Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.


May 28, 1992

PUBLIC CITIZEN, et al., Plaintiffs

The opinion of the court was delivered by: THOMAS F. HOGAN

 This case is brought by Public Citizen, the National Resources Defense Council, the Center for Science in the Public Interest, and the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment against the Department of Health and Human Services (HHS) for the alleged violation of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. § 5(b)(2) & (c). Before the Court are defendant's motion to dismiss and plaintiffs' cross motion for summary judgment. For the reasons that follow, this Court shall grant defendant's motion and deny plaintiffs' motion and dismiss this case.

 The material facts are not in dispute. On November 20, 1989, the Secretary of HHS, Louis Sullivan, chartered the Advisory Committee on the Food and Drug Administration (FDA Advisory Committee or the Committee) for the purpose of examining "the mission, responsibilities and structure of the FDA according to its legislative mandate and to make recommendations on how the Agency can be strengthened to fulfill its mission." See Plaintiffs' Exhibit 21 (Charter of the Advisory Committee on the Food and Drug Administration) (hereinafter Charter). The Committee was originally structured to have 13 members appointed by the Secretary. On April 4, 1990, the Secretary amended the Charter to add four members and give the Committee additional time to accomplish its assigned tasks. The Charter expired just over a year later, with the issuance of the Committee's May 1991 Final Report. See Plaintiffs' Exhibit 30 (Final Report of the Advisory Committee on the Food and Drug Administration, May 1991) (hereinafter Final Report).

 Plaintiffs' complaint takes issue with one of the recommendations in the final report: the recommendation that Congress pass legislation preempting additional and conflicting state requirements for all products subject to FDA jurisdiction. The Committee's recommendation includes a procedure whereby states may seek exemption from preemption in areas in which the FDA has acted, based on "convincing local need." Additionally, the recommendation provides that in areas in which the FDA has not acted, a state that wishes to act must notify the FDA and give it 120 days to respond. Finally, the recommendation provides that states should be allowed to petition for the adoption or amendment of national standards. The FDA Advisory Committee additionally recommended that if Congress does not pass preemption legislation by the end of the 102nd Congress, then the FDA should issue a preemption regulation accomplishing the same goals. See Final Report at 49-53.

 . Plaintiffs argue that the FDA Advisory Committee acted ultra vires by making the preemption recommendation because the Committee is not "fairly balanced in terms of the points of view represented and the functions to be performed," as required by the FACA, 5 U.S.C. App. § 5(b)(2) & (c). Plaintiffs argue that in order for the Committee to make a recommendation involving states' rights and interests, the FACA requires that the Committee include representatives of states' interests. The FDA Advisory Committee allegedly contains no such members. *fn1" Thus, plaintiffs seek a declaration that the Committee's recommendation regarding preemption is null and void. They also seek an injunction requiring HHS to amend the Final Report to delete the recommendation and to notify those who have received copies that the recommendation has been deleted.

 The government advances three arguments in support of its motion to dismiss: (1) that plaintiffs' claim is nonjusticiable because of the lack of a judicially manageable standard of review of the "fair balance" requirement; (2) that plaintiffs lack standing to pursue their claim; and (3) that, on the merits, the Secretary did not abuse his appointment discretion in appointing the members of the FDA Advisory Committee.


 A. The Case Law

 The FACA "fair balance" requirement has been addressed by this circuit on four occasions (and more frequently by the district court). Unfortunately, the decisions that have been rendered thus far have resulted in a legal quagmire with no coherent guidelines for district courts to follow.

 In Metcalf, the private citizen argued that citizens and consumers were injured by the NPC's composition because, as a result of the influence of the petroleum industry, the NPC would make recommendations that would result in higher prices for petroleum products, a lack of policy interest in alternative energy sources, and a threat to citizens' health and safety because of the environmental damage associated with petroleum products. The circuit court held that these alleged injuries did not rise to the "injury in fact" required for standing because "the occurrence of the asserted harm is speculative and conjectural in the purest sense." 553 F.2d at 186. Plaintiffs' own allegations mandated this conclusion: their claims rested on the theory that the unbalanced membership of the NPC "causes it to make certain biased recommendations, which in turn cause government agencies to adopt policies favoring the petroleum industry, which in turn cause the appellants to be injured as consumers and citizens." Id. at 185. This speculative chain of events was simply too attenuated to amount to injury in fact.

