United States v. Nutrition Service, Inc.
| Decision Date | 17 February 1964 |
| Docket Number | Civ. A. No. 64-4. |
| Citation | 227 F. Supp. 375 |
| Parties | UNITED STATES of America, Plaintiff, v. NUTRITION SERVICE, INC., a corporation, Drosnes-Lazenby Cancer Clinic, a partnership, Philip L. Drosnes, Lillian M. Lazenby, Joseph M. Wilson, M.D., and Geraldine M. Maiden, Individuals, Defendants. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
COPYRIGHT MATERIAL OMITTED
Gustave Diamond, U. S. Atty., Stanley Greenfield, Asst. U. S. Atty., Pittsburgh, Pa., Salvatore L. Franchino, Washington, D. C., Food & Drug Adms., for plaintiff.
Homer W. King, Pittsburgh, Pa., Kirkpatrick W. Dilling, Chicago, Ill., for defendants.
The United States of America, as plaintiff, filed its complaint for a permanent injunction, which included a prayer for a temporary restraining order, pending a hearing for a preliminary and final injunction.
The action is brought under the provisions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq.1 The plaintiff here seeks to restrain and prevent the defendants from the manufacture, preparation, propagation, compounding or processing and distributing in interstate commerce a product which they have named Mucorhicin.
The plaintiff maintains here that this is a drug, and the defendants have failed to comply with the Act in (1) that defendants are violating § 331(d)2 by shipping in interstate commerce a new drug, without having secured the Food and Drug Administration's approval of a new drug application as required by § 355(a)3; (2) that Mucorhicin is misbranded within the meaning of § 352(l)4 in that it purports to be and is represented as an antibiotic drug and is neither certified nor exempted from certifications as required by § 357(a)5; (3) that defendants are charged with the interstate shipment of drugs which are adulterated within the meaning of § 351(a) (2) (B)6 in that the methods used in and the facilities and controls used for its manufacturing, processing, packaging or holding do not conform to current good manufacturing practice; and (4) that the defendants violate the Federal Food, Drug, and Cosmetic Act by failing and refusing to register as producers of drugs, as required by § 360(b) and (c).7
A hearing on the petition was originally set for January 9, 1964, and by stipulation of the parties it was continued on two occasions and finally agreed to be heard on Monday, January 20, 1964.
The plaintiff produced a great deal of evidence, both testamentary and documentary, in support of its contentions, and the defendants offered in defense testamentary evidence to the effect that Mucorhicin was not a drug but a food supplement. They also raise a number of legal questions.
From all of the evidence produced at the hearing of this case, I make the following:
FINDINGS OF FACT
1. The defendant, Nutrition Service, Inc., is a corporation organized and existing under the laws of the State of Pennsylvania, incorporated October 7, 1963, and domiciled in the City of Pittsburgh at 4774 Liberty Avenue, Pittsburgh, Pennsylvania, within the jurisdiction of this Court.
2. The defendant, the Drosnes-Lazenby partnership, had been trading and doing business at 4774 Liberty Avenue, Pittsburgh, Pennsylvania, within the jurisdiction of this Court and has and had been trading and doing business as the Drosnes-Lazenby Cancer Clinic and the Drosnes-Lazenby Clinic.
3. Commencing on or about the year 1950, and prior to October 7, 1963, Lillian M. Lazenby and Philip L. Drosnes did business and operated under the name of "Drosnes-Lazenby".
4. There was at no time any official registration of an entity or combination of persons known as "Drosnes-Lazenby Cancer Clinic".
5. On May 19, 1950, Philip L. Drosnes had registered the name "Drosnes-Lazenby" under the Fictitious Names Act of the Commonwealth of Pennsylvania, said registration being in the Prothonotary's Office of Allegheny County, and being further registered in the State Department at Harrisburg, Pennsylvania. The avowed purposes of the business organization known as Drosnes-Lazenby were set forth in the application for said registration to be: "Research and development and manufacture of biologically processed foods".
6. The defendant, Philip L. Drosnes, an individual, is Secretary-Treasurer of the said corporation; has and had been acting at the said Drosnes-Lazenby Cancer Clinic as the Administrative Director; and resides at 914 N. Negley Avenue, Pittsburgh, Pennsylvania, within the jurisdiction of this Court.
7. The defendant, Lillian M. Lazenby, an individual, is president of the said corporation, Nutrition Service, Inc.; has and had been acting at the said Drosnes-Lazenby Cancer Clinic under the title of Associate Director; and maintains a summer residence at R. D. No. 2, Jamestown, Pennsylvania, within the jurisdiction of this Court.
