Doe v. Sullivan, Civ. A. No. 91-51 SSH.

• Decision Date: 31 January 1991
• Docket Number: Civ. A. No. 91-51 SSH.
• Citation: 756 F. Supp. 12
• Parties: John DOE and Mary Doe, Plaintiffs, v. Louis W. SULLIVAN, Secretary, Department of Health and Human Services, and Richard Cheney, Secretary, Department of Defense, Defendants.
• Court: U.S. District Court — District of Columbia

756 F. Supp. 12

John DOE and Mary Doe, Plaintiffs, v. Louis W. SULLIVAN, Secretary, Department of Health and Human Services, and Richard Cheney, Secretary, Department of Defense, Defendants.

Civ. A. No. 91-51 SSH.

United States District Court, District of Columbia.

January 31, 1991.

Michael Tankersley, Alan B. Morrison, Public Citizen Litigation Group, Washington, D.C., for plaintiffs.

Mona B. Alderson, Patricia M. Russotto, Civ. Div., Dept. of Justice, Washington, D.C., for defendants.

OPINION

STANLEY S. HARRIS, District Judge.

This matter now is before the Court on plaintiffs' motion for a preliminary injunction and defendants' motion to dismiss. The motion for a preliminary injunction in effect was consolidated with a trial on the merits pursuant to Fed.R.Civ.P. Rule 65(a)(2). Plaintiffs seek an order enjoining the Department of Defense (DoD) from using unapproved drugs on troops taking part in Operation Desert Storm without first obtaining informed consent from the individual military personnel. Upon consideration of the entire record herein, for the reasons set forth below, plaintiffs' motion for a preliminary injunction is denied and defendants' motion to dismiss is granted.

Background

In August 1990, the United States began deploying troops to Saudi Arabia in response to Iraq's unprovoked invasion of Kuwait. As Operation Desert Shield progressed toward the United Nations' deadline of January 15, 1991, for Iraq to withdraw from Kuwait, the DoD began planning for a possible war with Iraq. Because of well-publicized reports that Iraq has storehouses of chemical and biological weapons, the DoD developed plans to use certain drugs believed to have the ability to counteract the effects of such weapons on the troops. Some of the drugs have not yet received approval from the Food and Drug Administration (FDA) for distribution in the United States and, therefore, remain under the FDA classification of "investigational new drugs." Plaintiffs, a serviceman in the United States Army and his wife, seek an injunction preventing the DoD from using these unapproved drugs without first obtaining the informed consent of the military personnel taking part in the mission which is now known as Operation Desert Storm.

Shortly after Operation Desert Shield began, the DoD asked the FDA to recognize in its regulations that obtaining informed consent from military personnel before administering unapproved drugs is not feasible under circumstances of military exigency.¹ On December 21, 1990, the FDA published an interim rule that authorizes the Commissioner of Food and Drugs to determine that obtaining informed consent is not feasible in specific situations involving combat or the immediate threat of combat. 55 Fed.Reg. 52817 (to be codified at 21 C.F.R. 50.23(d)). Since the FDA adopted that interim rule, § 50.23(d), the Commissioner has concurred with the DoD's plans to administer two unapproved drugs to the troops in Operation Desert Storm. One of the drugs is a pretreatment to counteract the effects of organophosphate nerve agents. The other unapproved drug is a vaccine to prevent bacterial poisoning from biological warfare.

Plaintiffs challenge § 50.23(d) and the DoD's plans to administer unapproved drugs under the rule. Plaintiffs contend that § 50.23(d) violates the Food, Drug, and Cosmetic Act's (FDCA) limitations on using unapproved drugs on unconsenting humans. Plaintiffs further argue that § 50.23(d) marks a sharp departure from the FDA's longstanding regulations regarding the feasibility of obtaining informed consent. Citing the 1985 Department of Defense Authorization Act (DoD Act), which prohibits the use of DoD funds for research on involuntary human subjects, plaintiffs contend that the DoD plans to exceed the scope of its authority. Finally, plaintiffs argue that the use of unapproved drugs on military personnel without their informed consent constitutes a violation of their Fifth Amendment right to due process.

Discussion

In deciding a motion for a preliminary injunction, the Court must consider whether four factors weigh in favor of issuing the injunction.

(1) Has petitioner made a strong showing that it is likely to prevail on the merits of its appeal? ... (2) Has the petitioner shown that without such relief, it will be irreparably injured? ... (3) Would the issuance of a stay substantially harm other parties interested in the proceedings? ... (4) Where lies the public interest?

