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UNITED STATES v. 10 CARTONS

May 28, 1957

UNITED STATES of America
v.
10 CARTONS, More or Less, Each Containing 26,332 Black Tablets of an Article of Drug LABELED IN PART 'HOXSEY' -- 100 S C Tablets Black Control Number 06980* * * Testagar & Co., Inc., Detroit, Michigan * * *' and 4 DRUMS, More or Less, Each Containing 62,900 Red Tablets of an Article of Drug LABELED IN PART 'From Testagar & Company, 1354 West Lafayette, Detroit, Michigan Name Special Tablets S C red 06949 LACTOTABS * * *' etc



The opinion of the court was delivered by: MILLER

This is an action by the United States under the seizure and condemnation provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq., for the destruction of a large quantity of red and black medicinal tablets and their labeling. It is alleged that the tablets were misbranded while held for sale at the premises of the Hoxsey Cancer Clinic at Portage, Pennsylvania, after having been shipped in interstate commerce. 21 U.S.C.A. § 334(a). Upon a libel of information filed by the government, a warrant of seizure and monition was issued from this court, and on March 25, 1955, the tablets and certain pamphlets, magazines, and leaflets alleged to be the labeling were seized at the clinic. An answer to the libel has been filed on behalf of the Hoxsey Cancer Clinic and Dr. Newton C. Allen as claimants. The cause was tried before the court and a jury and after lengthy contested proceedings resulted in a verdict in favor of the United States. The claimants have filed a motion for judgment in accordance with their motion for a directed verdict and in the alternative a motion for a new trial. In the interim, execution of the order of condemnation entered on November 16, 1956, has been deferred.

The Hoxsey Cancer Clinic is an institution at Portage, Pennsylvania, in the Western District of Pennsylvania, specializing in the treatment of cancer and cancerous diseases in humans by means of drugs and chemicals. It maintains a staff of physicians, nurses and administrative personnel. Persons from many parts of the nation suffering from cancer visit the clinic in hope of obtaining relief. These persons are not admitted as patients but visit the clinic for a day or a few days at most during the course of which interviews and examinations are conducted. The examinations include blood tests, X-rays, rectal or vaginal inspection and other accepted medical procedures which do not involve surgery. Biopsies are rarely if ever performed. If as a result of the interviews and examinations superficial or skin cancer is diagnosed an escharotic compound -- not the subject of this action -- is prescribed as the chief means of treatment. If internal cancer is diagnosed, a prescription for the red or black tablets, depending on the nature of the cancer, is written out by the physician in charge. Other supportive medications, such as vitamins, are usually prescribed. The tablets and medications are received by the patient at the drug counter of the clinic and are taken home with him for consumption according to given directions. The basic fee for the cancer treatment, including examinations and medications, is $ 400. In addition laboratory fees of from $ 5 to $ 18 and X-ray fees at $ 10 per picture are charged. If the patient acquires additional tablets no further charge is made except for laboratory or X-ray services. The tablets involved in this action, concededly 'drugs' within the meaning of the Food and Drugs Act, were prepared by a Michigan pharmaceutical house at a cost of less than $ 2 a thousand and were transported in interstate commerce. The red tablets are composed of potassium iodide, red clover tops, stillingia root, berberis root, poke root, buckthorn bark and pepsin; the black tablets of potassium iodide, licorice, red clover tops, burdock root, stillingia, berberis root, poke root, cascara sagrada, prickley ash bark and buckthorn bark. The tablets are the essential part of the Hoxsey treatment for cancer and potassium iodide is considered by claimants the chief curative component.

 The clinic began its operations in February, 1955, in an atmosphere of great local interest. When the seizure was effected on March 25, 1955, patients were being received for examination and treatment. The medications, the subject of this action, were then located in the drug and sterilization rooms at the rear of the clinic in their original containers from which they were eventually to be transferred to small envelopes for distribution to patients. Copies of the leaflets and printed matter described above in the caption and seized with the tablets were found on a table in the foyer of the clinic which adjoined a waiting room used by patients and persons visiting the clinic. The bundled copies of the 'Defender' magazine were seized in one of the rear rooms. The government, centering its attack only on Hoxsey medications used in the treatment of internal cancer, contends that the leaflets and printed matter caused the red and black tablets to be misbranded in three particulars: by making false or misleading representations with respect to the adequacy or effectiveness of the tablets in the mitigation and treatment of internal cancer; with respect to the terms of an existing court decree prohibiting entities not parties to this action from making such labeling claims for similar drugs distributed in interstate commerce; with respect to a survey allegedly discounting the effectiveness of X-rays, radium and surgery in treating cancer patients. The issues submitted to the jury were whether the printed matter and leaflets constituted 'labeling' within the meaning of the Food and Drugs Act and if so, whether the labeling was false or misleading in any of those three particulars.

 The Motion for Judgment

 Under § 304(a) of the Food and Drugs Act, 21 U.S.C.A. § 334(a), any article of drug that is misbranded while held for sale after shipment in interstate commerce is subject to federal seizure and condemnation procedures in accordance with the act. Under § 502, 21 U.S.C.A. § 352, a drug is misbranded if its labeling is false or misleading in any particular, and labeling is defined in § 201, 21 U.S.C.A. § 321, as meaning all labels and other written, printed or graphic matter upon the article or its container or 'accompanying such article.' In their first point in support of the motion for judgment, claimants present the contention that the leaflets and printed matter involved in this action were not labeling in the statutory sense. In Kordel v. United States, 1948, 335 U.S. 345, 350, 69 S. Ct. 106, 109, 93 L. Ed. 52, the Supreme Court said:

 'One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant.'

