as they should have been applied to Richlyn's protocol. Mr. Weinberg further advised the government that since Mr. Loftus had certified that the protocol for diphenhydramine HCl capsules 25 mg. was acceptable and that Richlyn was able to manufacture the product, Richlyn "intended to resume manufacturing immediately." Mr. Weinberg also informed FDA that the Defendants had advised the Center for Disease Control and the Office of Generic Drugs that they were prepared to promptly manufacture batches of sulfadiazine tablets for use in the treatment of AIDS-related diseases. (See Exhibit "I" to Plaintiff's Motion for Summary Judgment).
35. Following several telephone conferences and exchange of correspondence between the parties concerning Richlyn's immediate readiness to resume manufacturing diphenhydramine for purposes of fulfilling a contract with a Defense Department contractor, a limited FDA acceptance inspection of Richlyn's facility was scheduled at Defendant's request for January 19-20, 1993. (See Exhibit "K" to Plaintiff's Motion for Summary Judgment).
36. At the conclusion of the inspection on January 20, 1993, Mr. Weinberg was presented with a two-page FDA Form 483 Notice of Inspectional Observations which contained some nine observations of deficiencies in, among other things, Richlyn's proposed record-keeping procedures, specifications and standard operating procedures as well as in its manufacturing facilities and laboratory. (Exhibit "L" to Plaintiff's Motion for Summary Judgment).
37. With respect to the physical condition of Richlyn's laboratory and manufacturing facilities, the FDA inspectors found overhanging pipes, dirt and dust in the area of the hanging fluorescent lights, excess equipment in the open blending area and no primary dust control system for the 20 cubic foot blender. In addition, the inspector found incomplete partitions between the blending and wash and weighing areas, missing or loose ceiling tiles in the milling area and no humidity control in the encapsulation room other than an air conditioner. Neither Mr. Weinberg nor Mr. Loftus dispute that these conditions existed at the time of the January, 1993 inspection. (Exhibits "L" and "M" to Plaintiff's Motion for Summary Judgment; Testimony of Bernard T. Loftus and Henry Avallone, 3/25/93).
38. Richlyn Laboratories now has limited resources, financial and otherwise, as a result of the imposition of the preliminary injunction on October 1, 1992. (Exhibit "M" to Plaintiff's Motion for Summary Judgment).
39. Although the Defendants responded to the January, 1993 FDA 483 by indicating a sincere interest in correcting the violations, they took exception to the government's concerns about the physical condition of the company's plant and the government's implication that the diphenhydramine protocol did not satisfy CGMP requirements. (Exhibit "M" to Plaintiff's Motion for Summary Judgment; Testimony of Bernard T. Loftus and Henry Avallone, 3/25/93).
Under Fed.R.Civ.P. 56(c), summary judgment is properly entered "if the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." In resolving a summary judgment motion then, the court must look beyond the bare allegations of the pleadings to determine if they have sufficient factual support to warrant their consideration at trial. Liberty Lobby, Inc. v. Dow Jones & Co., 267 U.S. App. D.C. 337, 838 F.2d 1287 (D.C. Cir. 1988), cert. denied, 488 U.S. 825, 109 S. Ct. 75, 102 L. Ed. 2d 51 (1988); Aries Realty, Inc. v. AGS Columbia Associates, 751 F. Supp. 444 (S.D. N.Y. 1990)
Generally speaking, the party seeking summary judgment always bears the initial responsibility of informing the district court of the basis for its motion and identifying those portions of the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, which it believes demonstrate the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 106 S. Ct. 2548, 91 L. Ed. 2d 265 (1986). In considering a summary judgment motion, the court must view the facts in the light most favorable to the party opposing the motion and all reasonable inferences from the facts must be drawn in favor of that party as well. U.S. v. Kensington Hospital, 760 F. Supp. 1120 (E.D. Pa. 1991); Schillachi v. Flying Dutchman Motorcycle Club, 751 F. Supp. 1169 (E.D. Pa. 1990).
This is not to say, however, that a non-movant may rest upon the allegations contained in his or her pleadings in defense of a summary judgment motion. See: Allen v. Denver Public School Board, 928 F.2d 978 (10th Cir. 1991). Indeed, Fed.R.Civ.P. 56(e) provides:
"When a motion for summary judgment is made and supported as provided for in this rule, an adverse party may not rest upon the mere allegations or denials of the adverse party's pleading, but the adverse party's response, by affidavits or as otherwise provided in this rule, must set forth specific facts showing that there is a genuine issue for trial. If the adverse party does not so respond, summary judgment, if appropriate, shall be entered against the adverse party."
In other words, the burden of demonstrating the absence of genuine issues of material fact is initially on the moving party regardless of which party would have the burden of persuasion at trial. Following such a showing, the non-moving party must present evidence through affidavits or depositions and admissions on file which comprise of a showing sufficient to establish the existence of every element essential to that party's case. Celotex Corp. v. Catrett, supra, 106 S. Ct. at 2552-2553 ; Keyes v. National Railroad Passenger Corp., 756 F. Supp. 863 (E.D. Pa. 1991); Applications Research Corp. v. Naval Air Development Center, 752 F. Supp. 660 (E.D. Pa. 1990).
It is well-settled that the power to grant a permanent injunction rests with the sound discretion of the trial court which may, in turn, grant a permanent injunction after a hearing if there are no material issues of fact and the issues of law have been correctly resolved. Clark v. Cohen, 613 F. Supp. 684, 690 (E.D. Pa. 1985), aff'd, 794 F.2d 79 (3rd Cir. 1986), cert. denied, 479 U.S. 962, 107 S. Ct. 459, 93 L. Ed. 2d 404 (1986). Permanent injunctive relief is appropriate if (1) plaintiff is successful in proving the merits of its case; (2) there is no available remedy at law; and (3) the balance of equities favors granting such relief. Ciba-Geigy Corp. v. Bolar Pharmaceutical Co., 747 F.2d 844, 850 (3rd Cir. 1984) cert. denied, 471 U.S. 1137, 105 S. Ct. 2678, 86 L. Ed. 2d 696 (1985); Travellers International AG v. Trans World Airlines, Inc., 722 F. Supp. 1087, 1096 (S.D. N.Y. 1989). However, it has been held that when the plaintiff is a governmental entity or private attorney general, and the activity may endanger public health, injunctive relief is proper without undertaking a balancing of the equities. Sierra Club v. United States Department of Energy, 770 F. Supp. 578, 582-583 (D. Colo. 1991); United States v. Production Plated Plastics, Inc., 762 F. Supp. 722, 728 (W.D. Mich. 1991). Similarly, it has also been held that an evidentiary hearing is not always required before a permanent injunction can be issued. Rather, when the evidence presented by affidavit and other documentation clearly establishes the plaintiff's right to an injunction, a hearing need not be conducted. Id., at 729 citing, inter alia, American Can Co. v. Mansukhani, 814 F.2d 421, 425 (7th Cir. 1987); McCarthy v. Briscoe, 429 U.S. 1317, 1324, 97 S. Ct. 10, 14, 50 L. Ed. 2d 49 (1976).
As was discussed in this Court's Memorandum and Order of October 1, 1992, the Food, Drug and Cosmetic Act, 21 U.S.C. § 331 expressly prohibits:
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded.