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HENLEY v. FDA THE COMMR. OF FOOD & DRUGS

January 17, 1995

ELIZABETH L. HENLEY, Plaintiff, against THE FOOD & DRUG ADMINISTRATION (DEPARTMENT OF HEALTH & HUMAN SERVICES) THE COMMISSIONER OF FOOD AND DRUGS, DR. DAVID KESSLER (OR HIS SUCCESSOR), AND THE UNITED STATES, Defendants.


The opinion of the court was delivered by: ARTHUR D. SPATT

 SPATT, District Judge.

 This is an action for review of a decision made by the United States Food and Drug Administration (the "FDA") and its Commissioner. Judicial review of the FDA's decision is authorized by the Administrative Procedure Act (the "APA"), 5 U.S.C. § 701-706. The plaintiff pro se, Elizabeth L. Henley, filed the Complaint on or about November 26, 1993. On September 27, 1994, following a pre-motion conference, the Court granted the government leave to move for summary judgment. The government's motion pursuant to Fed. R. Civ. P. 56 is now before the Court, as is a cross motion for summary judgment by the plaintiff.

 BACKGROUND

 This lawsuit is based the FDA's denial of a citizen petition filed by the plaintiff in February, 1992, and on the FDA's subsequent reconsideration and affirmation of that denial. The Complaint seeks judicial review of the FDA's decisions and requests that the Court compel the FDA to grant the plaintiff's petition and the action that the petition sought. The regulations governing citizen petitions to federal agencies are discussed below.

 The plaintiff's petitions challenged an FDA rule regarding the labeling of oral contraceptives. Authority for determination of labeling for oral contraceptives is granted to the FDA by Congress in the Food, Drug, and Cosmetic Act, 21 U.S.C. § 1 et seq, at §§ 352, 355. Specifically, the plaintiff sought to have the FDA include a warning regarding "the fact that estrogen, a component of oral contraceptives, has been shown to produce cancer in laboratory animals and may cause cancer in humans." See Compl. P8. The Complaint seeks, among other things, an order that: 1) sets aside the defendants' denial of the plaintiff's petition; 2) compels the defendants to grant the plaintiff's petition; and 3) mandates "disclosure of the fact that estrogen, a component of oral contraceptives, is known to cause cancer in animals and may cause cancer in humans . . . ."

 Prior to March of 1989, labeling for oral contraceptives did require a warning in the package insert stating that ". . . estrogens have been shown to cause cancer in animals, which showing justifies the inference that estrogens may cause cancer in humans . . . ." 21 C.F.R. 310.501 (1989). In 1989, after notice and comment proceedings, the FDA revised the rule regarding package inserts for oral contraceptives so that no specific wording was required. The Supplementary Information to the FDA's final rule states that this change was made to provide flexibility so that new information on the risks and benefits of the drug could be included in an ongoing basis without engaging in the notice and comment rulemaking procedure to change the precise wording of the information. See 54 Fed. Reg. 22,585-88 (1989).

 The plaintiff's citizen petition alleged that the amended labeling requirements are inadequate because 1) it is no longer required that oral contraceptives carry any warning regarding risk of cancer from estrogen; 2) potential consumers would want to know the information proposed in the petition; 3) the regulations do not reflect scientific literature regarding the relationship between oral contraceptive use and breast cancer; and 4) the method in which the information is conveyed (via package inserts) is not reasonably calculated to reach the consumer.

 The FDA denied Ms. Henley's petition by letter dated October 7, 1992. This letter stated, among other things, that "current scientific information no longer supports the conclusion that estrogen has been shown to cause cancer in animals, and therefore, by inference, in humans." Thereafter, on October 31, 1992, the plaintiff filed a petition for reconsideration with the FDA. She argued that animal studies did establish a causal link between estrogen and cancer in animals. The FDA reconsidered and responded by letter of September 30, 1993 by affirming is prior denial of the plaintiff's petition. In that letter the FDA stated that studies conducted in humans failed to reveal an increased risk of cancer caused by estrogen use. The FDA further stated that although the plaintiff was correct that studies of animals have revealed a causal connection between estrogen use and cancer in animals, those studies have little value in predicting a relationship between cancer and estrogen use by humans.

