1 Michael J. Davidson, A Guide To Military Criminal Law 65-66 (1999) (describing the impact of a court-martial proceeding in the civilian world).

2 Id.

3 E.g., Secretary of the Navy, Instruction 6230.4 (April 29, 1998), available at http://neds.nebt.daps.mil/usndirs.htm.

4 Consensus Statement: Anthrax as a Biological Weapon, 281 Jama 1735, 1736 (1999) (discussing the history of the vaccine). Licensing is now the responsibility of the Food and Drug Administration (FDA).

5 Thomas E. Ricks, Anthrax Shots' Effect Challenged, Wash. Post, July 18, 2000, at A21 (noting that, as of July 2000, about 350 service members out of 450,000 had refused the vaccine because of concerns regarding its possible side effects).

6 Thomas L. Rempfer, Sticking Point: Why Am I Resisting the Vaccine? The Military Trained Me To, Wash. Post, Jan. 30, 2000, at Bl (describing a “common-sense” test).

7 Id.

8 Id. (noting particularly the court-martial of Maj. Sonnie Bates).

9 See, e.g., O'Neil v. Sec'y of Navy, 76 F. Supp. 2d 641 (W.D. Pa. 1999) (discharged service member claimed that the order to receive the anthrax vaccine violated the Nuremberg Code, but the court found the issue irrelevant).

10 See discussioninfra Part V.B.

11 First Amendment issues were also raised when an Air Force nurse was punished for writing a letter critical of the vaccine program in a military newspaper. This topic is beyond the scope of this Note. See Bradley Graham, Air Force Censures Vaccine Critic, Wash. Post, Aug. 2, 1999, at A2 (describing the situation of Capt. Debra J. Egan) [hereinafterAir Force Censures].

12 Centers for Disease Control and Prevention, Use of Anthrax Vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices (“ACIP”), Morbidity & Mortality Wkly. Rep., Dec. 15, 2000, at 1 [hereinafter CDC].

13 Id. at 2.

14 Id. at 3.

15 House Comm. on Gov't Reform (Oct. 12, 1999) (statement of Kathryn C. Zoon, Ph.D., Director, Center for Biologies Evaluation and Research, Dep't of Health and Hum. Servs.), available at http://www.fda.gov/ola/1999/vaccine.html [hereinafter Zoon, Government Reform testimony].

16 CDC, supra note 12, at 3.

17 Id.

18 Id. at 3-4.

19 Id. at 3.

20 U.S. Dep't of Def., Information Paper: Anthrax as a Biological Warfare Agent (June 10, 1998), available at http://www.defenselink.mil/other_info/agent.html [hereinafterAnthrax as a Biological Warfare Agent].

21 Consensus Statement, supra note 4, at 1743 (describing the United Kingdom's difficult decontamination of Gruinard Island, where spores had been viable for 36 years).

22 Anthrax as a Biological Warfare Agent, supra note 20.

23 Subcomm. of Nat'I Sec, Veterans Affairs, and Int'l Relations, House Comm. on Gov't Reform (Apr. 29, 1999) (statement of Kathryn C. Zoon, Ph.D., Director, Center for Biologies Evaluation and Research, Dep't of Health and Hum. Servs.), available at http://www.fda.gov/ola/1999/ anthraxvaccine.html [hereinafter Zoon, National Security testimony].

24 Zoon, Government Reform testimony, supra note 15.

25 Id. (mentioning that four of the five who contracted inhalational anthrax died).

26 Id. (noting that two of the immunized who contracted anthrax had not received the entire course of immunizations).

27 Id.

28 CDC, supra note 12.

29 Preliminary Results of GAO's Survey of Guard/Reserve Pilots and Aircrew Members: Testimony Before the House Subcomm. on Nat'I Sec, Veterans' Affairs, and Int'l Relations, 106th Cong. 3 (1999) (statement of Kwai-Cheung Chan, Director, Special Studies and Evaluations, Nat'l. Sec. and Internal Affairs Division, General Accounting Office).

30 House Comm. on Gov't Reform (Oct. 3, 2000) (statement of Mark A. Elengold, Deputy Director, Operations, Center for Biologies Evaluation and Research) [hereinafter Elengold].

