MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES, APPLICANT v. LARRY LEON CHANEY, ET AL. No. A-761 In The Supreme Court Of The United States October Term, 1983 Application For A Stay Pending Petition For a Writ of Certiorari To The United States Court of Appeals For The District of Columbia Circuit Application For A Stay Pending Petition For A Writ of Certiorari To The United States Court of Appeals for The District of Columbia Circuit Pursuant to Rules 43 and 44 of the Rules of this Court and 28 U.S.C. 2101(f), the Solicitor General, on behalf of the Secretary of Health and Human Services, applies for a stay of the mandate of the United States Court of Appeals for the District of Columbia Circuit pending the filing and disposition of a petition for a writ of certiorari in this case. Five states carry out the death penalty by administering lethal injections of drugs. A sharply divided court of appeals has in effect directed the Food and Drug Administration (FDA) -- an agency devoted to insuring that consumers are protected against unsafe or ineffective foods and drugs -- to prohibit the enforcement of these capital punishment statutes until it has been demonstrated to the agency that these drugs are "'safe and effective' as a means of human execution." Attachment A at 3. The court of appeals reversed the judgment of the district court that the FDA's decision not to initiate enforcement action in this area was not reviewable. The court of appeals' mandate requires the FDA to explain its inaction consistently with the court of appeals' broad interpretation of the FDA's responsibility in this area. Attachment A at 34. If such an explanation is not "promptly forthcoming," the court of appeals effectively required that the district court order FDA enforcement action. Id. at 34 & n.47. As explained more fully below, the court of appeals' judgment sanctions unprecedented judicial interference in the decision-making processes of the Food and Drug Administration. Moreover, in view of the expedition on the part of the district court clearly contemplated by the court of appeals, issuance of the mandate may result in a district court order requiring agency enforcement action before this Court can review the court of appeals' decision. /1/ STATEMENT This case was brought by prison inmates sentenced to death in Texas and Oklahoma. They had petitioned the FDA to prohibit the enforcement of state capital punishment statutes on the ground that the states proposed to administer lethal injections of drugs that had been approved by the FDA as safe and effective for other purposes but had not been so approved for human execution. Plaintiffs asserted that the use of these drugs to carry out capital punishment violated the "misbranding" provisions of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 331(k), 352. They requested the FDA, among other things, to "(a)dopt a policy and procedure for the seizure and condemnation from prisons or state departments of correction of drugs which are destined or held for use as a means of execution" and to recommend the criminal prosecution of prison officials and others who "knowingly buy, possess, (sell) or use drugs for the unapproved use of lethal injections." Attachment A at 6. The FDA declined to take the requested enforcement actions as a matter of its enforcement discretion. Noting the uncertainty in the case law regarding the FDA's authority to regulate the unapproved use of approved drugs, the FDA decided not to initiate enforcement action in the absence of "a serious danger to the public health or a blatant scheme to defraud." Plaintiffs then brought this suit for injunctive and declaratory relief. The district court dismissed the complaint on the ground that the enforcement decisions of an agency are not subject to judicial review. On appeal, a divided panel of the court of appeals vacated the district court's judgment and held that the FDA's decision was subject to judicial review. The court reasoned that all agency action, including a decision not to initiate enforcement proceedings, is presumptively reviewable except in those rare situations "where the governing statute is 'drawn in such broad terms that in a given case there is no law to apply.'" Attachment A at 16-19. The court found "law to apply" in this case in the preface to an FDA rule proposed for notice and comment in 1972 but never promulgated. The court held that the FDA's reasons for declining enforcement were irrational in light of that preface, and it therefore directed the district court "to order the agency to fulfill its statutory function." Id. at 34. The court noted (ibid.) that "(w)e must be prepared to compel FDA to take action with respect to the (plaintiffs') prayer for relief where an acceptable explanation of (FDA's) inaction is not promptly forthcoming." /2/ In dissent, Judge Scalia