8. The defendant, Joseph W. Wilson, M.D., an individual, is a physician licensed to practice medicine in the Commonwealth of Pennsylvania; is and was employed at the said Drosnes-Lazenby Cancer Clinic in the position of Medical Supervisor; is Research and Nutrition Director of the said corporation; and resides at 217 Sunset Drive, Pittsburgh, Pennsylvania, within the jurisdiction of this Court.
9. The defendant, Geraldine M. Maiden, an individual, is vice-president of said corporation; is and was an employee at the Drosnes-Lazenby Cancer Clinic and resides at 103 Aberyl Drive, Ross Township, Allegheny County, Pennsylvania, within the jurisdiction of this Court.
10. The defendants have been, up to the issuance of a Temporary Restraining Order in this cause on January 3, 1964, engaged in the business of manufacturing, processing, packing, labeling, promoting, selling and distributing in interstate commerce, an article designated as Mucorhicin.
11. The product, Mucorhicin, is derived from a fermentation and molding process of natural components of wheat, yeast, salt and water.
12. The product contains no synthetic or drug constituents.
13. The product has been analyzed by the plaintiff and the analyses have demonstrated that Mucorhicin has no antibiotic effects.
14. The product, Mucorhicin, is not an antibiotic drug.
15. There is no evidence that Mucorhicin as such has harmed anyone.
16. For a number of years prior to the formation of the corporation, Nutrition Service, Inc., the defendants under the name of Drosnes-Lazenby Clinic and Drosnes-Lazenby Cancer Clinic initiated correspondence by mailing directly to clinics, chiropractors, naprapaths and to doctors, copies of literature, letters of instructions, testimonials and other labeling of the product Mucorhicin summarizing its uses and results.
17. Prior to October 7, 1963, defendants dispensed or caused to be dispensed Mucorhicin in ½ ounce bottles, which contained a label with the following language:
MUCORHICIN
Directions Take .......................... Drops Every ......................... Hours ......................... Times a Day ........................... Each Meal ............................ Bed Time _______________________________________ Joseph W. Wilson, M.D 4774 Liberty Avenue Pittsburgh 24, Pa.
18. The plaintiff has introduced uncontradicted evidence that in several instances the defendants under the name of Nutrition Service, Inc., employed the following method of distribution of Mucorhicin:
a. Separate letters were initiated by Food and Drug Administration Inspectors Larry Kerness and John W. Gilmore to the Drosnes-Lazenby Cancer Clinic and the Drosnes-Lazenby Clinic dated October 28, 1963 and December 10, 1963, respectively, which stated in effect that they had heard from friends that the Clinic had a treatment for cancer, or that Mucorhicin was good for cancer, and inquired whether this product was good for cancer of the lung and cancer of the prostate, respectively.
b. In response to the Inspectors' letters, they received answers under the signature of J. W. Wilson, M.D., advising, inter alia, that Nutrition Service, Inc. was the sole distributor of Mucorhicin and that it was available in a bottle containing an equivalent of a week's supply. The letter to Inspector Kerness also noted that there was no change in the formula of Mucorhicin, and that it was not a drug but a non-toxic food for special dietary uses.
c. Each inspector then placed a written order for several bottles of Mucorhicin.
d. Nutrition Service, Inc., responded to their request by sending an order of Mucorhicin with instructions that the product be taken according to the directions on the label without deviation from their suggested diet which was enclosed.
e. The answer of Nutrition Service, Inc., in each of the cases was in respect to the specific questions for cancer cure.
19. Prior to October 1963, the defendants' literature has consistently represented Mucorhicin as safe and effective in the treatment, mitigation, cure and prevention of many ailments and diseases, including cancer and some of the other serious diseases and ailments which affect mankind.
20. The labeling, promotional literature and other written, printed and graphic matter identified as Government's Exhibits Nos. 1 through 23, 26, 27, 29, 33, 35, 38, 40, 42 and 44 establish by means of specific claims, implications and overall effect upon the reader that Mucorhicin is an article intended for use in the cure, mitigation, treatment and prevention of cancer and other serious diseases in man.
21. On or about October 23, 1963, Nutrition Service, Inc., distributed a letter whereby it formally disclaimed any and all literature and publications theretofore issued pertaining to the product Mucorhicin requesting that the same be discontinued and disposed of.
22. The formation of the corporation, the mailing of Government's Exhibit 22 to all old customers of Mucorhicin requesting disposal of all literature and labeling sent by the Drosnes-Lazenby Cancer Clinic or Drosnes-Lazenby...
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