WMATA v. Holiday Tours, Inc., 559 F.2d 841, 842-43 (D.C.Cir.1977); Virginia Petroleum Jobbers Ass'n v. Federal Power Comm'n, 259 F.2d 921 (D.C.Cir.1958). Defendants argue that plaintiffs cannot show a likelihood of success on the merits because the DoD's decision to administer the unapproved drugs is a military decision that is not subject to judicial review. For the same reason, defendants contend that plaintiffs' claim should be dismissed.

A long line of cases backs defendants' argument that courts should not intrude on the "established relationship between enlisted military personnel and their superior officers." Chappell v. Wallace, 462 U.S. 296, 103 S.Ct. 2362, 76 L.Ed.2d 586 (1983); see Gilligan v. Morgan, 413 U.S. 1, 93 S.Ct. 2440, 37 L.Ed.2d 407 (1973); Feres v. United States, 340 U.S. 135, 71 S.Ct. 153, 95 L.Ed. 152 (1950); United States v. Johnson, 481 U.S. 681, 107 S.Ct. 2063, 95 L.Ed.2d 648 (1987); United States v. Shearer, 473 U.S. 52, 105 S.Ct. 3039, 87 L.Ed.2d 38 (1985); Stencel Aero Engineering Corp. v. United States, 431 U.S. 666, 97 S.Ct. 2054, 52 L.Ed.2d 665 (1977). The cases note the special nature of military discipline and conclude that courts are "ill-equipped to determine the impact upon military discipline that any particular intrusion on military authority might have." Chappell v. Wallace, 462 U.S. at 305, 103 S.Ct. at 2368. The cases also rely on the Constitution's express delegation of the duty to oversee the armed forces to Congress, Art. 1, § 8, cls. 12-14, and the fact that Congress has enacted comprehensive statutes regulating military life. Id. In Gilligan v. Morgan, 413 U.S. 1, 93 S.Ct. 2440, 37 L.Ed.2d 407 (1973), the Supreme Court construed Congress's analogous authority over the militia in a case seeking federal district court supervision over a state's National Guard. The Gilligan Court commented:

It would be difficult to think of a clearer example of the type of governmental action that was intended by the Constitution to be left to the political branches directly responsible — as the Judicial Branch is not — to the electoral process. Moreover, it is difficult to conceive of an area of governmental activity in which courts have less competence. The complex, subtle, and professional decisions as to the composition, training, equipping, and control of a military force are essentially professional military judgments, subject always to civilian control of the Legislative and Executive Branches. The ultimate responsibility for these decisions is appropriately vested in branches of the government which are periodically subject to electoral accountability.

Id. at 10, 93 S.Ct. at 2446.

The DoD's decision to use unapproved drugs is precisely the type of military decision that courts have repeatedly refused to second-guess. The DoD has elected to administer the drugs because of its determination that the drugs will improve the survival rate of troops that may encounter chemical and biological weapons. The DoD believes that protecting each individual serviceman, in turn, will increase the safety of other servicemen in the field and will decrease the medical burden of treating victims of chemical and biological weapons. Clearly, judicial interference in this type of strategic decision would not be proper. For this reason, plaintiffs' claim must be dismissed.²

Even if plaintiffs' claim were subject to judicial review, the Court would deny plaintiffs' motion for a preliminary injunction. Plaintiffs' claims under the DoD Act and the FDCA present issues of statutory construction and review of administrative action. The "starting point" in construing a statute is the statute's language. American Tobacco Co. v. Patterson, 456 U.S. 63, 68, 102 S.Ct. 1534, 1537, 71 L.Ed.2d 748 (1982). When the statute's meaning is clear, courts do not have to resort to legislative history. See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 2781, 81 L.Ed.2d 694 (1984). "If the statute is silent or ambiguous with respect to the specific issue," courts afford deference to the statutory interpretation of an agency charged with administering the statute. Id. at 843, 104 S.Ct. at 2782. The question for the court is whether the agency's answer is based on a permissible construction of the statute." Id.

The DoD's plans to administer unapproved drugs to the troops in Operation Desert Storm do not violate its authority under the DoD Act. The DoD Act prohibits the use of DoD funding "for any research involving a human being as an experimental subject," unless the subject's informed consent is obtained first. 10 U.S.C. § 980. The statute expressly requires informed consent even when the research is meant to be beneficial to the subject. Id. Plaintiffs argue that the DoD's use of unapproved drugs constitutes "research." They stress that, under FDA regulations, the DoD must collect data on the efficacy of the unapproved drugs. In addition, they contend that any use of unapproved drugs is research per se, despite the fact that the drugs are meant to be beneficial.³

Plaintiffs' definitional argument is not persuasive in light of the DoD Act's plain meaning. The DoD's use of unapproved drugs does not involve the type of scientific investigation under controlled circumstances that "research" connotes. On the contrary, the DoD has responded to very real circumstances and chosen what it views as the best alternative given current knowledge. The primary purpose of administering ...