31 Zoon, Government Reform testimony, supra note 15.

32 Id.

33 Id. (including statistics from 1962 to 1974, both before and after the vaccine was approved for use).

34 Id.

35 Id.

36 Elengold, supra note 30.

37 Zoon, Government Reform testimony, supra note 15.

38 Zoon, National Security testimony, supra note 23.

39 Biological Products: Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51,001, 51, 058-59 (Dec. 13,1985). For the FDA's regulations establishing procedures for the review and reclassification of biological products, see 21 C.F.R. 601.25-.26 (2002).

40 Id. at 51,058.

41 C.F.R. § 601.5 (2001) (listing the possible reasons for revocation of biologic license).

42 Zoon, Government Reform testimony, supra note 15.

43 Id.

44 Id.

45 Id.

46 Id.

47 Id.

48 Id. (reasoning that only the vaccination reaction cannot occur without vaccination, while the other syndromes can occur independently).

49 Subcomm. on Military Personnel, House Comm. on Armed Servs. (Sept. 30,1999) (statement of Hon. John J. Hamre, Deputy Sec'y of Def. et al.), available at http://www.defenselink.mil/dodgc/lrs/ docs/test99-9-30hamre.htm (detailing the massive educational effort) [hereinafter Hamre et al.].

50 Air Force Censures, supra note 11, at A2 (noting fears of carcinogens and infertility).

51 U.S. Dep't of Def., Information About Anthrax Vaccine Safety, at http://www.anthrax.osd. mil/Site_Files/safety/safety_info.htm (visited Nov. 2, 2000) (discussing short-term side effects) [hereinafter Information About Anthrax Vaccine Safety]; Bradley Graham, Dose of Explanation Comes with Anthrax Shots, Wash. Post, Oct. 30, 1998, at A3 (noting Lt. Gen. Blanck's reporting of side effects) [hereinafterDose of Explanation]. Interestingly, the same Lt. Gen. Blanck had reported to the Senate Veterans Affairs Committee that the “anthrax vaccine should continue to be considered as a potential cause for undiagnosed illnesses in Persian Gulf military personnel.” Rempfer, supra note 6, at Bl .

52 Information About Anthrax Vaccine Safety, supra note 51 (listing the known potential side effects of the vaccine).

53 Id. (noting frequency of severe reactions).

54 Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Inst, of Med., the Anthrax Vaccine: is it Safe? Does It Work? 173 (Lois M. Joellenbeck et al. eds., 2002) (citation omitted) [hereinafter Iom Committee].

55 Information about Anthrax Vaccine Safety, supra note 51.

56 CDC, supra note 12, at 9-10 (noting that published studies report no short-term adverse effects, and no long-term effects in a 25-year study of laboratory workers).

57 Dose of Explanation, supra note 51, at A3 (outlining concerns of service members). Whether or not the vaccine should have been approved in 1970, and whether it would be approved under current FDA standards, are beyond the scope of this Note, and irrelevant to this analysis.

58 Id.

59 Arthur M. Friedlander, Anthrax, in 1 Textbook of Military Medicine: Warfare, Weaponry, and the Casualty, Medical Aspects of Chemical and Biological Warfare 467, 474 (1997).

60 Iom Committee, supra note 54, at 61 (describing the ethical problems with testing the vaccine). The Nuremberg Code dictates that “[n]o experiment should be conducted where there is ana priori reason to believe that death or disabling injury will occur.” Trials of War Criminals Before the Nurenberg Military Tribunals Under Control Council Law No. 10, The Medical Case 182 (U.S. Gov't Printing Office 1949) [hereinafter Nuremberg Code].

61 Dose of Explanation, supra note 51, at A3 (relating the results of rodent tests). See Friedlander, supra note 59, at 474.

62 Iom Committee, supra note 54, at 67-68; Ricks, supra note 5, at A21 (reporting results of outside analysis of rhesus monkey tests). See generally Friedlander, supra note 59, at 473-74 (discussing prophylaxis against anthrax).

63 Iom Committee, supra note 54, at 69.

64 Id. at 69-70; Consensus Statement, supra note 4 (describing the discovery of several strains of anthrax in the 1979 release of spores from the Sverdlovsk weapons facility).

65 Id. at 70-71.

66 James Terry Scott, Sticking Point: In Defending its Troops Against Anthrax, the Pentagon has Injected Distrust Instead, Wash. Post, Jan. 30, 2000, at Bl (suggesting that anthrax warfare is only an “abstract horror”).

67 Anthrax as a Biological Warfare Agent, supra note 20.

68 Consensus Statement, supra note 4, at 1738 (discussing the history of anthrax as a weapon).

69 Michael D. Lemonick, Deadly Delivery, Time, Oct. 22, 2001, at 32, 36 (noting that the use of anthrax spores as a weapon in October 2001 was historic).

70 Id. at 33 (describing the anxiety created in the general public by the anthrax cases).

71 Rempfer, supra note 6.

72 Zoon, National Security testimony, supra note 23. The facility currently operated by BioPort was originally run by the Michigan Department of Public Health. In 1996 it became known as the Michigan Biologies Institute and was still controlled by the state government. In September of 1998, the facility was sold to BioPort Corporation. For a more detailed history of the transfer from state to private ownership, see Hamre et al., supra note 49.

73 Zoon, National Security testimony, supra note 23.

74 Id.

75 Id.

76 Id.

77 Keith Bradsher, The Supplies: The Only U.S. Laboratory for the Anthrax Vaccine Says Production Will Be Delayed, N.Y. Times, Nov. 12, 2001, at B7.

78 Id.

79 U.S. Food & Drug Admin., FDA News: FDA Approves License Supplements for Anthrax Vaccine, Jan. 31, 2002, available at http://www.fda.gov/bbs/topics/NEWS/2002/NEW00792.html.

80 Rempfer, supra note 6 (citing Arthur Friedlander, Vaccines (1994)). These concerns likely have not been lessened by the IOM Committee's report, which notes that the vaccine “is far from optimal whether it is considered from the point of view of the potential recipient, the manufacturer, or any involved party.” Iom Committee, supra note 54, at 207-08.

81 Bradley Graham, Pentagon Plans to Inoculate Troops Against Anthrax Bacteria, Wash. Post, Dec. 16, 1997, at A23 (describing decision process).

82 Id.

83 Id.

84 Scott, supra note 66, at Bl (noting the declining trust in the Pentagon's health decisions).

85 Id. (discussing the DOD's slow response to Agent Orange concerns).

86 United States v. Stanley, 483 U.S. 669, 671 (1987) (describing one volunteer's experiences).

87 Scott, supra note 66, at Bl (noting the compounding effect of Gulf War Syndrome on existing doubts).

88 See discussioninfra, Part V.B.

89 C.F.R. § 50.23 (2001) (outlining the procedures that the DOD must follow to obtain a waiver of informed consent for the armed forces)); Edmund G. Howe & Edward D. Martin, Treating the Troops, Hastings Ctr. Rep. Mar.-Apr. 1991, at 21, 21.

90 Cpt. Stephen E. Deardorff, Informed Consent, Termination of Medical Treatment, and the Federal Tort Claims Act -A New Proposal for the Military Health Care System, 115 Mil. L. Rev. 1, 7-9 (1987) (noting that Minnesota and Oklahoma have developed their own standards, known as the “hybrid” standard and the “subjective patient” standard, respectively).

91 Govin v. Hunter, 374 P.2d 421 (Wyo. 1962).

92 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972) (setting forth the physician standard).

93 Schloendorff v. Soc'y of N.Y. Hosp., 105 N.E. 92 (N.Y. 1914).

94 Truman v. Thomas, 611 P.2d 902 (Cal. 1980) (establishing the right of informed refusal).

95 Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence Within Health Care 12 (2d ed. 1998) (describing the battery aspect of informed consent); see generally Canterbury v. Spence, 464 F.2d at 772.

96 Wear, supra note 95, at 12 (discussing the impact of self-determination on doctor's disclosure); see generally James F. Childress, Who Should Decide? Paternalism in Health Care 59 (1982) (discussing patient autonomy generally).

97 Frances H. Miller, Pushing the Envelope on Informed Consent (1996) (on file with author).

98 Wear, supra note 95, at 12 (discussing the law's mechanisms).

99 Id. at 14

100 Id (discussing the competence exception).

101 Id. at 21 (clarifying the emergency exception).

102 Id. at 22 (describing the therapeutic privilege exception).

103 Id. (giving additional examples of appropriate situations for the therapeutic privilege exception).

104 Id. at 23 (describing the waiver exception). See also Childress, supra note 96, at 147 (noting that “disclosure of information against a patient's wishes .. . is paternalistic and prima facie wrong”).

105 Alan Meisel, The Exceptions to the Informed Consent Doctrine: Striking a Balance Between Competing Values in Medical Decisionmaking, 1979 Wisc. L. Rev. 413, 453-60 (1979).

