IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLORADO

Civil Action No.

JEMEKIA BARBER,

Plaintiff,

v.

UNITED STATES ARMY; LOUIS CALDERA, in his capacity as Secretary of the Army;
GEN. ERIC K. SHINSEKI, in his capacity as Chief of Staff of the Army; MAJ. GEN. EDWARD SORIANO, in his capacity as Commander of the 7th Infantry Div. and Ft. Carson;

Defendants.

VERIFIED COMPLAINT FOR INJUNCTIVE RELIEF

 

Plaintiff’s Address:

Jemekia Barber

5921 Normandy Drive
Unit E
Ft. Carson, CO 80913

 

  1. Plaintiff has filed this action to prevent immediate, substantial, and irreparable harm from Defendants’ pending decision to discharge her from the Army, on an other than honorable ("OTH") basis, because of Plaintiff’s refusal to submit to a series of anthrax vaccinations. Defendants’ order that Plaintiff submit to the anthrax vaccinations and her consequential pending OTH discharge is unconstitutional and unlawful for the reasons explained below. If the Court does not enjoin Plaintiff’s discharge, she will suffer an irreparable denial of her procedural and substantive due process rights, and her rights to equal protection, privacy, consent to medical procedures, procreation, bodily choice, and rights of the unborn. In addition, Plaintiff will be deprived of her rights to military benefits, and will face a lifetime of negative consequences each time she seeks civilian employment, and will be permanently stigmatized by this OTH discharge.
  2. Plaintiff is an enlisted soldier at the Army’s installation in Ft. Carson, Colorado. Plaintiff was ordered to take the anthrax vaccine on multiple occasions, pursuant to the Department of Defense’s ("DOD") Anthrax Vaccination Immunization Program ("AVIP"). See Declaration of Jemekia Barber, attached as Exhibit A.
  3. Believing that the anthrax vaccine posed a risk to her health and to the health of her future unborn children, Mrs. Barber refused to submit to the order to take the vaccine. Because of this refusal, court martial proceedings were begun against her. Faced with increasing harassment and intimidation, and her consequential mental anguish, Mrs. Barber signed paperwork requesting a Chapter 10 discharge from the military, in order to avoid the court martial proceedings. Mrs. Barber anticipated that pursuant to her completion of this paperwork she would receive an honorable or general discharge because of an earlier recommendation that she be discharged, for mental health reasons, pursuant to Chapter 5-13 AR 635-200.
  4. Because the order to submit to the anthrax vaccine was unlawful and unconstitutional, Mrs. Barber’s refusal to submit to that order should not interfere with her qualification for a Chapter 5-13 discharge. Finalization of the OTH discharge, if not enjoined, will irreparably harm Mrs. Barber by depriving her of her constitutional rights, and by subjecting her to a lifetime of stigmatization in the civil workplace.

    PARTIES

  5. Plaintiff Jemekia Barber is a Private First Class in the Army, and is stationed at Ft. Carson, Colorado.
  6. Defendant United States Army is responsible for implementing the AVIP program, and ultimately for the order that Plaintiff submit to the anthrax vaccine.
  7. Defendant Louis Caldera is the current Secretary of the Army, and has ultimate authority for ordering the anthrax vaccination of soldiers stationed at Ft. Carson.
  8. Defendant Gen. Eric K. Shinseki is the current Chief of Staff of the Army. He also has ultimate authority for implementing the AVIP program at Ft. Carson.
  9. Defendant Maj. Gen. Edward Soriano is the current Commander of the 7th Infantry Division and the Commander of Ft. Carson. As the facility commander, he oversees the implementation of the AVIP program at Ft. Carson. Defendant Soriano personally made the order requiring Mrs. Barber’s OTH discharge.

    Jurisdiction and Venue

  10. This Court has jurisdiction over this action pursuant to 28 U.S.C. ¤ 1331 because it arises under the laws of the United States, including 10 U.S.C. ¤ 1107, Presidential Executive Order 13139, and AR 40-7 and AR 40-562, as well as the Fourth, Fifth, Sixth, and Ninth Amendments of the United States Constitution. The Court also has jurisdiction pursuant to 5 U.S.C. ¤ 702 (APA), 28 U.S.C. ¤  1651 (All Writs Act), 28 U.S.C. ¤  2201 (Declaratory Judgment Act), and 28 U.S.C. 2241 (Habeas Corpus). Venue is proper in this district pursuant to 28 U.S.C. ¤ 1391(e) (1995).
  11. "It is established, of course, that the federal courts have the power and the duty to inquire whether a military discharge was properly issued under the Constitution, statutes, and regulations." Matlovich v. Secretary of the Air Force, 591 F.2d 852, 859 (D.C. Cir. 1978). The Supreme Court made clear that federal district courts have jurisdiction over such matters over 40 years ago. Harmon v. Brucker, 355 U.S. 579, 580-83 (1958).

