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 government would have the Court continue the Temporary Restraining Order in the form of a preliminary injunction, but defendants oppose this action upon three grounds. First, defendants maintain that while some form of injunctive relief is appropriate, that part of the injunction which directs defendants to operate their plant in conformity with "current good manufacturing practices" is too broad a command to be tolerable within the specificity requirement of Rule 65(d), Fed. R. Civ. Proc. Second, defendants argue that a restraint of interstate drug shipment until the government is satisfied that plant operation is within the confines of current good manufacturing practices is a procedure not authorized by the Federal Food, Drug and Cosmetic Act. Last, defendants claim that the injunction also exceeds the bounds of the Act in restraining the interstate shipment of drugs until all drugs presently in defendants' plant are assayed and defective lots are recalled to be destroyed or brought into compliance with legal standards. For reasons assigned herein, defendants' motion to limit the form and scope of the injunction is denied.
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, and any injunction which attempted to would be far broader and more harsh on the defendant.
Id. at 1236. In United States v. Bel-Mar Laboratories, Inc., 284 F. Supp. 875, 883, (E.D.N.Y. 1968), the court noted the observation of a prominent drug industry commentator that highly specified injunctive relief is impossible because of the great strides made by the industry in recent years and the great variety of circumstances under which those changes have been adopted. Likewise, I feel compelled to admit that defendants' imaginative capacity for contravening our federal drug laws has outrun this court's capacity for more explicit cautioning than provided in the injunction. Far from being ignorant of what is expected of them under the law, the defendants are in fact no "strangers to the Federal Food, Drug and Cosmetic Act." A brief account of defendants' recent involvement with the enforcement of the Act will testify to their familiarity.
In his affidavit, Weems L. Clevenger, Director of Food and Drugs, Region II, who is responsible for the day-to-day enforcement of the Food, Drug and Cosmetic Act in an area encompassing New York and New Jersey, describes the FDA's surveillance of defendants' plant operation. Mr. Clevenger states that since the operation of the plant at its Union, New Jersey location for the past five years the firm has continually violated current good manufacturing practices. Only during a brief span of months in 1968 involving rigorous supervision did the FDA consider Lit Drug Company to be in compliance with the law. A total of nine inspections were deemed necessary from June 15, 1970 through May 19, 1971. Each inspection revealed serious operational deficiencies, as earlier recounted. Since August 1969, Lit Drug, under pressure from the FDA, has made fifteen voluntary recalls of adulterated prescription and non-prescription drugs. The FDA conducted three hearings to deliberate over the violations of current good manufacturing practices incurred by Lit Drug, and on each occasion, the management replied that the deficiency would be corrected. As a result of a visit by inspection officials on January 22, 1971, the government filed a complaint for the forfeiture and condemnation of numerous drug batches and manufacturing equipment pursuant to 21 U.S.C.A. §§ 334(a)(2)(A), 372(e)(5). United States v. Articles of Drug, etc., Civ. Action No. 123-71 (D.N.J. Jan. 27, 1971). A consent decree was entered. In early April the government then filed a criminal complaint against Lit Drug setting forth three counts of improper and inadequate record keeping in violation of 21 U.S.C.A. §§ 360a(d)(1), 331(q)(4), 333(a). United States v. Lit Drug Co., Crim. No. 239-71 (D.N.J. Apr. 8, 1971). Lit Drug pleaded guilty on all three counts and was fined $3000 by this Court. And, of course, there is this present action, by which defendants stipulate their failure or refusal to abide by the repeated warnings of the FDA regarding innumerable, serious violations. Clearly, the grave, apparent, and immediate threat to public health and safety in this case is incomparable to that faced by courts in such cases as Vitasafe, supra, and the scope of the injunction must necessarily be broadened to accommodate this wider interest.
The danger of overbreadth, which confronted the Third Circuit in Vitasafe, is missing in this case. Unlike misbranding, "current good manufacturing practices" is a term of art within the industry. The drug industry is well aware of what is meant by current good manufacturing practices, and there is every reason to believe that reputable manufacturers have welcomed the efforts of the FDA in defining that phrase by regulations promulgated by the Secretary of Health, Education and Welfare under the Act. 21 C.F.R. § 133 (rev. 1971). Misbranding, on the other hand, is nowhere defined so elaborately in regulations, but is only incidentally defined by scattered references or examples. By and large, the metes and bounds of misbranding are delineated by case law.
An examination of the Regulations in depth reveals a history of governmental and industrial cooperation; these regulations were not adopted in the abstract, but in the context of an ongoing mutual educational program, by which the industry's more progressive practices were gradually developed into a uniform code. United States v. Bel-Mar Laboratories, Inc., supra, at 883. A few courts have considered this question, whether an injunction may refer incidentally to regulatory law, and the weight of authority favors this growing technique.
The court in United States v. Lanpar Co., supra, found that numerous drugs produced by defendants were adulterated within the meaning of 21 U.S.C.A. § 351(a)(2)(B). The court granted the government's request for an injunction prohibiting interstate drug commerce
* * * until the method used in, and the facilities and controls used for, their manufacture, processing, packaging and holding conform to and are operated and administered in conformity with current good manufacturing practices to assure that such products meet the requirements of the Act as to safety and have the identity and strength and meet the quality and purity characteristics which they purport or are represented to possess.
Id. at 154. The court suspended the operation of this order for ninety days so that defendants could align plant procedures with current good manufacturing practices by correcting the deficiencies specifically enumerated in the court's finding of facts. However, it cannot be inferred from a fair reading of the injunction that the court intended this reference to specific findings in any way to limit its overall mandate that defendants observe current good manufacturing practices in the future.
Other courts, in enforcing regulatory legislation, have used little more than a recitation of statutory language in wording injunctions and have not regarded this practice as offensive to Rule 65(d). United States v. Hill, supra ; United States v. Schlicksup Drug Co., 206 F. Supp. 801 (S.D. Ill. 1962); United States v. Sherwood, 175 F. Supp. 480 (S.D.N.Y. 1959). And if there is reason for defendants to fear that borderline activities may violate the injunction, an advisory opinion may be sought from the regulatory agency. United States v. Hill, supra.
While recitation of the statute wholly and without modification would run contrary to Rule 65(d), regulations may provide a legally sufficient guideline. This distinction is apparent in Gulf King Shrimp Co. v. Wirtz, 407 F.2d 508 (5th Cir. 1968), which was an action brought to enforce the Fair Labor Standards Act. Defendant had failed to keep proper records and had employed underaged workers. The court held that the reference to the Act by the lower court in forming its decree enjoining further prohibitions was not fatal to the decree's validity because
* * * the injunction does not engraft the statute in gross, * * * or rely on the statute for clarification of what is otherwise unclear in the decree itself. It merely supplements specific instructions in the decree with statutory authority from which the right to issue such instructions derives. The statutory material is thus given as a parenthetical reference, not as a substantive command.