 The circuit court reached the same conclusion with respect to the alleged injuries of Senator Metcalf. He argued that, as a member of the Senate Committee on Interior and Insular Affairs and Chairman of its Subcommittee on Minerals, Materials and Fuels, the subcommittee's work suffered because of the allegedly tainted and biased advice of the NPC. The court held that the senator had "alleged no 'particular concrete injury' which amounts to 'a claim of specific present objective harm or a threat of specific future harm.'" Id. at 188 (citations omitted) (emphasis in original). Rather, he presented only a generalized grievance that one of the sources of information to the subcommittee was not of the quality it should be.

 Finally, in affirming the district court's dismissal of the case, the circuit stated:

 The Supreme Court has stated that the standing doctrine "is founded in concern about the proper--and properly limited--role of the courts in a democratic society." The requirements relating to standing have been developed to ensure that a party invoking a federal court's jurisdiction does not do so in a manner inconsistent with the Constitution or sound prudential limitations. If we were to accept appellants' speculative, conjectural, generalized injuries in this case as sufficient for standing we would be called upon to supervise the membership and funding of federal advisory committees on a continual basis and to alter the composition of these committees according to our subjective determinations as to "fair balance." Such a role as the "continuing monitors of the wisdom and soundness of Executive action" is clearly inappropriate for the courts.

 Id. at 190 (citations omitted).

 The next case to address the FACA "fair balance" requirement is remarkably similar to the case before the Court today. In Physician's Education Network, Inc. v. Dep't of Health, Education and Welfare, et al., 653 F.2d 621 (D.C. Cir. 1981) (per curiam) (MacKinnon, Mikva & Edwards, J.J.), the circuit court again affirmed Judge Pratt's dismissal of a FACA case based on lack of standing. In this case, the plaintiff was an organization representing the interests of ophthalmologists. It sought the rescission of a report issued by the Secretary of the Department of Health, Education and Welfare (HEW) recommending that Medicare reimbursement for eye care limited to services performed by ophthalmologists be extended to certain services performed by optometrists. The report was prepared with the assistance of a panel of consultants. Plaintiff argued that the panel was constituted in violation of the FACA because the Secretary of the HEW had selected for the panel a majority of people who represented the interests of optometrists. The district court held, and the appellate court agreed, *fn2" that it was unnecessary to determine whether the optometrists had established injury in fact because it was clear that granting the relief requested would not redress the injury complained of. Judge Pratt's analysis is particularly relevant to the case now before the Court:

 According to plaintiff's allegations, the injury complained of here will occur only upon passage by Congress and signing into law by the President of legislation extending the medicare coverage as recommended in the 1976 report prepared by defendant HEW. To conclude that plaintiff has standing to maintain this action, it is therefore necessary for us to find that it is substantially likely that Congress will not pass the expansion of medicare coverage if we declare the 1976 report in violation of certain regulations, statutory provisions, and/or constitutional requirements and accordingly order it rescinded. Only speculative inferences could lead us to such a conclusion because the record does not carry us that far, and "unadorned speculation will not suffice to invoke the judicial power."

 653 F.2d at 627 (reprinting district court opinion) (emphasis in original). The district court concluded that the injury complained of, if it ever were to occur, would result from action by Congress, which as an independent third party was not before the court. *fn3"