    Factual background

    The AVIP Program

  12. The AVIP is intended to immunize over 2.4 million members of the military against the potential threat of anthrax when used as an airborne biological weapon.
  13. Anthrax is a relatively common, naturally occurring bacteria that can be found in the soil. Upon exposure to a lethal dose of anthrax, death can occur within one to six days of exposure. Anthrax is seen as a likely biological weapon, when inflicted as an airborne poison.
  14. The only facility for production of the anthrax vaccine was originally operated by the Michigan Department of Public Health. In the mid 1990s, this facility was sold to a private corporation, Michigan Biologic Products, Inc. ("MBPI"). In September 1998, MBPI was sold to a company called Bioport, Inc.
  15. The Michigan Department of Public Health obtained approval for the anthrax vaccine in 1970 from the National Institute of Health. This occurred two years before the FDA required efficacy and safety data prior to drug approval and licensing. Long-term safety data for the vaccine was not supplied with the original license application, and in fact has never been supplied to the FDA. In addition, the vaccine now being produced by Bioport is produced under a different procedure and is chemically different from the original vaccine approved by the National Institute of Health.
  16. The license to produce the anthrax vaccine was intended for use in an agricultural and veterinary setting as a protection against cutaneous contact with anthrax. The vaccine has never been licensed for use against airborne anthrax.

    The Anthrax Vaccine Is an Investigational New Drug.

  17. There are several reasons that the AVIP’s use of the anthrax vaccine makes the vaccine a investigational new drug ("IND"), as that term is used by the FDA.
  18. The anthrax vaccine, as implemented by the AVIP, is an IND because it employs a vaccine designed for prevention of infection arising from cutaneous exposure. Use of the vaccine to prevent infection from airborne anthrax constitutes an investigational new use.
  19. The anthrax vaccine is an IND, as implemented by the AVIP, because the DOD’s vaccination schedule differs from the vaccination schedule originally approved by the National Institute of Health. See Memorandum from Dr. Sue Bailey, Assistant Secretary of Defense, March 10, 2000, at 1 ("The Commissioner of Food and Drug Administration (FDA) recently expressed concern over reports that some members of the Armed Forces in both Active and Reserve components are receiving their anthrax vaccine doses substantially later than called for by the schedule approved by the Food and Drug Administration (FDA) as described in the vaccine manufacturer’s package insert. . . . This schedule is the only schedule approved by the FDA at this time."), attached as Exhibit J.
  20. MBPI applied for an IND application for the anthrax vaccine on September 20, 1996. This application is attached as Exhibit C. The application has never been withdrawn by MBPI or Bioport, nor has it ever been acted on by the FDA in any way.
  21. Members of Congress have frequently noted that the AVIP constitutes use of an IND. In March of this year, a member of Congress noted that "administration of the anthrax vaccine for mass prophylaxis and Biological Warfare should be considered an off-label use of the product to treat an indication for which it is not explicitly licensed . . . . [B]oth the new indication and the new schedule should be undertaken only pursuant to FDA regulations governing clinical trials on investigational new drugs." Department of Defense Anthrax Vaccination Immunization Program: Unproven Force Protection, Report of Subcomm. on National Security, Veterans Affairs and International Relations, House Comm. on Gov. Reform, 106th Congr., 2d Sess. at p. 3 (March 9, 2000), attached as Exhibit D.
  22. An IND may not be administered to service members without their informed consent, as directed by 10 U.S.C. ¤ 1107, Executive Order 13139, and AR 40-7 and AR 40-562. Accordingly, orders that military personnel submit to the vaccine as administered under the AVIP without their consent are per se in violation of a direct order from the President in his role as commander in chief.
  23. 10 U.S.C. ¤ 1107 states that whenever the Secretary of Defense requires a member of the armed forces to receive an "investigational new drug or a drug unapproved for its applied use," the drug cannot be administered without the service person’s consent.
  24. Section 3A of Executive Order No. 13139 states that:

    Before administering an investigational drug to members of the armed forces, the Department of Defense (DoD) must obtain informed consent from each individual unless the Secretary can justify to the President a need for a waiver of informed consent in accordance with 10 U.S.C. ¤ 1107(f). Waivers of informed consent will be granted only when absolutely necessary.

  25. A waiver under 10 U.S.C. ¤ 1107(f) may be granted only if obtaining consent of the service person is not feasible, is contrary to the best interest of the service member, or is not in the interest of national security. None of the conditions for waiver are relevant here.
  26. AR 40-7 and AR 40-562 forbid administering an IND without the service person’s informed consent. These regulations, in pertinent part, are attached as Exhibit E.

    The Anthrax Vaccine Has Not Been Proven To Be Safe or Effective.

  27. Serious concerns have been raised by the DOD, the Food and Drug Administration ("FDA"), Congress, and the general public with regard to the safety and efficacy of the anthrax vaccine. See Exhibit D.
  28. No human studies have been conducted on the anthrax vaccine at all. Therefore, no private or governmental entity has data to confirm that the vaccine is either safe or effective.
  29. Concerns about the vaccine’s safety are heightened with respect to women of child-bearing age, such as Mrs. Barber. The Product Insert to the anthrax vaccine reflects that Mrs. Barber’s questions about whether the vaccine is safe for women of childbearing age are well founded.
  30. The Product Insert for the vaccine states that:

    2. Carcinogenesis, mutagenesis, impairment of fertility: Studies have not been performed to ascertain whether Anthrax Vaccine Absorbed has carcinogenic action, or any effect on fertility.

    3. Pregnancy: PREGNANCY CATEGORY C. ANTHRAX VACCINE ABSORBED

    Animal reproduction studies have not been conducted with Anthrax Vaccine Absorbed. It is also not known whether Anthrax Vaccine Absorbed can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. Anthrax Vaccine Absorbed should be given to a pregnant woman only if clearly needed.

    (Emphasis added), attached as Exhibit F.

  31. The vaccine’s potential for mutagenicity and teratogenicity clearly indicate that the vaccine cannot be administered to women of child-bearing age under any circumstances short of a combat-related emergency.

    Mrs. Barber’s Eligibility for a 5-13 Discharge

  32. Mrs. Barber was first referred to Ft. Carson’s Evans Army Hospital Mental Health Unit ("Mental Health Unit") on May 24, 1999. Shortly thereafter, she was diagnosed with post-traumatic stress disorder due to an traumatic incident, unrelated to the AVIP, that occurred to her while she was stationed at Ft. Carson.
  33. Periodically thereafter, Mrs. Barber continued to be treated at the Mental Health Unit. See Exhibit A, which summarizes Mrs. Barber’s treatment at the Mental Health Unit. On March 27, 2000, a civilian psychiatric social worker employed by Defendants, Janet Barr, recommended that Mrs. Barber receive an expeditious discharge pursuant to Chapter 5-13 because of Mrs. Barber’s mental health issues. See Exhibit G.
  34. On April 3, 2000, Mrs. Barber was admitted to the Mental Health Unit after taking an overdose of sleeping pills. When she was released on April 5, 2000, Gary L. Kielpikowski, M.D., then Chief of Inpatient Psychiatry, also recommended an expeditious 5-13 discharge of Mrs. Barber. See Exhibit H.
  35. Defendants never processed Mrs. Barber’s Chapter 5-13 discharge, despite two recommendations for such a discharge.

