                       UNITED STATES, Appellee

                                    v.

                    Andrew J. KISALA, Specialist
                        U.S. Army, Appellant

                              No. 04-0246

                       Crim. App. No. 20000930

       United States Court of Appeals for the Armed Forces

                       Argued December 8, 2005

                     Decided September 27, 2006


GIERKE, C.J., delivered the opinion of the Court, in which
CRAWFORD, EFFRON, BAKER, and ERDMANN, JJ., joined.

                                 Counsel

For Appellant: Captain Todd N. George (argued); Colonel Mark
Cremin, Colonel Robert D. Teetsel, Lieutenant Colonel Mark
Tellitocci, Major Sean S. Park, and Captain Jeremy W. Robinson
(on brief).

For Appellee: Captain Michael C. Friess (argued); Colonel
Lauren B. Lecker, Colonel Steven T. Salata, Lieutenant Colonel
Margaret B. Baines, Lieutenant Colonel Theresa A. Gallagher,
Lieutenant Colonel Mark L. Johnson, Major Natalie A. Kolb,
Captain Mark J. Hamel, and Captain Edward E. Wiggers (on brief).

Amicus Curiae: Lieutenant Brian L. Mizer, JAGC, USN, and
Captain Pamela A. Holden, JAGC, USN, for the United States Navy-
Marine Corps Appellate Defense Division (on brief).

Military Judge:   Patrick J. Parrish


       This opinion is subject to revision before final publication.
United States v. Kisala, No. 04-0246/AR



        Chief Judge GIERKE delivered the opinion of the Court.

        Appellant was convicted, contrary to his pleas, of

willfully disobeying a lawful order of his superior commissioned

officer to receive an anthrax vaccination.1      Appellant has

challenged the lawfulness of the order.       We hold that Appellant

has not rebutted the presumption that the order was lawful.        In

particular, Appellant has not demonstrated that the order relied

improperly upon interpretations by the Food and Drug

Administration (FDA) of the long-standing approved license to

administer this specific Vaccine.2

                                 I.   FACTS

        Appellant’s Battalion Commander issued a direct order to

Appellant on August 24, 2000, in the presence of the sergeant

major, the company commander, and the first sergeant, to receive

the anthrax vaccination by the close of business that day.       Due

to the limited availability of the Vaccine at Fort Bragg at the

time, there was difficulty locating a clinic where Appellant

would be able to receive the inoculation.      A clinic with the

Vaccine was not located until after 1600 hours on August 24,

2000.    Because it would have been difficult to transport

Appellant to the clinic in time to receive the shot prior to the

1
  Appellant’s offense was a violation of Article 90, Uniform Code
of Military Justice (UCMJ), 10 U.S.C. § 890 (2000).
2
  Anthrax Vaccine Adsorbed is the vaccine that was the subject of
this order. Although it is commonly referred to as “AVA,” this
opinion refers to it as the “Vaccine.”

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United States v. Kisala, No. 04-0246/AR


termination of routine clinic hours, the battalion commander and

the company commander extended the time for Appellant to comply

with the order to August 25, 2000.

      On the morning of August 25, 2000, the company commander

issued Appellant a written counseling statement reiterating the

battalion commander’s order to receive the anthrax vaccination

prior to 1700 hours on August 25, 2000.       Appellant signed this

statement thereby acknowledging his understanding of the order.

At the time of the counseling statement, Appellant was told that

the Vaccine was available and that the company commander was

willing and able to take Appellant to the clinic to receive the

Vaccine.

      Appellant refused to receive the Vaccine and was charged

with willfully disobeying the lawful order of a superior

commissioned officer in violation of Article 90, UCMJ.       Contrary

to his pleas, Appellant was convicted of this offense (with the

date August 25, 2000, substituted for August 24, 2000).       The

military judge sentenced Appellant to be reduced to pay grade E-

1, confined for thirty days and to be discharged from the

service with a bad-conduct discharge.       The convening authority

approved the sentence as adjudged.        The United States Army Court




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United States v. Kisala, No. 04-0246/AR


of Criminal Appeals affirmed the findings and sentence as

approved.3

      This Court granted review of the following issue:

             WHETHER THE ORDER THAT APPELLANT SUBMIT TO AN ANTHRAX
             VACCINATION ON AUGUST 24, 2000, WAS A LAWFUL ORDER
             UNDER THE CIRCUMSTANCES AT THAT TIME.4

                              II.   DISCUSSION

      Long ago this Court recognized the foundational principle

of military discipline:      “Fundamental to an effective armed

force is the obligation of obedience to lawful orders.”5

Reflecting the authority of this principle, an order is presumed

to be lawful, and a subordinate disobeys an order at his own

peril.6   However, a servicemember may challenge the lawfulness of


3
  United States v. Kisala, No. Army 20000930 (A. Ct. Crim. Dec.
22, 2003).
4
  United States v. Kisala, 60 M.J. 128 (C.A.A.F. 2004).
5
  Lee v. Pearson, 18 C.M.A. 545, 546, 40 C.M.R. 257, 258 (1969)
(quoting United States v. Noyd, 18 C.M.A. 483, 491, 40 C.M.R.
195, 203 (1969)). Indeed, a professional military institution
could not otherwise function without a service member having a
duty to obey lawful orders.
6
  Manual for Courts-Martial, United States pt. IV, para.
14.c.(2)(a)(i) (2005 ed.)(MCM), states:

      An order requiring the performance of a military duty or
      act may be inferred to be lawful and it is disobeyed at the
      peril of the subordinate. This inference does not apply to
      a patently illegal order, such as one that directs the
      commission of a crime.

See also United States v. New, 55 M.J. 95, 108 (C.A.A.F. 2001);
United States v. Hughey, 46 M.J. 152, 154 (C.A.A.F. 1997);
United States v. Nieves, 44 M.J. 96, 98 (C.A.A.F. 1996); United
States v. Womack, 29 M.J. 88, 90 (C.M.A. 1989); Unger v.
Ziemniak, 27 M.J. 349, 359 (C.M.A. 1989); Nico Keijzer, Military
Obedience 97-98, 155-71 (1978); William Winthrop, Military Law

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United States v. Kisala, No. 04-0246/AR


an order at the time it is given or in later disciplinary

proceedings.7

      This Court has outlined the essential attributes of a

lawful order that sustain the presumption of lawfulness to

include:   “(1) issuance by competent authority –- a person

authorized by applicable law to give such an order; (2)

communication of words that express a specific mandate to do or

not do a specific act; and (3) relationship of the mandate to a

military duty.”8     In light of the presumption of lawfulness,

long-standing principles of military justice place the burden of

rebutting this presumption on the accused.9

      In this case, Appellant is attempting to overcome this

presumption of the lawfulness of the order to receive the

Vaccine.   Appellant’s assertion that the order was unlawful has

two components.     First, Appellant claims that the Vaccine is an

investigational new drug or a drug unapproved for its applied

use as a vaccine against inhalation anthrax.     Second, Appellant


and Precedents 575-76 (2d ed. 1920 reprint); see generally
William C. De Hart, Observations on Military Law and the
Constitution and Practice of Courts-Martial 165-66 (1946).
7
  This opinion, while relying on the presumption of lawfulness,
is not inconsistent with R.C.M. 916(d) under which, “It is a
defense to any offense that the accused was acting pursuant to
orders unless the accused knew the orders to be unlawful or a
person of ordinary sense and understanding would have known the
orders to be unlawful.”
8
  United States v. Deisher, 61 M.J. 313, 317 (C.A.A.F. 2005); MCM
pt. IV, para. 14.c.(2)(a)(ii)-(iii), para. 14.c.(2)(d); see also
Noyd, 18 C.M.A. at 489, 40 C.M.R. at 201 (presenting examples of
when an order may be unlawful).
9
  United States v. Hughey, 46 M.J. 152, 154 (C.A.A.F. 1997).

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United States v. Kisala, No. 04-0246/AR


claims that the order to receive this investigational new drug

violated federal law and was therefore unlawful.10


10
  Appellant asserts that 10 U.S.C. § 1107 (2000), and Exec.
Order 13,139, 64 Fed. Reg. 54,175 (Oct. 5, 1999), confer upon
him a right to refuse the order to receive the Vaccine. The
relevant portions of these two authorities appear below.

10 U.S.C. § 1107:

      (a)(1) Whenever the Secretary of Defense requests or
      requires a member of the armed forces to receive an
      investigational new drug or a drug unapproved for its
      applied use, the Secretary shall provide the member with
      notice containing the information specified in subsection
      (d)

      . . . .

      (d) Content of notice. The notice required under
      subsection (a)(1) shall include the following: (1) clear
      notice that the drug being administered is an
      investigational new drug or a drug unapproved for its
      applied use. (2) The reasons why the investigational new
      drug or drug unapproved for its applied use is being
      administered. (3) Information regarding the possible side
      effects . . . . (4) Such other information that, as a
      condition of authorizing the use of the investigational new
      drug or drug unapproved for its applied use, the Secretary
      of Health and Human Services may require to be disclosed.

Exec. Order 13,139:

      Sec. 3. Informed Consent Requirement and Waiver Provision.
      (a) Before administering an investigational drug to members
      of the Armed Forces, the Department of Defense (DOD) must
      obtain informed consent from each individual . . . .

      Sec. 6. (a) This order applies to the consideration and
      Presidential approval of a waiver of informed consent under
      10 U.S.C. § 1107 and does not apply to other FDA
      regulations.

      (b) This order is intended only to improve the internal
      management of the Federal Government. Nothing contained in
      this order shall create any right or benefit, substantive

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United States v. Kisala, No. 04-0246/AR


        We conclude that Appellant’s argument fails with regard to

both components and address them in turn.

     APPELLANT’S ASSERTION THAT THE VACCINE WAS AN INVESTIGATIONAL
            NEW DRUG OR DRUG UNAPPROVED FOR ITS APPLIED USE

        To support his argument, Appellant made several allegations

regarding the status of the Vaccine.      Appellant first asserts

that the Food and Drug Administration initiated an investigation

into the Vaccine but never issued a final rule approving use of

the Vaccine to protect against inhalation anthrax.      Second,

Appellant asserts that the Vaccine’s manufacturer, working in

conjunction with the Department of Defense (DoD), filed an

investigational new drug application in 1996.11      According to

Appellant, this application proposed to conduct investigations

that would support specifically adding “inhalation anthrax” to

the Vaccine label.

        Appellant also asserts that the Vaccine was and is an

investigational new drug unapproved for its applied use -- to

protect against inhalation anthrax.       In support of this


        or procedural, enforceable by any party against the United
        States, its agencies or instrumentalities, its officers or
        employees, or any other person.
11
  The Michigan Department of Public Health (MDPH) filed an
Investigational New Drug Application in 1996. “The
manufacturer’s stated purpose for filing the application was ‘to
conduct clinical investigations designed to investigate changes
in the approved labeling for the licensed product. The
potential labeling would affect the specific clinical
indication, route and vaccination schedule for AVA.’” Doe v.
Rumsfeld, 297 F. Supp. 2d 119, 132 (D.D.C. 2003) (quoting
letter from MDPH to Dr. Kathryn C. Zoon (Oct. 20, 1996)).

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United States v. Kisala, No. 04-0246/AR


argument, Appellant relies on two successive and related federal

district court opinions that issued first a temporary and then a

permanent injunction preventing the DoD from subjecting military

personnel to involuntary anthrax vaccinations absent informed

consent or a presidential waiver.12

      The federal district court’s evaluation of the civil

remedies differs from our evaluation of the criminal charges

that arise in the military context of Appellant’s willful

disobedience of a presumed lawful order.    The linchpin of this

case is the presumed legality of the military order to receive

the Vaccine.    The district court opinions neither recognize nor

address this critical presumption.

