John Doe v. Louis W. Sullivan, M.D., Secretary of Health and Human Services

938 F.2d 1370, 291 U.S. App. D.C. 111, 1991 U.S. App. LEXIS 14984, 1991 WL 126484
CourtCourt of Appeals for the D.C. Circuit
DecidedJuly 16, 1991
Docket91-5019
StatusPublished
Cited by48 cases

This text of 938 F.2d 1370 (John Doe v. Louis W. Sullivan, M.D., Secretary of Health and Human Services) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
John Doe v. Louis W. Sullivan, M.D., Secretary of Health and Human Services, 938 F.2d 1370, 291 U.S. App. D.C. 111, 1991 U.S. App. LEXIS 14984, 1991 WL 126484 (D.C. Cir. 1991).

Opinions

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. §§ 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 disposi-tively 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 [1372]*1372of 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.

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. § 355(a) (unapproved drugs may not be introduced into interstate commerce). Section 505(i) of the Act, 21 U.S.C. § 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. §§ 312.34, 312.35.

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. § 355(i); 21 C.F.R. § 50.20 (1990).3 Exceptions are authorized [1373]*1373when 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

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 investi-gational drugs.

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. § 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 investiga-tional drug or biologic is not feasible in certain battlefield or combat-related situations.” See id. at 52,814.5

[1374]*1374Rule 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. § 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.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Gordon Reid v. Hugh J. Hurwitz
920 F.3d 828 (D.C. Circuit, 2019)
Gordon Reid v. Mark S. Inch
914 F.3d 670 (D.C. Circuit, 2019)
Jeong Seon Han v. Lynch
223 F. Supp. 3d 95 (District of Columbia, 2016)
Whistleblower 14106-10W v. Commissioner
76 A.L.R. Fed. 2d 713 (U.S. Tax Court, 2011)
Vance v. Rumsfeld
653 F.3d 591 (Seventh Circuit, 2011)
Donald Vance v. United States
Seventh Circuit, 2011
Doe v. Rumsfeld
District of Columbia, 2011
Jordan v. Sosa
654 F.3d 1012 (Tenth Circuit, 2011)
Nattah v. Bush
770 F. Supp. 2d 193 (District of Columbia, 2011)
Bismullah ex rel. Bismullah v. Gates
514 F.3d 1291 (D.C. Circuit, 2008)
Anonymous v. Commissioner
127 T.C. No. 6 (U.S. Tax Court, 2006)
Anonymous v. Comm'r
127 T.C. No. 6 (U.S. Tax Court, 2006)
Qualls v. Rumsfeld
228 F.R.D. 8 (District of Columbia, 2005)
Al Odah, Khaled A.F. v. United States
321 F.3d 1134 (D.C. Circuit, 2003)

Cite This Page — Counsel Stack

Bluebook (online)
938 F.2d 1370, 291 U.S. App. D.C. 111, 1991 U.S. App. LEXIS 14984, 1991 WL 126484, Counsel Stack Legal Research, https://law.counselstack.com/opinion/john-doe-v-louis-w-sullivan-md-secretary-of-health-and-human-services-cadc-1991.