 DISCUSSION

 I. The summary judgment standard

 A court may grant summary judgment "only if the evidence, viewed in the light most favorable to the party opposing the motion, presents no genuine issue of material fact," Cable Science Corp. v. Rochdale Village, Inc., 920 F.2d 147, 151 (2d Cir. 1990), and the movant is entitled to judgment as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986); see also Fed. R. Civ. P. 56(c) (summary judgment standard). The Court must, however, resolve all ambiguities and draw all reasonable inferences in the light most favorable to the party opposing the motion. See Twin Laboratories, Inc. v. Weider Health & Fitness, 900 F.2d 566, 568 (2d Cir. 1990); Liscio v. Warren, 901 F.2d 274, 276 (2d Cir. 1990); Knight v. U.S. Fire Ins. Co., 804 F.2d 9, 11 (2d Cir. 1986), cert. denied, 480 U.S. 932, 94 L. Ed. 2d 762, 107 S. Ct. 1570 (1987).

  According to the Second Circuit "summary judgment is a tool to winnow out from the trial calendar those cases whose facts predestine them to result in a directed verdict." United National Ins. Co. v. Tunnel, Inc., 988 F.2d 351, 355 (2d Cir. 1993). Once a party moves for summary judgment, in order to avoid the granting of the motion, the non-movant must come forward with specific facts showing that a genuine issue for trial exists. See Western World Ins. Co. v. Stack Oil, Inc., 922 F.2d 118, 121 (2d Cir. 1990) (quoting Fed. R. Civ. P. 56(e)); see also National Union Fire Ins. Co. v. Turtur, 892 F.2d 199, 203 (2d Cir. 1989). A genuine issue of material fact exists if "a reasonable jury could return a verdict for the nonmoving party." Liberty Lobby,, 477 U.S. at 248; see Converse v. General Motors Corp., 893 F.2d 513, 514 (2d Cir. 1990).

 However, mere conclusory allegations, speculation or conjecture will not avail a party resisting summary judgment. See Western World, 922 F.2d at 121. If there is evidence in the record as to any material fact from which an inference could be drawn in favor of the non-movant, summary judgment is unavailable. See United National, 988 F.2d at 354-55; Rattner v. Netburn, 930 F.2d 204, 209 (2d Cir. 1991). Finally, the Court is charged with the function of "issue finding", not "issue resolution". Eye Assocs., P.C. v. Incomrx Sys. Ltd. Partnership, 912 F.2d 23, 27 (2d Cir. 1990).

 In this case, the parties do not dispute the facts with regard to the administrative record of the citizen petition that forms the basis of this lawsuit. Each party urges the Court that the applicable law requires summary judgment in its favor.

 II. Rulemaking pursuant to the APA

 A. Informal rulemaking

 The APA provides for two methods by which federal agencies may promulgate regulations, namely "notice and comment" and "adjudication." Section 553 of the APA sets forth the procedure for informal rule making by agencies, referred to as the "notice and comment" procedure. Under Section 553, agencies are required to 1) publish a general notice of proposed rulemaking in the Federal Register; 2) receive and consider written commentary on the matter, with or without oral presentations; and 3) issue a general statement of the basis and purpose of rules adopted following this procedure.

 Agency decisions made pursuant to this informal rule making procedure are subject to judicial review as to whether the findings and conclusions of the agency were arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law. 5 U.S.C. § 706(2)(A); National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688, 700 (2d Cir.), cert. denied, 423 U.S. 827, 46 L. Ed. 2d 44, 96 S. Ct. 44 (1975). Agency actions may also be set aside by a reviewing court if they are: 1) contrary to a constitutional right, power privilege or immunity (§ 706(2)(B)); 2) in excess of statutory jurisdiction (§ 706(2)(C)); 3) taken without observing requisite procedures (§ 706(2)(D)); or 4) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court (§ 706(2)(F)).

 B. Formal rulemaking

 APA § 553(c) also provides that where rules are required by statute to be made on the record after an opportunity for an agency hearing, Section 553 and its provisions for informal promulgation of rules do not apply. In such cases, adjudicative proceedings are covered by the provisions of APA Sections 556 & 557. Agency action taken pursuant to this "formal" procedure is subject to judicial review as to whether the action was supported by substantial evidence. 5 U.S.C. § 706(2)(E); National Nutritional Foods Ass'n, 512 F.2d at 700-701. Only cases subject to Sections 556 & 557, namely, those that require adjudication by the agency, are subject to this "substantial evidence" review. All other agency action, findings, and conclusions--including denial of citizen petitions--are held to the "arbitrary and capricious" standard discussed above.

 III. The citizen ...


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