 As happens, the next district judge to address the FACA "fair balance" requirement reached a different conclusion with respect to standing. In Nat'l Anti-Hunger Coalition, et al. v. Executive Committee of the President's Private Sector Survey on Cost Control, et al., 557 F. Supp. 524 (D.D.C. 1983), aff'd, 711 F.2d 1071 (D.C. Cir. 1983), j'ment amended, 566 F. Supp. 1515 (D.D.C. 1983), plaintiffs were individual recipients of federal food assistance benefits and the National Anti-Hunger Coalition. They alleged that the Executive Committee of the President's Private Sector Survey on Cost Control (the Executive Committee), which was established to conduct in-depth reviews of the Executive Branch operations and advise the President, the Secretary of Commerce, and other agency heads about cost control, had violated the FACA because its membership was not "fairly balanced" as required by the Act. The Executive Committee was made up of 150 members, virtually all of which were executives of major corporations. Plaintiffs alleged that the committee lacked balance because there were no public interest advocates or beneficiaries of federal food assistance programs on the committee.

 Interestingly, Judge Gesell held that plaintiffs had standing to challenge the composition of a federal advisory committee under § 5(b) of the FACA. See 557 F. Supp. at 527. First, Judge Gesell noted that numerous recent cases indicated that plaintiffs have standing to challenge the open meeting provisions of the FACA under § 10. He then cited the circuit court's opinion in Physician's Education Network as having held, in dicta, that a plaintiff denied actual representation on an advisory committee would have standing under the FACA. *fn4" Finally, Judge Gesell postulated that there was no distinction readily apparent between § 10 and § 5 of the FACA. He then concluded that "under the circumstances of this case plaintiffs will be granted standing to challenge committee membership. . . ." 557 F. Supp. at 527.

 In reaching the merits of plaintiffs' claim, however, Judge Gesell's analysis is strikingly similar to the government's nonjusticiability argument in the case now before the Court. First, Judge Gesell noted that nowhere in the FACA is the term "balanced" explained and that interpreted most broadly, it would take far more than 150 people to represent every viewpoint on the financial administration of federal programs. Id. at 528. He then focused on the function of the Executive Committee, noting that Congress had drafted the FACA to require balance in terms of "the functions to be performed by the advisory committee." He recognized that the function of the Executive Committee was very narrow and explicit: "to apply to federal programs the expertise of leaders in the private sector with 'special abilities to give detailed advice on cost-effective management of large organizations.'" Id. (quoting a House Press Release on the committee). Thus, he concluded that the "imbalances" alleged by plaintiffs were "irrelevant to the ability of the Executive Committee to perform its function fairly and impartially." Id. What Judge Gesell said next is illuminating:

 Plaintiffs have failed to demonstrate any imbalance in the Executive Committee within the meaning of the FACA. Thus it is unnecessary to confront plaintiffs' far-reaching suggestion that Congress contemplated that the courts should be placed in the role of reviewing the President's choice of advisors.

 Id. at 528-29. This comment indicates Judge Gesell's recognition of the lack of any judicially manageable standards by which to review the balance of the committee's members. His further comments also suggest the nonjusticiability of the "fair balance" requirement. In describing the FACA, he said:

 The statute that resulted is another example of unimpressive legislative drafting. It is obscure, imprecise, and open to interpretations so broad that in the present context at least it would threaten to impinge unduly upon prerogatives preserved by the separation of powers doctrine. Not surprisingly, litigants seize on such uncertainties and may try to press statutory claims beyond constitutional boundaries. The courts do not welcome their role in such disputes. Many with considerable merit on their side criticize the involvement of federal courts in matters of this kind although the fault lies primarily with congressional drafting. If more expertise were applied to such enactments to ensure that Congress states with more precision what it intends, the rules of the game would be more sharply drawn and court involvement could be less.

 The present controversy is a good example of this phenomenon. The Act leaves a myriad of questions unanswered, especially concerning the extent to which Congress intended to interfere with the President's formulation of policy. A president constantly seeks, as he should, informed advice. His choice of advisors should be largely his personal concern under our tripartite form of government.

 557 F. Supp. at 530.

 On appeal, the circuit court affirmed Judge Gesell's decision. In an opinion written by Judge Edwards for Judges Wilkey and McGowan, the court noted that Judge Gesell's standing determination had relied heavily on dicta from Physician's Education Network. It then stated that "the standing question is a close one that we need not resolve to decide this appeal, but we are inclined to agree with ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.