pointed out that "(a)n agency's decision to refrain from an investigation or an enforcement action is generally unreviewable." Attachment A at 1 (dissenting op.). He noted that the "policy statement" on which the majority relied had no binding legal effect and that, even if it were binding, it was "full of flexible terms, the precise application of which was obviously intended to be, and could properly be, left to the discretion of the agency -- for example whether an unapproved use has become 'widespread.'" Id. at 9. Judge Scalia concluded that the majority's decision constituted "a clear intrusion upon powers that belong to Congress, the Executive Branch and the states" (id. at 1). By a five-to-five vote, the court of appeals denied the government's suggestion for rehearing en banc. Attachment B. In a statement joined by Judges Wilkey, Bork, and Starr, Judge Scalia stressed the significance of the holding of this case to "the enforcement authority of all federal agencies." He stated that the panel's finding of a "general presumption of reviewability" of enforcement decisions "distorts the law and usurps the authority of the Executive Branch." On March 14, 1984, the court of appeals denied the government's second consent motion for a 30-day stay of mandate to permit the government to petition for review by this Court. The court ordered the mandate to issue on March 21, 1984. ARGUMENT The court of appeals' judgment requires the district court to interfere with the enforcement priorities of the FDA and to insert itself into the controversial debate concerning capital punishment. The Solicitor General accordingly has authorized the filing of a petition for a writ of certiorari. We respectfully request that the court of appeals' mandate be stayed pending this Court's disposition of the case. In deciding whether to grant a stay pending certiorari, the Court or Circuit Justice ordinarily regards it as appropriate "to determine whether four Justices would vote to grant certiorari, to balance the so-called 'stay equities', and to give some consideration as to predicting the final outcome of the case in this Court." Heckler v. Lopez, No. A-145 (Sept. 9, 1983) (Rehnquist, Circuit Justice), slip op. 3. See also id. (Brennan, J., dissenting), slip op. 2; Heckler v. Blankenship, No. A-589 (Jan. 26, 1984) (O'Connor, Circuit Justice), slip op. 2. In this case those factors clearly weigh in favor of a stay. 1. There is a strong probability that this Court will grant certiorari in this case. The court of appeals' holding regarding judicial review of the FDA's discretionary enforcement decisions is in direct conflict with the Eighth Circuit's decision in National Milk Producers Federation v. Harris, 653 F.2d 339 (1981). /3/ The decision below completely reverses the prior consistent case law and would appear to permit court review in a great many instances in which regulatory agencies decline to initiate enforcement actions. Compare, Southern Railway Co. v. Seaboard Allied Milling Corp., 442 U.S. 444 (1979); Kixmiller v. SEC, 492 F.2d 641, 645 n.27 (D.C.Cir. 1974) (collecting cases). Such review would substantially compromise the ability of enforcement agencies to marshal their resources effectively. The court of appeals' decision will also have exceptionally significant practical consequences that weigh strongly in favor of review by this Court. This decision, if not reversed, will require the FDA to intervene in a highly controversial area far removed from its proper responsibilities. This will hamper the FDA's performance of its intended mission to protect the consuming public from dangerous and misbranded drugs. Furthermore, the decision below is likely to interfere with state enforcement of capital punishment statutes that satisfy Eighty Admendment standards. In those states that, for humanitarian reasons, have adopted lethal injections as the method of capital punishment, the court of appeals' decision may thwart enforcement of capital punishment statutes or result in the carrying out of executions by other potentially more painful means. 2. a. Not only is certiorari likely to be granted, but there is also a strong probability that this Court will reverse the judgment of the court of appeals. The effective functioning of administrative agencies would be seriously impaired by judicial review of administrative enforcement decisions. In deciding how to employ their limited enforcement resources, agencies generally concentrate on those efforts that are most needed and offer the greatest changes of success. Such choices are necessarily based in large measure on policy considerations and discretion. Judicial review in this area is likely to result in the substitution of the preferences of the judicial branch for those of the executive. For this reason, enforcement decisions of regulatory agencies have been held to be unreviewable, absent special circumstances. See Judge Scalia's dissent, Attachment A at 1-8. The court's decision in this case is flatly inconsistent with this settled principle of administrative law. The Administrative Procedure Act, 5 U.S.C. 701(a)(2), provides that final agency action is not subject to judicial review if it is "committed to agency discretion by law." This bar to judicial review applies in those instances where the governing statute is "'drawn in such broad terms that in a given case there is no law to apply.'" Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 410 (1971) (quoting S. Rep. 752, 79th Cong., 1st Sess., 26 (1945)). This is a case in which there is "no law to apply." The FDCA, like most statutes granting enforcement powers to administrative agencies, does not set forth or even suggest standards by which the FDA is to determine whether and when it shall engage in enforcement activity. /4/ Thus, even if the states' use of drugs not approved for lethal injections constituted a technical violation of the FDCA, judicial review would not be available under the APA. As this Court has stated, the Commissioner of Food and Drugs possesses a "broad discretion -- broad enough undoubtedly to enable him to perform his duties fairly without wasting his efforts on what may be no more than technical infractions of the law." United States v. Sullivan, 332 U.S. 689, 694 (1948). For its contrary conclusion, the court of appeals relied upon what it termed the FDA's "policy statement." The court contended that this statement "made law to govern and guide (the FDA's) discretion in regulating the unapproved use of approved drugs" and thereby provided standards against which the court could determine whether the FDA's refusal to engage in enforcement activities was an abuse of discretion. Attachment A at 23. The court characterized this "statement" as a rule, claiming that the FDA has asserted the "statement" to be "binding and to have substantive effect." Ibid. As Judge Scalia noted in dissent, however, the FDA's policy statement was merely the preamble to a proposed rule that was never adopted and thus had no binding effect. Attachment A at 10-19 (dissenting op.). Not every informal, tentative opinion ventured by an agency constitutes a binding policy that may be enforced by the courts. Moreover, as the dissent observed, the policy statement is full of flexible terms, the precise applicability of which was obviously intended to be left to the agency. Attachment A at 9 (dissenting op.). In addition, a subsequently enacted FDA regulation clearly stated that the decision whether to initiate enforcement proceedings is a matter committed to the discretion of the agency. 21 C.F.R. 10.45(d)(2)(i). For these reasons, it is clear that the FDA's decision not to initiate enforcement action in this case was committed to agency discretion by law and therefore was not judicially reviewable. b. Even if the FDA's decision were reviewable, it nonetheless should have been upheld. Where statutes authorize judicial review of administrative enforcement decisions, the scope of review is limited to determining whether the agency has stated a rational basis for its decision. Dunlop v. Bachowski, 421 U.S. 560, 573 (1975). That standard was easily met here. First, the FDA had a serious basis for uncertainty concerning its jurisdiction under the FDCA to regulate the activity in question. See Judge Scalia's dissent, Attachment A at 14-18; United States v. Evers, 643 F.2d 1043 (5th Cir. 1981). Surely when Congress enacted the FDCA it could never have contemplated such FDA intervention. Furthermore, the FDA acted reasonably in relying in the alternative on the absence of a "serious danger to the public health." As the dissent below stated (Attachment A at 12 (dissenting op.) (emphasis in original)): the public health interest at issue is not widespread death or permanent disability, but (at most) a risk of temporary pain to a relatively small number of individuals * * * . Moreover, it is not a matter of pain verses no pain, but rather pain of one sort substituted for pain of another -- and in all likelihood substitution of a lesser pain, since that is the principal purpose of the lethal injection statutes. Thus, even if the FDA's decision not to initiate enforcement proceedings were judicially reviewable, that decision was soundly based and should not have been disturbed. 