      Additionally, on appeal from this decision, the United

States Court of Appeals for the District of Columbia Circuit

noted that the parties “still dispute whether [the Vaccine]’s

original 1970 license takes it outside the definition of a ‘drug

unapproved for its applied use’ within the meaning of 10 U.S.C.

§ 1107(g)(2).”13    In noting this disagreement of the parties, the

court expressly declined to resolve that issue because it would

have no impact on the litigants in the case.    Moreover, the D.C.

Circuit highlighted that the injunction issued by the district


12
   Doe, 297 F. Supp. 2d at 135; Doe v. Rumsfeld, 341 F. Supp. 2d
1, 15-16 (D.D.C. 2004).
13
   Doe v. Rumsfeld, 172 Fed. Appx 327, 328 (D.C. Cir. 2006), No.
04-5440, 2006 U.S. App. LEXIS 3275, at *3 (D.C. Cir. Feb. 9,
2006).

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United States v. Kisala, No. 04-0246/AR


court in 2004, by its own terms, remained in effect until the

FDA classified the Vaccine as safe and effective for its

intended use.    The D.C. Circuit also noted that after the

district court issued the permanent injunction, the FDA issued a

classification on December 19, 2005.14        Therefore, once this

classification was issued, the injunction was dissolved.

      As stated above, there is a presumption that orders are

lawful.15   Under this presumption, the servicemember challenging

the order bears the burden of demonstrating the illegality.

Where, as here, we are faced with an order based upon a rule

promulgated by an agency outside the normal purview of our

Court, we should treat the agency’s administrative

determinations with considerable deference.16        Given this degree

of deference to the determinations of the FDA, the burden on the

servicemember challenging the rule is particularly high.

      The National Institutes of Health (NIH) licensed the Vaccine

for use against anthrax in 1970.17        In 1972, the authority to



14
   Doe, 172 Fed. Appx at 328; 2006 U.S. App. LEXIS 3275, at *2
15
   See supra note 6.
16
   Cf. Auer v. Robbins, 519 U.S. 452, 461 (1997) (an agency’s
interpretation of its own regulation is entitled to deference);
Udall v. Tallman, 380 U.S. 1, 16 (1964) (“[T]his Court shows
great deference to the interpretation given the statute by the
[ ] agency . . . . When the construction of an administrative
regulation rather than a statute is in issue, deference is even
more clearly in order.”).
17
   36 Fed. Reg. 8704-05 (May 11, 1971), see also Hearing to
Review the Dep’t of Defense Anthrax Vaccine Immunization Program
Before the S. Comm. on Armed Services, 106th Cong. 9 (2000)

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United States v. Kisala, No. 04-0246/AR


license biological drugs shifted to the FDA.18     The licenses for

drugs approved by the NIH remained effective unless and until

the FDA actively decided to suspend or revoke the license.19     The

Vaccine’s license has never been suspended or revoked.

Additionally, Appellant has not shown that the license was

erroneously granted.      He has, therefore, not overcome the

presumption that the order to receive the Vaccine was lawful.

      In 1973 the FDA established a two-stage process for

reviewing biological products licensed prior to July 1, 1972.20

This two-stage process was composed of an advisory review panel,

and a request for “data and views.”21

      In accordance with this review, the FDA directed an

independent panel of nongovernmental scientists and medical

personnel to review the safety and labeling of biological

products that had been licensed prior to July 1, 1972.22

According to 21 C.F.R. 601.25, the panel was:     “(1) to evaluate

the safety and effectiveness of biological products for which a

license has been issued . . . (2) to review the labeling of such

biological products, and (3) to advise [the FDA Commissioner] on



(written statement of FDA), available at http://armed-
services.senate.gov/statemnt/2000/000413fd.pdf.
18
   See Press Release, FDA Issues Final Rule and Final Order
Regarding Safety and Efficacy of Certain Licensed Biological
Products Including Anthrax Vaccine, (Dec. 30, 2003).
19
   21 C.F.R. § 601.4 (2004); 21 C.F.R. § 601.4 (1977).
20
   21 C.F.R. § 601.25 (1974).
21
   Id. § 601.25(a), (b).
22
   Id. § 601.25(a).

