US v. Richlyn Laboratories, Inc.

• Decision Date: 25 May 1993
• Docket Number: Civ.A. No. 92-CV-5464.
• Citation: 822 F. Supp. 268
• Parties: UNITED STATES of America v. RICHLYN LABORATORIES, INC., a Corporation and Richard S. Weinberg, an Individual.
• Court: U.S. District Court — Eastern District of Pennsylvania

822 F. Supp. 268

UNITED STATES of America v. RICHLYN LABORATORIES, INC., a Corporation and Richard S. Weinberg, an Individual.

Civ.A. No. 92-CV-5464.

United States District Court, E.D. Pennsylvania.

May 25, 1993.

David A. Garrison, U.S. Attorney's Office, Philadelphia, PA, Jacqueline H. Eagle, Dept. of Justice-Consumer Litigation, Washington, DC, David J. Horowitz, Asst. Chief Counsel for Enforcement, Food and Drug Admin., Rockville, MD, for plaintiff.

Joseph McHale, William J. Barker, Jr., Frederick J. Bosch, Jeffrey M. Lindy, Stradley, Ronon, Stevens & Young, Philadelphia, PA, for defendant.

MEMORANDUM AND ORDER

JOYNER, District Judge.

This equity action is once again before the Court upon motion of the Plaintiff, United States of America for summary judgment and entry of a permanent injunction against the defendant pharmaceutical manufacturers preventing them from resuming their drug manufacturing and shipping operations until the Food and Drug Administration (FDA) finds and notifies them that they are in compliance with all relevant federal laws and regulations and permanently enjoining them from placing adulterated or misbranded drugs into interstate commerce. After carefully reviewing the entire record in this matter, we find that summary judgment in Plaintiff's favor is appropriately entered at this juncture and the motion shall therefore be granted.

The pertinent facts underlying the instant action were succinctly stated in the Findings of Fact and Conclusions of Law rendered in our Decision dated October 1, 1992 granting Plaintiff's motion for preliminary injunctive relief and are now incorporated herein by reference. See Generally: Fed.R.Civ.P. 65(a)(2). Since that time, the Defendants have engaged the services of an FDA-approved consultant, Bernard T. Loftus, and the parties have engaged in additional dialogue and discovery primarily in the form of depositions. A hearing on the Defendant's motion to hold the Plaintiff in contempt of the orders of October 1 and November 5, 1992 was held before this Court on March 25, 1993, 817 F.Supp. 26, at which time additional evidence and testimony were produced. Thus, in addition to the factual findings contained in our Decision of October 1, 1992, we now make the following supplemental Findings of Fact.

FINDINGS OF FACT

30. Pursuant to this Court's orders in this matter of October 1, 1992 and November 5, 1992, Defendants Richlyn Laboratories, Inc. and Richard Weinberg retained one Bernard T. Loftus as their expert consultant and inspector for compliance with CGMP regulations. Mr. Loftus was approved by the FDA as a consultant for purposes of the above-referenced court orders via letter dated October 26, 1992 signed by Jacqueline H. Eagle, Esquire, Office of Consumer Litigation, Civil Division, Department of Justice. (4/2/93, Affidavit of Bernard T. Loftus; Testimony of Bernard T. Loftus, 3/25/93).

31. On November 12, 1992, Mr. Loftus and Richard Weinberg met with Loren Johnson, the Philadelphia District Director, Charles Thorne, Director of FDA's Philadelphia Compliance Branch and Compliance Officer Karyn Campbell Bowen to discuss Richlyn's proposal to resume packaging operations in accordance with this Court's preliminary injunction orders. At that time, Messrs. Weinberg and Loftus proposed and the FDA representative agreed that it was a good idea for Richlyn to work toward the resumption of its operations by developing a protocol for the manufacture and validation of one capsule product. (Testimony of Bernard T. Loftus, 3/25/93; Exhibit "E" to Plaintiff's Motion for Summary Judgment).

32. Approximately one month later on December 10, 1992, Richlyn Laboratories submitted its Validation Program and a draft copy of its Validation Protocol for diphenhydramine HCl capsules 25 mg. along with a certification statement from Mr. Loftus which indicated that the said programs would, if followed, comply with Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act, (21 U.S.C. § 351(a)(2)(B)) and the regulations under 21 C.F.R. 210 and 211. (Exhibits "E" and "K" to Defendants' Motion for Contempt; Exhibit "F" to Plaintiff's Motion for Summary Judgment). A completed draft of those documents, as well as a second certification statement from Mr. Loftus was submitted to FDA on December 18, 1992. (Exhibit "C" to Plaintiff's Motion for Summary Judgment).

33. Via correspondence dated December 31, 1992, Charles Thorne responded on behalf of FDA to Richlyn's proposed programs and protocols. While he did not categorically reject Richlyn's submissions as inadequate, Mr. Thorne did raise a number of questions concerning the protocol's ability to ensure the manufacture of diphenhydramine HCl that consistently met its pre-determined specifications and quality characteristics. (Exhibit "H" to Plaintiff's Motion for Summary Judgment).

34. Mr. Weinberg thereafter responded to the December 31, 1992 letter on January 7, 1993 by attaching a copy of a response from Mr. Loftus in which he disagreed with many of the FDA's comments, observations and interpretations of the CGMP regulations 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).

DISCUSSION

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., 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 nonmovant 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

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