3. Issuance of the mandate during the pendency of proceedings in this Court will in all likelihood result in irreparable injury to the public interest. The court of appeals' opinion states that "(w)e must be prepared to compel FDA to take action with respect to the prayer for relief where an acceptable explanation of (FDA's) inaction is not promptly forthcoming." Attachment A at 34. And the court of appeals has already rejected as a matter of law the several reasonable bases asserted by the FDA for not regulating the states' administration of capital punishment. See id. at 30-33. While there may be additional sound reasons for not entering upon such a regulatory effort, it is unlikely, in light of the court of appeals' decision, that such additional grounds will be found "acceptable," and the court of appeals has indicated that the district court must act expeditiously if an "acceptable" basis for the agency's decision is not "promptly forthcoming." Id. at 34. It is therefore very likely that issuance of the mandate will result in imminent and serious judicial interference with the proper work of the FDA, as well as with the enforcement of constitutional state capital punishment statutes. The FDA has the task of protecting the consuming public from misbranded and adulterated drugs. Attempting to regulate state enforcement of capital punishment will waste the FDA's limited administrative resources and distract the agency from its proper responsibilities. Such unprecedented judicial interference with an agency's enforcement priorities and the exercise of its expert discretion should not be permitted absent a ruling from this Court. Moreover, the proceedings contemplated by the court below may well cause substantial federal intrusion into the legitimate province of the states. Again, this untoward result should not occur absent a ruling from this Court. If this Court grants certiorari, the case will not be heard and decided until next Term. Accordingly, if the mandate is not stayed, the FDA will in all likelihood be required in the interim to regulate the method of capital punishment used in several states. As Judge Scalia pointed out in dissent (Attachment A at 18 (dissenting op.): (The FDA) was properly refusing to permit its powers and the laws it is charged with enforcing from being wrongfully enlisted in a cause that has less to do with assuring safe and effective drugs than with preventing the states' constitutionally permissible imposition of capital punishment. This court should have done the same. While issuance of the mandate will cause serious harm, respondents have never asserted any urgent need for issuance of the mandate. Indeed, they consented to the stay motion that the court of appeals denied. CONCLUSION The mandate of the court of appeals should be stayed pending the timely filing and disposition of a petition for a writ of certiorari. Respectfully submitted. REX E. LEE Solicitor General MARCH 20, 1984 /1/ We have attached hereto copies of (a) the court of appeals' October 14, 1983, opinion (Attachment A) (718 F.2d 1174); (b) the court of appeals' January 17, 1984, order denying the government's petition for rehearing and suggestion of rehearing en banc (Attachment B) (724 F.2d 1030); and (c) the court of appeals' March 14, 1984, order denying the government's motion to stay the mandate until March 26, 1984 (Attachment C). /2/ Although the court of appeals acknowledged that "the state may take the life of a person as punishment" and that the "FDA is not responsible for the execution of these prisoners," the court observed that the "FDA's impermissible refusal to exercise enforcement discretion over the use of drugs for lethal injection * * * may also implicate the Eighth Amendment's prohibition of cruel and unusual punishment" (Attachment A at 35-36). /3/ National Milk Producers Federation concerned a petition by dairy producers to the FDA, requesting that the FDA initiate enforcement proceedings against persons alleged to be selling misbranded "cheese substitutes" in interstate commerce contrary to the FDCA. The Eighth Circuit held (653 F.2d at 343) that: The executive branch and its departments enjoy a discretion in the initiation of * * * enforcement * * * actions limited only by constitutional strictures and relevant statutory directives. Because the FDCA does not mandate enforcement actions, the court concluded that a "complaint which seeks the initiation of investigative, enforcement, or prosecutorial proceedings fails to state a claim upon which * * * relief can be granted." Id at 344. /4/ Nothing in the FDCA sets standards for the initiation of FDA enforcement proceedings. The mandatory language in the penalty provision of the FDCA, 21 U.S.C. 333(a), to which the court of appeals referred (Attachment A at 24 n.29), is no different from that of a typical criminal code provision. See Judge Scalia's dissent, Attachment A at 9 (dissenting op.). The only provision of the FDCA regarding the FDA's responsibility to initiate enforcement proceedings is 21 U.S.C. 336, which provides: Nothing in this Act shall be construed as requiring the Secretary to report for prosecution * * * minor violations of this Act whenever he believes that the public interest will be adequately served by a suitable written notice or warning. APPENDIX