United States v. Diapulse Corporation of America

Decision Date20 March 1972
Docket NumberDocket 71-2136.,No. 507,507
PartiesUNITED STATES of America, Plaintiff-Appellee, v. DIAPULSE CORPORATION OF AMERICA, also known as the Diapulse Manufacturing Corporation of America, a corporation, Defendant-Appellant.
CourtU.S. Court of Appeals — Second Circuit

Milton A. Bass, Bass & Ullman, New York City, for appellant.

Cyril Hyman, Asst. U. S. Atty. (Robert A. Morse, U. S. Atty., E. D. N. Y., Alvin L. Gottlieb, Deputy Asst. Gen. Counsel, Food, Drugs and Environmental Health Div., Joanne S. Sisk and Forrest T. Patterson, Attys., Dept. of Health, Education and Welfare, Rockville, Md., of counsel), for appellee.

Before SMITH, FEINBERG and MULLIGAN, Circuit Judges.

J. JOSEPH SMITH, Circuit Judge:

The Diapulse Corporation of America has been prohibited from shipping in interstate commerce the "Diapulse," a pulsed high frequency generator similar to a conventional diathermy unit but with a lower output, intended to create a unique athermal effect, until the labeling meets the standards of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. to the satisfaction of the Food and Drug Administration (FDA). Judge George Rosling of the United States District Court for the Eastern District of New York granted the government's motion for preliminary injunction against shipment of the device on the basis of testimony received in this proceeding and findings in earlier litigation condemning the machine as misbranded. Diapulse appeals. We affirm the judgment of the district court.

Related litigation arising from the marketing of this machine began six years ago. A condemnation action against a Diapulse machine was tried before a jury in Connecticut under 21 U.S.C. § 334. The issue was whether the labeling trumpeting the machine's effectiveness in the cure of 121 "specific" human ailments was false or misleading, making the machine misbranded under 21 U.S.C. §§ 352(a), 331(a). The jury returned a general verdict of mislabeling and in addition marked 49 of the claims as specifically misleading. The court instructed the jury that they were not required to pass on all claims; lack of a mark was not an indication that they considered any given claim true.1

The Diapulse was condemned as misbranded. Defendant did not take advantage of the opportunity granted to redeem the device by bringing it into compliance with the Food, Drug, and Cosmetic Act (the Act) with guidance from the FDA.2 In April 1968, the government began this action for injunctive relief under the Act because of alleged continuing violations of the Connecticut judgment.3 With Diapulse's consent, a preliminary injunction was entered prohibiting the interstate shipment of the device accompanied by claims on the 49 maladies marked by the Connecticut jury.4 Active prosecution was suspended to allow the company time to submit evidence of effectiveness to the FDA; such was not forthcoming, and after discovery proceedings and much unexplained delay, the case was heard in the fall of 1971. After hearing the bulk of the evidence, the court granted the government's motion for a preliminary injunction against shipment until the labeling was made acceptable under the statute. The trial judge based his conclusions on the fact that the condemned machine differed in detail only from later machines being marketed; that the device was still misbranded under the Connecticut judgment; and that the company had not corrected its earlier material, revealed that medical opinion differed sharply on the therapeutic value of the machine, or altered its advertising and labeling in more than an insignificant way.

Appellant first argues that the court did not consider the correct factors in making the decision on the preliminary injunction. To support this contention it cites numerous cases between private parties. But the function of a court in deciding whether to issue an injunction authorized by a statute of the United States to enforce and implement Congressional policy is a different one from that of the court when weighing claims of two private litigants. The Food, Drug, and Cosmetic Act has as its purpose the protection of the public from products not proven to be safe and effective for their alleged uses and the safeguarding of the public health by enforcement of certain standards of purity and effectiveness. The reach of the Act is broad and the provisions, touching the public interest in a direct way, are to be given a liberal construction. United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969); United States v. Sullivan, 332 U.S. 689, 68 S.Ct. 331, 92 L.Ed. 297 (1948); Pasadena Research Laboratories v. United States, 169 F.2d 375 (9th Cir.), cert. denied, 335 U.S. 853, 69 S. Ct. 83, 93 L.Ed. 401 (1948); United States v. 250 Jars, etc. of United States Fancy Pure Honey, 218 F.Supp. 208 (E. D.Mich. 1963). As the Supreme Court said in United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48 (1943):

The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words. 320 U.S. at 280, 64 S.Ct. at 136

The passage of the statute is, in a sense, an implied finding that violations will harm the public and ought, if necessary, be restrained. See United States v. City and County of San Francisco, 310 U.S. 16, 60 S.Ct. 749, 84 L.Ed. 1050 (1940). The district courts are given jurisdiction to restrain violations of the statute (21 U.S.C. § 332(a)); the legislative goals are the framework within which the court operates in deciding whether to grant injunctive relief. Hecht Co. v. Bowles, 321 U.S. 321, 64 S.Ct. 587, 88 L.Ed. 754 (1944). No specific or immediate showing of the precise way in which violation of the law will result in public harm is required. Shafer v. United States, 229 F.2d 124 (4th Cir.), cert. denied, 351 U.S. 931, 76 S.Ct. 788, 100 L.Ed. 1460 (1956); Walling v. Brooklyn Braid Co., 152 F.2d 938 (2d Cir. 1945); United States v. Ingersoll-Rand Co., 218 F. Supp. 530 (W.D.Pa.), aff'd 320 F.2d 509 (3d Cir. 1963). Thus, Diapulse's claim that a removal from commerce is not justified because there was no showing of irreparable injury or proof that the machine was unsafe is beside the point.5 In any case, the company's perspective in defining "unsafe" or "injury" is too narrow. As the court said in reviewing the labeling of a product called Mucorhicin in United States v. Nutrition Service, Inc., 227 F.Supp. 375 (W.D.Pa. 1964), aff'd 347 F.2d 233 (3d Cir. 1965):

That does not mean that because such evidence of unsafeness has not been introduced, that the hope held out by the producers of Mucorhicin to the medically aidable patients may not induce them to delay medical treatment by competent doctors to the extent that they become less capable or incapable of being aided, and so cause irreparable public injury. . . . Congress intended that all persons in the national domain be protected against any such injury. . . . 227 F.Supp. at 388

The other major consideration in the trial court's exercise of discretion is the likelihood of continuing violation or recommencement of the offensive behavior, if it has ceased during the pendency of the litigation. "The matter is in the broadest sense for the discretion of the trial court which is best qualified to form a judgment as to the likelihood of a repetition of the offense . . . `His discretion is necessarily broad and a strong showing of abuse must be made to reverse it.' United States v. W. T. Grant Co., 345 U.S. 629, 633, 73 S.Ct. 894, 898, 97 L.Ed. 1303." United States v. Article of Drug . . . Designated . . . B-Complex Cholinos Capsules, 362 F.2d 923, 928 (3d Cir. 1966); see United States v. Nysco Laboratories, Inc., 215 F.Supp. 87 (E.D.N.Y.), aff'd 318 F.2d 817 (2d Cir. 1963). The injunction may sweep broadly in its prohibition if that is necessary to enjoin future violations which appear likely to occur. May Dept. Stores Co. v. NLRB, 326 U.S. 376, 66 S.Ct. 203, 90 L.Ed. 145 (1945); United States v. Nysco Laboratories, Inc., supra. Nor can appellant complain that the injunction is impermissible because it will put him out of business. He "can have no vested interest in a business activity found to be illegal. It has long been settled that the Food and Drug Act itself is a constitutional exercise of the commerce power. United States v. Walsh, 331 U.S. 432, 67 S.Ct. 1283, 91 L.Ed. 1585 (1947)." United States v. Ellis Research Laboratories, Inc., 300 F.2d 550, 554 (7th Cir. 1962).

A consideration of the facts in this case in light of the above leads to the inescapable conclusion that the issuance of the injunction was warranted. The device had been found to be generally misbranded, in violation of the statute, and in addition, a jury of laymen had found 49 specific claims to be false or misleading. Yet the company continued its brazen advertising scheme, failing to inform its buyers and lessors of the litigation or of the dispute in medical circles about the machine's efficacy. It did not prove the machine's effectiveness or relabel it to the FDA's satisfaction. The company's persistence in marketing the device makes it highly likely that the prohibited activity will cease only on the issuance of a blanket prohibition on shipment.

Taking into account the fact that a final decision on the merits after a full trial would have to await transcripts and would therefore not be forthcoming in the near future, the district court concluded that it was necessary to take appellant's "welter of intermingled true, half-true, and false promotional material out of the mainstream of medicine." We agree that the action was...

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