if the left knee aches.” The defendants maintain that the assertions made in the pamphlet are false and misleading, and for that reason the bracelet is mislabeled.

Although the plaintiff asserts that the device was approved by a number of physicians, on the trial it relied principally upon lay witnesses, who claimed beneficial results, to establish the truth of its assertions that the bracelets actually had therapeutic value and that therefore there was no mislabeling.

The defendants called medical and other expert witnesses who, in substance, testified that the current generated by the bracelet was so infinitesimal that it was incapable of producing any of the benefits claimed for it in the printed matter on the box and the pamphlet enclosing the device. Tests made by a physicist, employed by the Federal Food and Drug Administration and previously by the Bureau of Standards, are very revealing. For example, the current from an ordinary standard flashlight battery held in the hands was five hundred thousand to a million times greater than that of the bracelet. Standard measuring devices failed to register any greater current emanating from the bracelet, than the human body itself produces. Dr. Rogoff, a specialist in physical medicine and rehabilitation and a clinical professor at one of the medical schools, concluded from the tests which he made that the current generated by the bracelet could have no effect whatever upon the human body under any circumstances.

The absurdity of the claims made by the plaintiff for its device is probably best demonstrated when one is made aware that the current used in accepted medical galvanic treatment would be 250 million times greater than that induced by the bracelet.

[296]*296The testimony of lay witnesses as to therapeutic value has been held to have very little weight in litigation involving mislabeling. (See United States v. Hoxsey Cancer Clinic, 94 F. Supp. 464, revd. on other grounds 198 F. 2d 273, cert. denied 346 U. S. 897; United States v. 50 3/4 Dozen Bottles, 54 F. Supp. 759, 762.)

The Sanitary Code provision (§ 116) and the Education Law (§ 6808) applicable to misbranding, reiterate almost in Jiaec verba the phrasing of section 502 of the Federal Food, Drug, and Cosmetic Act of 1938 (U. S. Code, tit. 21, § 321 et seq.). That act completely replaced the Food and Drug Act of 1906 as amended in 1912.

The Federal courts in construing the earlier enactments, held that they were intended to reach only false and misleading statements concerning the ingredients of the products covered thereunder, and that statements regarding therapeutic results, even though false and misleading, were beyond the purview of the legislation (United States v. Johnson, 221 U. S. 488 [1911] ; United States v. American Druggists’ Syndicate, 186 F. 387 [1911]).

In the 1938 Act, devices, i.e., “ instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to effect the structure or any function of the body of man or other animals” (§ 201, subd. [h]; U. S. Code, tit. 21, § 321, subd. [h]), were for the first time included within the scope of Federal regulation. Section 502 (U. S. Code, tit. 21, § 352) of the new act thus provided, in part: A drug or device shall be deemed to be misbranded—(a) If its labeling is false or misleading in any particular.” Thus, the act condemned all false or misleading ’ ’ claims, including those of therapeutic value, and no longer required, with respect to the latter, that they be shown to be false and fraudulent.”

In considering the questions of fact involved here, the learned Special Referee reached his determination upon the Federal law and cases concerning misbranding based upon false and fraudulent therapeutic claims under the 1906 Act as amended in 1912. He concluded that the proof failed to establish willful misrepresentations as required under the legislation referred to. The 1938 Act, however, does not require proof of fraud or willful misrepresentation. It is sufficient if the claims as to therapeutic value are false or misleading (U. S. Code, tit. 21, § 352 subd. [a]; United States v. Ghadiali, 165 F. 2d 957, cert. denied 334 U. S. 821). Intent to deceive is no longer material, in a [297]*297charge of misbranding (United States v. Buffalo Pharmacol Co., 131 F. 2d 500, revd. on other grounds sub nom. United States v. Dodderweich, 320 U. S. 277; United States v. 11 1/4 Dozen Packages, 40 F. Supp. 208).

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Bluebook (online)
4 A.D.2d 292, 164 N.Y.S.2d 227, 1957 N.Y. App. Div. LEXIS 4915, Counsel Stack Legal Research, https://law.counselstack.com/opinion/metallic-flowers-inc-v-city-of-new-york-nyappdiv-1957.