UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

_________________________________

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JOHN DOE #1, et al,

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Plaintiffs, )

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v.

) Civil Action No. 03-707 (EGS)

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DONALD H. RUMSFELD, et al

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Defendants. )

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MEMORANDUM OPINION Plaintiffs, members of the active duty and selected National Guardsmen components of the Armed Forces as well as civilian contract employees of the Department of Defense ("DoD") who have submitted or have been instructed to submit to anthrax vaccinations without their consent pursuant to the Anthrax Vaccine Immunization Program ("AVIP"), commenced this action against the Secretary of Defense (Donald Rumsfeld), the Secretary of Health and Human Services (Tommy Thompson), and the Commissioner of the Food and Drug Administration (Mark McClellan). Because plaintiffs maintain that Anthrax Vaccine Adsorbed ("AVA") is an experimental drug unlicensed for its present use and that the AVIP violates federal law (10 U.S.C. § 1107), a Presidential Executive Order (Executive Order 13139), and the
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DoD's own regulations (DoD Directive 6200.2), plaintiffs ask that in the absence of a presidential waiver the Court enjoin the DoD from inoculating them without their informed consent. Plaintiffs allege three causes of action against defendants: (1) violation of the Administrative Procedure Act ("APA") by defendant DoD based on the DoD's failure to follow federal law, a presidential executive order, and DoD directive with respect to its AVIP; (2) violation of the APA by defendant DoD for its intent to inoculate plaintiffs with an unlicensed drug that is unapproved for its intended use; and (3) violation of the APA by the defendants' alteration of the licensed Federal Drug Administration ("FDA")approved schedule of vaccination which rendered AVA a drug unapproved for its intended use.1
Defendants DoD and FDA maintain that the issues plaintiffs present are non-justiciable and that plaintiffs fail to present an evidentiary basis sufficient to support standing at the preliminary injunction stage. With respect to the merits, they allege that, in seeking to prevent the DoD from inoculating them, plaintiffs seek to undermine a key component of military readiness and defense against battlefield use of biological weapons.
Pending before this Court is a Motion for a Preliminary
1 None of the plaintiffs alleged that their vaccination schedule was altered, so the Court does not reach the third cause of action.
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Injunction. The central question before this Court is whether AVA is an "investigational" drug or a drug unapproved for its use against inhalation anthrax. Upon consideration of plaintiffs' motion for a preliminary injunction, the opposition, the reply, and oral arguments, as well as the statutory and case law governing the issues, and for the following reasons, it is, by the Court, hereby ORDERED that the Motion for a Preliminary Injunction is GRANTED. In the absence of a presidential waiver, defendants are enjoined from inoculating service members without their consent.
I. Background A. Factual Background
In 1970, the National Institutes of Health ("NIH"), the agency then charged with licensing biologic drugs, see 37 Fed. Reg. 4004, 4004-04 (Feb. 25, 1972), licensed AVA for use against anthrax. See 36 Fed. Reg. 8704, 8705 (May 11, 1971). Two years later, authority to approve biologic drugs was delegated to the FDA. 37 Fed. Reg. 4004, 4004-05 (Feb. 25, 1972).
After the authority to license biologic drugs was delegated to the FDA, the agency initiated a review of the safety, effectiveness, and labeling of all licensed biologics. 21 C.F.R. 601.25. The Federal Register published a proposed rule containing the results of AVA's review on December 13, 1985. In
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that product review, the independent Biologics Review Panel
recommended that the vaccine be classified as safe, effective,
and not misbranded. In their recommendations the panel discussed
the Brachman study2 and stated that the vaccine's "efficacy
against inhalation anthrax is not well documented...no meaningful
assessment of its value against inhalation anthrax is possible
due to its low incidence." Biological Products; Bacterial
Vaccines and Toxoids; Implementation of Efficacy Reviews, 50 Fed
Reg. 51,002 (Dec. 13, 1985)(to be codified at 21 C.F.R. pt. 610).
To date the AVA label does not specify which method of anthrax
exposure it protects against. The Proposed Rule published in the
December 13, 1985, Federal Register has never been finalized.
2 According to the December 13, 1995, Federal Register: The best evidence for the efficacy of anthrax vaccine comes from a placebo-controlled field trial conducted by Brachman covering four mills processing raw imported goat hair into garment interlining. The study involved approximately 1,200 mill employees of whom about 40 percent received the vaccine and the remainder received a placebo or nothing. The average yearly incidence of clinical anthrax in this population was 1 percent. During the evaluation period, 26 cases of anthrax occurred. Twenty-one had received no vaccines, four had incomplete immunization and one had complete immunization. Based on analysis of attack rates per 1,000 person-months, the vaccine was calculated to give 93 percent (lower 95 percent confidence limit = 65 percent) protection against cutaneous anthrax based on comparison with the control group. Inhalation anthrax occurred too infrequently to assess the protective effect of vaccine against this form of the disease. (emphasis added). Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Reviews, 50 Fed Reg. 51,002 (Dec. 13, 1985)(to be codified at 21 C.F.R. pt. 610).
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On October 5, 1995, the U.S. Army Medical Research and Material Command wrote the Michigan Department of Public Health ("MDPH"), the vaccine's manufacturer, that they were enclosing a plan "to expand the indication for use to include projections from aerosol exposure to B. anthraces spores." Pls.' Compl. Ex. G, Letter from Anna Johnson-Winegar to Robert Myers of October 5, 1995. The plan specifically asserts that "[t]his vaccine is not licensed for aerosol exposure expected in a biological warfare environment." Pls.' Compl. Ex. G, Attachment to Letter from Anna Johnson-Winegar to Robert Myers of October 5, 1995. The plan proposed was to amend the anthrax vaccine license through an Investigational New Drug ("IND") application submission.
On October 20, 1995 (as reflected in a November 13, 1995, memorandum from the Department of the Army Joint Program Office for Biological Defense) a meeting was held to discuss modifying the anthrax vaccine license "to expand the indication to include protection against an aerosol challenge of spores."3 Pls.' Compl. Ex. H, Mem. Regarding: Minutes of the Meeting on Changing the Food and Drug Administration License for the Michigan Department of Public Health (MDPH) Anthrax Vaccine to Meet
3 At this meeting, Colonel Arthur Friedlander, Chief of the Bacteriology Division of the U.S. Army Medical Research Institute for Infectious Diseases, briefed meeting participants on (1) evidence for a reduction in the number of doses of anthrax vaccine, (2) evidence for vaccine efficacy against an aerosol challenge, and (3) progress toward an in vitro correlate of immunity. SEALED.
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Military Requirements from David L. Danley to Distribution List on November 13, 1995.
On July 2, 1996, the FDA held a meeting to consult with and provide guidance to the DoD and MDPH officials who were formulating the forthcoming September 1996 IND application. The Army "presented a plan in progress to develop correlates in immunity in animals and then in humans vaccinated with MAVA in order to obtain a specific indication for inhalation anthrax." Pls. Reply Ex. 1, Summary of the Michigan Anthrax Vaccine Adsorbed (MAVA) Pre-IND Meeting with the FDA: Specific Indication for Inhalation Anthrax; Change in Schedule and Route at ¶ 5.
In September 1996, AVA's manufacturer submitted an IND application to the FDA in an attempt to get FDA approval for a modification of the AVA license to demonstrate the drug's effectiveness against inhalation anthrax. The IND application is still pending and, to date, there is no indication for inhalation anthrax on the label or in the product insert.
In 1997, the Assistant Secretary of Defense "took...steps to confirm that AVA is approved for use against inhalation anthrax." Defs.' Opp'n at 10. For instance, the Assistant Secretary of Defense (Health Affairs) wrote to the FDA's Lead Deputy Commissioner, stating that the "DoD has long interpreted the scope of the license to include inhalation exposure, including that which would occur in a biological warfare context" and
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inquiring "whether the FDA has any objection to our interpretation of the scope of the licensure for the anthrax vaccine." Defs. Opp'n. Ex. 3, Letter from Stephen Joseph to Mark Friedman of March 4, 1997. The Lead Deputy Commissioner responded "I believe your interpretation is not inconsistent with the current label." Defs. Opp'n. Ex. 2 Attach. 3, Letter from Mark Friedman to Stephen Joseph of March 13, 1997.
In a response to a citizen petition dated August 2002, the FDA's Associate Commissioner of Policy noted that the FDA still has yet to finalize the rule proposed in the December 13, 1985, Federal Register. But here, contradicting the panel's position regarding the Brachman study in the 1985 Federal Register, the FDA stated that the Brachman study included inhalation anthrax. Thus, the FDA concluded that "[t]he indication section of the labeling does not specify the route of exposure and thus includes both cutaneous and inhalation exposure." Pls.' Compl. Ex. D, Resp. to Citizen Pet. Dated October 12, 2001 from Margaret Dotzel to Russell Dingle on August 28, 2002.
The AVA product insert, which originally stated that the adverse reaction rate to the vaccine was 0.2 percent, was recently revised to reflect an adverse reaction rate between 5.0 percent and 35.0 percent. At least six deaths have been linked to the vaccine and the vaccine's pregnancy use risk has been upgraded from a Category C risk (risk cannot be ruled out) to a
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Category D risk (positive evidence of risk.)
B. Legal Background In 1998, in response to concerns about the use of
investigational new drugs during the 1991 Gulf War that may have led to unexplained illnesses among veterans, Congress signed into law 10 U.S.C. § 1107. This provision prohibts the administration of investigational new drugs, or drugs unapproved for their intended use, to service members without their informed consent. The consent requirement may be waived only by the President. In 1999, the President signed Executive Order 13139, pursuant to which the DoD must obtain informed consent from each individual member of the armed forces before administering investigational drugs and under which waivers of informed consent are granted only "when absolutely necessary." Exec. Order No. 13139, 64 Fed. Reg. 54,175 (September 30, 1999). In August, 2000, the DoD formally adopted these requirements in DoD Directive 6200.2.
In 1998, the DoD began a mass inoculation program using AVA as a preventative measure against inhalation anthrax for service members and civilian employees. The program was administered without informed consent or a presidential waiver. Plaintiffs contend that because AVA is not licensed for inhalation anthrax, its use by the DoD is not only investigational but it is also a drug unapproved for its intended use in violation of 10 U.S.C. §
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1107, Executive Order 13139, and DoD Directive 6200.2. Tr. at 78. Defendants maintain that they are not in violation of any law because AVA is not an investigational new drug and it is licensed for inhalation anthrax.
II. Standard of Review When seeking a preliminary injunction, the movant must demonstrate to the Court that: (1) there is a substantial likelihood that plaintiff will succeed on the merits; (2) plaintiff will be irreparably injured if an injunction is not granted; (3) an injunction will not substantially injure the other party; and (4) the public interest will be furthered by an injunction. Davenport v. Int'l Bhd. of Teamsters, 166 F.3d 356, 361 (D.C. Cir. 1999).
III. Discussion A. Justiciability
1. Jurisdiction in an Article III Court The parties in this case dispute whether the threshold requirement of justiciability is met. While plaintiffs maintain that the DoD's use of AVA in the AVIP is justiciable, defendants contend that the Article III case or controversy requirement is not met because (1) plaintiffs' claims are non-justiciable and (2) plaintiffs fail to present an evidentiary basis sufficient to
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support standing for purposes of a request for preliminary injunction. Whether or not this Court can exercise jurisdiction over plaintiffs' claims depends on whether those claims fall within the narrow category of demands for equitable relief that are not barred under the D.C. Circuit's jurisprudence.
Courts have traditionally been hesitant to intervene in the conduct of military affairs. See, e.g., United States v. Stanley, 483 U.S. 669, 683-84 (1987); Chappell v. Wallace, 462 U.S. 296, 300 (1983). The general concern that courts are "illequipped to determine the impact upon discipline that any particular intrusion upon military authority might have," Chappell, 462 U.S. at 305, is heightened when courts are called upon to intervene between soldiers and their military superiors. See, e.g. Gilligan v. Morgan, 413 U.S. 1, 10 (1973) (observing that the "complex subtle, and professional decisions as to the composition, training, equipping, and control of a military force are essentially professional military judgments...."). Based on concerns surrounding judicial competence, the Supreme Court has declined to entertain service-related damages claims under the Federal Tort Claims Act, see, e.g., Feres v. United States, 340 U.S. 135 (1950), and Bivens actions "whenever the injury arises out of activity 'incident to service.'" Stanley, 483 U.S. at 681.
While claims for damages are nonjusticiable, the circuits
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are divided with respect to the viability of claims for injunctive relief against the military. The case of Speigner v. Alexander, 248 F.3d 1292, 1296 (11th Cir. 2001), cert denied, 543 U.S. 1056 (2001), held that cases brought by enlisted personnel against the military for injuries incident to service are nonjusticiable, whether those claims request monetary or injunctive relief. In its decision, the Eleventh Circuit surveyed the appellate decisions addressing the justiciability of claims seeking injunctions against the military. The court noted that the Second, Fifth, Seventh, and Eighth Circuits had all found suits by enlisted personnel against the military for an injury incident to service nonjusticiable for injunctive relief as well as for damages. The Speigner court observed that the minority of circuits have held that injunctive relief is attainable against the military. The First Circuit, for instance, explicitly held that, "Chappell and Stanley make it clear that intramilitary suits alleging constitutional violations but not seeking damages are justiciable." Wiggington v. Centracchio, 205 F.3d 504, 512 (1st Cir. 2000). In Jorden v. Nat'l Guard Bureau, the Third Circuit held that "Chappell itself suggests that it leaves open claims for injunctive relief against the military." 799 F.2d 99, 100 (3d Cir. 1986).
The United States Court of Appeals for the D.C. Circuit, however, has not interpreted Chappell or Feres as embracing
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categorical rules. In a recent opinion addressing the justiciability of a service member's suit for equitable relief the D.C. Circuit stated that the "Supreme Court has made clear...that Feres does not bar all suits by service personnel...." Braanum v. Lake, 311 F.3d 1127, 1130 (D.C. Cir. 2002). The Braanum court rejected any distinction between facial challenges and as applied challenges and noted that "some as applied challenges are plainly permitted." Id. The court found that Braanum's assertions that his due process and other rights were violated by the military taking actions against him in excess of its jurisdiction under the Military Code fell squarely within the Supreme Court's decision in Schlesinger v. Councilman. See Braanum, 311 F.3d at 1130 (citing 420 U.S. 738, 740 (1975)). In Schlesinger, the Court held that Article III courts had jurisdiction to entertain an Army captain's suit seeking an injunction against pending court martial proceedings based on conduct he claimed was non "service-related" and therefore outside the court martial jurisdiction. Id.
Plaintiffs in this case argue that district courts called upon to review military decisions must employ the test adopted in Mindes v. Seamen, 453 F.2d 197 (5th Cir. 1971), affirmed on appeal after remand, 501 F.2d 175 (5th Cir. 1974). See Pls.' Mot. at 5; Pls.' Reply at 7. The Mindes court held that a court should only review internal military affairs if there is an
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allegation that a constitutional right has been deprived or an allegation that the military has acted in violation of applicable statutes or regulations. Mindes, 453 F.2d at 201. The Fifth Circuit determined that there are four factors a court must analyze:
(1) the nature and strength of the plaintiff's challenge to the military determination;
(2) the potential injury to the plaintiff if review is refused;
(3) the type and degree of anticipated interference with the military function;
(4) the extent to which the exercise of military expertise or discretion is involved (courts should defer to superior knowledge and experience of professionals in matters such as military personnel decisions or other areas that relate to specific military functions.)
Id.
While plaintiffs concede that the D.C. Circuit has not expressly adopted the Mindes test, they point out that it has not rejected the test in circumstances such as those presented in the case at bar. The case of Kreis v. Secretary of the Air Force, 866 F.2d 1508, 1512 (D.C. Cir. 1989), however, suggests to this Court that the D.C. Circuit Court may not look particularly favorably upon the Mindes analysis. In the Kreis case, an Air Force major brought suit seeking retroactive promotion or, in the alternative, correction of military records. The Court of Appeals held that the major's claim for retroactive promotion was a nonjusticiable military personnel decision and that his
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alternative claims for correction of military records were
justiciable. In holding that appellant's second claim was
justiciable as a request for review of agency action, the court
held that
In dismissing this case, the district court considered neither Chappell nor our decisions relying upon it. Instead, the court concluded that appellant's entire complaint is nonjusticiable based solely on Mindes...which, the district court noted, we cited in Dilley v. Alexander, 603 F.2d 914, 920 (D.C. Cir. 1979). Our reference to Mindes, however, was not intended to foreclose judicial review of decisions involving the correction of military records; indeed, in the same paragraph, we said that the federal courts may inquire whether the Secretary's action in this area is "arbitrary, capricious, or contrary to the statutes and regulations governing that agency." Id. Nor did we adopt the Mindes court's four factor analysis, which, as the Third Circuit has pointed out, erroneously "intertwines the concept of justiciability with the standards to be applied to the merits of the case." Dillard v. Brown, 652 F.2d 316, 323 (3d Cir. 1981).
Kreis, 866 F.2d at 1512.
As the above discussion highlights, there is no bright line
rule in the D.C. Circuit when it comes to establishing
justiciability. What can be said with certainty is that this
Circuit has not ruled out the right of individuals to seek
injunctive relief against the military in civilian courts in all
cases. Therefore, to assess the question of justiciability, this
Court examines: (1) whether a court martial was pending against
any of the plaintiffs, see, e.g., Schlesinger, 420 U.S. 738; (2)
the degree to which a ruling by this Court would interfere with
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supervisory-subordinate relationships on the battlefield and/or personnel decisions, see, e.g., Chappell, 462 U.S. 296; and (3) the extent to which action by this Court would affect or disrupt the goals of discipline, obedience, and uniformity, see, e.g., Goldman v. Weinberger, 475 U.S. 503 (1986).
First, this lawsuit was not instigated in an attempt to thwart a pending court martial, as was the case in Schlesinger, 420 U.S. 738. Moreover, this Court has no reason to believe that any of the plaintiffs are currently facing a court martial. In fact, three of the plaintiffs have complied with the order to take the inoculation and are seeking review of the DoD's order in this Court. Tr. at 38. Further, two of the plaintiffs are civilian employees and could not be subjected to court martial proceedings. Tr. at 36. At most, only one plaintiff could potentially be facing a court martial and, in the event that the situation arose, the case could be permitted to proceed with regard to the other plaintiffs. Thus, there are no concerns that this lawsuit was an attempt to interfere with pending court martial proceedings or that a judgment in this case will interfere with a pending court martial against one of the plaintiffs.
Second, plaintiffs allege that the DoD acted arbitrarily and capriciously by failing to adhere to statutes and regulations governing its activities. Their claim is against the Secretary
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of Defense about a decision made in headquarters, not about a tactical decision military supervisors made in the field. Tr. at 13. Similarly, because plaintiffs are a diverse class and include civilian individuals who are not in the employ of the military, the danger of disrupting discipline and/or supervisorysubordinate relationships is minimal at best. Thus, a judgment in this Court would not interfere with a supervisory-subordinate relationship on the battlefield.
Third, while the Court is cognizant of the fact that allowing some service members to refuse inoculations at this stage could threaten the uniformity of the military, this case is not analogous to Goldman, where plaintiff sued to enjoin application of an Air Force regulation that forbade officers from wearing a yarmulke while on duty. Goldman, 475 U.S. 503. In Goldman, the Court recognized that importance of the appearance of uniformity for a effective functioning military. Id. at 510 ("The Air Force has drawn the line essentially between religious apparel that is visible and that which is not, and we hold that those portions of the regulations challenged here reasonably and evenhandedly regulate dress in the interest of the military's perceived need for uniformity.") Rather, here there will be no visible differences between persons who choose to receive the vaccine and those who choose not to receive the vaccine. Thus, concerns about uniformity diminish and a judgment in this case
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would not affect the uniformity of military personnel to any substantial degree.
2. Availability of APA Review Defendants maintain that Section 10 of the APA precludes judicial review. Defs.' Opp'n at 20. Specifically, they point to 5 U.S.C. § 701(b)(1)(G), which renders the APA's judicial review provisions inapplicable to acts of "military authority exercised in the field in time of war or in occupied territory." In addition, they refer to 5 U.S.C. § 701(b)(1)(F), a provision barring judicial review of "court martial and military commissions." Finally, defendants aver that the APA "excludes from its waiver of immunity...claims for which an adequate remedy is available elsewhere." Transhio Sav. Bank v. Director OTS, 967 F.2d 598, 607 (D.C. Cir. 1992). The Court finds 5 U.S.C. § 701(b)(1)(G) inapplicable to the present situation. As plaintiffs note, the AVIP was announced in December, 1997, implemented initially in March, 1998, and implemented force-wide in May of that year. Due to the vaccine shortages discussed above, few of the service members who fought in Afghanistan in 2001-2003 were vaccinated at all. The recommencement of the AVIP program was announced on June 29, 2002, – a date which predated Congressional authorization for the
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use of force in Iraq by four months and the recent hostilities by almost eighteen months. The plaintiffs in the instant case are not challenging military authority exercised in the field in a time of war or in occupied territory. In fact, according to plaintiffs, "[n]one of the plaintiffs are presently in the 'field' or in 'occupied territory.'" Pls.' Reply at 9. Moreover, the order for the program at issue in this case was given by the Secretary of Defense, not by commanders in the field. Similarly, the Court finds 5 U.S.C. § 551(1)(F) inapplicable, as none of the plaintiffs in this case have asked this Court to review a court martial or military commission proceedings.
Finally, defendants submit that the proper forum for plaintiffs to raise their claims is in the military justice system after having refused orders to take the vaccine. They cite the case of New v. Cohen, 129 F.3d 639 (D.C. Cir. 1997), as the principal authority in support of their proposition. While this D.C. Circuit opinion does embrace comity principles and the exhaustion requirement, it explicitly states that, at the heart of the comity principle "is the general rule that a federal court must await the final outcome of court-martial proceedings in the military justice system before entertaining an action by a service member who is the subject of the court-martial." New, 129 F.3d at 642. (emphasis added.) Similarly, the decision
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refers repeatedly to "pending" court martial proceedings, service members "charged" with crimes by military authorities, and the prohibition on "collateral review" of court-martials. Id. at 643. The language in New strongly suggests that its holding applies to cases in which alternative channels within the military justice system are already being pursued by, or against, the plaintiffs. The thrust of the New decision is clearly that Article III courts should not interfere with the proceedings of military tribunals. In the present case, the Court has no reason to believe that any of the plaintiffs are currently facing a court martial. Moreover, the civilian plaintiffs cannot be subjected to court martial proceedings. Thus, the Court finds no reason to stay its hand based on New.
Instead, this Court reads New for the proposition that the courts are another option for plaintiffs. As New stated:
[u]pon receiving orders which he thought to be illegal, New had two options. He could have chosen to obey the orders and then sought judicial review of the military's policies. Cf. Goldman v. Weinberger, 475 U.S. 503 (1986) (suit to enjoin application of Air Force regulation that forbade officer from wearing yarmulke while on duty and in uniform). Or he could follow the path that he took: disobey the orders and challenge their validity in the subsequent disciplinary proceedings.
New, 129 F.3d at 647. At oral argument plaintiffs' counsel informed this Court that all six of the plaintiffs have been ordered to submit to the vaccine. Tr. at 38. Three of the
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plaintiffs obeyed the order and now seek judicial review. Id. This Court finds that it is one of the proper forums for this claim.
3. Standing A core element of Article III's case or controversy requirement is that a plaintiff must establish that he or she has standing to sue. Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992). The "question of standing is whether the litigant is entitled to have the court decide the merits of the dispute or of particular issues." Allen v. Wright, 486 U.S. 737, 750-51 (1984). A plaintiff must meet three requirements in order to establish Article III standing. See, e.g., Friends of Earth, Inc. v. Laidlaw Environmental Serv. (TOC), Inc., 528 U.S. 167, 180-91 (2000). First, she must demonstrate "injury in fact" – a harm that is "concrete," "actual or imminent, not conjectural or hypothetical." Whitmore v. Arkansas, 495 U.S. 149, 155 (1990); see also City of Los Angeles v. Lyons, 461 U.S. 95, 101 (1983). Second, she must establish causation – a "fairly...trace(able) connection between the alleged injury in fact and the alleged conduct of the defendant." Simon v. Eastern Ky. Welfare Rights Org., 426 U.S. 26, 41 (1976). Third, she must demonstrate redressability – a "substantial likelihood" that the requested
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relief will remedy the alleged injury in fact. Id. at 45.
A plaintiff seeking injunctive relief demonstrates the first two standing requirements only by showing that the defendant is likely to injure the plaintiff. Cone Corp. v. Florida Dep't of Transportation, 921 F.2d 1190, 1205 (11th Cir. 1991). "Mere allegations will not support standing at the preliminary injunction stage." Doe v. Nat'l Bd. Med. Exam'rs, 199 F.3d 146, 152 (3rd Cir. 1999); see also Nat'l Wildlife Fed. v. Burford, 878 F.2d 422, 423 (D.C. Cir. 1989) rev'd on other grounds sub non Lujan, 497 U.S. 871 (burden of establishing standing at preliminary injunction stage is no less than for summary judgment).
In the present case, the government alleges that plaintiffs' claims of injury are purely speculative because adverse personnel actions against them for refusing inoculations may or may not occur. However, the Court agrees with plaintiffs that the defendants' argument ignores the fact that when challenging an investigational drug under 10 U.S.C. § 1107 an inoculation without informed consent or a presidential waiver is the injury. Tr. at 32. Because all six plaintiffs have been ordered to appear for the inoculation, and three of the six have already begun the series with more inoculations to follow, all plaintiffs have established that they will imminently suffer a harm that is actual, concrete, and inflicted at the hands of defendants unless
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defendants are required to conform to 10 U.S.C. § 1107.
II. Likelihood of Success on the Merits
Having found that this claim is justiciable, the central question before the Court is whether AVA is being used as an investigational new drug or as a drug unapproved for its intended use. At bottom, this inquiry turns on whether the FDA has made a final decision on the investigational status of AVA; and if not (1) whether the 1996 IND application establishes the vaccine's status as an investigational drug and (2) whether the DoD is using AVA in a manner inconsistent with its license and intended use.4
As indicated previously, defendants' position is that 10 U.S.C. § 1107 is inapplicable because the AVA's license covers use against inhalation anthrax. Defs.' Opp'n Ex. 1, Goodman Decl. ¶ 11. They argue that the FDA has interpreted the lack of specificity concerning inhalation anthrax as permitting use of the vaccine against any route of exposure. While neither explaining the panel's finding in the December 15, 1985, Federal Register proposed rule stating that cases of inhalation anthrax
4 In light of the fact that, as defendants concede, a vaccine can be licensed for one purpose and investigational for another, plaintiffs are correct in asserting that whether or not the vaccine in question is "licensed" is not, in itself, dispositive.
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in the Brachman study were too infrequent to assess the vaccine against inhalation anthrax nor citing any additional studies of inhalation anthrax, defendants aver that agency officials have always considered the vaccine to include inhalation anthrax. Tr. at 92. They further allege that the 1996 IND application was submitted as a result of a dispute between underlings (Tr. at 9293) and state that while the application is still technically pending, it is not longer being actively pursued. Tr. at 119. In addition, defendants point to a 1997 letter written by the Assistant Secretary of Defense stating that the IND application in no way suggests an official position that the DoD believed the approved label did not already encompass inhalation exposure. See Defs.' Opp'n at 31. Defendants note that such interpretations by an agency within its area of expertise are entitled to substantial deference. In support of their position, they cite several cases, including Thomas Jefferson Univ. v. Shalala, 513 U.S. 504, 512 (1994) and Trinity Board of Fla., Inc. v. FCC, 211 F.3d 618, 625 (D.C. Cir. 2000), standing for the proposition that an agency is entitled to deference with respect to the interpretation of the statutes it is tasked with administering.
While defendants' arguments concerning deference are correct, the dispute in this case has not focused on the language of a particular DoD statute. Rather, it is the FDA's term
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"investigational" that is at the heart of the dispute. Title 10 U.S.C. § 1107 and the attendant DoD regulation apply only if the FDA determines that AVA is an investigational drug or a drug unapproved for its present purpose. As plaintiffs note, the letters and declarations defendants cite are not "formal FDA opinion(s)." See 21 C.F.R. § 10.85(k)(2000). Under 21 C.F.R. § 10.85(k)
A statement made or advice provided by an FDA employee constitutes an advisory opinion only if it is issued in writing under this Section. A statement or advice given by an FDA employee orally or given in writing but not under this section or § 10.90 is an informal communication that represents the best judgment of that employee at the time, but does not constitute an advisory opinion, does not bind or otherwise obligate or commit the agency to the views expressed.
Similarly, the personal opinions of FDA officials as expressed in a series of letters are not entitled to any particular deference. See Christensen, et al v. Harris County, et al., 529 U.S. 576 (2000) (holding that an agency statutory interpretations contained in opinion letters are entitled to respect but only to the extent that interpretations have power to persuade.) The apparent change in position from the December 1985 proposed rule and the cryptic use of a double negative (i.e. "it is not inconsistent"), fail to persuade this Court that the view expressed in the 1997 letter is the FDA's formal opinion. Given that finding, the FDA has failed to provide any formal opinion vis a vis AVA's investigational status and the Court must
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consider plaintiffs' arguments.5
In 1996, the manufacturer of the AVA, the Michigan Department of Public Health, filed an Investigational New Drug Application that remains open today. 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." Pls.' Compl. Ex. J, Letter from MDPH to Dr. Kathryn C. Zoon of October 20, 1996. The Introductory Statement to the 1996 IND application similarly provided that "[t]he ultimate purpose of this IND is to obtain a specific indication for inhalation anthrax and a reduced vaccination schedule." Pls.' Compl. Ex. K, Introductory Statement to the 1996 IND Application of September 20, 1996.
The source of the dispute concerns whether current use of the AVA for inhalation anthrax is licensed in light of the drug's present status and the IND application. Plaintiffs contend that,
5 At the oral argument, the government argued that the Citizen Petition states that the drug is licensed for inhalation anthrax and that is the agency's official position. Tr. at 86. However, the Court is persuaded by plaintiffs' arguments that the Citizen Petition addressed the licensing issue by merely relying on the 1997 Friedman letter and did not do the in-depth analysis as would be appropriate to make that kind of a determination or to contradict the opinion it expressed concerning the Bachman study in the 1985 Federal Register. See Tr. at 125.
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as there has been insufficient study of the vaccine, its license does not incorporate inhalation anthrax. They rely on a 1985 panel that found that the license for anthrax was not broad enough to include inhalation anthrax. The panel findings were based partially on the Brachman Study, which noted that there were too few cases of inhalation anthrax to determine the efficacy of the vaccine. See Brachman and Friedlander, Vaccines 736 (eds. Plotkin and Mortimer)(1999). The Brachman Study observed that there have been "no controlled clinical trials in humans of the efficacy of the currently licensed U.S. vaccine." Id.6 Plaintiffs correctly note that there have been no subsequent human studies on the efficacy of the vaccine against inhalation anthrax since that time. In addition, plaintiffs submit that defendants' own documents support their position that a vaccine is investigational if it is used in a manner, or for a purpose, identical to that set forth in the IND application. In this regard, plaintiffs cite a number of documents, including the October 5, 1995, letter by the U.S. Army Medical Research and Material Command, the November 13, 1995, memorandum from the Department of the Army's Joint Program Office for Biological Defense, and information provided by the Army at the July 2, 1996, FDA-sponsored meeting, chronicling the government's
6 See Pls.' Reply at 13 n. 12 for relevant congressional testimony.
26

statements that the AVA lacked licensure for protection against inhalation anthrax.
Plaintiffs conclude that, because there is insufficient scientific evidence demonstrating that the anthrax vaccine protects against anthrax inhalation exposure, the government's claims violate fundamental precepts of drug law. Specifically, plaintiffs submit that the government claim violates 21 C.F.R. § 201.56(c), detailing general requirements on content and format of labeling for prescription drugs, which provides:
The labeling shall be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans shall be identified as such and included with human data in the appropriate section of the labeling, headings for which are listed in paragraph (d) of this section.
Moreover, plaintiffs contend that 21 C.F.R. § 201.57 (c)(2) is violated. That section provides that "All indications shall be supported by substantial evidence of effectiveness based on adequate and well-controlled studies." Id. Plaintiffs assert
that the government cannot identify "substantial evidence of effectiveness based on adequate and well-controlled studies" for
the anthrax vaccine with respect to protection against inhalation anthrax.
While the issues presented to the Court are complex, and the
27

evidence somewhat contradictory, the Court is ultimately persuaded that plaintiffs enjoy a substantial likelihood of success on the merits for the following reasons. The FDA, the only agency that this Court could properly defer to in determining AVA's status as an investigational drug, has failed to provide a formal opinion as to AVA's investigational status. Having made that determination, the Court is required to make its own inquiry and determination regarding AVA's investigational status. The Court looked at the labeling requirement, 21 C.F.R. § 201.56, which mandates that "[n]o implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness." In the case of AVA, the 1985 panel found insufficient data to license the drug for use against inhalation anthrax. To date, no additional studies have been performed and AVA's label does not specify use of the vaccine for this purpose. Moreover, the Court is persuaded that the 1996 IND application remains pending today. The introduction to the application expressly states that one objective of the application is to obtain a specific indication for use of AVA against inhalation anthrax. While the government states that the inhalation anthrax aspect of the IND is no longer active, the documents submitted to this Court under seal suggest otherwise.7 Finally, statements made by DoD officials suggest
7 SEALED. 28

that the agency itself has, at some point at least, considered AVA experimental with respect to inhalation anthrax. Given all these factors, the Court would be remiss to conclude that the original license included inhalation anthrax. Having reached that conclusion, the DoD's administration of the inoculation without consent of those vaccinated amounts to arbitrary action.
III. The Public Interest
Plaintiffs maintain that Executive Order 13139, Department of Defense Directive 6200.2, and especially 10 U.S.C. § 1107, were enacted to protect soldiers from involuntarily serving as "guinea pigs" in a mass use of investigational medicine. Pls.' Mot. at 23. In their view, defendants' disregard of the violations has already caused half a million members of the armed forces to be experimental subjects without their consent.
Defendants base their public policy argument on the idea that requiring compliance with informed consent would render it infeasible to continue the AVIP for current military operations in Iraq or in conjunction with the war on terrorism. Essentially, defendants argue that the harm to the public interest would include disrupting the smooth functioning of the military, hampering military readiness, and reducing the military's ability to protect its service members. Should those individuals who have refused anthrax vaccinations be injured by
29

anthrax, their injuries or deaths would have a detrimental effect on the military and its operation at large. Defs.' Opp'n at 37. Plaintiffs counter by observing that if the risks of anthrax injuries were so manifestly present, the State Department, as well as the coalition forces of Britain and Australia, would have taken similar steps to protect their employees. Plaintiffs refute the government's argument concerning the cumbersome administrative results that could ensue from the granting of a preliminary injunction by stating that the DoD was able to comply with similar administrative proceedings in only three weeks between adoption of the predecessor of 10 U.S.C. § 1107 and the start of the Gulf War in 1991. Plaintiffs conclude by remarking that "if the danger articulated by the government is so clear...there should be little difficulty in convincing the President...to sign off on the required paperwork to make the AVIP mandatory...which is all plaintiffs can ask." Pls.' Reply at 24.
The Court is persuaded that the right to bodily integrity and the importance of complying with legal requirements, even in the face of requirements that may potentially be inconvenient or burdensome, are among the highest public policy concerns one could articulate. Moreover, the Court is not convinced that requiring the DoD to obtain informed consent will interfere with the smooth functioning of the military. However, if obtaining
30

informed consent were to significantly interfere with military function, defendants are free to seek a presidential waiver. If the Executive branch determines that this is truly an exigent situation, then obtaining a presidential waiver would be an expeditious end to this controversy.
IV. Irreparable Harm
Plaintiffs argue that their injuries from non-consensual inoculations would be irreparable. They note that the informed consent documents provided to civilians as a result of the anthrax laden letters in the Fall of 2001 identify side effects such as Guillain-Barre Syndrome, multiple sclerosis, angiodema, aseptic meningitis, severe injection site inflammation, diabetes, and systemic lupus erythmatosis. In addition, the pregnancy risk assessment has, as noted above, been recently upgraded. Pls.' Mot. at 15. It is impossible to tell with any certainty what the long-term effects of the vaccination will be. Regardless, plaintiffs submit that no monetary award can adequately compensate individuals whose right to informed consent has been violated.
Defendants' position is that harm in the form of potential side effects is "hypothetical or, at best, unlikely to occur." Defs.' Opp'n at 40. Defendants refer to a de minimis risk of serious adverse reactions and report 105 serious adverse
31

reactions from AVA in over 830,000 recipients. Id. They stress that AVA has been used effectively in civilian industry for over 30 years.
Having found that AVA is an investigational drug under 10 U.S.C. § 1107, the Court is persuaded that requiring a person to submit to an inoculation without informed consent or the presidential waiver is an irreparable harm for which there is no monetary relief.
Conclusion
The Court has considered Plaintiff's Motion for a Preliminary Injunction, the Response and Reply thereto, counsel's representations at oral argument, and the relevant statutory and case law. In sum, because the record is devoid of an FDA decision on the investigational status of AVA, this Court must determine AVA's status for itself. This Court is persuaded that AVA is an investigational drug and a drug being used for an unapproved purpose. As a result of this status, the DoD is in violation of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2. Thus, because the plaintiffs are likely to prevail on the merits, defendants will not face substantial harm by the imposition of an injunction, the public interest is served, and plaintiffs face irreparable harm, the Court finds that the plaintiffs meet the requirements for a Preliminary Injunction.
32

The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy. Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.
An appropriate Order accompanies this Opinion.
33

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

_________________________________

)

JOHN DOE #1, et al,

)

)

Plaintiffs, )

)

v.

) Civil Action No. 03-707 (EGS)

)

DONALD H. RUMSFELD, et al

)

)

Defendants. )

_________________________________)

ORDER Pursuant to Fed. R. Civ. P. 65 and for the reasons stated by the Court in its Memorandum Opinion docketed this same day, it is this 22nd day of December, 2003, hereby

ORDERED that the Motion for a Preliminary Injunction is GRANTED. In the absence of a presidential waiver, defendants are enjoined from inoculating service members without their consent; and it is

FURTHER ORDERED that defendants are directed to file responsive pleadings by January 30, 2004; and it is

FURTHER ORDERED that an Initial Scheduling Conference is scheduled for March 9, 2004 at 10:00 a.m. Pursuant to LCvR 16.3 of the Local Rules and Fed. R. Civ. P. 26(f) counsel shall meet and confer by no later than February 24, 2004 and submit their Report addressing all topics listed in LCvR 16.3(c) by no later than March 2, 2004.

Signed:

Emmet G. Sullivan United States District Judge December 22, 2003

34

 
 Page 1
View U.S. District Court Opinion
JOHN DOE #1, JOHN DOE #2, JOHN DOE #3, JOHN DOE #4, JANE DOE #1, JANE DOE #2 c/o Mark S. Zaid, Esq. 1133 21 st Street, N.W.Suite 800 Washington, D.C.
20036 and OTHER SIMILARLY SITUATED INDIVIDUALS, Plaintiffs, vs. DONALD H. RUMSFELD, SECRETARY OF DEFENSE DEPARTMENT OF DEFENSE 1000 Defense Pentagon Washington, D.C. 20301 and TOMMY THOMPSON SECRETARY OF HEALTH AND HUMAN SERVICES 200 Independence Avenue, S.W.Washington, D.C. 20201, and MARK B. McCLELLAN, COMMISSIONER FOOD AND DRUG ADMINISTRATION 5600 Fishers Lane Rockville, Maryland 20857-0001, Defendants.
No. 03-707
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378
March 18, 2003
Complaint
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s)
TITLE: [*1] COMPLAINT
TEXT: Plaintiffs John Doe #1, John Doe #2, John Doe #3, John Doe #4, Jane Doe #1 and Jane Doe #2, on behalf of themselves and all other similarly situated individuals, file this action against defendants Donald Rumsfeld, Secretary of Defense, Department of Defense ("DoD"), Tommy Thompson, Secretary of Health and Human Services, Department of Health and Human Services, and Mark B. McClellan, Commissioner, Food and Drug Administration, seeking temporary and permanent injunctive relief from the DoD's anthrax vaccination program, as well as a declaratory judgment that Anthrax Vaccine Adsorbed (" AVA"), currently being involuntarily administered to active and Reserve U.S. Armed Forces members and DoD civilian employees, is an investigational new drug ("IND"), as defined by 21 U.S.C. § 355, or a drug unapproved for its intended use, pursuant to 10 U.S.C. § 1107, Executive Order 13139, DoD Directive 6200.2, and 21 C.F.R. § 201.5 and is being administered to United States service members and federal employees in violation of federal law. Plaintiffs seek this relief pursuant to the Administrative Procedures Act, 5 U.S.C. § 551, [*2] et seq., the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 and the All Writs Act, 28 U.S.C. § 1651.
PARTIES 1. Plaintiffs are active duty service members, National Guardsmen and DoD civilian contract employees who have been ordered, or will imminently be ordered, to take AVA as part of their military duties or employment obligations. Similarly situated individuals include current members of the active duty and selected Reserve members of the Armed Forces and current civilian DoD employees and contractors who have been ordered, or will imminently be ordered, to

2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378, *2

Page 2

take the vaccination series.
2. Defendant Department of Defense, represented by the Secretary of Defense, is the principal user of AVA. By order of the Secretary of Defense, the DoD has, since 1998, engaged in the practice of mass inoculations of active duty and reserve members of the Armed Forces, and civilian employees, without seeking the informed consent of those individuals prior to giving the vaccination. The Secretary of Defense is personally responsible for compliance with his own directives.
3. The DoD was and is heavily involved in the manufacturing [*3] and licensing process for the AVA and is considered the de facto manufacturer of AVA by Defendant Food and Drug Administration.
4. Defendant Department of Health and Human Services ("HHS") through its agent, Defendant Food and Drug Administration ("FDA"), is the federal agency responsible for licensing and quality control of drugs and biologic products, such as vaccines like the AVA. The FDA is responsible for promulgating federal regulations that describe what makes a drug or vaccine an "IND" and how a drug is placed in IND status.
JURISDICTION AND VENUE
5. There is a legitimate matter in controversy between the named parties because Plaintiffs claim that AVA is a) an IND, b) an unlicensed or improperly licensed vaccine, and c) being used "off label", requiring the Secretary of Defense and DoD to secure Plaintiffs' informed consent before DoD may administer AVA to them. The AVA manufacturer has submitted an IND application for the AVA to amend the license, rendering AVA an IND in circumstances germane to this action. The FDA has not spoken on this issue and to date, its agents have issued only personal opinions with no legal effect concerning the status of the vaccine. [*4]
6. Plaintiffs will suffer substantial and irreparable injury if they are forced to take the vaccine, as a result of FDA's failure to define AVA's status as an IND and because of DoD's failure to follow presidential orders and federal law requiring informed consent prior to the administration of an IND to members of the Armed Forces.
7. Jurisdiction is proper in this Court under the Administrative Procedures Act, 5 U.S.C. § 702, and under 28 U.S.C. § 2201, which states that actions involving controversies with federal agencies may be pursued in any United States District Court, and under 28 U.S.C. §§ 1331 and 1346.
FACTUAL BACKGROUND
A. Anthrax Vaccine Adsorbed
8. AVA was originally licensed as a vaccine against anthrax on November 2, 1970 by the United States Public Health Service.
9. The vaccine was licensed as a preventive for anthrax for "individuals who may come in contact with imported animal hides, furs, bone meal, wool, hair (especially goat hair), and bristles; for all personnel and factories handling these materials and for individuals contemplating investigational studies involving [*5] Bacillus anthracis." See Attachment A, Anthrax Vaccine Adsorbed product insert, December 1979.
10. A 2002 product insert revision (the AVA is referred to as "BioThrax") stated that:
BioThrax is indicated for the active immunization against Bacillus anthracis of individuals between 18 and 65 years of age who come in contact with animal products such as hides, hair or bones that come from anthrax-indemic areas, and that may be contaminated with Bacillus anthracis spores. BioThrax is also indicated for individuals at high risk of exposure to Bacillus anthracis spores such as veterinarians, laboratory workers, and others whose occupations may involve handling potentially infected animals or

2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378, *5

Page 3

other contaminated materials. Since the risk of anthrax infection in the general population is low, routine immunization is not recommended. See Attachment B, 2002 Anthrax Vaccine Adsorbed Product Insert.
11. The license for AVA states that "primary immunization consists of three subcutaneous injections, 0.5mL each, given two weeks apart followed by three additional subcutaneous injections, 0.5 mL each given at 6, 12 and 18 months." Id.
12. In 1985, the DoD (through [*6] the Department of the Army) issued a Request for Proposals ("RFP") No. DAMD17-85-R-0078 soliciting the development of a new anthrax vaccine. The Request for Proposals stated that there was no vaccine in current use which would safely and effectively protect military personnel against exposure to anthrax. The Request for Proposals noted that AVA was highly reactogenic, required multiple boosters to maintain immunity, and might not protect against all strains of anthrax. See Attachment C, RFP DAMD17-85-R-0078.
B. FDA Failure to Finalize AVA Licensing
13. In 1985, as part of an FDA biologic and drug licensing review, the Biologics Review Panel, an independent advisory panel to the FDA, recommended that the FDA classify the AVA as "not misbranded". The FDA issued a Proposed Rule to adopt the Panel's recommendations and finalize FDA approval of the AVA license. However, FDA failed to complete the process and, as of yet, has not issued any final rule or labeling status for AVA. See Attachment D, August 28, 2002 letter to Russell Dingle in response to Citizen Petition Docket No. 01P-0471/CP1 ("Response to Citizen Petition").
14. FDA's failure to finalize the Proposed Rule means [*7] that the AVA is not a properly licensed vaccine under FDA regulations.
C. AVA is Not Licensed for Use Against Inhalation Anthrax
15. In addition, on December 13, 1985, as part of its license review process, the FDA published a specific product review of the AVA, stating that the vaccine's "efficacy against inhalation anthrax is not well documented . . . no meaningful assessment of its value against inhalation anthrax is possible due to its low incidence." See Attachment E, Federal Register, December 13, 1985.
16. In early 1990, the AVA manufacturer, then the Michigan Department of Public Health ("MDPH"), modified its production process for AVA to accommodate DoD needs. U.S. Army medical research personnel from Fort Detrick, Maryland, determined in October 1990, that these changes in the AVA manufacturing process resulted in a 100-fold increase in AVA protective antigen levels. See Attachment F, Testimony of Nancy Kingsbury, United States General Accounting Office, before the Sub-Committee on National Security, Veterans' Affairs and International Relations, Committee on Government Reform, House of Representatives, October 23, 2001, Page 5-6.
17. In March 1990, Army doctors [*8] Colonel Ernest T. Takafuji and Colonel Phillip K. Russell described AVA as a "limited use vaccine" and an "unlicensed experimental vaccine" in an article, "Military Immunizations: Past, Present and Future Prospects", published in Infectious Disease Clinics of North America.
18. In 1995 the Army contracted with the Science Applications International Corporation ("SAIC") to develop a plan to obtain FDA approval for a license amendment for AVA. The purpose of the license amendment was to add aerosolized anthrax exposure to the product license and to enable the manufacturer of AVA to list on the product license that AVA was effective against inhalation anthrax.
19. The SAIC license amendment plan, ultimately adopted by the Army, states that AVA is not licensed as protection for aerosol anthrax exposure as expected in a biological warfare environment. See Attachment G, October 5, 1995 License Amendment Plan.

2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378, *8

Page 4

D. The AVA Becomes an Investigational New Drug
20. On October 20, 1995, the Army Joint Program Office for Biological Defense met to begin the process of obtaining the FDA license modification to include an indication that AVA was effective against inhalation anthrax. [*9] At the meeting, the participants noted that studies of AVA effectiveness in people working in tanneries showed protection against skin contact anthrax, but that there was insufficient data to demonstrate protection against inhalation anthrax. See Attachment H, Minutes of October 20, 1995 Meeting.
21. On August 26, 1996, as a precursor to changing the AVA license by filing an investigational new drug application, the Army's Medical Research Institute of Infectious Diseases ("USAMRIID") discussed the purpose of the IND application by saying, "We wish to obtain an indication for protection against inhalation anthrax and to reduce the number of doses to two primary doses with a booster due at one year. These two goals will be studied and discussed as separate issues." See Attachment I (Col. Arthur O. Anderson, Chairman, USAMRIID Human Use Committee), "Comparative Study of the Safety and Immunogenicity of Two-Dose Priming Schedule of Human Anthrax Vaccine," August 26, 1996.
22. On September 20, 1996, as part of the Army/SAIC plan, the AVA manufacturer, Michigan Biologic Products Institute ("MBPI", the successor to MDPH) submitted to the FDA an investigational new drug application [*10] for AVA. The application was prepared, in whole or in part, by a U.S. Army agency located at Fort Detrick, Maryland.
23. The manufacturer's stated purpose for filing the IND application was to "conduct clinical investigations designed to investigate changes in the approved labeling for the licensed product. The potential labeling changes would affect the specific clinical indication, route and vaccination schedule for AVA." See Attachment J, September 20, 1996, MBPI Letter to Dr. Kathryn C. Zoon.
24. The Introductory Statement from the IND application states that "the ultimate purpose of this IND is to obtain a specific indication for inhalation anthrax and a reduced vaccination schedule." See Attachment K, IND Introductory Statement.
25. The submission of the IND application was accompanied by a testing protocol designed to demonstrate effectiveness against inhalation anthrax in animals and correlate that effectiveness with comparable effectiveness in human subjects.
26. FDA regulations found at 21 C.F.R § 312 address the requirements for IND status for biologic products such as AVA.
27. Under FDA regulations, a drug may be placed in investigational new drug status, even when [*11] the drug is properly licensed for use, if the drug is used for a different purpose or in a different manner than that specified in the license.
28. Under FDA regulations, a drug is placed in investigational new drug status when a manufacturer files an investigational new drug application seeking a product license change reflecting a different use for the product.
29. Under FDA regulations, a manufacturer which files an IND application seeking to change the license for a vaccine to show the vaccine as effective against a different method of infection uses the vaccine in IND status if the vaccine is used for the purpose for which the license amendment is sought.
30. The investigational new drug application filed by MBPI sought a license amendment for AVA stating that AVA is effective against inhalation anthrax.
31. On December 13, 1996, the FDA sent a letter to the Department of the Army, following the Army's publishing of an advertisement in the Washington Post on October 15, 1996, seeking experimental test subjects for the

2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378, *11

Page 5

investigation proposed in the AVA IND application. The December 13 letter advised the Army agency that it could not represent the vaccine as fully licensed when [*12] the Army was conducting tests pursuant to an IND application. Specifically, the letter advised the Army that the vaccine was not licensed for the indication for which the IND application was filed. See Attachment L, FDA letter of December 13, 1996.
32. The only indication for which the AVA IND application was filed was for inhalation anthrax.
E. DoD Uses AVA as an IND
33. In December 1997, DoD announced a multi-service vaccination program for all active duty, Reserve and National Guard service members using the AVA as a preventative for inhalation anthrax.
34. As part of this program, Plaintiffs and those similarly situated to them were ordered to submit to involuntary anthrax vaccinations.
35. If they refuse to comply with orders to take the AVA inoculations, Plaintiffs and those similarly situated to them will be subject to military disciplinary actions, including courts-martial convictions, forfeitures of pay and allowances, incarceration, bad conduct discharges, and administrative separation from the Armed Forces. Civilian Plaintiffs will be fired from their positions as DoD employees.
36. In December 1997, the Joint Program Office for Biological Defense, an agency [*13] of Defendant Department of Defense, noted that "Anthrax and Smallpox are the only licensed vaccines that are useful for the biological defense program, but they are not licensed for a biological defense indication." See Attachment M, Appendix G, "Industrial Capabilities Assessment Summary Report for the Production of the Anthrax Vaccine, Preliminary Report," December 1997, Joint Program Office for Biological Defense, Falls Church, Virginia.
37. The AVA IND application submitted by MBPI (now BioPort) has been supplemented and remains current and pending. See Attachment N, IND Application Supplements.
38. BioPort's subsequent submissions as part of the IND application process indicate that the license modification being sought is currently only for inhalation anthrax. Id.
39. The DoD inoculation program currently underway is specifically designed to inoculate members of the Armed Forces against inhalation anthrax, which has a high mortality rate and is identified by DoD as a military threat.
40. The use of AVA for a purpose which is the subject of a currently pending IND application, i.e. as a preventative against inhalation anthrax, means that DoD is using AVA as an IND. [*14]
41. By Memorandum of Decision dated April 1998, Army Secretary Togo West, Jr. took steps to approve a request to indemnify the anthrax vaccine manufacturer, Michigan Biologic Products Institute (the predecessor to the current manufacturer, BioPort) against all liability arising from "the unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the AVA." The indemnification concerns, according to Secretary West, were a result of the limited use of the vaccine on too small a scale to permit accurate assessments of types and severities of adverse reactions and, insufficient experience in mass immunization programs to evaluate the efficacy of the vaccine. See Attachment O, Indemnification Agreement.
42. By Memorandum of Decision dated September 3, 1998, Army Secretary Louis Caldera again authorized indemnification of the AVA manufacturer because:
the obligation assumed by MBPI under this contract involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients. The size of the [*15] proposed vaccination program may

2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378, *15

Page 6

reveal unforewarned idiosyncratic adverse reactions. Moreover, there is no way to be certain that the pathogen used in tests measuring vaccine efficacy will be sufficiently similar to the pathogen that U.S. forces might encounter to confer immunity.
F. DoD Deviates From the AVA License Requirements
43. On September 29, 1999, Dr. Kathryn Zoon, Director, FDA Center for Biologic Evaluation and Research, wrote to Dr. Sue Bailey, Assistant Secretary of Defense Health Affairs and stated:
We reiterate our previous statement made to DoD on December 16, 1997, that FDA approval of the anthrax vaccine is based on the six-dose regimen found in the approved labeling. Because we are unaware of any data demonstrating that any deviation from the approved intervals of doses found in the approved labeling will provide protection from anthrax infection, we strongly recommend that the Anthrax Vaccine Immunization Program follow FDA approved schedule.
See Attachment P, September 29, 1999 Letter to Bailey.
44. In July, 2000, DoD announced the first of several reductions in the scope of the AVIP because of a failure by Bioport Corporation to [*16] meet federal manufacturing standards. DoD stated that it was suspending AVA vaccinations for all but a limited number of personnel because of a shortage of the vaccine.
45. As part of this suspension, DoD announced that members of the Armed Forces who had received at least one of the sequence of six vaccinations required by the AVA product license would be subject to a modified vaccination schedule that is inconsistent with the vaccination schedule required by the AVA license. Specifically, DoD announced that members who had received one or more vaccinations, but who had not completed the six shot sequence of vaccinations, would not be required to restart the inoculation sequence as long as they received a subsequent shot within two years of their last vaccination.
46. DoD formally resumed the AVIP in June, 2002. On August 6, 2002, DoD published policy guidance to component services. In part, the guidance stated that, "Those individuals that have had their doses deferred shall resume the series when directed . . . . " See Attachment Q, August 6, 2002, Memorandum on Policy on Administrative Issues Related to the Anthrax Vaccine Immunization Program (AVIP).
47. On October 11, 2002, the [*17] Chief of Staff, United States Air Force, promulgated an AVIP policy and guidance for all active duty and reserve units. The policy states, in Annex B, Paragraph 4b:
The Anthrax vaccine is a six dose schedule [sic] followed by an annual booster. The vaccine doses are given at 0, 2 and 4 weeks, followed by doses at 6, 12, and 18 months, and an annual booster thereafter. The vaccine must be given in accordance with the above dosing schedule, as approved by the Food and Drug Administration (emphasis in original).
48. Notwithstanding the guidance to follow the licensed vaccination schedule, Paragraph 4c of Annex B states:
Personnel whose vaccination series was interrupted during the previous AVIP slowdown will not need to repeat any doses already received in the vaccine series or receive extra doses. Once these individuals are identified as requiring the vaccine, they will just continue with the next dose in the series. Upon information and belief, similar policies have been adopted by all other military services.
49. The deviation from the licensed application schedule for AVA and the use of AVA in a mass inoculation effort represent new uses of the AVA by DoD. [*18] Indeed, DoD is currently seeking test subjects to validate its practice of altering the shot sequence.

2003 U.S. Dist. Ct. Pleadings 707; 2003 U.S. Dist. Ct. Pleadings LEXIS 378, *18

Page 7

50. Such new uses of a product that are not in accordance with product labeling render the AVA "investigational" under FDA regulations and makes the AVA a drug "unapproved for its intended use" under 21 C.F.R. § 201.5, and subject to the requirements of 10 U.S.C. § 1107 (2000), Executive order 13139 and DoD Directive 6200.2.
G. Federal Law and Regulations Prohibit the Use of INDs Without Informed Consent of Recipients
51.10 U.S.C. § 1107 (2000) provides that investigational new drugs or drugs unapproved for their intended uses may not be given to members of the Armed Forces without their prior consent except in the case of a waiver by the President of the United States.
52. Similarly, Executive Order 13139 states that before administering an investigational drug or a drug unapproved for its intended use to members of the Armed Forces, the DoD must obtain informed consent from each individual unless a waiver of this requirement is signed by the President of the United States.
53. A judicial declaration that AVA is an IND [*19] does not preclude the use of AVA by DoD, as long as the appropriate consent or waiver is obtained.
54. DoD has adopted the requirements of 10 U.S.C. § 1107 and Executive Order 13139 and set up procedures to follow these requirements in DoD Directive 6200.2 dated August 1, 2000.
55. The FDA has never approved the AVA for use against inhalation anthrax.
56. The FDA has never issued an agency opinion that DoD's use of AVA is consistent with AVA license requirements, or that the AVA is being used in accordance with the current license for the product.
57 Peer-reviewed statistical analysis of adverse reactions associated with AVA vaccinations published by research physicians indicates substantial increases in joint-related medical conditions such as arthralgia, arthritis, myalgia, and others following AVA vaccination.
58. A similar analysis of adverse events for AVA shows a substantial increase in gastrointestinal adverse reactions as well.
59. Moreover, informed consent documents provided by the Center for Disease Control to civilian postal workers and congressional staff in the Fall of 2001 indicated adverse reactions including death, birth defects and a [*20] wide range of autoimmune disorders that were not included in the then-current March 1999 FDA-approved package insert. These adverse reactions were never disclosed to service members subject to mandatory vaccinations with AVA. The Center for Disease Control is a subordinate entity of Defendant Department of Health and Human Services.
60. In January 2002, the FDA-approved product insert for AVA was modified to include the above adverse reactions such as death, birth defects and autoimmune disorders, consistent with the informed consent provided to civilians in the Fall of 2001. The new FDA-approved package insert also changed the "use in pregnancy" rating from Category C ("risk cannot be ruled out") to Category D ("positive evidence of risk"). This information has not been provided to service members, and service members are not provided with a copy of the FDA-approved package insert prior to mandatory vaccination.
FIRST CAUSE OF ACTION
(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
61. Plaintiffs reallege the facts in Paragraphs 1 through 60 as if fully set forth in this Count.
62. Defendant Department of Defense will inoculate Plaintiffs with the AVA within the immediate [*21] future. Defendant Department of Defense notified Plaintiffs that they will be ordered to submit to AVA inoculation shortly, in

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some cases within 30 days.
63. The submission of an Investigational New Drug application by DoD and BioPort for AVA for inhalation anthrax renders the drug an investigational new drug if used as a preventative against inhalation anthrax.
64. The Department of Defense's actions in ordering Plaintiff's to submit to vaccination with an investigational new drug, without seeking the Plaintiff's informed consent, violate a federal statute, namely 10 U.S.C. § 1107, as well as Executive Order 13139 and DoD Directive 6200.2.
65. The Defendant's failure to follow federal law, a presidential executive order and DoD regulations in its AVIP creates a legal wrong against the Plaintiffs. Plaintiffs are entitled to seek review of Defendant's actions under the Administrative Procedure Act, 5 U.S.C. § 702.
SECOND CAUSE OF ACTION
(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
66. Plaintiffs reallege the facts in Paragraphs 1 through 60 as if fully set forth in this Count.
67. Defendant's use of an unlicensed or [*22] improperly licensed vaccine is a violation of Food and Drug Administration regulations found at 21 C.F.R. § 312, and a violation of the Food and Drug and Cosmetic Act, 21 U.S.C. § 301, et seq., and also means that DoD is using a drug unapproved for its intended use. DoD's actions violate 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2.
68. Defendant's intent to inoculate Plaintiffs with an unlicensed drug, unapproved for its intended use, is a legal wrong against Plaintiffs, entitling them to judicial review under the Administrative Procedure Act, 5 U.S.C. § 702.
THIRD CAUSE OF ACTION
(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
69. Plaintiffs reallege the facts in Paragraphs 1 through 60 as if fully set forth in this Count.
70. The Defendant's alteration of the licensed and FDA-approved schedule of vaccinations and use of AVA in a mass inoculation program renders the AVA a drug unapproved for its intended or applied use within the meaning of 21 U.S.C. § 355; 10 U.S.C. § 1107, 21 C.F.R. § 201.5, Executive Order 13139 and DOD Directive [*23] 6200.2.
71. Defendant's intent to inoculate Plaintiffs with the AVA according to an unlicensed and unapproved vaccination schedule, is a legal wrong against Plaintiffs, entitling them to judicial review under the Administrative Procedure Act, 5 U.S.C. § 702. WHEREFORE, Plaintiffs and those similarly situated to them respectfully ask this Court to:
A. Find and declare that AVA, as it is being used by Defendants, is an investigational new drug within the meaning of 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2;
B. Find and declare that AVA has been in investigational new drug status since the original investigational new drug application was filed on September 20, 1996;
C. Find and declare that as a result of the unilateral change in vaccination schedule by Defendant in June, 2000, the AVA is a drug unapproved for its intended use within the meaning of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2, as of June, 2000;
E. Find and declare that AVA is an unlicensed or improperly licensed biologic product under FDA regulations and, therefore, is a drug unapproved for its intended [*24] use within the meaning of 10 U.S.C. § 1107, Executive Order

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13139 and DoD Directive 6200.2; F. Enjoin Defendant from inoculating Plaintiffs and those similarly situated to them without Plaintiffs' informed
consent, or in accordance with the provisions of 10 U.S.C. 1107, Executive Order 13139 and DoD Directive 6200.2; and G. Award Plaintiffs their costs and attorneys' fees and any other relief this Court may find appropriate.
Date: March 18, 2003 Respectfully submitted, John J. Michels, Jr., Esq. D.C. Bar # 457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150 Mark S. Zaid, Esq. D.C. Bar # 440532 Krieger & Zaid, PLLC 1133 21st St., N.W. Suite 800 Washington, D.C. 20036 (202) 223-9050

 
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Go To U.S. District Court Opinion View Original Source Image of This Document
JOHN DOE # 1, JOHN DOE # 2, JOHN DOE # 3, JOHN DOE # 4, JANE DOE # 1, JANE DOE # 2, c/o Mark S. Zaid, Esq., 1133 21<st> Street, N.W., Suite 800,
Washington, D.C. 20036, and OTHER SIMILARLY SITUATED INDIVIDUALS, Plaintiffs, vs. DONALD H. RUMSFELD, SECRETARY OF DEFENSE,
DEPARTMENT OF DEFENSE, 1000 Defense Pentagon, Washington, D.C. 20301, and TOMMY THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES, 200 Independence Avenue, S.W., Washington, D.C. 20201, and MARK B. McCLELLAN,
COMMISSIONER FOOD AND DRUG ADMINISTRATION, 5600 Fishers Lane, Rockville, Maryland 20857-0001, Defendants. CASE NUMBER 1:03CV00707
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 707; 2003 U.S. Dist. Ct. Motions LEXIS 11124 March 18, 2003 Motion for Temporary Restraining Order
COUNSEL: [*1] John J. Michels, Jr., Esq., D.C. Bar # 457575, McGUIREWOODS LLP, 77 W. Wacker, Suite 4400, Chicago, Illinois 60601, (312) 849-8150. Mark S. Zaid, Esq., DC Bar # 440532, Krieger & Zaid, PLLC, 1133 21<st> St., N.W., Suite 800, Washington, D.C. 20036, (202) 223-9050. JUDGES: JUDGE: Emmet G. Sullivan TITLE: MOTION FOR TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION TEXT: Plaintiffs John Doe # 1, John Doe # 2, John Doe # 3, John Doe # 4, Jane Doe # 1 and Jane Doe # 2, on behalf of themselves and all similarly situated individuals, by their undersigned counsel, move this Court for a Temporary Restraining Order and Preliminary Injunction against defendants in this case to prevent Defendant DoD from inoculating plaintiffs with Anthrax Vaccine Adsorbed ("AVA"), in violation of federal law, a presidential executive order and DoD regulations.
Plaintiff's are entitled to this relief because: a. This matter raises a justiciable claim that defendants are violating federal law, a presidential executive order, and DoD regulations by involuntarily inoculating members of the armed forces with an investigational, unapproved,

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improperly licensed vaccine; b. Plaintiff's will likely succeed [*2] on the merits of their case based on the undisputed evidence concerning the
status of the AVA; c. Plaintiff's face irreparable injury as a result of defendant's illegal inoculation program; d. Defendants will not suffer comparable irreparable harm in that the AVA inoculation program can be continued
under presidential waiver; and e. Public interest militates in favor of granting the injunction. For these and other reasons as set forth in the accompanying Memorandum in Support, and other reasons as may be
developed at hearing, plaintiffs respectfully request this Court grant their motion enjoining the AVA inoculation program in its present form and directing defendants to comply with federal law, Presidential Executive Order and DoD regulations.
Date: March 18, 2003 Respectfully submitted, John J. Michels, Jr. / MSZ John J. Michels, Jr., Esq. D.C. Bar # 457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150 Mark S. Zaid Mark S. Zaid, Esq. DC Bar # 440532 Krieger & Zaid, PLLC 1133 21<st> St., N.W. Suite 800 Washington, D.C. 20036 (202) 223-9050 MEMORANDUM IN SUPPORT OF MOTION FOR TEMPORARY RESTRAINING ORDER AND/OR
PRELIMINARY [*3] INJUNCTION

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Plaintiffs John Doe # 1, John Doe # 2, John Doe # 3, John Doe # 4, Jane Doe # 1 and Jane Doe # 2, on behalf of themselves and all similarly situated individuals, by their undersigned counsel, file this Memorandum in Support of a Motion for Temporary Restraining Order against defendants Donald Rumsfeld, Secretary of Defense, and Department of Defense ("DoD"), to prevent defendant DoD from inoculating plaintiffs with Anthrax Vaccine Adsorbed ("AVA"), under circumstances that violate federal law and federal regulations. As noted in their Complaint, plaintiffs are members of the active duty and selected National Guardsman components of the Armed Forces, and civilian contract employees of defendant DoD who have been or will be imminently or shortly instructed to submit to anthrax vaccination without their consent in violation of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.
Plaintiffs seek this temporary restraining order to prevent irreparable harm to them as a result of being involuntarily inoculated with an experimental vaccine. This Court should grant the motion for a temporary restraining order as well as grant a preliminary [*4] injunction stopping the vaccine program because:
a. Plaintiffs raised a justiciable issue before this court in that the DoD's Anthrax Vaccine Immunization Program ("AVII") violates federal law, a Presidential Executive Order and DoD's own regulations.
b. There is a substantial likelihood plaintiffs will succeed on the merits of their case because there is no dispute that the vaccine is being used as an investigational new drug, and being used in a manner inconsistent with the AVA license, as well as being used in an unlicensed manner;
c. Plaintiff's face irreparable injury as a result of being forcibly and illegally inoculated with an experimental vaccine with substantial health risks;
d. The granting of the injunction will not prevent defendant DoD from continuing with its program in that DoD can require informed consent before administering the inoculation or can seek a presidential waiver of the informed consent requirement; and
e. Public interest will be furthered by granting the injunction because the public has an interest in the military's use of unlicensed and improperly administered vaccines that have already been used in response to public health crises.
FACTUAL [*5] BACKGROUND
Plaintiffs provided the Court with a detailed factual summary in their Complaint filed contemporaneously with this Motion. To summarize, plaintiffs are active duty and reserve members of the armed forces or civilian employees of defendant DoD. Because of their duties, they are being ordered to submit to inoculation with AVA. The plaintiffs must submit to these inoculations, they are not provided the opportunity to exercise informed consent, nor are they provided with product insert information concerning the vaccine.
In September 1996, the AVA manufacturer submitted an Investigational New Drug ("IND") application to defendant FDA seeking to get FDA approval for a modification of the AVA license to show that it was effective against inhalation anthrax. At the time of the IND application, neither defendant DoD nor defendant FDA believed that the AVA was licensed for inhalation anthrax; indeed, the FDA's own product review of AVA stated that the vaccine's efficacy against inhalation anthrax is not well documented and no meaningful assessment of its value against inhalation anthrax was possible due to the disease's low incidence. See Complaint, Attachment E. The IND [*6] application filed in September 1996 remains current and open. Although the AVA product insert has been amended several times since the vaccine was put on the market, there has never been an indication for inhalation anthrax on the label or in the product insert. See Complaint, PP 20-31. n1
n1 In fact, there is still no showing that AVA is effective in humans against inhalation anthrax. Animal studies have repeatedly failed to show a so-called "correlate of immunity" in vaccinated animals that translates into a similar correlate in humans. In other words, the vaccine does things to animals that have no equivalent in

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human beings, and animal studies regarding the effectiveness of the vaccine cannot be used to validate a license change for AVA. See, Official Transcript, "Anthrax Vaccine efficacy Testing and Surrogate Markers of Immunity Workshop", FDA Center for Biologies Evaluation and Research, April 23, 2002.
In 1998, in response to concerns about the use of investigational new drugs during the Gulf War [*7] that may have led to unexplained illnesses among Gulf War veterans, Congress passed 10 U.S.C. § 1107. This statute prohibits the administration of investigational new drugs, or drugs unapproved for their intended use, to service members without their informed consent. Under special circumstances, the President may waive the informed consent requirement upon application by the Secretary of Defense. See 10 U.S.C. § 1107 (2000). In 1999, the President signed Executive Order 13139, which echoes the prohibitions against use of investigational new drugs or drugs unapproved for their intended use on service members without their informed consent. defendant DoD had formally adopted these requirements in DoD Directive 6200.2 on August 1, 2000.
Notwithstanding these requirements, in 1998 defendant DoD initiated and has maintained a mass inoculation program using AVA as a preventative against inhalation anthrax for its service members and civilian employees without informed consent or a presidential waiver. See Complaint, PP 33-35. In addition, defendant DoD has unilaterally altered the shot timing sequence for AVA from its FDA approved [*8] sequence. See Complaint, PP 43-49. Under these circumstances, the vaccine becomes a drug unapproved for its intended use within the meaning of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2 and may not be administered without informed consent or a presidential waiver.
Finally, FDA recently admitted in a response to a citizen petition that it has never finalized the licensing review for AVA undertaken during the 1970s and reported out in 1985. Specifically, the FDA admits that it failed to issue a final rule or labeling status for AVA following the recommendation of its Biologies Review Panel. This failure by the FDA to finalize the proposed rule means that the vaccine is not properly licensed and, therefore, unapproved for its intended use, again, within the meaning of 10 U.S.C. § 1107, the Executive Order and the DoD Directive. See Complaint, PP 13-14.
Although 10 U.S.C. § 1107 itself seeks to prevent harm that may not develop for years as a result of experimental drugs or vaccines, there are already indications that AVA is creating irreparable health effects. For example, the AVA [*9] product insert, which originally stated that the adverse reaction rate to the vaccine was .2%, was recently revised (based on the adverse medical reactions to AVA in the U.S. military force) to reflect an adverse reaction rate of between 5% and 35%. At least six deaths have been linked to the vaccine and the vaccine's pregnancy use risk has been upgraded from a Category C (risk cannot be ruled out) to Category D (positive evidence of risk).
In other words, service men and women receiving involuntary inoculations with AVA face substantial health risks at a rate at least twice the rate of projected fatalities or serious reactions from another bioweapon vaccine, smallpox.
Because of the way DoD is using the vaccine, and because it is under a current Investigational New Drug application for inhalation anthrax, the vaccine is clearly investigational and unapproved for its intended use. Its continued involuntary administration by DoD violates 10 U.S.C. § 1107, the Presidential Executive Order and DoD's own Directive. For these reasons, the Court should grant the temporary restraining order and grant preliminary injunctive relief.
ANALYSIS
I. THE DEFENSE [*10] DEPARTMENT'S USE OF AVA IN THE AVIP IS JUSTICIABLE
Given the traditional deference accorded to military affairs, courts are required to balance several competing interests in reviewing internal military determinations. McVeigh v. Cohen, 986 F. Supp. 59, 60 (D.D.C. 1998). However, where the military violates a constitutional right, a federal statute, or its own regulations, the military and its

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decisions are subject to judicial review. Id.; Shaw v. Gwatney, 795 F.2d 1351, 1357 (8th Cir. 1986).
A district court called on to examine or review military decisions must analyze and weigh several factors. These factors are enumerated in the seminal case Mindes v. Seamen, 453 F.2d 197 (5th Cir. 1971), affirmed on appeal after remand, 501 F.2d 175 (5th Cir. 1974). The Mindes court determined that a court should not review internal military affairs in the absence of (a) an allegation of the deprivation of a constitutional right or an allegation that the military has acted in violation of applicable statutes or its own regulations, and (b) exhaustion of available intra-service corrective measures. Mindes, 453 F.2d at 201. [*11]
If a plaintiff seeking review of a military decision sufficiently alleges the appropriate violation, and exhaustion of administrative remedies, or if no such remedies are available, the court must then examine the substance of the allegations in light of the policy reasons that militate in favor of not reviewing military decisions. Id. The Mindes court determined there were four factors that a court must analyze:
(1) The nature and strength of the plaintiff's challenge to the military determination. An obviously tenuous claim of any sort must be weighted in favor of declining review.
(2) The potential injury to the plaintiff if review is refused.
(3) The type and degree of anticipated interference with the military function. Interference that would "seriously impede the military in the performance of vital duties" militates strongly against relief.
(4) The extent to which the exercise of military expertise or discretion is involved. Courts should defer to superior knowledge and experience of professionals in matters such as military personnel decisions or other areas that relate to specific military functions.
Id.
Plaintiffs in this case [*12] have no difficulty meeting all of the Mindes factors. Accordingly, this Court should exercise its jurisdiction over plaintiffs' claims and grant their motion for a temporary restraining order and preliminary injunction as requested.
As a threshold matter, plaintiffs allege not only a violation of a statute, but a Presidential Executive Order and the military's own service regulations. Any single one of these allegations is sufficient to meet the initial requirement under Mindes. See, e.g., McVeigh, 996 F. Supp. at 60.
With regard to the second preliminary inquiry, that plaintiffs show that they have exhausted applicable administrative remedies prior to bringing their action, it is well settled that federal courts cannot require a plaintiff to exhaust available administrative remedies before seeking judicial review under the Administrative Procedures Act. See e.g., Darby v. Cisneros, 509 U.S. 137, 153-4 (1993).
In addition, neither the statute in question, the Administrative Order, nor the DoD Directive require an aggrieved service member to appeal an order to subject themselves to involuntary inoculation to a higher authority. Indeed, in its [*13] rush to inoculate the Armed Forces, defendant DoD has summarily and rapidly disciplined soldiers, sailors and airmen who have refused to take the shot. See, e.g., Ponder v. Stone, 54 M.J. 613 (N-M Ct. Crim. App. 2000); Perry v. Wesley, No. NMCM 200001397, 2000 WL 1775249 (N-M Ct. Crim. App. Nov. 29, 2000).
Moreover, this is not a situation where a service member can simply request her disciplinary records be expunged, that she receive appropriate back pay and allowances, or have a bad performance report removed from her permanent record. The harm resulting from DoD's violation of the statute and regulations in question is immediate and permanent, resulting from inoculation with an untested vaccine. In short, there are no administrative remedies to exhaust for a

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service member faced with what is palpably an illegal order. Accordingly, plaintiffs readily satisfy the second prong of the Mindes analysis.
Having determined that the initial allegations are sufficient, this Court must then turn to the four-factor analysis delineated in Mindes. These factors, comparable to a test for a preliminary injunction, readily show that this case is appropriate [*14] for judicial intervention and remedy.
A. The AVIP is being administered in violation of federal law, a presidential executive order, and a DoD directive
The first factor is the nature and strength of the plaintiffs' challenge to the military program or determination. It would be difficult to imagine a more conclusively established case than the one plaintiffs present in their Complaint. plaintiffs provide this Court with fact after undisputed fact, substantiated by the government's own documents and declarations, that the vaccine is being used in an investigational status, that it is being used in a manner that is inconsistent and unapproved by its current labeling, and that the vaccine is not properly licensed by the FDA.
1. The AVA is being used as an investigational new drug
The vaccine's status as an investigational new drug is conclusively established by the Investigational New Drug Application filed by the manufacturer in September, 1996. See Complaint, PP 21-25.
The purpose of the application is undisputed -- it is to conduct experiments to make up for a previously identified deficiency in the vaccine licensing, namely that there is insufficient evidence [*15] that the vaccine works against inhalation anthrax. See Complaint, PP 13-15.
Once the Investigational New Drug Application is filed, there is no dispute that the vaccine is not considered licensed if it is used in a manner consistent with the IND application. The FDA itself advised the Army of this in a December 13, 1996 letter. The Army published an advertisement in the Washington Post on October 15, 1996, seeking experimental test subjects as part of the AVA IND application. The Army noted in the advertisement that the AVA was fully licensed. The FDA's letter to the Army strongly criticizes the Army for describing the vaccine as fully licensed and advises the Army that the vaccine is not licensed for the indication for which the IND application was filed, namely as a preventative against inhalation anthrax.
The undisputed status of the AVA as an investigational new drug, based on the application and the FDA's contemporaneous interpretation of the application, make a substantial likelihood that plaintiffs will succeed on the merits of proving a violation of 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2.
2. The AVA is a drug unapproved [*16] for its intended use
The AVIP has had a rocky road from its inception. The program itself was virtually shut down in July of 2000, after the FDA effectively closed down the BioPort manufacturing facility, preventing additional lots of vaccine from being produced. The resulting shortage caused DoD to suspend the mass inoculation program it began in 1998. For many of the vaccine recipients, this meant stopping the vaccine administration in mid-sequence. Rather than reinitiate the sequence in accordance with the FDA approved license, defendant DoD has elected to start the sequence of shots as if no hiatus occurred. Service members who received their last vaccination more than two years ago will pick up the sequence of shots as if they were still meeting the labeled requirements.
FDA representatives warned DoD that deviation from the shot schedule was not approved. See Complaint, P 43 and attachment.
Accordingly, there is a substantial likelihood that plaintiffs will succeed in showing that DoD is currently using AVA in a manner unapproved by its license and its intended usage and, therefore, is in violation of 10 U.S.C. § 1107,

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Executive Order 13139 and [*17] DoD Directive 6200.2.
3. AVA is not properly licensed
In a response to a citizen petition, the FDA admitted in August 2002 that it had not completed its licensing review of AVA. Incredibly, the failure of the FDA to properly complete the licensing for the vaccine goes back more than 30 years. In 1972, Congress directed that the FDA be given authority to regulate biological products, i.e., vaccines, from the National Institute of Health (Public Health Service). As part of this new responsibility, in 1973 FDA initiated a comprehensive review of the safety, effectiveness and labeling of all licensed biologics. Biologics review panels recommended to FDA that the agency classify individual biological products as either safe, effective and not misbranded (so-called Category I); safe, ineffective or misbranded (Category II); or insufficient information to classify, further testing required (Category III). After reviewing each panel's recommendations and conclusions, FDA published a proposed order to classify the biological products under review. After providing an opportunity for public comment, FDA then issued a final order with final product classifications. See generally, Complaint, [*18] P 13, and attachment.
Failure to complete this process essentially means that the FDA failed to complete its review of the product license. In 1985, the panel reviewing AVA concluded the vaccine was safe, effective and not misbranded, although it also noted that there was no basis for determining that the vaccine worked against inhalation anthrax. n2 Although the proposed rule issued on December 13, 1985, FDA failed to issue a final rule for the AVA. It has yet to do so. See generally, Complaint Attachment D, August 28, 2002 letter to Russ Dingle, Citizen Petition Response.
n2 The panel also noted that there was a disparity between the number of shots required for effective vaccination. Apparently, one source noted that three shots were the prescribed dose, while another source stated that six shots, the current licensed dosage, was effective treatment.
The failure of the FDA to finalize its proposed rule making and properly certify AVA is undisputed proof that, unlike other commercially available biologics, [*19] the vaccine is not properly vetted and, therefore, not fully licensed by the FDA. The AVA has not completed the FDA's certification process and, therefore, cannot be approved for the mass inoculation program undertaken by defendant DoD without compliance with 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2.
B. Plaintiffs Will Suffer Irreparable Harm in Violation of Federal Law
The second factor to be weighed by the Court is the potential injury to the plaintiff if the Court refuses to review the military action. It cannot be emphasized enough that the harm in this case to plaintiffs, and to those similarly situated to them, is irreparable.
10 U.S.C. § 1107 was enacted in response to the use of investigational new drugs on service members during the Gulf War. n3 The medical implications and issues concerning the involuntary inoculation of service members with investigational drugs during the Gulf War are still being heavily debated by the medical community. Recognizing that harm from use of investigational medications might not be immediately apparent, 10 U.S.C. § 1107 was passed and signed [*20] into law to prevent the military from using experimental or untested medications on service members, except with informed consent by the service member or in cases where such use was required by military necessity. In those limited cases, of military necessity, a Presidential waiver is required to involuntarily inoculate service members. The loss of the right to informed consent, granted specifically by the statute, is irreparable harm in and of itself and suffices to satisfy the standard for a preliminary injunction.
n3 See generally, Rand Report on Interim Rule and Byrd Amendment located at www.Rand.org/publications/MR/MR1018.9/.

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In addition, service members are now faced with the prospect of being injected with an improperly licensed, untested and unapproved vaccine with ramifications that are completely unknown in both the near and far term. This risk of harm is not speculative; the informed consent documents provided to civilian employees as a result of anthrax mailings in the Fall of 2001 clearly [*21] identify side effects such as Guillain-Barre Syndrome, multiple sclerosis, angioedema, aseptic meningitis, severe injection site inflammation, diabetes, and systemic lupus erythmatosis. In addition, the pregnancy risk assessment for AVA has recently been upgraded from Category C to Category D, indicating a definitive risk for servicewomen who are pregnant at the time of the inoculation.
Finally, the Court should not be deterred from a finding of irreparable harm based on a lack of conclusive medical evidence that the vaccine causes debilitating illness, fertility problems, and even death. The prohibitions contained in 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2 were put in place to obviate precisely this issue. Congress, knowing that the epidemiology of the effects of experimental medications is often difficult, time consuming and may not be resolved for years after administration of the subject drug, enacted 10 U.S.C. § 1107 to prevent this problem from arising in the first place. The irreparable harm suffered by service members subjected to this vaccine is the loss of their statutory rights to informed consent, [*22] or to at least have the President make a formal determination that the use of the vaccine trumps those informed consent rights. Once the soldiers are injected with the vaccine without their consent, and without a presidential waiver, the irreparable harm has occurred.
C. There will be virtually no interference with the military's ability to vaccinate service members if the court grants Plaintiffs' motions
The third factor under Mendes for the Court to consider is the type and degree of anticipated interference with the military function resulting from the requested action. In fact, the granting of the requested injunctive relief does not bar defendant DoD from administering the vaccine to U.S. troops. If DoD believes that anthrax vaccination is militarily necessary for its forces, the Secretary of Defense can formally request a waiver of the informed consent requirement by the President. Such a request could be made and granted within a matter of hours, and the program will continue. The Court should give no consideration to any arguments by defendants that granting an injunction will somehow affect military readiness or troop protection. defendant can remedy that situation [*23] easily if it is willing to follow the requirements of the statute and its own directives.
D. Virtually no military discretion is involved in the determination necessary to grant Plaintiffs' motion
The final factor to be considered is the extent to which the exercise of military expertise or discretion is involved in the matter at issue. Mindes, 453 F.2d at 201.
Although courts generally should defer to the superior knowledge and expertise of military members in matters directly related to specific military functions, in this case, Congress has preempted the deference normally given to military decisions about inoculations and use of medications on troops with the passage of 10 U.S.C. § 1107. In fact, there is very little military expertise or discretion in the determination the Court is being asked to make. The military does not have any particular expertise regarding investigational medications, drugs unapproved for their intended use, or unlicensed medications. In fact, the expertise in these areas lies solely with the Food and Drug Administration which has remained virtually silent on this entire issue over the last five years. [*24]
Given the fact that the military can easily maintain its vaccination program by Presidential waiver of informed consent, there would appear to be little impact on the exercise of military discretion, particularly since Congress has seen fit to insert itself into the matter through legislation reinforced by a Presidential Executive Order and DoD's own directive.
II. PLAINTIFFS MEET THE REQUIREMENTS FOR THE GRANTING OF A TEMPORARY

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RESTRAINING ORDER AND PRELIMINARY INJUNCTION
The legal standard plaintiffs must meet in moving for a Temporary Restraining Order or preliminary injunction is not in dispute. "A court considering a plaintiff's request for a preliminary injunction must examine whether: (1) there is a substantial likelihood plaintiff will succeed on the merits; (2) plaintiff will be irreparably injured if an injunction is not granted; (3) an injunction will not substantially injure the other party; and (4) the public interest will be furthered by the injunction." Serono Lab v. Shalala, 158 F.3d 1313, 1317-18 (D.C.Cir 1998). See Sea Containers Ltd. v. Stena AB, 890 F.2d 1205, 1208 (D.C.Cir. 1989); Washington Metro Area Transit Comm'n v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C.Cir. 1977). [*25] The court "must balance the strengths of the requesting party's arguments in each of the four required areas." CityFed Fin. v. Office of Thrift Supervision, 58 F.3d 738, 747 (D.C.Cir. 1995). An injunction may be issued if the arguments in favor of one particular factor are particularly strong "even if the arguments in other areas are rather weak." Id. Therefore, "[a]n injunction may be justified, for example, where there is a particularly strong likelihood of success on the merits even if there is a relatively slight showing of irreparable injury." Id.
The Plaintiffs' arguments relating to the first three requirements for a preliminary injunction are virtually identical to the Mindes factors discussed at length above and plaintiffs will not recount them here. Because plaintiffs make such a strong showing of a likelihood of success on the merits, and irreparable harm, inquiry into the remaining factors should be minimal. The only factor that is not discussed in the Mindes analysis relates to the effect of the proposed action on public policy, plaintiffs discuss this remaining aspect below.
A. Public policy concerns argue in favor of granting the [*26] requested restraining order and injunction
10 U.S.C. § 1107 and its progeny -- Executive Order 13139 and Department of Defense Directive 6200.2 -- were enacted to protect soldiers from involuntarily serving as "guinea pigs" in a mass use of investigational medicine. In fact, defendants' flagrant disregard of statutory and regulatory requirements have already caused over half a million members of the armed forces to be experimental subjects without their consent. The Center for Disease Control informed consent form and recent changes in the licensing inserts for AVA reflect, to a large degree, the experience the manufacturer has gained from DoD inoculating hundreds of thousands of active duty service members over the last five years.
The public policy of the United States, as codified in the Food, Drug and Cosmetic Act, its associated regulations, the establishment of the Food and Drug Administration and its regulatory framework for monitoring drugs and biologic products, and the policies behind 10 U.S.C. § 1107 argue for enjoining a program that ignores the rights of American service members.
DoD's actions are contrary to public [*27] policy as indicated in the above-referenced statutes and regulations. The Court should grant the injunctive relief to insure compliance by the federal government with the laws Congress enacts. Accordingly, there is no basis for opposing the granting of an injunction on public policy grounds; in fact, public policy demands that this program, conducted in violation of federal law, be brought into consonance with that law.
CONCLUSION
Because there is no issue of material fact concerning the status of the vaccine, this Court should grant injunctive relief to plaintiffs and order defendant DoD and FDA to suspend the AVIP as it is currently constituted. AVA's manufacturer placed the vaccine in investigational status for inhalation anthrax in September 1996. Six and a half years later, that status has not been changed. In addition, DoD is willfully deviating from the vaccine's shot regimen, using the vaccine in a manner completely unapproved by FDA. Finally, the FDA itself has failed to finalize the licensing and approval for the vaccine for almost twenty years. As a result, the vaccine cannot be considered a drug approved for its use, because its licensing has not been finalized. [*28] Under all or any of these bases, AVIP should be suspended. The Court should grant plaintiffs' motion for a restraining order and injunction and set a final trial date to resolve these issues.
Date: March 18, 2003

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Respectfully submitted, John J. Michels, Jr. / MSZ John J. Michels, Jr., Esq. D.C. Bar # 457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150 Mark S. Zaid Mark S. Zaid, Esq. DC Bar # 440532 Krieger & Zaid, PLLC 1133 21<st> St., N.W. Suite 800 Washington, D.C. 20036 (202) 223-9050
[SEE APPENDIX IN ORIGINAL] CERTIFICATE OF COUNSEL Pursuant to Local Rule 65.1, the undersigned counsel for the plaintiffs hereby certifies as follows: 1. Notice of plaintiffs' intention to file a Motion for Temporary Restraining Order ("TRO") and Preliminary Injunction was given to Madelyn Johnson, Deputy Chief, United States Attorney's Office for the District of Columbia, on the afternoon of March 17, 2003. 2. Courtesy copies of all pleadings and papers filed in this action, or to be presented to the Court in support of plaintiffs' Motion, were furnished to Ms. Johnson via e-mail and hand delivery on March 18, 2003. 3. Ms. [*29] Johnson's telephone number is 202-514-7135. Dated: March 18, 2003 Respectfully submitted, Mark S. Zaid Mark S. Zaid, Esq.

2003 U.S. Dist. Ct. Motions 707; 2003 U.S. Dist. Ct. Motions LEXIS 11124, *29
D.C. Bar # 440532 Krieger & Zaid, PLLC 1133 21<st> St., N.W. Suite 800 Washington, D.C. 20036 (202) 223-9050 Attorney For The Plaintiffs

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View U.S. District Court Opinion
JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, SECRETARY OF DEFENSE, et al., Defendants.
1:03-cv-00707-EGS
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
2003 U.S. Dist. Ct. Motions 707; 2003 U.S. Dist. Ct. Motions LEXIS 8166
March 18, 2003
Motion for Preliminary Injunction
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s)
TITLE: [**1] DEFENDANTS' OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION
TEXT: INTRODUCTION With our military forces currently engaged in armed hostilities in which the threat of biological and chemical
weapons is a constant and substantial reality, plaintiffs ask this Court to grant extraordinary and unprecedented relief. They seek to undermine a key component of military readiness and defense against battlefield use of biological weapons -- the Department of Defense's Anthrax Vaccination Immunization Program ("AVIP"). In implementing AVIP, the Secretary of Defense has determined that mandatory inoculation of military personnel deployed in the Persian Gulf region with Anthrax Vaccine Adsorbed ("AVA") -- the only known effective vaccine against exposure to anthrax -- is necessary to shield our military against a possible biological attack using anthrax. Nevertheless, plaintiffs ask this Court to enjoin defendants from inoculating certain military service members and civilian employees with AVA, arguing that the anthrax vaccination program violates 10 U.S.C. § 1107, a statute requiring the Department of Defense to comply with the "prior consent [**2] requirement imposed under section 505(i)(4) of the Federal Food, Drug and Cosmetic Act" ("FFDCA") anytime it seeks to administer "an [*2] investigational new drug or a drug unapproved for its applied use" to a member of the armed forces. 10 U.S.C. § 1107(f).
The legal predicate for plaintiffs' suit and for their assertion of irreparable harm is their mistaken understanding that the vaccine has not been approved for the treatment of inhalation anthrax. To the contrary, as the relevant history and attached declaration from the Food and Drug Administration ("FDA") make clear, the FDA has indeed approved the vaccine for treatment of inhalation anthrax. Accordingly, use of the vaccine for that approved purpose plainly does not trigger the applicability of the informed consent requirements of 10 U.S.C. § 1107. For similar reasons, the balance of harms also tips decidedly against injunctive relief. The military has a strong interest in administering an anthrax vaccine that has been approved as safe and effective, and the receipt of such an approved vaccine will cause plaintiffs no

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irreparable injury. By contrast, enjoining the administration [**3] of that vaccine as plaintiffs request would interfere with the ability of the military to conduct its crucial operations during wartime, a result that underscores the impropriety of such relief as a matter of equitable discretion for much the same reasons that it also demonstrates the lack of a justiciable controversy.
For a number of reasons, plaintiffs' request for preliminary injunctive relief should be denied. As an initial matter, plaintiffs cannot demonstrate a likelihood of success on the merits -- the touchstone of injunctive relief -- both because this Court lacks jurisdiction over their claims and because their claim to relief under section 1107 is legally erroneous. First, this Court lacks jurisdiction to hear plaintiffs' claims, which are nothing short of an attack on decisions of the military chain-of-command regarding military readiness and the conduct of battle. As the [*3] Supreme Court has held: "Civilian courts must, at the very least, hesitate long before entertaining a suit which asks the court to tamper with the established relationship between enlisted military personnel and their superior officers," because "that relationship is at the heart of the necessarily [**4] unique structure of the Military Establishment." Chappell v. Wallace, 462 U.S. 296, 300 (1983). Indeed, the Administrative Procedure Act ("APA") itself recognizes that this unique relationship inherent in the military chain-of-command is especially outside the ken of judicial expertise during times, such as these, of military conflict, expressly excepting from APA review all "military authority exercised in the field in time of war or in occupied territory." 5 U.S.C. § 701(b)(1)(G). Instead, the military justice system affords the military plaintiffs their proper remedy for claims that an order to submit to inoculation is unlawful. see New v. Cohen, 129 F.3d 639, 643 (D.C. Cir. 1997). Given this important and unique disciplinary structure, this Court should not entertain plaintiffs' claims here.
Plaintiffs' request for preliminary injunctive relief is especially inappropriate on the record now before the Court. The anonymous plaintiffs have failed to present this Court with anything other than speculative and unsupported allegations that they may be harmed. But because preliminary injunctive relief alters the relations between [**5] the parties, a much more substantial evidentiary showing is required to support court intervention. See Wisconsin Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985).
Second, notwithstanding these jurisdictional defects, plaintiffs would not prevail were this Court to reach the merits of their claims. Defendants simply did not violate the informed consent/waiver provisions of section 505(i)(4) of the FFDCA and section 1107 because AVA is, [*4] and always has been, approved for anthrax generally, including inhalation anthrax. While plaintiffs suggest that the vaccine is only approved for cutaneous (or skin) exposure, they are simply mistaken. The license and label for AVA are silent as to the route of exposure by the victim, and that silence means AVA is approved for exposure to anthrax bacterium regardless of how the victim became infected. This interpretation has been consistently applied to the vaccine by both the Department of Defense ("DoD") and the FDA, an interpretation confirmed by the only published opinion to have reached the issue. O'Neil v. Secretary of the Navy, 76 F. Supp. 2d 641, 645 (W.D. Pa. 1999) (holding that AVA is [**6] not subject to Executive Order 13139). AVA is not an "investigational new drug" or a drug that is not approved for the use for which the military has required it, i.e., to protect against inhalation anthrax. Accordingly, section 1107 does not apply here.
Not only are plaintiffs unable to demonstrate a likelihood of success on the merits, but they also cannot satisfy any of the remaining factors necessary for preliminary injunctive relief. The balance of harms tips decidedly in favor of the government in this case. Any order now compelling informed consent under section 505(i)(4) of the FFDCA unless there is a Presidential waiver under section 1107 would have the effect of halting the military's use of the vaccine during wartime and would have potentially devastating effects on military preparedness on the battlefield. At the very least, even if relief were limited to these particular plaintiffs (as plaintiffs themselves, at the initial status conference, indicated might be appropriate), judicial relief would impact severely on the combat readiness of plaintiffs' particular military units. Moreover, any success in this action would embolden further suits by others seeking to avoid [**7] the vaccination. [*5] The collective second-guessing of military orders that these suits would engender, even if ultimately unsuccessful, would seriously compromise military discipline and readiness.
Moreover, the harm to the nation's fighting strength from fielding combat or support units in which some members are susceptible to an anthrax attack significantly outweighs the de minimis potential harm plaintiffs could face if they

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proceed with the vaccination. AVA is a safe vaccine that has been used for over 30 years in the civilian world with minor side effects comparable to other common vaccines. Within the AVIP itself, the rate of serious adverse reactions is only 0.013%.
Finally, the public policy underlying the judiciary's usual deference to military decisions is all the more appropriate in this time of actual combat both in Iraq and in the global war on terrorism. The public interest is best served by fielding a combat force that is protected to the greatest feasible extent against potential theater threats. Such protection will lower casualties and, possibly, shorten any conflict. The Secretary of Defense's decision to require AVA for the combat forces of the [**8] United States furthers that interest.
For all of these reasons, as set forth more fully below, the plaintiffs' requested relief should be denied.
BACKGROUND
I. Plaintiffs' Claims
Plaintiffs are an anonymous group of six military members and civilians either employed by DoD or by private companies under contract with DoD, n1 purportedly under orders to receive [*6] AVA. Plaintiffs' claims for relief are based upon the so-called "informed consent" provisions of 10 U.S.C. § 1107 as well as the section-1107-implementing Executive Order and DoD regulation. Under section 1107, whenever the DoD intends to provide an "investigational new drug or a drug unapproved for its applied use" to a member of the armed forces, the "prior consent requirement imposed under" the FFDCA -- which requires that the Secretary give certain information to a person required to receive such a drug and obtain each person's consent prior to use of the drug -- "may be waived only by the President." See 10 U.S.C. § 1107(f). While plaintiffs suggest that AVA is approved for cutaneous (skin contact) anthrax, they argue here that the military [**9] violates the informed-consent provision of section 1107 because AVA is not currently approved for inhalation anthrax -- that is, exposure through breathing in the spores -- and because no Presidential waiver has been obtained. Plaintiffs also allege that the defendants have failed to adhere to the vaccine's approved dosage schedule.
n1 The complaint alleges that the six plaintiffs are military members or "DoD civilian contract employees." Complaint, P 1. But at the March 27, 2003 status conference, plaintiffs' counsel asserted that the six unnamed plaintiffs include one DoD civilian employee.

II. The Anthrax Threat
Anthrax is a deadly disease caused by spores of the bacterium Bacillus anthracis. Ex. 1, Grabenstein Decl. P 4. Human infection may occur by three routes of exposure to the spores: by skin contact (cutaneous), by ingestion (gastrointestinal), and by inhalation (pulmonary). Id. Fatality rates from anthrax vary depending on the exposure route: cutaneous anthrax without antibiotics [**10] -- approximately 20%; gastrointestinal anthrax -- 25 to 75%; pulmonary anthrax -- 45 to 80% or higher. Id.
U.S. military forces now in combat against Iraq or stationed elsewhere in Southwest Asia [*7] fighting the global war on terrorism face a very significant threat from anthrax as a biological weapon. Id. P 3; see also H.J. Res. 114, Pub. L. 107-243, 107th Cong., 116 Stat. 1498 (Oct. 16, 2002) (declaring that "Iraq both poses a continuing threat to the national security of the United States and international peace and security in the Persian Gulf region and remains in material and unacceptable breach of its international obligations by, among other things, continuing to possess and develop a significant chemical and biological weapons capability, actively seeking a nuclear weapons capability, and supporting and harboring terrorist organizations"). As President Bush stated in his 2003 State of the Union Address.

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The United Nations concluded in 1999 that Saddam Hussein had biological weapons material sufficient to produce over 25,000 liters of anthrax -- enough doses to kill several million people. He has not accounted for that material. He has given [**11] no evidence that he has destroyed it.
149 Cong. Rec. H214 (Daily ed. Jan. 28, 2003) (also available at http://www.whitehouse.gov /news/releases/ 2003/01/20030128-19.html). Accordingly, the Secretary of Defense determined that the highest threat area of the world for anthrax attack is the geographical area near Iraq, and he directed that military personnel and certain civilians who perform emergency-essential functions n2 with the force deployed to this region must be vaccinated against anthrax. Ex. 1, Grabenstein Decl. P 3.
n2 Emergency-essential civilians occupy positions that perform duties of "immediate and continuing support for combat operations or to support maintenance and repair of combat essential systems" and do so "in a combat zone." 10 U.S.C. § 1580, see also DoD Dir. 1404.10, encl. 2, P E2.1.5. Similarly, "contractors providing services designated as essential by a DoD Component are expected to use all means at their disposal to continue to provide such services, in accordance with the terms and conditions of the contract during periods of crisis, until appropriately released or evacuated by military authorities." DoD Inst. 3020. 37 P 4.2.
[**12]
[*8] III. Regulatory History of AVA
A. AVA's License
The only known, effective prevention against anthrax is the vaccine referred to as Anthrax Vaccine Adsorbed. Ex. 1, Grabenstein Decl. P 5. Prior to AVA being licensed, a well-controlled field trial using a similar precursor vaccine n3 was conducted using mill workers who processed animal hair. Id. During this trial, 26 cases of anthrax were reported at the mills -- 21 cutaneous and 5 inhalation. Id. Of the five inhalation cases, two individuals had received the placebo, while three individuals (in the observational group) had received no injections. Id. Four of the five people who developed inhalation anthrax died. Id. No cases of inhalation anthrax occurred in any of the individuals who had received the anthrax vaccine. Id. Based upon a comparison between the anthrax vaccine and placebo recipients, the authors calculated a vaccine efficacy level of 92.5 percent. Id.
n3 As the FDA has determined, the differences between the precursor vaccine and AVA are minor changes in the manufacturing process and in the formulation of the drug. Ex. 2, Goodman Decl. Attach. 2, Citizen Pet. Resp. to R. Dingle, Docket No. 01P-0471 (Aug. 28, 2002) p. 8. The comparability of the two vaccines has been verified using potency data and safety/immunogenicity tests. Id. p. 9.
[**13]
Largely on the basis of this field study, in 1970, the National Institutes of Health, the agency then charged with licensing biologic drugs, see 37 Fed. Reg. 4004, 4004-05 (Feb. 25, 1972), licensed AVA for use against anthrax. See 36 Fed. Reg. 8704, 8705 (May 11, 1971). In 1972, authority to approve biologic drugs such as AVA was delegated to the FDA. 37 Fed. Reg. 4004, 4004-05 (Feb. 25, 1972). Despite this change in licensing authority, AVA, like all other biologic drugs, remains licensed unless the FDA takes formal action to suspend or revoke its [*9] license. 21 C.F.R. § 601.4(a). AVA's license has never been suspended or revoked. See Ex. 2, Goodman Decl. P 9.
B. FDA License Review of AVA
After authority to license biologic drugs like AVA was delegated to the FDA, it initiated a comprehensive review of the safety, effectiveness, and labeling of all licensed biologies. 21 C.F.R. § 601.25; Ex. 2, Goodman Decl. P 6. In this

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review, independent advisory panels of scientific experts from outside the government examined each biologic. 21 C.F.R. § 601.25(a); Ex. 2, Goodman Decl. P 6. Based on their examination, the panels [**14] were to recommend to the FDA that the agency classify each individual biologic in one of the following ways: (1) safe, effective, and not misbranded; (2) unsafe, ineffective, or misbranded; or (3) insufficient information to classify, further testing required. 21 C.F.R. § 601.25(e); Ex. 2, Goodman Decl. P 6.
AVA underwent this review in the mid-1980s, and the panel recommended that the vaccine be classified as safe, effective, and not misbranded. 50 Fed. Reg. 51002 (Dec. 13, 1985); Ex. 2, Goodman Decl. P 9. Pursuant to the governing regulation, the FDA then published a proposed order adopting the panel's classification. Id. In its order, the FDA did not propose revoking the license for AVA, an action that it would have taken if FDA had determined that AVA was unsafe. 21 C.F.R. § 601.25(f); see Ex. 2, Goodman Decl. P 9. Thus, notwithstanding that the FDA has not issued a final order on AVA's classification, see 21 C.F.R. § 601.25(g), AVA's license remains valid because the FDA has never sought to revoke or suspend it, 21 C.F.R. § 601.4(a); Ex. 2, Goodman Decl. P 9.
[*10] C. AVA's Approved Uses
For any licensed product, the approved uses are derived [**15] from the FDA-approved label. See 21 C.F.R. § 201.100. The approved labeling for AVA states that it is indicated for individuals who may come in contact with animal products that may be contaminated with Bacillus anthracis spores and for individuals engaged in diagnostic or investigational activities which may bring them in contact with Bacillus anthracis spores. Ex. 1, Grabenstein Decl. P 5; Ex. 2, Goodman Decl. P 10. It is also recommended for persons at high risk of exposure, such as veterinarians, lab workers, and others whose occupation may involve exposure to contaminated materials. Id.; Complaint, Ex. B (AVA product insert). This non-exhaustive list of high-risk persons has been interpreted by DoD to encompass military personnel serving in areas where there is a significant threat of a biological attack from anthrax. Ex. 1, Grabenstein Decl. P 5.
Importantly, AVA's label does not limit its use to any particular route of anthrax exposure. Id. P 7; Ex. 2, Goodman Decl. P 11. The label does not distinguish among individuals who may be infected by spores entering the body through skin contact, ingestion, or inhalation. Id. DoD and FDA have thus consistently [**16] interpreted the label as encompassing inhalation exposure. Id.; Ex. 2, Goodman Decl. P 11 & Attach. 2 (Pet. Resp.) p. 6.
Prior to commencing the current anthrax vaccination program, and prior to passage of section 1107, DoD took appropriate steps to confirm that AVA is approved for use against inhalation anthrax. On March 4, 1997, the Assistant Secretary of Defense (Health Affairs) wrote to the Lead Deputy Commissioner for the FDA, stating "DoD has long interpreted the scope of the license to include inhalation exposure, including that which would occur in a biological [*11] warfare context," and asking "whether the FDA has any objection to our interpretation of the scope of the licensure for the anthrax vaccine." Ex. 3, Letter from Stephen C. Joseph, M.D., Asst. Sec'y of Defense, Health Affairs to Michael A. Friedman, M.D., Lead Dep. Comm'r, FDA (Mar. 4, 1997). The Lead Deputy Commissioner for the FDA responded on March 13, 1997: "I believe your interpretation is not inconsistent with the current label." Ex. 2, Attach. 3, Letter from Michael A. Friedman, M.D., Lead Dep. Comm'r, FDA to Stephen C. Joseph, M.D., Asst. Sec'y of Defense, Health Affairs (Mar. 13, 1997).
The FDA [**17] recently reiterated its determination that AVA is licensed against inhalation anthrax. In an August 28, 2002 response to a citizen petition filed by an opponent of the DOD AVIP, the FDA's Associate Commissioner for Policy stated: "The indication section of the labeling does not specify the route of exposure and thus includes both cutaneous and inhalation exposure." Ex. 2, Goodman Decl. P 11 & Attach. 2 p. 6.
D. AVA's Approved Dosing Schedule
AVA's label currently recommends six doses administered subcutaneously. Ex. 1, Grabenstein Decl. P 16; Ex. 2, Goodman Decl. P 12. After the first dose, the label recommends that the remaining doses be injected at 2 weeks, 4

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weeks, 6 months, 12 months, and 18 months. Id. DoD currently adheres to this schedule. Ex. 1, Grabenstein Decl. P 16.
Beginning in July 2000, a shortage of AVA required the DoD to suspend inoculations for many individuals. Ex. 1, Grabenstein Decl. P 16. Thus, some individuals who had received one or more of the first five doses had their remaining doses deferred. Id. When the shortage of AVA abated last year, DoD resumed inoculating those individuals who had doses deferred and [*12] who remained in units [**18] or positions subject to combat duty in Iraq or duty elsewhere in Southwest Asia. Id. This reinitiating of the dosing schedule at the point where it was interrupted is consistent with sound vaccination practice and the recommendation of the United States Centers for Disease Control and Prevention, id., and it is routinely followed for other, more common, vaccines. Id.; Ex. 2, Goodman Decl. P 13. In this particular case, FDA has stated that
The resumption of a multi-dose vaccine series unavoidably interrupted by a vaccine shortage is not a clinical investigation' that requires the filing of an Investigational New Drug application. See 21 C.F.R. Part 312. The resumption of the anthrax vaccine series under these circumstances is not inconsistent with the product labeling, in that the labeling does not specifically address closing in the event of unavoidable vaccine shortages, and resumption of the dosing series at the point at which it was interrupted is consistent with the principles of safety and efficacy underlying the dosing regimen in the anthrax vaccine labeling.
Ex. 2, Goodman Decl. P 14.
As for individuals who began the inoculation series after the shortage [**19] abated, DoD is adhering to the schedule recommended on the label. Ex. 1, Grabenstein Decl. P 16. Significantly, plaintiffs have not alleged that any of their dosing schedules were ever interrupted by the AVA shortage.
ARGUMENT
Plaintiffs Are Not Entitled To Injunctive Relief
Injunctive relief is an extraordinary remedy, and the party seeking it has a substantial burden of proof. See American Coastal Line Joint Venture v. United States Lines, Inc., 580 F. Supp. 932, 935 (D.D.C. 1983). Because of the extraordinary nature of this form of judicial relief, courts should grant preliminary injunctions sparingly. Barton v. District of Columbia, 131 F. Supp. 2d 236, 242 (D.D.C. 2001) (citing Moore v. Summers, 113 F. Supp. 2d 5, 17 (D.D.C. [*13] 2000)). Moreover, when plaintiffs seek to intrude into areas reserved to the Executive Branch -- such as the protection of our armed forces during a time of war -- they must make an especially strong showing that they are entitled to relief. Adams v. Vance, 570 F.2d 950, 956 (D.C. Cir. 1978); Palestine Info. Office v. Schultz, 674 F. Supp. 910, 918 (D.D.C. 1987). [**20] Plaintiffs fail to do that and, thus, are not able to meet the basic requirements for obtaining a preliminary injunction.
When seeking a preliminary injunction, the movant must demonstrate to the Court that: (1) there is a substantial likelihood plaintiff will succeed on the merits, (2) plaintiff will be irreparably injured if an injunction is not granted; (3) an injunction will not substantially injure the other party; and (4) the public interest will be furthered by an injunction. Davenport v. Int'l Bhd. of Teamsters, 166 F.3d 356, 361 (D.C. Cir. 1999). Although this is a flexible standard, both the elements of likelihood of success on the merits and irreparable harm must be shown to prevail. District 50, United Mine Workers of Am. v. International Union, United Mine Workers of Am., 412 F.2d 165, 167 (D.C. Cir. 1969). n4 Here, plaintiffs cannot satisfy any of the standards for preliminary injunctive relief; thus, the Court must deny plaintiffs' motion.
n4 Where the plaintiff makes a particularly weak showing on one factor, the other factors may not be enough to compensate. Taylor v. RTC, 56 F.3d 1497, 1506 (D.C. Cir.), amended on other grounds on reh'g 66

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F.3d 1226 (D.C. Cir. 1995). Therefore, for example, if the plaintiff fails to make a strong showing of likelihood of success on the merits, "it would take a very strong showing with respect to the other preliminary injunction factors to turn the tide in plaintiff's favor." Davenport, 166 F.3d at 367.
[**21]
[*14] I. Plaintiffs Cannot Demonstrate A Likelihood Of Success On The Merits
A. The Court Lacks Jurisdiction
Plaintiffs' prayer for injunctive relief founders on the most basic requirement -- that this Court has jurisdiction over the asserted claims. Article III of the Constitution restricts the jurisdiction of the federal courts to "Cases" and "Controversies." U.S. Const, art. III, § 2; Flast v. Cohen, 392 U.S. 83, 94 (1968); Allen v. Wright, 468 U.S. 737, 750 (1984). Indeed, "no principle is more fundamental to the judiciary's proper role in our system of government than the constitutional limitation of federal-court jurisdiction to actual cases and controversies. Simon v. Eastern Ky. Welfare Rights Org., 426 U.S. 26, 37 (1976); Valley Forge Christian Coll. v. Americans United for Separation of Church & State, Inc., 454 U.S. 464, 471 (1982) (noting the "bedrock requirement" that courts hear only "cases or controversies"). For two independent reasons, the case or controversy jurisdictional requirement is lacking here. First, the issues that plaintiffs present are non-justiciable. Second, [**22] plaintiffs fail to present an evidentiary basis sufficient to support standing at the preliminary injunction stage.
1. Plaintiffs' Challenge To The Decisions Of The Military Chain-of-Command Presents a Non-Justiciable Question
The plaintiffs' challenge to orders requiring their inoculation with the anthrax vaccine is an extraordinary one. It represents an attempt by military servicemen and emergency-essential civilians during wartime to judicially countermand decisions by their superiors about military preparedness and conduct of the war. It thus seeks relief which, if granted, may imperil the lives of military personnel and civilians and jeopardize the prosecution of ongoing military operations. [*15] Plaintiffs' attempt to interpose the federal courts between themselves and their superiors in a theater of active military operations is foreclosed by established principles of judicial restraint and by the explicit text of the Administrative Procedure Act.
Traditional principles of judicial deference to military decisions counsel strongly against judicial intervention here. Although framed as a garden-variety APA challenge to agency action, the relief that is sought would [**23] require this Court to engage in review of military decisions regarding the battlefield activities of troops engaged in combat. While their complaint names as defendants the Secretary of Health and Human Services ("HHS") and the Commissioner of the Food and Drug Administration, plaintiffs do not complain of any agency action by either HHS or the FDA, and they do not seek any relief against those defendants. Rather this case focuses solely on the decision by the Secretary of Defense to prepare his combat forces for battle by vaccinating them against anthrax, a known biological weapon. We know of no precedent for entertaining such a suit, and there are compelling reasons why it should not be.
Courts traditionally have been reluctant to intervene in the conduct of military affairs. See, e.g., United States v. Stanley, 483 U.S. 669, 684 (1987); Chappell v. Wallace, 462 U.S. 296, 300 (1983); Schlesinger v. Councilman, 420 U.S. 738, 757-58 (1975); Gilligan v. Morgan, 413 U.S. 1, 10 (1973); Orloff v. Willoughby, 345 U.S. 83, 93-94 (1953). This reluctance rests on the fundamental and highly salutary [**24] principle that judges "are not given the task of running [the military]," Orloff, 345 U.S. at 93, and that they are "ill-equipped" to determine the impact of judicial intrusion on military authority, Chappell, 462 U.S. at 305.
These general concerns take on an added dimension when courts are called on to [*16] interpose themselves between soldiers and their military superiors. In the words of the Supreme Court, "no military organization can function without strict discipline and regulation that would be unacceptable in a civilian setting." Chappell, 462 U.S. at 300.

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Judicial intervention risks disrupting the "the inescapable demands of military discipline and obedience to orders," id., that are integral to the military's performance. See also Gilligan, 413 U.S. at 10 (noting inappropriateness of judicial intervention in "the complex, subtle, and professional decisions as to the composition, training, equipping, and control of a military force").
Judicial reluctance to interfere with military decisions has been manifest in a wide range of cases and has drawn on a variety of judicial doctrines. In some instances, [**25] concerns about judicial competence in military matters have implicated the tenets of the political question doctrine. See, e.g., Gilligan, 413 U.S. at 5-12. Similar concerns have been viewed in other cases as "special factors counseling hesitation" in the recognition of remedies for constitutional violations. See, e.g., Chappell, 462 U.S. at 298-304 (citations omitted). And in still other cases, these concerns have influenced the course of statutory interpretation, leading courts to give narrow compass to broadly written statutory provisions. See, e.g., Feres v. United States, 340 U.S. 135 (1950).
Relying on these concerns, the Supreme Court has declined to entertain service-related damages claims by military personnel, even in peacetime and even concerning claims for which no explicit "military exception" exists. Thus, in Feres and its progeny, the Supreme Court disallowed claims by servicemen against the United States under the Federal Tort Claims Act ("FTCA") for service-related injuries, despite the absence of any explicit exception for such [*17] claims in the text of the FTCA and regardless [**26] of whether the claims related to an actual military undertaking. See Chappell, 462 U.S. at 298-99 (discussing Feres). Similarly, the Court has refused to entertain Bivens actions by servicemen against their superiors "whenever the injury arises out of activity "incident to service." Stanley, 483 U.S. at 681. Stanley is particularly noteworthy because the specific claim before the Court there was a claim of unlawful medical experimentation on members of the military.
The same principles apply to injunctive claims. At least five courts of appeals have held that Chappell and Stanley categorically preclude soldiers from seeking injunctive relief against their commanding officers, see Speigner v. Alexander, 248 F.3d 1292, 1296-98 (11th Cir.), cert. denied, 534 U.S. 1056 (2001) (collecting cases), n5 on the ground that "the potential for [*18] disruption of the hierarchical structure [of the military] exists each time a soldier hales his superior into court . . . regardless of the remedy the soldier seeks," Watson v. Arkansas Nat'l Guard, 886 F.2d 1004, 1008 (8th Cir. 1989). [**27]
n5 Meister v. Texas Adjutant General's Dept., 233 F.3d 332 (5th Cir. 2000) (court has little competence in military discipline and management), cert. denied, 532 U.S. 1052 (2001); Jones v. New York State Div. of Military & Naval Affairs, 166 F.3d 45 (2d Cir. 1999) (injuctive relief would compromise military discipline and readiness for combat); Knutson v. Wisconsin Air Nat'l Guard, 995 F.2d 765 (7th Cir. 1993) (military reinstatement cases are nonjusticiable because their review would undermine military discipline and decision-making or impair training programs and operational readiness); Watson v. Arkansas Nat'l Guard, 886 F.2d 1004 (8th Cir. 1989) (Feres doctrine bars both damages and injunctive relief; to do otherwise would be to exalt form over substance); Crawford v. Texas Army Nat'l Guard, 794 F.2d 1034 (5th Cir. 1986) (suits for injunctive relief must be restricted to prevent intrusion of courts into the military structure). One of these courts even went so far as to hold that military decisions concerning civilian employees were also non-justiciable for the same reasons, Meister, 233 F.3d at 340, a position also adopted by at least one district court, Mann v. Heigh, 891 F. Supp. 256, 263 (E.D.N.C. 1995), aff'd on other grounds, 120 F.3d 34 (4th Cir. 1997)
The recent decision in Brannum v. Lake, 311 F.3d 1127 (D.C. Cir. 2002), is not to the contrary. There the court applied the well-established, narrow exception that federal courts may entertain equitable suits that challenge the military's jurisdiction over a citizen. Id. at 1130; see also Reid v. Covert, 354 U.S. 1, 30 (1957); New v. Cohen, 129 F.3d 639, 644 (D.C. Cir. 1997). Simply put, the military cannot court martial civilians. Reid, 354 U.S. at 30; New, 129 F.3d at 644. Brannum is inapplicable here because the plaintiffs do not claim that the military is improperly asserting jurisdiction over any of them.

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[**28]
The case against judicial intervention is at its most compelling here. Unlike Stanley and Feres, which involved damages claims arising out of peacetime controversies, this suit is brought during ongoing hostilities and seeks to have this Court second-guess and overturn a military decision relating to military preparedness and conduct on the battlefield. The demands of military discipline are at their zenith during armed combat. See Chappell, 462 U.S. at 300 (the requirement that servicemen "meet certain overriding demands of discipline and duty' . . . becomes imperative in combat"). When a judicial decision affects conduct on the battlefield by the military (and its civilian leadership), the consequences of judicial error are potentially ruinous, especially when the court's decision involves prospective injunctive relief (as in this case) rather than damages after the event (as in Stanley and Feres). n6
n6 The deference that defendants ask this Court to exercise is very narrow. This Court need not consider whether all prospective injunctive relief is precluded by Chappell. Rather, this Court need only rule that it should defer in cases such as this, where military orders relating to ongoing hostilities are at issue. This Court need not define the further contours of this doctrine in this case.
[**29]
For this very reason, the decision of the Court of Appeals for the District of Columbia in Doe v. Sullivan, 938 F.2d 1370 (1991), is inapposite to this case. In Sullivan, the court emphasized that "deference is owed to the political branches in military matters," but nevertheless permitted the plaintiffs to bring a facial challenge to the FDA's issuance of a regulation relating to the military's use of vaccines. Id. at 1380. Notably, Sullivan was decided [*19] after hostilities had ended, yet the Court still refused to question the military's decisions, focusing solely on the straightforward APA-appeal of the FDA's rulemaking. Here, plaintiffs have not made any such facial challenge to an FDA regulation but, instead, have asserted claims against their superior officers and the Department of Defense. This distinction was not lost on the court in Sullivan, which was careful to narrowly limit its holding to the facial challenge made and to note specifically that the dispute was not one between soldiers and their superiors. Id. ("His claim, as now advanced, entails no judicial interference with the relationship between soldiers [**30] and their military superiors. . . . We confront at this time not a dispute over military strategy or discipline, not one between soldiers and their superiors, but one over the scope of authority Congress has entrusted to the FDA.") (citations omitted) (emphasis added). Sullivan permits, at most, only ordinary APA review of typical, non-DoD agency activities during peacetime. n7 The case before this Court differs because plaintiffs challenge, in the midst of ongoing combat, military orders by commanding officers regarding how to prepare for battle. If Chappell is to have any meaning, it is surely in a case such as presented now in which plaintiffs seek relief from decisions regarding military preparedness and combat readiness during the middle of an ongoing military conflict. n8
n7 Unlike Sullivan, plaintiffs here are not alleging any improper agency action by either of the non-DoD defendants. Plaintiffs did not petition HHS or FDA for review of AVA, nor have they ever attempted to appeal a denial of a petition for review submitted by others. Rather plaintiffs' claims focus on one decision: that of the Secretary of Defense to inoculate his forces. Accordingly, the non-DoD defendants are not proper parties to this case. [**31]

n8 The FDA waiver provisions that were challenged in Sullivan are no longer applicable to DoD's decision to inoculate military personnel as a result of 10 U.S.C. § 1107, enacted after Sullivan. Thus, the relevant factual context in which Sullivan was decided -- and the key regulatory factor at issue in Sullivan, i.e., an independent decision by the FDA challenged by the plaintiffs -- is simply not the same in this case.

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[*20] If Congress were to desire to grant plaintiffs a judicial remedy in these circumstances, it would have to say so in explicit terms. But tellingly, Congress did not grant an express cause of action in enacting section 1107. See Alexander v. Sandoval, 532 U.S. 275, 286-87 (2001) (in the absence of clear congressional intent, courts may not infer private rights of action from statutes). Thus, plaintiffs may not rely on the text of that statute to seek relief before this Court.
Nor may plaintiffs seek relief under the APA because that statute contains an explicit statutory bar against judicial review. [**32] Section 10 of the APA expressly makes the APA's judicial review provisions inapplicable to acts of "military authority exercised in the field in time of war or in occupied territory." 5 U.S.C. § 701(b)(1)(G). n9 The APA thus recognizes and incorporates the traditional judicial deference to military decisionmaking and avoids judicial interference with that authority in critical times of war.
n9 5 U.S.C. § 701(b)(1)(G) excludes "military authority exercised in the field in time of war or in occupied territory" from the definition of "agency." It thereby places such actions outside the scope of 5 U.S.C. § 702, which waives the sovereign immunity of the United States for claims ("other than ones for money damages") by persons "suffering legal wrong" or "adversely affected or aggrieved" by "agency action." See also 5 U.S.C. § 551(1)(G).
Here, plaintiffs are seeking to enjoin their superiors from requiring them and others [**33] similarly situated to take AVA before entering duty in Iraq or elsewhere in Southwest Asia. Plaintiffs' claims thus ask the Court to countermand acts of "military authority exercised in the field." And given the level of armed hostilities, the requirement that the decision relate to "time of war" is obviously met. See, e.g., Rasul v. Bush, 215 F. Supp. 2d 55, 64 (D.D.C. 2002) [*21] (holding that APA review unavailable under "military authority" exception for claims by alien detainees captured during military action against A1 Qaeda and Taliban in Afghanistan), aff'd, 321 F.3d 1134 (D.C. Cir. 2003). Accordingly, Section 10's prohibition against judicial review is squarely applicable. n10
n10 For the same reasons already explained, Sullivan does not foreclose reliance on the APA's "military authority" exception. As explained, supra at 18, that case involved the review of an independent decision of the FDA, separate and apart from the military chain of command. Here, however, the FDA has no role in the decision to require inoculations and thus plaintiffs' attack is directly on the decisions of "military authority exercised in the field in time of war or in occupied territory." 5 U.S.C. § 701(b)(1)(G).
[**34]
As to the military plaintiffs, another section of the APA bars judicial review of "courts martial and military commissions." 5 U.S.C. § 701(b)(1)(F). n11 As set out below, should the military plaintiffs refuse to receive the vaccine, they may be charged with violations of the Uniform Code of Military Justice. Such charges could be heard, at their option, by courts martial, potentially subject to at least five levels of post-trial review. See 10 U.S.C. §§ 860-869. Congress established this military justice system to handle claims just like this that require a court to balance the needs of military preparedness with fairness to the individual military member. Schlesinger v. Councilman, 420 U.S. 738, 758 (1975). The military plaintiffs here are, in essence, attempting to bypass that system and have this Court predetermine the outcome of their military cases. Such forum-shopping is expressly barred by the APA and should not be [*22] countenanced here.
n11 This exception for courts martial and the exception for military authority exercised in the field in time of war not only bar judicial review, but have several distinct, independently dispositive consequences. Section

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701 actually excludes these two categories from the definition of "agency" under the APA. Accordingly, these categories of decisions are excluded from any right of review under section 702, any waiver of sovereign immunity under section 702, any review under section 704, and any scope of review under section 706.
[**35]
Finally, the APA "excludes from its waiver of sovereign immunity . . . claims for which an adequate remedy is available elsewhere." Transhio Sav. Bank v. Director OTS, 967 F.2d 598, 607 (D.C. Cir. 1992). n12 As discussed below, both service members and civilian employees have adequate alternative remedies.
n12 Defendants note that, other than the APA, there is no basis for a waiver of sovereign immunity. Section 1107, the statute under which plaintiffs seek relief, contains no waiver of sovereign immunity. And it is well-settled that the general federal question provision, 28 U.S.C. § 1331, is not a waiver of sovereign immunity. See, e.g., Clopton v. Department of the Navy, 1996 WL 680189 (D.C. Cir. 1996) (per curiam). It is similarly well-established that the Declaratory Judgment Act, 28 U.S.C. § 2201, does not grant jurisdiction or waive sovereign immunity; it simply provides a remedy. See Skelly Oil Co. v. Phillips Petroleum Co., 339 U.S. 667 (1950). And the Little Tucker Act, 28 U.S.C. § 1346, is only relevant with respect to claims for money damages, not for the injunctive or declaratory relief that plaintiffs seek. See 28 U.S.C. § 1346 (providing district court jurisdiction over claims against the United States not exceeding $ 10,000). That plaintiffs have requested the Court to award them costs and attorneys' fees does not alter this conclusion. See Sharp v. Weinberger, 798 F.2d 1521, 1524 (D.C. Cir. 1986). Accordingly, the lack of a waiver of sovereign immunity also bars this suit.
[**36]
(a) Service Members Have An Adequate Remedy In The Military Justice System
The proper forum for the military plaintiffs to raise their claims is in the military justice system after having refused an order to take the vaccine. This action improperly seeks to preempt that military system from considering the issues presented. But under principles of comity recognized in this Circuit, this Court should not become entangled in matters that are better left to that process. See New v. Cohen, 129 F.3d 639, 643 (D.C. Cir. 1997).
The military plaintiffs' refusal or pending refusal to take AVA will result in one of three possible outcomes. First, no action may be taken against them. Second, they may be charged with a violation of the Uniform Code of Military Justice for refusing to obey a lawful order. And [*23] third, they may be processed for administrative separation from the service. The first option obviously entails no harm to the plaintiffs and is not at issue here. Plaintiffs have filed this action as a defense to preempt the second and third possibilities. But the resolution of that defense is more appropriately handled within the military justice [**37] system.
To balance military preparedness and fairness, Congress created the military court system. New v. Cohen, 129 F.3d 639, 643 (D.C. Cir. 1997). This military system includes such procedural safeguards as the rights to counsel; to present evidence; to assert defenses (including their claims here); to be tried by a jury or by a judge at their option; and to have their case considered by up to five levels of review, including two neutral appellate panels. See 10 U.S.C. §§ 860-869. Via a petition for certiorari, ultimate review by the Supreme Court may also be available. 10 U.S.C. § 867a. In creating this system, Congress recognized that the military is a specialized society separate from civilian society with laws and traditions of its own, a society whose need to prepare for and fight wars requires a respect for duty far beyond that required in the civilian world. Schlesinger v. Councilman, 420 U.S. 738, 757 (1975).
Honoring Congress's concerns in this regard, federal courts have invoked the doctrine of comity and followed a general rule that they must await the final outcome of a court martial [**38] before entertaining a military member's claim for relief. New, 129 F.3d at 642. Indeed, New explained the options available to military members, like plaintiffs,

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who seek to challenge the orders of their superiors. There, plaintiff sought judicial relief against pending court martial proceedings for failure to follow an order requiring the wearing of the United Nations insignia by U.S. troops stationed in Macedonia as part of a peacekeeping mission. Rejecting the judicial [*24] challenge, the D.C. Circuit explained that plaintiffs had adequate remedies in the military justice system:
Upon receiving the orders which he thought to be illegal, New had two options. He could have chosen to obey the orders and then sought judicial review of the military's policies. . . . Or he could follow the path that he took: disobey the orders and challenge their validity in the subsequent disciplinary proceedings. Having chosen the latter course of action, New might yet obtain vindication through court-martial proceedings. . . . However, any option contemplating an exception to the exhaustion requirement is foreclosed by the doctrine of comity. . . .
Id. at 647 [**39] (citations omitted).
Plaintiffs are no differently situated here. As set out in more detail below, plaintiffs are asking this Court -- with the country now at war -- essentially to stop the anthrax vaccination program. If they wish to challenge the decisions of their superiors to impose the inoculation requirement, however, they must do so in the context of the military justice system. The "need for duty and discipline in the armed forces makes clear that, absent a clearly defined right enforceable in proceedings other than a court martial . . . the federal courts normally should not interfere with the day-to-day operations of the military services." Id. (emphasis added). Consequently, federal courts have routinely deferred to the military justice system on matters that will have significantly less impact on the military's preparedness for war. See, e.g., Councilman, 420 U.S. at 740 (drug crimes); New, 129 F.3d at 641 (refusal to wear a United Nations beret); Noyd v. Boyd, 395 U.S. 683 (1969) (refusal to serve as an instructor pilot); Gusik v. Schilder, 340 U.S. 128 (1950) (murder). Given this precedent, [**40] an order depriving the services of their best defense against a devastating enemy weapon best comes from the institution expressly set up to balance the combat needs of the nation against the fairness due to each service member.
[*25] (b) Civilian Employees Have Adequate Remedies For Adverse Employment Decisions
Like their military counterparts, certain civilian employees, n13 both of the DoD and of private companies with DoD contracts, are essential to the conduct of military operations. Also like their military counterparts, civilian employees have adequate remedies for adverse personnel actions. Civilian employees of DoD, for example, have a right to appeal to the Merit Systems Protection Board (MSPB) and obtain relief if "the agency decision was not in accordance with law." 5 U.S.C. §§ 7701(a) & (c)(2)(C). Further, any employee "adversely affected or aggrieved by a final order or decision of the Merit Systems Protection Board may obtain judicial review of the order or decision," generally in the United States Court of Appeals for the Federal Circuit. 5 U.S.C. § 7703. In Mazares v. Department of the Navy, 302 F.3d 1382 (Fed. Cir. 2002), [**41] cert. denied, No. 02-846, (U.S. Apr. 7, 2003), two DoD civilian employees who refused anthrax vaccinations had the opportunity to present their contention that the agency order to them to receive the vaccine was improper. In that case, the MSPB and the Court of Appeals ruled specifically on the merits of the employees' arguments (both upholding the DoD decision).
n13 Plaintiffs filed this action anonymously, though plaintiffs' counsel has now disclosed the identity of one of them, a DoD civilian employee, to forestall adverse action before this Court can hear this motion. By filing this opposition, the government does not acquiesce in the plaintiffs' wish to remain anonymous. Should this matter proceed further, the government reserves its right to seek to require the identities of the remaining five plaintiffs.
With respect to employees of private companies under contract with the DoD, they have no employer-employee relationship with DoD, and DoD cannot take any personnel action, favorable or unfavorable, [**42] affecting them.

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However, they likely have some grievance procedures with their employers, or their employers could address these issues in dispute with the DoD [*26] components with which they contract. In any event, plaintiffs have failed to establish for purposes of APA jurisdiction that there is not an adequate remedy available elsewhere. It is well-settled that they have adequate remedies in damages actions for any adverse employment decisions. See Sampson v. Murray, 415 U.S. 61, 91-92 (1974) (adequate legal remedies exist for loss of income and damaged reputation; such injuries are not irreparable). Thus the civilian plaintiffs, too, fall outside the APA.
2. Plaintiffs Have Failed To Provide Evidentiary Support Sufficient To Confer Standing For Purposes Of Preliminary Injunctive Relief
Not only do plaintiffs present nonjusticiable claims, but they fail to present evidence sufficient to establish standing. One core element of Article Ill's case-or-controversy requirement is that a plaintiff must establish that he or she has standing to sue. Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992). Hence, "the question [**43] of standing is whether the litigant is entitled to have the court decide the merits of the dispute or of particular issues." Allen v. Wright, 468 U.S. at 750-51.
"Mere allegations will not support standing at the preliminary injunction stage." Doe v. National Bd. of Medical Examiners, 199 F.3d 146, 152 (3d Cir. 1999); see also National Wildlife Fed. v. Burford, 878 F.2d 422, 432 (D.C. Cir. 1989)(burden of establishing standing at preliminary injunction stage is no less than for summary judgment), rev'd on other grounds sub nom. Lujan v. National Wildlife Fed., 497 U.S. 871 (1996). Moreover, bare allegations of harm will not suffice to justify equitable relief. Wisconsin Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985).
[*27] Here, to preserve their anonymity, plaintiffs have chosen not to submit evidence that they are subject to imminent orders to take the vaccine or any adverse personnel action for refusing. Their very standing to pursue these claims is at issue, and yet the Court and defendants have nothing more on which to analyze that claim than their allegations. Plaintiffs' [**44] allegations alone do not suffice to permit the exercise of jurisdiction at the preliminary injunction stage.
With respect to the anonymous civilian plaintiffs, they would be unable to establish standing to sue here, even if they had provided factual support. The most fundamental constitutional prerequisite for standing is that of an injury-in-fact, one that is actual and imminent, not conjectural or hypothetical. Lujan, 504 U.S. at 560-61. Here, the injury that the civilian plaintiffs plead is wholly speculative; simply put, adverse employment actions against them for refusal to be inoculated may or may not occur. And as to the DoD civilians, DoD's own policy is to transfer them to other duties, if available, if they refuse to agree to the requirements for serving in an emergency-essential position. DoD Dir. 1404. 10 P 6.5.3. As to the contractor personnel, their employers may be able to use them on other projects or in other geographic areas. The potential actions of these third-party employers are far removed from the decision of the DoD to protect military and other personnel deployed to high threat areas from a biological warfare attack with anthrax [**45] and, thus, not a basis to find irreparable injury. Lujan, 504 U.S. 562 (When the future action of a third party not before the court is needed to establish standing, "it becomes the burden of the plaintiff to adduce facts showing that those choices have been or will be made in such a manner as to produce causation and redressability of injury.") (citation omitted), Simon v. Eastern Ky. Welfare Rights Org., 426 U.S. 26, 43-46 (1976) (action by third [*28] parties needed to redress harm too speculative to support standing). In summary, while an adverse personnel action may result for either the civilian DoD or contractor employees, that prospect is far from likely and, for the moment, wholly speculative.
B. Plaintiffs Cannot Prevail On The Merits Of Their Claims
Even were this Court to reach the merits of this dispute, plaintiffs cannot prevail. AVA is a licensed vaccine, and one for which the label includes protecting against inhalation anthrax. Defendants, moreover, have complied with the vaccine's dosage schedule. Consequently, there is no "prior consent requirement imposed under section 505(i)(4)" of the FFDCA and no need for a Presidential [**46] waiver under 10 U.S.C. § 1107(f), either with respect to plaintiffs' claim

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that use for inhalation anthrax is not an "approved use" (or renders the vaccine an investigational new drug) or with respect to plaintiffs' challenge to the resumed dosing schedule for persons whose doses were interrupted by a temporary vaccine shortage.
1. The AVA License Covers Use Against Inhalation Anthrax
Section 1107, upon which plaintiffs' base their entire claim for relief, is inapplicable here because AVA's license covers use against inhalation anthrax. n14 Since its licensing in 1970, see Ex. 2, Goodman Decl. P 9, AVA's label has not specified an exposure route. The FDA, as the government agency responsible for approving drugs, has interpreted this lack of specificity [*29] concerning the route of exposure to mean that the AVA license permits use of the vaccine against any route of exposure. Ex. 2, Goodman Decl. P 11. Such an interpretation by an agency within its area of expertise is entitled to substantial deference. Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994); Trinity Broad. of Fla., Inc. v. FCC, 211 F.3d 618, 625 (D.C. Cir. 2000); [**47] cf. NLRB v. Bell Aerospace Co., 416 U.S. 267, 274-75 ("a court may accord great weight to the long-standing interpretation placed on a statute by the agency charged with its administration"); Massachusetts Trs. of E. Gas & Fuel Assocs. v. United States, 377 U.S. 235, 241 (1964) (some weight is due to the consistent interpretation of the agency entrusted with the administration of the statute). This interpretation is eminently reasonable as it pertains to AVA. In the initial field study, no one vaccinated with the anthrax vaccine contracted inhalation anthrax. Additionally, from 1962 through 1974, the United States Centers for Disease Control and Prevention continued to collect epidemiological data on the vaccine's efficacy. Ex. 2, p. 9. Those data show that no cases of anthrax, including inhalation anthrax, were detected in persons who had received the full vaccine. Id. Thus, the FDA's clearly and repeatedly stated conclusion that AVA's label includes inhalation anthrax is proper. n15
n14 The informed consent requirements of section 1107 arise from and are those required by section 505(i)(4) of the FFDCA. Section 1107 simply does two things: (1) prescribes the form of notice required for military members; and (2) restricts authority to waive these requirements to the President. [**48]

n15 Although the reviewing panel's report on AVA noted that inhalation anthrax occurs too infrequently to assess the protective effect of the vaccine, the initial field study's calculated overall effectiveness rate was 92.5%, a calculation that applied to both the cutaneous and inhalation cases in the study. Ex.2, Attach. 2 (Pet. Resp.) n. 9. Thus, the FDA concluded that because the indication section of the labeling does not specify the route of exposure, it includes both inhalation and cutaneous exposure. Id. p. 6.
The FDA's position on AVA predates the passage of section 1107. The exchange of letters between the Assistant Secretary of Defense for Health Affairs and the Lead Deputy Commissioner occurred in March 1997, see Ex. 2, Attach. 3; Ex. 3, over six months before the [*30] statute passed. Importantly, the FDA has been consistent in its assessment about AVA's applicability to inhalation anthrax, confirming it in a non-litigation context as recently as last year in a response to a citizen petition. Ex. 2, Attach. 2 (Pet. Resp.) p. 3. n16 Thus, DoD is not using AVA as an investigational [**49] new drug or in an unapproved manner. Absent such uses, the informed consent requirements of the FFDCA do not apply, thereby rendering 10 U.S.C. § 1107, Executive Order 13139, and DOD Directive 6200.2 inapplicable.
n16 FDA's citizen petition procedures are set forth in 21 C.F.R. §§ 10.25, 10.30, & 10.45(d). Final decisions issued by the FDA pursuant to these procedures, if subject to judicial review, are accorded deference by the courts. See, e.g., Henley v. FDA. 77 F.3d 616, 620-21 (2d Cir. 1996).
Plaintiff's reliance on the DoD-initiated 1996 investigational new drug (IND) application for AVA is misplaced.

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That application does not establish that DoD considers use of AVA for inhalation anthrax to be an unlicensed use. Subsequent to the first Gulf War, as part of the effort to refine medical countermeasures to chemical and biological weapons, DoD began research to determine whether the same level of protection against anthrax could be achieved with a shorter shot [**50] schedule -- specifically, two shots with annual boosters, instead of the current requirement of six shots over 18 months -- and by administering the vaccine through intramuscular, rather than subcutaneous, injections (to reduce inflammation at the shot site). Ex. 1, Grabenstein Decl. P 8. This led to the 1996 IND application. Id. The IND application included a proposed study of the effectiveness of the vaccine against inhalation exposure (using an animal model) under the investigational, two intramuscular shot schedule. Id. If this study were successful, a by-product would have been an explicit statement that AVA is approved for inhalation anthrax. But as the Assistant Secretary's subsequent March 1997 letter establishes, see Ex. 3, the IND application in [*31] no way suggests an official position that DoD believed the approved label did not already encompass inhalation exposure. n17
n17 Nor does the fact that FDA has not issued a final order in its license review change this analysis. That review found AVA to be safe, effective, and not misbranded. 50 Fed. Reg. 51002 (Dec. 13, 1985). The FDA issued a proposed rule adopting the panel's finding in 1985. Id. At no time has the FDA initiated proceedings to revoke or suspend the AVA license. Ex. 2, Goodman Decl. P 9. Accordingly, the lack of a final order endorsing the panel's review is irrelevant. By regulation, AVA has remained licensed. 21 C.F.R. § 601.4(a).
[**51]
The only opinion published to date on this issue holds that Executive Order 13139 (and thus section 1107), is not applicable to AVA as it is being used by the military. In O'Neil v. Secretary of the Navy, 76 F. Supp. 2d 641 (W.D. Pa. 1999), a service member sought a hardship discharge based in part on having to take part in DoD's anthrax inoculation program. Chief Judge Ziegler disposed of the very issue in this case, ruling that "Executive Order No. 13139 is irrelevant to the instant dispute because the anthrax vaccine has been licensed by the FDA since 1970, and the vaccine is not an experimental drug." Id. at 645. As in O'Neil, nothing here supports plaintiffs' contention that AVA is either an investigational new drug or a drug unapproved for its use.
Congressional action subsequent to the military's adoption of the AVIP confirms the correctness of DoD's interpretation of section 1107 as excluding the anthrax vaccine. Fully aware that DoD had long taken the position that AVA was not covered by section 1107, Congress addressed the AVIP program by statute in 2000, requiring only that DoD keep a count of the number of service members separated [**52] as a result of "a refusal to participate in the anthrax vaccination program" and annually to report that number to Congress. 10 U.S.C. § 1178. Similarly, Congress required DoD to have regulations to ensure that any civilian emergency-essential [*32] employees required to participate in the AVIP are "notified of the requirement to participate and the consequences of a decision not to participate." 10 U.S.C. § 1580a. n18 By addressing the existing program without changing DoD's interpretation of the "informed consent" requirement, Congress has effectively acquiesced in DoD's mandatory vaccination program, deferring to the considered judgment of military leaders as to how best to ready their troops for combat. n19 See Utah v. Evans, 536 U.S. 452, 472 (2002) (Utah has failed to overcome the fact that the Bureau has long and consistently interpreted § 195 as permitting imputation, while Congress, aware of this interpretation, has enacted related legislation without changing the statute); North Haven Board of Ed. v. Bell, 456 U.S. 512, 535 (1982) (when Congress is aware of an agency's interpretation [**53] of a statute but then fails to alter that interpretation when amending the statute, then presumably the agency correctly inferred Congress's intent).
n18 In addition, the Court of Appeals for the Federal Circuit recently held that "there is ample authority in the appropriate Navy regulations" to "require all civilian employees, including those not designated emergency essential' to receive the anthrax vaccine when the Navy determines that such action is necessary and appropriate to protect the health of such employees." Mazares v. Department of the Navy, 302 F.3d 1382, 1385 (Fed. Cir. 2002), cert. denied, No. 02-846 (U.S. Apr. 7, 2003).

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n19 The Constitution having delegated authority for and oversight of military decisions to the political branches, this Court should not supplant their judgment with its own. Thus, the suit also implicates the principles underlying the political question doctrine, for there plainly is "an unusual need for unquestioning [judicial] adherence to a political decision already made" regarding the means of prosecuting the war, and there is a "textually demonstrable commitment" of military governance to the political branches of the federal government. Baker v. Carr, 369 U.S. 186, 217 (1962).
[**54]
2. Defendants Are Adhering To The Approved Dosing Schedule
Plaintiffs cannot base their claim on the altered dosing schedule prompted by a shortage of the vaccine. First, based on the limited allegations of the complaint, plaintiffs lack standing to [*33] challenge this dosing schedule. None of the plaintiffs allege that his or her dosing schedule was interrupted by prior suspensions of production of the vaccine. Rather, they allege that they are concerned with starting the inoculation series. Complaint P 1. Because they cannot assert that they are "injured in fact" by the continuation of an approved dosing schedule, they cannot establish standing to challenge this practice before this Court. See, e.g., Lujan v. Defenders of Wildlife, 504 U.S. 555, 563 (1992) ("'injury in fact'" requirement of standing "requires that the party seeking review be himself among the injured"). n20
n20 As to all prospective recipients who have never received a dose of the vaccine prior to now, DoD is currently adhering to the label's requirement of six doses over an 18 month schedule. Ex. 1, Grabenstein Decl. P 16. Thus, plaintiffs, who do not allege that they have received any prior dose, cannot be heard to complain that the inoculation schedule applied to them is unlawful.
[**55]
Even assuming that plaintiffs have standing to challenge the interruption and resumption of the normal dosing schedule, that practice is medically appropriate. Beginning in July 2000, an unexpected shortage of the vaccine forced DoD to defer scheduled doses for some individuals who were not assigned to high-risk locales. Ex. 1, Grabenstein Decl. P 16. When vaccine supplies were restored, DoD recommenced the interrupted dosing schedules for those members still assigned to high-risk areas. Id. Consistent with the well-established and prevailing practice of vaccination and the recommendation of the U.S. Centers for Disease Control and Prevention, DoD resumed these dosing series at the points at which they were interrupted, directing the administration of all subsequent doses consistent with the intervals recommended in the approved labeling. Id. Restarting of a vaccine series such as AVA at the first dose is medically inappropriate. Id. As the FDA explicitly states, "resumption of a multi-dose vaccine series [*34] unavoidably interrupted by a vaccine shortage is not a clinical investigation that requires the filing of an Investigational New Drug application." Ex. 2, [**56] Goodman Decl. P 14. Moreover, such resumption "is not inconsistent with the product labeling, in that the labeling does not specifically address dosing in the event of unavoidable shortages." Id. Thus, the interrupted dosing schedule for individuals not before this Court provides no basis for subjecting AVA to the requirements of section 505(i)(4) of the FFDCA, nor are 10 U.S.C. § 1107 or its implementing regulations at all relevant.
II. The Requested Relief Will Severely Harm Defendants And Is Contrary To the Public Interest
The harm to defendants and the public interest both counsel strongly against any form of injunctive relief, whether such relief is limited to the individually named Plaintiffs or is broadly applied to those similarly situated to them. n21
n21 It is not clear whether plaintiffs seek relief only as to themselves or also as to those similarly situated to them. In their Complaint, Plaintiffs seek to "enjoin Defendant from inoculating Plaintiffs and those similarly

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situated to them. . . ." Compl. Relief at P F. At the initial status conference, however, plaintiffs' counsel indicated that plaintiffs would identify themselves in the event this Court determines to permit preliminary injunctive relief. Thus, according to plaintiffs' counsel, interim relief could be limited to the individual plaintiffs. For the reasons set forth herein, see Argument § II, both the public interest and the harm to defendants weigh against the granting of injunctive relief whether the relief is broadly applied to all those similarly situated to plaintiffs or is applied only to the named plaintiffs.
[**57]
Armed combat with Iraq has begun and the global war on terrorism continues. Iraq is believed to have stockpiled great quantities of anthrax. See 149 Cong. Rec. H214 (daily ed. Jan. 28, 2003). The public interest will not be served by depriving the troops of the vaccine, thereby subjecting them to increased risk either from anthrax itself or from the increased battlefield risk [*35] caused by the unnecessary loss of comrades. Indeed, DoD believes that the mere existence of an anthrax vaccination program may deter an opponent from using the pathogen in an attack. Ex. 1, Grabenstein Decl. P 14.
Moreover, requiring compliance with the informed consent requirements of the FFDCA or the waiver requirements of 10 U.S.C. § 1107 would render it infeasible to continue the program for the current military operations against Iraq or the global war on terrorism. DoD has experience complying with the informed consent requirements for investigational new drugs for force health protection, including several in relation to current events. Ex. 1, Grabenstein Decl. P 17. The process requires the development of a detailed protocol, approval through necessary channels, [**58] approval by an Institutional Review Board, submission and discussions with the FDA, a 30-day review period, training of principal and associate investigators, education of recipients of the drug, execution of consent forms, and the other steps required by 21 C.F.R. Part 312. Id. Experience has demonstrated that this is a several month undertaking, even with a generous allotment of personnel to implement it. Id. Thus, if the Court ordered the defendants to comply with section 505(i)(4) of the FFDCA or obtain a Presidential waiver under section 1107 before administering AVA, the AVIP would have to halt for a period of months.
The ability to seek a presidential waiver of these requirements does not lessen the impact. Were the Secretary of Defense to request a waiver from the President, the procedure outlined in Executive Order 13139 requires further layers of review and compliance beyond those above and, so, would take at least as much time if not more to obtain. Id. Compliance with either the informed consent or waiver provisions would be onerous, effectively shutting down the [*36] inoculation program for months. Thus, should this Court enjoin the Secretary as requested [**59] by plaintiffs, the inoculation program would effectively grind to a halt. Id. The war in Iraq and the global war on terrorism would proceed (as would other military missions), but some troops would not be protected against anthrax. Id.
The harm to military readiness resulting from judicial intrusion in military affairs weighs heavily against plaintiffs' request for an injunction. If a program-wide injunction is issued, n22 the President and his military commanders will have to cease inoculating the replacement troops currently slated to reinforce the combat forces, as well as to interrupt the shot series for many other personnel. Id. Many military members will have to carry out duties in the combat zone -or occupied territory, where the threat will remain until all stores of anthrax are discovered and destroyed -- without being as protected. Id. The effect of an injunction thus would be to alter military strategy decisions in the midst of ongoing combat hostilities. Article III courts have traditionally shied away from interfering with military affairs. E.g., Kries v. Secretary of the Air Force, 866 F.2d 1508, 1513-14 (D.C. Cir. 1989); see discussion [**60] supra at Section I(A)(1). Second-guessing military orders such as those in this case would be extremely disruptive to the military chain of command. The requested preliminary injunction seeks to interfere with affairs peculiarly within the jurisdiction of the military authorities. Orloff, 345 U.S. at 95. As the long line of deferential precedent establishes, because such interference is not in the public interest, the federal judiciary generally shuns intervention in the management and control of the military, [*37] areas constitutionally reserved to the executive and legislative branches of government. Chappell, 462 U.S. at 301; Gilligan, 413 U.S. at 7; Cargill v. Marsh, 902 F.2d 1006, 1007 (D.C. Cir. 1990). This well-settled prudential rule has even more force today, as our troops are in combat and this action seeks to affect their

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means of defending themselves from a potential threat.
n22 Plaintiffs sued on behalf of themselves and others "similarly situated." Complaint P 1. No other class allegations have been made, nor have they sought class certification. See Fed. R. Civ. P. 23(c). Absent class certification, this Court should not issue a program-wide injunction.
[**61]
The impact is severe and detrimental to the public interest even if injunctive relief is limited only to the named plaintiffs. Particularly with respect to matters involving military readiness, an injunction only as to one or a few individuals would be disruptive, others similarly situated to those obtaining injunctive relief would then seek similar relief. The Court thus cannot focus narrowly on the individually named plaintiffs in this case:
The harm to the Army is greater than it first appears. If we upheld the injunction granted under the facts before us, injunctions would routinely be sought in drug discharge cases. The result would be judicial second-guessing of a kind that courts have been reluctant to engage in. . . . To start second-guessing the military under these circumstances "would be a disruptive force as to affairs peculiarly within the jurisdiction of the military authorities. . . ." We conclude that the harm to the Army would be substantial if we upheld this injunction.
Guerra v. Scruggs, 942 F.2d 270, 275 (4th Cir. 1991) (citations omitted). Collective second-guessing of military orders by the judiciary would frustrate the dual [**62] objectives of fairness to the member and ensuring military readiness that Congress sought to achieve in creating the military justice system. Schlesinger v. Councilman, 420 U.S. at 758. Individual relief as to multiple claimants seeking similarly to avoid participation in the vaccine program could then result in the same degree of harm to defendants and to the public interest as if the Court were to order [*38] systemic injunctive relief.
Moreover, even if the relief were somehow limited only to some who wish not to be inoculated, their refusal to take AVA could have a serious impact on the overall success of the military mission and on the ultimate resolution of the conflict. Ex. 1, Grabenstein Decl. P 14. Should a soldier or essential civilian member contract anthrax in combat, the consequences could be devastating; in the event members are subjected to an anthrax attack, any who declined the AVA inoculation would be more likely to become a casualty and, probably, a fatality. Id. Attention would be diverted from the immediate task at hand -- fighting the battle -- to assisting the injured member. Id. Such assistance would in many combat situations [**63] increase the peril faced by those rendering the aid. Id. In addition, medical resources would be diverted from other casualties to care for such a member, all because the member refused to be inoculated. Id. Moreover, the loss of the member would reduce the fighting strength of the member's unit, lessening its effectiveness and possibly its chances of survival on the battlefield. Id. On a large scale, unnecessary reductions in combat effectiveness would greatly affect the conduct of the battle and, possibly, determine its outcome.
For all of these reasons, whether injunctive relief is given as to all similarly situated to plaintiffs or merely to plaintiffs, the consequences are detrimental to defendants and contrary to the public interest.
[*39] III. Plaintiffs Have Not Established Irreparable Injury If Injunctive Relief Is Denied
Though plaintiffs couch their potential irreparable harm in terms of job loss or military punishment, neither of these events are irreparable harm. As noted above, civilian contractor employees may not necessarily be compelled by defendants to take the vaccine. Were they to refuse to take the vaccine and suffer adverse employment [**64] consequences as a result, they would have an adequate remedy and thus would not suffer irreparable harm. See Sampson v. Murray, 415 U.S. 61, 91-92 (1974) (loss of income and damaged reputation are not irreparable injury); Veitch v. Danzig, 135 F. Supp. 2d 32 (D.D.C. 2001)(same). Moreover, as to them, it is entirely speculative that they

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would have their employment adversely affected. For example, efforts would be made to find other DoD employment, if available, for those employees who refuse the vaccine and therefore disqualify themselves from serving in an emergency-essential position. See DoD Dir. 1404. 10 P 6.5. Similarly, a contractor's employees serving in DoD maybe able to find other positions (with the same employers) that do not require the vaccine.
As for the military members, they have the full panoply of legal rights available to them under the Uniform Code of Military Justice, including the right to be represented by counsel and to present defenses (such as their claims here) to any charges brought against them. Thus, they will not be legally prejudiced by the denial of an injunction. Sampson, 415 U.S. at 91-92. [**65]
The only remaining possible harm stems from a potential adverse reaction from the vaccine. But such harm is hypothetical or, at best, very unlikely to occur. AVA's adverse events profile is similar to that for other vaccines. 30% of men and 60% of women report soreness, redness, itching, and swelling at the injection site. Ex. 1, Grabenstein Decl. P 13. These minor [*40] reactions typically go away on their own after a few days. Id. Commonly, a lump occurs at the site, usually lasting for a few weeks before going away on its own. Id. Systemic reaction beyond the injection site -muscle or joint aches, headaches, rashes, chills, low-grade fever, nausea -- are reported by 5 to 35% of those vaccinated. Id. There have been no deaths attributed to AVA by the CDC. Id. AVA has been administered to over 830,000 military members since March 1998. Id. Of this group, representing over 2.8 million inoculations, there have been only 1,857 formal reports of adverse events reported under the HHS Vaccine Adverse Events Reporting System. Id. Only 64 of those inoculated were hospitalized, and only 11 of those hospitalizations were found to have been probably caused by [**66] AVA. Id. All 11 of those hospitalizations involved allergic or inflammation reactions at the injection site. Id. An additional 172 of the military personnel inoculated were absent from duty for more than 24 hours, and only 94 of those were absences that were certainly or probably caused by AVA. Id. In summary, DoD has recorded 105 serious adverse events from AVA in over 830,000 recipients. The Institute of Medicine, which reviewed AVA in a Congressionally mandated report, also found AVA to be a safe and effective vaccine. Id. PP 12, 13. CDC, which tracks data on adverse effects from all vaccines, has found AVA to be a safe and effective vaccine. Id.
In short, plaintiffs will be subject to a de minimis risk of a serious adverse reaction if required to take the inoculation. AVA has been used effectively in civilian industry for over 30 years, being voluntarily taken by those working with animals to guard against anthrax. The potential for an adverse reaction to plaintiffs from taking the inoculation is virtually non-existent. It provides no basis for the relief that they seek.
[*41] CONCLUSION
Plaintiffs cannot demonstrate a substantial likelihood [**67] of success on the merits and have failed to demonstrate any significant harm to outweigh the palpable damage that an injunction would cause to the defendants and the public at large. Plaintiffs' application for injunctive relief should be denied.
Respectfully submitted,
ROBERT D. McCALLUM, Jr.
Assistant Attorney General
ROSCOE C. HOWARD, Jr.
United States Attorney
SHANNEN W. COFFIN
Deputy Assistant Attorney General

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/s/ Ronald J. Wiltsie. II JOSEPH H. HUNT VINCENT M. GARVEY RONALD J. WILTSIE, II (D.C. Bar # 431562) Civil Division United States Department of Justice P.O. Box 883 Washington, D.C. 20044 Telephone: (202) 307-1401 Counsel for Defendants

 
 Page 1
View U.S. District Court Opinion JOHN DOE # 1 et al., Plaintiffs, vs. DONALD H. RUMSFELD et al., Defendants. Civil Action No. 03-00707(EGS) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 707; 2003 U.S. Dist. Ct. Motions LEXIS 6304 April 25, 2003 Motion for Preliminary Injunction
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s) TITLE: [**1]
REPLY TO DEFENDANTS' OPPOSITION TO PLAINTIFFS' MOTION FOR A PRELIMINARY INJUNCTION TEXT: Rather than directly confront the law and/or facts facing it, the government -- in this case represented by the Secretary of the Department of Defense ("DoD"), Secretary of the Department of Health & Human Services ("HHS") and the Commissioner of the Food & Drug Administration ("FDA") -- seeks to paint a picture exaggerated in danger and designed to avoid adjudication of the merits. In response to the plaintiffs' motion, defendants rely on a mixture of unsupported speculation and outright misrepresentations in an effort to stymie service members and civilian employees from asserting protections granted to them by Congress and the President -- notably, the right to require their informed consent before treatment with experimental drugs.
The plaintiffs in this case, two active duty military members, two national guardsmen, one DoD civilian employee and one DoD civilian contractor -- present the simple question of whether one branch of the government must abide by the legal obligations statutorily imposed upon it by another. n1 Nothing less, nothing more.
n1 The plaintiffs also brought this case on behalf of all others similarly situated. See Complaint at P 1 (filed March 18, 2003). The government objects to this characterization and notes that the plaintiffs have not sought class certification under Rule 23 of the Federal Rules of Civil Procedure. See Defendants' Opposition to Plaintiffs' Motion for a Preliminary Injunction at 36 fn.22 (dated April 9, 2003)("Defs' Memo"). The plaintiffs are more than willing to pursue this route. Frankly, the government cannot escape from the fact that at least one or more plaintiffs will be deemed to have proper standing. All that is needed for this Court to adjudicate the merits of plaintiffs' claims is one plaintiff.

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[**2]
[*2] Specifically, this case challenges the mandatory inoculations with anthrax vaccine absorbed ("AVA") faced by the plaintiffs through DoD's implementation of the Anthrax Vaccination Immunization Program ("AVIP"), which under present circumstances is occurring in violation of a clear Congressional mandate forbidding such action. Such a finding is undeniable if this Court determines the anthrax vaccine is either in an investigational new drug status or a drug unapproved for its use when administered for protection against inhalation anthrax exposure. As is evident, without the granting of preliminary injunctive relief to prevent imminent inoculation, the plaintiffs will face irreparable harm at the hands of final agency action.
The Administrative Procedure Act, 5 U.S.C. § 701 et seq., permits the plaintiffs to challenge the final agency action of the DoD for implementing the AVIP, and the arbitrary and capricious decision of HHS and FDA to support it; each of which is in violation of a federal statute -- 10 U.S.C. § 1107. This Court has the unquestionable authority to not only hear this case, but should be persuaded to decide [**3] in favor of the plaintiffs.
ARGUMENT
Ironically, although the defendants' brief is replete with references to numerous cases, FDA regulations, and questionable declarations from unqualified sources, the defendants fail to cite the language of the very statute that will begin and end the analysis in this case -- 10 U.S.C. § 1107. A simple review of the statutory language conclusively demonstrates that defendants' justiciability arguments, as well as those attacking the merits of the plaintiffs' request for a preliminary injunction, should be rejected. The statute clearly demonstrates Congressional intent to eliminate military discretion in military combat operations; the time when DoD is most likely to use investigational new drugs or drugs unapproved for a certain use on those under its control.
[*3] The clear language of the statute in question -- 10 U.S.C. § 1107 -- states:
In the case of the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the members' participation in a particular military operation, the requirement [**4] that the member provide prior consent to receive the drug in accordance with the prior consent requirement imposed under Section 505(i)(4) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(i)(4) may be waived only by the President.
This unambiguous statutory language, reaffirmed by Presidential Executive Order 13139 and DoD's own regulations n2, demonstrates that Congress intended to prevent the unbridled and unrestrained use of military discretion in using certain drugs during military operations. To accept the defendants' arguments renders this statutory language meaningless and ineffective. Essentially, the defendants ask this Court to override the express direction of Congress and the President by ruling in their favor.

n2 See e.g., Department of Defense Directive 6200.2 (August 1, 2000)(http://www.dtic.mil/ whs/directives/corres/html/62002.htm).
Once 10 U.S.C. § 1107 is taken into consideration, it should become evident that by [**5] being ordered to take the anthrax vaccine, each of the plaintiffs are suffering a "legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute" thereby entitling them to judicial review thereof. See 5 U.S.C. § 702. Thus, this Court has been presented with, and it should decide, a relevant question of law and statutory provision. Id. at § 706. Based on this authority, it can "hold unlawful and set aside agency action . . . found to be -- (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; . . . (C) in excess of

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statutory jurisdiction, authority, or limitations, or short of statutory right; (D) without observance of procedure required by law; . . . or (F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court." Id.
The APA erects a "presumption of judicial review" at the behest of those adversely affected by agency action. Abbott Laboratories v. Gardner, 387 U.S. 136 (1967); Dennis [*4] Dickson, et al v. Secretary of Defense, et al., 68 F.3d 1396 (D.C.Cir. 1995). [**6] The only statutory exceptions to this rule are if a particular statute "precludes judicial review" or if "agency action is committed to agency discretion by law." See §§ 701(a)(1),(2). Here, no statute precludes judicial review. n3 Nor does any exception of the APA apply thereby permitting judicial review.

n3 The mere fact that a statute is silent on the issue of review is not controlling. To the contrary, we "begin with the strong presumption that Congress intends judicial review of administrative action." Bowen v. Michigan Acad. of Family Physicians, 476 U.S. 667, 670 (1986). Thus, "judicial review of a final agency action by an aggrieved person will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress." Abbott Labs., 387 U.S. 136, 140 (1967)(collecting cases).

I. THE PLAINTIFFS' CHALLENGE TO THE GOVERNMENT'S FAILURE TO FOLLOW ESTABLISHED LAW IS JUSTICIABLE EVEN WHEN THE MILITARY IS INVOLVED
From the outset the [**7] defendants challenge this Court's ability to resolve this dispute by claiming it is non-justiciable. See Defs' Memo at 14-22. In pursuing this route, they mischaracterize the plaintiffs' challenge as requiring "this Court to engage in review of military decisions regarding the battlefield activities of troops engaged in combat." Id. at 15. This is untrue. Let it be perfectly clear that neither the merits of the government's decision to inoculate the plaintiffs with the anthrax vaccine, or the soundness of the policy that led to that decision, are questions before this Court. Still, as this Court may likely come to realize, the AVIP is nothing more than an obscene loyalty test. It has little to do with military or medical readiness. n4
n4 That being said, there are numerous factual inaccuracies contained throughout the government's brief regarding the safety and efficacy of the anthrax vaccine, most of which relate to the policy decision to utilize the anthrax vaccine. Because these issues are little more than peripherally related, if at all, to the narrow legal issue underlying the plaintiffs' claim, the plaintiffs will not seek to distract the Court with a point by point rebuttal of these facts. The plaintiffs can address any factual questions during oral arguments or in a supplemental pleading if requested.
[**8]
[*5] Instead, the sole question that requires adjudication by this Court is representative of the typical dispute brought before an Article III judge; whether agencies of the Executive Branch are properly following requirements enacted into law by the Legislative Branch and the President. In this specific case, the question pertains to enforcing Congressional intent to ensure DoD does not experiment on military service members without informed consent, as history has revealed the military has done too many times in the past. See S.Rpt. 103-97: "Is Military Research Hazardous To Veterans' Health: Lessons Spanning Half A Century", 103d Cong., 2d Sess. (1994)(http://www. gulfwarvets.com/senate.htm). n5

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n5 Both the FDA and the Presidential Advisory Committee on Gulf War Illnesses have criticized the Pentagon for its past history of using experimental drugs and vaccines during the Gulf War and exercises in Bosnia. The FDA criticized the Pentagon for "failing to document immunizations in soldiers' permanent medical records and for touting the vaccine in handouts given to troops as very safe and extremely effective' when the FDA never authorized such glowing language." Patrick Pexton, Pentagon Can't Be Trusted With Experimental Drugs, Navy Times, Feb. 16, 1998. The President's Committee went even further and declared that the Pentagon "currently is incapable" of handling unapproved drugs. Id.
[**9]
The relief sought by the plaintiffs will have absolutely no impact upon military discipline or duty. Nor does it interfere with military judicial proceedings. Strictly speaking, all that would occur is that DoD would be required to either obtain informed consent from those that it wished to be inoculated with the anthrax vaccine, or a waiver of informed consent from the President. Such a ruling would not require the cessation of the AVIP, nor jeopardize any military missions or the life of a soldier. The government has failed to explain how such relief questions or challenges a military decision, much less the military justice system.
The Constitution explicitly conferred upon Congress the power, inter alia, "to make Rules for the Government and Regulation of the land and naval Forces," U.S. Const. Art. I, 8, cl. 14, thus showing that "the Constitution contemplated that the Legislative Branch have plenary control over rights, duties, and responsibilities in the framework of the Military Establishment. . . . ." Chappell v. Wallace, 462 U.S. 296, 301 (1983). Congress [*6] exercised that authority to "establish a comprehensive internal system of justice to regulate [**10] military life, taking into account the special patterns that define the military structure." Id. at 302. In furtherance of its oversight of the military and in light of past misconduct, Congress enacted 10 U.S.C. § 1107, thereby indicating its unequivocal intent to ensure the military does not undertake experimentation on individuals under the exercise of its control. The Judiciary is, most obviously, the appropriate branch of government to ensure timely compliance with this statute; otherwise, its purpose would be lost forever.
Yet the defendants assert that courts "traditionally have been reluctant to intervene in the conduct of military affairs," see Defs' Memo at 15, because judges "are not given the task of running [the military], and that they are ill-equipped' to determine the impact of judicial intrusion on military authority." Id. (citations omitted). To be sure, under certain circumstances this is true. The Constitution vests "the complex, subtle, and professional decisions as to the composition, training, equipping, and control of a military force" exclusively in the Legislative and Executive branches. Gilligan v. Morgan, 413 U.S. 1, 10 (1973). [**11] Thus, under Feres v. United States, 340 U.S. 135 (1950), and its progeny, the courts have often disallowed damage claims by servicemen against the United States under the Federal Tort Claims Act. And Bivens claims are not available to remedy injuries suffered by service members in the course of military service. United States v. Stanley, 483 U.S. 669 (1987). Yet, neither type of claim is presented here.
In any event, the government's argument paints with far too broad a brush. There are countless examples of the Judiciary adjudicating claims involving the military, and this case clearly falls among them. For example, in John F. Kreis, v. Secretary of the Air Force, 866 F.2d 1508 (D.C.Cir.1989), the D.C. Circuit Court of Appeals addressed the very issue [*7] of "second-guessing" military decisions with respect to officer promotions. n6 The Court declined to adjudicate that issue because:
Appellant's request for retroactive promotion falls squarely within the realm of non-justiciable military personnel decisions. To grant such relief would require us to second-guess the Secretary's decision about how best to allocate [**12] military personnel in order to serve the security needs of the Nation. This court is not competent to compare appellant with other officers competing for such a promotion. Not only is that task inherently unsuitable to the judicial branch, but also Congress has vested in the Secretary alone the authority to determine whether the original selection boards erred in comparing appellant to the

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other candidates for promotion.
Id. at 1511. Yet the Court's analysis did not stop there. It noted that there
is also a more modest request in appellant's complaint, however. While all his efforts are aimed ultimately at securing his promotion to lieutenant colonel, his alternative claims require the district court merely to evaluate, in light of familiar principles of administrative law, the reasonableness of the Secretary's decision not to take certain corrective action with respect to appellant's record. Adjudication of these claims requires the district court to determine only whether the Secretary's decision making process was deficient, not whether his decision was correct. To grant the relief implicit in these claims would not require the district court to [**13] substitute its judgment for that of the Secretary regarding the allocation of military personnel in light of the security needs of the Nation. n7

n6 In their Memorandum in Support of Motion for Temporary Restraining Order and/or Preliminary Injunction (filed March 18, 2003), the plaintiffs relied upon the justiciability test enunciated in Mindes v. Seamen, 453 F.2d 197 (5th Cir. 1971), affirmed on appeal after remand, 501 F.2d 175 (5th Cir. 1974). For the record, the plaintiffs note that the D.C. Circuit has not expressly adopted this test, although neither has it rejected it under such circumstances as presented in this instant matter. See Kreis, 866 F.2d at 1512. A reading of the defendants' Opposition appears to support the plaintiffs' premise that the Mindes' factors are appropriate for consideration. n7 The Court further stated wrote that "The Secretary would remain free, following this reevaluation, to reaffirm his original determination to deny appellant further relief. In short, once we dispose of the request for a judicially ordered promotion, the review sought by appellant looks like nothing more than the normal review of agency action, in which we require only that the agency exercise its discretion in a reasoned manner, but we defer to the agency's ultimate substantive decision." Kreis, 866 F.2d at 1512, citing Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971).
[**14]
[*8] Id.
Although the defendants assert that "at least five courts of appeals have held that Chappell and [Stanley], categorically preclude soldiers from seeking injunctive relief against their commanding officers", see Defs' Memo at 17, it is far more persuasive that the D.C. Circuit is not among them. Indeed, the D.C. Circuit has repeatedly interpreted the Supreme Court's ruling in Chappell as anything but a categorical rule. See e.g. Brannum v. Lake, 311 F.3d 1127 (D.C.Cir. 2002); Kreis, 866 F.2d at 1511, Gay Veterans Association, Inc. v. Secretary of Defense, 850 F.2d 764, 768 (D.C.Cir. 1988); Bois v. Marsh, 801 F.2d 462, 467 n.9 (D.C.Cir. 1986); Roelofs v. Secretary of Air Force, 628 F. 2d 594, 599-601 (D.C.Cir 1980). n8
n8 The defendants seek to distinguish the D.C. Circuit's ruling in Doe v. Sullivan, 938 F.2d 1370 (1991), which dealt with similar factual issues. See Defs' Memo at 18-19. However, that dispute dealt primarily with whether FDA was appropriately exercising its discretionary authority under its own regulations. In the instant matter, the plaintiffs are expressly challenging DoD's deliberate non-discretionary rejection of an explicit statute requiring certain conduct, and the FDA/HHS's failure to ensure DoD's compliance with the statute, as well as their arbitrary and capricious litigation support for DoD's actions.
[**15]

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The government argues that "when a judicial decision affects conduct on the battlefield by the military (and its civilian leadership), the consequences of judicial error are potentially ruinous, especially when the court's decision involves prospective injunctive relief (as in this case) rather than damages after the event (as in Stanley and Feres)." See Defs' Memo at 18. Such a broad statement, if applied to this specific case, would have the perverse effect of rendering the Legislative Branch's enactment of 10 U.S.C. § 1107 null and void.
The government attempts to further shield its unlawful mandatory inoculation program by claiming that 5 U.S.C. § 701(b)(1)(G) precludes judicial review. See Defs' Memo [*9] at 20. This provision, which excludes "military authority exercised in the field in time of war or in occupied territory" from the definition of "agency," is inapplicable. n9

n9 Another peripherally relevant exclusion is "courts-martial and military commissions". 5 U.S.C. § 551(1)(F). However, none of the plaintiffs are involved with either.
[**16]
First, the AVIP was first announced in December 1997, implemented in certain areas in March 1998, and then force-wide in May 1998. See Secretary of Defense Memorandum, "Implementation of the Anthrax Vaccine Program for the Total Force", May 18, 1998, at http://www.anthrax.osd.mil/media/pdf/implementationpolicy.pdf. "A vaccine shortage in 2000 caused the scope of AVIP to be reduced from 70,000 shots per month to approximately 100 per month by mid-2001. Consequently, few of the service members who fought in combat operations in Afghanistan (against terrorists who potentially possessed weaponized anthrax) in 2001-2003 were vaccinated at all, and it appears that for the few that have been they are not current in their vaccination schedule; a fact that has obviously not hindered successful mission accomplishment. The recommencement of the AVIP program was announced on June 29, 2002, which predates the Congressional authorization for the use of force in Iraq by four months, and the current hostilities by nearly a year. See Assistant Secretary of Defense (Health Affairs) Dr. William Winkenwerder, June 29, 2002, DoD press briefing transcript, at http://www.defenselink.mil/news/Jun2002/t06292002_t0628ww. [**17] html.
Second, the plaintiffs are not challenging "military authority exercised in the field in time of war or in occupied territory." None of the plaintiffs are presently in the "field" or in "occupied territory." See Declaration of Mark S. Zaid, Esq. (dated March 17, 2003)(identifying plaintiffs and their presently known locations)(filed under seal)("Zaid Decl."), accompanying Plaintiffs' Ex-Parte Motion for Leave to File Complaint Using "John Does" and "Jane Does" and Counsel's Address in Violation of LCvR 5.1(e) and to Seal Declaration of Mark S. Zaid, Esq. (filed March 18, 2003). Moreover, the policy in question was issued by the Secretary of Defense, not commanders in the field. Any [*10] modifications to the AVIP will originate from the Office of the Secretary of Defense. Obviously, the Secretary is neither in the "field" or in "occupied territory." n10

n10 To the extent the defendants repeatedly rely on the threat of anthrax use on the battlefield, this Court should note that there has not been one iota of evidence of Iraq's use of anthrax in the current conflict, much less any indications that an attack was contemplated or that Iraq is even still in possession of anthrax spores. London Financial Times, "Iraq After Saddam: Finding Iraq Arms Evidence Rests On Taking Full Control", April 23, 2003. Since the filing of the government's Opposition on April 9, 2003, significant favorable events have transpired in Iraq that defuses much of the alleged risk. By April 14, 2003, DoD officials were declaring victory was at hand, and begun recalling troops starting with two aircraft carriers. Indeed, the only use of weaponized anthrax against this country has been against civilians by a perpetrator that is widely believed to be a member of the American bioweapons establishment. See "Anthrax: The Hunt Narrows," Time, February 4, 2002.
[**18]

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There are very few, if any, court decisions that analyze the applicability of § 701(b)(1)(G). The Honorable Colleen Kollar-Kotelly recently referenced the lack of case law or substantive analysis in Rasul v. Bush, 215 F. Supp. 2d 55 (D.D.C. 2002), aff'd 321 F.3d 1134 (D.C.Cir. 2003); a case that determined the claims of aliens incarcerated at Guantanamo Bay, Cuba, for allegedly participating in hostilities against the United States in Afghanistan were nonjusticiable. Judge Kollar-Kotelly noted:
Plaintiffs argue that Section 702 of the Administrative Procedure Act provides such a waiver. Assuming that Section 702 of the Administrative Procedure Act provides a waiver, the Court finds that the actions of the government in this case would be exempt by 5 U.S.C. § 701(b)(1)(G) (providing an exemption for, "military authority exercised in the field in time of war or in occupied territory"). Cases that have analyzed Section 701(b)(1)(G) have had occasion to address it only in the context of "judicial interference with the relationship between soldiers and their military superiors." Doe v. Sullivan, 938 F.2d 1370, 1380 (D.C.Cir. 1991). [**19] Despite the absence of pertinent case law, the language of Section 701(b)(1)(G) supports the view that this Court is unable to review the claim Plaintiffs make under the Administrative Procedure Act. There is no dispute that Plaintiffs were captured in areas where the United States was (and is) engaged in military hostilities pursuant to the Joint Resolution of Congress. Am. Compl. P 16 ("the Kuwaiti Detainees were seized against their will in Afghanistan or Pakistan"). This situation plainly falls within Section 701(b)(1)(G). The Court was unable to find any material in the legislative history that addressed Section 701(b)(1)(G) [*11] of the Administrative Procedure Act, see, e.g., S. Rep. No. 89-1350, at 32-33 (1966); H.R. Rep. No. 89-901, at 16 (1965), and the parties have not provided any legislative history, that would change the Court's view of this provision.
Rasul, 215 F. Supp. 2d at 64 fn.11.
However, for the reasons expressed throughout this pleading, § 701(b)(1)(G) simply does not prevent this Court's consideration of the present dispute.
B. The Plaintiffs Have No Other Adequate Remedy Except For This Court
Whether or not each and [**20] every plaintiff sufficiently can prove standing, or has exhausted any necessary alternative remedies, is irrelevant for purposes of this Court to adjudicate the underlying substantive question. At least one, and undoubtedly more, of the plaintiffs fit both descriptions thereby allowing this Court to reach the merits of the dispute. If the Court decides in favor of the defendants, the standing issues for the other plaintiffs are moot. However, if the Court recognizes standing for even one plaintiff and then rules in their favor on the merits, additional information can be provided to the Court, and if necessary to the defendants, in order to demonstrate individual applicability.
Therefore, the specific case of John Doe # 4 supplies the Court with an appropriate plaintiff. John Doe # 4 is a national guard member who was activated to Title 10 status and ordered to take the anthrax vaccine, but had refused. See Zaid Decl. at P 5d. Since the filing of this litigation, he changed his mind and began the shot series. However, he remains a legitimate plaintiff because he opposes the mandatory AVIP requirement as being in violation of the law. Therefore, under the D.C. Circuit's analysis [**21] in New v. Cohen, 129 F.3d 639 (D.C.Cir. 1997) and the Supreme Court's decision in Goldman v. Weinberger, 475 U.S. 503 (1986), this Court can adjudicate the merits of his dispute. As was recognized in New:
upon receiving the orders which he thought to be illegal, New had two options. He could have chosen to obey the orders and then sought judicial review of the military's policies. Cf. Goldman v. Weinberger, 475 U.S. 503 (1986)(suit to enjoin application of Air Force regulation [*12] that forbade officer from wearing yarmulke while on duty and in uniform). Or he could follow the path that he took: disobey the orders and challenge their validity in the subsequent disciplinary proceedings. n11

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n11 With respect to the two civilian plaintiffs in this litigation, a person need not exhaust remedies in a military tribunal if the military court has no jurisdiction over him. In other words, the military has no authority to subject civilians to court-martial proceedings. See, e.g., McElroy v. Guagliardo, 361 U.S. 281 (1960); Reid v. Covert, 354 U.S. 1 (1957); Toth v. Quarles, 350 U.S. 11 (1955).
[**22]
It is the former that John Doe # 4 does now, and this fact permits this Court to adjudicate the merits of this dispute.
II. PLAINTIFFS ARE ENTITLED TO INJUNCTIVE RELIEF
A. Plaintiffs Have Made A Substantial Likelihood Of Showing They Will Prevail On The Merits Of Their Claims
Defendants start out by misstating and deliberately misconstruing Plaintiffs' arguments. They claim, erroneously, that Section 1107 "is inapplicable here because AVA's license covers use against inhalation anthrax." See Defs' Memo at 28. This is incorrect, and the heart of this dispute. Section 1107 proscribes the use of "investigational new drugs" and "drugs unapproved for their applied use" on service members without their consent only if excused by a Presidential waiver. Whether a vaccine is licensed is irrelevant because, as defendants must admit, a vaccine may be licensed for one purpose and investigational for another. Indeed, the AVA is the subject of at least two investigational studies now, one of which provides the basis for this litigation.
It is the plaintiffs' contention that the license for the vaccine does not incorporate inhalation anthrax because it fails to comply with [**23] established drug laws and FDA regulations, particularly given that there has never been a sufficient study of the vaccine that would validate this role. This was even expressly noted by the independent advisory panel of scientific experts relied upon by the defendants. In 1985, that panel found that the license was not broad enough to include inhalation anthrax because inhalation cases were far too scarce to provide any meaningful data. See Complaint, Attachment "E". This [*13] determination was based, at least in part, on the so-called Brachman Study itself, which noted that there were too few cases of inhalation anthrax in the mill in which the study was taking place to make a determination of the efficacy of the vaccine. See Brachman and Friedlander, Vaccines 736 (ed. Plotkin and Mortimer)(1999). In fact, Brachman noted that there have been "no controlled clinical trials in humans of the efficacy of the currently licensed U.S. vaccine." Id. n12
n12 On October 12, 1999, Kwai-Cheung Chan, GAO, testified before the House Committee on Gov't Reform and stated:
"A study on the efficacy of the earlier vaccine concluded that it provided protection to humans against anthrax penetrating the skin but did not provide information to determine its effectiveness against inhalation anthrax. In the 1980's, DOD began testing the efficacy of the licensed vaccine in animals, focusing on its protection against inhalation anthrax. The studies showed that the vaccine protected some animals against inhalation anthrax. However, the level of protection varied for different species and the results cannot be extrapolated to humans. DOD recognizes that correlating the results of animal studies to humans is necessary and told us that it is planning research in this area. DOD also plans to develop a second generation anthrax vaccine and, as part of this effort, will need to address whether strains of deliberately engineered or naturally occurring anthrax can overcome the protective immunity of such a vaccine."

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Page 9

See http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_house_ hearings &docid=f: 65604. wais
[**24]
What this means is that the vaccine license does not encompass inhalation anthrax, at least not since 1985, when FDA finally published the findings of its advisory panel as a proposed rule. There have been no subsequent human studies on the efficacy of the vaccine against inhalation anthrax, and while there are numerous animal studies in place, none of these studies have found a link between the vaccine's protective qualities in animals and a corresponding marker for protection in human beings. See "Department of Defense, Chemical and Biological Defense Program, FY2001-2003 Performance Plan ", April 2002, at http://www. acq. osd. mil/cp/nbc02/vol2-2002cbdpperformanceplan.pdf (Page 100, CB.33).
[*14] Although the government now points to the Friedman letter of March 13, 1997, and subsequent declarations (including the Goodman Declaration in this case) as providing a basis for its legal claim that the license is valid for inhalation anthrax, none of these opinions have been issued in accordance with FDA's own regulations for a formal FDA opinion. See 21 C.F.R. § 10.85(k)(2000)("A statement made or advice provided by an FDA employee constitutes an advisory [**25] opinion only if it is issued in writing under this Section. A statement or advice given by an FDA employee orally or given in writing but not under this section or § 10.90 is an informal communication that represents the best judgment of that employee at the time, but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.")
Under these circumstances, the opinions of Drs. Friedman, Goodman and any other FDA official concerning the vaccine are merely the personal opinions of those individuals. They are not binding on the agency, and are not entitled to any particular deference by this Court. See Christensen, et al. v. Harris County, et al., 529 U.S. 576 (2000)(Agency statutory interpretations contained in opinion letters entitled to respect but only to extent interpretations have power to persuade). In this case, although having years of opportunity in which to do so, the FDA has refused to provide a formal opinion as to the IND status of AVA. The opinions that have been expressed in response to litigation fly in the face of the [**26] documentary trail created by the defendants before the plaintiffs challenged the status of the vaccine in court. Thus, the FDA's recent statements should not be accorded any significant weight by the Court.
The best evidence of what the vaccine license encompasses is the 1985 pronouncement by the FDA's advisory panel, which was charged to review the adequacy of the licensing language, that the license did not encompass inhalation anthrax because there was insufficient data to do so. See Complaint, Attachment "E". Although the FDA has been on [*15] notice for years concerning this determination, it has yet to issue an official opinion -- in the form of a required Final Rule -- that the vaccine license encompasses inhalation anthrax. FDA's inaction has persisted, despite a decade of controversy over the use of the anthrax vaccine during the 1991 Gulf War, and the 1994 finding of the Senate Committee on Veterans Affairs that the use of AVA for inhalational anthrax was, in fact, investigational.
The failure to provide agency guidance on a critical issue, in the face of conclusive statements by the FDA's own independent review panel of experts, is conclusive that the vaccine's [**27] license does not incorporate inhalation anthrax.
B. The Anthrax Vaccine Is Either An Investigational New Drug Or A Drug Unapproved For Its Applied Use
Even if the vaccine license was not at issue, it is clear that the AVA is either an investigational new drug or drug unapproved for its applied use within the meaning of 10 U.S.C. § 1107, thereby requiring informed consent before its administration to personnel involved in military operations. n13

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Page 10

n13 The statute defines the term "investigational new drug" as a drug covered by section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(i)) and the term "drug unapproved for its applied use" means a drug administered for a use not described in the approved labeling of the drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355).
The defendants do not dispute that DoD initiated a 1996 investigational new drug application for AVA; an application [**28] that is still open and current with the FDA. However, in discussing this matter, the defendants again misstate the issue. The question before the Court is not whether the IND application establishes that "DoD considers use of AVA for inhalation anthrax to be an unlicensed use." See Defs' Memo at 30. The issue is whether the IND application means that the AVA is investigational with regard to the subject matter of the application. Simply put, the issue before the Court concerning the IND status is as follows: When a drug manufacturer files an IND application with the FDA to [*16] permit a specific indication or purpose for a vaccine, is the vaccine investigational if it is used in the manner, or for a purpose, identical to that set forth in the IND application?
The defendants implicitly admit that the answer to this question is "yes," because they take great pains to conceal the original purpose of the 1996 IND application, and especially their interpretation of its meaning. Id. Fortunately, this Court does not need to decide between the parties' differing positions. The defendants own documents explicitly support the plaintiffs' view. Consider the following:
. [**29] On October 5, 1995, the U.S. Army Medical Research and Materiel Command wrote the Michigan Department of Public Health (manufacturer)("MDPH") that they were enclosing a plan "to expand the indication for use to include protection from aerosol exposure to B. anthraces spores." The "plan" specifically asserts that "this vaccine is not licensed for aerosol exposure expected in a biological warfare environment." It was designed to "obtain licensure of an additional indication for protection against aerosol exposure to anthrax." The approach was to amend the anthrax vaccine license through an IND submission. See Complaint, Attachment "G".
. On October 20, 1995 (as reflected in a November 13, 1995 memorandum from the Dept of Army's Joint Program Office for Biological Defense), a meeting was held to discuss modifying the anthrax vaccine license "to expand the indication to include protection against an aerosol challenge of spores." The vaccine manufacturer specifically noted "there are a number of challenges to obtaining a Product License Application (PLA) Supplement . . . for a labeled indication change (aerosol challenge)". See Complaint, Attachment "H".
. On July 2, 1996, FDA [**30] held a meeting to consult with and provide guidance to DoD and MDPH (manufacturer) officials who were formulating the forthcoming September 1996 IND application. See Exhibit "1". The Army presented information showing that although a millworker's study (Brachman Study) indicated that AVA was "93% effective in preventing cutaneous anthrax . . . there were insufficient cases of inhalation anthrax in the unvaccinated group to draw any conclusions for a specific indication for inhalation anthrax." The Army also "presented plans in progress to develop correlates of immunity in animals and then in humans vaccinated with MAVA in order to obtain a specific indication for inhalation anthrax." Id. at P 5. The FDA participants in this meeting told DoD that" . . . there were insufficient cases of inhalation anthrax to warrant a specific indication for this route. . . ." The FDA also advised DoD that it was undecided as to whether animal studies would be adequate for a specific indication for inhalation anthrax without a link [*17] to the vaccine response in humans. Id. at P 8. Nowhere in this preplanning document is there a statement linking the IND application for inhalation [**31] anthrax with the two-shot inoculation IND.
. On August 26, 1996, as a precursor to changing the AVA license by filing an investigational new drug

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application, the Army's Medical Research Institute of Infectious Diseases discussed the purpose of the IND application by saying, "We wish to obtain an indication for protection against inhalation anthrax and to reduce the number of doses to two primary doses with a booster due at one year. These two goals will be studied and discussed as separate issues." See Complaint, Attachment "I".
. On September 20, 1996, Michigan Biologic Products Institute (the successor to MDPH) submitted to the FDA an investigational new drug application. The application was prepared, in whole or in part, by a component of the Department of the Army. The manufacturer's stated purpose for filing the IND application was to "conduct clinical investigations designed to investigate changes in the approved labeling for the licensed product. The potential labeling changes would affect the specific clinical indication, route and vaccination schedule for AVA." See Complaint, Attachment "J".
. The Introductory Statement from the IND application states [**32] that "the ultimate purpose of this IND is to obtain a specific indication for inhalation anthrax and a reduced vaccination schedule," not to obtain an indication for inhalation anthrax with a reduced vaccination schedule. The submission of the IND application was accompanied by a testing protocol designed to demonstrate effectiveness against inhalation anthrax in animals and correlate that effectiveness with comparable effectiveness in human subjects. See Complaint, Attachment "K".
. On December 13, 1996, the FDA sent a letter to the Department of the Army, following the Army's publishing of an advertisement in the Washington Post on October 15, 1996, seeking experimental test subjects for the investigation proposed in the IND application. The letter advised the Army that it could not represent the vaccine as fully licensed when the Army was conducting tests pursuant to an IND application. Specifically, the FDA stated the "Anthrax vaccine is approved for the indication specified in the labeling of the vaccine, but not for the indication currently under investigation." To represent otherwise "would be a violation of the Agency's regulations concerning the promotion of investigational [**33] drugs and of investigational devices." See Complaint, Attachment "L". n14
[*18] On December 4, 1998, BioPort Corporation, the new manufacturer of AVA, sent FDA an annual report documenting its progress on the 1996 IND application. The sole reason listed on the attached FDA Form for the IND is "Inhalation Anthrax". No mention was made of a change in either dosage or route of administration. The timing of this annual report, and the sole rationale noted therein, is important because it occurred more than six months after DoD initiated the so-called "Total Force" AVIP in May 1998. See Exhibit "2".

n14 Interestingly, in a 1990, article entitled "Military Immunizations: Past, Present, and Future Prospects", and co-written by Drs. Ernest T. Takafuji and Philip K. Russell, both former Commanders of the U.S. Army Medical Research and Development Command at Fort Detrick, it was concluded that:
Limited use vaccines and products are defined as those unlicensed experimental vaccines, toxoids, and immunoglobulins that have been developed against specific military threats associated with high morbidity. These products would be used in specific contingency situations. Some of the limited use vaccines could be considered to be experimental deployment vaccines since they are directed against serious region-specific endemic diseases. Limited use vaccines include . . . anthrax.
4 Infectious Disease Clinics of North America 156 (1990).

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[**34]
It is also quite noteworthy that the government's attempted refutation of the plaintiffs IND argument comes not from FDA -- the agency that possesses the necessary expertise on the subject -- but instead from a DoD representative who is neither qualified in this field nor was involved in the original IND application process. The attempt to disguise the true nature of the IND application is even more galling given the high level involvement by both defendants DoD and FDA in the IND planning process. In fact, the defendants' litigation argument that the 1996 IND application linked the inhalation anthrax indication to the proposed new shot regimen has never been made by either DoD or FDA in even one of more than a dozen Congressional hearings or numerous DoD press briefings about AVIP since 1998. For the defendants to come forward now and try to alter this clear record merely highlights the legal and factual insufficiency of their case. n15
n15 The defendants' reliance on the district court's decision in O'Neil v. Secretary of the Navy, 76 F. Supp. 2d 641 (W.D.Pa. 1999), is misplaced. It is undisputed that the district court in O'Neil did not consider the legal implications of the IND or 10 U.S.C. § 1107, particularly since it was not aware of the filing of the IND application. Nor, of course, is this Court bound by any factual determinations reached in O'Neil.
[**35]
[*19] Though internal FDA and DoD documents, many of which were concealed from the public for years, time and time again refute the legal arguments placed before this Court by the defendants, the plain-speaking FDA regulations that have existed for years governing labeling additionally demonstrate the fallacy of the defendants' claims. The government's unsupported conclusion that because the "indication section of the labeling does not specify the route of exposure" means it "includes both cutaneous and inhalation exposure" simply does not comport with established law. See Defs' Memo at 11. As previously detailed, there is no scientifically accepted evidence, at least by FDA's current standards, that demonstrate the anthrax vaccine protects against inhalation anthrax exposure. Thus, the government's claims violate fundamental precepts of drug law.
21 CFR § 201.56 (General requirements on content and format of labeling for human prescription drugs) requires, in relevant part, that:
(a) The labeling shall contain a summary of the essential scientific information needed for the safe and effective use of the drug.
(b) The labeling shall be informative and accurate [**36] and neither promotional in tone nor false or misleading in any particular.
(c) The labeling shall be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans shall be identified as such and included with human data in the appropriate section of the labeling, headings for which are listed in paragraph (d) of this section.
There can be no question that the anthrax vaccine violates this provision with respect to claims it can be utilized to protect against inhalation anthrax. But the violations do not stop there.
21 C.F.R. § 201.57 (Specific requirements on content and format of labeling for human prescription drugs) requires, in relevant part:

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[*20] (c) Indications and Usage.
(1) Under this section heading, the labeling shall state that:
(i) The drug is indicated in the treatment, prevention, or diagnosis of a recognized disease or condition, e.g., penicillin is indicated for the treatment of pneumonia [**37] due to susceptible pneumococci; and/or
(ii) The drug is indicated for the treatment, prevention, or diagnosis of an important manifestation of a disease or condition, e.g., chlorothiazide is indicated for the treatment of edema in patients with congestive heart failure; and/or
(iii) The drug is indicated for the relief of symptoms associated with a disease or syndrome, e.g., chlorpheniramine is indicated for the symptomatic relief of nasal congestion in patients with vasomotor rhinitis; and/or
(iv) The drug, if used for a particular indication only in conjunction with a primary mode of therapy, e.g., diet, surgery, or some other drug, is an adjunct to the mode of therapy.
(2) All indications shall be supported by substantial evidence of effectiveness based on adequate and well-controlled studies as defined in § 314.126(b) of this chapter unless the requirement is waived under § 201.58 or § 314.126(b) of this chapter.
The government cannot identify, for example, that "substantial evidence of effectiveness based on adequate and well-controlled studies" exists for the anthrax vaccine with respect to protection against inhalation anthrax. If it could do so under [**38] the guise of law, surely the FDA and/or DoD would have identified for this Court the language in the label that serves to meet the legal requirements, or stated that the 1996 IND, which is designed to comply with this legal requirement, had been approved. It has not, and most assuredly cannot, do either.
Any way this issue is viewed, the defendants are in violation of the law with respect to the anthrax vaccine. Based on the DoD and FDA's own regulations and documents, the anthrax vaccine must be considered either an investigational new drug or one unapproved for use against inhalation anthrax. Therefore, 10 U.S.C. § 1107 applies, and the plaintiffs are entitled to their preliminary injunction. n16
n16 The FDA has repeatedly shirked its lawful responsibilities when overseeing use of the anthrax vaccine. Thirty years ago, the FDA published a Proposed Rule Making notice governing the "Legal Status of Approved Labeling for Prescription Drugs; Prescribing for uses unapproved by the Food and Drug Administration", 37 Fed. Reg. No. 158 (Aug. 15, 1972), 21 CFR Part 130. It read, in pertinent part, that "where the unapproved use of an approved drug becomes widespread or endangers the public health, the Food and Drug Administration is obligated to investigate it thoroughly and to take whatever action is warranted to protect the public." The fact that the anthrax vaccine has been administered to nearly one million people without informed consent in just the last five years alone is a sad demonstration of the FDA's interest in enforcing its own regulations and policies.
[**39]
[*21] C. The Defendants Are Not Following The Licensed Vaccine Schedule For Shot Sequences
As an initial matter, this Court can readily determine that defendants are not adhering to the licensed schedule for

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Page 14

the vaccine. That schedule calls for a specified shot sequence of 0, 2, and 4 weeks, followed by 6, 12 and 18 month inoculations. In fact, the defendants admit that they are not following this schedule, but attempt to explain it away by noting that the license itself does not specifically address dosing in the event of a "shortage." See Defs' Memo at 33-34.
Although the AVA license may be silent on every single possible thing that might go wrong with AVIP, the FDA has not allowed this silence to stifle the exercising of its lawful authority. FDA officials specifically informed the DoD that any deviation from the shot schedule was inappropriate and outside of the approved licensing. See Complaint P 43 and Attachment P. In 1999, at the time this statement was made, it was clear from representations made by the manufacturer to the Army that there was going to be a shortage of the vaccine sometime in the year 2000. In fact, at a meeting on December 17, 1997, between [**40] MBPI, its consultant SAIC, Army and FDA regulatory officials, MBPI's Executive Director (and later BioPort's Chief Operating Officer), Dr. Robert Myers, stated "that within 18 to 24 months after immunization begins, the vaccine will be in short supply." See Exhibit "3".
Moreover, the justification offered by the defendants in support of the interrupted schedule is baseless. The DoD's declarant, Colonel Grabenstein, is not a physician, but a pharmacist. There is no study of AVA showing that the vaccination schedule could be interrupted and then resumed without loss of efficacy. Colonel Grabenstein's assessment of [*22] what is medically appropriate or inappropriate should be given no weight as he is unqualified to testify to that point.
In short, the defendants' evidence now directly contradicts statements made by the same government agencies at a time when there was no lawsuit and when the impending vaccine shortage was well-known. n17
n17 It is the plaintiffs' current understanding that DoD has failed to continue the anthrax inoculations for those individuals who are currently on the "battlefield" in either Iraq or Afghanistan, notwithstanding repeated promises to the FDA that it would abide by the required shot sequence. The Court may wish to inquire of the defendants for confirmation of this fact at oral arguments since, if true, it impugns the government's credibility even further. If necessary, the plaintiffs can supply sworn declarations attesting to these facts.
[**41]
D. Public Interest Militates In Favor Of Granting The Injunction
The defendants emphasize that "armed combat with Iraq has begun and the global war against terrorism continues." See Defs' Memo at 34. Therefore, the "public interest will not be served by depriving the troops of the vaccine, thereby subjecting them to increased risk either from anthrax itself or from the increased battlefield risk caused by the unnecessary loss of comrades." Id. While the government's interest in protecting our troops is admirable and important (though highly suspect given its apparent disregard of continuing vaccinations in the "battlefield" region), the underlying claims are nothing more than exaggerated rhetoric.
If the concern and risks were so manifestly present, then why does the Department of State, whose employees are in the same regions as that of the plaintiffs and tens of thousands of military troops, not mandate the anthrax vaccine for its personnel? Instead, it offers them a supply of antibiotics. Surely, the defendants would not argue that the State Department cares less about its employees than does the Defense Department? Indeed, why are both British and Australian troops [**42] -- the other coalition nations with significant [*23] forces participating in the present Iraqi military conflict -- being offered an anthrax vaccine on a voluntary basis? n18

n18 See Ministry of Defence, "The Voluntary Immunisation Programme (VIP) Against Anthrax", June 13, 2002, at http://www.guardian.co.uk/military/story/0,11816,893825,00.html (United Kingdom); Australian Chief of Navy Vice Admiral Chris Ritchie message to all Naval personnel, February 13, 2003, SUBJ: ANTHRAX

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Page 15

VACCINATIONS AND WELL BEING OF NAVY PEOPLE, at http://www.defence.gov.au/media/2003/ 16020303.htm (Australia). The Canadian military also offers the anthrax vaccine on a voluntary basis. In fact, the highest ranking judge in the Canadian military ruled that use of AVA was a "violation of the Canadian Charter of Human Rights." The Christian Science Monitor, "Canada: Soldiers have right to refuse anthrax vaccine", May 9, 2000. It is noteworthy to add that the Canadian military judge reached his conclusion after hearing extensive testimony by the U.S. Army's top anthrax vaccine researcher, Colonel Arthur Friedlander, M.D. (ret), whose testimony the judge characterized in his ruling as "somewhat contradictory." See http://www.majorbates.com/ law/canadatranscript.htm # (transcript of Military Judge Colonel G.L. Brais' ruling, May 5, 2000). Although the ruling was overturned on appeal, it was done on the basis that dismissal of the court martial charges should not have occurred during the pre-trial phase. Despite this apparent victory, the Canadian military chose not to retry the case, nor has it reinstituted a mandatory anthrax vaccine program
[**43] .
The defendants also claim that the public interest favors denial of the plaintiffs' request because of administrative inconvenience over a process they control. It is alleged that an injunction would require layers of administrative review that would derail the program for months. See Defs' Memo at 35. n19 However, DoD was able to comply with similar administrative provisions in only three weeks between the adoption of the Interim Rule (predecessor of 10 U.S.C. § 1107) on December 20, 1990, and the start of Gulf War combat operations on January 16, 1991. Moreover, DoD and FDA have had over four years since the passage of 10 U.S.C. § 1107 to comply with the law. The Court cannot [*24] now allow the defendants to jointly violate the law simply because they have chosen to ignore its requirements.

n19 Plaintiffs are at a loss to understand what onerous administrative requirements defendants refer to with regard to Executive Order 13139 ("E.O."). The E.O. requires certification from the FDA that the IND is safe and effective relative to the risk to troops without the IND, a recommendation from the Secretary of Defense that the waiver is necessary, and notice to the troops concerning the side effects of the IND. See E.O. 13139, PP 3(b)-(i). Such documentation is already in place following the civilian anthrax attacks. In fact the Center for Disease Controls provided a far more detailed assessment of the risks of the AVA than has ever been given to military members. See Exhibit "4".
[**44]
Surely, if the danger articulated by the government is so clear and immediate, there should be little difficulty in convincing the President and other necessary agencies to sign off on the required paperwork to make the AVIP mandatory and in compliance with the law, which is all the plaintiffs can ask.
E. Plaintiffs Face Irreparable Injury Because They Cannot Be Compensated For The Loss Of A Statutorily Guaranteed Right To Informed Consent Before Being Inoculated With An Investigational New Drug Or A Drug Unapproved For Its Use
If the Court does not grant this injunction, no monetary award can adequately compensate individuals whose right to informed consent has been violated as a result of the AVIP program. Although the defendants argue that the vaccine is safe and effective, the FDA itself has stated that the Army's so-called safety studies of AVA have "significant methodological limitations" because they were "not randomized or well-controlled." See FDA letter to Mark S. Zaid, Esq., dated January 7, 2002, at http://www.fda.gov/ohrms/ dockets/dailys/02/Jan02/012302/00p-0653_ans0001_voll.pdf. It is also undisputed that the vaccine label has recently been dramatically [**45] modified with respect to the systemic reaction rate (which went from 2% in the 1999 and preceding labels to between 5% and 35% in the January 2002 revised label; an increase of 175 fold) and in the variety of chronic illnesses that are associated with the vaccine (notably, the Pregnancy Rating was changed to Category D, which denotes "positive evidence of risk").

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Moreover, it is impossible to tell with any certainty what the long-term effects of the vaccination will be. Establishing the etiology of vaccine-related illnesses or medical conditions is a costly and time-consuming process. It is for precisely this reason that 10 U.S.C. § 1107 was passed, so that drugs undergoing investigational studies would not [*25] be used on soldiers absent their informed consent of the risks, or a presidential waiver determination that the benefits outweigh the risks.
Accordingly, the plaintiffs can establish irreparable injury if their vaccinations are allowed to go forward because the AVIP will violate their statutory rights established by Congress and because there is no adequate remedy at law for the loss of these rights and for the potential medical injury that may [**46] result.
CONCLUSION
Based on the foregoing, this Court should declare that the anthrax vaccine is either an investigational new drug or a drug unapproved for its use, with respect to inhalation exposure, and grant the plaintiffs' Motion for a Preliminary Injunction.
Date: April 25, 2003
Respectfully submitted,
/s/
John J. Michels, Jr., Esq.
D.C. Bar # 457575
McGUIREWOODS LLP
77 W. Wacker, Suite 4400
Chicago, Illinois 60601
(312)849-8150
/s/
Mark S. Zaid, Esq.
D.C. Bar # 440532
Krieger & Zaid, PLLC
1133 21st St., N.W.
Suite 800
Washington, D.C. 20036
(202) 223-9050

 
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View U.S. District Court Opinion View Original Source Image of This Document
JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, SECRETARY OF DEFENSE, et al., Defendants. 1:03-cv-00707-EGS
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 40715; 2004 U.S. Dist. Ct. Motions LEXIS 19977 January 2, 2004 Motion to Stay
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Motion(s) COUNSEL: [**1] PETER D. KEISLER, Assistant Attorney General. ROSCOE C. HOWARD, Jr., United States Attorney. SHANNEN W. COFFIN, Deputy Assistant Attorney General. JOSEPH H. HUNT, VINCENT M. GARVEY, RONALD J. WILTSIE, II (D.C. Bar # 431562), Civil Division, United States Department of Justice, P.O. Box 883, Washington, D.C. 20044, Telephone: (202) 307-1401. Counsel for Defendants. TITLE: DEFENDANTS' EMERGENCY MOTION FOR IMMEDIATE ADMINISTRATIVE STAY PENDING DISPOSITION OF DEFENDANTS' MOTIONS TEXT: For the reasons stated in the accompanying memorandum, Defendants Donald H. Rumsfeld, Tommy Thompson, and Mark B. McClellan hereby move the Court on an emergency basis for an immediate administrative stay of it preliminary injunction entered on December 22, 2003 as to all service members but the six Doe. Plaintiffs in this matter while the Court considers Defendants' pending motions. Defendants ask the Court to issue a decision with respect to this motion on or before January 6, 2004 so that Defendants can seek an immediate administrative stay or other relief in the D.C. Circuit, if necessary.
Pursuant to Local Civil Rule 7.1(m), counsel for Plaintiffs was contacted concerning the motion [**2] and has indicated that Plaintiffs do not consent to the requested relief. A proposed Order accompanies this motion. Respectfully submitted,

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PETER D. KEISLER Assistant Attorney General
ROSCOE C. HOWARD, Jr. United States Attorney
SHANNEN W. COFFIN Deputy Assistant Attorney General
/s/ Ronald J. Wiltsie. II JOSEPH H. HUNT VINCENT M. GARVEY RONALD J. WILTSIE, II (D.C. Bar # 431562) Civil Division United States Department of Justice P.O. Box 883 Washington, D.C. 20044 Telephone: (202) 307-1401
Counsel for Defendants
January 2, 2004
MEMORANDUM IN SUPPORT OF DEFENDANTS' EMERGENCY MOTION FOR IMMEDIATE ADMINISTRATIVE STAY PENDING DISPOSITION OF DEFENDANTS' MOTIONS
Defendants respectfully request that the Court enter an immediate administrative stay of its injunction - except insofar as the six Doe Plaintiffs are concerned - pending disposition by this Court of Defendants' Emergency Motion To Vacate Preliminary Injunction And For Stay ("Emergency Motion") and Defendants' related Motion For Clarification Or In The Alternative For Reconsideration ("Motion For Clarification"). Defendants ask the Court to issue a decision with respect to [**3] this motion on or before January 6, 2004 so that Defendants can seek an immediate administrative stay or other relief in the D.C. Circuit, if necessary, on January 7, 2004. n1
n1 By the relief they have requested since the Court entered its preliminary injunction order, Defendants have consistently maintained that immediate review in the D.C. Circuit would not be necessary if the Court would clarify that its injunction applies only insofar as the six Doe Plaintiffs are concerned or if the Court would issue a stay of the injunction with respect to all but the six Doe Plaintiffs during the Court's consideration of Defendants' pending emergency motions.
[*2] The relief sought in this motion is both exceedingly narrow and exceedingly urgent. We do not seek, at this stage, to affect the preliminary injunction at all insofar as it concerns the six Doe plaintiffs who filed this lawsuit and who wish to avoid exposure to the anthrax vaccine. We also do not seek to affect the Court's current scheduling order, which [**4] contemplates a hearing on the pending emergency motions on January 14 and a decision at some unspecified date thereafter. And we do not seek an immediate determination that defendants are likely to prevail on the merits of the case, or even on their pending emergency motions, although (as explained below), we believe they will. Instead, we seek only a brief administrative stay, limited in its scope to non-parties and limited in time until this Court decides our pending motions. See In re Rice, 2003 WL 2287627 (D.C. Cir. Dec. 3, 2003) (purpose of administrative stay is "to give the court sufficient time to consider the merits of the motion for stay, and should not be construed in any way

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as a ruling on the merits of that motion").
An administrative stay will allow the court, before effectively shutting down the military's ongoing anthrax vaccination program on a worldwide basis, to consider the merits of our pending arguments that (i) the preliminary injunction cannot properly be applied to non-parties, many of whom are soldiers who may desire the vaccine not only for combat readiness, but also for their own personal protection; and (2) intervening FDA action has foreclosed [**5] any basis for the preliminary injunction. Because of the significant legal issues raised by these arguments and the substantial likelihood that the government will succeed on either or both, the default rule in the interim (i.e., prior to this Court's January 14th hearing and subsequent decision), should be that the injunction issued by this Court should be limited to the six Doe plaintiffs currently before the Court. Even in the civilian context, there is no basis for a court to issue an injunction with [*3] respect to persons not before the court. A fortiori that is so in the military context of this case, in which a military-wide injunction would broadly affect the protection of the Nation's military personnel against attack, their combat readiness, and matters of military judgment and command. See Department of Defense v. Meinhold, 510 U.S. 939, 939 (1993) (staying military-wide injunction issued against Department of Defense to extent it related to any person other than named plaintiff); Lever Brothers Co. v. United States, 981 F.2d 1330, 1338 (1993), (vacating injunction to the extent it barred government from enforcing a regulation as to [**6] all foreign goods, and not merely those of the plaintiff's own foreign affiliates). Accordingly, a stay should be granted until the Court has ruled on the government's motion to clarify that the preliminary injunction is limited to the six plaintiffs before the Court (or, in the alternative, to modify the injunction insofar as it might be read to extend beyond those six plaintiffs).
The Court Should Grant An Immediate Stay
On December 31, 2003, the Court issued a Minute Order granting Plaintiffs' Motion for Extension of Time and setting a hearing on Defendants' pending emergency motions for January 14, 2004 ("Minute Order"). The Defendants appreciate that the Court, while granting Plaintiffs' Motion for Extension of Time, also granted Defendants' request to expedite consideration of Defendants' pending emergency motions, thereby recognizing some measure of immediacy associated with those motions. In their pending Emergency Motion, however, Defendants asked not only that the Court vacate its preliminary injunction order, but also that the Court grant an immediate stay of its injunction with respect to all but the six Doe Plaintiffs pending disposition of the Emergency Motion [**7] and pending disposition of the related Motion For Clarification. Because of the urgent nature of these requests, Defendants asked that the Court rule on that [*4] motion and the related Motion For Clarification by January 6, 2004 so that Defendants would have a timely opportunity to seek review in the D.C. Circuit if necessary. Mem. in Support of Emergency Motion at 4 n.4. n2
n2 Defendants did not repeat this request for a decision on these motions by January 6th in the text of the motion itself or in the motion for expedited consideration of the motions. Out of an abundance of caution and to ensure that the Court understood the urgent nature of those requests, therefore, defendants file the instant motion with the Court.
By its Minute Order, the Court effectively denied Defendants' request for such a stay by granting Plaintiffs' Motion for Extension of Time and setting a hearing on Defendants' pending motions for January 14, 2003. Without a stay pending disposition of the motions, the effect of the Court's [**8] Minute Order is to keep the injunction in place, without clarification as to its scope, until at least January 14, 2004 and some indefinite period of time thereafter necessary for the Court to render a decision. That is too long given the substantial and irreparable injury that flows from the Court's preliminary injunction.
In their Emergency Motion, together with accompanying memorandum and supporting documents, all of which are incorporated by reference herein, Defendants set forth the reasons that justify immediate relief from the Court's preliminary injunction order. As noted therein, the propriety of a stay turns on whether (1) '"the petitioner [has] made a strong showing that it is likely to prevail on the merits of its appeal'"; (2) '"the petitioner [has] shown that without such

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relief, it will be irreparably injured'"; (3) '"issuance of a stay [would] substantially harm other parties interested in the proceedings'"; and (4) the public interest favors a stay. Washington Metropolitan Area Transit Commission v. Holiday Tours. Inc., 559 F.2d 841, 843 (D.C. Cir. 1977) (quoting Virginia Petroleum Jobbers Assoc. v. FPC, 259 F.2d 921, 925 (D.C. Cir. 1958)). [**9] [*5] Each of those factors, as already set forth in Defendants' prior submissions in support of their pending motions, militates in favor of a stay. n3
n3 Without restating all of the arguments in support of Defendants' showing with respect to each factor set forth in Defendants' pleadings already submitted, Defendants herein focus primarily on the substantial and irreparable harm that demonstrates the urgency of the situation and, therefore, explains why the Court should issue an immediate stay pending disposition of Defendants' motions.
Without restating our arguments in full, Defendants are likely to succeed on the merits of their pending motions for two major reasons. First, this Court lacks authority to issue a preliminary injunction for service members not before this Court, since Plaintiffs have not sought class certification and no class has been certified. See, e.g., Zepeda v. United States INS, 753 F.2d 719, 728 & n.1 (9th Cir, 1983) (in the absence of class certification, preliminary [**10] injunctive relief may cover only the named plaintiffs); Easyriders Freedom F.I.G.H.T. v. Hannigan, 92 F.3d 1486, 1501 (9th Cir. 1996) (injunctive relief should be limited to apply only to named plaintiffs in the absence of class certification); Davis v. Romney, 490 F.2d 1360, 1366 (3d Cir. 1974) ("Relief cannot be granted to a class before an order has been entered determining that class treatment is proper."). Second, since the Court issued its decision in this case, the Food and Drug Administration ("FDA") has issued a Final Order categorizing Anthrax Vaccine Adsorbed ("AVA") as safe and effective for the treatment of inhalation anthrax. See Final Rule/Final Order, Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, Food and Drug Administration, Health and Human Services, December 30, 2003 ("Final Order"). This Final Order removes the legal rationale underpinning the Court's earlier decision, i.e., that FDA had not definitively spoken to this issue. The arguments setting forth the reasons Defendants are likely to succeed on the merits of their claims are developed more fully in the [*6] papers and [**11] supporting documents Defendants have previously submitted in support of their pending motions. See, e.g., Memorandum in support Of Defendants' Emergency Motion, pp. 4-8; Memorandum in support of Defendants' Motion For Clarification, pp. 2-6.
Significant and irreparable harm will result if Defendants are not allowed to expeditiously resume the anthrax inoculation program. Anthrax is a deadly disease, the only known effective prevention against which is the anthrax vaccine known as Anthrax Vaccine Adsorbed. Declaration of William Winkenwerder, Jr., M.D., Assistant Secretary of Defense (Health Affairs) (Exhibit 2 to Defendants' Emergency Motion) ("Winkenwerder Declaration"), at P 4. Men and women of the United States armed forces face a continuing significant threat from the use of anthrax as a biological weapon by enemy forces. Id. at P 5. Those risks not only have been present in the conflict in Iraq but also are a constant presence in the more widely dispersed Global War on Terrorism. Id Chemical and biological weapons could be used in a regional conflict or a terrorist attack, particularly in southwest Asia and other areas outside the United States where our service members [**12] are deeply engaged against adversaries in the Global War on Terrorism. Id. The anthrax threat does not need a massive program or sophisticated delivery devices, and our adversaries possess the potential capability to attack with the deadly anthrax spores. Id. at P 6. Indeed, it was the threat of anthrax exposure to our service members engaged in military operations that led the Department of Defense ("DoD") to activate the Anthrax Vaccine Immunization Program. Id. n4
n4 The judgment of the military that service members should be vaccinated for their protection and for the accomplishment of their military missions is entitled to some measure of deference. Goldman v. Weinberger, 475 U.S. 503, 507 (1986) (courts "must give great deference to the professional judgment of military authorities concerning the relative importance of a particular military interest.")

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[*7] The anthrax vaccination is mandatory for designated personnel at high risk "because the vulnerability of any individual [**13] to anthrax threatens the life of that individual, endangers others in his or her unit, and jeopardizes the success of the military mission." Id. at P 10. Approximately 30,0000 new troops begin the anthrax vaccination series each month, and more than 100,000 service members receive one in the series of anthrax vaccinations during the same period. Id. at P 9. Thus, on average, approximately 1,000 new service members begin the anthrax vaccination series each day, and more than 3,300 service members receive one in the series of anthrax vaccinations each day. In light of the continuing threat of anthrax attack from hostile forces or terrorist organizations, it is imperative that DoD's ability to vaccinate personnel at risk be restored as quickly as possible. Id. at P 8. Large scale troop movements are underway in connection with ongoing military operations in Iraq and elsewhere in the Global War on Terrorism. Id. at P 8.
Ceasing anthrax vaccinations threatens significant harm to the health and safety of service members and to military readiness. Id. at P 10. "If this interruption [in the vaccination program occasioned by the Court's injunction] were to continue, it [**14] would leave masses of military personnel without the best around-the-clock protection against the bioweapon that demonstrated its lethality in the fall of 2001 in our own country." Id. at P 7. Without a clarification that the Court's injunction applies only with respect to the six Doe Plaintiffs or without a stay of the injunction pending resolution of Defendants' motions, a significant number of service members would be deployed to hostile regions without adequate protection against the deadly anthrax [*8] disease. The longer the injunction remains in place, the fewer service members who are deployed to hostile regions will be protected against the deadly anthrax disease. These service members serve in positions that are the most distant on the globe from medical reinforcement in the event of a catastrophic release of anthrax spores. Id. Sending them to these military operations without the only known effective protection against anthrax is akin to sending them into combat without their flack jackets. "If service members who did not receive the vaccine were subjected to an anthrax attack, they would be much more likely to contract inhalation anthrax and become a casualty. [**15] " Id. at P 10. The substantial and irreparable harm to the lives and safety of our service members alone justifies entry of an immediate stay of the injunction with respect to all but the six Doe Plaintiffs.
But the injunction not only endangers the lives and safety of our service members, it comes at a great cost to the military missions of the United States. As Dr. Winkenwerder attests, "[i]f this preliminary injunction applies to the worldwide program, rather than only the six named plaintiffs in the case before this Court, it will inflict substantial and irreparable harm on combat readiness and military preparedness." Id. at P 7. Dr. Winkenwerder attests that, if troops are not given the vaccine prior to deployment as a consequence of "the current disruption in the [vaccine] program [it] will result in the need to provide many more shots to units widely dispersed in overseas field settings, increasing the burden on combat commanders who should instead focus on other operational and force protection issues." Id. at P 8. And the vulnerability of individual service members to anthrax "endangers others in his or her unit, and jeopardizes the success of the military [**16] mission." Id. at P 10. If a service member contracts anthrax while deployed in combat with his unit, it would require other unit members "to divert attention from [*9] the battle to render aid." Id. "[S]tricken service members would have to be sent quickly to a medical facility for treatment," where they "would require significant attention from medical personnel, attention that would be diverted from other wounded." Id. "Vaccinated troops could be harmed by the loss or absence of their unvaccinated colleagues," and [t]heir loss from the unit would degrade the unit's combat effectiveness." Id.
While the Court's injunction does not, by its terms, preclude inoculations if service members provide informed consent under the FDA's investigational new drug regulations or the President waives the consent requirement, neither of those options is viable here. Because the Food and Drug Administration has made clear that AVA is safe and effective against inhalation anthrax, requiring service members to consent to treatment or compelling the President to waive the consent requirement would improperly "sen[d] a conflicting message to service members about whether the [**17] vaccine has been determined to be safe and effective or whether it is investigational and experimental." Id. P 15. "Even if the President waived informed consent under 10 USC 1107, because those consent requirements only apply to clinical investigations, AVIP [the Anthrax Vaccine Inoculation Program], by definition, would proceed as a clinical research trial, with requirements including notice that the vaccine is unapproved." Id. But the AVIP is not and never has

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been a clinical research trial. Id. To qualify would require "the development of a detailed IND [Investigational New Drug] protocol, approval through necessary channels, approval by an Institutional Review Board, submission and discussions with the FDA, FDA's 30-day review period, training of principal and associate investigators, education of recipients of the IND, execution and storage of consent forms, and other steps required by [regulation], [all of which] is a several-month undertaking, even with a generous allotment of [*10] personnel to implement it." Id. at P 14. According to Dr. Winkenwerder, "[i]f the use of AVA for protection against inhalation exposure required [**18] compliance with Investigational New Drug requirements of the Federal Food, Drug, and Cosmetic Act, it would be extraordinarily difficult to continue the program in relation to current military operations against Iraq or the continuing Global War on Terrorism." Id. Even if it qualified, "[t]he additional labor required to diligently execute an FND protocol would be massive ... and divert scarce labor from other defense missions." Id. Dr. Winkenwerder attests that "[a]n order that DoD must comply with IND requirements in the AVIP could stop the program cold for a very substantial period of time." Id.
In the face of the complications associated with obtaining consent or a Presidential waiver under the circumstances concerning use of AVA for inhalation anthrax, Plaintiffs have introduced no evidence, and the Court has made no finding, that the six Doe Plaintiffs adequately represent the interests of all service members. For all of the reasons just set forth, the effect of the Court's injunction, read literally, would be to preclude even those service members who want to get the vaccine from getting it, thus subjecting them to risk of contracting a fatal disease when they [**19] would rather get the vaccine. This is the precise type of fundamental unfairness that is to be avoided by the rule against granting injunctions that affect an entire class without having satisfied the requirements of class certification. n5 The interests of absent service members is thus yet an additional compelling reason to grant Defendants' motion for an immediate stay pending disposition of Defendants' motion absent clarification that the injunction applies only to the six Doe Plaintiffs.
n5 Zepeda, 753 F.2d at 728-30 ("A person who desires to be a 'self-chosen representative' and 'volunteer champion'... must qualify under [Fed. R. Civ. P] 23.")
[*11] The greater the number of service members who are deployed to hostile regions without the vaccine, the greater is the danger to their own protection and to the military missions to which they have been tasked. Given the magnitude of irreparable harm that would result, the lack of any harm to Plaintiffs, and the likelihood of Defendants' [**20] success on the merits of the arguments set forth in their pending motions, an immediate and limited administrative stay as to all but the six Doe Plaintiffs until the motions are disposed of is warranted.
For all of the reasons set forth above, Defendants ask that the Court grant this emergency motion and issue an immediate administrative stay of its injunction with respect to all but the six Doe Plaintiffs pending disposition of Defendants' motions. Such an administrative stay would have no effect whatsoever on the rights of the Plaintiffs, because the injunction can remain in effect as to them at least until this Court's January 14 hearing. As noted above, Defendants respectfully urge the Court to decide this motion on or before January 7, 2004 so that Defendants may seek an immediate administrative stay or other relief in the D.C. Circuit on January 8, 2004 if necessary.
[*12] Respectfully submitted,
PETER D. KEISLER Assistant Attorney General
ROSCOE C. HOWARD, Jr. United States Attorney
SHANNEN W. COFFIN

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Deputy Assistant Attorney General
/s/ Ronald J. Wiltsie. II JOSEPH H. HUNT VINCENT M. GARVEY RONALD J. WILTSIE, II (D.C. Bar # 431562) Civil [**21] Division United States Department of Justice P.O. Box 883 Washington, D.C. 20044 Telephone: (202) 307-1401 Counsel for Defendants
January 2, 2004
[EDITOR'S NOTE: See JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, SECRETARY OF DEFENSE, et al., Defendants., 1:03-cv-00707-EGS, IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA]

 
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View U.S. District Court Opinion View Original Source Image of This Document
JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, SECRETARY OF DEFENSE, et al., Defendants. 1:03-cv-00707-EGS
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 40715; 2004 U.S. Dist. Ct. Motions LEXIS 19978 January 4, 2004 Motion to Stay
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Motion(s) COUNSEL: [*1] Mark S. Zaid, Esq., D.C. Bar # 440532, Krieger & Zaid, PLLC, 1747 Pennsylvania Avenue, N.W., Suite 300, Washington, D.C. 20006, (202) 454-2809. John J. Michels, Jr., Esq., D.C. Bar # 457575, McGUIREWOODS LLP, 77 W. Wacker, Suite 4400, Chicago, Illinois 60601, (312) 849-8150. Attorney For The Plaintiffs. TITLE: OPPOSITION TO EMERGENCY MOTION FOR IMMEDIATE ADMINISTRATIVE STAY PENDING DISPOSITION OF DEFENDANTS' MOTIONS TEXT: Despite the clarity of this Court's Minute Order dated December 31, 2003, which set forth a briefing and oral argument schedule on all pending defense motions, the government has filed an Emergency Motion for Immediate Administrative Stay Pending Disposition of Defendants' Motions (filed January 2, 2004)("Defs' Memo"). Thus, once again, the defendants are effectively seeking a second-level reconsideration of a prior court ruling. This latest attempt to modify the Court's December 22, 2003, decision merits nothing more than a brief response, and should be denied again.
First, the Court has, as the defendants acknowledge, already ruled on this very issue by issuing its December 31, 2003, Minute Order. The defendants have offered absolutely no new [*2] arguments in support of their stay request, nor explained why any styled "new" arguments were not previously submitted to the Court in its last several filings. n1 The plaintiffs fully intend to respond to the government's substantive stay arguments by January 9, 2004, the date by which the Court specifically granted the plaintiffs after considering earlier, identical, defense arguments.

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n1 The brashness of the defendants in resubmitting its stay request is apparently consistent with the public comments being disseminated by the Defense Department's Public Affairs Office. On the very same day the government filed its Emergency Motion, the Defense Department announced it had placed a $ 29.7 million order for anthrax vaccine based on the assumption that this Court's injunction will be reversed. Bryan Whitman, a Defense Department spokesman, said the move demonstrates confidence "we will resume the anthrax vaccination program as it existed before the judge's order." Reuters, "U.S. Army Buys $ 30 Million in Anthrax Shots", January 2, 2004, at http://reuters. com/newsArticle.jhtml;jsessionid= ?type=topNews&storyID=4067293.
[*3]
Second, while in no way conceding the viability of the defendants' arguments, which the plaintiffs fully prepare to oppose on legal grounds n2, the plaintiffs are preparing a First Amended Complaint specifically asserting class allegations. This will be filed no later than Wednesday, January 7, 2004. If deemed necessary by the Court, after reviewing the plaintiffs' legal arguments against restricting the scope of its injunction, the plaintiffs will seek class certification in a timely manner. n3
n2 In fact, the plaintiffs' have full confidence that the defendants' arguments to limit the scope of the Court's injunction are unfounded. See e.g. Nat'l Mining Assn. V. U.S. Army Corps. of Engineers, 145 F.3d 1399 (D.C.Cir. 1998), citing, Harmon v. Thornburgh, 878 F.2d 484, 495 n. 21 (D.C.Cir. 1989).
n3 The defendants continually complain that this litigation is ostensibly negatively impacting the good morale and discipline of the Armed Forces. Yet the defendants' own actions are creating a scenario where, as a matter of fact and law, every single member of the Armed Forces - active duty, reservist and national guard - may become a plaintiff against the Secretary of Defense and the Department of Defense.
[*4]
Finally, the defendants' claim that this Court has "effectively shut[] down the military's ongoing anthrax vaccination program on a worldwide basis" is specious. See Defs' Memo at 4. The Court has done no such thing. It merely required the defendants to abide by the law, at least as the law existed up to December 22, 2003, when the injunction was imposed. The defendants chose to voluntarily shut down the program.
The Defense Department is not prohibited from administering the anthrax vaccine to any service member or civilian employee or contractor who provides their informed consent, as the law (and preliminary injunction) permits. Moreover, it is inconceivable that the defendants could not have anticipated - or at least prepared for - this Court's action, particularly given that the plaintiffs' attorneys have been asserting the same legal claims at issue for years in military and civil court proceedings, congressional hearings and at meetings with the defendants themselves (including Dr. Winkenwerder). To the extent the defendants were actually unprepared to have to deal with the notion of an injunction being imposed, then the circumstances that now exist are of their own [*5] doing. Defendants' asserted policy position is thus comparable to the well-known story of the criminal defendant who murders his parents and then seeks mercy from the court because he is an orphan. n4
n4 As this Court stated in a recent decision, "[t]he case law is well settled that a preliminary injunction movant does not satisfy the irreparable harm criterion when the alleged harm is self-inflicted." Fund for Animals et al v. Gale Norton, Order at 5, Civil Action No. 02-2367 (D.D.C. Dec. 23, 2003) (EGS)(available at

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http://www.dcd.uscourts.gov/02-2367a.pdf) citing Lee v. Christian Coalition of Am., Inc., 160 F.Supp.2d 14, 33 (D.D.C. 2001).
With respect to the specific claim that seeking informed consent is not feasible, it is more likely that the Defense Department simply desires to avoid, for public relations purposes, asking the necessary question which it knows will likely be answered overwhelmingly against taking a vaccine millions of people consider to be experimental for [*6] purposes of combating inhalational anthrax.
The government's Motion should be denied - again.
Respectfully submitted,
Mark S. Zaid, Esq. D.C. Bar # 440532 Krieger & Zaid, PLLC 1747 Pennsylvania Avenue, N.W., Suite 300 Washington, D.C. 20006 (202) 454-2809
John J. Michels, Jr., Esq. D.C. Bar # 457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150
Attorney For The Plaintiffs

 
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JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, SECRETARY OF DEFENSE, et al., Defendants.
1:03-cv-00707-EGS
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
2003 U.S. Dist. Ct. Motions 707; 2004 U.S. Dist. Ct. Motions LEXIS 6629
January 5, 2004
Motion to Stay
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s)
TITLE: [**1] DEFENDANTS' REPLY IN SUPPORT OF EMERGENCY MOTION FOR IMMEDIATE ADMINISTRATIVE STAY PENDING DISPOSITION OF DEFENDANTS' MOTIONS
TEXT: In response to this Court's January 5, 2004 Minute Order, Defendants file this reply in support of their Emergency Motion For Immediate Administrative Stay Pending Disposition Of Defendants' Motions ("Emergency Motion For Administrative Stay"). Defendants do so well in advance of this Court's January 6, 2004 4:00 p.m. deadline for filing a reply, and note that they would be available at any time prior to this Court's January 7, 2004 scheduled hearing if this Court could dispose of Defendants' Emergency Motion For Administrative Stay prior to the time set in the Minute Order.
Plaintiffs' Opposition To Emergency Motion For Administrative Stay ("Opposition") is bereft of any evidence -- or, indeed, any argument -- that Plaintiffs would be harmed by the limited stay sought by Defendants. It would, in fact, be impossible for Plaintiffs to put forth such an argument because the interim stay sought here would not affect in any way the relief granted to these six Doe Plaintiffs in this Court's December 22, 2003 Preliminary Injunction Order.
[*2] [**2] Instead, the administrative stay sought by Defendants would simply limit the effect of that preliminary injunction to those Doe Plaintiffs during the time that the Court considers the pending motions.
Plaintiffs' only grounds for opposing the stay are two-fold. First, they argue that the preliminary injunction should be read broadly to reach service members not before the Court because Plaintiffs will, at some uncertain point in the future, be seeking class certification. Second, they contend that the substantial injury suffered by the military as a result of the preliminary injunction is both of its own making and easily corrected. But neither argument is a reason for denying the relief sought by Defendants in their Emergency Motion For Administrative Stay.
First, because Plaintiffs' original complaint did not properly make class allegations or seek class certification, preliminary injunctive relief issued on a nationwide and military-wide basis is far too broad to remedy the injuries

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purportedly suffered by the Plaintiffs here. Plaintiffs, apparently recognizing this flaw, now contend that they are "preparing a First Amended Complaint specifically asserting class allegations" which [**3] they intend to file, n1 and that if necessary they will "seek class certification." Opposition at 2. But such a process of establishing entitlement to class certification requires a "specific presentation" by the Plaintiffs that the various requirements of Rule 23 have been satisfied, and the Court, in turn, must undertake a "rigorous analysis" of this presentation, because "actual, not presumed, conformance" with Rule 23 is "indispensable." General Telephone Co. of Southwest v. Falcon, 457 U.S. 147, 158, 160-61 [*3] (1982). There is no reason to conclude at this stage that Plaintiffs would be successful in making this "specific presentation" with respect to all the requirements or that the Court, upon "rigorous analysis," would certify a class. There is no reason to believe, for instance, that these six Doe Plaintiffs speak for all of their military colleagues when they argue that they would not receive the anthrax vaccine in the absence of informed consent. Given their potential exposure to deadly biological weapons, many members of the military overseas may well be eager to receive the full compliment of shots as soon as possible. Thus, serious questions of [**4] commonality and adequacy of representation would be raised by any attempt to certify a class. n2 See Falcon 457 U.S. at 156, 161 (noting the Supreme Court's repeated holding "that a class representative must be part of the class and possess the same interest and suffer the same injury as the class [*4] members," and further noting as "most significant" the "potential unfairness to the class members bound by the judgment if the framing of the class is overbroad").
n1 Mere conclusory averments or parroting of the elements of Rule 23 are insufficient to obtain class certification. See, e.g., In re American Medical Systems, 75 F.3d 1069, 1083, 1086 (6th Cir. 1996).
n2 Plaintiffs' vague citation to National Mining Ass'n v. Army Corps of Engineers, 145 F.3d 1399 (D.C. Cir. 1998), for the proposition that the current preliminary injunction is not overbroad is unhelpful to them here. That case did not involve a preliminary injunction; rather, it spoke to the proper scope of permanent injunctive relief where a court had ruled on the substantive issues in the case and had finally adjudged an agency rule to be invalid. The Court here has not, of course, adjudged an applicable agency rule to be invalid and has only found preliminarily that the Plaintiffs have a fair chance of prevailing on the merits of their claims. The scope of preliminary and permanent injunctive relief is different, and with respect to preliminary relief should be narrowly tailored to remedy the harm demonstrated by parties before the court. See, e.g., Bresgal v. Brock, 843 F.2d 1163, 1169-71 (9th Cir. 1987) (distinguishing scope of preliminary and permanent injunctive relief, noting that "where relief can be structured on an individual basis it must be narrowly tailored to remedy the specific harm shown" and that an injunction should not extend beyond giving the "prevailing parties the relief to which they are entitled."). Importantly, National Mining involved a rule of general applicability, and the only way to accord plaintiffs the relief they requested there was to invalidate the rule in its entirety. Here, by contrast, a more narrowly tailored injunction could accord Plaintiffs the relief they seek without unduly affecting others or doing unnecessary harm to Defendants. Where there are significant questions regarding the continuing viability of this Court's preliminary injunction ruling in light of a subsequent FDA Final Order, moreover, a more modest preliminary injunction, directed only at the six Doe Plaintiffs, is sufficient to afford them all the relief they require while the Court considers and disposes of pending motions.
[**5]
Second, Plaintiffs' suggestion that the substantial harm suffered by the military as a result of this Court's preliminary injunction Order is self-inflicted ignores both the nature of the preliminary injunction and the regulatory scheme to which it relates. As long as the preliminary injunction is in effect and is read broadly, as Plaintiffs suggest, then the military had no choice but to shut down the anthrax vaccination program. This result follows from the detailed regulatory scheme that arises from "informed consent" requirements. As Assistant Secretary of Defense William Winkenwerder Jr., M.D. explains in his Declaration (Exhibit 2 to Defendants' Emergency Motion To Vacate And In The Alternative For Stay), obtaining informed consent would mandate compliance with Investigational New Drug ("IND") requirements of the Federal Food, Drug, and Cosmetic Act. Winkenwerder Declaration at P 14. Dr. Winkenwerder attests that "the development of a detailed IND protocol, approval through necessary channels, approval

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by an Institutional Review Board, submission and discussions with the FDA, FDA's 30-day review period, training of principal and associate investigators, education of recipients [**6] of the IND, execution and storage of consent forms, and other steps required by 21 CFR Part 312, is a several-month undertaking, even with a generous allotment of personnel to implement it." Id. He adds, furthermore, that "the additional labor required to diligently execute an IND protocol would be massive . . . and divert scarce labor from other defense missions." Id.
Thus, even if the Department of Defense wanted to comply with this Court's preliminary injunction Order through the informed consent route, it could not do so in the immediate future, and certainly not before this Court's January 14, 2004 hearing. Nor could a Presidential Waiver [*5] be obtained under the governing Executive Order in such a short period of time. Id. at PP 14-15. n3 To be clear, in either circumstance, an average of 1,000 soldiers per day would go without any form of protection from anthrax exposure during the interim period, at a cost both to the individuals and to the military's missions. Id. P 11. Given the impossibility of immediate compliance, this is a direct result of the Preliminary Injunction Order. n4
n3 As we have explained in previously filed papers, given the December 30, 2003 FDA Final Order making clear that AVA is safe and effective for exposure to anthrax by inhalation, neither the Presidential Waiver nor the "informed consent" option is required by 10 U.S.C. § 1107. [**7]

n4 Any claims that the government should have anticipated this Court's preliminary injunction ruling by devoting numerous scarce resources to developing these protocols or taking the steps necessary to obtain a waiver in advance is absurd. The government has respectfully and in good faith maintained throughout the course of this litigation that Anthrax Vaccine Adsorbed ("AVA") is and has been fully approved for use as a vaccine against inhalation anthrax and need not have acted to the contrary prior to this Court's ruling.
Finally, Plaintiffs' own characterization of the nature of the injunction at issue in this case -- as "requiring the defendants to abide by the law, at least as the law existed up to December 22, 2003", Opposition at 2 (emphasis added) -- underscores the reason for granting Defendants' request for administrative stay here. By their own admission, the law and facts underpinning this Court's forward-looking preliminary injunction Order have changed. As a result, the legal basis for that relief no longer exists. While Defendants respect this Court's desire for more time to [**8] resolve that underlying question, their urgent need to restart their vaccination program as to persons not before this Court -unanswered by the Plaintiffs and certainly not offset by countervailing harm to the Plaintiffs as a result of the limited nature of the request -- dictates the grant of the administrative stay sought by Defendants' Emergency Motion For Administrative Stay.
[*6] Respectfully submitted,
PETER D. KEISLER
Assistant Attorney General
ROSCOE C. HOWARD, Jr.
United States Attorney
SHANNEN W. COFFIN
Deputy Assistant Attorney General

2003 U.S. Dist. Ct. Motions 707, *6; 2004 U.S. Dist. Ct. Motions LEXIS 6629, **8
/s Ronald J. Wiltsie, II JOSEPH H. HUNT VINCENT M. GARVEY RONALD J. WILTSIE, II (D.C. Bar # 431562) Civil Division United States Department of Justice P.O. Box 883 Washington, D.C. 20044 Telephone: (202) 307-1401 Counsel for Defendants January 5, 2004

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JOHN DOE # 1, JOHN DOE # 2, JOHN DOE # 3, JOHN DOE # 4, JANE DOE # 1, JANE DOE # 2, c/o Mark S. Zaid, Esq., Krieger & Zaid, PLLC, 1747 Pennsylvania
Avenue, N.W., Suite 300, Washington, D.C. 20006 and OTHER SIMILARLY SITUATED INDIVIDUALS, Plaintiffs, vs. DONALD H. RUMSFELD, SECRETARY OF DEFENSE DEPARTMENT OF DEFENSE, 1000 Defense Pentagon, Washington, D.C. 20301, and TOMMY THOMPSON SECRETARY OF HEALTH AND HUMAN SERVICES, 200 Independence Avenue, S.W., Washington, D.C. 20201, and MARK B. McCLELLAN, COMMISSIONER, FOOD AND DRUG ADMINISTRATION, 5600
Fishers Lane, Rockville, Maryland 20857-0001, Defendants.
Civil Action No. 1:03-cv-00707-EGS
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
2003 U.S. Dist. Ct. Pleadings 707; 2004 U.S. Dist. Ct. Pleadings LEXIS 4434
January 6, 2004
Complaint
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s)
TITLE: [**1] FIRST AMENDED COMPLAINT
TEXT: [*2] CLASS ACTION COMPLAINT
Plaintiffs John Doe # 1, John Doe # 2, John Doe # 3, John Doe # 4, Jane Doe # 1 and Jane Doe # 2, on behalf of themselves and all other similarly situated individuals, file this action against defendants Donald Rumsfeld, Secretary of Defense, Department of Defense ("DoD"), Tommy Thompson, Secretary of Health and Human Services, Department of Health and Human Services, and Mark B. McClellan, Commissioner, Food and Drug Administration ("FDA"), seeking temporary and permanent injunctive relief from the DoD's anthrax vaccination program, as well as a declaratory judgment that Anthrax Vaccine Adsorbed ("AVA"), currently being involuntarily administered to active and Reserve U.S. Armed Forces members and DoD civilian employees, is an investigational new drug ("IND"), as defined by 21 U.S.C. § 355, or a drug unapproved for its intended use, pursuant to 10 U.S.C. § 1107, Executive Order 13139, DoD Directive 6200.2, and 21 C.F.R. § 201.5, and is being administered to United States service members, federal employees and civilian defense contractors in violation *2 of federal [**2] law. Plaintiffs seek this relief pursuant to the Administrative Procedures Act, 5 U.S.C. § 551, et seq., the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 and the All Writs Act, 28 U.S.C. § 1651.
PARTIES

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1. Plaintiffs are active duty service members, reservists, national guardsmen and civilian employees and DoD contractors who have been ordered, or will imminently be ordered, to take AVA as part of their military duties or employment obligations, or have been administered AVA in violation of the FDA's mandated sequence protocol. Similarly situated individuals include current members of the active duty, reserve members of the Armed Forces, national guardsmen and current civilian DoD employees and contractors who have been ordered, or will imminently be ordered, to take the vaccination series, or who have been administered the vaccine in violation of the FDA's mandated sequence protocol.
2. Defendant Department of Defense, represented by the Secretary of Defense, is the principal user of AVA. By order of the Secretary of Defense, the DoD has, since 1998, engaged [*3] in the practice *3 of mass [**3] inoculations of active duty and reserve members of the Armed Forces, and civilian employees, without seeking the informed consent of those individuals prior to giving the vaccination. The Secretary of Defense is personally responsible for compliance with his own directives.
3. The DoD was and is heavily involved in the manufacturing and licensing process for the AVA and is considered the de facto manufacturer of AVA by the FDA.
4. Defendant Department of Health and Human Services ("HHS"), through its agent FDA, is the federal agency responsible for licensing and quality control of drugs and biologic products, such as vaccines like the AVA. The FDA is responsible for promulgating federal regulations that describe what makes a drug or vaccine an "IND" and how a drug is placed in IND status.
JURISDICTION AND VENUE
5. There is a legitimate matter in controversy between the named parties because Plaintiffs claim that AVA is a) an IND, b) an unlicensed or improperly licensed vaccine, and c) being used "off label", requiring the Secretary of Defense and DoD to secure Plaintiffs' informed consent before DoD may administer AVA to them. The AVA manufacturer has submitted *4 an [**4] IND application for the AVA to amend the license, rendering AVA an IND in circumstances germane to this action.
6. Plaintiffs will suffer substantial and irreparable injury if they are forced to take the vaccine because of Defendants' failure to follow presidential orders and/or federal law requiring informed consent prior to the administration of an IND to members of the Armed Forces.
7. Jurisdiction is proper in this Court under the Administrative Procedures Act, 5 U.S.C. § 702, and under 28 U.S.C. § 2201, which states that actions involving controversies with federal agencies may be pursued in any United States District Court, and under 28 U.S.C. §§ 1331 and 1346.
[*4] CLASS ACTION ALLEGATIONS
8. This action is brought by the plaintiffs, on their own behalf and on behalf of the class of all others similarly situated, under the provisions of Fed. R. Civ. P. 23 (a) and (b).
9. The class so represented by the plaintiffs in this action, and of which they are members, consists of active duty, reservists and national guardsmen of the United States Armed Forces, as well as any civilian federal employees [**5] *5 or DoD contractors who have taken, been ordered to take, or will be ordered to take, the anthrax vaccine.
10. The exact number of members of the class, as hereinabove identified and described, is not known, but it is estimated that there are in excess of 2.5 million members. The class is so numerous that joinder of individual members is impractical.
11. The relief sought is common to the entire class, and there are common questions of law and fact that relate to

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and affect the rights of each member of the class. These common questions include and involve whether the AVA is an IND, as defined by 21 U.S.C. § 355, or a drug unapproved for its intended use, pursuant to 10 U.S.C. § 1107, Executive Order 13139, DoD Directive 6200.2, and 21 C.F.R. § 201.5, or is being administered to United States military service members, federal employees and civilian defense contractors in violation of federal law. Certain defenses raised by the defendants would apply equally to all members of the class.
12. The claims of the plaintiffs are typical of the claims of the class in that the claims of all members of the class depend on a showing of the acts [**6] *6 and omissions of defendants as giving rise to rights to the relief sought herein. There is no conflict as between the plaintiffs and other members of the class with respect to this action, or with respect to the claims for relief contained herein.
[*5] 13. The plaintiffs are representative parties for the class, and are able to and will fairly and adequately protect the interests of the class. The attorneys for the plaintiffs are experienced and capable in litigating the claims at issue and have successfully represented claimants in other litigation matters of this nature. Attorneys John J. Michels, Jr. of McGuire Woods, LLP, and Mark S. Zaid of Krieger & Zaid, PLLC, will actively conduct and be responsible for the conduct of the action on behalf of the plaintiff class.
14. This action is properly maintained as a class action in that the prosecution of separate actions by individual members of the class would create a risk of adjudications with respect to individual members of the class which would as a practical matter be dispositive of the interests of others not parties to the adjudications, or would substantially impair or impede their ability to protect their interests. [**7] *7
15. This action is properly maintained as a class action inasmuch as the questions of law and fact common to the members of the class predominate over any questions affecting only individual members, and a class action is superior to other available methods for the fair and efficient adjudication of the controversy.
FACTUAL BACKGROUND
A. Anthrax Vaccine Adsorbed
16. AVA was originally licensed as a vaccine against anthrax on November 2, 1970 by the United States Public Health Service.
17. The vaccine was licensed as a preventive for anthrax for "individuals who may come in contact with imported animal hides, furs, bone meal, wool, hair (especially goat hair), and bristles; for all personnel and factories handling these materials and for individuals contemplating investigational studies involving Bacillus anthracis." See Attachment A, Anthrax Vaccine Adsorbed product insert, December 1979.
[*6] 18. A 2002 product insert revision (the AVA is referred to as "BioThrax") stated that:
BioThrax is indicated for the active immunization against Bacillus anthracis of individuals between 18 and 65 years of age who come in contact with animal [**8] products *8 such as hides, hair or bones that come from anthrax-indemic areas, and that may be contaminated with Bacillus anthracis spores. BioThrax is also indicated for individuals at high risk of exposure to Bacillus anthracis spores such as veterinarians, laboratory workers, and others whose occupations may involve handling potentially infected animals or other contaminated materials. Since the risk of anthrax infection in the general population is low, routine immunization is not recommended.
See Attachment B, 2002 Anthrax Vaccine Adsorbed Product Insert.
19. The license for AVA states that "primary immunization consists of three subcutaneous injections, 0.5mL each, given two weeks apart followed by three additional subcutaneous injections, 0.5mL each given at 6, 12 and 18 months."

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Id.
20. In 1985, the DoD (through the Department of the Army) issued a Request for Proposals ("RFP") No. DAMD17-85-R-0078 soliciting the development of a new anthrax vaccine. The Request for Proposals stated that there was no vaccine in current use which would safely and effectively protect military personnel against exposure to anthrax. The Request for Proposals noted that [**9] AVA was highly *9 reactogenic, required multiple boosters to maintain immunity, and might not protect against all strains of anthrax. See Attachment C, RFP DAMD17-85-R-0078.
B. FDA Failure to Finalize AVA Licensing
21. In 1985, as part of an FDA biologic and drug licensing review, the Biologics Review Panel, an independent advisory panel to the FDA, recommended that the FDA classify the AVA as "not misbranded". The FDA issued a Proposed Rule to adopt the Panel's recommendations and finalize FDA approval of the AVA license. A 2001 Citizen Petition challenge to the FDA's unreasonable delay to finalize the Rule was rejected. See Attachment D, August 28, 2002 letter to Russell Dingle in response to Citizen Petition Docket No. 01P-0471/CP1 ("Response to Citizen Petition"). However, in direct response to this litigation, after 18 years, on December 30, 2003, the FDA announced it was issuing its Final Rule and Final Order Regarding Safety and [*7] Efficacy of Certain Licensed Biological Products Including Anthrax Vaccine. The alleged Final Rule was published in the Federal Register on January 5, 2004, at http://www.fda.gov/cber/rules/ bvactox.pdf.
22. The FDA's delayed [**10] issuance of *10 its Final Rule and Order was undertaken in violation of its own internal procedures and requirements, and was so arbitrary and capricious as to amount to bad faith. The circumstances that led to its issuance, and the contents of the actual Final Rule Order, are nothing less than extraordinary and are completely inconsistent with the prior history of FDA Final Rules. Upon information and belief, the FDA would never permit a private drug manufacturer to rely upon the type of information cited in the FDA's Final Rule and Order for purposes of vaccine licensing or efficacy studies. Additionally, the Final Rule and Order relies upon flawed and inconsistent data so as to nullify its application. Upon further information and belief, the FDA's Final Rule and Order was issued as a result of policy pressures by DoD and other sources.
C. AVA is Not Licensed for Use Against Inhalation Anthrax
23. In addition, on December 13, 1985, as part of its license review process, the FDA published a specific product review of the AVA, stating that the vaccine's "efficacy against inhalation anthrax is not well documented . . . no meaningful assessment of its value against inhalation [**11] anthrax is possible *11 due to its low incidence." See Attachment E, Federal Register, December 13, 1985.
24. In early 1990, the AVA manufacturer, then the Michigan Department of Public Health ("MDPH"), modified its production process for AVA to accommodate DoD needs. U.S. Army medical research personnel from Fort Detrick, Maryland, determined in October 1990, that these changes in the AVA manufacturing process resulted in a 100-fold increase in AVA protective antigen levels. See Attachment F, Testimony of Nancy Kingsbury, United States General Accounting Office, before the Sub-Committee on National Security, Veterans' Affairs and International Relations, Committee on Government Reform, House of Representatives,
October 23, 2001, Page 5-6.
[*8] 25. In March 1990, Army doctors Colonel Ernest T. Takafuji and Colonel Phillip K. Russell described AVA as a "limited use vaccine" and an "unlicensed experimental vaccine" in an article, "Military Immunizations: Past, Present and Future Prospects", published in Infectious Disease Clinics of North America.
26. In 1995 the Army contracted with the Science Applications International Corporation ("SAIC") to develop a plan to obtain [**12] FDA approval for a license *12 amendment for AVA. The purpose of the license amendment was to add aerosolized anthrax exposure to the product license and to enable the manufacturer of AVA to list on the product

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license that AVA was effective against inhalation anthrax.
27. The SAIC license amendment plan, ultimately adopted by the Army, states that AVA is not licensed as protection for aerosol anthrax exposure as expected in a biological warfare environment. See Attachment G, October 5, 1995 License Amendment Plan.
D. The AVA Becomes an Investigational New Drug
28. On October 20, 1995, the Army Joint Program Office for Biological Defense met to begin the process of obtaining the FDA license modification to include an indication that AVA was effective against inhalation anthrax. At the meeting, the participants noted that studies of AVA effectiveness in people working in tanneries showed protection against skin contact anthrax, but that there was insufficient data to demonstrate protection against inhalation anthrax. See Attachment H, Minutes of October 20, 1995 Meeting.
29. On August 26, 1996, as a precursor to changing the AVA license by filing an investigational [**13] new drug application, the Army's *13 Medical Research Institute of Infectious Diseases ("USAMRIID") discussed the purpose of the IND application by saying, "We wish to obtain an indication for protection against inhalation anthrax and to reduce the number of doses to two primary doses with a booster due at one year. These two goals will be studied and discussed as separate issues." See Attachment I (Col. Arthur O. Anderson, Chairman, USAMRIID Human Use Committee), "Comparative Study of the Safety and Immunogenicity of Two-Dose Priming Schedule of Human Anthrax Vaccine," August 26, 1996.
[*9] 30. On September 20, 1996, as part of the Army/SAIC plan, the AVA manufacturer, Michigan Biologic Products Institute ("MBPI", the successor to MDPH) submitted to the FDA an investigational new drug application for AVA. The application was prepared, in whole or in part, by a U.S. Army agency located at Fort Detrick, Maryland.
31. The manufacturer's stated purpose for filing the IND application was to "conduct clinical investigations designed to investigate changes in the approved labeling for the licensed product. The potential labeling changes would affect the specific clinical indication, [**14] route and vaccination schedule *14 for AVA." See Attachment J, September 20, 1996, MBPI Letter to Dr. Kathryn C. Zoon.
32. The Introductory Statement from the IND application states that "the ultimate purpose of this IND is to obtain a specific indication for inhalation anthrax and a reduced vaccination schedule." See Attachment K, IND Introductory Statement.
33. The submission of the IND application was accompanied by a testing protocol designed to demonstrate effectiveness against inhalation anthrax in animals and correlate that effectiveness with comparable effectiveness in human subjects.
34. FDA regulations found at 21 C.F.R § 312 address the requirements for IND status for biologic products such as AVA.
35. Under FDA regulations, a drug may be placed in investigational new drug status, even when the drug is properly licensed for use, if the drug is used for a different purpose or in a different manner than that specified in the license.
36. Under FDA regulations, a drug is placed in investigational new drug status when a manufacturer files an investigational new drug application seeking a product license change reflecting a different use for the product.
37. Under [**15] FDA regulations, a manufacturer *15 which files an IND application seeking to change the license for a vaccine to show the vaccine as effective against a different method of infection uses the vaccine in IND status if the vaccine is used for the purpose for which the license amendment is sought.

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[*10] 38. The investigational new drug application filed by MBPI sought a license amendment for AVA stating that AVA is effective against inhalation anthrax.
39. On December 13, 1996, the FDA sent a letter to the Department of the Army, following the Army's publishing of an advertisement in the Washington Post on October 15, 1996, seeking experimental test subjects for the investigation proposed in the AVA IND application. The December 13 letter advised the Army agency that it could not represent the vaccine as fully licensed when the Army was conducting tests pursuant to an IND application. Specifically, the letter advised the Army that the vaccine was not licensed for the indication for which the IND application was filed. See Attachment L, FDA letter of December 13, 1996.
40. The only indication for which the AVA IND application was filed was for inhalation anthrax.
E. DoD [**16] Uses AVA as an IND
41. In December *16 1997, DoD announced a multi-service vaccination program for all active duty, Reserve and National Guard service members using the AVA as a preventative for inhalation anthrax.
42. As part of this program, Plaintiffs and those similarly situated to them were ordered to submit to involuntary anthrax vaccinations.
43. If they refuse to comply with orders to take the AVA inoculations, the military Plaintiffs, and those similarly situated to them, will be subject to military disciplinary actions, including courts-martial convictions, forfeitures of pay and allowances, incarceration, bad conduct discharges, and administrative separation from the Armed Forces. Civilian Plaintiffs will be fired from their positions as DoD employees or defense contractors. Those individuals who take the anthrax vaccine will be subject to significant adverse health effects, including the possibility of death or permanent disability, and will not even receive full protection given the DoD's continuing violation of the FDA required vaccination sequence schedule of six shots in 18 months followed by an annual booster.
[*11] 44. In December 1997, the Joint [**17] Program Office for Biological Defense, an agency *17 of Defendant Department of Defense, noted that "Anthrax and Smallpox are the only licensed vaccines that are useful for the biological defense program, but they are not licensed for a biological defense indication." See Attachment M, Appendix G, "Industrial Capabilities Assessment Summary Report for the Production of the Anthrax Vaccine, Preliminary Report," December 1997, Joint Program Office for Biological Defense, Falls Church, Virginia.
45. The AVA IND application submitted by MBPI (now BioPort) has been supplemented and remains current and pending. See Attachment N, IND Application Supplements.
46. BioPort's subsequent submissions as part of the IND application process indicate that the license modification being sought is currently only for inhalation anthrax. Id.
47. The DoD inoculation program currently underway is specifically designed to inoculate members of the Armed Forces against inhalation anthrax, which has a high mortality rate and is identified by DoD as a military threat.
48. The use of AVA for a purpose which is the subject of a currently pending IND application, i.e. as a preventative against inhalation [**18] anthrax, means that DoD is using AVA as an IND. *18
49. By Memorandum of Decision dated April 1998, Army Secretary Togo West, Jr. took steps to approve a request to indemnify the anthrax vaccine manufacturer, Michigan Biologic Products Institute (the predecessor to the current manufacturer, BioPort) against all liability arising from "the unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the AVA." The indemnification concerns, according to Secretary West, were a result of the limited use of the vaccine on too small a scale to permit accurate assessments of types and severities of adverse reactions and, insufficient experience in mass immunization programs to evaluate the

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efficacy of the vaccine. See Attachment O, Indemnification Agreement.
50. By Memorandum of Decision dated September 3, 1998, Army Secretary Louis Caldera again authorized indemnification of the AVA manufacturer because:
[*12] the obligation assumed by MBPI under this contract involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological [**19] effect will not be obtained by all recipients. . . . *19 The size of the proposed vaccination program may reveal unforewarned idiosyncratic adverse reactions. Moreover, there is no way to be certain that the pathogen used in tests measuring vaccine efficacy will be sufficiently similar to the pathogen that U.S. forces might encounter to confer immunity.
F. DoD Deviates From the AVA License Requirements
51. On September 29, 1999, Dr. Kathryn Zoon, Director, FDA Center for Biologic Evaluation and Research, wrote to Dr. Sue Bailey, Assistant Secretary of Defense Health Affairs and stated:
We reiterate our previous statement made to DoD on December 16, 1997, that FDA approval of the anthrax vaccine is based on the six-dose regimen found in the approved labeling. Because we are unaware of any data demonstrating that any deviation from the approved intervals of doses found in the approved labeling will provide protection from anthrax infection, we strongly recommend that the Anthrax Vaccine Immunization Program follow FDA approved schedule.
See Attachment P, September 29, 1999 Letter to Bailey.
52. In July 2000, DoD announced the first of several reductions [**20] in the scope of the AVIP because of a failure by Bioport *20 Corporation to meet federal manufacturing standards. DoD stated that it was suspending AVA vaccinations for all but a limited number of personnel because of a shortage of the vaccine.
53. As part of this suspension, DoD announced that members of the Armed Forces who had received at least one of the sequence of six vaccinations required by the AVA product license would be subject to a modified vaccination schedule that is inconsistent with the vaccination schedule required by the AVA license. Specifically, DoD announced that members who had received one or more vaccinations, but who had not completed the six shot sequence of [*13] vaccinations, would not be required to restart the inoculation sequence as long as they received a subsequent shot within two years of their last vaccination.
54. DoD formally resumed the AVIP in June 2002. On August 6, 2002, DoD published policy guidance to component services. In part, the guidance stated that, "Those individuals that have had their doses deferred shall resume the series when directed. . . ." See Attachment Q, August 6, 2002, Memorandum on Policy on Administrative Issues [**21] Related to the Anthrax Vaccine Immunization Program (AVIP). *21
55. On October 11, 2002, the Chief of Staff, United States Air Force, promulgated an AVIP policy and guidance for all active duty and reserve units. The policy states, in Annex B, Paragraph 4b:
The Anthrax vaccine is a six-dose schedule [sic] followed by an annual booster. The vaccine doses are given at 0, 2 and 4 weeks, followed by doses at 6, 12, and 18 months, and an annual booster thereafter. The vaccine must be given in accordance with the above dosing schedule, as approved by the Food and Drug Administration (emphasis in original).
56. Notwithstanding the guidance to follow the licensed vaccination schedule, Paragraph 4c of Annex B states:

2003 U.S. Dist. Ct. Pleadings 707, *13; 2004 U.S. Dist. Ct. Pleadings LEXIS 4434, **21

Page 8

Personnel whose vaccination series was interrupted during the previous AVIP slowdown will not need to repeat any doses already received in the vaccine series or receive extra doses. Once these individuals are identified as requiring the vaccine, they will just continue with the next dose in the series.
Upon information and belief, similar policies have been adopted by all other military services.
57. The deviation from the licensed application [**22] schedule for AVA and the use of AVA in a mass inoculation effort represent *22 new uses of the AVA by DoD. Indeed, DoD is currently seeking test subjects to validate its practice of altering the shot sequence.
58. Such new uses of a product that are not in accordance with product labeling render the AVA "investigational" under FDA regulations and makes the AVA a drug "unapproved for its [*14] intended use" under 21 C.F.R. § 201.5, and subject to the requirements of 10 U.S.C. § 1107 (2000), Executive order 13139 and DoD Directive 6200.2.
G. Federal Law and Regulations Prohibit the Use of INDs Without Informed Consent of Recipients
59. 10 U.S.C. § 1107 (2000) provides that investigational new drugs or drugs unapproved for their intended uses may not be given to members of the Armed Forces without their prior consent except in the case of a waiver by the President of the United States.
60. Similarly, Executive Order 13139 states that before administering an investigational drug or a drug unapproved for its intended use to members of the Armed Forces, the DoD must obtain informed consent from each individual unless a waiver [**23] of this requirement is signed by the President of the United States.
61. A judicial *23 declaration that AVA is an IND does not preclude the use of AVA by DoD, as long as the appropriate consent or waiver is obtained.
62. DoD has adopted the requirements of 10 U.S.C. § 1107 and Executive Order 13139 and set up procedures to follow these requirements in DoD Directive 6200.2 dated August 1, 2000.
63. Peer-reviewed statistical analysis of adverse reactions associated with AVA vaccinations published by research physicians indicates substantial increases in joint-related medical conditions such as arthralgia, arthritis, myalgia, and others following AVA vaccination.
64. A similar analysis of adverse events for AVA shows a substantial increase in gastrointestinal adverse reactions as well.
65. Moreover, informed consent documents provided by the Center for Disease Control to civilian postal workers and congressional staff in the Fall of 2001 indicated adverse reactions including death, birth defects and a wide range of autoimmune disorders that were not included in the then-current March 1999 FDA-approved package insert. These adverse reactions were never disclosed [**24] to service members subject to mandatory vaccinations with AVA. The Center for Disease *24 Control is a subordinate entity of Defendant Department of Health and Human Services.
[*15] 66. In January 2002, the FDA-approved product insert for AVA was modified to include the above adverse reactions such as death, birth defects and autoimmune disorders, consistent with the informed consent provided to civilians in the Fall of 2001. The new FDA-approved package insert also changed the "use in pregnancy" rating from Category C ("risk cannot be ruled out") to Category D ("positive evidence of risk"). This information has not been provided to service members, and service members are not provided with a copy of the FDA-approved package insert prior to mandatory vaccination.
FIRST CAUSE OF ACTION

2003 U.S. Dist. Ct. Pleadings 707, *15; 2004 U.S. Dist. Ct. Pleadings LEXIS 4434, **24

Page 9

(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
67. Plaintiffs reallege the facts in Paragraphs 1 through 66 as if fully set forth in this Count.
68. Defendant DoD will inoculate Plaintiffs with the AVA within the immediate future. Defendant DoD notified Plaintiffs that they will be ordered to submit to AVA inoculation shortly, in some cases within 30 days.
69. The submission of [**25] an Investigational New Drug application by DoD and BioPort for AVA for inhalation anthrax *25 renders the drug an investigational new drug if used as a preventative against inhalation anthrax.
70. The DoD's actions in ordering Plaintiff's to submit to vaccination with an investigational new drug, without seeking the Plaintiff's informed consent, violate a federal statute, namely 10 U.S.C. § 1107, as well as Executive Order 13139 and DoD Directive 6200.2.
71. The Defendant's failure to follow federal law, a presidential executive order and DoD regulations in its AVIP creates a legal wrong against the Plaintiffs. Plaintiffs are entitled to seek review of Defendant's actions under the Administrative Procedure Act, 5 U.S.C. § 702.
SECOND CAUSE OF ACTION
(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
72. Plaintiffs reallege the facts in Paragraphs 1 through 66 as if fully set forth in this Count.
73. Defendant's use of an unlicensed or improperly licensed vaccine is a violation of Food and Drug Administration regulations found at 21 C.F.R. § 312, and a violation of the Food and [*16] Drug and Cosmetic Act, 21 U.S.C. § 301, [**26] et seq., and also means that DoD is using a drug unapproved for *26 its intended use. DoD's actions violate 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2.
74. Defendant's intent to inoculate Plaintiffs with an unlicensed drug, unapproved for its intended use, is a legal wrong against Plaintiffs, entitling them to judicial review under the Administrative Procedure Act, 5 U.S.C. § 702.
THIRD CAUSE OF ACTION
(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
75. Plaintiffs reallege the facts in Paragraphs 1 through 66 as if fully set forth in this Count.
76. The DoD's intentional alteration of the licensed and FDA-approved schedule of vaccinations and use of AVA in a mass inoculation program renders the AVA a drug unapproved for its intended or applied use within the meaning of 21 U.S.C. § 355; 10 U.S.C. § 1107, 21 C.F.R. § 201.5, Executive Order 13139 and DOD Directive 6200.2. Upon information and belief, the DoD routinely only administers two or three vaccination shots based on its belief that additional shots are unnecessary to afford adequate protection. [**27] Oftentimes, individuals receive only one or two vaccinations.
77. The *27 DoD's intent to inoculate, and in fact the inoculation of, Plaintiffs with the AVA according to an unlicensed and unapproved vaccination schedule, is a legal wrong against Plaintiffs, entitling them to judicial review under the Administrative Procedure Act, 5 U.S.C. § 702.
78. In fact, at least one plaintiff, John Doe # 3, who spent more than 30 days assigned to a military base in the Middle East and was ordered to take the vaccine, received only one shot. No follow-up by the DoD ever occurred to ensure he received his second through sixth shots, in violation of the FDA's licensing requirement for AVA.

2003 U.S. Dist. Ct. Pleadings 707, *16; 2004 U.S. Dist. Ct. Pleadings LEXIS 4434, **27

Page 10

79. The FDA has recognized the DoD as a manufacturer of the AVA. The deviation from the FDA licensing requirements governing shot sequence constitutes an off-label use prohibited by federal statute and regulation.
[*17] 80. The DoD's intentional alteration of the AVA shot sequence schedule creates a legal wrong against the Plaintiffs. Plaintiffs are entitled to seek review of DoD's actions under the Administrative Procedure Act, 5 U.S.C. § 702.
FOURTH [**28] CAUSE OF ACTION
(VIOLATION OF ADMINISTRATIVE PROCEDURE ACT)
81. *28 Plaintiffs reallege the facts in Paragraphs 1 through 66 as if fully set forth in this Count.
82. In 1985, as part of an FDA biologic and drug licensing review, the Biologics Review Panel, an independent advisory panel to the FDA, recommended that the FDA classify the AVA as "not misbranded". On December 13, 1985, the FDA published in the Federal Register a Proposed Rule to adopt the Panel's recommendations and finalize FDA approval of the AVA license.
83. On October 12, 2001, a Citizen Petition was filed with the FDA challenging the FDA's unreasonable delay to finalize the Rule. The specific relief requested in the Petition was rejected by the FDA on August 28, 2002.
84. On January 5, 2004, the FDA published in the Federal Register a Final rule and final order concerning the AVA. The Final rule and final order purports to respond to matters covered in the proposed rule published in the Federal Register on December 13, 1985. The issuance of this Final rule and final order constitutes final agency action under the Administrative Procedure Act. 5 U.S.C. § 704.
85. [**29] The FDA published the Final rule and final order in direct response to this litigation and due *29 to pressure imposed on it by DoD and other sources.
86. The FDA's 1985 Proposed Rule did not propose that the anthrax vaccine was effective against exposure to aerosolized anthrax. The review panel concluded that the vaccine's "efficacy against inhalation anthrax is not well documented . . . no meaningful assessment of its value against inhalation anthrax is possible due to its low incidence." As the question of efficacy against aerosolized exposure was not at issue, the FDA did not respond to the panel's conclusion or seek public comment on this specific matter either in 1985 or 2003.
[*18] 87. In issuing its Final rule and final order, the FDA acted in bad faith and excluded evidence adverse to its determination which was known to it at the time of the decisionmaking. Additionally, it has distorted or exaggerated the scientific conclusions upon which it relied for its decision, and failed to note significant limitations asserted by the authors of anthrax-related studies. The FDA's stated rationale is but a pretext masking the true basis of its decision. It has no rational connection [**30] and is unsupported by substantial evidence. Therefore, the Final rule and final order, to the *30 extent it applies to AVA, is arbitrary and capricious.
88. The FDA's reliance on studies involving animal data to support its conclusion that the AVA is effective against inhalation anthrax is inappropriate and violates its own regulations. No scientific correlation has been demonstrated between animal studies and human reaction with respect to AVA, thereby negating its value. FDA's reliance on faulty data to justify the issuance of its Final rule and final order constitutes an abuse of discretion.
89. The FDA's judgment and analysis in issuing the Final rule and final order does not merit deference under the circumstances and is so unwarranted by the facts that it is subject to trial de novo.
90. The FDA's Final rule and final order was issued in violation of its own internal procedures and requirements, and was so arbitrary and capricious as to amount to bad faith. The issuance and contents of the Final rule and final order

2003 U.S. Dist. Ct. Pleadings 707, *18; 2004 U.S. Dist. Ct. Pleadings LEXIS 4434, **30

Page 11

are nothing less than extraordinary and demonstrate a departure from the FDA's consistent and long-standing precedents and policies. The FDA has failed to explain [**31] the reasons for its departure from precedent. The FDA's Final rule and final order was issued without *31 observance of procedure as required by law.
WHEREFORE, Plaintiffs, and those similarly situated to them, respectfully ask this Court to:
A. Certify this action as a class action, including creating any subclasses which the Court deems appropriate;
[*19] B. Designate the law firms of McGuire Woods, LLP and Krieger & Zaid, PLLC, as class counsel;
C. Find and declare that AVA, as it is being used by Defendants, is an investigational new drug within the meaning of 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2;
D. Find and declare that AVA has been in investigational new drug status since the original investigational new drug application was filed on September 20, 1996;
E. Find and declare that as a result of the unilateral change in vaccination schedule by Defendant DoD, the AVA is a drug unapproved for its intended use within the meaning of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2, as of June, 2000;
F. Find and declare that AVA is an unlicensed or improperly licensed biologic product [**32] under FDA regulations and, therefore, is a drug unapproved for its intended use within the meaning of *32 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2;
G. Find and declare that the FDA's Final rule and final order was issued in violation of the Administrative Procedure Act, thereby voiding its application, and remand the matter to the FDA for further evaluation;
H. Enjoin Defendant from inoculating Plaintiffs, and those similarly situated to them, without informed consent, or in accordance with the provisions of 10 U.S.C. § 1107, Executive Order 13139 and DoD Directive 6200.2; and
I. Award Plaintiffs their costs and attorneys' fees and any other relief this Court may find appropriate.
Date: January 6, 2004
[*20] Respectfully submitted,
/s/
Mark S. Zaid, Esq.
D.C. Bar # 440532
Krieger & Zaid, PLLC
1747 Pennsylvania Avenue, N.W.
Suite 300
Washington, D.C. 20006
(202) 454-2809
/s

2003 U.S. Dist. Ct. Pleadings 707, *20; 2004 U.S. Dist. Ct. Pleadings LEXIS 4434, **32

Page 12

John J. Michels, Jr., Esq. D.C. Bar # 457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150 Attorney For The Plaintiffs

 
 Case 1:03-cv-00707-EGS Document 28 Filed 01/07/04 Page 1 of 2

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

_________________________________

)

JOHN DOE #1, et al,

)

)

Plaintiffs, )

)

v.

) Civil Action No. 03-707 (EGS)

)

DONALD H. RUMSFELD, et al

)

)

Defendants. )

_________________________________)

ORDER

On December 22, 2003 the Court issued a Preliminary

Injunction enjoining the defendants from inoculating service

members without their consent. The Court was persuaded that the

record evidence before the Court was devoid of an FDA final

decision on the investigational status of Anthrax Vaccine

Adsorbed ("AVA"). Within days of the Court's injunction, the

Food and Drug Administration ("FDA") published a final rule

categorizing AVA as safe and effective for use against inhalation

anthrax. Although the timing of the issuance of the rule is

arguably highly suspicious, nevertheless, the rule has been

issued and the principle reason for the issuance of the

injunction has been addressed by the government. Accordingly,

upon consideration of the government's Motion to Stay the

Injunction as Applied to Persons Other than the Named Parties,

the Response and Reply, hereto, and pursuant to the proceedings

1

Case 1:03-cv-00707-EGS Document 28 Filed 01/07/04 Page 2 of 2
held in open court on January 7, 2004, it is hereby ORDERED that the government is entitled to a stay of the
Court's injunction pending further order of the Court and further challenges to the government's final rule; and it is
FURTHER ORDERED that the Motions Hearing previously scheduled for January 14, 2004 at 10:00 a.m. in Courtroom One has been converted to a Status Hearing.

Signed:

Emmet G. Sullivan United States District Judge January 7, 2004

2

 
 Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 1 of 53

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

JOHN DOE #1, et al.,

)

)

Plaintiffs,

)

)

v.

)

)

DONALD H. RUMSFELD, et al.,

)

)

Defendants.

)

__________________________________________)

Civil Action No. 03-707 (EGS)

DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

In accordance with the Court's January 16, 2004 scheduling order, defendants move for

summary judgment under Rule 56 of the Federal Rules of Civil Procedure with respect to

plaintiffs' claims under the Administrative Procedure Act challenging the Final Order of the Food

and Drug Administration ("FDA") categorizing Anthrax Vaccine Adsorbed as a Category I

product. FDA's decision is not arbitrary, capricious, or an abuse of discretion and is fully

supported by the administrative record. The grounds for this motion are set forth in detail in the

accompanying memorandum of points and authorities. Also filed herewith is defendants'

statement of material facts under Local Rule 7.1(h).

PETER D. KEISLER Assistant Attorney General

ROSCOE C. HOWARD, JR. United States Attorney

BRIAN D. BOYLE Principal Deputy Associate Attorney General

SHANNEN W. COFFIN Deputy Assistant Attorney General

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 2 of 53

Date: March 3, 2004

/s/ Craig M. Blackwell JOSEPH H. HUNT VINCENT M. GARVEY CRAIG M. BLACKWELL, DC Bar # 438758 RONALD J. WILTSIE ANDREW H. TANNENBAUM Civil Division U.S. Department of Justice P.O. Box 883 Washington, D.C. 20044 Tel: (202) 307-1401 Fax: (202) 616-8470
Attorneys for defendants

-2-

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 3 of 53

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

JOHN DOE #1, et al.,

)

)

Plaintiffs,

)

)

v.

)

)

DONALD H. RUMSFELD, et al.,

)

)

Defendants.

)

__________________________________________)

Civil Action No. 03-707 (EGS)

MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

Respectfully submitted,

PETER D. KEISLER Assistant Attorney General ROSCOE C. HOWARD, JR. United States Attorney BRIAN D. BOYLE Principal Deputy Associate Attorney General SHANNEN W. COFFIN Deputy Assistant Attorney General JOSEPH H. HUNT VINCENT M. GARVEY CRAIG M. BLACKWELL, DC Bar # 438758 RONALD J. WILTSIE ANDREW H. TANNENBAUM Attorneys Civil Division U.S. Department of Justice P.O. Box 883 Washington, D.C. 20044 Tel: (202) 307-1401 Fax: (202) 616-8470

Date: March 3, 2004

Attorneys for defendants

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 4 of 53

TABLE OF CONTENTS Page

TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

PRELIMINARY STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1. Statutory and Regulatory Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

a. The PHSA and the FDCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

b. Section 601.25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2. Review of AVA under 21 C.F.R. § 601.25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

a. Anthrax disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

b. AVA license granted by NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

c. Panel review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

d. Citizen petition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

e. Final Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3. Prior Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

4. Plaintiffs' Amended Complaint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

I. PLAINTIFFS LACK STANDING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

.

II. FDA'S DECISION TO CLASSIFY AVA AS A CATEGORY I

PRODUCT IS NOT ARBITRARY, CAPRICIOUS, OR AN

ABUSE OF DISCRETION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

A. FDA's Safety Determination Is Not Arbitrary, Capricious, or An Abuse of Discretion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

B. FDA's Effectiveness Determination Is Not Arbitrary, Capricious, or An Abuse of Discretion . . . . . . . . . . . . . . . . . . . . . . . . . . 35

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 5 of 53
TABLE OF AUTHORITIES
CASES
Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166 (D.D.C. 2000) .......................................................................... 27
**Berlex Labs., Inc. v. FDA, 942 F. Supp. 19 (D.D.C. 1996) ..................................................... 8, 27, 28, 31, 35, 41
**Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212 (D.D.C. 1996) ................................................. 26, 27, 28, 31, 36, 42
**Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (1971) .................................................................................................. 26
Doe v. Rumsfeld, — F.Supp.2d —, 2003 WL 22994225 (Dec. 22, 2003) ..................................... passim
Ethicon, Inc. v. FDA, 762 F. Supp. 382 (D.D.C. 1991) ............................................................................... 35
FW/PBS, Inc. v. City of Dallas, 493 U.S. 215 (1990) .................................................................................................. 29
Federal Power Comm'n v. Florida Power & Light Co., 404 U.S. 453 (1972) .................................................................................................. 27
Henley v. FDA, 77 F.3d 616 (2d Cir. 1996) ........................................................................................ 27
**Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) ............................................................................................ 29, 31
**Motor Vehicle Mfrs. Ass'n of the United States v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) ........................................................................................ 26, 34, 42
Public Citizen v. Foreman, 631 F.2d 969 (D.C. Cir. 1980) .................................................................................. 28
Schering Corp. v. FDA, 51 F.3d 390 (3d Cir.), cert. denied, 516 U.S. 907 (1995) ............................................................................................ 28, 31
Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) .......................................................................... 27, 34
Simpson v. Young, 854 F.2d 1429 (D.C. Cir. 1988) ................................................................................ 27
-ii-

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 6 of 53
Troy Corp. v. Browner, 120 F.3d 277 (D.C. Cir. 1997) .................................................................................. 27
United States Postal Serv. v. Gregory, 534 U.S. 1 (2001) ...................................................................................................... 42
United States v. Armstrong, 517 U.S. 456 (1996) .................................................................................................. 42
United States v. Chemical Found., Inc., 272 U.S. 1 (1926) ...................................................................................................... 42
United States v. Rutherford, 442 U.S. 544 (1979) ...................................................................................... 31, 34, 41
Vermont Yankee Nuclear Power Corp. v. Natural Res. Def. Council, 435 U.S. 519 (1978) .................................................................................................. 26
Weinberger v. Bentex Pharms., Inc., 412 U.S. 645 (1973) .................................................................................................. 28 STATUTES
Administrative Procedure Act, 5 U.S.C. §§ 552 et seq. .................................................... 2 5 U.S.C. § 706(2)(A) ................................................................................................. 26
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq. ................................... 5 21 U.S.C. § 321(g) ...................................................................................................... 5 21 U.S.C. § 352 ........................................................................................................... 9 21 U.S.C. § 353 ........................................................................................................... 9 21 U.S.C. § 355(d) .................................................................................................. 5, 8
The Public Health Service Act, 42 U.S.C. §§ 201, et seq. ................................................ 5 42 U.S.C. § 262 ........................................................................................................... 8 42 U.S.C. § 262(2)(C)(i)(I) ......................................................................................... 5 42 U.S.C. § 262(2)(C)(i)(II) ........................................................................................ 5 42 U.S.C. § 262(d) ...................................................................................................... 5 42 U.S.C. § 262(i) ....................................................................................................... 5
10 U.S.C. § 1107 ............................................................................................................. 23
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Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 7 of 53
10 U.S.C. § 1107(a) .................................................................................................. 23 10 U.S.C. § 1107(f) ................................................................................................... 23 10 U.S.C. § 1110 ............................................................................................................. 43 10 U.S.C. § 1178 ............................................................................................................. 43 10 U.S.C. § 1580a ........................................................................................................... 43
REGULATIONS 21 C.F.R. Part 300
21 C.F.R. § 314.126 .............................................................................................. 9, 35 21 C.F.R. Part 600
21 C.F.R. § 600.3(p) ................................................................................................. 32 21 C.F.R. § 600.3(s) .................................................................................................... 5 21 C.F.R. § 601.25 ................................................................................................ 6, 26 21 C.F.R. § 601.25(a) .................................................................................................. 6 21 C.F.R. § 601.25(d) ..................................................................................... 8, 32, 34 21 C.F.R. § 601.25(d)(1) ................................................................................. 8, 31, 34 21 C.F.R. § 601.25(d)(2) ................................................................... 6, 8, 9, 17, 35, 40 21 C.F.R. § 601.25(d)(3) ....................................................................................... 8, 41 21 C.F.R. § 601.25(d)(5) ............................................................................................. 8 21 C.F.R. § 601.25(e) .................................................................................................. 6 21 C.F.R. § 601.25(e)(1) ....................................................................................... 7, 17 21 C.F.R. § 601.25(e)(2) ............................................................................................. 7 21 C.F.R. § 601.25(e)(3) ............................................................................................. 7 21 C.F.R. § 601.25(f) .................................................................................................. 7 21 C.F.R. § 601.25(f)(1) ............................................................................................. 7 21 C.F.R. § 601.25(f)(2) ............................................................................................. 7
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21 C.F.R. § 601.25(f)(3) ............................................................................................. 7
21 C.F.R. § 601.25(g) ........................................................................................... 7, 19
21 C.F.R. § 601.25(i) .................................................................................................. 8
21 C.F.R. § 601.26 ...................................................................................................... 7
21 C.F.R. § 620.24 .................................................................................................... 12
FEDERAL REGISTER PROVISIONS
Licensed Biological Products, 36 Fed. Reg. 8,704 (May 11, 1971) .......................................................................... 12
Redelegation of Authority to Administer Certain Provisions of the Federal Food, Drug, and Cosmetic Act 37 Fed. Reg. 4,004 (Feb. 25, 1972) ............................................................................. 6
Statement of Organization, Functions, and Delegations of Authority, 37 Fed. Reg. 12,865 (June 29, 1972) .......................................................................... 6
Procedures for Review of Safety, Effectiveness, and Labeling, 37 Fed. Reg. 16,679 (Aug. 18 1972) ................................................................. 6, 8, 35
Procedures for Review of Safety, Effectiveness and Labeling, 38 Fed. Reg. 4,319 (Feb. 13, 1973)) ........................................................................... 7
Request for Data Information, 38 Fed. Reg. 5,358 (Feb. 28, 1973) ........................................................................... 13
Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51,002 (Dec. 13, 1985) ................................................................. passim
Revocation of Certain Regulations; Biological Products, 61 Fed. Reg. 40,153 (Aug. 1, 1996) .......................................................................... 13
Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 69 Fed. Reg. 255 (Jan. 5, 2004) ......................................................................... passim
OTHER SOURCES
Executive Order 13,139 .................................................................................................. 24
H.R. Rep. No. 106-371 (1999) .................................................................................. 10, 40
Fed. R. Civ. P. 56(d) ................................................................................................. 29, 30
-v-

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 9 of 53 **Philip S. Brachman, et al., "Field Evaluation of A Human Anthrax Vaccine,"
52 American J. of Pub. Health 632 (1962) ........................................................ passim P.F. Fellows, et al., "Efficacy of a Human Anthrax Vaccine in Guinea Pigs,
Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin," 19 Vaccine 3241 (2001) ................................................................................ 22, 36, 40 Institute of Medicine, Committee To Assess the Safety and Efficacy of the Anthrax Vaccine, "The Anthrax Vaccine: Is It Safe? Does It Work?" (National Academy Press 2002) ......................................................................... passim B.E. Ivins, et al., "Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques," 16 Vaccine 1141 (1998) ............................................................................................................... 23 B.E. Ivins, et al., "Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys," 87 Salisbury Medical Bulletin 125 (1996) ................................................... 23, 36, 40 Phillip R. Pittman, et al., "Anthrax Vaccine: Immunogenicity and Safety of a Dose-Reduction, Route-Change Comparison Study in Humans," 20 Vaccine 1412 (2001) ..................................................................................... 20, 34
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PRELIMINARY STATEMENT In a Final Order dated December 30, 2003, defendant Food and Drug Administration ("FDA") categorized Anthrax Vaccine Adsorbed ("AVA"), a vaccine indicated to provide immunization against disease caused by Bacillus anthracis ("B. anthracis"), as a Category I product — that is, as safe, effective, and not misbranded. See Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review ("FDA Order" or "Order"), 69 Fed. Reg. 255 (Jan. 5, 2004). B. anthracis is the bacterium whose spores cause anthrax, a rare but deadly disease. Anthrax spores can enter the body any of three ways: through the skin (cutaneous), through breathing (inhalation), or through ingestion (gastrointestinal). The Order confirms the use of AVA as a safe and effective vaccine against disease caused by the anthrax bacterium, regardless of the route of exposure. AVA is the only vaccine licensed in the United States for prevention against anthrax. The FDA Order marks the culmination of study regarding the safety, effectiveness, and labeling of certain bacterial vaccines (including AVA) previously licensed by a predecessor agency. FDA's decision to categorize AVA as "safe, effective, and not misbranded" is consistent with both the Panel on Review of Bacterial Vaccines and Toxoids ("Panel") recommendation that AVA be designated as a Category I product, see Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51,002, 51,058-59 (Dec. 13, 1985), and with FDA's proposed order adopting the Panel's Category I recommendation. See id. at 51,104. FDA's categorization of AVA is also consistent with the published findings of an independent, congressionally-mandated study of AVA's safety and effectiveness by the Institute of Medicine. See Institute of Medicine, The Anthrax Vaccine: Is it Safe? Does it Work? (2002). Moreover, as this Court has recognized, FDA's Order "categorizing AVA as safe and effective

Case 1:03-cv-00707-EGS Document 42 Filed 03/03/04 Page 11 of 53
for use against inhalation anthrax" addressed the "principle reason" for the Court's earlier injunction in this case. See Order dated January 7, 2004 at 1.
Plaintiffs, six anonymous individuals, challenge the FDA Order with respect to AVA under the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 551, et seq.1 Notwithstanding the broad language in their Amended Complaint, plaintiffs do not challenge AVA's Category I categorization in its entirety. Plaintiffs, in a recent filing, conceded that AVA is "lawfully approved" — i.e., safe, effective, and not misbranded — for use against cutaneous anthrax. See Reply to Defendants' Memorandum of Law in Opposition to Plaintiffs' Motion to Determine that Class Certification Is Not Required for Program-Wide Injunctive Relief ("Class Cert. Reply") at 4 n.4. Plaintiffs challenge the Order only to the extent it "lawfully approves" AVA for use against inhalation anthrax. This challenge is meritless.
Plaintiffs have not established Article III standing. Plaintiffs claim they have been ordered, or will imminently be ordered, to take AVA as part of their military duties, but eleven months after filing their complaint, plaintiffs themselves have presented no specific facts in support of that claim. Indeed, because plaintiffs are litigating anonymously, defendants have been unable to test plaintiffs' allegations of injury. At this stage of the litigation, having failed to produce evidence of standing, plaintiffs' claims must be dismissed.
Plaintiffs' claims fare no better on the merits. Those claims are reviewed, of course, under the APA's deferential standard. Under that standard, agency action is presumed valid, and the Court must consider only whether the challenged decision was based on a consideration of
1Plaintiffs' amended complaint raises other claims unrelated to the legality of the Order. Pursuant to the Court's scheduling order, this brief addresses only the "validity of the FDA Order under the Administrative Procedure Act." See Order dated January 16, 2004 at 1-2.
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the relevant factors and whether there has been a clear error of judgment; so long as the agency adequately articulates an explanation for its actions, it must be upheld. Indeed, because FDA's determination involves an expert evaluation of scientific data, judicial review is especially deferential. FDA's judgments about safety and effectiveness of drugs and biologics are at the very heart of its expertise.
With respect to safety, plaintiffs have not argued that AVA is unsafe for human use; in fact, plaintiffs affirmatively have conceded that AVA is safe for immunization against cutaneous anthrax. Plaintiffs thus effectively have conceded AVA's safety for immunization against inhalation anthrax because AVA is administered in advance of potential exposure to the anthrax bacterium, regardless of whether the intention is to protect against cutaneous or inhalation anthrax. In any event, AVA's safety is evidenced through numerous reports, studies, and data in the record, including the Institute of Medicine report ("IOM report"), and data collected by the Centers for Disease Control ("CDC") during a five-year open-label safety study.2
FDA's effectiveness determination is based on the adequate and well-controlled study conducted by Drs. Brachman, Gold, Plotkin, Fekety, Werrin, and Ingraham ("Brachman" or "Brachman study"), and corroborated by, among other things, CDC surveillance data on the occurrence of anthrax in at-risk industrial settings and the IOM report (which concluded that AVA, as licensed, is an effective vaccine to protect humans against inhalation anthrax).
2Defendants filed the fifteen volume administrative record relating to the portions of the Order involving AVA on February 2, 2004. In this memorandum, we refer to documents in the administrative record by the prefix "AR" followed by the bates-stamp number on the document. As we previously informed plaintiffs, the documents at pages AR681-AR1112 were inadvertently included in the record; these documents relate to portions of the Order not involving AVA.
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Plaintiffs' argument that AVA is not effective appears to be based, almost entirely, on a misreading of both the Brachman data and the Panel report.3 The former did not (as plaintiffs previously have argued) conclude that anthrax vaccine is effective only against cutaneous anthrax; the Brachman study calculated the effectiveness of the vaccine to prevent all types of anthrax disease combined — regardless of the route of exposure — as 92.5 percent. And the latter did not (as plaintiffs also previously have argued) recommend that AVA be licensed only for use against cutaneous exposure; AVA's label does not specify a route of exposure, and the Panel recommended that AVA, as licensed, be categorized as a Category I product.
In classifying a drug or biological product, FDA must make complex judgments about the quantity and quality of scientific evidence, and must weigh the risks and benefits associated with use. Here, FDA analyzed the evidence, weighed the risks, and decided, consistent with the Panel's recommendation, to classify AVA in Category I. Especially here, where the product at issue is licensed for vaccination against a fatal disease, FDA's expert scientific judgment that the product is safe and effective merits great deference from the Court. FDA's decision is rational, supported by the evidence, and should be upheld.
3The Panel report, as noted above, was published in the Federal Register with FDA's proposed order relating to the Panel's recommendations. When citing to the Panel report as published in the Federal Register, we use the shorthand "(Panel)" after the citation. The Panel report is also separately in the administrative record at AR004-600.
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BACKGROUND
1. Statutory and Regulatory Framework
a. The PHSA and the FDCA
The Public Health Service Act ("PHSA"), 42 U.S.C. §§ 201, et seq., and the Federal
Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301, et seq., govern the regulation of
biological products in the United States.4 The PHSA governs licensing of biological products; it
grants FDA authority to issue licenses based on a demonstration that the biological product is
"safe, pure, and potent," 42 U.S.C. § 262(a)(2)(C)(i)(I), and that the facility in which the product
is manufactured "meets standards designed to assure that the biological product continues to be
safe, pure, and potent." Id. § 262(a)(2)(C)(i)(II).5 Biological products, such as vaccines, intended
for human use also are "drugs" for purposes of the FDCA, see 21 U.S.C. § 321(g)(1)(B), and,
under the FDCA, FDA is charged with approving drugs that are, among other things, safe,
effective, and not misbranded. See id. § 355(d).6 See generally Procedures for Review of Safety,
4The PHSA defines biological products as any "virus, therapeutic serum, toxin, antitoxin, vaccine . . . or analogous product . . . applicable to the prevention, treatment, or cure of a disease or condition of human beings." 42 U.S.C. § 262(i).
5Prior to 1997, when the licensing provisions were amended to their current form, the PHSA similarly granted FDA authority to issue licenses "upon a showing that the establishment and the products for which a license is desired meet standards, designed to insure the continued safety, purity, and potency of such products." 42 U.S.C. § 262(d)(1) (1996).
6Under the FDCA, as amended in 1962, a drug for human use must be shown to be effective prior to approval. FDA, by regulation, has interpreted "potency" under the PHSA to mean "the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result." 21 C.F.R. § 600.3(s). Therefore, both biologics under the PHSA and drugs under the FDCA must be demonstrated to be effective before approval. As explained below, see infra p. 9 n.9, in 1972, when FDA initiated a review of the safety and effectiveness of all previously licensed biologics, it stated that proof of effectiveness should consist of "controlled clinical investigations" except in certain limited circumstances. See 21
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Effectiveness, and Labeling, 37 Fed. Reg. 16,679, 16,679-80 (Aug. 18, 1972) (explaining interplay between PHSA and FDCA with respect to biologics).
Prior to 1972, the Division of Biologics Standards of the National Institutes of Health ("NIH") implemented PHSA's licensing provisions. See Redelegation of Authority to Administer Certain Provisions of the Federal Food, Drug, and Cosmetic Act, 37 Fed. Reg. 4,004, 4,005 (Feb. 25, 1972). In 1972, the Division of Biologics Standards (now the Center for Biologics Evaluation and Research) was transferred to FDA. See Statement of Organization, Functions, and Delegations of Authority, 37 Fed. Reg. 12,865 (June 29, 1972). That same year, FDA proposed, for notice and comment, regulations establishing procedures for reviewing the safety, effectiveness, and labeling of all biological products previously licensed by NIH. See Procedures for Review of Safety, Effectiveness and Labeling, 37 Fed. Reg. at 16,679. These comprehensive regulations, finalized in 1973, are codified at 21 C.F.R. § 601.25.
b. Section 601.25 Section 601.25 establishes a two-stage process for reviewing biological products licensed prior to July 1, 1972. First, it directs FDA's Commissioner ("Commissioner") to appoint an advisory review panel for each category of biological products to (i) evaluate the safety and effectiveness of the licensed products, (ii) review the labeling of such products, and (iii) advise the Commissioner "on which of the biological products under review are safe, effective, and not misbranded." See 21 C.F.R. § 601.25(a). In advising the Commissioner, each panel must submit a report containing its conclusions and recommendations. See 21 C.F.R. § 601.25(e). The report must contain a "statement . . .
C.F.R. § 601.25(d)(2). -6-

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designat[ing] those biological products determined by the panel to be safe and effective and not misbranded," id. § 601.25(e)(1), and this statement "may include any condition relating to active components, labeling, tests required prior to release of lots, product standards, or other conditions necessary or appropriate for their safety and effectiveness." Id. Products in this category are deemed "Category I" products. The report must also contain a statement designating those products determined to be unsafe, ineffective or misbranded ("Category II" products); see id. § 601.25(e)(2); as well as those products for which the available data are insufficient to make the required determination such that further testing is required ("Category III" products). See id. § 601.25(e)(3). Product licenses remain in effect during the review process.
Second, after reviewing the recommendations, the Commissioner must publish in the Federal Register the panel report and a proposed order.7 See 21 C.F.R. § 601.25(f). The proposed order must contain a statement designating those biological products "determined by the Commissioner . . . to be safe and effective and not misbranded" (i.e., those products in Category I), id. § 601.25(f)(1), as well as a statement designating those products determined to be in Category II and III. See id. § 601.25(f)(2)-(3); see also id. § 601.26 (reclassification procedures for certain Category III products). After reviewing comments on the proposed order, the Commissioner "shall publish . . . a final order on the matters covered" therein, id. § 601.25(g), which shall "constitute final agency action from which appeal lies to the courts." Id.
7As FDA noted in the Federal Register notice publishing Section 601.25, "the report of each panel is advisory to the Commissioner, who has the final authority either to accept or to reject the conclusions and recommendations of the panel." Procedures for Review of Safety, Effectiveness and Labeling, 38 Fed. Reg. 4,319, 4,321 (Feb. 13, 1973). Accord FDA Order at 257 ("[t]he Panel's recommendations are not binding but represent the scientific opinions of a Panel of experts").
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§ 601.25(i). Section 601.25(d) establishes the standards for FDA (and the panels) to apply in
evaluating safety, effectiveness, and labeling. See 21 C.F.R. § 601.25(d). In the Federal Register notice proposing Section 601.25, FDA noted the "unique problems involved in applying the requirement of 'substantial evidence of effectiveness' to biological products under the [FDCA]," 37 Fed. Reg. at 16,679, and stated that advisory panels, subject to FDA review, would develop "the standard and methodology for effectiveness for a particular class of biological products, taking into account all of the circumstances involved." Id.; see also 50 Fed. Reg. at 51,005 (Panel) ("the judgment concerning safety and efficacy of bacterial vaccines and toxoids presents some complex and knotty overall problems"). The resulting standards, by necessity, thus are not uniform numeric thresholds, but are more in the nature of definitions to guide FDA's expert, case-by-case determinations with respect to particular products. See Berlex Labs., Inc. v. FDA, 942 F.Supp. 19, 25 (D.D.C. 1996) (discussing FDA regulations for determining safety, purity, and potency under the PHSA).
"Safety" is defined in the regulations as: the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time. See 21 C.F.R. § 601.25(d)(1).8 This standard is not absolute; it requires only "the relative freedom" from harmful effects. Id. Moreover, as the Panel noted, the standard for safety must
8Proof of safety "shall consist of adequate tests by methods reasonably applicable to show the biological product is safe under the prescribed conditions of use, including results of significant human experience during use." 21 C.F.R. § 601.25(d)(1); see also 21 U.S.C. § 355(d)(1).
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"be individualized for each kind of vaccine." 50 Fed. Reg. at 51,006 (Panel). "Effectiveness" is defined in the regulations as: a reasonable expectation that, in a significant proportion of the target population, the pharmacological or other effect of the biological product, when used under adequate directions, for use and warnings against unsafe use, will serve a clinically significant function in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.
21 C.F.R. § 601.25(d)(2).9 Again, this standard "must be applied separately to each vaccine," according to "current expectations of . . . performance." 50 Fed. Reg. at 51,007 (Panel).
In determining safety and effectiveness, FDA (and the panels) must consider "[t]he benefit-to-risk ratio" of the product under review. 21 C.F.R. § 601.25(d)(3). Risk/benefit analysis, "a fundamental [concept] in a consideration of vaccines," see 50 Fed. Reg. at 51,005 (Panel), requires FDA to determine whether the benefits of the product outweigh the risks of the product for the intended population. See id. at 51,006 (Panel) (noting that "[g]reater risks of adverse effects might be tolerated for a vaccine that provided protection against a lethal disease than for a vaccine against a disease that is basically benign"). Each product "must be assessed individually for its special features that vary from the norm." See id. (Panel).
Finally, with respect to the misbranding determination, FDA (and the panels) must determine whether the product labeling is "clear and truthful in all respects" and not "false or misleading in any particular," 21 C.F.R. § 601.25(d)(5), and whether the labeling complies with applicable statutory and regulatory requirements. See id. (citing 42 U.S.C. § 262, 21 U.S.C. §§
9Proof of effectiveness "shall consist of controlled clinical investigations" as defined in 21 C.F.R. § 314.126, unless this requirement is waived or alternate methods are adequate to substantiate effectiveness. See 21 C.F.R. § 601.25(d)(2). Investigations "may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing." Id.
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352 & 353, 21 C.F.R. §§ 610.60- 610.65, and 21 C.F.R. Part 201, Subpart D).
2. Review of AVA under 21 C.F.R. § 601.25
a. Anthrax disease
Anthrax is an acute bacterial disease caused by infection with spores of Bacillus anthracis
("B. anthracis"). See 50 Fed. Reg. at 51,058 (Panel). The "reservoir is any of several animal
species (cattle, sheep, goats, horses, pigs) and the organism produces extremely resistant spores
which may persist in soil and contaminate animals or their products." Id. (Panel).
Anthrax spores may enter the body in three ways: by skin contact (cutaneous), by
ingestion (gastrointestinal), and by breathing (inhalation). For cutaneous anthrax, the fatality rate
is approximately 20 percent. See AR3363 (Institute of Medicine, The Anthrax Vaccine: Is it
Safe? Does it Work? (2002) ("IOM")).10 For gastrointestinal anthrax, the fatality rate is 25 to 75
percent. See AR3364 (IOM). Until recent terrorist attacks involving anthrax spores, inhalation
anthrax was extremely rare;11 the fatality rate for inhalation anthrax is estimated to be
approximately 45 to 90 percent. See AR639 (AVA package insert); see also AR3364 (IOM).
10In the House Conference Report accompanying the Department of Defense ("DoD") appropriations bill for the fiscal year ending September 30, 2000, Congress directed DoD to "enter into a contract with the National Research Council to independently study the effectiveness and safety of the anthrax vaccine." See H.R. Rep. No. 106-371, at 254 (1999). In October 2000, the Institute of Medicine convened the "Committee to Assess the Safety and Efficacy of the Anthrax Vaccine" ("IOM committee") to prepare this report. See AR3308 (IOM). The IOM report, the substance of which we discuss below, see, e.g., infra p. 22, is in the record at AR3303-3583.
11Only eighteen cases of inhalation anthrax were reported in the United States in the twentieth century. See AR3361 (IOM) (noting most cases occur in workers handling animal hides, hairs, or wools). Five of those cases were observed as part of the Brachman study, see id.; AR3734, the well-controlled clinical trial FDA relied upon as the basis for its effectiveness determination. See FDA Order at 259-60. Eleven additional inhalation cases were confirmed in 2001 after letters containing B. anthracis spores were sent through the mail. See AR3362 (IOM).
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Once inside the body, and regardless of the route of exposure, the virulence of B. anthracis derives from three proteins — protective antigen (PA), edema factor (EF), and lethal factor (LF) — and a capsule. See AR3366-67 (IOM). The proteins are not toxic by themselves; rather, to produce active toxins, PA must "bind to cellular receptors and then bind with either EF or LF." AR3367 (IOM). The "resulting edema toxin or lethal toxin can then enter the cell," id., where "the toxins lead to damage." Id. (Figure 2-4).
"The available data indicate that immunity to anthrax is associated with the presence of antibody to protective antigen." AR3328 (IOM); see also AR639 (AVA package insert). AVA contains PA as its principal immunogen. See AR3368 (IOM). It is the only vaccine licensed for active immunization against B. anthracis. See AR3308, AR3322, AR3368-69 (IOM).
b. AVA license granted by NIH "During 1965, it became apparent to many investigators at the National Communicable Disease Center [CDC] and elsewhere tha[t] an anthrax vaccine was needed for human immunization — no such vaccine was available from commercial sources." See AR3764. That year, DoD, through the U.S. Army Biological Laboratories, Fort Detrick, MD, contracted with the Michigan Department of Public Health ("MDPH") to engage in the large-scale production of a PA-based anthrax vaccine. See AR3647-52. Prior to the MDPH contract, the Army had contracted with Merck Sharpe & Dohme ("MS&D") to produce a PA-based vaccine ("MS&D vaccine"); see AR3764, 3831, 3862; prior to that, the Army produced a PA-based vaccine itself ("original DoD vaccine"). See AR3845-46, AR645-50; see also AR3300 (describing the three vaccines). In 1966, CDC filed with NIH a "Notice of Claimed Investigational Exemption" (file #
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DBS-IND-180) for "Anthrax Protective Antigen, Aluminum Hydroxide Adsorbed." See
AR3829, AR3665; see also AR3607-3923 (portion of record relating to DBS-IND-180). Under
this "investigational new drug" application (or "IND"), CDC began an open-label study designed
to collect safety data on anthrax vaccine, the results of which it detailed in annual progress
reports to NIH. In 1967, MDPH filed with NIH a product license application ("PLA") for
"Anthrax Protective Antigen, Aluminum Hydroxide Adsorbed," see AR3943-50, the vaccine it
was producing under contract with the Army. See AR3647; see also AR3924-4030 (portion of
record relating to PLA file). During the licensing process, the product name was changed to
"Anthrax Vaccine, Adsorbed." See AR3977.
NIH licensed AVA manufactured by MDPH in November 1970. See AR1377; Licensed
Biological Products, 36 Fed. Reg. 8,704, 8,705 (May 11, 1971). The NIH committee tasked with
reviewing MDPH's application, see AR3974, recommended that a license be granted based on, among other things, the CDC safety data,12 laboratory tests showing AVA's ability to protect guinea pigs against challenge (potency data),13 and the development and publication of additional standards relating to production and potency testing for AVA.14 See AR4021 (Nov. 2, 1970
12These data, contained in the five annual progress reports CDC filed under DBS-IND180, are in the record at AR3668-75 (report #5), AR3676-84 (report #4), AR3685-97 (report #3), AR3781-3820 (report #2), and AR3761-80 (report #1). In the first year of its open-label study, CDC distributed the MS&D and MDPH vaccines. See AR3764. After the first year, the progress reports reflect that CDC distributed only MDPH's product. See reports cited above; see also FDA Order at 260 (noting that approximately 15,000 doses of AVA were used). We discuss the CDC safety data in detail below. See, e.g., infra pp. 14, 19-20.
13See, e.g., AR3947 (MDPH describing "time-to-death" animal potency tests based on challenge with injection of b. anthracis spores); AR 3684 (potency data); AR3994-95 (potency data comparing AVA and MS&D vaccine).
14See AR1138-39. These standards, originally codified at 21 C.F.R. § 620.24, were revoked along with numerous other biologics regulations in 1996. See Revocation of Certain
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memorandum from review committee chair); AR3930-31 (June 21, 1968 review committee memorandum); see also AR4022 (letter forwarding product license to MDPH).15
The NIH-approved label (or "package insert") recommended immunization with AVA for certain identified classes of persons with a risk of exposure to B. anthracis spores. See, e.g., AR3291 (recommending immunization for "individuals who may come in contact with imported animal hides, furs, bonemeal, wool, hair (especially goat hair), and bristles"); see also 50 Fed. Reg. at 51,058 (Panel) (AVA immunization "indicated only for certain occupational groups with risk of uncontrollable or unavoidable exposure to the organism"). It did not recommend that immunization be limited to any particular route of exposure. See AR3291-92 (package insert) ("recommendations for use").
c. Panel review In 1973, FDA announced the Section 601.25 safety and effectiveness review for "bacterial vaccines and toxoids with standards of potency" — the category of products including AVA — and solicited relevant data and information. See Safety, Effectiveness and Labeling Review; Request for Data Information, 38 Fed. Reg. 5,358 (Feb. 28, 1973). The Panel considering these products (well over 100 products in all) submitted its report in 1980; see AR0001-0600; in 1985, FDA published the report and a proposed order relating to the
Regulations; Biological Products, 61 Fed. Reg. 40,153, 40,154 (Aug. 1, 1996). 15In various memoranda in the IND and PLA file, the NIH review committee commented
that MDPH's vaccine had not itself been employed in a controlled field trial, and that the review committee therefore believed CDC's IND lacked controlled evidence of effectiveness. See, e.g., AR3629 (Sept. 30, 1969 memorandum); AR3630 (Sept. 30, 1969 memorandum). As explained below, however, see infra pp. 18, 21 n.23, & 36 n.31, the original DoD vaccine was used in a well-controlled trial conducted by Brachman, et al., and both the Panel and FDA concluded that, given the similarity between the PA-based vaccines, cf. infra n.19, the Brachman study may be relied upon for proof of AVA's effectiveness.
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matters addressed therein. See 50 Fed. Reg. at 51,002. With respect to AVA, the Panel recommended that it "be placed in Category I" — the
category for products deemed safe, effective, and not misbranded — "and that the appropriate license(s) be continued because there is substantial evidence of safety and effectiveness for this product." 50 Fed. Reg. at 51,059 (Panel). See supra pp. 6-7 (discussing difference between product category designations). FDA, in its proposed order, concurred in the Panel's recommendation, and proposed to adopt the Panel's conclusion. See id. at 51,104. We review the Panel's findings below.
Safety. In determining safety, the Panel reviewed accumulated data from the CDC openlabel study. During that study, as explained in the FDA Order, approximately 7,000 at-risk persons were vaccinated with either the MS&D vaccine or the MDPH vaccine and monitored for adverse reactions. See FDA Order at 260. Approximately 15,000 doses of MDPH-manufactured AVA were administered. See id.
Noting that "[i]n general, safety of this product is not a major concern," 50 Fed. Reg. at 51,058 (Panel), the Panel found the CDC data "suggest[] that [AVA] is fairly well tolerated with the majority of reactions consisting of local erythema [i.e., redness] and edema [i.e., swelling]," id. at 51,059 (Panel), and that "[s]evere local reactions and systemic reactions are relatively rare." Id. (Panel); see also id. at 51,058 (Panel) (in summarizing CDC data, noting that ("[l]ocal reactions are typically mild"; "[s]ome individuals may have more severe local reactions with edema, erythema greater than 5x5 cm, induration, local warmth, tenderness and pruritus"; and "[o]nly a few systemic reactions with marked chills and fever have been recorded"). Based on these data, the Panel concluded: "there is substantial evidence of safety . . . for this product." Id.
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at 51,059 (Panel).
Effectiveness. In determining effectiveness, the Panel considered two sets of data: (i) the
placebo-controlled human field trial conducted by Drs. Brachman, Gold, Plotkin, Fekety, Werrin,
and Ingraham in the 1950s (in the record at AR3732-3745); and (ii) surveillance data collected
and summarized by CDC. See 50 Fed. Reg. 51,058 (Panel).
The Brachman study involved 1,249 workers in four textile mills in the northeastern United States processing raw imported goat hair.16 See AR3732, AR3733. A portion of the
workers received anthrax vaccine ("vaccine group"), a portion received placebo ("placebo
group"), and a portion received no treatment but were monitored for the occurrence of anthrax
disease ("observational group"). See AR3734 (Table 2), AR3736 (Table 4); 50 Fed. Reg. at
51,058 (Panel); FDA Order at 259. During the evaluation period, which included an "outbreak"
of inhalation anthrax, see AR3733, twenty-six cases of anthrax occurred:
five of the twenty-six cases were inhalation cases; see AR3736 (Table 4); none of these cases was in the vaccine group; see id.; two were in the placebo group, see id., and three were in the observational group; see id.; four of the five inhalation cases were fatal; see AR3734;
the remaining twenty-one cases were cutaneous; see AR3734; fifteen were in the placebo group (two in persons deemed not completely inoculated), see AR3736 (Table 4), three were in the observational group, see id., and three were in the vaccine group (two in persons deemed not completely inoculated); see id.
Based on the occurrence of a total of fifteen cases of cutaneous and inhalation anthrax in
16As the Brachman study noted, "[t]he necessary requirements of a well defined, exposed, susceptible population among whom cases of anthrax were reported with some regularity could only be met, in this country, in an industrial area" containing certain types of textile businesses. See AR3732. Brachman, et al., conducted their study in the 1950s. See AR3737 (Figure 1). By 1980, when the Panel submitted its report, this industrial setting was "vanishing, precluding any further clinical studies." 50 Fed. Reg. 51,058 (Panel).
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completely inoculated members of the placebo group (some of the workers allocated to the vaccine and placebo groups did not receive the complete vaccination series), see AR3736 & Table 4, Brachman, et al., calculated "[t]he total expected cases" in the completely inoculated vaccine group as 13.35. See AR3737. Given that "only one case was actually observed" in the completely inoculated vaccine group (a cutaneous case), Brachman, et al., calculated the effectiveness of the vaccine against anthrax at 92.5 percent. See id. The authors of the study based their calculation on a comparison with the completely inoculated placebo group, see id., which, as noted above, included both cutaneous (13) and inhalation (2) cases. The calculated effectiveness rate did not include data from the observational group. See id.; AR1381 at n.9.
While relying on the Brachman study for its recommendation of effectiveness, see 50 Fed. Reg. at 51,059 (Panel), the Panel stated the study demonstrated "93 percent . . . protection" only against cutaneous anthrax, and that "[i]nhalation anthrax occurred too infrequently to assess the protective effect of vaccine against this form of the disease." 50 Fed. Reg. at 51,058 (Panel).17 This observation, as FDA explained in its Final Order (see FDA Order at 259-60), was erroneous; that is, as noted above, Brachman, et al., calculated the effectiveness of the vaccine to prevent all types of anthrax, not just cutaneous. See AR3736 (Table 4); AR3740-41 (Table 8). Nevertheless, and notwithstanding this error, the Panel recommended no change with respect to the "recommendations for use" section of AVA's label (which, as stated supra p. 13,
17See also id. at 51,059 (Panel) (describing vaccine as "93 percent protective . . . against cutaneous anthrax" and noting that "[n]o meaningful assessment of its value against inhalation anthrax is possible due to its low incidence"); id. at 51,058 (Panel) (stating that "[a]nthrax vaccine poses no serious special problems other than the fact that its efficacy against inhalation anthrax is not well documented," and that "[t]his question is not amenable to study due to the low incidence and sporadic occurrence of the disease").
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recommended AVA for immunization against B. anthracis, without specifying a route of exposure). See 21 C.F.R. § 601.25(e)(1) (Category I recommendation "may include any condition relating to . . . labeling" or "other conditions necessary or appropriate for . . . safety and effectiveness"); see also infra n.33.
The Panel also considered surveillance data collected by CDC "on the occurrence of anthrax in at-risk industrial settings." 50 Fed. Reg. at 51,058 (Panel). These data, the Panel observed:
were summarized for the period 1962-1974. Twenty-seven cases were identified. Three cases were not mill employees, but worked in or near mills; none of these cases were vaccinated. Twenty-four cases were mill employees; three were partially immunized (one with 1 dose, two with 2 doses); the remainder (89 percent) being unvaccinated. Therefore, no cases have occurred in fully vaccinated subjects while the risk of infection has continued. These observations lend further support to the effectiveness of this product. 50 Fed. Reg. at 51,058 (Panel); see also id. at 51,059 (Panel) (reviewing surveillance data). Based on the summarized CDC surveillance data and the Brachman study, the Panel concluded there was "substantial evidence of . . . effectiveness for this product." Id. at 51,059 (Panel).
d. Citizen petition On October 12, 2001, a group of individuals filed a citizen petition requesting that FDA find AVA ineffective for its intended use, and issue a final order classifying AVA as a Category II product.18 See AR1313-75. The petitioners argued in part that the Panel had erred in concluding the Brachman study qualified as a well-controlled field trial for purposes of 21 C.F.R.
18In late 1995, MDPH became the Michigan Biologic Products Institute (MBPI). See AR1377 at n.1. In September 1998, BioPort, the current manufacturer, purchased MBPI. See id. The petitioners raised other issues relating to AVA's manufacturing by BioPort, which FDA addressed in its response. See AR1385-1392.
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§ 601.25(d)(2); see AR1316-17 & n.6; they also argued the vaccine used in the Brachman study was not comparable to AVA. See AR1316 at n.5. In its August 28, 2002 response, FDA explained it was "working to complete [a final order] as soon as possible," and that, given "the pendency of this rulemaking," it could not "evaluate the adequacy of the Panel recommendation." AR1378. Nevertheless, FDA provided its "position at this time" with respect to several issues raised in the petition. See AR1378 (emphasis removed).
For example, FDA explained that the Brachman study qualifies as a well-controlled study under its regulations. See AR1380 (noting the study "permitted a valid comparison of the vaccine with a placebo control group to provide a quantitative assessment of effectiveness"). Relying on the published guidance for determining comparability, see AR1382, FDA also explained that AVA "is comparable to the DOD vaccine used in the Brachman study." See AR1382-84 (reviewing the history of DoD's involvement in the development of all three versions of the PA-based anthrax vaccine).19 FDA also concluded (contrary to the Panel's observation) that "the efficacy analysis actually conducted in the Brachman study includes all cases of anthrax disease regardless of the route of exposure or manifestation of the disease." AR1381; see also AR4032 (Mar. 4, 1997 letter from DoD to FDA stating DoD's view that "the scope of [AVA's] license . . . include[s] inhalation exposure"); AR4031 (Mar. 13, 1997 response from FDA stating "the current package insert does not preclude this use").
19The Panel concluded correctly that the vaccine used by Brachman, et al., was "very similar" to AVA, and that the Brachman study could be used to establish AVA's effectiveness. See 50 Fed. Reg. at 51,059 (Panel); see also id. (Panel) (noting that AVA was "patterned after" the vaccine used in the Brachman study). The Panel stated erroneously, however, see id., that Brachman, et al., used the MS&D vaccine; they used the original DoD vaccine. See AR3732. As noted infra n.23, FDA, in its Final Order, explained that AVA is comparable to both predecessor PA-based vaccines.
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Finally, FDA noted AVA's package insert had been amended most recently in January 2002, see AR1378 at n.5, and that the amended approved package insert, like the earlier package insert, stated the indication is based on risk of exposure. See AR1377-78; see also AR640 (amended package insert) (AVA indicated for "the active immunization against Bacillus anthracis of individuals between 18 and 65 years of age who come in contact with animal products such as hides, hair or bones that come from anthrax endemic areas, and that may be contaminated with Bacillus anthracis spores," and "for individuals at high risk of exposure to Bacillus anthracis spores such as veterinarians, laboratory workers and others whose occupation may involve handling potentially infected animals or other contaminated materials"). Thus, the current package insert, like the original package insert, see AR3291-92, does not recommend that use of AVA be limited to any particular route of exposure.
e. Final Order On December 30, 2003, FDA issued a final order under 21 C.F.R. § 601.25(g) regarding the status of the products addressed in the Panel report. See FDA Order at 257-59.20 With respect to AVA, FDA "adopted Category I" — safe, effective, and not misbranded — "as the final category." See FDA Order at 257 & Table 1. The Order explained in detail FDA's reasoning with respect to its "determination that the data support the safety and efficacy of AVA," id. at 259, and also explained certain "points of disagreement with statements in the Panel report." Id. We review these portions of the Order below. Safety. FDA, like the Panel, relied on data from CDC's open-label study in finding AVA
20The Order also contained a final rule relating to certain additional standards for one of the biological products under review. See FDA Order at 265.
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safe. See FDA Order at 260 (noting that, from 1967-1971, approximately 7,000 at-risk persons
"were vaccinated with anthrax vaccine and monitored for adverse reactions"; that approximately
15,000 doses of MDPH-manufactured AVA were administered during the study; and that the
Panel found the CDC data "'suggests that this product is fairly well tolerated'").
FDA also considered, among other things, the results of a "small, randomized clinical
study of the safety and immunogenicity of AVA" conducted by DoD,21 as well as "post licensure
adverse event surveillance data available from the Vaccine Adverse Event Reporting System
(VAERS)."22 FDA Order at 260. These data, FDA noted, "provided the basis for a description
of the types and severities of adverse events associated with administration of AVA included in"
the FDA-approved amendments to AVA's labeling in 2002. Id.; see also AR641-43.
Effectiveness. FDA cited two principal sources in support of its effectiveness
determination: (i) Brachman, et al.'s well-controlled field study; and (ii) the CDC surveillance
data. See FDA Order at 259-60. With respect to Brachman, FDA reviewed the nature and scope
21This study, in the record at AR1407-16, is Phillip R. Pittman, et al., "Anthrax Vaccine: Immunogenicity and Safety of a Dose-Reduction, Route-Change Comparison Study in Humans," 20 Vaccine 1412-1420 (2002) ("Pittman"). The study noted, among other things, that local reaction rates associated with AVA are comparable to those associated with other licensed vaccines "in common use today." See AR1414.
22VAERS, co-administered by CDC and FDA, is "the nation's principal system for the collection of reports on adverse events following the use of any vaccine licensed in the United States." AR3422 (IOM). It is a passive surveillance system that "relies on spontaneous reporting" of suspected adverse events. AR3425 (IOM). All VAERS reports related to AVA as of December 31, 2001 are in the record at AR1417-AR3244. An FDA summary of VAERS reports related to AVA as of September 30, 2001 is in the record at AR3584-AR3606; the summary notes there is "[n]o clear pattern of association between deaths or serious adverse events and anthrax vaccine." E.g., AR3587. Certain VAERS data related to AVA as of October 30, 2001 also is discussed in the IOM report at AR3433-34; the IOM committee found the data "present no signals of previously undescribed serious adverse reactions associated with exposure to AVA." AR3434 (IOM); see also AR3333 (IOM) (summary of findings relating in part to VAERS data).
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of the study, as well as the study's findings. See id. at 259-60; see also discussion supra pp. 15-
16. FDA also reviewed the Panel's statement that the study demonstrated a "'93 percent . . .
protection against cutaneous anthrax'" and that "'inhalation anthrax occurred too infrequently to
assess the protective effect of vaccine against this form of the disease.'" FDA Order at 259
(quoting Panel report). Explaining its disagreement with these statements by the Panel, FDA
concluded:
[b]ecause the Brachman comparison of anthrax cases between the placebo and vaccine groups included both inhalation and cutaneous cases, FDA has determined that the calculated efficacy of the vaccine to prevent all types of anthrax disease combined was, in fact, 92.5 percent . . . . The efficacy analysis in the Brachman study includes all cases of anthrax disease regardless of the route of exposure or manifestation of disease.
Id. at 259-60.
FDA noted that the five cases of inhalation anthrax reported in the course of the
Brachman study, see discussion supra pp. 15-16, were "too few to support an independent
statistical analysis." FDA Order at 260. But, FDA continued:
of these [five] cases, two occurred in the placebo group, three occurred in the observational group, and no cases occurred in the vaccine group. Therefore, the indication section of the labeling for AVA does not specify the route of exposure, and the vaccine is indicated for active immunization against Bacillus anthracis, independent of the route of exposure.
FDA Order at 260.23
23FDA noted the Panel had erred in stating that Brachman, et al., used the MS&D vaccine in their study. See FDA Order at 260; see also supra n.19. Explaining it had "reviewed the historical development of AVA," FDA "concluded that DoD's continuous involvement with, and intimate knowledge of, the formulation and manufacturing processes of all of these versions of the anthrax vaccine" — i.e., the original DoD vaccine, the MS&D vaccine, and the MDPH vaccine — "provide a foundation for a determination that the MDPH anthrax vaccine is comparable to the original DoD vaccine" used in the Brachman study. Id. at 260-61 (citing, e.g., potency data demonstrating that the different vaccines protected rabbits and guinea pigs against
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FDA also addressed the summary of the CDC surveillance data considered by the Panel "as supportive of the effectiveness of AVA." FDA Order at 260. These data, the Panel noted, were collected by CDC for the years 1962-1974 on the occurrence of anthrax disease in at-risk industrial settings. See 50 Fed. Reg. at 51,058 (Panel); see also discussion supra p. 17. Reviewing the Panel's discussion, FDA concluded the summary "provide[s] confirmation that the risk of disease still existed for those persons who were not vaccinated and that those persons who had not received the full vaccination series (six doses) were susceptible to anthrax infection, while no cases occurred in those who had received the full vaccination series." FDA Order at 260.
Finally, FDA discussed the congressionally-mandated "independent examination" by IOM of AVA's safety and effectiveness, during which the IOM committee "reviewed all available data, both published and unpublished, [and] heard from Federal agencies, the manufacturer, and researchers." FDA Order at 260. Noting that IOM's published report concluded "that AVA, as licensed, is an effective vaccine to protect humans against anthrax including inhalation anthrax," id.; see also AR3323 (IOM), FDA stated it
agrees with the report's finding that studies in humans and animal models support the conclusion that AVA is effective against B. anthracis strains that are dependent upon the anthrax toxin as a mechanism of virulence, regardless of the route of exposure. FDA Order at 260; see also id. at n.5.24
challenge with virulent B. anthracis and human data comparing the safety and immunogenicity of the MDPH vaccine and the original DoD vaccine). See also AR3994-95, AR3868, AR3996, AR3732, AR3930, AR3698-3705.
24Citing, e.g., P.F. Fellows, et al., "Efficacy of a Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin," 19 Vaccine 3241-47 (2001) ("Fellows") (AR621-27); B.E. Ivins, et al.,
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3. Prior Proceedings Plaintiffs are six anonymous members of the U.S. military and/or DoD contractors who claim they "have been ordered, or will imminently be ordered, to take AVA as part of their military duties or employment obligations." Amended Complaint ("Amd. Compl.") ¶ 1. At the time they filed their original complaint, plaintiffs also sought a preliminary injunction to prevent their inoculation with AVA under DoD's Anthrax Vaccine Immunization Program ("AVIP"), an ongoing program under which DoD vaccinates service members with AVA. See Memorandum in Support of Motion for Temporary Restraining Order and/or Preliminary Injunction ("PI Mem.") at 1. Plaintiffs claimed that inoculation would violate 10 U.S.C. § 1107 and certain implementing regulations/executive orders. See id. Section 1107 addresses the use of an "investigational new drug" or a "drug unapproved for its applied use" on members of the armed forces. See 10 U.S.C. § 1107(a). It authorizes the President to waive certain (but not other) otherwise applicable FDCA requirements relating to the use of "investigational" drugs upon a determination that obtaining consent is not feasible, contrary to the best interests of the military, or not in the interests of national security. See 10 U.S.C. § 1107(f). Plaintiffs claimed that, because AVA assertedly had not been approved as effective for use against inhalation anthrax, such use was "investigational" within the meaning of Section 1107. See PI Mem. at 1. Plaintiffs did not dispute that AVA has been approved as safe and effective for use against cutaneous anthrax.
"Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys," 87 Salisbury Medical Bulletin 125-26 (1996) ("Ivins, Salisbury") (AR628-29); B.E. Ivins, et al., "Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques," 16 Vaccine 1141-48 (1998) ("Ivins, Vaccine") (AR630-37).
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On December 22, 2003, the Court enjoined defendants, "[i]n the absence of a presidential waiver [under Executive Order 13139], . . . from inoculating service members [with AVA] without their consent." Doe v. Rumsfeld, — F.Supp.2d —, 2003 WL 22994225 at *14 (Dec. 22, 2003). The Court entered the injunction based upon its conclusion that AVA is "an investigational drug" and a drug unapproved for use against inhalation anthrax. See id. In framing the issue for resolution, the Court stated: "[a]t bottom, this inquiry turns on whether the FDA has made a final decision on the investigational status of AVA[.]" Id. at *10. Noting that "FDA, the only agency that this Court could properly defer to in determining AVA's status as an investigational drug, has failed to provide a formal opinion as to AVA's investigational status," id. at *12, the Court conducted its own inquiry into the "complex" issue regarding "AVA's investigational status." Id.; see also id. at *14 ("because the record is devoid of an FDA decision . . . this Court must determine AVA's status for itself").25
After FDA issued its final order on December 30, 2003, defendants immediately requested, among other things, that the Court stay its injunction with respect to persons other than the named plaintiffs. See Docket # 21; Docket # 24. In granting defendants' motion, the Court reiterated that, at the preliminary injunction stage, it had been "persuaded that the record evidence before the Court was devoid of an FDA final decision on the investigational status of [AVA]." See Order dated January 7, 2004 at 1. Noting that "the principle reason for the issuance of the injunction has been addressed" by FDA's Final Order "categorizing AVA as safe
25The Court based its conclusion that AVA's "original license" did not "include[] inhalation anthrax" in part on the fact that an IND application filed by AVA's manufacturer in 1996 "remains pending today." 2003 WL 22994225 at *12. We have informed plaintiffs' counsel, and wish to inform the Court, that, after FDA issued its Order relating to AVA, BioPort, in January 2004, withdrew this IND application.
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and effective for use against inhalation anthrax," id., the Court stayed its injunction as to all but the six Doe plaintiffs. See id. at 2.
4. Plaintiffs' Amended Complaint On January 6, 2004, plaintiffs filed an amended complaint adding a count challenging the Order as arbitrary and capricious under the APA. See Amd. Compl. ¶¶ 81-90 (Count IV). Other than this new count, the bulk of the amended complaint simply repeats the claims and allegations in plaintiffs' original complaint, many of which are irrelevant to the legality of FDA's determination. With respect to the Order, plaintiffs claim FDA's determination to place AVA in Category I "has no rational connection and is unsupported by substantial evidence." See Amd. Compl. ¶ 87. Specifically, plaintiffs claim FDA "distorted or exaggerated the scientific conclusions upon which it relied for its decision," id., "failed to note significant limitations asserted by the authors of anthrax-related studies," id., and inappropriately "reli[ed] on studies involving animal data to support its conclusion that the AVA is effective against inhalation anthrax." Id. ¶ 88. They also claim the Order is "so arbitrary and capricious as to amount to bad faith." Id. ¶ 90; see also id. ¶ 87 ("[i]n issuing its Final rule and final order, the FDA acted in bad faith and excluded evidence adverse to its determination which was known to it at the time of the decisionmaking"). For relief, plaintiffs seek a declaration that the Order "was issued in violation of the [APA], thereby voiding its application," and a remand "to the FDA for further evaluation." Id. at p. 19, ¶ G. Subsequent to filing their amended complaint, however, plaintiffs, in a filing relating to the class certification issue, acknowledged that AVA is "lawfully approved" for use against cutaneous anthrax. See Class Cert. Reply at 4 n.4.
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ARGUMENT FDA's decision to confirm AVA as a Category I product pursuant to 21 C.F.R. § 601.25 must be upheld under the APA unless that decision is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. See 5 U.S.C. § 706(2)(A). The "arbitrary and capricious" standard is highly deferential to the agency; there is "'a presumption in favor of the validity of administrative action,'" Bristol-Myers Squibb Co. v. Shalala, 923 F.Supp. 212, 216 (D.D.C. 1996) (internal citation omitted), and a reviewing court must consider only whether "the [agency] decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment." Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971); accord Motor Vehicle Mfrs. Ass'n of the United States v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) ("the agency must examine the relevant data and articulate a satisfactory explanation for its action including a 'rational connection between the facts found and the choice made'") (internal citation omitted).26 A critical component of arbitrary/capricious review is that a court may not "substitute its judgment for that of the agency." State Farm, 463 U.S. at 43; see also, e.g., Vermont Yankee Nuclear Power Corp. v. Natural Res. Def. Council, Inc., 435 U.S. 519, 558 (1978) ("[a]dministrative decisions should be set aside . . . only for substantial procedural or substantive reasons as mandated by statute, not simply because the court is unhappy with the result reached")
26The reverse side of this coin, the Supreme Court has noted, is that an agency decision may be deemed arbitrary and capricious only in circumstances where the agency "has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise." State Farm, 463 U.S. at 43.
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(internal citation omitted); Henley v. FDA, 77 F.3d 616, 621 (2d Cir. 1996) ("we might not have
chosen the FDA's course had it been ours to chart . . . . [b]ut that is hardly the point"). Judicial
review, moreover, is limited to the administrative record. See, e.g., Berlex, 942 F.Supp. at 23
(refusing to consider extra-record affidavits submitted by plaintiff); Alliance for Bio-Integrity v.
Shalala, 116 F.Supp.2d 166, 177 (D.D.C. 2000) (same).
This ordinary deference may be heightened even further in cases involving scientific or
technical decisions. For example, like other agencies operating in highly technical areas, see,
e.g., Federal Power Comm'n v. Florida Power & Light Co., 404 U.S. 453, 463 (1972), FDA is
entitled to a "'high level of deference'" when its regulatory determination rests on its
"'evaluation[] of scientific data within its area of expertise.'" Serono Labs., Inc. v. Shalala, 158
F.3d 1313, 1320 (D.C. Cir. 1998) (internal citation omitted).27 The "determination whether a
drug is generally recognized as safe and effective within the meaning of [the FDCA] necessarily
27Accord id. at 1327 ("Neither we, nor the district judge, are scientists independently capable of assessing the validity of the agency's determination — beyond holding it to the standards of rationality required by the [APA]"); Henley, 77 F.3d at 621 ("FDA possesses the requisite know-how to conduct such analyses, by sifting through the scientific evidence to determine the most accurate and up-to-date information regarding a particular drug, and how those data affect human usage"); Simpson v. Young, 854 F.2d 1429, 1434 (D.C. Cir. 1988) ("[t]his court has 'neither the expertise nor the resources to evaluate complex scientific claims'"; "we cannot decide . . . whether technical evidence beyond our ken supports the proposition it is asserted to support") (internal citation omitted); Alliance for Bio-Integrity, 116 F.Supp.2d at 177 ("'[I]n an area characterized by scientific and technological uncertainty[,] . . . this court must proceed with particular caution, avoiding all temptation to direct the agency in a choice between rational alternatives'") (internal citation omitted) (alterations in original); Bristol-Myers, 923 F.Supp. at 220 ("[t]he parties' dispute is fundamentally a scientific one over which the court lacks expertise and over which the FDA is the expert"); see also Troy Corp. v. Browner, 120 F.3d 277, 283 (D.C. Cir. 1997) (EPA determination) ("[a]s we have said, we review scientific judgments of the agency 'not as the chemist, biologist, or statistician that we are qualified neither by training nor experience to be, but as a reviewing court exercising our narrowly defined duty of holding agencies to certain minimal standards of rationality'") (internal citation omitted).
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implicates complex chemical and pharmacological considerations." Weinberger v. Bentex Pharms., Inc. 412 U.S. 645, 654 (1973). FDA's "'judgments as to what is required to ascertain the safety and efficacy of drugs'" thus fall "'squarely within the ambit of FDA's expertise and merit deference from' the courts." Bristol-Myers, 923 F.Supp. at 220 (quoting Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir.), cert. denied, 516 U.S. 907 (1995)).
Similarly, "FDA's policies and its interpretation of its own regulations will be paid special deference because of the breadth of Congress' delegation of authority to FDA and because of FDA's scientific expertise." Berlex, 942 F.Supp. at 25; accord Bristol-Myers, 923 F.Supp. at 216 ("because this action implicates, in part, an interpretation by the agency of its own regulations, the court must be especially deferential"); cf. Public Citizen v. Foreman, 631 F.2d 969, 975 (D.C. Cir. 1980) (USDA regulation) (traditional deference accorded agency interpretation of its own regulations "especially prudent in areas involving scientific and medical controversies").
With these principles in mind, we turn to the FDA Order, and demonstrate, first, that plaintiffs lack standing,28 and second, that, even assuming standing, FDA's determination with respect to AVA is reasonable, not arbitrary or capricious, supported by the record, and fully consistent with law.
28Defendants raised other justiciability arguments at the preliminary injunction stage, which the Court rejected. See, e.g., Defendants' Opposition to Plaintiff's Motion for a Preliminary Injunction at 14-26. Defendants stand by those arguments and incorporate them by reference here, understanding that the Court already has ruled on them. Defendants recognize that the Court found plaintiffs had standing at the preliminary injunction phase of this case, see Doe, 2003 WL 22994225 at *9, but, as explained below, see infra p. 29, that decision does not control whether plaintiffs also have standing at this latter stage of the litigation with respect to their challenge to the Order.
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I. PLAINTIFFS LACK STANDING The party asserting jurisdiction always has the burden "'clearly to allege facts demonstrating that he is a proper party to invoke judicial resolution of the dispute.'" FW/PBS, Inc. v. City of Dallas, 493 U.S. 215, 231 (1990) (internal citation omitted). To have standing under the Constitution, a plaintiff must allege: (i) an "actual or imminent" injury-in-fact; (ii) "fairly . . . trace[able] to the challenged action of the defendant"; and (iii) "likely" to be "redressed by a favorable decision." Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992) (internal quotations and citations omitted) (alteration in original). Standing is an "indispensable part of the plaintiff's case," and "must be supported . . . with the manner and degree of evidence required at the successive stages of the litigation." Lujan, 504 U.S. at 561. At the summary judgment stage, "the plaintiff can no longer rest on . . . 'mere allegations,'" id., but must "'set forth' by affidavit or other evidence 'specific facts'" establishing the elements of standing. Id. (quoting Fed. R. Civ. P. 56(e)). Indeed, because summary judgment is the final stage with respect to plaintiffs' APA challenge to the FDA Order (i.e., there will be no trial), any facts proffered by plaintiffs to support standing should not be taken as true; rather, defendants should have the opportunity to challenge those facts, and plaintiffs, to establish standing, must demonstrate that their proffered facts are "'supported adequately by the evidence.'" Id. (internal citation omitted). The Court recognized in its prior ruling that, to establish injury, plaintiffs must demonstrate they have taken, or have been ordered imminently to take, the anthrax vaccine. See Doe, 2003 WL 22994225 at *9. Plaintiffs, in their amended complaint, allege they have "been ordered, or will imminently be ordered, to take AVA as part of their military duties or
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employment obligations," or have been administered AVA. Amd. Compl. at ¶ 1; see also id. at ¶ 78 (alleging one anonymous plaintiff received "one shot" of AVA). But plaintiffs themselves have presented no "specific facts" in support of these claims. See Fed. R. Civ. P. 56(e). The only "facts" plaintiffs apparently have submitted are contained in a sealed affidavit of plaintiffs' counsel, see Docket #1, on which the Court presumably relied in finding standing at the preliminary injunction phase (these facts also were referenced by plaintiffs' counsel at the preliminary injunction hearing). Doe, 2003 WL 22994225 at *9 (noting that "all six plaintiffs have been ordered to appear for the inoculation, and three of the six have already begun the series with more inoculations to follow"). But a lawyer's hearsay affidavit (or statements by a lawyer at a hearing) cannot be sufficient to establish standing at the summary judgment stage. See Fed. R. Civ. P. 56(e) (summary judgment affidavits "shall be made on personal knowledge" and "shall set forth such facts as would be admissible in evidence"). And, even if one or more plaintiffs had filed a party affidavit, plaintiffs could not establish standing (if at all) unless defendants were first provided an opportunity to examine any such affidavit and contest any claim of injury therein.29
In fact, while defendants have not seen counsel's sealed affidavit, the information defendants do have cuts against standing (at least by implication). After this Court limited its original injunction to the six Doe plaintiffs, defendants' counsel asked plaintiffs' counsel to inform defendants if one of the Doe plaintiffs received an order to report for inoculation (so that defendants would be able to honor the Court's injunction). Plaintiffs' counsel agreed to so inform
29Defendants reserve the right to seek discovery in the event plaintiffs proffer facts with respect to standing.
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defendants, and, to date, has not alerted defendants that any plaintiff has been ordered to receive the vaccine. For all these reasons, plaintiffs' allegations of injury are not "supported adequately by the evidence," Lujan, 504 U.S. at 561, and their claims, accordingly, should be dismissed for lack of standing.
II. FDA'S DECISION TO CLASSIFY AVA AS A CATEGORY I PRODUCT IS NOT ARBITRARY, CAPRICIOUS, OR AN ABUSE OF DISCRETION
Even assuming standing, plaintiffs cannot prevail on the merits. FDA categorized AVA as a Category I product under 21 C.F.R. § 601.25 based on its conclusion that AVA is safe, effective, and not misbranded. FDA's determination is reasonable, not arbitrary or capricious, supported by the scientific evidence, and should be upheld.
A. FDA's Safety Determination Is Not Arbitrary, Capricious, or An Abuse of Discretion
Section 601.25 defines "safety" as "the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time." 21 C.F.R. § 601.25(d)(1). Proof of safety "shall consist of adequate tests by methods reasonably applicable to show the biological product is safe under the prescribed conditions of use, including results of significant human experience during use." Id.
Safety is not an absolute standard; the regulations require only the "relative freedom" from harmful effects. See 21 C.F.R. § 601.25(d)(1); see also AR3402 (IOM) ("safety is relative, not absolute"); United States v. Rutherford, 442 U.S. 544, 555 (1979) ("[f]ew if any drugs are completely safe in the sense that they may be taken by all persons in all circumstances without risk"). The standard also is not quantitative or measurable; rather, the regulations provide a
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definition to guide FDA's expert, case-by-case determinations. See Berlex, 942 F.Supp. at 25 (discussing FDA regulations for determining safety, purity, and potency under the PHSA, including, e.g., the definition of safety in 21 C.F.R. § 600.3(p)). FDA's judgment about what is required to ascertain safety lies at the core of its expertise. See Bristol-Myers, 923 F.Supp. at 220 (citing Schering Corp., 51 F.3d at 399).
Plaintiffs have not argued in this case that AVA is not safe for human use. In fact, plaintiffs have conceded that AVA is "lawfully approved" — i.e., safe, effective, and not misbranded — for use against cutaneous anthrax, see Class Cert. Reply at 4 n.4, and have never argued that AVA's safety somehow varies depending on the route of exposure. Nor would such an argument make sense. AVA is administered pre-exposure, see AR640 (package insert) (AVA is indicated for "active immunization" against B. anthracis); AR3331, 3402 (IOM), regardless of whether the intention is to protect against cutaneous or inhalation anthrax. If, as plaintiffs acknowledge, AVA is safe for immunization against cutaneous anthrax, then it necessarily also is safe for immunization against inhalation anthrax.
Plaintiffs are right to concede the point, for there is ample scientific evidence in the record to support FDA's determination that AVA meets the safety standard in Section 601.25(d). Significantly, FDA's decision is supported by the accumulated data from CDC's five-year openlabel study. These data, discussed in detail above, see supra pp. 14, 19-20, "'suggest[] that [AVA] is fairly well tolerated with the majority of reactions consisting of local erythema and edema," and that "'[s]evere local reactions and systemic reactions are relatively rare.'" FDA Order at 260 (quoting 50 Fed. Reg. at 51,059 (Panel)); accord AR3744 (Brachman) (noting that "[i]ndividual reactions to the vaccine was a relatively minor problem," "[e]dema-producing local
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reactions occurred following 2.8 percent of all inoculations," and "[s]ystemic reactions were rare
with only 0.2 per cent of inoculations followed by noticeable symptoms"); cf. AR645-49 (early
study conducted with DoD vaccine).
Other data and studies in the record corroborate the CDC study. For example, a more
recent DoD study of the safety and immunogenicity of AVA found that local reaction rates
associated with AVA, although higher than those reported in the CDC data, are comparable to
those associated with other licensed vaccines. See AR1414 (Pittman). With respect to more
serious adverse events, VAERS reports, reviewed and summarized by FDA from 1990 through
September 30, 2001, see AR3584-AR3606, show "[n]o clear pattern of association between
deaths or serious adverse events and anthrax vaccine." E.g., AR3587.
And the IOM committee, specifically charged by Congress to study AVA's safety,
concluded in its published report that AVA is safe. AR3323 (IOM) ("AVA is reasonably safe").
The committee reviewed case reports (primarily from VAERS), see AR3331-32, considered
formal epidemiological studies, AR3332, and heard testimony "regarding adverse events
following vaccination with AVA." Id. Again, although finding the reactogenicity for AVA
higher than that reflected in the CDC data, the IOM committee concluded:
[w]ithin hours or days following vaccination, it is fairly common for recipients to experience some local events (e.g., redness, itching, swelling, or tenderness at the injection site), while a smaller number of vaccine recipients experience some systemic events (e.g., fever and malaise). But these immediate reactions, and the rates at which they occur, are comparable to those observed with other vaccines regularly administered to adults. The [IOM] committee found no evidence that vaccine recipients face an increased risk of experiencing life-threatening or permanently disabling adverse events immediately after receiving AVA, when compared with the general population. Nor did it find any convincing evidence that vaccine recipients face elevated risk of developing adverse health effects over the long term, although data are limited in this regard (as they are for all vaccines).
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AR3323 (emphasis added); see also AR3332 (local and systemic reactions associated with AVA occur at rates comparable to those observed with diphtheria and tetanus toxoids and influenza vaccines); AR1414 (Pittman) (local reaction rates for AVA comparable to rates for "other vaccines in common use today," including diphtheria and tetanus toxoids and pertussis vaccine adsorbed); AR641-43 (package insert) (reporting pre- and post-licensure safety data).
No vaccine is one-hundred percent safe.30 See Rutherford, 442 U.S. at 555. The regulatory standard — "relative freedom from harmful effects" — reflects this reality. See 21 C.F.R. § 601.25(d)(1). FDA, based on its review of the scientific evidence, determined that AVA meets the safety standard in Section 601.25(d). This expert determination, which FDA explained at length in its Order, is rational, supported by the evidence, and should be upheld. See, e.g., Serono, 158 F.3d at 1320 (FDA entitled to a "'high level of deference'" for regulatory determinations resting on "'evaluations of scientific data within its area of expertise'") (internal citation omitted); State Farm, 463 U.S. at 43.
30In its preliminary injunction opinion, the Court noted that the "Adverse Reactions" section of AVA's package insert, which describes VAERS data related to AVA from 1990 to October 2001, indicates that VAERS received six reports of fatalities. See Doe, 2003 WL 22994225 at *3; see also AR643 (package insert) (reporting VAERS data and noting that one reported fatality was a suicide). As the package insert states, however, "[b]ecause of the limitations of spontaneous reporting systems, determining causality for specific types of adverse events, with the exception of injection-site reactions, is often not possible using VAERS data alone." AR642; accord AR3585 (FDA summary of VAERS data) ("it is usually not possible to determine causal associations between vaccines and adverse events from VAERS reports, unless the event is a well-recognized reaction (e.g., injection site reaction) or confirmatory laboratory results are included (e.g. vaccine strain virus detected in paralytic polio case")). Neither FDA nor the IOM committee found any causal link between AVA and life-threatening events. See AR3587 (FDA summary of VAERS data); AR3323 (IOM).
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B. FDA's Effectiveness Determination Is Not Arbitrary, Capricious, or An Abuse of Discretion
Section 601.25(d) defines effectiveness as "a reasonable expectation that, in a significant proportion of the target population, the pharmacological or other effect of the biological product, when used under adequate directions, for use and warnings against unsafe use, will serve a clinically significant function in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." 21 C.F.R. § 601.25(d)(2). Proof of effectiveness "shall consist of controlled clinical investigations" as defined in 21 C.F.R. § 314.126, unless this requirement is waived or alternate methods are adequate to substantiate effectiveness. See id. Investigations "may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing." Id.
Effectiveness, like safety, must be determined in the context of each vaccine. See 21 C.F.R. § 601.25(d)(2) (requiring a "reasonable expectation" that product will serve a "clinically significant function"); AR3376 (IOM). And, like safety, the regulatory standard provides a definition to guide FDA's expert, case-by-case determinations for particular drugs and products. See Berlex, 942 F.Supp. at 25 (discussing FDA regulations for determining safety, purity, and potency under the PHSA).
Effectiveness determinations, at bottom, require judgments about the quantity and quality of scientific evidence. See Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388 (D.D.C. 1991). These determinations can be quite complex. See 37 Fed. Reg. at 16,679 (FDA noting the "unique problems involved in applying the requirement of 'substantial evidence of effectiveness' to biological products under the [FDCA]," and that standards and methodologies for particular classes of products will "tak[e] into account all of the circumstances involved"); 50 Fed. Reg. at
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51,005 (Panel) (noting that "the judgment concerning safety and efficacy of bacterial vaccines
and toxoids presents some complex and knotty overall problems"); see also Doe, 2003 WL
229943225 at *12 (noting the "complex[ity]" of the issues in this case). FDA judgments about
effectiveness — like its judgments about safety — are at the very heart of FDA's expertise.
Bristol-Myers, 923 F.Supp. at 220.
FDA's determination that AVA is effective is amply supported by the record evidence.
Most significantly, FDA relied on the well-controlled field study conducted by Brachman, et al.,
in four textile mills processing raw imported goat hair. See FDA Order at 259-60.31 The mills
provided a natural exposure setting: raw materials (goat hair) were "Bacillus anthracis-
contaminated," AR3732 (Brachman), and workers were at risk of both cutaneous and inhalation
exposure. Indeed, during the course of the study, there was an "outbreak" of inhalation anthrax
cases. See AR3733 (Brachman).
During the Brachman trial, twenty-six cases of anthrax were observed; twenty-one
31As explained supra n.15, when NIH licensed AVA in 1970, the review committee noted there were no clinical trials specifically involving MDPH's vaccine. See, e.g., AR3629. The record indicates the review committee did not rely upon the Brachman trial to provide clinical evidence of effectiveness for MDPH's product. See AR3635 (Jan. 6, 1969 memorandum). Both the Panel and FDA determined that this initial NIH view was incorrect, given the similarity of the PA-based vaccines, and that the Brachman study qualifies as a well-controlled study for purposes of determining AVA's effectiveness. See 50 Fed. Reg. at 51,058-59 (Panel); FDA Order at 259-61; cf. AR621 (Fellows) (Brachman study "demonstrated that a vaccine similar to AVA afforded a significant degree of protection to humans"); AR628 (Ivins, Salisbury) (in Brachman study "a vaccine similar to MDPH showed protection against anthrax"). It is FDA's determination, of course, which is due deference in this challenge, see, e.g., Serono, 158 F.3d at 1321 (courts owe deference to the "authorized decisionmaker for the agency on th[e] matter"), and FDA's conclusion is consistent with a 1996 guidance document setting forth FDA policy for accepting clinical trials completed on "comparable" products. See AR1382-83 (response to citizen petition); Berlex, 942 F.Supp. at 25. Indeed, plaintiffs' concession that AVA is effective for cutaneous exposure presumably is based on the Brachman study.
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cutaneous and five inhalation. See FDA Order at 259. Of the five inhalation cases (four of which were fatal), "two received placebo and three were in the observational group." Id. None of the vaccinated workers contracted inhalation anthrax. Of the twenty-one cutaneous cases (some of which occurred in persons who were not completely inoculated), fifteen received placebo, three were in the observational group, and three received anthrax vaccine. See id. Comparing anthrax cases between the completely inoculated placebo and vaccine groups, Brachman, et al., calculated the vaccine efficacy at 92.5 percent. See id. As FDA noted, because the placebo group included two inhalation cases, this figure represented the "calculated efficacy of the vaccine to prevent all types of anthrax disease combined" (id.), i.e., "regardless of the route of exposure or manifestation of disease."32 Id. at 260; accord AR3378 (IOM) ("[t]he overall effectiveness of the vaccine against anthrax infection generally was 92.5 percent"); AR628 (Ivins, Salisbury) (Brachman trial "showed protection against anthrax").
The Panel, as discussed above, misread the significance of Brachman, et al.'s effectiveness analysis, believing, erroneously, that the study authors analyzed effectiveness only with respect to cutaneous anthrax. See supra p. 16. Even so, the Panel did not, as this Court stated in its preliminary injunction opinion, find "insufficient data to license [AVA] for use against inhalation anthrax." Doe, 2003 WL 22994225 at *12. When the Panel issued its report, AVA was indicated for persons at risk of exposure to B. anthracis, and its label did not specify a
32As CDC noted in the original submission of its 1966 IND application, following the Brachman trial, all employees in the mills who received the placebo inoculations subsequently received anthrax vaccine. See AR3840. "No case of anthrax has occurred among individuals who have remained immunized as recommended." Id.
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route of exposure. See AR3291-92.33 The Panel recommended, and FDA agreed, that AVA, as licensed, be categorized as a Category I product (i.e. as safe, effective, and not misbranded). The Panel did not, for example, as it did with respect to other products under review, recommend that AVA be placed in different categories depending on its use (i.e., for cutaneous vs. inhalation exposure). Compare, e.g., 50 Fed. Reg. at 51,019 (Panel) (for Diphtheria Toxoid, Fluid, manufactured by Texas Department of Health Resources, recommending Category I "as regards its use for booster immunization" and Category IIIA "as regards its use for primary immunization"); id. at 51,021 (Panel) (for Tetanus Toxoid Adsorbed, manufactured by MDPH, recommending Category I "as regards its use for booster immunization" and Category IIIA "as regards its use for primary immunization") (license revoked in 2000 at request of MDPH); cf. id. at 51,102 (Panel) (for Streptokinase-Streptodornase products, recommending that some indications/presentations be placed in Category I, and other indications/presentations be placed in Category II or III).
Although FDA has noted that the five inhalation cases in the Brachman study "are too few to support an independent statistical analysis," FDA Order at 260; see also AR3743 (Brachman), those five cases accounted for nearly one-third of the total (eighteen) cases of inhalation anthrax reported in this country in the twentieth century. See AR3361 (IOM). And each of the inhalation cases in the Brachman study occurred in the placebo or observational groups. See FDA Order at 261. No vaccinated worker contracted inhalation anthrax (even at the
33AVA's package insert was amended in 1979. See Amd. Compl. ¶ 17. It is not clear whether the Panel considered this amended insert in issuing its report, see AR3290-94 (MDPH submitting original package insert to the Panel), but, as plaintiffs' amended complaint makes clear, the 1979 package insert, like the original package insert, stated that AVA was indicated based on risk, and did not specify a route of exposure. See Amd. Compl. ¶ 17.
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mill where the outbreak occurred), and FDA concluded, based on this data, that the vaccine protected against inhalation exposure. See id. at 259-60. Thus, weighing the evidence in the aggregate, FDA concluded that the Brachman study provides proof of AVA's claim of effectiveness against B. anthracis: "the indication section of the labeling for AVA does not specify the route of exposure, and the vaccine is indicated for active immunization against Bacillus anthracis, independent of the route of exposure."34 Id. at 260. Further clinical investigation of effectiveness, FDA noted, would be either impractical (given the low incidence of anthrax disease in nature) or unethical. Id. at 260 n.4; see also AR3381 (IOM) ("[c]ontrolled trials in which [human] subjects are exposed to potentially lethal agents such as anthrax spores are simply not ethical").
FDA pointed to other data and studies corroborating its effectiveness determination, such as the surveillance data collected by CDC on the occurrence of anthrax in at-risk industrial settings, which CDC summarized and presented to the Panel. See FDA Order at 260. Over thirteen years of observation (1962-1974), CDC identified twenty-seven anthrax cases; no cases (inhalation or cutaneous) were reported in "fully vaccinated" individuals. See 50 Fed. Reg. at 51,058 (Panel summary of CDC data). These data, FDA concluded, "provide confirmation that the risk of disease still existed for those persons who were not vaccinated and that those persons
34As noted supra pp. 10-11, the pathogenesis of B. anthracis is the same regardless of the route of exposure. That is, however B. anthracis enters the body, to produce active toxins, protective antigen binds to cellular receptors which then bind with either edema factor or lethal factor; AR3366-67 (IOM); the resulting toxin (EF or LF) can then enter the cell, leading to damage. Id. at AR3367 & Figure 2-4. AVA creates antibodies to protective antigen. See AR639 (package insert); AR3396 (IOM) ("the available data indicate that immunity to anthrax is associated with the presence of antibodies to PA, such as those stimulated by the anthrax vaccine").
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who had not received the full vaccination series (six doses) were susceptible to anthrax infection, while no cases occurred in those who had received the full vaccination series." FDA Order at 260.
FDA's effectiveness determination also is corroborated by the IOM report. The IOM committee, charged by Congress to consider the "inhalation efficacy of the vaccine," H.R. Rep. No. 106-371, at 254 (1999), specifically concluded that "AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalation anthrax." AR3323 (IOM); see also FDA Order at 260. In addition to considering the Brachman study and human serological studies, see AR3377-80, the IOM committee reviewed studies in animal models. See, e.g. AR3385-88 (IOM). After noting that "the pathology of anthrax in nonhuman primates such as macaques best mimics that seen in humans after inhalation exposure to B. anthracis," AR3385, the IOM committee concluded: "it appears that AVA is effective in protecting . . . macaques . . . from inhalation exposure to the strains of anthrax tested." AR3387-88 (IOM).
FDA, citing several animal studies in its Order, see FDA Order at 260 n.5, stated its "agree[ment] with the [IOM] report's finding that studies in humans and animal models support the conclusion that AVA is effective against B. anthracis strains that are dependent upon the anthrax toxin as a mechanism of virulence, regardless of the route of exposure." Id. at 260; see also AR626 (Fellows) (animal study) ("[t]hese results confirm previous reports showing that AVA is highly protective in this non-human primate animal model [rhesus macaques]"); AR629 (Ivins, Salisbury) (animal study) ("[t]he data in this study demonstrates that the MDPH vaccine is
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highly efficacious against inhalation anthrax in rhesus monkeys").35
Moreover, FDA's determination is fully consistent with the benefit-to-risk ratio FDA
generally applies in evaluating the safety and effectiveness of biological products. See
discussion supra p. 9 (noting that risk/benefit analysis requires FDA to determine whether the
benefits of the product outweigh the risks of the product for the intended population).36 The
benefits of AVA are clear: it is the only vaccine licensed to provide immunity against B.
anthracis, see AR3308, AR3322 (IOM), a rarely-occurring, but potentially deadly, disease; see
AR3363-66 (IOM); its effectiveness has been established in a well-controlled field trial; see FDA
Order at 259-60; and, while ethical considerations and the "low incidence and sporadic
occurrence of anthrax disease" make "further adequate and well-controlled clinical studies of
effectiveness not possible," FDA Order at 260 n.4; see also AR1381, strong corroborating data
exist. See FDA Order at 260 & n.5. In terms of risk, AVA is associated with local injection site
reaction, but, as the IOM report noted, "these immediate reactions, and the rates at which they
occur, are comparable to those observed with other vaccines regularly administered to adults."
35In their amended complaint, plaintiffs allege that "FDA's reliance on studies involving animal data to support its conclusion that the AVA is effective against inhalation anthrax is inappropriate and violates its own regulations." Amd. Compl. ¶ 88. Plaintiffs apparently believe that FDA relied on animal studies to "substantiate [AVA's] effectiveness" for purposes of 21 C.F.R. § 601.25(d)(2). It did not. FDA relied on Brachman, et al.'s controlled clinical investigation as "[p]roof of effectiveness" for purposes of Section 601.25(d)(2). See FDA Order at 259-60. The animal studies, CDC surveillance data, and other supportive data and studies were considered as corroborating evidence.
36See also 21 C.F.R. § 601.25(d)(3) (FDA must consider the "benefit-to-risk ratio of a biological product . . . in determining safety and effectiveness"); 50 Fed. Reg. at 51,005 (Panel) ("concept of risks and benefits is a fundamental one in a consideration of vaccines"); id. at 51,006 (Panel) (noting that "[g]reater risks of adverse effects might be tolerated for a vaccine that provided protection against a lethal disease than for a vaccine against a disease that is basically benign").
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AR3323 (IOM). Given the highly lethal nature of the anthrax disease, there can be no serious question that AVA's benefits outweigh its risks for the intended population — those at risk of exposure to B. anthracis. See, e.g., Rutherford, 442 U.S. at 555 ("the Commissioner generally considers a drug safe when the expected therapeutic gain justifies the risk entailed by its use").
At bottom, FDA weighed all of the scientific evidence and concluded, based on the data to which it applied its expertise, that AVA is effective for active immunization against Bacillus anthracis, regardless of the route of exposure. See FDA Order at 260. We acknowledge that the Court, in its preliminary injunction opinion, suggested a contrary conclusion, but FDA is the expert agency charged by Congress with making effectiveness determinations; having rendered that determination, the Court "may not substitute its own judgment for that of the FDA." Berlex, 942 F.Supp. at 25; see also Doe, 2003 WL 229943225 at *12 (noting the "Court could properly defer to [FDA] in determining AVA's status as an investigational drug"); January 7, 2004 Order at 1 (noting "the principle reason for the issuance of the injunction has been addressed" by FDA's final order "categorizing AVA as safe and effective for use against inhalation anthrax").
FDA plainly has "examined the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made." Bristol-Meyers, 923 F.Supp. at 219-20 (quoting State Farm, 463 U.S. at 43) (alteration in original) (internal quotations omitted). It considered the relevant factors, and made no "clear error of judgment." State Farm, 463 U.S. at 43. Nothing more is required. Its decision should be upheld.37
37Plaintiffs' assertion (Amd. Compl. at ¶¶ 87, 90) that FDA issued its Order in "bad faith" is meritless. There is a well-established presumption of regularity accorded official acts, including, of course, the acts of agencies. See, e.g., United States Postal Serv. v. Gregory, 534
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CONCLUSION
For all the foregoing reasons, the Court should grant summary judgment for defendants
with respect to plaintiffs' APA claims challenging the legality of the FDA Order. Moreover,
because the Order confirms the safety and effectiveness of AVA, DoD's use of the vaccine is not
subject to 10 U.S.C. § 1107;38 to the extent plaintiffs challenge DoD's vaccine program based on
a claim that AVA's approval is invalid, those claims also must be dismissed.
Respectfully submitted,
PETER D. KEISLER Assistant Attorney General
ROSCOE C. HOWARD, JR. United States Attorney
BRIAN D. BOYLE Principal Deputy Associate Attorney General
U.S. 1, 10 (2001) ("a presumption of regularity attaches to the actions of Government agencies"); Bristol-Myers, 923 F.Supp. at 216 (noting the "'presumption in favor of the validity of administrative action'") (internal citation omitted). The presumption of regularity requires that, "in the absence of clear evidence to the contrary, courts presume that [government officials] have properly discharged their official duties." United States v. Chemical Found., Inc., 272 U.S. 1, 14-15 (1926); see also, e.g., United States v. Armstrong, 517 U.S. 456, 464 (1996) (quoting this statement from Chemical Foundation). There is no evidence — let alone "clear evidence" — that the challenged portions of the Order were the product of bad faith.
38Although DoD's AVIP is not at issue in this brief, we note that Congress has enacted legislation concerning AVIP, and that these laws reflect Congress's acceptance of AVIP's mandatory program of immunization against inhalation exposure. See 10 U.S.C. § 1110 (requiring DoD to establish uniform procedures for exemptions from AVIP for administrative or medical reasons); id. § 1178 (requiring an annual report on the number of military members separated due to refusals to participate in AVIP); id. § 1580a (requiring notification of emergency-essential civilian employees required to participate in AVIP). Indeed, Congress mandated the independent study of AVA's safety and effectiveness in response to "concerns about the anthrax vaccine and AVIP." AR3324 (IOM). The IOM committee, as noted above, specifically concluded that "AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalation anthrax." AR3323 (IOM).
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Date: March 3, 2004

SHANNEN W. COFFIN Deputy Assistant Attorney General
/s/ Craig M. Blackwell JOSEPH H. HUNT VINCENT M. GARVEY CRAIG M. BLACKWELL, DC Bar # 438758 RONALD J. WILTSIE ANDREW H. TANNENBAUM Attorneys Civil Division U.S. Department of Justice P.O. Box 883 Washington, D.C. 20044 Tel: (202) 307-1401 Fax: (202) 616-8470
Attorneys for defendants

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 Case 1:03-cv-00707-EGS Document 43-1 Filed 03/03/04 Page 1 of 24

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

JOHN DOE #1 et al.,

*

*

Plaintiffs,

*

* Civil Action No.: 1:03CV00707 (EGS)

v.

*

*

DONALD H. RUMSFELD et al.,

*

*

Defendants.

*

*************

PLAINTIFF’S MEMORANUM OF LAW IN SUPPORT OF

MOTION FOR SUMMARY JUDGMENT AND PERMANENT

INJUNCTIVE RELIEF OR, IN THE ALTERNATIVE, FOR DISCOVERY

PRELIMINARY STATEMENT

Six plaintiffs, known to the public as John and Jane Does #1 through #6 for fear of

retaliation by their commanding officers or civilian superiors (but known to this Court and, if

necessary, willing to be revealed to the defendants), brought this action to challenge the

unlawfulness of the government’s Anthrax Vaccination Immunization Program (“AVIP”).

Over the past five years nearly one million members of the military or federal

civilian/contractor workforce have been inoculated illegally under the guise of the AVIP for the

alleged purpose of obtaining protection from inhalation anthrax. Although it is the defendant

Department of Defense (“DoD” or “Defense Department”) that has (and is) engaging in the

improper and unlawful use of the anthrax vaccine, the defendant Food & Drug Administration

(“FDA”) bears legal responsibility for the status of the vaccine and the extent to which DoD

seeks to exploit that status.

This Motion for Summary Judgment does not call into question the DoD’s decision to use

the anthrax vaccine. It does not challenge any military decision or, for that matter, any level of

expertise appropriately possessed or exercised by the Defense Department. The focus of this

Motion is directly on an action by the FDA that determined that anthrax vaccine adsorbed

Case 1:03-cv-00707-EGS Document 43-1 Filed 03/03/04 Page 2 of 24
(“AVA”) is licensed for the purposes of combating inhalation anthrax (also known as aerosolized or weaponized anthrax).
On December 22, 2003, this Court issued a Preliminary Injunction based on a finding that “because the record is devoid of an FDA decision on the investigational status of AVA … [it] is persuaded that AVA is an investigational drug and a drug being used for an unapproved purpose. As a result of this status, the DoD is in violation of 10 U.S.C. § 1107, Executive Order 13139, and DoD Directive 6200.2.” See Memorandum Opinion (dated December 23, 2003) at 32.
As a direct response to this Court’s decision, on December 30, 2003, the FDA revived (and significantly modified) the proposed findings of one of its own expert panels that had disbanded nearly 20 years earlier and issued a Final Rule and Order to contradict the Court’s findings. See Bio. Prods; Bacterial Vaccines & Toxoids; Implementation of Efficacy Review, 69 Fed. Reg. 255, 265-66 (Jan. 5, 2004)(“Final Rule”). The timing of the release of this Rule, just one week after the Court issued its opinion, is hardly a coincidence. Confirming that its actions were driven more by legal strategy than by sound regulatory practice, the FDA’s press release concerning the Final Rule specifically states that this Court should take note of FDA’s action.1 With this change in landscape, the Court reasonably choose to lift the Preliminary Injunction (except as it applied to the six plaintiffs), and proceed forward in the litigation.
1 The press release concluded by noting a “recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as ‘investigational’ with regard to protecting against inhalation anthrax. Today's final rule and order make it clear that FDA does not regard the approved anthrax vaccine as ‘investigational’ for protection against inhalation anthrax. FDA's final determination of the safety and effectiveness of the anthrax vaccine, independent of route of exposure, as well as its conclusions regarding the Expert Panel's report, being announced today in the final order, are relevant and should be considered in any further litigation in this matter.” See http://www.fda.gov/bbs/topics/NEWS/ 2003/NEW01001.html (emphasis added). The extraordinariness of the FDA actually commenting on ongoing litigation with the issuance of regulatory action cannot be understated.
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As a result of the FDA’s hurried action2, and since the Court’s lifting of the Preliminary Injunction, the DoD, according to its own statements, has involuntarily inoculated approximately 60,000 individuals. However, the process and basis for the issuance of the FDA's Final Rule – the only existing legal support for the continuation of the AVIP – is invalid as a matter of fact and law. Thus, upwards of 60,000 additional individuals have been irreparably victimized and possibly harmed.
Based on the evidence and arguments expressed herein, this Court should vacate the FDA’s recent Final Rule and Order and remand the matter to the FDA for proper consideration and determination, as is required by law, of the licensing status of AVA. Even a cursory review of the FDA’s administrative record confirms that the Final Rule is simply a procedural sop thrown to the Court in an effort to lift the injunction. The Rule is fatally flawed in terms of both its procedural status (particularly with the FDA baldly considering additional evidence more than 17 years after it closed public comment on the proposed rule) and its factual basis. In granting this motion, the Court will show that the federal judiciary is not at the mercy of federal agencies and can refuse to simply rubber stamp or accept Executive Branch assertions.
At the same time, the Court should reinstate the injunctive relief, although this time on a permanent basis, that was granted in its initial ruling of December 22, 2003. In the absence of the FDA’s Final Rule and Order, the Court’s conclusion that the vaccine is improperly licensed for inhalation anthrax remains in effect.3
2 As but just one example of the haste exercised by FDA to publish its Final Rule, the version originally posted on its Website contained numerous handwritten notations where the drafters had neglected to include even some of the most basic words. See Exhibit “1”. 3 Alternatively, given the numerous factual inconsistencies in the record, summary judgment should not be granted to the Defendants. Instead, plaintiffs should be permitted to conduct discovery in order to ensure the administrative record is complete and explore the extent to which the DoD improperly influenced the FDA’s licensing and rule-making process.
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ARGUMENT Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment is appropriate only if “‘there is no genuine issue as to any material fact and ... the moving party is entitled to a judgment as a matter of law.’” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986) (quoting Fed.R.Civ.P. 56(c)). In determining whether a “genuine issue” exists, courts “must view the evidence in the light most favorable to [the plaintiff] and draw all reasonable inferences in [its] favor.” Waterhouse v. District of Columbia, 298 F.3d 989, 991 (D.C. Cir. 2002). I. THE FDA’S FINAL RULE AND ORDER MUST BE INVALIDATED AND REMANDED TO THE AGENCY FOR FURTHER RULEMAKING
The Administrative Procedure Act “(APA”) requires that an agency provide notice of a proposed rulemaking, and that notice must include “either the terms or substance of the proposed rule or a description of the subjects and issues involved.” 5 U.S.C. § 553(b). Once a proposed rule is issued, it is black letter law that the agency must “give interested persons an opportunity to participate in the rulemaking through submission of written data, views, or arguments.” 5 U.S.C. § 553(c).
In its haste to publish something to save the DoD’s ill-advised anthrax vaccine program, the FDA, in at least two significant ways, violated the procedures of notice and comment rulemaking, denying affected parties the opportunity to participate in the process in a meaningful way, much less in any way.
First, the Final Rule relies on studies and data that did not exist either at the time of the proposed rule or at the close of the comment period, thereby denying its own expert panel the opportunity to evaluate the information. More importantly, the hurried process stripped the affected parties of their right to present views on the data used by the FDA. Second, the FDA’s Final Rule differs
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in substance from the proposed rule, which had been issued nineteen years earlier. Either of these shortcomings is sufficient to require the Court to invalidate and remand the Final Rule to the FDA in order to complete the proper administrative process.
A. The Final Rule Is Procedurally Flawed Because The FDA Relied On Data That Came Into Existence After The Close Of The Comment Period, Which Improperly Denied Affected Parties An Opportunity To Respond The role of timely public comments for executive rulemaking is so critical that it is
embodied in a statute. 5 U.S.C. § 553 (c). As previously noted federal agencies are required to provide a period of public comment following the announcement of a proposed rule to allow interested citizens and others the opportunity to voice their concerns. Indeed, the original notice of proposed rulemaking for AVA contained a public comment period that ran from December 13, 1985, until March 13, 1986. Notwithstanding the proper notice and comment period, for reasons unknown, the FDA chose not to contemporaneously finalize the Proposed Final Rule concerning the AVA.
Nineteen years later, in promulgating its new Final Rule the, FDA deliberately violated the purposes of its own notice and comment timeframe by relying on studies and data that were not in existence at the conclusion of the comment period. It should come as no surprise that the D.C. Circuit has stated that “[i]n order to allow for useful criticism, it is especially important for the agency to identify and make available technical studies and data that it has employed in reaching the decisions to propose particular rules.” Conn. Light & Power Co. v. Nuclear Regulatory Comm’n, 673 F.2d 525, 530 (D.C. Cir. 1982). “An agency commits serious procedural error when it fails to reveal portions of the technical basis for a proposed rule in time to allow for meaningful commentary.” Id. at 530-31. It is clear that when an agency relies on studies or data after the comment period has ended, no meaningful commentary on such data is possible. See American Iron & Steel Inst. v. OSHA, 939 F.2d 975, 1009-10 (D.C. Cir. 1991);
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Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 540-41 (D.C. Cir. 1983); Sierra Club v. Costle, 657 F.2d 298, 398 (D.C. Cir. 1981).
In American Iron & Steel, OSHA relied on a professional industry analysis that was completed after the comment period had ended in evaluating the economic feasibility of certain workplace exposure levels. The D.C. Circuit held that “reliance on the [post-comment period data] without providing an opportunity for comment was improper,” and the Court vacated the portion of the regulation that relied on the late data. 939 F.2d at 1010.
Here, the FDA relied on at least four extensive studies that commenced and concluded after the comment period ended in issuing the final rule. See 69 Fed. Reg. at 265-66. For example, the FDA cites to, and significantly relies on, a report on the anthrax vaccine issued by the Institute of Medicine (“IOM”) in 2002—more than sixteen years after the comment period ended. Id. at 259-60.4 Obviously, it would have been impossible for an interested party seeking to comment on the proposed Final Rule in late 1985 or early 1986, to have responded to studies and data that would not come into existence until over a decade later. Thus, like the plaintiffs in American Iron & Steel, neither the plaintiffs in this case or anyone who otherwise might have been interested parties were provided any notice that the FDA intended to rely on this data. Nor were they provided an opportunity to respond to the data. This flaw is so fundamental as to require the invalidation of the FDA’s Final Rule.
In fact, the amount of information that post-dates the original notice and comment period (even beyond the four substantive studies) is voluminous. The FDA Administrative Record, as noted in the Administrative Record Index produced by the government as part of this litigation, lists 4,209 pages that were relied upon or at least considered by the FDA in issuing its Final
4 The IOM Report evaluated “all available data, both published and unpublished” on the anthrax vaccine, specifically focusing on three studies from 1996, 1998 and 2001. See 69 Fed. Reg. at 260 & n.5.
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Rule.5 Of the 4,209 pages in the open record, approximately 2,653 (63%) post-dated 1986. In fact, the majority of these pages were created between 1996-2002. Of the remaining 1,556 pages, the vast majority pertain to the original licensing of the vaccine and were created between 19661971. Of course, evidence, much less a discussion, of whether the vaccine is effective against inhalation anthrax cannot be found within any of these pages.6
Nevertheless, the plaintiffs are mindful of the desire “to avoid perpetual cycles of new notice and comment periods,” and concede that “a final rule that is a logical outgrowth of the proposal does not require an additional round of notice and comment.” Bldg. Indus. Ass’n of Superior Cal. v. Norton, 247 F.3d 1241, 1246 (D.C. Cir. 2001)(internal quotation omitted). However, as explained below, the FDA’s Final Rule is not, and cannot even be reasonably considered as, a “logical outgrowth” of the 1985 Proposed Final Rule.
In Building Industry Assoc., the Fish and Wildlife Service relied on a study that was released after the proposed rule to classify certain species as endangered. The D.C. Circuit upheld the final rule because the belated study only “confirmed the findings delineated in the proposal.” Id. Here, however, the subsequent studies relied on by the FDA are not only an illogical outgrowth the Proposed Final Rule but explicitly contradict the very findings of the Proposed Rule that are directly relevant to this dispute.
5 There are also several thousand pages withheld by the FDA under the deliberative process privilege and by BioPort due to assertion of the trade secrets privilege. These documents were primarily created during the past 5 years. 6 In addition to the licensing related documents, there is the Brachman study, various Federal Register pages, a published legal decision from 1996, and some procedural documents pertaining to the 1985 Proposed Final Rule. The only references to inhalation anthrax within these pages are that insufficient evidence exists to conclude the vaccine is effective. There is certainly no information contained therein that reasonably supports the FDA’s new conclusions. Thus, not only did the FDA procedurally violate the APA, but its conclusions were also arbitrary and capricious, as further set forth below, as the relied upon documents do not provide the necessary
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In the 1985 Proposal Final Rule, the FDA supposedly relied on a 1962 field study (the “Brachman Study”) which indisputably concluded “inhalation anthrax occurred too infrequently to assess the protective effect of vaccine against this form of the disease.” Bio. Prods; Bacterial Vaccines & Toxoids; Implementation of Efficacy Review; Proposed Rule, 50 Fed. Reg. 51002, 51058 (Dec. 13, 1985)(“Proposed Final Rule”). Thus, the FDA’s Expert Panel concluded that “no meaningful assessment of [the vaccine]’s value against inhalation anthrax is possible.” Id. at 51059. Almost twenty years later, relying wholly on studies completed after the comment period had closed, the FDA now asserts that it “does not agree with the Panel report,” and believes that the vaccine is effective against all forms of anthrax exposure. 69 Fed. Reg. at 259-60.
This statement, so key to the current litigation, constitutes a complete reversal of position. Yet, unlike the studies relied upon in Building Industry Assoc., the studies relied upon by FDA do not “provide support for the same decision it had proposed to take.” 247 F.3d at 1246. In fact, the studies referenced in the Final Rule, all of which were undertaken in the last ten years, are substantively different than all the data known at the time of the 1985 Proposed Final Rule. There is no confusing the fact that these new studies are not simply “‘supplementary’ data, unavailable during the notice and comment period, that ‘expand on and confirm’ information contained in the proposed rulemaking.” Solite Corp. v. EPA, 952 F.2d 473, 484 (D.C. Cir. 1991).
Therefore, in issuing its December 30, 2003, Final Rule, the FDA violated the procedural requirements of the APA by relying on studies and data not in existence at the close of the comment period, and by issuing a final rule substantially different from the proposed rule. For those reasons alone this Court should vacate the Final Rule and remand the matter to the FDA for further notice and comment rulemaking.
support for its actions. See Lloyd Noland Hospital & Clinic v. Heckler, 762 F.2d 1561 (11th Cir. 1985).
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B. The Final Rule Substantially Deviates From The Proposed Rule, Denying Affected Parties An Opportunity To Respond While “a final rule need not be identical to the original proposed rule,” when the final
rule “deviates too sharply from the proposal, affected parties will be deprived of notice and an opportunity to respond to the proposal.” AFL-CIO v. Donovan, 757 F.2d 330, 338 (D.C. Cir. 1985)(internal quotation omitted). The test is whether the final rule is a “logical outgrowth” of the proposed rule. If “a new round of notice and comment would provide the first opportunity for interested parties to offer comments that could persuade the agency to modify its rule,” then the final rule is not a “logical outgrowth,” and has not adequately served the purposes of notice and comment rulemaking. American Water Works Assoc. v. EPA, 40 F.3d 1266, 1274 (D.C. Cir. 1994). See also Nat’l Mining Assoc. v. Mine Safety & Health Admin., 116 F.3d 520, 531 (D.C. Cir. 1997); Nat’l Resources Def. Council v. EPA, 824 F.2d 1258, 1284 (1st Cir. 1987).
In Shell Oil Co. v. EPA, 950 F.2d 741 (D.C. Cir. 1991), the D.C. Circuit reviewed a final rule promulgated by the Environmental Protection Agency (“EPA”) that dealt with hazardous waste. The plaintiffs asserted that the EPA’s final rule contained a definition of “hazardous waste” that was much broader than the definition contained in the proposed rule and, as a result, they claimed not to have had notice of the definition that was finally adopted. Id. at 748. The EPA argued that it intended to include the broader aspects of the definition, and that interested parties should have anticipated the substance of the final rule. Id. at 749-50. The D.C. Circuit disagreed with EPA and ruled that “unexpressed intention cannot convert a final rule into a ‘logical outgrowth’ that the public should have anticipated. Interested parties cannot be expected to divine the EPA’s unspoken thoughts.” Id. at 751. “Because the EPA has not provided adequate notice and opportunity for comment,” the D.C. Circuit opined, the final rule “must be set aside and remanded to the EPA.” Id. at 752.
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In the case of AVA, the FDA issued a notice of proposed rulemaking nearly 20 years ago in which it proposed that the anthrax vaccine be classified as safe and effective for use in “the limited circumstances for which this vaccine is employed.” 50 Fed. Reg. at 51059. At the time, the vaccine was employed for use by “certain occupational groups,” mainly “individuals in industrial settings” who worked with various animal furs, hides and hairs. Id. at 51058.7 The vaccine’s use was intended to be for “protection against cutaneous anthrax in fully immunized subjects.” Id. at 51059. Thus, the 1985 Proposed Final Rule set out a very limited proposed use for the anthrax vaccine: to protect a small set of textile workers against cutaneous exposure to anthrax.
By contrast, the 2004 Final Rule issued by the FDA contemplates an obviously broader use of the vaccine that potentially affects millions of people. The Final Rule states that “the vaccine is indicated for active immunization against [anthrax], independent of the route of exposure,” and that the vaccine will “protect humans against…inhalation anthrax.” 69 Fed. Reg. at 260 (emphasis added).
Thus, rather than simply protect limited occupational groups from exposure to cutaneous anthrax, the FDA now believes that the vaccine protects all humans from exposure to either cutaneous or inhalation anthrax.8 This is a substantial change from the Proposed Rule. It is certainly not a “logical outgrowth” to assert that because the vaccine is known to protect against
7 And, as the FDA’s Expert Panel noted, even this number of affected individuals was declining as the impacted industries underwent continuing transformation from human to machine labor. 50 Fed. Reg. at 51058. 8 Apparently in an effort to be all inclusive, the FDA now notes that the vaccine is also effective against “all cases of anthrax disease regardless of the route of exposure”, which necessarily includes gastrointestinal anthrax. 69 Fed. Reg. at 260. There is absolutely no evidence in any record (not even one page), including the Brachman study, studies undertaken by the CDC, or any Defense Department study, that AVA has ever been tested against gastrointestinal anthrax or would prove effective against this method of exposure. The sweeping nature of the FDA’s pronouncement underscores its basic unreliability.
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one method of exposure – again, for a limited population working exclusively in certain industrial settings - it will protect individuals in a wide-ranging population from another method of exposure as a result of a biological attack. In fact, such a conclusion is absurd given that the 1985 Experts Panel specifically stated that the vaccine’s “efficacy against inhalation anthrax is not well documented;” thus, “[n]o meaningful assessment of [the vaccine]’s value against inhalation anthrax is possible.” 50 Fed. Reg. at 51058-59.
There is no way around the fact that the 2004 Final Rule is the first time the FDA publicly proposed approving the anthrax vaccine for protection against inhalation anthrax. Therefore, there was no way that interested parties could have possibly commented on an FDA response to the Panel’s report that would include approval of the vaccine for use against inhalation anthrax. As the D.C. Circuit has continually noted, a final rule is invalid if a “new round of notice and comment would provide the first opportunity for interested parties to offer comments that could persuade the agency to modify its rule.” American Water Works Assoc., 40 F.3d at 1274. See also Fertilizer Institute v. EPA, 935 F.2d 1303, 1311 (D.C. Cir. 1991); United Steelworkers of Am. v. Marshall, 647 F.2d 1189, 1225 (D.C. Cir. 1980).
In American Water Works, the Court of Appeals reviewed the EPA’s adoption of a definition of the word “control” in its final rule; a change that was seen not have been contemplated at the time of the proposed rule. Therefore, the Circuit Court vacated the rule because “interested parties could not reasonably have anticipated the final rulemaking from the draft rule.” 40 F.3d at 1275 (internal quotation and alteration omitted). Similarly, interested parties in 1985 could not have anticipated that – nineteen years later – the FDA would interpret the limited use recommendations from its expert panel as describing an anthrax vaccine believed to be safe and effective when used by millions of people as protection against inhalation anthrax as a result of exposure through a biological attack. Airborne exposure to anthrax was not an
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indication under the licensing contemplated by the 1985 Proposed Final Rule; thus, a new notice and comment period would be the first opportunity that an interested party would be able to address the vaccine’s efficacy against such exposure.
The 2004 Final Rule is far from a logical outgrowth of the 1985 Proposed Final Rule. It is instead “the result of a complex mix of controversial and uncommented upon data and calculations,” and should be remanded for a new round of notice and comment. Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1031 (D.C. Cir. 1978).
C. The FDA’s Issuance Of The Final Rule Was Arbitrary And Capricious, An Abuse Of Discretion, Unsupported By Substantial Evidence And Unwarranted By The Facts And, Therefore, Must Be Invalidated Even if this Court finds that FDA’s bizarre procedure to issue the Final Rule was legally
sound, the substance of the rule is arbitrary and capricious and should be invalidated. See Spirit of the Sage Council v. Norton, 294 F. Supp. 2d 67, 90 (D.D.C. 2003).
1. The FDA Relied Upon Animal Efficacy Studies That Have No Correlation To Humans Thereby Invalidating The Final Rule
The Final Rule relies on the IOM report, which is based principally on animal studies which are, as a matter of uncontroverted law, inadmissible under FDA’s own regulations and applicable statutes. For an FDA final rule to be valid, it must be based on some factual or clinically proper analysis. Indeed, the FDA is required to license drugs according to a "substantial evidence" standard of safety and efficacy. See Weinberger v. Hynson 412 U.S. 609 (1973).
In the Final Rule at issue, it is undisputed that the sources FDA substantially relies on for its determination that the AVA is effective against inhalation anthrax are animal efficacy studies. See 69 Fed. Reg. at 266 (listing three animal studies). These studies are nothing more than tests of the vaccine's effectiveness for protecting various types of animals, such as guinea pigs, rabbits and monkeys, from inhalation exposure to anthrax. Not one of them, however, contains a shred
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of evidence that a correlation exists between the studies’ results and the impact on humans. The importance of this fact cannot be underscored – none of the animal studies, no matter how favorable the results may be, can be extrapolated to apply to humans, i.e., simply because the vaccine may appear to protect a monkey against inhalation exposure to anthrax does not mean it will do the same for a human.9
For example, in the 1998 Vaccine article, cited by the FDA as source reference 5, the authors discuss the differences they noted in how effective the vaccine appeared to be depending upon the animal that was exposed to the spores. As non-human primates (in this case rhesus macaques) survived in greater numbers than guinea pigs or mice, it was no surprise that the authors (all of whom are employed by the defendant DoD) rely heavily on these test results. Although the authors appeared to comprehend why the animals reacted differently, the same assurance did not exist for humans. “It is unknown what immune mechanisms in humans are important in specific resistance to anthrax,” they wrote. See B.E. Ivins et al., “Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques”, Vaccine, 16 (11-12): 1141, 1146 (1998)(Bates #000635 in the Administrative Record Index). Moreover, the authors’ failed “efforts to find a single surrogate marker or correlate of immunity indicate that specific immunity to anthrax in primates may be complex and involve multiple mechanisms of immunity.” Id. See also Department of Defense Chemical and Biological Defense Program, Vol. II, April, 2002, p. 100, at http://www/acq/osd.mil/cp/nbc02/ vol2-2002cbdpperformanceplan.pdf (“Preliminary efficacy experiments in a rabbit model have already demonstrated that protection is afforded by rPA produced from either B. anthracis or E.
9 In fact, the success of these non-human primate tests has been called into question. See “Anthrax Shots' Effect Challenged; Army Disputes Expert Who Reviewed Vaccine Tests”, Washington Post, July 18, 2000 (noting review of Ft. Detrick anthrax text notebooks revealed immunized monkeys exposed to anthrax remained ill for up to two weeks).
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coli. To date, an in vitro correlate in humans to vaccine-induced immunity against anthrax does
not exist.”)
Beyond the fact that absolutely no evidence exists correlating animal efficacy studies
with human efficacy, until May 31, 2002, it was improper – indeed, unlawful - for a drug
manufacturer to rely on animal testing as a means of validating the requirement that a drug or
vaccine be shown to be effective for human beings. However, the FDA promulgated a new Final
Rule (“Animal Efficacy Rule”) allowing animal testing data to be used to validate the
effectiveness of certain kinds of drugs or vaccines. Specifically, animal testing was allowed to
provide substantial evidence of effectiveness for drugs or vaccines needed in biological
radiological or chemical warfare situations, where human testing could not ethically be
conducted. See Final Rule, New Drugs and Biological Products; Evidence Needed to
Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are Not Ethical or
Feasible, 21 CFR Parts 314 and 601, Docket No. 98N-0237 (May 31, 2002), codified at 67 Fed.
Reg. 37988-37998.
The Animal Efficacy Rule provided for animal efficacy testing as a stand-in for human
efficacy testing if four conditions were met:
! There is a reasonably well understood pathophysiological mechanism for the toxicity of the chemical, biological, radiological, or nuclear substance and its amelioration or prevention by the product;
! The effect is demonstrated in more than one animal species expected to react with a response predicted for humans, unless the effect is demonstrated in a single animal species that represents a sufficiently well characterized animal model (meaning that the model has been adequately evaluated for its responsiveness) for protecting the response in humans;
! The animal study and point is clearly related to the desired benefit in humans, which is generally the enhancement of survival or prevention of major morbidity; and
! The data or information on the pharmacokinetics and pharmacodynamics of the product or other relevant data or information in animals and humans is sufficiently well understood to allow selection of effective dose in humans and that it is therefore 14

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reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans. Id. It is undisputed that the AVA, despite years of investigational testing, does not meet the criteria for the so-called animal efficacy rule listed above. Accordingly, it is entirely improper to allow reliance on animal efficacy testing data in order to validate an FDA final rule on the efficacy of the AVA. Yet for no apparent or justifiable reason, the FDA has bowed to pressure exerted by the DoD in order to preserve the AVIP and abandoned its long-standing prohibition on utilizing animal efficacy tests in the place of human testing. From the DoD’s standpoint, the need to do so was imperative as it was the only way to validate the claim that the AVA is effective against inhalation anthrax exposure. Because the entire substantive basis of the Final Rule relies on animal studies and data regarding the efficacy of the vaccine that have absolutely no correlation to human efficacy, the Court should invalidate the Rule and remand the matter to the FDA for proceedings consistent with the law (as well as the proper public comment).
2. The FDA’s Final Rule Fails To Take Into Account Significant Changes In The Manufacturing Process Of The Vaccine And, Therefore, Must Be Invalidated
One of the more curious discussions in the FDA’s Final Rule concerns the finding by the 1985 Expert Panel that the vaccine originally tested in the Brachman study was manufactured by Merck Sharp & Dohme. See 69 Fed. Reg. at 260. The FDA, in the 2004 Final Rule, objected to its panel findings and clarified that the original vaccine tested by Dr. Brachman was actually provided by the United States Army and its bioweapons facility at Fort Detrick, Maryland. Id. The FDA then went on to note that the vaccine went through two additional manufacturers, Merck and the Michigan Department of Public Health, as well as undergoing formulation and manufacturing changes, before reaching its current form. Id.
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Typically, these types of changes in manufacturer and formulation require a new license
application and testing. See FDA Guidance Concerning Demonstration of Comparability of
Human Biological Products, Including Therapeutic Biotechnology-derived Products, Center for
Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER),
April 1996, found at http://www.fda.gov/cber/gdlns/comptest.txt; First Amended Complaint
(filed January 6, 2004), Exhibit D, Response to Citizen Petition, Docket No.01P-0471/CPI,
Aug. 28, 2002, at 7-8. This was not done in the case of AVA, and the FDA, well aware of these
shortcomings in the licensing process, attempts to deal with this problem in the Final Rule by bestowing the mantle of “manufacturer” on the Defense Department.10 This regulatory slight-of-
hand to create a manufacturing status out of the whole cloth for a federal executive agency on the
basis of its oversight of a manufacturing process is unprecedented and flies in the face of FDA's
previous regulatory framework.
Again, the bizarre procedural twists and turns involved in this licensing process require
public comment. The Court should remand the Final Rule so that these considerations can be
publicly vetted.
D. The Final Rule Violates Federalism Concerns And, Therefore, Must Be Invalidated
The FDA’s Final Rule notes that it:
has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as
10 The Final Rule states that “FDA has reviewed the historical development of AVA and concluded that DoD’s continuous involvement with, and intimate knowledge of, the formulation and manufacturing processes of all of these versions of the anthrax vaccine provide a foundation for a determination that the MDPH anthrax vaccine is comparable to the original DoD vaccine.” See 69 Fed. Reg. at 260-61.
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defined in the Executive order and, consequently, a federalism summary impact statement is not required. See 69 Fed. Reg. at 265 (Section IX.D). No doubt this language was included by FDA officials who were drafting the Final Rule with no more than an afterthought. Identical language has probably been incorporated in dozens of FDA Final Rules. Indeed, has the FDA ever drafted a “federalism summary impact statement”? Probably not very often, for there are likely very few circumstances where FDA action would implicate States’ rights. After all, why would there be federalism concerns with whether the FDA approves a new form of foot crème? However, this is not one of the FDA’s typical cases. The use of the anthrax vaccine very clearly has “substantial direct effects on the States”, particularly because hundreds of thousands of the involuntary recipients of the vaccine are members of Army and Air National Guard units across the United States; more commonly known as the state militia.11 Thus, this is very much “a case about federalism,” Coleman v. Thompson, 501 U.S. 722, 726 (1991), that is, about respect for “the constitutional role of the States as sovereign entities.” Alden v. Maine, 527 U.S. 706, 713 (1999). This concern is “crucial when the pre-emptive effect of an administrative regulation is at issue. Unlike Congress, administrative agencies are clearly not designed to represent the interests of States, yet with relative ease they can promulgate comprehensive and detailed regulations that have broad pre-emption ramifications for state law.” Geier v. American Honda Motor Co., 529 U.S. 861, 908 (2000)(Stevens, J., dissent). This judicial expectation is shared by the Executive Branch; hence, the adoption of Executive Order 13132, which serves to ensure that States will be afforded a dialog with
11 For a discussion of the National Guard’s history and interplay between federal and state status, see e.g., Perpich v. Dep’t of Defense, 496 U.S. 334, 345-9 (1990).
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agencies regarding federal regulations that will have substantial direct effects on them. This is to be achieved through the normal APA notice-and-comment procedure. 5 U.S.C. § 553. See Exec. Order No. 12612, § 4(e), 3 C.F.R. § 252, 255 (1988)(“When an Executive department or agency proposes to act through adjudication or rule-making to preempt State law, the department or agency shall provide all affected States notice and an opportunity for appropriate participation in the proceedings."); Exec. Order No. 13132, § 4(e), 64 Fed. Reg. 43255, 43257 (1999)(same); cf. Medtronic, Inc. v. Lohr, 518 U.S. 470, 496 (1996)(discussing 21 C.F.R. § 808.5 (1995), an FDA regulation allowing a State to request an advisory opinion regarding whether a particular statelaw requirement is pre-empted, or exempt from pre-emption, under the Medical Device Amendments of 1976).
The opening section of Executive Order 13132 states that “‘[p]olicies that have federalism implications’ refers to regulations … and other policy statements or actions that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Exec. Order No. 13132, § 1(a), 64 Fed. Reg. 43255, 43255. Of course, as a superficial matter, it should be clear that use of the AVA is having at least “substantial direct effects on the States.” If a member of a state’s national guard, for example, becomes ill as a result of the forcible inoculation of the vaccine, as tens of thousands have, there will be a significant direct impact on the involved state. There may be medical costs, job impact (such as loss of work because of illness, unemployment costs, etc) and other strains on the economic and family state system.
The Executive Order requires a federal agency that intends to promulgate a regulation that has federalism implications to consult, “prior to the formal promulgation of the regulation,”
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with “State and local officials early in the process of developing the proposed regulation.” Id. at
§ 6(b), 64 Fed. Reg. 43255, 43257. The FDA failed to adhere to this requirement.
In fact, at least one state has implicitly, if not explicitly, raised federalism concerns
directly with the defendants FDA and DoD over how the AVIP is impacting the members of its
National Guard, as well as everyone subject to the forcible inoculations. In 2001, the Attorney
General of the State of Connecticut, Richard Blumenthal, wrote separate letters to both Defense
Secretary Donald Rumsfeld and Acting FDA Deputy Commissioner Dr. Bernard Schwetz
asserting that the compulsory vaccination program is compelling military personnel, including
members of the Connecticut Air National Guard, to “put either their health or their careers at
risk.” See Exhibit “2” (FDA version), a copy of which can also be found at http://www.cslib.org/attygenl/press/2001/health/fda.pdf.12
There is no evidence in the existing record that the State of Connecticut’s concerns were
ever heeded. Nor did the FDA ever consult with Connecticut, or any other State, in violation of
Executive Order 13132. Given that compliance with the Executive Order is mandatory for the
FDA in order to validate its promulgated Final Rule, the Final Rule is invalid until such time
12 Interestingly, Attorney General Blumenthal has advocated identical arguments to that espoused by the plaintiffs. He asserted that “directly contrary to law, the AVA is being administered to military personnel under threat of imprisonment, loss of pay and discharge” and that “[i]n effect, the military is forcing its personnel to serve as human guinea pigs for an unlicensed drug that has not been proven to be safe or effective.” See Exhibit “2”. He also noted that the only license for the manufacture of Anthrax vaccine, granted in 1970 to MBPI/Bioport Corporation, was obtained exclusively for agricultural and veterinary settings as protection against cutaneous exposure, not inhalation exposure. Id. Furthermore, he argued that because AVA's present use is inconsistent with its original licensing and is for a purpose that was never tested, the vaccine is therefore an Investigational New Drug under FDA regulations and may not be used on humans without their specific and informed consent. Id. Additionally, the State of Connecticut believes the mandatory vaccination of troops with a biologic product not licensed for its current use violates the Federal Food, Drug, and Cosmetic Act. Id. A copy of Attorney General Blumenthal’s letter to the DoD can be found at http://www.cslib.org/attygenl/press/2001/health/ dod.pdf.
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federalism concerns are properly addressed. Therefore, the Final Rule must be invalidated and remanded to the FDA for appropriate proceedings. II. ALTERNATIVELY, SHOULD SUMMARY JUDGMENT IN FAVOR OF THE
PLAINTIFFS NOT BE GRANTED AT THIS TIME, DISCOVERY IS JUSTIFIED Although the plaintiffs firmly believe they are entitled to summary judgment based on the arguments above, the defendants are contemporaneously cross-filing their own Motion for Summary Judgment. Should this Court determine, for some reason, that the plaintiffs are not yet entitled to summary judgment, then very similar arguments exist to justify discovery before summary judgment is accorded the defendants. The APA requires courts to “review the whole record or those parts of it cited by a party.” 5 U.S.C. § 706. Ordinarily, courts confine their review to the “administrative record.” Edison Elec. Inst. v. OHSA, 849 F.2d 611, 617-18 (D.C. Cir. 1988). The administrative record includes all materials “compiled" by the agency, Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 419 (1971), that were “before the agency at the time the decision was made,” Environmental Defense Fund, Inc. v. Costle, 657 F.2d 275, 284 (D.C. Cir. 1981). Although discovery is not routinely granted in APA record review cases, there are exceptions that apply here. For example, discovery is permitted when the agency deliberately or negligently excluded documents that may have been adverse to its decision. See Kent County v. EPA, 963 F.2d 391, 395-96 (D.C. Cir. 1992).13 It is also permissible when a party demonstrates that it is necessary to supplement the record with “background information” in order to determine whether the agency considered all of the relevant factors, Environmental Defense
13 The Circuit noted that in San Luis Obispo Mothers for Peace v. NRC, 751 F.2d 1287, 1327 (D.C. Cir. 1984), vacated in another part, 760 F.2d 1320 (D.C. Cir. 1985)(en banc), aff’d 789 F.2d 26 (D.C. Cir.)(en banc), cert. denied 479 U.S. 932 (1986), it had recognized that supplementing the administrative record might be proper “if petitioners made a prima facie showing that the agency excluded from the record evidence adverse to its position ....”
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Fund, Inc., 657 F.2d at 285 (quotation omitted), or where an agency failed “to explain administrative action [so] as to frustrate effective judicial review.” Id. (quoting Camp v. Pitts, 411 U.S. 138, 142-43 (1973).
A. The FDA Administrative Record Is Woefully Inadequate And Documents Were Either Deliberately Or Negligently Excluded From Consideration
As referenced earlier, 4,209 pages have been placed into the public record by the government on the basis that they were relied upon or at least considered by the FDA in issuing its Final Rule. Of the 4,209 pages in the open record, approximately 2,653 (63%) post-date 1986, and primarily originate during the period 1996-2002. Not surprisingly, there are very few pages that are part of the administrative record which are adverse to the stated DoD/FDA conclusion that the AVA is safe and effective. How can the FDA arrive at this decision, particularly after 19 years following issuance of the Proposed Final Rule, without considering all the relevant evidence? A list of just a sampling of relevant scientific studies concerning the anthrax vaccine, none of which were apparently considered by the FDA, is attached at Exhibit “3”.
As another example, over two thousand pages of the FDA’s Administrative Record pertain to VAER’s reports. See Bates #001417-003244, 003584-003606. VAERs refers to Vaccine Adverse Event Reporting System, which is a cooperative program for vaccine safety of the CDC and FDA. These reports are filed as part of a post-marketing safety surveillance program, and attempt to collect information about adverse events (possible side effects) that occur after the administration of vaccines such as AVA. See www.vaers.org. Within the FDA administrative record there are a few VAERS reports from 2003. Yet, the vaers.org Website lists nearly 700 VAERS reports for the first half of 2003. Why the discrepancy?
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B. Prima Facia Evidence Exists Indicating The DoD Exerted Improper Pressure Upon FDA
Based on the documentary record and the available evidence, it would be reasonable to conclude that the DoD has exerted improper pressure upon the FDA when it comes to the AVA, and in particular the issuance of the Final Rule. Were it just the fact that throughout this case it has been the DoD asserting all the primary arguments and filing substantive declarations that address specific FDA matters rather than the FDA, the plaintiffs might not be concerned. Were it just the fact that in the aftermath of the Court’s December 22, 2003, ruling it was DoD officials, rather than those from the FDA, who publicly condemned the Court’s decision regarding FDA legal issues, the plaintiffs might not have thought twice. Indeed, were it just the fact that the FDA had magically issued its Final Rule just one week after this Court’s decision, the plaintiffs still would pause for just a moment. However, taken together, and considering so much other evidence of strong DoD influence and pressure upon FDA, the entire validity of the administrative process that led to the issuance of the Final Rule is in question, thereby justifying discovery.
For example, on May 3, 1999, when the controversy over the AVA was truly in its infancy, senior DoD officials responsible for AVIP exchanged emails discussing the second Congressional hearing on the anthrax vaccine that had just taken place. These e-mails provide a glimpse of the degree of pressure applied by DoD on FDA and the Government Accounting Office, and the latitude DoD was given by FDA to act as the de-facto manufacturer. Brigadier General Eddie Cain, director of the Joint Program Office for Biological Defense, wrote: “And if you think Congressman Shays was critical of the current relationship between FDA & DoD, wait until he finds out that DoD is calling all the shots onsight [sic][ i.e. at BioPort].” BG Cain's subordinate, Colonel John V. Wade, replied that senior Pentagon civilian appointees would have
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“SECDEF calling either FDA or HHS with the message ‘we (DoD/FDA) didn't do to [sic] well on this one...’” See Exhibit “4”.
This request is not unheard of or unsupported by law. At least one court has invalidated agency action where it was based, even in part, on pressure from Congressional sources. Congressman Texas Medical Assoc. v. Mathews, 408 F.Supp. 303 (W.D. Tex 1976). It should be no different when the pressure is from a non-expert federal agency (DoD) on the expert federal agency (FDA). Of course, here the plaintiffs are merely seeking discovery on the issue, not outright invalidation. Inquiry into the mental processes of an administrative decision is appropriate where there is a strong showing of bad faith or improper behavior. Citizens to Preserve Overton Park, Inc., 401 U.S. at 420.
The DoD has been in the background and foreground of the entire history of the AVA. See 69 Fed. Reg. at 260-61. Very few meetings since the first Gulf War, when the DoD began down the slippery slope of utilizing the AVA to combat inhalation anthrax, have occurred involving the FDA where DoD presence was not felt. This Court has already recognized some of the interplay between the two organizations. See Memo Op. at 5-7. The relationship, though onesided it was, has a lengthy history. Yet, a review of the FDA’s Administrative Record Index reveals that just two pages relate to communications between the DoD and FDA. See Bates #004031-32 (correspondence between Stephan Joseph/DoD and Michael Friedman/FDA); Memo Op. at 6-7.24-25.
Where is the documentary record of the numerous years of DoD-FDA interaction on the very questions now at issue in this litigation, much of which has been cited by the defendants themselves in briefs and oral arguments before this Court? To what extent did the DoD improperly or unduly influence the FDA’s actions with respect to the Final Rule. These are legitimate questions and grounds for permitting discovery.
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CONCLUSION Based on the foregoing, the Court should grant the plaintiffs’ motion for summary judgment and impose a permanent injunction or, alternatively, permit the plaintiffs to conduct discovery. Date: March 3, 2004
Respectfully submitted, /s/
______________________________ Mark S. Zaid, Esq. D.C. Bar #440532 Krieger & Zaid, PLLC 1747 Pennsylvania Avenue, N.W. Suite 300 Washington, D.C. 20006 (202) 454-2809 John J. Michels, Jr., Esq. D.C. Bar #457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150 Attorney For The Plaintiffs
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View U.S. District Court Opinion JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, et al., Defendants. Civil Action No. 03-707(EGS) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 707; 2004 U.S. Dist. Ct. Motions LEXIS 6278 April 7, 2004 Motion for Summary Judgment
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s) COUNSEL: [**1] Respectfully submitted, PETER D. KEISLER, Assistant Attorney General, ROSCOE C. HOWARD, JR. United States Attorney, BRIAN D. BOYLE, Principal Deputy Associate Attorney General, SHANNEN W. COFFIN, Deputy Assistant Attorney General, JOSEPH H. HUNT, VINCENT M. GARVEY, CRAIG M. BLACKWELL, DC Bar # 438758, RONALD J. WILTSIE, ANDREW H. TANNENBAUM, Attorneys, Civil Division, U.S. Department of Justice, P.O. Box 883, Washington, D.C. 20044, Tel: (202) 307-1401, Fax: (202) 616-8470. Attorneys for defendants. TITLE: DEFENDANTS' MEMORANDUM OF POINTS AND AUTHORITIES IN OPPOSITION TO PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT TEXT: PRELIMINARY STATEMENT
The broad Administrative Procedure Act ("APA") challenge in plaintiffs' amended complaint has been reduced almost entirely to a claim that the Food and Drug Administration ("FDA"), in issuing its Final Order categorizing Anthrax Vaccine Adsorbed ("AVA") as a Category I, safe and effective, biological product, see Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review ("FDA Order" or "Order"), 69 Fed. Reg. 255 (Jan. 5, 2004), violated certain procedural requirements for rulemakings under the APA. Indeed, plaintiffs, in their summary judgment brief ("P1. [**7] Br."), barely discuss the substance of FDA's determination or the critical scientific evidence upon which FDA relied, namely, the adequate and well-controlled study conducted by Drs. Brachman, Gold, Plotkin, Fekety, Werrin, and Ingraham ("Brachman" or "Brachman study").
Plaintiffs' procedural claim, however, like their now de-emphasized substantive challenge, is meritless. The procedural challenge proceeds, initially, from an incorrect premise: that the Order is a "rule" subject to APA rulemaking requirements. It is not. FDA's determination to confirm AVA's previously-issued license by categorizing it in Category I is an "order," not a "rule," and, as such, is not subject to APA requirements for rulemaking.

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Even if those requirements do apply, however, the Order is procedurally sound. Again, plaintiffs' arguments proceed from faulty assumptions. Plaintiffs' "logical outgrowth" argument, for example, assumes that the Order represents a change in agency position. But as we explained in our opening brief ("Def. Br."), FDA's final decision is identical to what FDA proposed in 1985 -- i.e., to place AVA in Category I, thereby confirming it as a properly-licensed, safe and effective, [**8] biological product -- and to the recommendation of the Panel on Review of Bacterial Vaccines and Toxoids ("Panel"). Moreover, plaintiffs' argument that FDA erred in considering [*2] post-comment studies and data assumes that these post-comment sources formed the basis for FDA's determination that AVA is effective. Not so. FDA relied for its effectiveness determination on the Brachman study. The post-comment sources corroborated FDA's determination.
Plaintiffs' narrow substantive challenge -- that FDA relied improperly on animal studies for its effectiveness determination -- flows from their procedural argument with respect to post-comment sources and is wrong for the same reason. FDA relied on the Brachman study for effectiveness and considered the Panel's summary of the CDC surveillance data and the animal study data as corroborative information, as it was entitled to do. Plaintiffs' brief argument that FDA failed to take into account historical changes in the vaccine also lacks merit. The Order explains at length the basis for FDA's determination that AVA is comparable to the predecessor versions of the anthrax vaccine, including the vaccine used in the Brachman study.
Plaintiffs' [**9] remaining arguments are also easily dismissed, and only serve to illustrate how marginal their challenge has become. Plaintiffs contend the Order violates an Executive Order dealing with federalism issues, but the Executive Order, by its very terms, does not create privately enforceable rights, and, in any event, has no conceivable bearing on any issue in this case. Plaintiffs' argument for discovery is grasping at straws. Plaintiffs acknowledge, as they must, the fundamental rule that review in APA cases should be confined to the administrative record. Although plaintiffs contend discovery is appropriate under that rule's "bad faith" exception, they offer no credible reason in support of their assertion that FDA's decision was the product of bad faith. Nor could they. FDA's decision to agree with the Panel's recommendation and affirm the Category I classification for AVA was based on the merits, and it is the merits for [*3] which plaintiffs simply have no answer. For all these reasons, and those explained at length in our opening brief and below, plaintiffs' motion for summary judgment should be denied.
ARGUMENT n1
n1 This brief responds only to the arguments raised in plaintiffs' brief in support of their motion for summary judgment. We incorporate by reference arguments in our opening brief which provide additional grounds for denying plaintiffs' motion. See, e.g., Def. Br. at 29-31 (demonstrating that plaintiffs lack standing).
[**10]
I. PLAINTIFFS' PROCEDURAL APA CHALLENGE IS MERITLESS
A. The Order Is Not Subject to APA Rulemaking Requirements in 5 U.S.C. § 553
Plaintiffs' challenge to the Order is largely procedural. They claim that FDA failed to comply with certain notice-and-comment requirements under the APA's rulemaking provision, 5 U.S.C. § 553. See P1. Br. at 4-12. This argument is wrong, however, because the Order is not subject to APA rulemaking requirements.
The APA defines two broad, mutually exclusive categories of agency action -- rules and orders. See Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 216 (1988) (Scalia, J., concurring) (distinction between rules and orders is "the entire dichotomy upon which the most significant portions of the APA are based"); see also id at 218-19 (citing Attorney General's Manual on the Administrative Procedure Act ("AG Manual") 13-14 (1947)). The APA defines a "rule" as:

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the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, [**11] procedure, or practice requirements of an agency and includes the approval or prescription for the future of rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances, services or allowances therefor or of valuations, costs, or accounting, or practices [*4] bearing on any of the foregoing.
5 U.S.C. § 551(4). "Rule making," which can be formal or informal, is the "agency process for formulating, amending, or repealing a rule." Id. § 551(5). When promulgating a "substantive" rule, an agency must comply with the notice-and-comment requirements of 5 U.S.C. § 553. See 5 U.S.C. § 553(b).
The APA defines an "order" as:
the whole or a part of a final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making but including licensing an agency in a matter other than ruling.
Id. § 551(6). n2 "Adjudication," which also can be formal or informal, is the "agency process for the formulation of an order." Id. § 551(7). Agency action which falls outside the definition [**12] of a "rule" is not subject to APA rulemaking requirements. See Id. § 553 (establishing procedures for "rule making"); see also, e.g., Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 401, 414, 417 (1971) ("procedural requirements" in 5 U.S.C. § 553 related to formal rulemaking "do not apply" to agency action deemed "not an exercise of a rulemaking function"); Sprint Corp. v. F.C.C., 315 F.3d 369, 373 (D.C. Cir. 2003) (noting that, "in contrast to an informal adjudication," agency action meeting the definition of a substantive rule "triggers the APA notice requirement"); Underwater Exotics, Ltd. v. Secretary of the Interior, 1994 WL 80878, at *9-10 (D.D.C. Feb. 28, 1994) (licensing determination not subject to APA notice and comment [*5] requirements).
n2 The APA defines a "license" as "the whole or a part of an agency permit, certificate, approval, registration, charter, membership, statutory exemption or other form of permission." 5 U.S.C. § 551(8). "Licensing" is further defined as the "agency process respecting the grant, renewal, denial, revocation, suspension, annulment, withdrawal, limitation, amendment, modification, or conditioning of a license." Id. § 551(9). APA requirements for licensing proceedings are set out in 5 U.S.C. § 558.
[**13]
FDA's decision to place AVA in Category I, thereby confirming it as a properly-licensed, safe and effective biological product, is not a "rule" within the meaning of the APA. As we explained in our opening brief (see Def. Br. at 6), prior to 1972, a predecessor agency, the National Institutes of Health ("NIH"), was responsible for licensing biological products under the Public Health Service Act. See Redelegation of Authority to Administer Certain Provisions of the Federal Food, Drug, and Cosmetic Act, 37 Fed. Reg. 4,004, 4,005 (Feb. 25, 1972). In 1972, NIH's licensing authority was transferred to FDA. See Statement of Organization, Functions, and Delegations of Authority, 37 Fed. Reg. 12,865 (June 29, 1972). That same year, FDA, of its own accord, determined to review the safety, effectiveness, and labeling of all previously-licensed biological products. See Procedures for Review of Safety, Effectiveness and Labeling, 37 Fed. Reg. 16,679 (Aug. 18, 1972).
In its Federal Register notice proposing the review procedures -- which ultimately were codified at 21 C.F.R. § 601.25 ("Section 601.25") -- FDA explained that, at the end [**14] of the review process, the "applicable product licenses" would be "confirmed, revoked, or permitted to remain in effect on an interim basis pending further study." See 37 Fed. Reg. at 16,679. The regulations thus require FDA to designate products under review as either (a) "safe and effective and not misbranded" ("Category I"); (b) "unsafe, or ineffective, or . . . misbranded" ("Category II"), in which

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case the product licenses "shall be proposed to be revoked"; or (c) neither category, because "the available data are insufficient to classify such biological products" ("Category III"). See 21 C.F.R. §§ 601.25(f), (g); see also id. § 601.26 (procedures for reclassifying certain products in Category III into Category I or II).
[*6] A decision by FDA to place a biological product in Category I, thereby confirming its license, falls squarely within the definition of an "order" for purposes of the APA. See 5 U.S.C. § 551(6) (defining "order" to mean "the whole or a part of a final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making but including licensing" [**15] ) (emphasis added). n3 Section 601.25 itself refers to FDA's determination as an "order." See 21 C.F.R. § 601.25(f) (requiring FDA to publish a "proposed order" designating the products under review according to their safety, effectiveness, and labeling); Id. § 601.25(g) (requiring FDA to publish a "final order on the matters covered in the proposed order").
n3 The process by which FDA reviewed NIH's prior licensing determinations is best characterized, for APA purposes, as an "informal" adjudication. See Bettucci v. United States, 14 F. Supp. 2d 45, 51 (D.D.C. 1998) (noting that "an informal adjudication . . . is a residual category including all agency actions that are not rulemaking and that need not be conducted through' on the record' hearings'") (internal citation omitted).
Indeed, it is hard to see how FDA's decision could be viewed as anything but an "order" for purposes of the APA. For example, FDA's process for licensing biological products is not itself subject to rulemaking [**16] requirements. See, e.g., 42 U.S.C. § 262(a)(2)(A) ("the Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses"); 21 C.F.R. §§ 601.2-601.9 (procedures for applying for, issuing, denying, suspending, and revoking biological licenses). Thus, if AVA were a new biological product for which its manufacturer were seeking an initial license, FDA, in determining whether to grant the license, would not be required by the APA's rulemaking provision to publish its licensing decision for notice and comment. It follows, a fortiori, then, that FDA's review of AVA's existing license -- to confirm, or not, whether the license continues to be appropriate -- is not [*7] subject to notice-and-comment requirements.
FDA's decision placing AVA in Category I and confirming its status as properly licensed also bears none of the hallmarks of a "rule." For example, the decision does not "implement, interpret, or prescribe law or policy." 5 U.S.C. § 551(4). It merely applies already-existing legal standards (those set forth in Section 601.25(d)) to specific facts involving a specific [**17] party before the agency. This is the very hallmark of adjudication. n4 And the decision also has no "future effect" (5 U.S.C. § 551(4)); it merely determines the "'past and present rights and liabilities'" of AVA's manufacturer with respect to an already-issued license. Bowen, 488 U.S. at 219 (Scalia, J., concurring) (quoting AG Manual at 13-14); see also Goodman v. F.C.C., 182 F.3d 987, 994 (D.C. Cir. 1999) ("also like an adjudicatory decision, and unlike a rule, the Implementation Order was retrospective in that it extended the build out deadline to licenses that had already been issued") (citing, e.g., Justice Scalia's concurring opinion in Bowen).
n4 See, e.g., Bowen, 488 U.S. at 221 (Scalia, J., concurring) ("adjudication deals with what the law was; rulemaking deals with what the law will be") (emphasis deleted); United States v. Florida East Coast R.R. Co., 410 U.S. 224, 245-46 (1973) (in discussing distinction between rulemaking and adjudication, noting the "recognized distinction in administrative law between proceedings for the purpose of promulgating policy-type rules or standards, on the one hand, and proceedings designed to adjudicate disputed facts in particular cases on the other"); F.T.C. v. Brigadier Indus. Corp., 613 F.2d 1110, 1117 (D.C. Cir. 1979) ("Rulemaking is prospective in scope and nonaccusatory in form, directed to the implementation of general policy concerns into legal standards. Adjudication, on the other hand, is individual in impact and condemnatory in purpose,' directed to the determination of the legal status of particular persons or practices through the application of preexisting legal standards") (internal citations and footnotes omitted). FDA complied with APA rulemaking requirements in promulgating Section 601.25. See Procedures for Review of Safety, Effectiveness and Labeling, 37 Fed. Reg.

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16,679-80 (Aug. 18, 1972) (proposed regulation); Procedures for Review of Safety, Effectiveness and Labeling, 38 Fed. Reg. 4,319 (Feb. 13, 1973) (final regulation).
[**18]
Consistent with Section 601.25(g), FDA referred to its licensing decision as a "final order" in several places in the Order. See FDA Order at 257 ("IV. Categorization of Products -- [*8] Final Order"); accord id. at 255 ("Action: Final rule and final order"); Id. ("Dates: This rule is effective January 4, 2003. The final order on categorization of products is effective January 5, 2004"). n5 We acknowledge, however, that the label an agency puts on a given exercise of administrative power is not conclusive. See, e.g., National Family Planning and Reproductive Health Assoc., Inc. v. Sullivan, 979 F.2d 227, 237 (D.C. Cir. 1992). In fact, the Federal Register document containing FDA's proposal concerning the Panel report was called a "proposed rule," see Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51,002 (Dec. 13, 1985), because it also "proposed to amend certain existing biologics regulations." See AR1377 n.4 (FDA citizen petition response). n6 Moreover, the Federal Register document publishing the Order also refers generically at times to "this final rule." See, e.g. [**19] , FDA Order at 258, 259 n.2. n7 In any event, to the extent the label ("order") in Section 601.25 is relevant, it is because the label is consistent with what FDA has, in fact, done -- confirm a predecessor agency's licensing determination. See 5 U.S.C. § 551(6) (defining "order" to include "the whole or a part of a final disposition . . . of an agency in a matter . . . including licensing"); see also Goodman, 182 F.3d at 994 ("that the Implementation Order appeared under the [*9] heading Final Rules' may reveal something about the care taken in writing headings when documents are published in the Federal Register but does not alter the clearly adjudicatory nature of the Order itself").
n5 As noted in our opening brief (see Def. Br. at 19 n.20), the Federal Register document publishing the Order was designated a "Final Rule and Final Order" (see FDA Order at 255) because it also contained a final rule relating to certain additional standards for one of the biological products under review. See id. at 265 .
n6 Thus, the citizen petition response also referred to the review process related to AVA as the "Biologics Review rulemaking for anthrax vaccine." AR1378; see also id (stating that "FDA should complete the Biologics Review for anthrax vaccine by issuing a final rule pursuant to 21 CFR 601.25"). Under Section 601.25(f), the Federal Register document publishing FDA's proposal concerning the Panel report could properly have been called a "proposed rule and proposed order." See 21 C.F.R. § 601.25(f) [**20] .
n7 Some such statements in the Order are references to the part of the document that is, in fact, a final rule. See FDA Order at 265 (Part IX.A).
Finally, as plaintiffs note (Pl. Br. at 5), FDA did provide interested parties an opportunity to comment on its proposed order categorizing AVA as a Category I product. FDA was required to do so under Section 601.25, which, as a matter of agency discretion, affords interested persons 90 days to comment on a proposed order after publication in the Federal Register. See 21 C.F.R. § 601.25(f)(4). Agencies, of course, have such discretion to employ "extra procedural devices," Vermont Yankee Nuclear Power Corp. v. N.R.D.C., Inc., 435 U.S. 519, 546 (1978); Brigadier Indus. Corp., 613 F.2d at 1116, and FDA's decision to provide more procedures than the APA required did not transform the license review into a rulemaking proceeding. See Florida East Coast R.R., 410 U.S. at 236 n.6; Goodman, 182 F.3d at 994 (noting that an agency may seek comment in an "adjudicatory" proceeding). [**21] It is the "nature of the decision to be reached in the proceeding" which is decisive. Brigadier Indus. Corp., 613 F.2d at 1117. The substance of FDA's decision was to "confirm" a predecessor agency's licensing decision; that action, we have explained,

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is not a "rule" for purposes of the APA. See Goodman, 182 F.3d at 994 (although proceeding bore some "semblance of a rulemaking," resulting decision was a "non-rulemaking" order because, among other things, it had a "clearly adjudicatory nature"). For all these reasons, FDA's decision to place AVA in Category I, thereby confirming its license, was not an exercise of a rulemaking function, and plaintiffs' procedural challenge based on 5 U.S.C. § 553 should be rejected.
[*10] B. Even Assuming Rulemaking Requirements Apply, the Order is Consistent with 5 U.S.C. § 553
Even if FDA's licensing decision could somehow be considered a "rule" for purposes of the APA, the Order is fully consistent with APA rulemaking requirements. Plaintiffs contend the Order is procedurally invalid for two related reasons (both based on the incorrect assumption that the Order [**22] is a rule). Plaintiffs claim the Order is not a "logical outgrowth" of the classification FDA proposed in 1985. Pl. Br. at 9-12. Plaintiffs also claim FDA improperly "relied on studies and data that were not in existence at the conclusion of the comment period." Pl. Br. at 5, 6-8. Both arguments are wrong. Moreover, even if FDA technically violated rulemaking requirements, any error is not reversible because plaintiffs have suffered no prejudice.
1. The Order is a "Logical Outgrowth" of FDA's Category I Proposal
Plaintiffs argue the Order violates the APA because it is not a "logical outgrowth" of the proposed classification FDA published for comment in 1985. See Pl. Br. at 9-12. Courts use "logical outgrowth" analysis to determine whether a final rule so differs from a proposed rule that it requires an additional round of notice and comment. The logical outgrowth test does not apply to the Order because it is not a rule. Assuming, arguendo, however, that logical outgrowth applies, the logical outgrowth test is a "functional[]" one, which, as plaintiffs note (see Pl. Br. at 11), asks "whether the purposes of notice and comment have been adequately served,' that [**23] is, whether a new round of notice and comment would provide the first opportunity for interested parties to offer comments that could persuade the agency to modify its rule." American Water Works Ass'n v. E.P.A., 40 F.3d 1266, 1274 (D.C. Cir. 1994) (internal citation omitted); see also Spirit of the Sage Council v. Norton, 294 F. Supp. 2d 67, 89 (D.D.C. 2003). An agency need not [*11] include "every possible version of a proposed rule in its notice of proposed rulemaking"; so long as it includes a "description of the subjects and issues involved," the APA is satisfied. National Ass'n of Psychiatric Health Sys. v. Shalala, 120 F. Supp. 2d 33, 39 (D.D.C. 2000); see also 5 U.S.C. § 553(b)(3).
The "logical outgrowth" doctrine would not apply to this case even if the Order were a rule. The entire premise of logical outgrowth analysis is that an agency's final decision has differed in some way from its proposal. See, e.g., City of Waukesha v. E.P.A., 320 F.3d 228, 245 (D.C. Cir. 2003) ("the traditional APA logical outgrowth' test applies where an agency changes its final regulation in some [**24] way from the proposed regulation for which it provided notice and requested comment"). Here, FDA's final decision is identical to what it proposed in 1985, i.e., to place AVA in Category I, thereby confirming it as a properly-licensed, safe and effective, biological product. Compare Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51,002, 51,104 (Dec. 13, 1985) (proposing, consistent with Panel recommendation, that AVA be placed in Category I); with FDA Order at 259 (FDA "continues to accept the Panel's recommendation and places AVA in Category I"); see also id. at 258 (Table I); Def. Br. at 14.
Plaintiffs' argument that the proposed and final orders differ is based on a misunderstanding of the Panel's recommendation (which FDA proposed to adopt). The Panel did not, as plaintiffs contend in their brief, recommend that AVA be licensed only "to protect a small set of textile workers against cutaneous exposure." Pl. Br. at 10 (emphasis in original); see also id. at 11 (arguing that the Order is "the first time the FDA publicly proposed approving the anthrax vaccine for protection against inhalation [**25] anthrax"). As we have explained (see Def. Br. [*12] at 37-38), when the Panel issued its report, AVA, as it is today, was indicated for persons at risk of exposure to the anthrax bacterium ("B. anthracis"), and its label did not specify a route of exposure. See, e.g., 50 Fed. Reg. at 51,059 (Panel) (noting AVA's risk-based indication); AR3291-92 (NIH-approved package insert); PL First Amd. Compl., Ex. A (1979 revised package insert). n8 The Panel recommended, and FDA agreed, that AVA, as licensed, be categorized as safe and

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effective. See 50 Fed. Reg. at 51,059 (Panel); see also id at 51,104. Indeed, in their statement of facts, plaintiffs acknowledge that AVA originally was licensed by NIH "for use against anthrax" -- i.e., without specifying a route of exposure -- and that the Panel recommended that AVA be classified as "'not misbranded.'" See Plaintiffs' Statement of Material Facts as to Which There Is No Genuine Issue, PP 1, 5. n9
n8 Plaintiffs note (see Pl. Br. at 10) that AVA's package insert identified classes of persons presumed to be at risk of exposure to B. anthracis for which the manufacturer recommended immunization. But this has no bearing on the route of exposure issue. AVA's package insert, as noted above, does not specify a route of exposure. Moreover, the classes of persons identified in no way implies a limitation in the use of AVA to people only at risk of cutaneous exposure. To the contrary, in addition to recommending immunization for persons "who may come in contact with" certain imported animal hides and furs, etc., the package insert also recommended immunization for "all personnel in factories handling these materials" and for "individuals contemplating investigational studies involving [B. anthracis]" See AR3291 (NIH-approved package insert) (emphasis added); Pl. First Amd. Compl., Ex. A (package insert as revised in 1979) (emphasis added). Indeed, the Brachman study makes clear that, even for persons "who may come in contact with" imported animal hides and hair, there is a risk of inhalation exposure. See AR3736 at Table 4. [**26] .
n9 For these reasons, and as we explained in our opening brief (see Def. Br. at 37), the Court erred in its preliminary injunction opinion when it stated that the Panel found "insufficient data to license [AVA] for use against inhalation anthrax." Doe v. Rumsfeld, 297 F. Supp. 2d 119, 133 (D.D.C. 2003). We note that, since the Court issued its opinion, FDA, in its Order, plainly has interpreted the Panel's ultimate Category I recommendation as a recommendation that AVA be categorized as safe and effective regardless of the route of exposure. See FDA Order at 259 (noting that, while "FDA has identified points of disagreement with statements in the Panel report," FDA "has determined that the data do support the safety and efficacy of the vaccine and, thus, the agency continues to accept the Panel's recommendation and places AVA in Category I").
[*13] Plaintiffs note (Pl. Br. at 8, 10-11) that FDA, although adopting the Panel's recommendation, disagreed in its Order with certain statements in the Panel report about whether the Brachman study supported the vaccine's [**27] use as protection against inhalation anthrax (suggesting, in effect, that this disagreement represents a "departure" from FDA's proposal). See FDA Order at 259; see also Def. Br. at 20-21, 36-39. But this does not change the fact that FDA and the Panel reached the same conclusion with respect to AVA's license. Moreover, FDA, in its 1985 proposal, was not seeking comment on specific statements in the Panel report; it was seeking comment on its "proposed classification of products into Category I." See 50 Fed. Reg. at 51,002; see also FDA Order at 257 ("the purpose of the opportunity for comment was to allow comment on FDA's responses to the Panel's report and not on the Panel's report directly"). All aspects of FDA's proposed Category I designation for AVA were open for public comment, including, of course, the issue of the vaccine's effectiveness against inhalation exposure.
To the extent the Panel statements are relevant, they show the degree to which the inhalation issue was presented for public comment. The Panel recommended Category I notwithstanding its (erroneous) belief that the Brachman study did not assess the protective effect [**28] of the vaccine against inhalation anthrax. This plainly ''framed . . . for discussion,'" Omnipoint Corp. v. F.C.C., 78 F.3d 620, 631 (D.C. Cir. 1996) (internal citation omitted), the issue whether AVA should be placed in Category I for use against inhalation exposure. n10 Thus, even if the [*14] logical outgrowth doctrine applies, FDA provided the "opportunity for interested parties to offer comments that could persuade the agency to modify its rule." American Water Works Ass'n, 40 F.3d at 1274; see also Spirit of the Sage Council, 294 F. Supp. 2d at 89 (same). n11 For all these reasons, plaintiffs' logical outgrowth argument should be rejected.

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n10 In fact, for other products under review, the Panel did recommend different categories for different product uses. See, e.g., 50 Fed. Reg. at 51,019 (Panel) (for Diphtheria Toxoid, Fluid, manufactured by Texas Department of Health Resources, recommending Category I "as regards its use for booster immunization" and Category IIIA "as regards its use for primary immunization"); Id. at 51,021 (Panel) (for Tetanus Toxoid Adsorbed, manufactured by Michigan Department of Public Health, recommending Category I "as regards its use for booster immunization" and Category IIIA "as regards its use for primary immunization") (license revoked in 2000 at request of manufacturer).
[**29]
n11 Indeed, the October 2001 citizen petition discussed in our opening brief (see Def. Br. at 17-19) specifically requested that FDA "issue a Final Rule on the drug category placement of anthrax vaccine as Category II." AR1313. The petition -- which was signed by plaintiffs' counsel John Michels, Jr. (see AR1344) -argued, among other things, that the scientific evidence the Panel discussed did not establish AVA's effectiveness, see, e.g., AR1316, AR1319, AR1320, and specifically noted the Panel's statement that the vaccine's "'efficacy against inhalation anthrax is not well documented.'" AR1319 (quoting 50 Fed. Reg. at 51,058 (Panel)). Thus, members of the public, including plaintiffs' counsel, plainly interpreted FDA's proposal as raising the issue of the vaccine's effectiveness "against inhalation anthrax." Pl. Br. at 11.
2. Consideration of the IOM Report and Animal Study Data as Corroborating Evidence Was Appropriate
Plaintiffs contend FDA violated APA notice-and-comment [**30] requirements by "relying on studies and data that were not in existence at the conclusion of the comment period." Pl. Br. at 5. Specifically, plaintiffs contend FDA improperly "relied'' on (i) the Institute of Medicine report ("IOM report") prepared by the "Committee to Assess the Safety and Efficacy of the Anthrax Vaccine" ("IOM Committee"); and (ii) three animal studies considered by the IOM Committee and FDA. See Pl. Br. at 6 (citing references in the FDA Order). This argument is wrong.
As an initial matter, the Order is not a rule, but even assuming that it should be treated as a rule, plaintiffs' argument is fully answered by our showing, supra, that the Order satisfies "logical outgrowth" analysis. Where a final rule is a logical outgrowth of the proposal, an agency may consider post-comment sources without submitting those sources for notice and comment. See Spirit of the Sage Council, 294 F. Supp. 2d at 88 ("'a final rule that is a logical outgrowth of [*15] the proposal does not require an additional round of notice and comment even if the final rule relies on data submitted during the comment period'") (quoting Building Indus. Ass'n of Superior California v. Norton, 247 F.3d 1241, 1246 (D.C. Cir. 2001), [**31] cert. denied, 534 U.S. 1108(2002)).
But even if a separate analysis is required, plaintiffs' argument lacks merit. Plaintiffs acknowledge, as they must, that the APA does not bar agencies from using post-comment studies and data in all circumstances. For example, as plaintiffs note, an agency may consider post-comment studies that "provide support for the same decision [the agency] had proposed to take,'" Pl. Br. at 8 (quoting Building Indus. Ass'n, 247 F.3d at 1246), or "supplementary data, unavailable during the notice and comment period, that expand on and confirm' information contained in the proposed rulemaking." Pl. Br. at 8 (quoting Solite Corp. v. E.P.A., 952 F.2d 473, 484 (D.C. Cir. 1991)); accord Community Nutrition Inst. v. Block, 749 F.2d 50, 58 (D.C. Cir. 1984) (Scalia, J.) (distinguishing such data from "entirely new information critical' to the [agency's] determination").
The IOM report and animal studies fall squarely within this rule. First, these post-comment sources merely "provided support for the same decision" FDA proposed in 1985 -- i.e., to place AVA in Category I, thereby confirming [**32] it as a properly-licensed, safe and effective, biological product. See discussion supra Part I.B.1. And second, as explained in our opening brief (see Def. Br. at 41 n.35), and in more detail below (see infra Part II), FDA relied on the Brachman study for proof of AVA's effectiveness. See FDA Order at 259-60. The post-comment sources were

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"supplementary" data ( Solite Corp, 952 F.2d at 484), which corroborated Brachman, et al.'s findings. FDA agreed with these sources, but did not rely on them for proof of effectiveness for purposes of Section 601.25(d)(2). See FDA Order at 260 ("FDA agrees with [*16] the [IOM] report's finding that studies in humans and animal models support the conclusion that AVA is effective against B. anthracis . . . regardless of the route of exposure"). n12 Plaintiffs' post-comment-studies argument, accordingly, should be rejected.
n12 Indeed, FDA reached the same conclusions about AVA's effectiveness in its citizen petition response without citing the IOM report or the animal studies referenced in the Order. See AR1379-81 (concluding that the Brachman study qualifies as a well-controlled study for purposes of evaluating AVA's effectiveness); AR1381 (concluding that "the efficacy analysis actually conducted in the Brachman study includes all cases of anthrax disease regardless of the route of exposure or manifestation of the disease"); Id. (concluding that, consistent with the Brachman study findings, "the indication section of the [vaccine's] labeling does not specify the route of exposure and thus includes both cutaneous and inhalation exposure").
[**33]
3. Plaintiffs Cannot Establish Prejudice from the Alleged Procedural Violations
Even if (i) FDA's decision to confirm AVA's license could somehow be considered a "rule" for purposes of the APA, and (ii) plaintiffs' procedural argument is accepted, the Court should not, as plaintiffs request, "vacate" the Order and "remand the matter to the FDA for proper consideration and determination . . . of the licensing status of AVA." Pl. Br. at 3. Although vacatur is the normal remedy for an APA violation, a plaintiff must still "show prejudice from an agency procedural violation." City of Waukesha, 320 F.3d at 246; accord 5 U.S.C. § 706(2) (in determining whether to "set aside" agency action taken "without observance of procedure required" by law, "due account shall be taken of the rule of prejudicial error"). Plaintiffs cannot make such a showing here.
To establish prejudice on the basis of their "logical outgrowth" argument (i.e., their argument that FDA failed to seek public comment on the vaccine's effectiveness against inhalation exposure (see Pl. Br. at 11)), plaintiffs generally must show (i) that, "had proper notice been provided, [**34] they would have submitted additional, different comments that could have [*17] invalidated the rationale for the revised rule"; or (ii) that "the agency has entirely failed to comply with notice-and-comment requirements, and the agency has offered no persuasive evidence that possible objections to its final rules have been given sufficient consideration'" (in which case prejudice is presumed). City of Waukesha. 320 F.3d at 246 (internal citations omitted). n13
n13 See also id. (leaving "open the possibility that there may be situations" where a plaintiff "is unable to provide a proffer of additional comments for valid reasons"); Sprint Corp., 315 F.3d at 377 (showing of actual prejudice not required in situation similar to (ii)).
Plaintiffs cannot make the first showing because FDA did consider (and reject) arguments against "the rationale" for its effectiveness determination in the course of responding to the citizen petition. See, e.g., AR1376-85 (FDA [**35] citizen petition response dealing at length with, among other things, arguments about the Brachman study); see also supra n.10. In its Order, FDA expressly referred to the citizen petition and its response. See FDA Order at 259 n.2. Plaintiffs likewise cannot make the second showing for the same reason. Even assuming that the Order is subject to rulemaking requirements and that FDA "'entirely failed'" to comply with notice-and-comment procedures (an unwarranted assumption given that FDA in fact provided a 90-day comment period), FDA's citizen petition response provides "'persuasive evidence'" that it considered fully "'possible objections'" to the Order. City of Waukesha, 320 F.3d at 246 (internal citations omitted); compare Sprint Corp., 315 F.2d at 377 (finding reversible error where the effect of a procedural error is "uncertain").

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As for plaintiffs' post-comment studies argument, consideration of a post-comment source "is reversible error" where an agency rule "cannot be supported without it or where there is [a] substantial likelihood [the] rule would have been significantly changed had opportunity for [*18] comment existed. [**36] " American Iron and Steel Inst. v. O.S.H.A., 939 F.2d 975, 1010 (D.C. Cir. 1991) (summarizing, in a parenthetical, Small Refiner Lead Phase-Down Task Force v. E.P.A., 705 F.2d 506, 541 (D.C. Cir. 1983)). As we explained at length in our opening brief, see Def. Br. at 36-39 & 41 n.35, FDA's effectiveness determination is fully, and adequately, supported by the Brachman study, upon which FDA relied for proof of AVA's effectiveness under Section 601.25(d)(2). See also infra Part II (discussing this issue in detail). Although the IOM report and animal studies corroborated FDA's effectiveness decision, see id., the Order plainly can be "supported without [them]." American Iron and Steel Inst., 939 F.2d at 1010. Moreover, and for this same reason, there is no "substantial likelihood" the Order would have changed if FDA had published the IOM report and animal studies for comment. For all these reasons, plaintiffs' procedural APA challenge should be rejected.
II. PLAINTIFFS' SUBSTANTIVE APA CHALLENGE IS MERITLESS
Plaintiffs' substantive challenge is most notable for what plaintiffs do not argue. Plaintiffs do [**37] not, for example, challenge the Order to the extent it confirms AVA as safe for human use, or as safe and effective for use against cutaneous anthrax; they do not challenge FDA's interpretation of the Brachman study, or contend that study is not a controlled clinical investigation for purposes of assessing AVA's effectiveness; and they do not challenge FDA's interpretation of AVA's label as "indicated for active immunization against Bacillus anthracis, independent of the route of exposure." FDA Order at 260. What plaintiffs do raise are two narrow challenges to the Order. They contend, first, that FDA improperly "relied" on animal studies for substantial evidence of AVA's effectiveness; see Pl. Br. at 12-15; and, second, that FDA "failed to take into account significant changes in the manufacturing process of the [*19] vaccine." See Id. at 15. Both contentions are wrong. n14
n14 Plaintiffs acknowledge that the Order's substance should be judged under the "arbitrary and capricious" standard of review set forth in 5 U.S.C. § 706(2)(A). See Pl. Br. at 12 (citing Spirit of the Sage Council, 294 F. Supp. 2d at 90)). We explained the deferential nature of this review at length in our opening brief. See Def. Br. at 26-28. Plaintiffs also acknowledge that judicial review in APA cases should be limited to the administrative record. See Pl. Br. at 20; see also, e.g., Berlex Labs., Inc. v. FDA, 942 F. Supp. 19, 23 (D.D.C. 1996) (refusing to consider extra-record materials submitted by plaintiff). Notwithstanding this latter acknowledgment, plaintiffs, at various points throughout their brief and in their exhibits, cite extra-record sources in support of their position. See, e.g., Pl. Br. at 13 n.9 (citing a Washington Post article); Id. at 19 & n.12 (citing a letter from the Connecticut Attorney General, also attached as an exhibit). Plaintiffs do not seek to "supplement" the record with these extra-record sources (nor could they), and the Court, accordingly, may not consider them. See, e.g., National Treasury Employees Union v. Hove, 840 F. Supp. 165, 169 (D.D.C. 1994) ("consideration of outside evidence to determine the correctness or wisdom of the agency's decisions is not permitted'") (internal citation omitted). In Part IV infra, we explain that plaintiffs' request for discovery should be denied.
[**38]
Plaintiffs' first argument is based on a misreading of the Order. That is, plaintiffs' contention that "the entire substantive basis" of the Order "relies on animal studies and data regarding the efficacy of the vaccine" (Pl. Br. at 15) is simply wrong. FDA has never contended that the animal efficacy rule (see Part 601, Subpart H) formed the basis for its decision to retain the Category I classification for AVA. Rather, as we have explained, see, e.g., Def. Br. at 36-39 & 41 n.35, FDA relied on the Brachman study-a "controlled clinical investigation" -- to provide "proof of effectiveness" for purposes of Section 601.25(d)(2). n15 See also AR1379-81 (citizen petition response explaining that the Brachman study qualifies as an adequate and well-controlled investigation for purposes of 21 C.F.R. § 601.25(d)).
n15 Section 601.25(d)(2), which defines the standard for determining "effectiveness," states that: "proof of

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effectiveness shall consist of controlled clinical investigations as defined in § 314.126 of this chapter, unless this requirement is waived on the basis of a showing that it is not reasonably applicable to the biological product or essential to the validity of the investigation, and that an alternative method of investigation is adequate to substantiate effectiveness." 21 C.F.R. § 601.25(d)(2).
[**39]
[*20] Plaintiffs are correct that FDA cited the IOM Committee's findings with respect to animal data and three animal studies in its Order. See FDA Order at 260; see also Def. Br. at 40-41 (reviewing these sources). But FDA did not rely on animal studies to establish effectiveness under Section 601.25; it relied on the Brachman study for that point, and considered the IOM Committee's findings and the animal studies as corroborating evidence. n16 See FDA Order at 260 ("FDA agrees with the [IOM] report's finding that studies in humans and animal models support the conclusion that AVA is effective against B. anthracis strains that are dependent upon the anthrax toxin as a mechanism of virulence, regardless of the route of exposure") (emphasis added); id at 260 n.5 (citing three animal studies from the IOM report). n17
n16 As noted in our opening brief (see Def. Br. at 39), FDA also considered the Panel's summary of the CDC surveillance data as corroborating evidence of effectiveness. See FDA Order at 260 .
n17 The animal studies FDA considered as corroborative evidence are: P.F. Fellows, et al., "Efficacy of a Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin," 19 Vaccine 3241-47 (2001) ("Fellows") (AR621-27) (cited in the IOM report at AR3397); B.E. Ivins, et al., "Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys," 87 Salisbury Medical Bulletin 125-26 (1996) ("Ivins, Salisbury") (AR628-29) (cited in the IOM report at AR3398); B.E. Ivins, et al., "Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques," 16 Vaccine 1141-48 (1998) ("Ivins, Vaccine") (AR630-37) (cited in the IOM report at AR3398).
[**40]
Plaintiffs contend these studies are "inadmissible" (Pl. Br. at 12), but offer no support for that point. Nor could they. Section 601.25 specifically states that clinical investigations "may be corroborated" by data which, standing alone, would not be adequate to substantiate effectiveness. See 21 C.F.R. § 601.25(d)(2) ("investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing"). And even without Section 601.25, plaintiffs offer no [*21] reason why FDA should be precluded from considering the IOM Committee's findings with respect to animal data. That Committee was specifically charged by Congress with considering AVA's safety and effectiveness, including the "correlation of animal models to safety and effectiveness in humans." See H.R. Rep. No. 106-371, at 254 (1999).
In terms of their weight, the animal studies FDA considered as corroborating evidence demonstrate that humans and nonhuman primates both manifest anthrax disease after infection with B. anthracis and that both are protected by immunization with AVA, which elicits [**41] the production of antibodies to protective antigen ("PA"). See Def. Br. at 40-41 (summarizing animal data); AR626 (Fellows); AR629 (Ivins, Salisbury); AR635 (Ivins, Vaccine); see also AR3387-88 (IOM); Def. Br. at 10-11 & 39 n.34 (explaining the pathogenesis of B. anthracis and the importance of PA antibodies to establishing immunity).
It is true that researchers have not yet established a quantitative correlation of the protective levels of PA antibodies in animals with the antibodies obtained after immunization in humans. See, e.g., AR 629 (Ivins, Salisbury); see also

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AR3392 (IOM). n18 But again, the animal studies were not the basis for FDA's effectiveness determination; they simply corroborated that determination and were cited to illustrate additional support for FDA's decision. FDA's consideration of the IOM Committee's findings and animal data as corroborating evidence thus plainly is reasonable, and certainly not arbitrary, capricious, or an abuse of discretion. See, e.g., Bristol-Myers Squibb Co. Shalala, 923 F. Supp. 212, 220 (D.D.C. 1996).
n18 We note that, notwithstanding the lack of a quantitative correlation between human and animal models, see AR3329 (IOM), the IOM Committee concluded, based on "evidence from studies in both humans and animals," that "AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalation anthrax." AR 3323.
[**42]
[*22] Plaintiffs' second basis for challenging the Order is difficult to follow. Plaintiffs note that there were two prior versions of the anthrax vaccine -- the PA-based vaccine manufactured by the Department of Defense ("DoD") at Fort Detrick (which Brachman, et al., used in their study), and a subsequent PA-based vaccine manufactured by Merck Sharp & Dohme. See Pl. Br. at 15 (discussing FDA Order at 260). Plaintiffs then state that "typically, these types of changes in manufacturing and formulation require a new license application and testing." Pl. B. at 16. But the "changes in manufacturing" plaintiffs cite occurred prior to licensure of AVA by NIH (the manufacturer at the time of licensure was the Michigan Department of Public Health). By definition, therefore, these "changes" could not have required a "new" license. Compare 21 C.F.R. § 601.12 (requiring manufacturers to submit to FDA for approval changes made to manufacturing after licensure is approved).
Moreover, plaintiffs' argument also misunderstands FDA's comparability policy, under which a manufacture may use data gathered with a previous version of a product to support the effectiveness [**43] of a comparable version of the same product after a manufacturing change. See AR 1400 (FDA comparability guidance). In its Order, FDA explained at length the basis for its conclusion that AVA is comparable to the original DoD vaccine used in the Brachman study. See FDA Order at 260-61; Def. Br. at 21-22 & n.23. Indeed, plaintiffs' concession that AVA is effective for cutaneous exposure presumably is based on the Brachman study. For all these reasons, plaintiffs' substantive APA challenge should be rejected.
III. AGENCY COMPLIANCE WITH EXECUTIVE ORDER 13,132 IS NOT SUBJECT TO JUDICIAL REVIEW
Plaintiffs contend the Order should be "invalidated" because it "violates federalism concerns." Pl. Br. at 16. In support, plaintiffs cite Executive Order ("EO") 13,132, 64 Fed. Reg. [*23] 43,255 (Aug. 4, 1999), which establishes guidelines and criteria for federal agencies to follow in formulating and implementing policies with federalism implications. See Pl. Br. at 17-20. According to plaintiffs, FDA violated EO 13,132 because it failed to consult with "State and local officials'" prior to issuing the Order. See Pl. Br. at 19 (quoting EO 13,132, § [**44] 6(b)). This farfetched claim, which plaintiffs did not even raise in their complaint, is meritless for numerous reasons.
First, FDA's compliance with EO 13,132 is not subject to judicial review. Section 11 expressly states the EO is not intended to create privately enforceable rights:
Judicial Review. This order is intended only to improve the internal management of the executive branch, and is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers, or any person.
EO 13,132, § 11. Courts have interpreted similar language in other executive orders as precluding judicial review of an agency's compliance with the order's underlying provisions. n19 In particular, courts have noted that judicial review is

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not available for agency compliance with EO 12,612, 52 Fed. Reg. 41,685 (Oct. 26, 1987), the predecessor executive order to EO 13,132 which contained a provision identical to Section 11. n20 This is consistent with the test courts [*24] apply in determining whether statutes create privately enforceable rights, where "the dispositive question" is "whether [**45] Congress intended to create any such remedy." Transamerica Mortgage Advisors, Inc. v. Lewis, 444 U.S. 11, 24 (1979); see also Alexander v. Sandoval, 532 U.S. 275, 285-287 (2001) ("the judicial task is to interpret the statute Congress has passed to determine whether it displays an intent to create not just a private right but also a private remedy"). EO 13,132 expressly disclaims any intent to create privately enforceable rights.
n19 See State of Michigan v. Thomas, 805 F.2d 176, 187 (6th Cir. 1986) ("given this clear and unequivocal intent that agency compliance with Executive Order 12,291 not be subject to judicial review, we hold that the Order provides no basis for rejecting the [agency's] final action"); cf. In re Surface Mining Regulation Litig., 627 F.2d 1346, 1357 (D.C. Cir. 1980) (stating general rule that "executive orders without specific foundation in congressional action are not judicially enforceable in private civil suits"). .
n20 See Hecht v. Barnhart, 217 F. Supp. 2d 356, 359-60 (E.D.N.Y. 2002) (denying motion to remand to agency for purpose of complying with various executive orders, including EO 12,612, because the executive orders at issue did not create private rights of action); State of Kansas ex rel. Todd v. United States, 995 F.2d 1505, 1511 (10th Cir. 1993) ("judicial review is not available for the [agency's] alleged violations of the various Executive Orders [including EO 12,612], which [plaintiff] concedes in its brief"); Murphy v. Smithkline Beecham Animal Health Group, 898 F. Supp. 811, 815 (D. Kan. 1995) (citing State of Kansas holding regarding EO 12,612, and noting that "the order serves only as a guideline for executive agencies"); cf. Public Citizen v. H.H.S., 795 F. Supp. 1212, 1221 (D.D.C. 1992) (noting that EO 12,612 "specifically states that it does not create a private right of action").
[**46]
Second, even if Section 11 were not dispositive, plaintiffs would lack standing to challenge FDA's compliance with EO 13,132. The executive order (which bears the title "Federalism") is addressed to "the division of governmental responsibilities between the national government and the States"; EO 13,132 (preamble); it does not purport to govern private individual rights. See City of Roseville v. Norton, 219 F. Supp. 2d 130, 147-48 (D.D.C. 2002) (holding, in analogous context, that private citizens lack standing to bring claims under the Tenth Amendment), aff'd on other grounds, 348 F.3d 1020 (D.C. Cir. 2003), petition for cert. filed, No. 03-1156 (Feb. 11, 2004). Moreover, the "federalism" interest plaintiffs seek to raise on behalf of states relates to an issue -- vaccine safety (see Pl. Br. at 18) -which plaintiffs do not even challenge in this litigation. See Singleton v. Wulff, 428 U.S. 106, 115 (1976) (noting that, in "third-party" standing context, courts consider in part whether "the relationship between the litigant and the third party may be such that the former is fully, or very nearly, as effective a proponent [**47] of the right as the latter").
[*25] Third, EO 13,132 does not apply to FDA's decision confirming AVA as a properly-licensed biological product. The EO provision plaintiffs cite -- § 6(b) (see Pl. Br. at 19) -- requires agencies, in certain circumstances, to "consult[]" with State and local officials before "promulgating any regulation that has federalism implications, that imposes substantial direct compliance costs on State and local governments, and that is not required by statute." EO 13,132 § 6(b) (emphasis added). n21 But these conditions are not applicable to the FDA Order, which, among other things: (a) is not a "regulation"; see supra Part LA; (b) does not purport to address state law or the relationship between the states and the federal government; and (c) does not impose "compliance costs" on state and local governments. n22 For all of these reasons, plaintiffs' challenge based on EO 13,132 should be rejected.
n21 Plaintiffs contend this consultation process "is to be achieved through the normal APA

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notice-and-comment procedures" (Pl. Br. at 18), but nothing they cite even remotely supports that claim. Indeed, EO 13,132, which does not mention the APA, expressly states it is not intended to create "procedural" rights. See EO 13,132, § 11. [**48]

n22 Plaintiffs claim the Order has "substantial direct effects on the States" for purposes of EO 13,132 because DoD, under its mandatory vaccination program ("AVIP"), requires inoculation of State National Guard members called for duty in the National Guard of the United States. See Pl. Br. at 17-18. But the burdens plaintiffs cite -- health-related "strains on the economic and family state system" (id at 18) -- are not ones "imposed" by FDA. See EO 13,132, § 6(b). Moreover, to the extent plaintiffs challenge DoD's conduct (which, as plaintiffs note (see Pl. Br. at 1), is not at issue in their motion), AVIP raises no federalism issues. States have no constitutional authority over their guard members ordered to active federal duty in the U.S. National Guard. See Perpich v. Department of Defense, 496 U.S. 334, 347 (1990) (members of state guard "ordered into federal service with the National Guard of the United States lose their status as members of the state militia during their period of active duty"); Id. at 348 (when state guard members called into federal service, "the second Militia Clause is no longer applicable").
[**49]
IV. PLAINTIFFS ARE NOT ENTITLED TO DISCOVERY
Finally, in the event their summary judgment motion is denied, plaintiffs seek discovery "to ensure the administrative record is complete" and to "explore the extent to which the DoD [*26] improperly influenced the FDA's licensing and rule-making process." Pl. Br. at 3 n.3; see also id. at 21-23. Neither ground provides a basis for discovery in this case.
Plaintiffs begin their argument by acknowledging, as they must, that discovery "is not routinely granted in APA record review cases." Pl. Br. at 20. But plaintiffs then confuse the issue by discussing circumstances under which a court may supplement an administrative record with specifically-identified documents (something plaintiffs do not seek). See Id. & n.13; see also discussion supra n.11; James Madison Ltd. v. Ludwig, 82 F.3d 1085, 1095 (D.C. Cir. 1996) (describing all of the circumstances cited by plaintiffs as related to "supplementation" issues), cert. denied, 519 U.S. 1077 (1997). Although courts permit supplementation by a plaintiff in certain narrow instances (but never to determine the wisdom of [**50] an agency's decision), discovery of an agency's decisionmaking process is permissible in only two circumstances: (i) where there is a "strong showing of bad faith or improper behavior"; Community for Creative Non-Violence v. Lujan, 908 F.2d 992, 997 (D.C. Cir. 1990); or (ii) where discovery "provides the only possibility for effective judicial review and when there have been no contemporaneous administrative findings." Id. (citing Overton Park, 401 U.S. at 420); accord Saratoga Dev. Corp. v. United States, 21 F.3d 445, 457-58 (D.C. Cir. 1994). Neither exception applies here.
For example, plaintiffs contend discovery is appropriate because FDA did not "consider[] all the relevant evidence." Pl. Br. at 21 (emphasis in original). In support, plaintiffs attach a so-called list of "relevant scientific studies concerning the anthrax vaccine, none of which were apparently considered by the FDA." Id. But this is an (improper) argument about the merits of FDA's decision, see infra n.20, not an argument for discovery. See National Treasury Employees Union v. Seidman, 786 F. Supp. 1041, 1046 (D.D.C. 1992) [**51] (rejecting request for discovery of [*27] information plaintiff alleged the agency "should have considered"; noting in part that such discovery "would create a new administrative record for the purpose of second-guessing the agency"). Indeed, notwithstanding the statement in their argument heading (see Pl. Br. at 21), plaintiffs do not contend that FDA excluded evidence it considered from the record, or that it failed to produce the "whole" record; they contend only that FDA failed to consider evidence it should (by plaintiffs' reckoning) have considered. Discovery can shed no light on that issue; it is undisputed that the sources in

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plaintiffs' exhibit were not considered. Plaintiffs, tellingly, do not even argue that the sources they cite undermine in any way the merits of FDA's effectiveness decision.
Nor, contrary to plaintiffs' suggestion, is it in any way significant that FDA failed to consider every conceivable article concerning a widely-discussed topic such as AVA. In making effectiveness determinations, FDA is required to rely on scientific data -- i.e., primary data adduced from "controlled clinical investigations." See 21 C.F.R. § 601.25(d)(2). [**52] None of the sources in plaintiffs' list contains such data. n23 Rather, the sources that discuss effectiveness -- and many of the sources are concerned primarily, if not solely, with issues of safety (which plaintiffs do not challenge) -- merely review, summarize, and/or analyze the existing data and literature. This is no surprise. As we have explained, see, e.g., Def. Br. at 39, the only controlled [*28] clinical investigation of effectiveness involving anthrax vaccine -- the Brachman study -- was conducted in the 1950s; for ethical and other reasons, there have been no subsequent controlled clinical effectiveness studies. See, e.g., FDA Order at 260 n.4. n24
n23 After receiving plaintiffs' brief, FDA obtained and reviewed the sources listed in plaintiffs' Exhibit 3. By briefly discussing these sources, we in no way suggest they should be considered by the Court. They may not. See, e.g., National Treasury Employees Union v. Hove, 840 F. Supp. at 169 ("consideration of outside evidence to determine the correctness or wisdom of the agency's decision is not permitted'") (internal citation omitted); Doraiswamy v. Secretary of Labor, 555 F.2d 832, 842 (D.C. Cir. 1976) (affirming denial of discovery where plaintiffs challenged "the correctness" of the agency's decision as opposed to the "fullness of the reasons" given). [**53] .
n24 Plaintiffs also attempt to raise questions about the Vaccine Adverse Event Reporting System ("VAERS") reports in the record, suggesting a "discrepancy" because the record does not include all VAERS reports from 2003. See Pl. Br. at 21. But this is just another red herring. As the Order states, FDA considered VAERS reports in reviewing "labeling revisions [to AVA's package insert] approved by FDA in January 2002." See FDA Order at 260. Thus, the VAERS reports in the record -- which, for all but a small number of pages, encompass the time period from 1993 through 2001 -- are the reports FDA considered during that process. See AR1418-AR3227.
Plaintiffs also argue they are entitled to discovery into the "validity of the administrative process" under the "bad faith" exception, because (plaintiffs say) they have "evidence of strong DoD influence and pressure upon FDA." Pl. Br. at 22. This is meritless. Agencies are entitled to a "presumption of administrative regularity and good faith." TOMAC v. Norton, 193 F. Supp. 2d 182, 195 (D.D.C. 2002). To overcome that presumption, [**54] and justify "court-sanctioned probing of the administrative process," a plaintiff must make a "'strong showing' of corrupt decisionmaking." Saratoga Dev. Corp., 21 F.3d at 458; see also Balaton. Inc. v. Reno, 93 F. Supp. 2d 61, 62 (D.D.C. 2000) (assertion that agency "rubber stamps decisions . . . hardly makes out a showing of the kind of devious or corrupt behavior that could qualify as bad faith'"); TOMAC, 193 F. Supp. 2d at 195. Conclusory statements of bad faith are insufficient. See James Madison Ltd., 82 F.3d at 1095 (citing Overton Park, 401 U.S. at 420).
Plaintiffs have not even come close to making this showing. Plaintiffs "evidence" is a series of (what appear to be) almost-five-year-old internal DoD e-mails purporting to discuss a 1999 congressional hearing at which representatives from DoD and FDA testified. See Pl. Br. at [*29] 22-23 & Ex. 4. Plaintiffs note (see Id. at 22) that one email states "'DoD is calling all the shots'" onsite at BioPort (AVA's manufacturer). But even taking this assertion at face value, nothing in DoD's relationship with BioPort suggests that FDA's [**55] decisionmaking process was "corrupt." To the contrary, during this time period, FDA actively carried out its oversight responsibilities with respect to AVA's manufacturer. See AR3511-14 (detailing FDA inspections between 1998 and 2001); AR1326 (citizen petition noting that "FDA has regularly inspected the vaccine production facility").

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Indeed, in January 1998, the Michigan Biologics Products Institute ("MBPI"), AVA's prior manufacturer, voluntarily suspended production of AVA to begin a comprehensive renovation of its anthrax vaccine production facility. See AR1388 (FDA citizen petition response). These renovations, while not required by FDA, see id, were corrective actions voluntarily undertaken by MBPI as part of a comprehensive plan to respond to a 1997 Notice of Intent to Revoke letter issued by FDA, see AR1388-89, and it was necessary for FDA to approve the renovations before MBPI could resume shipping licensed anthrax vaccine made in the renovated facilities. See AR1388. Thus, BioPort, which purchased MBPI in September 1998, see AR1377 n.l, did not even ship any licensed finished product anthrax vaccine, made after January 1998, until FDA approved two [**56] license supplements related to the renovations, the last of which was approved in January 2002. n25 See AR 1388.
n25 Indeed, plaintiffs contend that DoD, in 2000, was forced to "suspend[] AVA vaccinations for all but a limited number of personnel because of a shortage of the vaccine." First Amd. Compl. P 52.
Finally, plaintiffs argue that the very fact there is no evidence of DoD "influence" in the administrative record justifies discovery into the question whether "DoD improperly or unduly [*30] influenced the FDA's actions with respect to the [Order]." See Pl. Br. at 23. But this turns the presumption of regularity on its head. Courts do not authorize discovery to find evidence of bad faith or some interagency "conspiracy"; there is a presumption of administrative regularity, and, absent strong evidence of impropriety, judicial review is confined to the agency record. See TOMAC, 193 F. Supp. 2d at 195. We note, moreover, that the Order is not limited to AVA; it addresses [**57] the range of products discussed in the Panel's report and FDA's 1985 proposal. See, e.g., FDA Order at 257 (Table I).
The Order sets out, at length, the reasons for FDA's decision to confirm AVA as a properly-licensed, safe and effective biological product. The administrative record is comprehensive, and provides ample support for FDA's decision. The Order and the record together make clear that FDA reached its decision on the merits, without reference to extraneous considerations or pressures. Plaintiffs have submitted no evidence suggesting otherwise, and its request for discovery, accordingly, should be denied.
[*31] CONCLUSION
For all the foregoing reasons, the Court should deny plaintiffs' motion for summary judgment.
Respectfully submitted,
PETER D. KEISLER
Assistant Attorney General
ROSCOE C. HOWARD, JR.
United States Attorney
BRIAN D. BOYLE
Principal Deputy Associate Attorney General
SHANNEN W. COFFIN
Deputy Assistant Attorney General
/s

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JOSEPH H. HUNT VINCENT M. GARVEY CRAIG M. BLACKWELL, DC Bar # 438758 RONALD J. WILTSIE ANDREW H. TANNENBAUM Attorneys Civil Division U.S. Department of Justice P.O. Box 883 Washington, D.C. 20044 [**58] Tel: (202) 307-1401 Fax: (202) 616-8470 Attorneys for defendants Date: April 7, 2004

 
 Page 1
View U.S. District Court Opinion JOHN DOE # 1 et al., Plaintiffs, v. DONALD H. RUMSFELD et al., Defendants. Civil Action No.: 1:03CV00707(EGS) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 707; 2004 U.S. Dist. Ct. Motions LEXIS 6277 April 7, 2004 Motion for Summary Judgment
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s) TITLE: [**1]
PLAINTIFFS' OPPOSITION TO DEFENDANTS' MOTION FOR SUMMARY JUDGMENT TEXT: Plaintiffs John and Jane Doe one through six, by counsel, submit their Opposition to the Government's Motion for Summary Judgment, pursuant to Fed. R. Civ. P. 56 and this Court's Order of January 16, 2004.
I. PRELIMINARY STATEMENT Although the Defendants apparently treat this case as a routine challenge to administrative rulemaking, in reality, the straightforward issue before the Court affects the health of millions of service members and contractors who either received or will receive the Anthrax Vaccine Adsorbed ("AVA"). Because this litigation involves the first widespread use of a bioweapon vaccine in response to a public health threat, the questions raised with regard to the integrity of Defendants' approval process and decision to use the vaccine are critical to this nation's preparations for attacks with weapons of mass destruction. The history of AVA dates back some 50 years. The primary FDA decision, albeit in a preliminary form, issued nearly 20 years ago. Defendant DoD's policies and decisions regarding AVA occurred during the last 15 years, and primarily in the last 7 years. Yet [**2] with all the information that exists concerning AVA, its development and its [*2] approval, comprising hundreds of thousands of pages of relevant documents, and with 9 lawyers analyzing the issues before the Court, the principal argument of Defendants DoD and FDA is that AVA is properly licensed "because we said so." In fact, the Government's Motion for Summary Judgment and supporting Memorandum of Law systematically ignore FDA's complete failure to follow the requirements of the Administrative Procedures Act, 5 U.S.C. § 706 (2003). Instead, the Defendants ponderously retrace the licensing history of the vaccine, omitting key details along the way, in an attempt to obfuscate FDA's regulatory failure. In attempting to show that FDA's determination that the vaccine is

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safe and effective (and therefore presumably properly licensed) against inhalation anthrax is proper, the government baldly distorts the record, misrepresents the findings upon which the vaccine's license is supposedly based, and provides key evidence demonstrating why AVA is still a drug unapproved for its intended use.
Plaintiffs respectfully ask the Court to keep in mind the nature of [**3] this case. The relevant statute, 10 U.S.C. § 1107, says nothing about whether a drug or biologic is safe or effective or even licensed. The statute simply prohibits the use of investigational new drugs or drugs unapproved for their intended use on service members without the informed consent of those service members. In its decision suspending the anthrax vaccine immunization program ("AVIP") on December 22, 2003, this Court determined that the vaccine was investigational (or that the plaintiffs were likely to prove it was investigational) because FDA failed to complete its licensing review and because there was an outstanding investigational new drug application still in effect. See Memorandum Opinion at p. 29, December 22, 2003.
[*3] Eight days later, FDA hurriedly and (the government would have the Court believe) coincidentally completed processing on a final rule that had been pending for 18 years. See Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 69 Fed. Reg. 255 (Jan. 5, 2004) ("FDA Rule" or "Final Rule"). Base on the new Final Rule, this Court properly reassessed its ruling and lifted [**4] the injunction. The Court then asked the parties to move for summary judgment on the issue of whether the Final Rule issued by FDA was proper. But the real heart of this dispute remains whether the vaccine is an IND and/or a drug unapproved for its intended use. If the Court finds that FDA did not issue its Final Rule in accordance with statutory requirements, then the AVA is not properly licensed for its intended use as prophylactic against inhalation anthrax. Under the circumstances, the Court should reinstate its injunction until the FDA brings the vaccine's license into compliance.
The Defendants' Motion for Summary Judgment simply ignores the regulatory compliance issue. By submitting page after page of irrelevant factual information, the Defendants attempt to "paper" the Court into disposing of this case by telling the Court that FDA has found the vaccine to be safe, effective and not misbranded, and that this decision is effectively unreviewable.
The numbing detail of the alleged FDA review does not save the Defendants' case because all of their recited facts are irrelevant to the real issues in this case. The numerous omissions in the Defendants' recitation of events n1 and [**5] the Defendants' continuing inability to explain the fact that both the original, and only, human study of an [*4] anthrax vaccine and the assessment of the FDA's own expert panel categorically conclude that there is insufficient evidence to license the vaccine against inhalation anthrax, effectively doom the Defendants' motion. Instead, the numerous intentional omissions of events and determinations in the record provide overwhelming evidence that the failure of the FDA to reopen the comment period for AVA is fatal to vaccine's license status. n2
n1 For example, Defendants simply fail to discuss, or even acknowledge, the IND applications and process begun in 1996; the application goes to the very issue under consideration now, i.e. did FDA properly issue its Final Rule?
n2 Defendants also mysteriously raise the issue of Plaintiffs' standing, although the Court dealt conclusively with this matter in its Opinion of December 22, 2003. See Memorandum Opinion at pp. 20-22.
The Defendants are not entitled [**6] to summary judgment on their motion because the undisputed facts in this case show that:
a. The FDA's Final Rule ignores the findings of both the studies and the expert report upon which the final rule is based;
b. There has never been a statistically valid trial of AVA against inhalation anthrax involving human subjects;

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c. The FDA's Final Rule is improperly based on animal studies with the vaccine; and
d. The FDA engages in regulatory sleight of-hand to approve AVA when it is undisputed that the only controlled field study used to validate AVA effectiveness was performed with a different vaccine.
For these and other reasons, this Court should deny the Government's Motion for Summary Judgment, void the Final Rule issued on December 30, 2003, order the FDA to follow proper statutory requirements in its licensing process for AVA, and reinstate the injunction on further inoculations.
[*5] II. ARGUMENT
A. The FDA's Final Rule Relies on Invalid Studies
It is undisputed that the "most significant" piece of evidence relied on by FDA to establish the efficacy of the AVA is the so-called Brachman study; the only "controlled" field study of the vaccine involving [**7] human participants. See Defendants' Memorandum of Points and Authorities (filed March 3, 2004)("Defendants' Memo") at p. 36. FDA's reliance on the study to support its determination that the vaccine is effective against inhalation anthrax is flawed in at least two respects.
First, Brachman himself indicated at the time of the study, and on numerous occasions thereafter, that there was insufficient evidence (because of a paucity of cases) to determine if the vaccine was effective against inhalation anthrax. Although the government engages in pages of double talk in an effort to justify its complete reliance on the Brachman study for its finding, it cannot escape an essential fact, namely, that Brachman himself has never asserted that his study demonstrates AVA's effectiveness against inhalation anthrax. See Plaintiff's Memorandum in Support of Its Motion for Summary Judgment (filed March 3, 2004)(Plaintiff's Memo) at p. 8; Brachman, et al., "Field Evaluation of a Human Anthrax Vaccine," 52 Am. J. of Pub. Health 632 (1962).
Likewise, FDA's own expert panel determined in 1985 that there were too few instances of overlap between exposure to inhalation anthrax and vaccine [**8] use to validate AVA's effectiveness. It categorically stated that the vaccine's effectiveness against inhalation anthrax could not be determined, although it did recommend approving AVA as a Category I biologic. See Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51, 002 (December 13, 1985).
[*6] In an effort to get around this fatal limitation, the government engages in an analysis that can only be described as bizarre. Ignoring the clear language of the Brachman study, FDA simply notes that because Brachman included inhalation cases in his total count of cases for the determination of vaccine effectiveness, this must mean that the vaccine is effective regardless of route of exposure. See Defendants' Memo. at pp. 16-17; FDA Rule at 259-60.
In other words, even though the researcher himself repudiated any conclusion about the effectiveness of AVA against inhalation anthrax, the fact that he included inhalation cases (apparently by mistake) in determining the total effectiveness of the vaccine means that the FDA can disregard his specific determination with regard to efficacy and inhalation anthrax. This, [**9] of course, is pure nonsense.
Second, a recent statistical analysis of Brachman data, using analytical tools unavailable to Brachman in 1962, reveals that there is no statistical correlation between vaccination with AVA and inhalation anthrax protection. See Declaration of Dr. Walter Schumm, Colonel, USAR (Ret.) attached as Exhibit "1"; Schumm, et al., A Statistical Re-Analysis of the Relationship Between Anthrax Vaccination and Anthrax Infections in Goat Hair Mills in the 1950s, March 2004, attached as Exhibit "1-A". n3
n3 This Circuit has considered extra-administrative record documents when there are allegations that the agency either deliberately excluded from the record evidence adverse to its position, or was negligent in failing

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to include such documents. Kent Cty, Del. Ct. v. US EPA, 963 F.2d 391, 395-6 (D.C. Cir. 1992), citing San Louis Obispo Mothers for Peace v. NRC, 751 F. 2d 1287, 1327 (D.C.Cir. 1984) (subsequent history omitted). See also Esch v. Yeutter, 876 F.2d 976, 991 (D.C. Cir. 1989)(there are as many as eight different bases when extra-record evidence may be considered by the reviewing court, including when agency action is not adequately explained, when the agency failed to consider relevant factors, and in cases where relief is at issue, particularly at the preliminary injunction stage)(emphasis added).
[**10]
[*7] Of particular note in Dr. Schumm's analysis is his validation of Dr. Brachman's initial assessment that it was impossible to determine any correlation of effectiveness for AVA against inhalation anthrax. Dr. Schumm's studies also validate the Institute of Medicine's similar determination that the small number of inhalation cases makes it impossible to validate the effectiveness of the vaccine. Id. at para. 5; See also Strom, et.al., Institute of Medicine, "The Anthrax Vaccine: Is it Safe? Does it Work?" (2002) ("IOM Report") found at (http: //www.nap.edu/catalog/10310.html) at pp. 58-59.
In addition to statistically validating the findings of Brachman and the Expert Panel that there was no valid evidence of efficacy for inhalation anthrax, Dr. Schumm's analysis notes that the CDC surveillance data, used by FDA to support the effectiveness of the vaccine, is statistically invalid and entitled to no weight whatsoever. Schumm, et al., at para. 5. Schumm further notes that, using modern statistical analyses, the vaccine used in the Brachman field trial (which FDA uses as a surrogate for AVA) does not protect against infection by any route in the majority of [**11] cases.
Even taking both cutaneous and inhalation anthrax into account, we found that the vaccine's protective effects were not significant in 75% of the mills tested. In addition, partial vaccination status was never a significant predictor of infection risk, suggesting that incomplete vaccinations were relatively ineffective, even in preventing cutaneous anthrax infection.
Id., at para. 4.
Of course, had the FDA properly reopened the rule-making comment period for the vaccine when it began considering new information after 1985, as required by law, this information could have been before the FDA and a meaningful assessment of the vaccine' s efficacy could have been made. Instead, the FDA elected to proceed with certifying the Final Rule as quickly as possible, given that this Court was aware of the [*8] numerous deficiencies in the DoD's anthrax vaccination program. n4 The end result is a Final Rule that not only contradicts the specific determinations found in the reports upon which the Final Rule ostensibly relies, but also uses a tortured analysis in an effort to escape those inherent contradictions.
n4 In its press statement of December 30, 2003, announcing the Final Rule, the FDA calmly announced that it issued its determination in an effort to influence this litigation:
A recent ruling by United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as "investigational" with regard to protecting against inhalation anthrax. Today's Final Rule and Order make it clear that FDA does not regard the approved anthrax vaccine as "investigational" for protection against inhalation anthrax. FDA's final determination of the safety and effectiveness of the anthrax vaccine, independent of route of exposure, as well as its conclusion regarding the Expert Panel's Report, being announced today in the Final Order, are relevant and should be considered in any further litigation in this matter."
A copy of this press statement can be found at http: //www.fda.gov/bbs/topics/News/2003/ New01001.html. It is

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a rare event indeed for a federal agency to issue an administrative ruling followed by a press release, noting the agency's specific intent to influence ongoing litigation.
[**12]
Accordingly, there are numerous issues of material fact at the heart of the FDA's action in issuing the final rule approving the status of the vaccine as safe and effective. Their own documents show that Defendants cannot demonstrate that the approval of AVA was done in a proper manner. On this basis the court should deny the Government's motion.
B. The FDA's Decision Also Relies on the Inappropriate and Improper Use of Animal Data to Validate the Vaccine's Effectiveness
The FDA does not limit the basis for its Final Rule to unjustified reliance on the flawed Brachman study. Other assessments of AVA relied on by the FDA are heavily [*9] influenced by the use of various animal studies conducted by the DoD in effort to determine AVA's efficacy against inhalation anthrax. See Defendants' Memo at p. 41.
Defendants in their brief admit that use of animal studies to substantiate AVA's effectiveness is improper under the requirements of 21 CFR § 601.25 (d)(2). Id. at p. 41, n. 35. Defendants try to dance away from this particular problem by noting that FDA relied solely on the Brachman study as "proof of effectiveness" for purposes of § 601.25 (d) (2), and [**13] the animal studies, CDC surveillance data and other support data and studies were considered merely as "corroborating" evidence. See Defendants' Memo. at p. 41, n. 35.
But, as has been discussed previously, the Brachman study specifically states that it could not determine the effectiveness of AVA with regard to inhalation anthrax. The FDA's own expert panel also found that it could not rely on the Brachman study to determine inhalation anthrax efficacy. Under the circumstances, the government's reliance on animal data for any corroboration is improper, especially since it is undisputed that no correlate of immunity has been found between any of the animals tested and human beings, a requirement for use of animal studies. See Plaintiff's Memo. at pp. 12-15 and authorities cited therein.
A cursory review of information contained in the Defendants' Memo. clearly shows that the FDA's use of animal data is key to its finding that AVA is safe and effective, if for no other reason than AVA's only controlled study of AVA does not support such a conclusion. See Defendant's Memo at pp.40-41, n.35. Following the determination of FDA's Expert Panel that there was insufficient evidence [**14] to establish the effectiveness of the vaccine against inhalation anthrax, FDA realized it needed some [*10] other source of information to support its rejection of the Panel's conclusions. The only testing data in the record on efficacy that came into existence after the Expert Panel made its findings is animal testing data. See Administrative Record Document ("AR") AR 3385-88. The use of such impermissible data is clear evidence of the arbitrary and capricious nature of the FDA decision-making process with regard to AVA. This improper reliance on questionable data provides yet another basis for the Court to deny the Government's motion.
C. There Has Never Been a Properly Controlled Field Test of AVA Because it is a Different Vaccine From the Vaccine Used in the 1962 Brachman Study
As noted in both the Final Rule and the Defendants' Memo., the vaccine used in the Brachman study was not the same vaccine that is the subject of this litigation. In fact, the original vaccine was manufactured by the DoD at Fort Detrick, Maryland, and went through at least two other manufacturing variations to arrive at its current formulation AVA. See Defendant's Memo at pp.11-12. [**15]
As noted in the Plaintiff's Memorandum at p. 15-16, a manufacturer may not validate the safety and efficacy of its product by relying on testing data from a product manufactured by another entity, absent special circumstances. In

2003 U.S. Dist. Ct. Motions 707, *10; 2004 U.S. Dist. Ct. Motions LEXIS 6277, **15

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contrast, FDA's so-called "comparability policy" allows a single manufacturer to make manufacturing changes to a product without performing additional clinical studies to demonstrate the safety and efficacy of the successor product. See Guidance Concerning Demonstration of Comparability of Human Biological Products Including Therapeutic Biotechnology-Derived Products Center for Biologics Evaluation and Research (CBER), April 19, 1996, found at http: //www.FDA.gov/cber/gdlns/comptest.txt ("FDA Guidance").
[*11] But of course in this case there is no manufacturer creating a successor product. Instead, there are four different variations of the vaccine -- the original vaccine used by Brachman, and manufactured by DoD; a later variation of the Brachman vaccine, also manufactured by DoD; a third version of the vaccine manufactured by Merck, Sharp & Donne; and a fourth variation of the vaccine manufactured by the Michigan Department of Public Health, [**16] which was ultimately licensed in 1970. See FDA Response to Citizen's Petition, p. 8, Plaintiff's First Amended Complaint, Atch D., (filed January 6, 2004).
In order to overcome this glaring discrepancy, FDA fabricates a new status for DoD, specifically for the purpose of thwarting this challenge to the vaccine. FDA converts the DoD into a de facto vaccine manufacturer.
There is no FDA precedent for this arbitrary and capricious action. Defendant's citation to Berlex Laboratories, Inc. v. FDA, 942 F. Supp. 19 (D.D.C. 1996) is readily distinguishable. Berlex deals with a situation involving a single manufacturer doing precisely what the FDA Guidance contemplates, namely, developing a biologic on which it conducted a complete round of human clinical testing, and then seeking FDA approval of a derivative product in the United States. Under these circumstances, FDA had little difficulty in approving the successor product with no additional testing because of its similarity to the previous product, and because a single manufacturer created and developed the biologic product in question. Berlex, 942 F. Supp. at 22-23.
The situation could hardly [**17] be more different with AVA. Four different variations of the vaccine, manufactured by three different manufacturers, are at issue. Indeed, AVA's human clinical tests were performed with the earliest version of the vaccine only and are now more than 40 years old. The time between the initial clinical tests of the [*12] product in question in Berlex and its approval by FDA was two years, 1994 to 1996. There were only two variations of the Berlex drug to connect together, while here there are at least four. n5
n5 For the record, Plaintiff's note a fifth AVA variant which was created following the dramatic change in AVA's manufacturing status in the early 1990s in response to DoD's demand for vaccine during the first Gulf War. See testimony of Nancy Kingsbury, United States General Accounting Office, before the Sub-Committee on National Security, Veteran's Affairs, and International Relations, Committee on Government Reform, House of Representatives, October 23, 2001, pp. 5-6, Plaintiff's First Amended Complaint, attachment F (filed Jan. 6, 2004).
[**18]
III. CONCLUSION
Because the AVA currently used is substantially different from the vaccine originally tested vaccine, and because the FDA has provided no reasonable basis for certifying the current vaccine, its action in drafting the Final Rule is factually unsupportable, arbitrary and capricious. The Court should so find, and order Defendant's to properly complete the licensing process.
Date: April 7, 2004
Respectfully submitted,
/s/

2003 U.S. Dist. Ct. Motions 707, *12; 2004 U.S. Dist. Ct. Motions LEXIS 6277, **18
John J. Michels, Jr., Esq. DC Bar # 457575 McGuire Woods LLP 150 N. Michigan, Ste. 2500 Chicago, IL 60601 (312) 849-8150 Mark S. Zaid, Esq. DC Bar # 440532 Krieger & Zaid PLLC 1747 Pennsylvania Ave., Ste. 300 Washington, DC 20006 (202) 454-2809

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View U.S. District Court Opinion JOHN DOE # 1, et al., Plaintiffs, v. DONALD H. RUMSFELD, et al., Defendants. Civil Action No. 03-707(EGS) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 707; 2004 U.S. Dist. Ct. Motions LEXIS 6275 April 21, 2004 Motion for Summary Judgment
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s) COUNSEL: [**1] Respectfully submitted, PETER D. KEISLER, Assistant Attorney General, ROSCOE C. HOWARD, JR., United States Attorney, BRIAN D. BOYLE, Principal Deputy Associate Attorney General, SHANNEN W. COFFIN, Deputy Assistant Attorney General, JOSEPH H. HUNT, VINCENT M. GARVEY, CRAIG M. BLACKWELL, DC Bar # 438758, RONALD J. WILTSIE, ANDREW H. TANNENBAUM, Attorneys, Civil Division, U.S. Department of Justice, P.O. Box 883, Washington, D.C. 20044, Tel: (202) 307-1401, Fax: (202)616-8470. Attorneys for defendants. TITLE: REPLY MEMORANDUM IN SUPPORT OF DEFENDANTS' MOTION FOR SUMMARY JUDGMENT TEXT: PRELIMINARY STATEMENT
Our opening brief established that the Final Order of the Food and Drug Administration ("FDA") categorizing Anthrax Vaccine Adsorbed ("AVA") [**3] as a Category I, safe and effective, biological product, see Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review ("FDA Order" or "Order"), 69 Fed. Reg. 255 (Jan. 5, 2004), is reasonable, supported by the administrative record, and not arbitrary, capricious, or an abuse of discretion for purposes of the Administrative Procedure Act, 5 U.S.C. §§ 551, et seq. ("APA"). n1 Plaintiffs' short opposition brief offers nothing to rebut our showing. In fact, plaintiffs' opposition is based on a fundamental misunderstanding of the nature of the Court's role in this case.
n1 We refer to the briefs filed thus far as follows: "Def. Br." (for defendants' opening summary judgment brief); "Def. Opp." (for defendants' opposition to plaintiffs' motion for summary judgment); "P1. Br." (for plaintiffs' opening summary judgment brief); and "P1. Opp." (for plaintiffs' opposition to defendants' motion for summary judgment).