 That case and United States v. Urbuteit, 1948, 335 U.S. 355, 69 S. Ct. 112, 93 L. Ed. 61, establish that if the written, printed or graphic matter is used in the distribution or sale of a drug which has been shipped in commerce to explain the drug's use or usefulness, it may be considered labeling in a functional sense, even though there is a separation between the article and the printing. It is unnecessary to determine here how wide the separation may be before written, printed or graphic matter ceases to 'accompany' the drug article. In the present instance, the literature was prominently displayed and available for reading by or distribution to patients or other persons at the very place where the Hoxsey medications were distributed. In addition, undisputed evidence demonstrated that the literature was sometimes mailed to patients. Under such circumstances, this court will not permit the yards of distance between the clinic's waiting room and the drug rooms or the intervening plaster walls to be the measurement of the application of the federal regulatory law. The pamphlet entitled, 'Hoxsey Cancer Clinic' *fn1" states that its purpose is to acquaint the public with the clinic and its method of treating cancer 'in terms the average layman can understand.' It contains the statement 'we do feel that we have the most advanced and efficient method of treating cancer today' -- a method not including X-ray, surgery or radiation. It describes the procedure to be followed by prospective patients desiring consultations or treatment. The leaflet, 'Procedure and Information' *fn2" lists the fees charged by the clinic for the cancer treatment and laboratory and X-ray services. The article from 'Man's Magazine' entitled, 'I Conquered Cancer' *fn3" details what appears to be a disinterested person's statement and report on the case histories of seven persons who were, the article indicated, treated successfully by the Hoxsey method after other treatment had failed. It includes a report on Mrs. Verne Kielbowick, sister of John Haluska, a former member of the Pennsylvania legislature and Administrator of the Portage Clinic. Mrs. Kielbowick attributed the recovery of her health to the Hoxsey remedy and is quoted as saying:

 'If anybody doubts that Hoxsey cures cancer, let him come to Patton and talk to the Haluskas.'

 The pamphlet, 'Findings of Doctors' *fn4" contains the statement:

 '[Our] investigation has demonstrated to our satisfaction that the Hoxsey Cancer Clinic at Dallas, Texas, is successfully treating pathologically proven cases of cancer, both internal and external, without use of surgery, radium, or X-ray.'

 The 'Defender' magazine *fn5" includes a reproduction of a speech by former Senator Haluska to the Pennsylvania Senate in which he referred repeatedly to cures of cancer victims by the use of the Hoxsey treatment. It will be seen therefore that the materials consistently extolled the merits of the Hoxsey drugs in terms which the average layman would understand and which would be appealing to persons afflicted with the disease of cancer. Although modestly disclaiming that the drugs were a 'cure-all' and putting the case for the tablets in terms of 'you be the judge,' the literature nevertheless explained what the drugs were for and implied that they were effective and superior medicines. The facts were clear and great liberality was shown in permitting the jury to pass upon the contention that the literature was not labeling.

 In their second point, claimants argue that the drug articles in question were not 'held for sale * * * after shipment in interstate commerce' within the meaning of § 304(a), supra. However, they concede that the red and black tablets were shipped in interstate commerce and were the 'essential part' of the Hoxsey treatment for internal cancer in humans and that in the ordinary case a charge of $ 400 was made for a complete course of treatment exclusive of laboratory fees and X-ray charges. Upon those undisputed facts it would seem clear that the articles were held for sale. Claimants urge nevertheless that the drugs were intended, not for sale in the statutory sense, but for prescription by physicians in the pursuit of a local practice of medicine with which the act was not intended to deal and with which this court could not interfere. In this contention they are wrong.

 The overriding purpose of the federal Food and Drugs Law was to protect the lives and health of the public by keeping misbranded, adulterated and impure foods and drugs out of the channels of interstate commerce. The coverage of the statute was enlarged by the Act of 1938 to every article that had gone through interstate commerce until it finally reached the ultimate consumer by making its prohibitions applicable to such articles 'while * * * held for sale after shipment in interstate commerce.' United States v. Sullivan, 1947, 332 U.S. 689, 697, 68 S. Ct. 331, 336, 92 L. Ed. 297. It may be that physicians are not understood as holding for sale the drugs which they may administer or prescribe in connection with their treatment of patients. But the potentiality of harm to the public from misbranded drugs is not less because the intervening agency of distribution may be a physician rather than a layman. The terms 'while held for sale' have been given an expansive rather than a technical construction, United States v. Kocmond, 7 Cir., 1952, 200 F.2d 370, certiorari denied 345 U.S. 924, 73 S. Ct. 782, 97 L. Ed. 1355; United States v. 1800.2625 Wine Gallons, D.C.W.D.Mo.1954, 121 F.Supp. 735, and must be deemed to include the operations of the claimants in distributing their drug tablets at the Hoxsey Cancer Clinic. It is not the holding for sale in a technical legal sense which gives rise to the federal jurisdiction in cases arising under § 304(a) but the fact that the channels of commerce have been used. United States v. 1800.2625 Wine Gallons, supra. Since interstate transportation has been admitted, the ban of the section applies to the tablets here involved regardless of the claims of the Hoxsey Cancer Clinic and Dr. Newton C. Allen, its medical director. If forfeiture works any interference with claimants' practice of medicine it is a mere incident of their violation of the law in making representations concerning their drugs which the jury found were unwarranted, false or misleading. *fn6"

 The only other point which is urged in support of the motion for judgment may be dismissed without much discussion. Claimants say that the proper standard to be applied in determining whether there was a misbranding of the Hoxsey tablets while they were 'held for sale' is to be found in ...


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