106 Id.

107 Deardorff, supra note 90, at 68 (noting that the Army requires neither disclosure nor consent).

108 Id. (describing the application of the Army regulation).

109 N. Fotion & G. Elfstrom, Military Ethics: Guidelines for Peace and War 58 (1986) (describing the loss of autonomy when joining the military).

110 Howe & Martin, supra note 89, at 23 (noting the sacrifices that members of the armed forces are required to make).

111 Id. (claiming that the service members freely agree to this arrangement).

112 James H. McGrath, The Officer's Oath: Words that Bind, in Ethics and National Defense 17, 22 (James C. Gaston & Janis Bren Hietala eds., 1993) (noting that the oath involves mutually conditional promises); Howe & Martin, supra note 89, at 23 (noting that the military promises to protect its soldiers in combat).

113 McGrath, supra note 112, at 26-27 (suggesting that the oath is an acceptance of the government's offer).

114 See Howe & Martin, supra note 89, at 23 (describing the decrease in autonomy in combat).

115 Id.

116 Fotion & Elfstrom, supra note 109, at 58 (stating that, due to the rigors of combat, behaviors must be ingrained); Lawrence B. Radine, The Taming of the Troops: Social Control in the United States Army 61-62 (1977) (noting that it is unimportant whether there is a relationship between the orders in peacetime and the orders in war).

117 Army Command Policy AR 600-20 § 4.1(a) (Aug. 15, 1999), available at http://books.usapa.belvoir.army.mil (noting the importance of training in the development of discipline) [hereinafter Army Command Policy]; Fotion & Elfstrom, supra note 109, at 58 (claiming that the harshness of training makes battle seem less harsh).

118 Army Command Policy, supra note 117, § 2.1(b) (describing the value of delegation up and down the chain of command).

119 Howe & Martin, supra note 89, at 23 (noting that since the military has promised to protect all soldiers, it must require acts by the individual to protect the whole).

120 Id. (illustrating the tradeoffs between individual and unit).

121 U.S. Dep't of Def., Directive 6200.2, Use of Investigational New Drugs for Force Health Protection § 4.1 (Aug. 1, 2000) [hereinafter Directive 6200.2]. “Personnel carrying out military operations shall be provided the best possible force health protection, including safe and effective medical countermeasures to chemical, biological or radiological warfare and endemic disease threats.” Id.

122 United States v. Chadwell, 36 C.M.R. 741, 748 (1965) (finding military orders to receive vaccines legal). Immunizations can also be required by municipalities for public health reasons. Jacobson v. Massachusetts, 197 U.S. 11, 18-19 (1905) (finding that compulsory smallpox vaccines do not violate constitutionally protected rights). However, in the military, it is unnecessary to reach this Constitutional argument.

123 The DOD currently requires vaccines for adenovirus; anthrax; cholera; hepatitis A and B; Influenza; Japanese B encephalitis, measles, mumps and rubella; meningococcus; plague; polio; rabies; smallpox; tetanus-diphtheria; typhoid; varicella; and yellow fever. U.S. Dep't of Army, Reg. 40-562, Immunizations and Chemoprophylaxis § D (Nov. 1, 1995) (also issued as Navy, Air Force and Coast Guard Instructions) [hereinafter Immunizations and Chemoprophylaxis].

124 U.S. Dep't of Def., Refusals, at http://www.anthrax.osd.mil/Site_Files/refusals.htm (last visited Apr. 8, 2002).

125 Immunizations and Chemoprophylaxis, supra note 123, § A(2) (granting authority to commanders, commanding officers, and officers-in-charge to enforce immunization requirements).

126 Dose of Explanation, supra note 51, at A3 (claiming that commanders can force subordinates to receive the injection). But see Steven Lee Myers, Airman is Ousted as Rebellion Against Anthrax Vaccine Grows, N.Y. Times, Mar. 11, 1999, at A24 (claiming that service members cannot be forced to receive injection).

127 Immunizations and Chemoprophylaxis, supra note 123, § A(2.1).

128 Dose of Explanation, supra note 51, at A3 (quoting Lt. Gen. Blanck).

129 Immunizations and Chemoprophylaxis, supra note 123, § B(13.5.1) (outlining requirements for obtaining an immunization waiver for religious purposes).

130 Id. § B(l 3) (reserving the military's right to revoke a waiver if individual is at imminent risk of exposure to disease).

131 U.S. Dep't of Def., Vaccine Religious Waivers, at http://www.anthrax.osd.mil/Site_Files/ qna/religiouswaivers.htm (last visited Apr. 8, 2002).

132 Immunizations and Chemoprophylaxis, supra note 123, § B(13.6.1).

133 U.S.C. § 892 (2000). Refusals also might be punished as willful disobedience of a superior commissioned officer under 10 U.S.C. § 890(2) (2000), but as most of the discussion in the media has been about failure to obey an order, this Note focuses on that charge.

134 U.S.C. § 113(b) (2000) (outlining the responsibilities of the Secretary of Defense and noting that he has “authority, direction, and control over the Department of Defense”); Parker v. Levy, 417 U.S. 733, 751 (1974).

135 10 U.S.C. § 815 (2000) (describing possible punishment imposed by a commanding officer).

136 Manual for Courts-Martial, United States, App. 12: Maximum Punishment Chart (2000).

137 Davidson, supra note 1, at 61 (describing the various possible punishments).

138 Air Force Censures, supra note 11, at A2 (relating the punishment of Cpt. Egan).

139 Davidson, supra note 1, at 61 (outlining the requirements for various punishments).

140 Assoc. Press, No Court Martial for Major Who Refused Anthrax Shot, N.Y. Times, Feb. 17, 2000, at A27 (describing the concerns of reservists and the response by officers).

141 Id. (noting transfer of former base commander).

142 Rempfer, supra note 6, at Bl (describing the impact on himself for refusing).

143 Myers, supra note 126, at A29 (noting additional punishments).

144 Davidson, supra note 1, at 61 (noting the requirements of the Rule for Courts-Martial).

145 Manual for Courts-Martial, United States, App. 12: Maximum Punishment Chart (2000).

146 Assoc. Press, Marine Convicted in Anthrax Shot Case, N.Y. Times, June 20, 1999, at A29 (reporting treatment of Marine who refused the vaccine).

147 United States v. Stark, 2000 CCA LEXIS 205 at *2 (N-M. Ct. Crim. App. Aug. 31, 2000).

148 10 U.S.C. § 822(a)(5) (2000); see Radine, supra note 116, at 181 (describing the process for calling a court-martial).

149 Stephen Kinzer, A Nation Challenged: The Biological Threat, N.Y. Times, Oct. 6, 2001, at Bl (describing the call for the anthrax vaccine to be distributed to civilians and the related issues).

150 United States v. Washington, 54 M.J. 936, 942 (A.F. Ct. Crim. App. 2001) (recounting the statistics of punishments).

151 Many other defenses to charges might apply in specific cases. See generally Davidson, supra note 1, at 111-127 (describing potential defenses). Coercion and duress are other possible generally applicable defenses. However, military courts have recently dispensed with these arguments for many of the same reasons that I argue the “illegal order” defense fails. See Perry v. Wesely, 2000 CCA LEXIS 244, at *4 (N-M. Ct. Crim. App. Nov. 29, 2000); United States v. Washington, 54 M.J. at 938.

152 Id. at 68 (noting that palpably illegal orders must be disobeyed).

153 Rempfer, supra note 6, at Bl.

154 Id. (justifying his refusal to accept the vaccine). Enlisted personnel take the following oath:

10 U.S.C. § 502 (2000).

155 Gary D. Solis, Obedience of Orders and the Law of War: Judicial Application in American Forums, 15 Am. U. Int'l. L. Rev. 481, 485 (1999) (noting that the rules of war date back at least to the ancient Greeks).

156 See, e.g., The Geneva Convention Relative to the Treatment of Prisoners of War, Aug. 12, 1949, art. 3 § 1, 6 U.S.T. 3316; Convention Respecting the Laws and Customs of War on Land (the Hague Conventions), Oct. 18, 1907, 1 Bevans 631 (defining proper military targets).

157 United States v. Griffen, 39 C.M.R. 586 (1968).

158 Id. at 590.

159 Mark J. Osiel, Obeying Orders: Atrocity, Military Discipline, and the Law of War, 86 Cal. L. Rev. 939, 971 (1998) (describing the American rule); Solis, supra note 155, at 520.

160 Richard T. DeGeorge, A Code of Ethics for Officers, in Military Ethics 13, 21-22 (1987) (stating that most orders are routinely followed unless clearly immoral); Richard A. Gabriel, Legitimate Avenues of Military Protest in a Democratic Society, in Military Ethics 101, 109 (1987) (noting that refusing to obey an order is one's “ultimate response” to an amoral choice).

