United States v. KN Enterprises, Inc.
| Decision Date | 09 November 1978 |
| Docket Number | No. 78 C 2781.,78 C 2781. |
| Citation | 461 F. Supp. 988 |
| Parties | UNITED STATES of America, Plaintiff, v. K-N ENTERPRISES, INC. and Leon Kirschner, Defendants. |
| Court | U.S. District Court — Northern District of Illinois |
Frederick H. Branding, Asst. U. S. Atty., Chicago Ill., for plaintiff.
Allan A. Lapidus, Chicago, Ill., for defendants.
DECISION ON MOTION FOR PRELIMINARY INJUNCTION
This case comes on to be heard on the Government's Amended Motion for Preliminary Injunction and Temporary Restraining Order filed August 1, 1978. The Amended Motion has been allowed to stand with the Government's Second Amended Complaint for Injunction subsequently filed October 2, 1978. Defendants filed an answer on October 23, 1978, thereby putting both pleadings in issue. The parties have filed affidavits relating to the merits of the Government's Amended Motion and have supported their respective positions by memoranda, all of which have been considered as a substitute for testimonial hearing, if sufficient.
The Second Amended Complaint was filed pursuant to the civil enforcement provision of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 332(a)). It seeks to preclude the manufacture and distribution of certain specified drugs and devices until the requirements of the statute and the Food and Drug Administration regulations have been satisfied. Defendants have voluntarily agreed to cease distribution of the drugs until further notice, but they have not agreed to cease distribution of the devices nor to recall any drugs or devices which have already been distributed. We find and conclude that the drugs covered by the Second Amended Complaint should be recalled and not further distributed or manufactured until the F.D.A. regulations have been complied with, but that further proceedings may be necessary to determine what specific types of compliance are necessary. The government is not entitled to any relief with respect to the devices at this time, because their affidavits do not show a reasonable probability of prevailing on the merits.
The drugs are those prepared by the defendants which contain Renacidin or Neomycin or a salt thereof. Section 331(a) prohibits the introduction into interstate commerce of any drug or device that is "adulterated or misbranded." Section 352(l) provides that an antibiotic drug is misbranded if its batch was not certified or released by the Secretary of H.E.W. pursuant to § 357. The government's evidence in the record shows without contradiction that the defendants' Neomycin sulfate solution was not so certified or released and therefore that it is misbranded within the meaning of § 352(l). (Affidavit of Frederic J. Geissel dated July 11, 1978.)
Likewise, § 355(a) requires that any new drug be approved by the F.D.A. before introduction into interstate commerce. No application was filed or approved for the defendants' Renacidin 10 percent solution. It must therefore be excluded from interstate commerce pursuant to § 331(d). E. g., United States v. Nutrition Service, Inc., 227 F.Supp. 375 (W.D.Pa.1964), aff'd, 347 F.2d 233 (3d Cir. 1965).
We will enter a preliminary injunction pendente lite with respect to the two drugs covered by the Second Amended Complaint on the grounds of failure to obtain the required certification and approval. We find and conclude that the government is likely to prevail on these issues and that the harm which may be inflicted upon the public by the defendants' continued distribution of these drugs greatly outweighs the possible damage inflicted upon the defendants. The government has no adequate remedy at law, and we find that all of the other requirements for the exercise of this equitable jurisdiction are satisfied. Banks v. Trainor, 525 F.2d 837 (7th Cir. 1975), cert. den. 424 U.S. 978, 96 S.Ct. 1484, 47 L.Ed.2d 748 (1976).
The government further seeks the injunction on the grounds of defendants' improper manufacturing processes, supported by an affidavit of William R. Clark dated July 13, 1978. Mr. Clark's affidavit is based primarily upon reports of government inspections made at the defendants' establishment during May 1978. They qualify as official records under Rule 803(8) and are not contradicted by defendants. In fact according to par. 15 of the affidavit, defendant Kirschner has acquiesced in these issues. Therefore, the government is entitled to a preliminary injunction against manufacturing or distributing the drugs, on the basis of improper manufacturing or processing procedures. 21 U.S.C. § 351(a)(2)(A) and (B) and 21 C.F.R. 211. An affirmative mandatory injunction will not be issued with respect to manufacturing procedures at this time, however.
The government also contends that the foregoing drugs are "adulterated" within the meaning of § 351(a) and (c) because their purity and quality are deficient. Here the government relies on the affidavit of its expert, Mary K. Bruch, who reviewed the qualitative analyses performed by its technicians. On this point, however, defendants have filed a counteraffidavit of John Giesing who supervised sterility tests and found no deficiency in that respect in the two drugs. The government's affidavit does not satisfy the hearsay requirements of Rule 803. Nor are we able to determine on the basis of conflicting affidavits that the government has a reasonable likelihood of prevailing on the issue of sterility or quality. Therefore, we will not issue a preliminary injunction on these grounds.
The government does not support its contention that the drugs are misbranded because of inadequate labelling under § 352(f)(1). Hence no preliminary injunction can be granted on this ground.
The Second Amended Complaint also seeks relief against certain devices known as Opti Disposable Ophthalmic Dressing Tray and Sterile Vent-Air Refresh Ophthalmic Irrigating Solution. We find and conclude that these devices are covered by the definition in § 321(h)(3) in that they are for use in human eyes. However, genuine issues of material fact exist with respect to the sterility and quality of these devices. Specifically, the affidavits of Mary K. Bruch on behalf of the government and John Giesing on behalf of the defendants are in such conflict with each other that we cannot at this juncture find that the government has a reasonable likelihood of prevailing on the merits with respect to the two devices. As to manufacturing procedures, the government relies on the incorporated and republished affidavit of William R. Clark, but this was directed toward the drugs. Since his original affidavit did not...
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