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United States v. Kisala, No. 04-0246/AR


which of the biological products under review are safe,

effective, and not misbranded.”23

      The Vaccine was included in this review of all biological

products licensed prior to July 1972.      The expert panel

recommended that the Vaccine, originally licensed in 1970, be

classified as a Category I product.24      This classification

indicates that the Vaccine was safe and effective as labeled.

The panel recommended that the Vaccine continue to be licensed

on the basis of the evidence of its safety and effectiveness.25

      As required by 21 C.F.R. § 601.25, the proposed rule

required public comment, and the FDA received four total

comments, none of which addressed the Vaccine.26

      In 1996, the Vaccine’s manufacturer submitted an

investigational new drug application to the FDA.27      The

application identified three areas in which the current anthrax

license could be modified:       (1) the labeling of the Vaccine, (2)

the administration method, and (3) the dosage.28      It is important


23
   Id.
24
   50 Fed. Reg. 51,002-03, 51,058-59, (Dec. 13, 1985).
25
   Id. at 51,059.
26
   See 70 Fed. Reg. 75,180, 75,182 (Dec. 19, 2005).
27
   See supra note 11.
28
   See Doe, 297 F. Supp. 2d at 132 (citing letter from MDPH to
Dr. Kathryn C. Zoon (Oct. 20, 1996)). The introductory
statements to the 1996 Investigational New Drug (IND)
application likewise provided that “the ultimate purpose of the
IND is to obtain a specific indication for inhalation anthrax
and a reduced vaccination schedule.” Doe, 297 F. Supp. 2d at
132 (quoting introductory statement to the IND application
(Sept. 20, 1996)).

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United States v. Kisala, No. 04-0246/AR


to note that this application is limited to the three listed

purposes and had no effect on the original license of the

Vaccine or its subsequent recognition as safe and effective.

       The licensing history reflects that the Vaccine has been

licensed as approved for anthrax inoculation since 197029 without

interruption, revocation, or suspension.   Moreover, the agency

approval has been reaffirmed as recently as December 19, 2005.30

       Therefore, based on the high degree of deference we give to

the FDA determination that served as the basis for the order,

and in light of Appellant’s failure to demonstrate that the 1970

license was incorrect, modified, or withdrawn, we conclude that

Appellant has not carried his burden of demonstrating that the

FDA’s classification was erroneous.

       Because Appellant has not established that the Vaccine is

an investigational new drug or a drug unapproved for its applied

use, the notice requirements of 10 U.S.C. § 1107,31 are not

implicated by the order to receive the Vaccine.   Additionally,

Exec. Order 13,139, directing that DoD obtain informed consent

from each individual to whom an investigational new drug is to

be administered unless the Secretary of Defense can justify a




29
     36 Fed. Reg. 8704.
30
     70 Fed. Reg. 75,180, 75,182.
31
     10 U.S.C. § 1107(a).

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United States v. Kisala, No. 04-0246/AR


need for a waiver of informed consent from the President,32 is

not implicated by the order to receive the Vaccine.

       Therefore, we conclude that the Vaccine is not an

investigational drug that would implicate 10 U.S.C. § 1107 or

Exec. Order 13,139.      Accordingly, Appellant has failed to

overcome the presumption of the lawfulness of the orders.

                              III.   DECISION

       The decision of the United States Army Court of Criminal

Appeals is affirmed.




32
     Exec. Order 13,139, 64 Fed. Reg. 54,175.

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