    Mrs. Barber’s Objection to the AVIP

  36. Because of concerns about her health and that of a potential unborn child, Mrs. Barber refused to submit to the anthrax vaccine, despite repeated orders to do so.
  37. During this timeframe, Mrs. Barber was subjected to frequent harassment and intimidation by Defendants, all urging her to submit to the AVIP. See Barber Declaration. As a result, Mrs. Barber’s mental health continued to suffer.
  38. Mrs. Barber was assigned military defense counsel, Captain Jacqueline Emanuel, to represent her during the threatened court martial for Mrs. Barber’s refusal to take the vaccine.
  39. Capt. Emanuel repeatedly counseled Mrs. Barber to accept a Chapter 10 discharge, although it involved the potential for receiving an OTH characterization. However, Capt. Emanuel explained to Mrs. Barber that despite the pending court martial proceedings arising from her objection to the AVIP, Mrs. Barber nevertheless qualified for the Chapter 5-13 discharge, should Defendant Soriano deem her deserving of that type of discharge.
  40. Throughout her dealings with Captain Emanuel, Mrs. Barber explained her legal and medical opposition to the AVIP. Despite this, Ms. Emanuel prepared a defense packet, supposedly on Mrs. Barber’s behalf, which stated that: "PFC Barber is not at this time questioning the legality of the order her vaccine refusal violates." See Exhibit B.
  41. On May 8, 2000, at a regularly scheduled appointment with Janet Barr, Mrs. Barber discussed the stress that she was experiencing. Ms. Barr insisted that Mrs. Barber be admitted to the Mental Health Unit on an emergency referral.
  42. On May 8, 2000, while Mrs. Barber was admitted as an inpatient at the Mental Health Unit, she was escorted to JAG headquarters and was convinced by Capt. Emanuel and her superior, Major James Patterson, to sign a request for a Chapter 10 discharge. Upon signing the discharge, Mrs. Barber was escorted back to the Mental Health Unit. Upon her discharge, Mrs. Barber was given 72 hours rest in her quarters to recuperate from the stress she was experiencing.
  43. Mrs. Barber signed the Chapter 10 request solely in an effort to end the weeks of harassment and intimidation that she experienced following her refusal to comply with the AVIP program. See Barber Declaration.
  44. Because of her immediate mental health concerns, Mrs. Barber lacked full mental capacity to appreciate the consequences of her actions when she signed the Chapter 10 request. See Barber Declaration.
  45. Mrs. Barber did not have adequate, competent, or independent military counsel to advise her concerning the consequences or wisdom of signing the Chapter 10 paperwork.
  46. On May 11, 2000, Defendant Soriano issued a decision ordering that Mrs. Barber be discharged on an OTH status. See Exhibit I.
  47. Pursuant to this OTH discharge, Mrs. Barber will be ineligible for military benefits. She will also face a lifetime of difficulty in obtaining civilian employment because of this permanent stigma.
  48. Defendants’ pending OTH discharge of Mrs. Barber will cause her substantial and immediate harm. Her constitutional rights will be violated, for which there is no monetary remedy. Mrs. Barber will also lose her entitlement to military benefits, and will face a lifetime of stigma in the civilian workplace, for which there is no adequate remedy at law.

    Count I
    (Violation of U.S. Constitution, including Amendments 4 and 5)

  49. Plaintiff incorporates by reference paragraphs 1 through 48 above.
  50. No studies have been conducted regarding the vaccine’s potential for carcinogenic, mutagenic and teratogenic results, or its affect on fertility and human reproduction.
  51. Therefore, the vaccine’s potential for mutagenicity and teratogenicity clearly indicate that the vaccine cannot be administered to a woman of child-bearing age under any circumstances short of a combat-related emergency.
  52. Because of her mental health concerns, Plaintiff is ineligible for assignment to combat. No combat-related emergency exists in Plaintiff’s circumstances. Accordingly, the very rationale for the AVIP, threat of biological warfare, is absent in her case.
  53. Ordering Plaintiff to take the anthrax vaccine despite her status as a woman of child-bearing age violates her 4th and 5th Amendment rights to equal protection, privacy, consent to medical procedures, procreation, bodily choice, and rights of the unborn.
  54. The manner in which the AVIP program was implemented with respect to Plaintiff violated Plaintiff’s substantive and procedural due process rights.
  55. Accordingly, Plaintiff is entitled to a temporary restraining order and a preliminary injunction prohibiting Defendants from finalizing Plaintiff’s pending OTH discharge, and allowing Plaintiff’s recommended Chapter 5-13 discharge to be considered.

    Count II
    (Violation of 10 U.S.C. ¤ 1107)

  56. Plaintiff incorporates by reference paragraphs 1 through 55 above.
  57. The anthrax vaccine, as implemented by the AVIP, is an investigational new drug.
  58. 10 U.S.C. ¤ 1107 states that whenever the Secretary of Defense requires a member of the armed forces to receive an "investigational new drug or a drug unapproved for its applied use," the drug cannot be administered without the service person’s consent.
  59. Defendants ordered Plaintiff to submit to the anthrax vaccine without her consent.
  60. Therefore, the order to comply with the AVIP was in violation of Section 1107.
  61. Accordingly, Plaintiff is entitled to a temporary restraining order and a preliminary injunction prohibiting Defendants from finalizing Plaintiff’s pending OTH discharge, and allowing Plaintiff’s recommended Chapter 5-13 discharge to be considered.

    Count III
    (Violation of Executive Order 13139)

  62. Plaintiff incorporates by reference paragraphs 1 through 61 above.
  63. The anthrax vaccine, as implemented by the AVIP, is an investigational new drug.
  64. Section 3A of Executive Order No. 13139 prohibits the administration of an investigational new drug to members of the armed services absent a waiver from the President.
  65. A waiver of Executive Order No. 13139 may be granted only if obtaining consent of the service person is not feasible, is contrary to the best interest of the service member, or is not in the interest of national security. None of the conditions for waiver are relevant here.
  66. Defendants neither applied for a waiver of Executive Order 13139 nor obtained Plaintiff’s consent to administer the anthrax vaccine.
  67. Therefore, the AVIP, as implemented with respect to Plaintiff, violates Executive Order 13139.
  68. Accordingly, Plaintiff is entitled to a temporary restraining order and a preliminary injunction prohibiting Defendants from finalizing Plaintiff’s pending OTH discharge, and allowing Plaintiff’s recommended Chapter 5-13 discharge to be considered.

    Count IV
    (Violation of AR 40-7 and AR 40-562)

  69. Plaintiff incorporates by reference paragraphs 1 through 68 above.
  70. The anthrax vaccine, as implemented by the AVIP, is an investigational new drug.
  71. AR 40-7 and AR 40-562 forbid administering an IND without informed consent.
  72. Defendants ordered Plaintiff to submit to the AVIP without her informed consent.
  73. Accordingly, the AVIP as implemented with respect to Plaintiff violates AR 40-7 and AR 40-562.
  74. Accordingly, Plaintiff is entitled to a temporary restraining order and a preliminary injunction prohibiting Defendants from finalizing Plaintiff’s pending OTH discharge, and allowing Plaintiff’s recommended Chapter 5-13 discharge to be considered.

Prayer for Relief

WHEREFORE, Plaintiff respectfully requests that the Court:

  1. Enter a temporary restraining order and a preliminary injunction prohibiting Defendants from finalizing Plaintiff’s OTH discharge and allowing consideration of her pending recommendation for a Chapter 5-13 discharge; and
  2. Award such other relief, including costs and reasonable attorney fees, as the Court may deem just and proper.

Local Rule 7.1 Certificate

Plaintiff’s counsel hereby certifies that they have made a good faith effort to resolve this dispute prior to filing this motion. Defendants’ counsel refused to agree to the relief Plaintiff needs.

Dated: May 18, 2000 Respectfully submitted,

By:

Herbert L. Fenster

Eloise Henderson Bouzari
Steven M. Masiello
McKenna & Cuneo, L.L.P.

370 Seventeenth Street, Suite 4800

Denver, CO 80202

Telephone: (303) 634-4000

ATTORNEYS FOR PLAINTIFF

VERIFICATION

STATE OF COLORADO )

)ss.

CITY AND COUNTY OF DENVER )

Jemekia Barber, being first duly sworn, deposes and says, I have read the foregoing Verified Complaint for Injunctive Relief and know the contents thereof, and believe the facts recited therein are true and correct.


Jemekia Barber

Executed this 18th day May, 2000.
My Commission expires: ______________________, ____

[S E A L]

Notary Public

CERTIFICATE OF SERVICE

I hereby certify that on this 18th day of May, 2000, a true and correct copy of the foregoing VERIFIED COMPLAINT FOR INJUNCTIVE RELIEF was sent certified mail, postage prepaid, and addressed to the following:


Honorable Charles A. Blanchard
General Counsel
U.S. Department of the Army
2200 Army Pentagon
Room 2E722
Washington, DC 20310-2200

Louis Caldera
Secretary of the Army
101 Army Pentagon
Washington, DC 20310-0101

Gen. Eric K. Shinseki
Chief of Staff
U.S. Department of the Army
2200 Army Pentagon
Room 3E668
Washington, DC 20310-2200

Maj. Gen. Edward Soriano
Commanding General
5930 Woodfill Drive
Ft. Carson, CO 80913-4309

and was hand delivered to the following:

United States Attorney’s Office
1961 Stout Street
Suite 1200
Denver, CO 80294