161 See, e.g., Ponder v. Stone, 54 M.J. 613, 617 (N-M. Ct. Crim. App. 2000) (finding that petitioner failed to rebut the presumption of legality).

162 Solis, supra note 155, at 520 (noting that” a service person's conscience, religious beliefs, moral judgment, or personal philosophy cannot justify or excuse the disobedience of an otherwise lawful order”).

163 Edgar Denton III, Limits of Loyalty 19 (1980).

164 Solis, supra note 155, at 520 (noting that the reason cannot be related to the individual's moral beliefs).

165 Thomas J. Begines, Special Trust and Confidence, in Ethics and National Defense 3, 12 (James C. Gaston & Janis Bren Hietala eds., 1993).

166 John Rawls, A Theory of Justice 365(1971).

167 Solis, supra note 155, at 520 (describing the modern American test).

168 Id.

169 Perry v. Wesely, 2000 CCA Lexis 244, at *5 (N-M. Ct. Crim. App. Nov. 29, 2000); Ponder v. Stone, 54 M.J. 613, 614 (N-M. Ct. Crim. App. 2000); Randall D. Katz, Note, Friendly Fire: The Mandatory Military Anthrax Vaccination Program, 50 Duke L.J. 1835, 1859 (2001).

170 Nuremberg Code, supra note 60, at 181.

171 George J. Annas, Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat, 24 Am. J.L. & Med. 245, 246-47 (1998).

172 Directive 6200.2, supra note 121, § 4.2.2.

173 U.S.C. § 355(i)(4) (establishing informed consent requirement in research for new drugs and setting out exceptions).

174 U.S.C.S. § 1107(0 (2001) (requiring consent in accordance with the Food, Drug and Cosmetic Act unless waived by the President).

175 Service members cannot sue the military directly for a violation of the Nuremberg Code. Furthermore, the relevant regulations implementing these protections also do not contain private causes of action. See United States v. Stanley, 483 U.S. 669 (1987); Perry v. Wesely, 2000 CCA LEXIS 244, *10 (N-M. Ct. Crim. App. 2000). Therefore, the soldiers must assert that the order is illegal because it violates these rules.

176 Annas, supra note 171, at 250.

177 See generally Hamre et al., supra note 49 (describing the DOD's safety requirements as being more stringent than those for the civilian population).

178 See id.

179 U.S.C.S. § 1107(g)(2) (2001).

180 Katz, supra note 169.

181 While the FDA recently approved a change to the product labeling, these relevant portions were not changed. Iom Committee, supra note 54, at 199-200.

182 Katz, supra note 169.

183 See discussionsupra Part I.B.

184 Katz, supra note 169, at 1854.

185 For discussion of the changes, see supra text accompanying note 29.

186 Chan, supra note 29, at 2.

187 M.

188 CDC, supra note 12, at 7-9 (describing the ongoing studies to determine the efficacy of other dosage regimes).

189 Katz, supra note 169, at 1853-54.

190 See Zoon, Government Reform testimony, supra note 15 (noting that the DOD plan specified the FDA-approved dose of six doses over eighteen months).

191 CDC, supra note 12.

192 Katz, supra note 169, at 1854.

193 CDC, supra note 12.

194 Id.

195 Id.

196 See text accompanying notes 60-61.

197 “[T]he [FDA] is empowered to recall any vaccine or vaccine lot found to be associated with an unacceptably high rate of reports of adverse events.” Iom Committee, supra note 54, at 105 (citation omitted).

198 21 C.F.R. § 50.23(d)(1) (2001) (creating an exception from the general informed consent requirements). See 10 U.S.C.S. § 1107 (2001). See also Directive 6200.2, supra note 121, § 4 (outlining the requirements to get a waiver of informed consent when using an experimental drug in a combat setting).

199 55 Fed. Reg. 52, 814 (1990) (suggesting that waiver be granted to botulinum and to pyridostigmine bromide). This waiver was granted before the President asserted the power to make the final waiver decision, so it was made jointly between the FDA, DOD, and Department of Health and Human Services. See Howe & Martin, supra note 89, at 21.

200 p_{or a} n interesting discussion of the right of waiver generally, see Annas, George J. & Grodin, Michael A., Commentary, Hastings Ctr. Rep. Mar.-Apr. 1991CrossRefGoogle Scholar, at 24, 24.