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UNITED STATES v. LIT DRUG CO.

September 24, 1971

UNITED STATES of America, Plaintiff,
v.
LIT DRUG COMPANY, a corporation, et al., Defendants


Coolahan, District Judge.


The opinion of the court was delivered by: COOLAHAN

This action proceeds from certain admitted violations of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq. The government seeks to enjoin numerous irregularities practiced by defendants in violation of the Act, 21 U.S.C.A. § 331(a), (k). This Court has jurisdiction under 21 U.S.C.A. § 332(a).

 The government filed its complaint for an injunction restraining defendants from their alleged illegal activities on July 27, 1971. This lengthy prayer for relief, supported by several detailed affidavits, charged defendants with manufacturing and holding for sale adulterated and misbranded drugs, within the meaning of 21 U.S.C.A. § 351(b), (c), (d)(2) and § 352(a), (f)(2), and with the unlawful introduction of these drugs into interstate commerce, in violation of 21 U.S.C.A. § 331(a). The government also alleged a violation of 21 U.S.C.A. § 331(k) in that defendants had adulterated or misbranded component drugs which it had received through interstate commerce. This Court granted the government's request for a Temporary Restraining Order which enjoined further interstate shipment of drugs by defendant until certain conditions had been fulfilled. First, the methods, facilities and controls for manufacturing, processing, packaging, and labeling of defendants' drugs were to be brought in conformity with the current good manufacturing practices, as defined in 21 C.F.R. § 133.1-14. Specifically, but not exclusively, defendants were directed to correct ten deficient practices in their quality control and record keeping. As a second condition upon future interstate commerce, defendants were required to grant duly authorized Food and Drug Administration inspectors access to defendants' plant for the purpose of inspecting defendants' records, materials, equipment and labeling in order to insure, to the satisfaction of the government, that defendants had in fact realigned the operation of the plant in conformity with current good manufacturing practices. Third and finally, all the drugs on hand at defendants' plant site were to be subject to examination by officials of the Food and Drug Administration, assays were to be made in order to assure the safety, identity, purity, strength and quality of these drugs, and recalls were to be made of any line of drug determined to be adulterated or misbranded. These drugs would then likewise be examined and, if similarly defective, destroyed or brought into compliance with the law under the supervision of the Food and Drug Administration. The expenses for the inspecting, assaying and recall operations were to be borne by the defendants.

 In view of the immediate threat to the public health and safety presented by defendants' alleged activities, and also considering the admittedly broad injunctive relief temporarily granted the government, a trial date within the next few days following filing of the complaint was fixed. Shortly before trial, however, the defendants and the government entered a Stipulation, vitiating the need for a fact finding, by which the defendants confessed virtually every wrongdoing attributed to them in the complaint. Paragraph Six of the Stipulation recites the illegalities detected by Food and Drug Administration inspectors during nine visits to defendants' plant beginning in June 1970 and ending in May 1971. The evidence collected during that time is also set out in the numerous affidavits which formed the basis of the government's request for a Temporary Restraining Order on July 27, 1971. The length of Paragraph Six prevents a full, verbatim recitation of defendants' concededly unlawful activities, but some mention should be made to demonstrate that these illegalities ran the full gamut of the assembly line.

 The defendants concede that they failed to provide written specifications for raw materials, failed to examine raw materials sufficiently prior to their release for manufacturing, and failed to assay raw materials and/or maintain assay records. Numerous quality control tests designed to insure uniformity, potency, purity and drug stability within each batch were either omitted or haphazardly performed, and in many instances, test results were incompletely or incorrectly recorded or not recorded at all. Where batch records failed to match specifications, the discrepancy was sometimes unexplained. Innumerable adulterations were discovered by the inspectors, many of which were found in such widely used drugs as reserpine and digitalis. It also appears that final inspections observed throughout the industry were not performed by defendants. Moreover, packaging and labeling controls were grossly deficient according to all inspectors. Incredibly, even those goods which failed laboratory tests were occasionally shipped out. The Stipulation stating these facts was filed on August 3, 1971. At that time the Court ordered, with the consent of the parties, that the Temporary Restraining Order continue in effect until an order of preliminary injunction was entered by the Court.

 THE BREADTH OF THE INJUNCTION

 Defendants vigorously oppose what they regard as a loosely worded order. The complaint is that "current good manufacturing practices" presents no ascertainable standard of performance assuming defendants make a good faith effort to cooperate with FDA officials in complying with the sanctions with which it has no quarrel. Because they are reputedly without guidelines, the defendants fear they are left "at the peril of a summons of contempt."

