Doe v. Sullivan, 91-5019

• Decision Date: 16 July 1991
• Docket Number: No. 91-5019,91-5019
• Citation: 938 F.2d 1370
• Parties: , 60 USLW 2080 John DOE, et al., Appellants, v. Louis W. SULLIVAN, M.D., Secretary of Health and Human Services, et al., Appellees.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 1370

938 F.2d 1370

291 U.S.App.D.C. 111, 60 USLW 2080

John DOE, et al., Appellants, v. Louis W. SULLIVAN, M.D., Secretary of Health and Human

Services, et al., Appellees.

No. 91-5019.

United States Court of Appeals, District of Columbia Circuit.

Argued March 18, 1991.

Decided July 16, 1991.

As Amended July 16, 1991.

Appeal from the United States District Court for the District of Columbia.

Daniel J. Popeo, Utica, N.Y., Paul D. Kamenar and Richard A. Samp were on the brief, Washington, D.C., for amici curiae urging affirmance.

Michael Tankersley, with whom Alan B. Morrison was on the brief, Washington, D.C., for appellants.

Scott R. McIntosh, Atty., Dept. of Justice with whom Stuart M. Gerson, Asst. Atty. Gen., Jay B. Stephens, U.S. Atty. and Douglas N. Letter, Atty., Dept. of Justice were on the brief, Washington, D.C., for appellees.

Before WALD, RUTH BADER GINSBURG and CLARENCE THOMAS, Circuit Judges.

Opinion for the Court filed by Circuit Judge RUTH BADER GINSBURG.

Dissenting opinion filed by Circuit Judge CLARENCE THOMAS.

RUTH BADER GINSBURG, Circuit Judge:

This appeal concerns an interim regulation promulgated in urgent circumstances under the Food, Drug and Cosmetic Act, 21 U.S.C. Secs. 301 et seq. ("FDC Act"). The regulation provides that the Food and Drug Administration ("FDA") may permit Department of Defense ("DOD") use of unapproved, investigational drugs on military personnel, in certain combat-related situations, without obtaining the service member's informed consent. The setting for the case is the military operation known first as Desert Shield and, once hostilities commenced between the coalition forces and Iraq, as Desert Storm. Ruling dispositively within three weeks of the action's commencement, the district court dismissed the complaint, which the plaintiffs attempted to bring on behalf of a class, on alternate grounds. See Doe v. Sullivan, 756 F.Supp. 12 (D.D.C.1991). First, the court held that the complaint questioned "a military decision that is not subject to judicial review." Id. at 14. Alternately, the court rejected on the merits the statutory and constitutional challenges stated in the complaint.

Operation Desert Storm ended during the pendency of this appeal. The challenged FDA regulation, however, remains in place. Neither the DOD nor the FDA has proposed its withdrawal. The named plaintiffs therefore persist in urging adjudication of their facial challenge to the FDA's regulation. They maintain, and we agree, that the controversy they press is one "capable of repetition, yet evading review." While we further conclude that the consistency of the regulation with the governing law is justiciable, we agree with the district court that the regulation is within the FDA's statutory authority under the FDC Act, and does not transgress any other legal constraint. For that reason, we affirm the order dismissing the complaint.

I. BACKGROUND

On August 2, 1990, Iraq invaded Kuwait. In response, the United States deployed troops to Saudi Arabia as part of Operation Desert Shield and, under the mandate of the United Nations, began preparing for war. In addition to conventional arms, the Iraqi government had stockpiled a variety The DOD identified as useful against the Iraqi threat two investigational drugs which had not been approved by the FDA for the specific uses proposed. ¹ The FDC Act generally prohibits the use of unapproved drugs. See 21 U.S.C. Sec. 355(a) (unapproved drugs may not be introduced into interstate commerce). Section 505(i) of the Act, 21 U.S.C. Sec. 355(i), authorizes regulations exempting from the general prohibition unapproved drugs that are "intended solely for investigational use." ² Pursuant to that authorization, the FDA has promulgated regulations allowing investigational drugs "to be made available ... primarily for treatment use" in specified circumstances. See, e.g., 21 C.F.R. Secs. 312.34, 312.35.

of chemical and biological warfare agents. Iraq had shown its willingness to employ these weapons by using them in the Iran-Iraq war of the 1980s and against Iraq's own civilian Kurdish population. See Chemical and Biological Weapons Threat: The Urgent Need for Remedies, Hearings Before the Senate Comm. on Foreign Relations, 101st Cong., 1st Sess. 29, 31 (1989) (statement of Hon. William H. Webster, Director of Central Intelligence). The DOD therefore undertook a review of medical treatments that might be used to counter an Iraqi chemical and biological weapons attack. See Declaration of Edward D. Martin, M.D., Deputy Assistant Secretary of Defense (Professional Affairs and Quality Assurance) ("Martin Declaration") at 2, reproduced in Joint Appendix ("J.A.") at 32.

Section 505(i) of the FDC Act and FDA regulations generally require that the experts who administer investigational drugs first obtain from recipients their informed consent. See 21 U.S.C. Sec. 355(i); 21 C.F.R. Sec. 50.20 (1990). ³ Exceptions are authorized After identifying the two investigational drugs it wished to use in Operation Desert Shield, the DOD concluded that obtaining informed consent in the heat of imminent or ongoing combat would not be practicable. In battlefield situations, the DOD maintained, "[i]f a soldier's life will be endangered by nerve gas ... it is not acceptable from a military standpoint to defer to whatever might be the soldier's personal preference" for treatment. 55 Fed.Reg. 52,814, 52,815 (1990) (Letter from DOD's Assistant Secretary of Defense (Health Affairs) (October 30, 1990) to Department of Health and Human Services Assistant Secretary for Health). The safety of other personnel in a soldier's unit and the accomplishment of the combat mission, the DOD urged, warranted mandatory use of investigational drugs.

                when obtaining consent is deemed "not feasible."    See id.    The consent waiver regulation in effect at the start of Operation Desert Shield required both the drug investigator and an independent physician to certify that the drug recipient was physically or mentally unable to give effective consent, and that there was insufficient time to get consent from a legal representative. 4
                

The combat-ready personnel, whom DOD wanted to treat with the investigational drugs prior to any exposure to nerve gas or biological warfare, did not fit within the existing regulatory exception from informed consent requirements. The DOD therefore sought, and the FDA adopted, a regulatory change. On December 21, 1990, the FDA promulgated Rule 23(d) as an interim regulation. See 55 Fed.Reg. 52,817 (to be codified at 21 C.F.R. Sec. 50.23(d)). Rule 23(d) permits "the Commissioner of Food and Drugs to make the determination that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain battlefield or combat-related situations." See id. at 52,814. ⁵

Rule 23(d) sets exacting conditions for waivers of informed consent. The DOD's request for a waiver "must be limited to a specific military operation involving combat or the immediate threat of combat." 55 Fed.Reg. at 52,817 (to be codified at 21 C.F.R. Sec. 50.23(d)(1)). The DOD must include in the request written justification for the conclusions of the responsible DOD physicians and drug investigators that the requisite military combat exigency exists. The request must also affirm that an institutional review board has approved the use of the investigational drug without informed consent. See id. The FDA, prior to granting a requested waiver, must evaluate the risks and benefits of the investigational drug in the circumstances of the use proposed by the DOD. See 55 Fed.Reg. 52,817 (to be codified at 21 C.F.R. Sec. 50.23(d)(2)). The FDA may grant a waiver, i.e., rule that informed consent is not feasible, "only when withholding treatment would be contrary to the best interests of the military personnel and there is no available satisfactory alternative therapy." 55 Fed.Reg. 52,817 (to be codified at21 C.F.R. Sec. 50.23(d)(1)). Waivers expire after one year, but they may be renewed. Based on changed circumstances, a waiver may be terminated by the DOD or the FDA before the year is up. See 55 Fed.Reg. 52,817 (to be codified at 21 C.F.R. Sec. 50.23(d)(4)).

On December 31, 1990, and January 8, 1991, in response to DOD requests, the FDA issued waiver rulings under Rule 23(d). Those rulings determined that obtaining informed consent was not feasible, because of military combat exigencies in Operation Desert Shield, for the use of two investigational drugs, a nerve gas pretreatment and a botulism poisoning preventative. See supra note 1.

Doe, a serviceman stationed in Saudi Arabia, brought this action on January 11, 1991. His wife, suing derivatively, joined him as co-plaintiff. Proceeding under a fictitious name, and invoking Rule 23(b)(2) of the Federal Rules of Civil Procedure, Doe sought to represent a class consisting of "all United States military personnel who are or will be serving in Operation Desert Shield in Saudi Arabia, Kuwait, or Iraq." Complaint for Declaratory and Injunctive Relief para. 31. Doe's complaint presented three claims for relief; each claim was stated first on behalf of the named plaintiffs, and then repeated on behalf of the class. First, Doe challenged Rule 23(d) on its face as outside the authority Congress granted to the FDA under section 505(i) of the FDC Act, 21 U.S.C. Sec. 355(i). Second, Doe charged that the The district court dismissed Doe's action on January 31, 1991, twenty days after the complaint was filed and seventy days short of the time allowed for a motion to certify an alleged class. See D.D.C. Local Rule 203(b) (motion for certification due "[w]ithin 90 days after the filing of a complaint"). Since the date of the district court's final order, the United States and its allies have fought and defeated Iraq. At midnight, February 27, 1991, President Bush declared a ceasefire. On March 15, 1991, the DOD...