CGMP regulations. (Declaration of Loren Johnson; Exhibits E and F)
It has long been recognized that the grant of injunctive relief is an extraordinary remedy which should be granted only in limited circumstances and only upon a showing by the moving party: (1) of the reasonable probability of eventual success in the litigation and (2) that the movant will be irreparably injured pendente lite if relief is not granted. Moreover, while the burden rests upon the moving party to make these two requisite showings, the Court should also take into account, when relevant, (3) the possibility of harm to other interested persons from the grant or denial of the injunction, and (4) the public interest. Instant Air Freight Co. v. C.F. Air Freight, Inc., 882 F.2d 797, 800 (3rd Cir. 1989), citing In Re Arthur Treacher's Franchisee Litigation, 689 F.2d 1137, 1143 (3rd Cir. 1982). See Also: Government of Virgin Islands, Department of Conservation & Cultural Affairs v. Virgin Islands Paving, Inc., 714 F.2d 283, 285 (3rd Cir. 1983).
Where, however, an injunction is being sought pursuant to a statutory provision, a different standard is to be applied. U.S. v. Toys "R" Us, Inc., 754 F. Supp. 1050, 1053 (D.N.J. 1991). Indeed, because Congress has seen fit to act in a given area by enacting a statute, irreparable injury must be presumed in a statutory enforcement action. United States v. Odessa Union Warehouse Co-Op, 833 F.2d 172, 176 (9th Cir. 1987). The passage of the Food, Drug and Cosmetic Act is, in a sense, an implied finding that violations will harm the public and ought to be restrained if necessary. United States v. Diapulse Corporation of America, 457 F.2d 25 (2nd Cir. 1972). In actions for statutory injunctions then, the moving party need show only that probable cause exists to believe that the statute in question is being violated and that there is some reasonable likelihood of future violations. Instant Air Freight Co. v. C.F. Freight, Inc., supra at 803; Commodity Futures Trading Commission v. Hunt, 591 F.2d 1211, 1220 (7th Cir. 1979), cert. denied, 442 U.S. 921, 99 S. Ct. 2848, 61 L. Ed. 2d 290 (1979), rehearing denied, 444 U.S. 888, 100 S. Ct. 189, 62 L. Ed. 2d 122 (1979). No specific or immediate showing of the precise way in which violations of the law will result in public harm is required. United States v. Diapulse Corp., supra, 457 F.2d at 28.
In determining whether a movant has satisfied its burden of showing a reasonable likelihood of future violations in the absence of injunctive relief, it has been held that the Court may consider, among other factors, (1) the degree of scienter involved on the part of the defendant; (2) the isolated or recurrent nature of the infraction; (3) the defendant's recognition of the wrongful nature of his conduct; (4) the sincerity of the defendant's assurances against future violations; and (5) the nature of the defendant's occupation. It is deemed important to consider as well the defendant's voluntary cessation of challenged practices, the genuineness of the defendant's efforts to conform to the law, the defendant's progress toward improvement and the defendant's compliance with any recommendations made by the government. U.S. v. Toys "R" Us, Inc., supra, 754 F. Supp. at 1058-1059 citing, inter alia, City of Mesquite v. Aladdin's Castle, Inc., 455 U.S. 283, 289, 102 S. Ct. 1070, 1074, 71 L. Ed. 2d 152 (1982); United States v. Odessa Union Warehouse Co-Op, supra, 833 F.2d at 176; United States v. Sars of Louisiana, Inc., 324 F. Supp. 307, 310 (E.D. La. 1971).
Furthermore, while past misconduct does not lead necessarily to the conclusion that there is a likelihood of future misconduct, it is highly suggestive of the likelihood of future violations and the court should therefore look at the totality of the circumstances and any factors suggesting that the infraction might not have been an isolated occurrence. Commodity Futures Trading Commission v. Hunt, supra, 591 F.2d at 1220 citing, inter alia, SEC v. Management Dynamics, Inc., 515 F.2d 801, 807 (2nd Cir. 1975).
The Food, Drug and Cosmetic Act, 21 U.S.C. § 331 prohibits:
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded and the delivery of proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344 or 355 of this title.
21 C.F.R. Part 210 entitled "Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General" provides, at § 210.1(b):
"The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this Chapter in the manufacture, processing, packing or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the [FDC] Act and such drug, as well as the person who is responsible for the failure to comply shall be subject to regulatory action."
Similarly, 21 U.S.C. § 351(a)(2)(B) states that:
"A drug or device shall be deemed to be adulterated . . . (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess . . . .