The opinion of the court was delivered by: ROSENBERG
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.
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)
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)
; (2) that Mucorhicin is misbranded within the meaning of § 352(l)
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);
(3) that defendants are charged with the interstate shipment of drugs which are adulterated within the meaning of § 351(a)(2)(B)
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).
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.
From all of the evidence produced at the hearing of this case, I make the following:
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, Pennsylvania, 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, ...