 The form and scope of injunctions or restraining orders issued by federal courts is governed by Rule 65(d) of the Fed. R. Civ. Proc., which states in pertinent part:

 
Every order granting an injunction and every restraining order shall set forth the reasons for its issuance; shall be specific in terms; shall describe in reasonable detail, and not by reference to the complaint or other document, the act or acts sought to be restrained. * * *

 Historically, the specificity rule may be traced to a concern for fair play; a party is more likely to disobey an order of the court when it cannot easily determine exactly what is expected of it. Correspondingly, court enforcement of its decree under such circumstances is bound to be either awkward or severe. As Professor Moore has observed, "[loose] injunctive orders are neither easily obeyed nor strictly enforceable, and are apt to be oppressive." 7 Moore's Federal Practice P65.11 at p. 1666 (1970). But specificity, as demanded by Rule 65(d) and as envisioned by scholars like Professor Moore, is a matter relative to each case. Where, as here, the defendants have been engaged in an overt, long standing, schematic and unpenitent thwarting of the law, particularly a law enacted for the protection of an otherwise helpless consumer public, the specificity which defendants can respectfully demand under Rule 65(d) can hardly compare to that which might be afforded were there only a single, isolated infraction. None of the cases cited by defendants offers situations in which the public interest in barring adulterated or misbranded drugs from interstate commerce has been sacrificed or attenuated by an overbearing concern for tightly drawn orders bearing only enumerated violations.

 Defendants rely on United States v. Article of Drug, etc., 362 F.2d 923 (3d Cir. 1966), also an action for misbranding. The court below had ordered the defendant to state, aside from the directions for proper uses claimed by the producer, directions for use in such "other conditions if any there be, for which such drug or device is commonly and effectively used." On appeal, the Third Circuit struck that part of the order as incomplete and insufficiently specific in itself. That result was clearly justified because insofar as defendant was required to anticipate the uses to which its drug would be put -- uses which it by no means recommended -- the order as prepared below required perceptiveness and intuition approaching clairvoyance. In any event, the manufacturer certainly has the right to limit its product to specified uses and to disclaim others. Therefore, I find nothing in this case helpful to defendant.

 Defendants also cite United States v. Vitasafe Corp., 345 F.2d 864 (3d Cir. 1965). This was initially an in rem action brought against certain misbranded vitamin-mineral capsules. The government then proceeded against the producer on the ground that accompanying labeling and advertisements were misleading. The court below enjoined not only the misleading statements specified but also all statements "otherwise false and misleading." The Third Circuit determined that this part of the order was insufficiently particular and thus offered no guidelines for compliance. While the wording of the injunction in Vitasafe which was struck appears on its face to raise objections similar to those presented by defendants in the instant case, the abuse(s) sought to be remedied and the evil of overbreadth to be guarded against in each case are strikingly different. While misbranding is an obvious threat to public health, the prohibition against misbranding is certainly not as susceptible to repeated violations as in the case of adulteration. In misbranding cases, it is a relatively simple matter for the court to fashion an order which shall proscribe the false or misleading material. United States v. Lanpar Co., 293 F. Supp. 147, 155 (N.D. Tex. 1968). Supervising compliance is also relatively easy. The facts in this case alone are excellent proof that a narrowly worded order enjoining adulteration, on the other hand, can hardly curb the reckless infractions of a highly culpable drug manufacturer, whether his adulterating tactics are ingenious or ingenuous. Similarly, considering the multifaceted imperfections of the Lit Drug plant operation, and considering also the innumerable possible defects which may be located in the future, it would be extremely impractical to ask the FDA, which must supervise compliance, to bring a new action for each added infraction detected, no matter how small or no matter how closely incident to past violations. This proposition was neatly summarized by the court in United States v. Hill, 298 F. Supp. 1221 (D. Conn. 1969), in which the Securities and Exchange Commission had asked for and received an injunction closely worded to Sections 5(a), (c) and 17(a) of the 1933 Act, with the enumeration of a few additional unlawful practices. The question before the court in the case was whether the injunction had been violated. This depended, naturally, on whether a liberal or strict construction would be given to the statutorily worded order:

 
In today's complex society it would be unreasonable to require injunctions to be more specific than that utilized here. There are an unlimited number of techniques which can be used to distribute unregistered securities or to make fraudulent representations when selling securities. * * * No injunction could be written anticipating all such techniques, ...

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