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Plaintiffs' argument rests almost [**4] entirely on an extra-record declaration and unpublished manuscript prepared for plaintiffs for purposes of this litigation by a professor of family studies. The Court may not consider these materials. The claims before the Court on summary judgment arise solely under the APA, and judicial review is limited to the administrative record. Plaintiffs offer no credible reason for supplementing that record with a litigation affidavit attacking the merits of FDA's decision. Nor could they. FDA is the expert agency charged by Congress with reviewing the safety and effectiveness of biological products like AVA, and it is FDA, not plaintiffs' "expert," to which the Court must defer.
Plaintiffs actually chide defendants for reviewing, in our opening brief, the "numbing detail of the alleged FDA review," P1. Opp. at 3, as if the specifics and rationale of FDA's decision, and its underlying scientific basis in the administrative record, are somehow not [*2] relevant here. But again, plaintiffs misunderstand the nature of the Court's review. Under the APA, the focal point for review is the agency record, and the only question before the Court is whether the agency has considered the [**5] relevant factors and whether there has been a clear error of judgment; so long as the agency adequately articulates an explanation for its actions, it must be upheld. FDA's licensing decision, we have explained, easily satisfies that standard.
Plaintiffs' challenge in this case has been steadily shrinking since they filed this action over a year ago. Notwithstanding the rhetoric in their brief (see, e.g., P1. Opp. at 1), plaintiffs do not challenge AVA's safety for human use. Plaintiffs also do not challenge AVA's effectiveness for use against cutaneous anthrax. Now, in their latest brief, plaintiffs rest their challenge to AVA's inhalation effectiveness principally on extra-record materials the Court is precluded from considering. Plaintiffs, in the end, simply have no response to defendants' showing that FDA's decision to confirm AVA's license is rational, supported by the administrative record, and certainly not arbitrary or capricious. In its preliminary injunction opinion, the Court stated it could "properly defer" to FDA in determining AVA's status. See Doe v. Rumsfeld, 297 F. Supp. 2d 119, 133 (D.D.C. 2003); see also id at 131 (noting that, [**6] "at bottom," the question of AVA's status "turns on whether the FDA has made a final decision"). FDA has now rendered its decision. The Court, accordingly, should defer to that reasonable decision, and grant defendants' motion for summary judgment.
[*3] ARGUMENT
FDA'S EFFECTIVENESS DETERMINATION IS NOT ARBITRARY, CAPRICIOUS, OR AN ABUSE OF DISCRETION
We established in our opening brief that FDA's effectiveness determination is reasonable, supported by the administrative record, and not arbitrary, capricious, or an abuse of discretion. See Def. Br. at 35-42. Plaintiffs offer three brief arguments in response, contending that: (i) the controlled clinical investigation conducted by Drs. Brachman, Gold, Plotkin, Fekety, Werrin, and Ingraham ("Brachman" or "Brachman study") does not support FDA's determination that AVA is effective (see P1. Opp. at 5-8); (ii) FDA improperly "relied" on animal data in support of its effectiveness conclusion (see id. at 8-10); and (iii) AVA is not comparable to the original Department of Defense ("DoD") anthrax vaccine which Brachman, et al., used in their study. See id. at 10-12. Each argument is meritless. [**7]
A. The Brachman Study Provides Proof of AVA's Effectiveness
Plaintiffs claim FDA wrongly relied on the Brachman study for effectiveness because the study produced "insufficient evidence . . . to determine if the [anthrax] vaccine was effective against inhalation anthrax." PL Opp. at 5. This argument is based almost exclusively on an extra-record declaration and unpublished manuscript submitted by Dr. Walter R. Schumm, Professor of Family Studies at Kansas State University. See Pl. Opp., Ex. 1, Declaration of Dr. Walter R. Schumm ("Schumm Dec."); P1. Opp., Ex. 1-A, "A Statistical Reanalysis of the Relationship Between Anthrax Vaccination and Anthrax Infections in Goat Hair Mills in the 1950s" ("Schumm Ms."); P1. Opp., Exs. 1-B, 1-C (extra-record materials attached to Dr. Schumm's declaration); see also Pl. Opp. at 6-8. Dr. Schumm prepared these

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materials at [*4] plaintiffs' request for their use in this litigation. See, e.g., Schumm Dec. at 3, P 3 ("I have been asked to comment on the study that serves as the scientific underpinning of the FDA's arguments before this Court on the legal status of the currently licensed anthrax vaccine"). These extra-record [**8] materials are not part of the administrative record and may not be considered by the Court.
It is a fundamental rule of administrative law that, in an APA challenge, "the focal point for judicial review should be the administrative record already in existence, not some new record made initially in the reviewing court." Camp v. Pitts, 411 U.S. 138, 142 (1973). The D.C. Circuit has "repeatedly applied" this rule "to bar introduction of litigation affidavits to supplement the administrative record." AT&T Info. Sys., Inc. v. G.S.A., 810 F.2d 1233, 1236 (D.C. Cir. 1987) (applying rule in review of informal agency proceeding to bar agency attempt to "offer post-hoc rationalizations"). And courts in this district have specifically applied this rule to bar consideration of litigation affidavits in cases involving FDA. See Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 177 & n.7 (D.D.C. 2000) (refusing to consider extra-record affidavits "showing significant disagreements among scientific experts"); Berlex Labs., Inc. v. F.D.A., 942 F. Supp. 19, 23 (D.D.C. 1996) ("affidavits submitted by Berlex have not been considered, [**9] nor are they deemed to be part of the record in this case").
Plaintiffs do not even mention the law on this point. They merely note, half-heartedly and in a footnote, that courts may, in narrow circumstances, permit plaintiffs to "supplement" an agency's administrative record with extra-record materials. See P1. Opp. at 6 n.3. But the grounds plaintiffs cite -- under which courts may permit supplementation where "the agency either deliberately excluded from the record evidence adverse to its position, or was negligent in failing to include such documents" (id) -- have no application here. Dr. Schumm's declaration [*5] and (unpublished) manuscript were prepared in April and March, 2004, respectively, well after FDA issued its Order and submitted the administrative record in this case. See FDA Order at 255 (published January 5, 2004); Docket # 33 (February 2, 2004, notice of filing of the administrative record). FDA, by definition, could not have considered these materials or included them in the administrative record.
Moreover, plaintiffs have submitted the Schumm materials for the sole purpose of challenging the merits of FDA's effectiveness determination. [**10] See Pl. Opp. at 6-8; Schumm Dec. at 10. Again, it is a basic principle of administrative law that courts may not examine extra-record evidence to determine the correctness of an agency decision. Environmental Def. Fund, Inc. v. Costle, 657 F.2d 275, 286 & n.37 (D.C. Cir. 1981) ("a judicial venture outside the record . . . can never, under Camp v. Pitts, examine the propriety of the decision itself) (emphasis added): accord National Treasury Employees Union v. Hove, 840 F. Supp. 165, 169 (D.D.C. 1994) ("consideration of outside evidence' to determine the correctness or wisdom of the agency's decisions is not permitted") (emphasis added) (internal citation omitted); Doraiswamy v. Secretary of Labor, 555 F.2d 832, 842 (D.C. Cir. 1976) (affirming denial of discovery where plaintiffs challenged "the correctness" of the agency's decision as opposed to the "fullness of the reasons" given). n2 For all these reasons, the Court may not consider plaintiffs' extra-record materials.
n2 In Esch v. Yeutter, 876 F.2d 976 (D.C. Cir. 1989), the D.C. Circuit noted, in dicta, that one instance in which courts have permitted supplementation of an agency record is where "evidence arising after the agency action shows whether the decision was correct or not." See id. at 991. The contours of this exception are unclear, but it plainly has no relevance here. Plaintiffs are not seeking to supplement the record with "evidence" arising after FDA issued its Order; rather, they are seeking to add to the record their expert's "reanalysis" of a study published in 1962.
[**11]
[*6] Plaintiffs do cite two record sources in support of their assertion that the Brachman study failed to assess the protective effect of the anthrax vaccine against inhalation anthrax -- the Brachman study itself and the report of the Panel on Review of Bacterial Vaccines and Toxoids ("Panel"). See P1. Opp. at 5-6. But with respect to the Brachman study, Brachman, et al., specifically included two cases of inhalation anthrax in their effectiveness calculation. See

2003 U.S. Dist. Ct. Motions 707, *6; 2004 U.S. Dist. Ct. Motions LEXIS 6275, **11

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AR3736-37 & Table 4 (Brachman); see also Def. Br. at 15-17, 36-39 (explaining this point). Thus, far from "repudiat[ing] any conclusion about the effectiveness of AVA against inhalation anthrax" (P1. Opp. at 6), the study authors calculated the effectiveness of the vaccine to prevent all types of anthrax disease, regardless of the route of exposure (which they calculated at 92.5 percent). See FDA Order at 259-60. n3
n3 Indeed, even plaintiffs' expert acknowledges that "the Brachman field trial is accepted by scholars as the cornerstone of the arguments favoring efficacy of anthrax vaccine for preventing cutaneous or inhalational anthrax in humans." Schumm Ms. at 15; see also id at 4-6 (citing articles, including a recent publication authored in part by Dr. Brachman, observing that the Brachman study showed effectiveness against anthrax generally).
[**12]
It is true, as we have explained (see Def. Br. at 16-17), that the Panel, although recommending that AVA be placed in Category I, failed to recognize that Brachman, et al., included inhalation cases in their effectiveness calculation. But that Panel mistake has no relevance here; plaintiffs acknowledge (as they must) that the calculation actually included inhalation cases. See Pl. Opp. at 6. Plaintiffs, in fact, attempt to dismiss the inclusion of inhalation cases as a "mistake." See id But this only shows plaintiffs' continued failure to grasp the significance of Brachman et al.'s analysis.
The Brachman study was designed to gauge the overall effectiveness of the vaccine against the anthrax bacterium, Bacillus anthracis. Thus, the study was conducted in "a [*7] susceptible industrial population known to be chronically exposed to anthrax." AR3732 (Brachman) (emphasis added). There is no question that inhalation was one of the routes of exposure included in the study. See, e.g., AR3736 (Table 4) (categorizing observed anthrax cases in part by the "site of lesion"); AR3740-41 (Table 8) (including inhalation cases in effectiveness calculation). [**13] Indeed, during the study period, there was an "outbreak" of inhalation anthrax (see AR3733), which accounted for nearly one-third (five) of the total (eighteen) cases of inhalation anthrax reported in this country in the twentieth century. See AR3361 (IOM). But none of the recipients of the vaccine contracted inhalation anthrax. See AR3736 (Table 4) (Brachman).
At bottom, the most plaintiffs can say is that the number of inhalation cases observed in the Brachman study are too few to support an independent statistical analysis. n4 This is true enough; FDA noted this point in its Order. See FDA Order at 260; see also AR3743 (Brachman) (making a similar observation). But, FDA observed, the inhalation results, viewed separately, are wholly consistent with the cutaneous results (which were independently significant). Of the five reported inhalation cases, "two occurred in the placebo group, three occurred in the observational group, and no cases occurred in the vaccine group." FDA Order at 260. Thus, weighing the evidence in the aggregate, FDA concluded:
the indication section of the labeling for AVA does not specify the route of exposure, and the vaccine [**14] is indicated for active immunization against Bacillus [*8] anthracis, independent of the route of exposure.
Id. This conclusion is consistent with Brachman, et al.'s conclusion, n5 and with the pathogenesis of the anthrax bacterium (which suggests that the immune response induced by AVA would be protective regardless of the route of exposure). See Def. Br. at 10-11, 39 n.34. Moreover, there is no contrary clinical data. FDA's determination on this point falls "'squarely within the ambit of [its] expertise and merits deference'" from the Court. Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 220 (D.D.C. 1996) (quoting Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir.), cert, denied, 516 U.S. 907 (1995)). It is reasonable, supported by the administrative record, and should be upheld. n6
n4 This is the ultimate conclusion of plaintiffs' expert, see Schumm Dec. at 5, P 4.b, although even he acknowledges that the inhalation outbreak was a "more rigorous challenge," Schumm Ms. at 33, which "fortuitously allow[ed] all employees in the experimental group enough time to receive at least three

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inoculations before the epidemic began." Id. As we have noted, the vaccine withstood this "rigorous challenge," and none of the employees in the vaccine group contracted inhalation anthrax. [**15]

n5 See AR3737; see also AR3744 (concluding paragraph on effectiveness, which does not specify a route of exposure) ("An anthrax vaccine was clinically and epidemiologically evaluated in an exposed, susceptible, supervised population. Twenty-six cases occurred among the population during the evaluation period. Four cases occurred in individuals who had incomplete inoculations. Of the remaining 22 cases, 15 occurred in placebo-inoculated employees, six in uninoculated employees, and one in a vaccine-inoculated employee. The data indicate that the vaccine has an effectiveness of 92.5 per cent with a lower 95 per cent confidence limit of 65 per cent.").
n6 We note, briefly and for the sake of completeness, that Dr. Schumm's "statistical reanalysis" of the Brachman study in no way undercuts FDA's effectiveness determination. Dr. Schumm does not hold a degree in statistics, see Schumm Dec. at 1, P 1; compare AR3736 (Brachman) (noting that Brachman, et al.'s statistical analysis was performed by the chief of the Statistics Section, Epidemiology Branch, Communicable Disease Center), and his analysis -- which is unpublished, see Schumm Dec. at 4, P 4, and apparently has not been peer-reviewed -- is substantively flawed. For example, his manuscript "reanalyzes" the data in the Brachman study mill-by-mill, concluding that, at three of the four mills participating in the study, the data was not independently "statistically significant." See Schumm Ms. at 28. But there is no indication that the study was designed to produce statistically significant results at each mill; rather, Brachman, et al., likely included multiple sites precisely because they wanted a sample size that, in the aggregate, would produce statistically significant results. This approach is typical of multi-site clinical trials, where the primary result ordinarily is the overall result, not the result in each site separately. Indeed, Dr. Schumm's analysis of the overall result, although using a different statistical methodology, is fully consistent with Brachman, et al.'s effectiveness calculation. See Schumm Ms. at 29 ("overall, combining all four mills, the Fisher's Exact Test was significant"). Moreover, the site-specific data presented by Dr. Schumm (see id. at 28, Table 11), although perhaps not "statistically significant," are fully supportive of the study's powerful overall conclusion, which formed the basis for FDA's effectiveness determination.
[**16]
[*9] B. FDA's Consideration of Corroborating Evidence of Effectiveness Was Appropriate
It is not clear why plaintiffs continue to press their point that FDA somehow erred in considering the Institute of Medicine ("IOM") Committee's findings with respect to animal data and the three animal studies cited in the Order. See P1. Opp. at 8-10. n7 Plaintiffs appear to acknowledge -- contrary to the statements in their opening brief (see P1. Br. at 15) -- that FDA relied on the Brachman study for proof of effectiveness under 21 C.F.R. § 601.25(d)(2), and considered the IOM Committee's findings and certain animal studies as corroborating evidence of effectiveness. See P1. Opp. at 9; see also FDA Order at 260 ("FDA agrees with the [IOM] report's finding that studies in humans and animal models support the conclusion that AVA is effective against B. anthracis . . . regardless of the route of exposure"); Def. Opp. at 19-21 (addressing this point at length).
n7 We reiterate our argument (see Def. Br. at 43 n.38) that, although DoD's vaccination program (AVIP) is not at issue in this brief, Congress specifically charged the IOM Committee with studying AVA's safety and effectiveness, and the Committee specifically concluded that "AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax." AR3323 (IOM). Given this IOM Committee conclusion, and the various statutes reflecting Congress's ratification of DoD's mandatory program of

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immunization against inhalation exposure (e.g., 10 U.S.C. § 1110 (requiring Secretary of Defense to establish "uniform procedures" for "administrative or medical" exemptions from AVIP); id § 1178 (requiring heads of military departments to track and report to Congress separations of service members due to their refusal to participate in AVIP)), we continue to maintain that the general provisions of 10 U.S.C. § 1107 cannot be applied to constrain DoD's AVIP.
[**17]
Having acknowledged this point, plaintiffs' argument is reduced entirely to their contention that, because (they say) the Brachman study does not provide proof of effectiveness, "the government's reliance on animal data for any corroboration is improper." P1. Opp. at 9. [*10] That argument, however, is fully answered by our showing supra. Part A. Plaintiffs' contention with respect to FDA's consideration of the IOM Committee's findings and animal studies thus has no independent force, and should be rejected.
Plaintiffs also acknowledge that FDA considered the Panel's summary of the CDC surveillance data as corroborating evidence of effectiveness. See P1. Opp. at 9; see also FDA Order at 260 (noting these data "provide confirmation"); Def. Br. at 17, 22, 39-40 (describing these data). Nevertheless, plaintiffs, through Dr. Schumm, argue that the summarized surveillance data are "entitled to no weight whatsoever" (P1. Opp. at 7) because they were "much less well controlled than the Brachman" study. Schumm Dec. at 7, P 5.c. This is wrong. FDA may rely on "partially controlled or uncontrolled" data as corroborating evidence of effectiveness, see 21 C.F.R. [**18] § 601.25(d)(2) ("investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing"), and its consideration of the Panel's summary of the CDC surveillance data was thus entirely appropriate.
C. FDA Properly Determined That AVA Is Comparable to the DoD Vaccine
Finally, plaintiffs argue that FDA erred in relying on the Brachman study for proof of effectiveness because the Brachman study used a predecessor anthrax vaccine (the DoD vaccine manufactured at Fort Detrick). See Pl. Opp. at 10-12. We have fully addressed this argument in our previous filings, and have explained that FDA properly concluded, based on its review of the record evidence, that AVA is comparable to the original DoD vaccine used in the Brachman study. See FDA Order at 260-61; Def. Br. at 21-22 at n.23; Def. Opp. at 22. We do not repeat those arguments here, but rather address the one new argument plaintiffs raise.
[*11] Plaintiffs acknowledge FDA's comparability policy -- under which a manufacture may use data gathered with a previous version of a product to support [**19] the effectiveness of a comparable version of the same product after a manufacturing change -- but argue that the policy only allows "a single manufacturer to make manufacturing changes to a product without performing additional clinical studies." P1. Opp. at 10 (emphasis in original). This is wrong. Although FDA's policy is addressed in parts to manufacturers contemplating a manufacturing change, nothing in the policy states that it is limited to changes undertaken by a single manufacturer. See generally AR1399-1406 (comparability policy). n8 And FDA does not interpret the policy as being limited in this way. See Berlex, 942 F. Supp. at 25 ("FDA's policies and its interpretation of its own regulations will be paid special deference because of the breadth of Congress' delegation of authority to FDA and because of FDA's scientific expertise"). Indeed, in Berlex. which plaintiffs cite in support of their position (see Pl. Opp. at 11), the court upheld FDA's determination to "allow[] Biogen [the product manufacturer] to rely on the results of a clinical study of another company's . . . product." See 942 F. Supp. at 22, 25; see also [**20] id. at 22 (noting, as well, that Biogen was a part owner of the other company, a joint venture, which failed and went into receivership).
n8 For example, the policy states generally that, "for manufacturing changes prior to product approval," FDA regulations permit the approval of biological products on the basis of "clinical data generated from a precursor product, made prior to a manufacturing change, so that the manufacturer can demonstrate that the

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precursor product is comparable to the manufactured product." AR1402.
As FDA's comparability policy makes clear, the manufacturing process for a biological product is critical, and biological products often are defined by that process. See AR1401. Thus, if two or more entities, working together, share the critical manufacturing process information -- as [*12] Biogen did with the joint venture in Berlex, and as DoD did with Merck Sharp & Dohme and with the Michigan Department of Public Health concerning AVA -- such products may be [**21] deemed comparable under FDA's policy. That, presumably, is why plaintiffs have conceded that AVA is lawfully approved for use against cutaneous anthrax. See Reply to Defendants' Memorandum of Law in Opposition to Plaintiffs' Motion to Determine that Class Certification Is Not Required for Program-Wide Injunctive Relief at 4 n.4. Indeed, that concession, which presumably is based on the Brachman study, is hopelessly inconsistent with plaintiffs' argument that AVA is not comparable to the DoD vaccine. For all these reasons, and those we previously have explained, that argument should be rejected. n9
n9 Finally, we note that plaintiffs, in their summary judgment motion, asserted they should be entitled to "discovery before summary judgment is accorded to the defendants" in the event their own motion for summary judgment is denied. See Pl. Br. at 20. In their opposition brief, however, plaintiffs did not argue that they needed discovery in order to oppose defendants' motion for summary judgment (which they opposed on the merits). Nor did plaintiffs follow the procedures in Fed. R. Civ. P. 56(f) for seeking such relief. This is yet another reason for rejecting plaintiffs' discovery argument. See James Madison Ltd. v. Ludwig, 82 F.3d 1085, 1096 (D.C. Cir. 1996), cert denied, 519 U.S. 1077 (1997); see also Def. Opp. at 25-30 (setting forth defendants' other arguments for rejecting plaintiffs' discovery contention).
[**22]
[*13] CONCLUSION
For all the foregoing reasons, the Court should grant defendants' motion for summary judgment.
Respectfully submitted,
PETER D. KEISLER
Assistant Attorney General
ROSCOE C. HOWARD, JR.
United States Attorney
BRIAN D. BOYLE
Principal Deputy Associate Attorney General
SHANNEN W. COFFIN
Deputy Assistant Attorney General
/s/ Craig M. Blackwell
JOSEPH H. HUNT
VINCENT M. GARVEY

2003 U.S. Dist. Ct. Motions 707, *13; 2004 U.S. Dist. Ct. Motions LEXIS 6275, **22
CRAIG M. BLACKWELL, DC Bar # 438758 RONALD J. WILTSIE ANDREW H. TANNENBAUM Attorneys Civil Division U.S. Department of Justice P.O. Box 883 Washington, D.C. 20044 Tel: (202) 307-1401 Fax: (202) 616-8470 Attorneys for defendants Date: April 21, 2004

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View U.S. District Court Opinion JOHN DOE # 1 et al., Plaintiffs, v. DONALD H. RUMSFELD et al, Defendants. Civil Action No.: 1:03CV00707(EGS) UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA 2003 U.S. Dist. Ct. Motions 707; 2004 U.S. Dist. Ct. Motions LEXIS 8628 March 3, 2004 Motion for Summary Judgment
VIEW OTHER AVAILABLE CONTENT RELATED TO THIS DOCUMENT: U.S. District Court: Brief(s); Motion(s); Pleading(s) TITLE: [**1]
PLAINTIFFS' REPLY TO DEFENDANTS' OPPOSITION TO PLAINTIFFS' MOTION FOR SUMMARY JUDGMENT TEXT: One learns in basic trial advocacy class in law school that when your facts are weak, argue the law, and when the law is weak, argue your facts. When both your facts and law are weak then either shout as loud as possible or ridicule the other side's case. This dispute, however, is not before a law school professor and the defendants' shouting and ridiculing do not diminish the merits of the plaintiffs' case.
Again, the issue before the Court is fairly straightforward -- Is the Anthrax Vaccine Adsorbed vaccine ("AVA") an investigational new drug or a drug unapproved for its intended use following FDA's issuance of its Final Rule and Order? n1 The answer to this question must be a resounding "yes," because, as plaintiffs have demonstrated, the FDA's issuance of its Final Rule, and particularly its inexplicable distortion of the conclusions reached during the only human trial of the vaccine upon which it relies, [*2] represents an example of arbitrary and capricious federal agency action prohibited by the Administrative Procedure Act. 5 U.S.C. § 551 et [**2] seq.
n1 The relevant statute, 10 U.S.C. § 1107, says nothing about whether a drug or biologic is safe or effective or even licensed. The statute simply prohibits the use of investigational new drugs or drugs unapproved for their intended use on service members without the informed consent of those service members."
The government's misconstrued interpretation of why the plaintiffs primarily chose to pursue obvious procedural violations in their summary judgment motion rather than outline every specific substantive deficiency does nothing to alter the posture of this case. n2 In fact, the Court's determination of the validity of FDA's Final Rule concerning AVA

2003 U.S. Dist. Ct. Motions 707, *2; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **2

Page 2

turns on the incontrovertible fact that there exists no valid human study of the vaccine showing effectiveness against inhalation anthrax. n3

n2 Defendants once again reveal how they have failed to anticipate events in this case. Given that dual summary judgment motions were to be filed there was absolutely no need to simply duplicate substantive arguments in cross-motions, particularly when those arguments should best be addressed at the agency level anyway. Since it was obvious the government was intent on arguing it was entitled to summary judgment purely on substantive grounds, there was more than enough opportunity to prove the fallacy of that position in response to the defendants' Motion while at the same time providing this Court with more than enough evidence that the FDA also violated numerous procedural requirements as part of the plaintiffs' Motion. Either way, whether solely on procedural or substantive grounds or a combination thereof, the government's arguments fail and the plaintiffs have demonstrated why the FDA's Final Rule and Order must be vacated and the injunction reinstated. [**3]
n3 As a substantive matter, the Plaintiffs' Opposition to the Government's Motion for Summary Judgment includes a detailed statistical analysis showing that the vaccine is ineffective against inhalation anthrax. Moreover, the government's contorted effort to twist Brachman's data is statistically invalid. As an aside, the best that can be said based on modern statistical analysis of Dr. Brachman's data is that the vaccine is only probably better than nothing with regard to cutaneous anthrax exposure. See Declaration of Dr. Walter Schumm, Colonel, USAR (Ret.) at PP 6-9 ("Schumm Decl."), attached as Exhibit "1" to Plaintiffs' Opposition to Defendants' Motion for Summary Judgment (filed April 7, 2004).
Defendants solitary reliance on the Brachman Study, which categorically states that there is insufficient evidence to show effectiveness of the vaccine against inhalation anthrax, epitomizes the arbitrary and capricious actions of FDA in approving AVA. [*3] FDA's assertion that the conclusions in its Final Rule do not differ from that espoused by the Expert Panel in 1985 is deliberately, [**4] in fact breathtakingly, misleading. The Expert Panel stated categorically that there were insufficient cases of inhalation anthrax to determine whether the vaccine was effective. The FDA's Final Rule says that AVA is effective against all forms of anthrax regardless of route of exposure. How these two recommendations are consistent is unexplained and inexplicable. n4

n4 It cannot be emphasized enough how highly unreasonable it is to believe that the 1985 Expert's Panel could ever have anticipated the scope of use within the military that became prevalent for the anthrax vaccine. The essence of the 1985 determination was specifically grounded on the limited use of the vaccine and a benefit/risk analysis. The Panel stated that the vaccine was to be used by "individuals in industrial settings who come into contact with imported animal hides, furs, wool, hair (especially goat hair), bristles and bone meal, as well as laboratory workers involved in ongoing studies on the organism." 50 Fed.Reg. 51002, 51058 (Dec. 13, 1985). The Panel then recommended that "there is sufficient evidence to conclude that anthrax vaccine is safe and effective under the limited circumstances for which this vaccine is employed." Id. at 51059 (emphasis added). Thus, it is clear that the FDA's 2003 Final Rule and Order, which addresses a situation where millions of people in the military or serving as defense contractors are being forced to take the vaccine, and the 1985 FDA's Expert Panel's recommendations, which understood that the vaccine was being used voluntarily by perhaps a few hundred people, are completely different.
[**5]

2003 U.S. Dist. Ct. Motions 707, *3; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **5

Page 3

Because the Government can raise no issue of material fact with regard to its failure to follow the appropriate APA comments procedures, and because the basis of FDA's licensing decision is fundamentally flawed, Plaintiffs' Motion for Summary Judgment should be granted, and Defendants' Motion denied.
ARGUMENT
I.THE FDA'S ISSUANCE OF ITS FINAL RULE AND ORDER REGARDING THE AVA'S STATUS IS REVIEWABLE BY THIS COURT
In yet another attempt by this Administration to avoid any type of judicial review of improper Executive Branch actions, the defendants for the first time now characterize FDA's approval of its 1985 Expert Panel recommendations as an exercise in agency [*4] adjudication (resulting in an Order) versus agency rule making. See Defendants' Memorandum of Points and Authorities in Opposition to Plaintiffs' Motion for Summary Judgment at 3-9 (filed April 7, 2004)("Defs' Opp."). As part of this effort, the defendants spend a substantial portion of their argument contorting generic various case language and statutory definitions to place their square argument into a round hole. The simple truth is that FDA has previously, if not always, considered determinations [**6] like the one issued regarding the AVA as rule making subject to judicial review. Furthermore, FDA specifically considered its actions with regard to AVA an exercise in rule making through the day it issued its decision on December 30, 2003. n5

n5 FDA has routinely failed to extricate itself from judicial review, notwithstanding prior attempts. See e.g., Community Nutrition Institute v. Young, 818 F.2d 943 (D.C. Cir. 1987)(action levels were invalid in that they were issued without the requisite notice-and-comment procedures); Cutler v. Hayes, 818 F.2d 879 (D.C. Cir. 1987)(FDA failure to review safety and efficacy concerns subject to review); Upjohn Co. v. Finch, 303 F. Supp. 241, 262 (W.D.MI 1969)(Commissioner should proceed with all due care and caution and extend to all interested parties a full opportunity to develop and present pertinent information relative to the safety and efficacy of drugs which have been on the market for many years and have been generally and widely prescribed by the medical profession).
[**7]
Indeed, the government does not cite to a single specific on-point case that supports its analysis of the FDA's decision making process, and with good reason. A review of comparable FDA determinations demonstrates that this type of FDA action constitutes rule making subject to public comment. Two brief examples will suffice. n6 First, in Contact Lens Manufacturers Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986), a commercial association sued FDA over its decision [*5] to classify contact lenses according to the product's safety effectiveness. n7 Id. at 594. In describing the safety and effectiveness of the lenses, the FDA utilized a familiar three class categorization system. Thereafter, contact lens manufacturers, whose products had been placed in a Class III status (product safety and effectiveness could not be reasonably assured and product could not be sold to the general public without FDA pre-marked approval) lobbied to reverse the FDA's proposal to stop a transfer of a category of lenses from Class III to Class I (safety and effectiveness of product is reasonably assured by current [**8] controls). The determinations made by FDA with regard to the product status are virtually identical to the determinations at issue here. Nevertheless, FDA provided extensive comment periods, and even a public hearing on it determination. Id. at 596-7.

n6 See also Ethicon, Inc. v. Food & Drug Admin., 762 F. Supp. 382 (D.D.C. 1991)(Court permitted APA review challenge regarding FDA's reclassification process). n7 For a drug to be generally recognized as effective, there must be "expert consensus . . . founded upon substantial evidence."' Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609, 632 (1973). "Substantial

2003 U.S. Dist. Ct. Motions 707, *5; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **8

Page 4

evidence" is defined as "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof." 21 U.S.C. § 355 (d). "In the absence of any evidence of adequate and well-controlled investigation supporting . . . efficacy . . ., [a drug] would be a new drug' subject to the provisions of the [FDC] Act." Weinberger, 412 U.S. at 629-630. Thus, the additional information would have to be significant enough to change the view of those experts who previously rejected classification of the drug as effective.
[**9]
Second, in Cutler et al. v. Hayes et al., 818 F.2d 879 (D.C. Cir. 1987), the FDA engaged in a comprehensive review of the safety and effectiveness of all over-the-counter drugs readily available to consumers without medical supervision. In doing so, FDA used a process virtually identical to the one at issue here. To start, advisory review panels of experts were appointed to analyze existing test data and make recommendations in the form of monographs concerning marketing for the drugs at issue. Id. at 884. The [*6] FDA then reviewed the monographs, published them in the Federal Register, and opened a period for public comment, followed by FDA's final recommendation, which was also open for public comment. Id. FDA then promulgated a final determination classifying the drug as either Category I (safe and effective), Category II (drug not generally recognized as safe and effectiveness), or Category III (data is insufficient to justify classification in either Category I or II). FDA's final determination was legally binding as to the drug's status as generally recognized as safe and effective. In making its determination as to the safety and [**10] efficacy of the drugs at issue, FDA invited public comment not once but twice in the process.
Moreover, in the instant matter, FDA and DoD spokesmen have consistently referred to the determination concerning AVA as a "Final Rule." See e.g., Citizens' Petition Response, August 28, 2002, at 1, attached as Attachment "D" to First Amended Complaint (filed January 6, 2004)("We agree that the Food and Drug Administration (FDA or the Agency) should complete the Biologics Review for the anthrax vaccine by issuing a final rule. Due to the pendency of this rule making, at this time we do not know what the result of the rule making will be. In the proposed rule, however, FDA agreed with the Panel on Review of Bacterial Vaccines and Toxoids' (the Panel's) recommendation and conclusion concerning anthrax vaccine and FDA proposed to classify anthrax vaccine in Category I. . . ."); See also Meeting of Armed Forces Epidemiology Board, Feb. 17, 2004, Comments by Colonel John Grabenstein, ("AFEB") found at www.ha.osd.mil/afeb/meeting/transcript-February172004.pdf ("and one of the key bases for the Judge's decision was that the Food & Drug Administration had never finalized the 1985 proposed [**11] rule, and therefore, the FDA had made no final statement [*7] with regard to the vaccine status . . . so on December 30, the FDA issued that final rule . . ."). n8

n8 Colonel Grabenstein, a Doctor of Pharmacy and Deputy Director of the Army Anthrax Vaccine Immunization Program, has served in this case as a primary declarant for the defendant Department of Defense ("DoD") on the basis of his overseeing AVA development and DoD's Anthrax Vaccination Immunization Program. 9 The Court should note that the original notice that appeared in the Federal Register on December 30, 2003, described the FDA's action as a final "Rule". Apparently only after hurried review were the words "and order" added by hand. Interestingly, the link on FDA's website to the handwritten annotation version of the Final Rule has been removed, but the plaintiffs preserved a copy. See Exhibit "1".
In conducting its review of AVA, the FDA acted in a manner consistent with the exercise of rule making. It was not until the government [**12] filed its Memorandum in Opposition that the FDA construed its actions in a different light. It is clear that defendants now seek to recast the entire AVA certification process, much as they seek to recast the

2003 U.S. Dist. Ct. Motions 707, *7; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **12

Page 5

findings of the Brachman study and the Expert Panel's determinations, in order to gain a litigation advantage. See Louisiana Ass's of Independent Producers & Royalty Owners v. FERC, 958 F.2d 1101, 1123 n.12 (D.C. Cir. 1992)(Court does not "give an agency the benefit of a post hoc rationale of counsel.").
The Court does not have to wade through the pages of irrelevant citations in the Government's brief to determine that the FDA has engaged in rule making in this matter. A simple review of the history of the process, along with a review of similar types of FDA inquiries, shows conclusively that the review conducted by FDA was a rule making exercise and not one resulting in an unreviewable final order. n9

n9 The Court should note that the original notice that appeared in the Federal Register on December 30, 2003, described the FDA's action as a final "Rule". Apparently only after hurried review were the words "and order" added by hand. Interesttingly, the link on FDA's website to the handwritten annotation version of the Final Rule has been removed, but the plaintiffs preserved a copy. See Exhibit "1".
[**13]
[*8] II. FDA'S RULE MAKING PROCESS WAS ARBITRARY AND CAPRICIOUS
Plaintiffs will give short shrift to Defendants' remarkable argument that FDA has somehow complied with rule making procedures because its determination is in fact "a logical outgrowth" of the proposed rule in 1985.
As a reminder, in 1985, the Expert Panel organized by the FDA acknowledged the fact that there was insufficient evidence for a determination of efficacy against inhalation anthrax. Nevertheless, given the extremely limited use of AVA in industrial settings, they proposed approving the vaccine as labeled. The FDA now proposes to alter this determination by explicitly stating that the vaccine is properly licensed, regardless of route of exposure (for which there is no sufficient clinical evidence) and despite the fact that the vaccine's usage has expanded from a limited industrial setting (perhaps several hundred or a thousand doses annually, if that) to some 4 million doses administered to more than one million people over the last five years. n10

n10 At the AFEB meeting, Colonel Grabenstein, who believes the litigants and counsel in this case are "zealots" (page 52), noted that from March 1998 through February 2004, 3.9 million vaccinations were administered to almost 1.1 million people (page 44). See http://www.ha.osd.mil/afeb/meeting/021704meeting/Transcript%20-%20February%2017%202004.pdf.
[**14]
Defendants' tortured analysis notwithstanding, it is clear that they cannot escape the fact that the sole human trial upon which they anchor their determination does not provide a foundation for FDA's Final Rule. Neither can the defendants find support in the recommendations of the Expert Panel. The only way defendants can justify FDA's Final Rule is by relying upon the statistically invalid method of combining results from different routes of exposure and lumping them together into a single group to reach the [*9] desired conclusion n11 or by using invalid animal study data that has no correlation with human effectiveness. Accordingly, there is no issue of material fact regarding the arbitrary and capricious nature of Defendants' actions.

n11 The statistical foolishness of such an approach is properly demonstrated by the analysis discussed in Dr.

2003 U.S. Dist. Ct. Motions 707, *9; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **14

Page 6

Schumm's declaration. See Schumm Decl. at passim.
A. The FDA's Improper Use of Animal Efficacy Data
The defendants do not (and cannot) [**15] dispute that there is no correlate of immunity for AVA between animal test subjects and human beings. Accordingly, defendants admit arbitrarily relying on data with virtually no established validity in a clinical setting. The arbitrary nature of FDA's reliance is particularly apparent since it is undisputed that the animal test results are being used to validate the effectiveness of a multiple variation vaccine last tested on human beings more than 40 years ago. In fact, at the time the FDA issued its Final Rule, AVA was still subject to two separate investigational new drug application processes which were trying to determine whether it was possible to establish correlates of immunity for annulations anthrax testing. n12

n12 The two pending IND's were IND 6847, which had been pending since September 1996, and one pursued by the Center for Disease Control, which has been pending (and remains pending) since 2001. Both INDs seek to study the same issue -- whether AVA can be effectively tested in animals through the establishment of correlates of immunity between animals and humans following AVA inoculation.
[**16]
Moreover, the Government's assertion that the animal efficacy data is not used to substantiate effectiveness, but merely to "corroborate" effectiveness is both misleading and factually incorrect. See Defs' Opp. at 2. The vaccine was not licensed for inhalation anthrax in any way until no earlier than the 11<th> hour, i.e., when FDA issued its Final Rule on December 30, 2003. Until the fortuitous withdrawal of IND 6847 in February, 2004, the FDA had approved and was reviewing on an annual basis an IND experimental [*10] process specifically designed to obtain an indication for inhalation anthrax on the AVA license. In other words, seven years ago FDA approved an experimental regimen for the vaccine to accomplish what the FDA now says was a foregone conclusion; i.e., that AVA was effective against inhalation anthrax, and indeed, was already licensed for such an indication.
In addition, the animal efficacy data is being used to do more than simply corroborate AVA effectiveness. Because there is no meaningful number of inhalation anthrax cases in any of the human trials of AVA, it is only by animal data that the effectiveness of the vaccine against inhalation anthrax can be [**17] measured in any capacity. The animal tests referred to by defendants are all aerosol anthrax tests against various types of animals. See Defs' Opp. at 17 fn.20. In fact, the animal studies provide the only evidence of vaccine effectiveness against inhalation challenge.
Although defendants ignore the plaintiffs' citation to FDA regulations that sanction the use of animal testing data only in very limited circumstances (and which are not present in defendants' cited animal studies), they cite to 21 CFR § 601.25 as authority for their use of animal data. Interestingly, the cited section does not seem to allow for the use of animal data, but rather references various types of studies and "reports a significant human experience during marketing." Indeed, the implication of this section is that FDA may consider data involving human subjects, not animal subjects. Given that the FDA has already spoken on the very limited types of situations where animal data may be used to substantiate effectiveness, it is curious that the government raises an argument that would seem to open the door to any type of unsubstantiated data using unverifiable animal studies, as long as they were [**18] used for "corroboration."
[*11] The defendants' use of unsubstantiated animal testing data is a clear violation of the arbitrary and capricious standard applicable to APA actions. Therefore, the Court should remand this matter for proper consideration.
B. The Current AVA Has Never Been Subject Of Human Testing In Any Form

2003 U.S. Dist. Ct. Motions 707, *11; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **18

Page 7

In their initial Memo of Law, the defendants rely heavily on Berlex Labs., Inc. v. FDA, 942 F. Supp. 19 (D.D.C. 1996), to support their assertion that the Brachman study, conducted on the earliest variant of anthrax vaccine, is applicable to the latest AVA variation, notwithstanding the fact that the vaccine has gone through three different manufacturers and four different formulations and manufacturing changes in the interim. However, as noted, Berlex is easily distinguished and has no applicability in the situation here. See Plaintiffs' Opposition to Defendants' Motion for Summary Judgment at 11-12 (dated April 7, 2004)("Pls' Opp."). Yet, defendants now state that because all the changes and manufacturing occurred prior to AVA's licensure by NIH, the plaintiffs' argument somehow fails. See Defs' Opp. at 22.
The defendants [**19] deliberately misconstrue plaintiffs' argument, which is, simply, that the clinical data derived through the Brachman study of the first version of the vaccine, which was manufactured by the Department of Defense in the early 1950s, may not be applied to the fourth version of the vaccine, which has been altered by two other manufacturers and by three variations in formulation and manufacturing technology. These kind of changes typically require either a new license (for already licensed products) or a new clinical study validating the effectiveness of the changes in formula and manufacturing technology. See Pls' Opp. at 16.
[*12] Plaintiffs' argument, in fact, relies on FDA's so called comparability policy, which requires a single manufacturer of different variants of a product in order to allow testing data from an earlier version to the applied to a later version. The comparability policy would prohibit the use of the Brachman's study's data to support an efficacy determination on the Bioport vaccine. See AR1400 (FDA comparability guidance). To get around this, the FDA takes the unprecedented step of placing the mantle of "manufacturer" on the DoD. But DoD is not [**20] a commercial vaccine manufacturer despite the FDA's willingness to make it one. There is no evidence anywhere in the administrative record showing a continuous DoD manufacturing presence over the production of the vaccine from 1950 through 19998. Absent such a record, FDA's decision to effectively void its comparability policy is an arbitrary and capricious act.
Therefore, this Court should void FDA's Final Rule and remand the matter for further consideration.
C. A Review Of FDA's Bad Faith Actions And Decisions With Regard To The AVA
Defendants admit that Plaintiffs may properly seek discovery of an agency's decision-making process when there is a strong showing of bad faith or improper behavior, or where discovery provides the only possibility for effective judicial review. See Defs' Opp. at 26. The appropriate bad faith and improper behavior standard is indeed a difficult one to meet, but the plaintiffs believe the facts demonstrate that the standard has been met in this case.
The FDA's decision-making process with regard to AVA has been fundamentally flawed from the initial regulatory actions regarding the vaccine. FDA engaged in invalid statistical gerrymandering [**21] when it asserted that Brachman's data inadvertently included [*13] inhalation anthrax by improperly merging statistical results from two different routes of exposures into one mathematical result. Despite Dr. Brachman's specific contrary comments concerning the validity of his own results regarding inhalation anthrax, FDA used this altered number to reverse the determinations of its own expert panel and issue its Final Rule 18 years later. n13 FDA's administrative record deliberately omits the investigational new drug status of AVA, which began with AVA's manufacturer and defendant DoD applying to properly alter to the license for AVA so that it would provide them with a legal basis to use the vaccine against the inhalation anthrax. FDA deliberately issued a non-binding memorandum letter to DoD in March 1997 in an effort to provide a smoke screen for the AVIP. See AR004031-004032.

n13 The defendants, though informing this Court how they rely upon the conclusions reached by the Institute of Medicine ("IOM"), continue to ignore that the IOM specifically noted that "the small number of inhalational cases in those studies provides insufficient information to allow a conclusion about the vaccine's efficacy against

2003 U.S. Dist. Ct. Motions 707, *13; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **21

Page 8

inhalational infection to be made." See http://books.nap.edu/books/0309083095/html/ 59.html # pagetop. Additionally, Dr. Anna Johnson-Winegar, Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense, presented a briefing on April. 2, 2002, at the Chemical and Biological Arms Control Institute Senior Working Group on "Health as a Global Security Challenge" where she noted that the "Brachman study suggests efficacy in humans against inhalational anthrax." See www.acq.osd.mil/cp/winegarcbaic4-2-02.pdf (slide 11)(emphasis added).
[**22]
Despite having waited 18 years after the dismantling of the Expert Panel to characterize the AVA, the FDA then hurriedly issues a Final Rule one week after the Court issued its determination that the vaccine was an investigational drug and a drug unapproved for its intended use within the meaning of 10 USC § 1107. The Final Rule, obviously promulgated for defendants' advantage in this litigation, contained a specific reference to this case, as well as a complete reversal of all prior findings and internal statements.
[*14] These actions epitomize arbitrary and capricious conduct by a federal agency and they form the basis of the plaintiffs' request for discovery should it be determined that summary judgment not be appropriate at this time.
CONCLUSION
For the foregoing reasons, the Court should grant the plaintiffs' Motion for Summary Judgment and invalidate FDA's Final Rule and Order and remand it to the FDA for proper public comment and consideration of additional evidence. n14

n14 To the extent a specific argument of the government has not been addressed, the plaintiffs rely upon, and duly incorporate, their prior submissions filed in support of their Motion for Summary Judgment and in opposition to the defendants' Motion for Summary Judgment.
[**23] Respectfully submitted, /s/ John J. Michels, Jr., Esq. DC Bar # 457575, McGuireWoods LLP, 150 N. Michigan, Ste. 2500, Chicago, IL 60601, (312) 849-8150. Mark S. Zaid, Esq. DC Bar # 440532, Krieger & Zaid PLLC,

2003 U.S. Dist. Ct. Motions 707, *14; 2004 U.S. Dist. Ct. Motions LEXIS 8628, **23
1747 Pennsylvania Ave., Ste. 300, Washington, DC.20006, (202) 454-2809. Attorney for Plaintiffs.

Page 9

 
 Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 1 of 41

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

_________________________________

)

JOHN DOE #1, et al,

)

)

Plaintiffs, )

)

v.

) Civil Action No. 03-707 (EGS)

)

DONALD H. RUMSFELD, et al

)

)

Defendants. )

_________________________________)

MEMORANDUM OPINION

I. Introduction

Six plaintiffs, known as John and Jane Doe #1 through #6,

bring this action to challenge the lawfulness of the government’s

Anthrax Vaccination Immunization Program (“AVIP”). Specifically,

plaintiffs, who are members of the active duty or National

Guardsmen components of the Armed Forces and civilian contract

employees of the Department of Defense ("DoD") who have submitted

or have been instructed to submit to anthrax vaccinations without

their consent pursuant to AVIP, have filed a Motion for Summary

Judgment challenging the Food & Drug Administration’s (“FDA”)

determination that anthrax vaccine adsorbed (“AVA”) is licensed

for the purposes of combating inhalation anthrax (also known as

aerosolized or weaponized anthrax). Defendants, the Secretary of

Defense (Donald Rumsfeld), the Secretary of Health and Human

Services (Tommy Thompson), and the Commissioner of the Food and

1

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 2 of 41
Drug Administration (Mark McClellan) have filed a Cross Motion for Summary Judgment asking this Court to declare that FDA’s Final Rule and Order determining that AVA is licensed for anthrax regardless of the route of exposure is not arbitrary and capricious.
In 1997, the Department of Defense (“DoD”) instituted AVIP and began inoculating service members with AVA to prevent the harmful effects caused by exposure to anthrax.1 Compl. ¶ 33. Anthrax is an acute bacterial disease caused by infection with spores of Bacillus anthracis, which can enter the body in three ways: by skin contact (cutaneous), by ingestion (gastrointestinal), and by breathing (inhalation). See 50 Fed. Reg. at 51,058.
The AVIP is a multi-service vaccination program for active duty, Reserve and National Guard service members. Compl. ¶ 33. Under AVIP, military personnel are ordered to submit to a series of AVA inoculations over the course of eighteen months, followed by an annual booster vaccine. Compl. ¶ 47. If military personnel refuse to submit to the AVA inoculations, plaintiffs claim that they will be subject to military disciplinary actions, including court-martial convictions, forfeitures of pay, incarceration and other sanctions. Compl. ¶ 35. Civilian
1 For manufacturing-related reasons, the vaccine program was reduced and later suspended beginning in July 2000. DoD formally resumed the program in June 2002.
2

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 3 of 41
plaintiffs who refuse to comply with AVIP are subject to dismissal as DoD employees or defense contractors. Id.
II. Statutory & Regulatory Framework A. The Public Health Service Act & The Food, Drug, and Cosmetic Act The Public Health Service Act (“PHSA”), 42 U.S.C. §§ 201 et
seq., and the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301, et seq., govern the regulation of biological products in the United States. The FDCA charges FDA with approving drugs, including vaccines, that are safe, effective, and not misbranded. 21 U.S.C. § 355(d). The PHSA grants FDA authority to issue licenses for products that are “safe, pure, and potent.” 42 U.S.C. § 262(a)(2)(C)(i)(I).
Prior to 1972, the National Institute of Health (“NIH”) was charged with implementing the PHSA’s licensing requirement. In 1972, this authority was transferred to FDA. See Statement of Organization, Functions, and Delegations of Authority, 37 Fed. Reg. 12,865 (June 19, 1972). Upon the transfer of responsibility, FDA promulgated regulations establishing procedures for reviewing the safety, effectiveness, and labeling of all biological products previously licensed by the NIH. See Procedures for Review of Safety, Effectiveness and Labeling, 37 Fed. Reg. at 16,679. These regulations are codified in 21 C.F.R.
3

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 4 of 41
§ 601.25.
B. 21 C.F.R. § 601.25 21 C.F.R. § 601.25 established a two-stage process for reviewing biological products licensed prior to July 1, 1972. It directs FDA’s Commissioner (“Commissioner”) to appoint an advisory panel (1) to evaluate the safety and effectiveness of the previously licensed product, (2) to review the labeling of the product, and (3) to advise the Commissioner “on which of the biological products under review are safe, effective, and not misbranded.” See 21 C.F.R. § 601.25(a). Each panel must submit a report. See § 601.25(e). The report must contain a “statement . . . designat[ing] those biological products determined by the panel to be safe and effective and not misbranded” and this statement “may include any conditions relating to active components, labeling, tests required prior to release of lots, product standard, or other conditions necessary or appropriate for their safety and effectiveness.” § 601.25(e)(1). After reviewing the recommendation, the Commissioner must publish the panel report and a proposed order. See 21 C.F.R. § 601.25(f). After reviewing comments on the proposed order, the Commissioner “shall publish . . . a final order on the matters covered” therein, which shall “constitute final agency action
4

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 5 of 41
from which appeal lies to the courts.” See §§ 601.25(g), 601.25(i).
C. Expert Panel Review In 1973, FDA announced the Section 601.25 safety and effectiveness review of several “bacterial vaccine[s]” previously licensed under PHSA, including AVA, and solicited relevant data and information from manufacturers in order to determine whether the drugs were “safe, effective, and not misbranded.” See Safety, Effectiveness and Labeling Review; Request for Data Information, 38 Fed. Reg. 5,358 (Feb. 28, 1973). A scientific Advisory Panel was convened, and in 1980, after considering the relevant data and information, the Panel submitted its report. See A.R. 1-600. The Panel observed that AVA “appears to offer significant protection against cutaneous anthrax.” The Panel noted that “there is sufficient evidence to conclude that anthrax vaccine is safe and effective under the limited circumstances for which [it] is employed.” See A.R. at 338, 342. Therefore, the Report recommended that AVA “be placed in Category I” (safe, effective, and not misbranded) and that the appropriate licenses be continued because there is substantial evidence of safety and effectiveness for this product.” Id. at 342. In the Panel’s review of “recommended use,” it found that “this product is intended solely for immunization of high-risk of
5

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 6 of 41

exposure industrial populations such as individuals who contact imported animal hides, furs, bone meal, wool, hair (especially goathair) and bristles” along with “laboratory investigators handling the organism.” Id. at 340.
In arriving at this decision, the Panel considered two sets of data: (1) a human field trial conducted by Drs. Brachman, Glod, Plotkin, Fekety, Werrin, and Ingraham in the 1950's (“Brachman study”), A.R. 3732-45, and (2) surveillance data collected and summarized by the Center for Disease Control (“CDC”). See A.R. at 337-38.
The Brachman study involved 1,249 workers in four textile mills that processed imported goat hair. See A.R. 3732-33. A portion of the workers received the anthrax vaccine, a portion received a placebo vaccine, and a portion received no treatment. See A.R. 3737 (Table 2), A.R. 3736 (Table 4); 50 Fed. Reg. at 51,058 (Panel). During the evaluation period, which included an “outbreak” of inhalation anthrax, twenty-six cases of anthrax occurred. See A.R. 3733. The results can best be summarized as follows:

Total Cases (26)

Inhalation

5

Cutaneous

21

Anthrax Vaccine
0
3 (2 incomplete vaccine)

Placebo

No vaccine

2

3

15 (2 incomplete vaccine)

3

A.R. 3733-36. The Brachman study calculated the effectiveness of

the anthrax vaccine at 92.5 percent. See A.R. 3737. The authors

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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 7 of 41
of the study based their calculations on a comparison between the placebo and the anthrax vaccine group regardless of the route of exposure.
While relying on the Brachman study for its recommendation of effectiveness, the Panel stated that the study demonstrates “93 percent . . . protection” against only cutaneous anthrax and that “[i]nhalation anthrax occurred too infrequently to assess the protective effect of vaccine against this form of the disease.” 50 Fed. Reg. at 51,058 (Panel).
The Panel also considered surveillance data collected by the CDC “on the occurrence of anthrax in at-risk industrial settings.” 50 Fed. Reg. at 51,058 (Panel). While twenty-seven cases were observed, no cases occurred in persons who were fully vaccinated. Id.
D. FDA’s Proposed Rule and Order In 1985, citing Section 601.25's procedural requirements, FDA published notice of a Proposed Rule to reclassify bacterial vaccines and toxoids covered by the Panel Report. See Bio. Prods; Bacterial Vaccines & Toxoids; Implementation of Efficacy Review; Proposed Rule, 50 Fed. Reg. 51,002 (Dec. 13, 1985) (“Proposed Rule”).2 The Proposed Rule adopted the Panel Report
2 Although 21 C.F.R. § 601.25 contemplates the publication of the report and proposed order, FDA called its issuance a “proposed rule.”
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 8 of 41
verbatim with respect to AVA, including the Panel’s recommendation to classify AVA as Category I and the Panel’s note that “[i]mmunization with this vaccine is indicated only for certain occupational groups with risk of uncontrollable or unavoidable exposure to the organism.” See 50 Fed. Reg. at 51,058. The Proposed Rule found that “the benefit-to-risk assessment is satisfactory” for this “limited high-risk population.” 50 Fed. Reg. at 51,059.
The Proposed Rule required comments “on the proposed classification of products into Category I ... be submitted by March 13, 1986.” 50 Fed. Reg. at 51,002. Four total comments were received, none of them specifically addressing the proposal to reclassify AVA. See 69 Fed. Reg. 255, 256-259 (“Final Rule and Order”). FDA took no further action until December 30, 2003–eighteen years after the Proposed Rule, but only eight days after this Court’s Order enjoining DoD’s AVIP.
E. The Law Regarding Unapproved Drugs and Military Personnel In 1998, in response to concerns about the use of investigational new drugs during the 1991 Gulf War that may have led to unexplained illnesses among veterans, Congress enacted 10 U.S.C. § 1107. This provision prohibits the administration of investigational new drugs, or drugs unapproved for their intended use, to service members without their informed consent. The
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 9 of 41
consent requirement may be waived only by the President. In 1999, the President signed Executive Order 13,139, pursuant to which DoD must obtain informed consent from each individual member of the armed forces before administering investigational drugs and under which waivers of informed consent are granted only “when absolutely necessary.” Exec. Order No. 13,139, 64 Fed. Reg. 54,175 (Sept. 30, 1999). In August 2000, DoD formally adopted these requirements in DoD Directive 6200.2.
F. Citizen Petition On October 12, 2001, a group of individuals filed a citizen petition requesting that FDA declare that AVA is ineffective for use against inhalation anthrax and issue a final order classifying AVA as a Category II product. See A.R. 1313-75. The petitioners argued that the Panel had erred in concluding that the Brachman study qualified as a well-controlled field trial for purposes of 21 C.F.R. § 601.25(d)(2). See A.R. 1316-17 & n.6. In its August 28, 2002 response, FDA explained that it was “working to complete this rulemaking as soon as possible,” and that given “the pendency of this rulemaking,” it could not “evaluate the adequacy of the Panel recommendation.”3 A.R. 1378.
3 Again, although 21 C.F.R. § 601.25 contemplates the publication of a report and proposed order, FDA called its issuance a “proposed rule.”
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 10 of 41
G. The Preliminary Injunction In March 2003, plaintiffs filed suit in this Court, alleging that the AVIP violates federal law because AVA had never been approved as a safe and effective drug for protection against inhalation anthrax. Plaintiffs asked this Court to enjoin DoD from inoculating them without their informed consent. On December 22, 2003, this Court issued a Preliminary Injunction enjoining inoculations under the AVIP in the absence of informed consent or a Presidential waiver. Because the record was devoid of an FDA final decision on the investigational status of AVA, the Court was persuaded that AVA was an investigational drug being used for an unapproved purpose in violation of 10 U.S.C. § 1107, Executive Order 13,139, and DoD Directive 6200.2. See Doe v. Rumsfeld, 297 F. Supp. 2d 119, 135 (D.D.C. 2003).
H. Final Rule and Order Eight days after this Court’s Preliminary Injunction and eighteen years after FDA proposed to reclassify AVA, the agency announced a Final Rule and Order classifying AVA as a Category I drug. See Bio. Prods; Bacterial Vaccines & Toxoids; Implementation of Efficacy Review; 69 Fed. Reg. 255, 265-66 (Jan. 5, 2004)(“Final Rule and Order”). The Final Rule and Order stated that AVA was safe and effective “independent of the route of exposure.” See id. at 257-59. At the same time, FDA issued a
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 11 of 41
press release noting that a
recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as ‘investigational’ with regard to protecting against inhalation anthrax. Today’s final rule and order make clear that FDA does not regard the approved anthrax vaccine as ‘investigational’ for protection against inhalation anthrax. FDA’s final determination of the safety and effectiveness of the anthrax vaccine, independent of route of exposure, as well as its conclusions regarding the Expert Panel’s report, being announced today in the final order are relevant and should be considered in any further litigation in this matter.
See http://www.fda.gov/bbs/topics/NEWS/2003/NEW01001.html.
The Final Rule and Order relied on several sources of data
to support its finding of safety and efficacy, including the
Brachman Study, the CDC surveillance data, the results of a
“small randomized clinical study of the safety and immunogenicity
of AVA” conducted by the DoD, “post licensure adverse event
surveillance data available from the Vaccine Adverse Event
Reporting System (VAERS),” and an independent examination by the
Institute of Medicine (“IOM”). See Final Rule and Order at 260.
In its discussion, FDA explained, for the first time,
certain “points of disagreement with statements in the Panel
Report.” See id. at 259. Specifically, FDA disagreed with the
Expert Panel’s interpretation of the Brachman Study. FDA
concluded:
because the Brachman comparison of anthrax cases between the placebo and vaccine groups included both inhalation and cutaneous cases, FDA has determined that the calculated efficacy of the vaccine to prevent all types
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 12 of 41
of anthrax disease combined was, in fact, 92.5 percent. . . . The efficacy analysis in the Brachman study includes all cases of anthrax disease regardless of the route of exposure or manifestation of disease.
Id. at 259-60.
FDA did note that the five cases of inhalation anthrax were
“too few to support an independent statistical analysis.” Id. at
260. However, FDA explained that:
of these [five] cases, two occurred in the placebo group, three ocurred in the observation group, and no cases occurred in the vaccine group. Therefore, the indication section of the labeling for AVA does not specify the route of exposure, and the vaccine is indicated for active immunization against Bacillus anthracis [anthrax], independent of the route of exposure.
Id.
Moreover, FDA noted that the surveillance data was
“supportive of the effectiveness of AVA.” Id. at 260. FDA also
discussed the independent examination by IOM of AVA’s safety and
effectiveness, during which the IOM Committee “reviewed all
available data, both published and unpublished, [and] heard from
Federal agencies, the manufacturer and researchers.” Id. Noting
that the abstract of the IOM’s Report stated “that AVA, as
licensed, is an effective vaccine to protect humans against
anthrax including inhalation anthrax,” FDA stated it
agrees with the report’s finding that studies in human and animal models support the conclusion that AVA is effective against B. Anthracis strains that are dependant upon the anthrax toxin as mechanism or virulence, regardless of the route of exposure.
Id. at 260 & n.5.
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I. The Present Case Following the announcement of FDA’s Final Rule and Order, the Court granted defendants’ request to stay the Court’s earlier Preliminary Injunction except as it applied to the six Doe plaintiffs.4 See Order dated January 7, 2004, at 1-2. Plaintiffs now ask this Court to vacate FDA’s recent Final Rule and Order and to remand the matter to FDA for proper consideration and a determination of the licensing status of AVA. In addition, plaintiffs request that the Court reinstate the injunctive relief, albeit now on a permanent basis, that was granted in its initial ruling of December 22, 2003, because absent a valid final rule and/or order, the Court’s conclusion that the vaccine is improperly licensed for inhalation anthrax remains in effect. Alternatively, plaintiffs ask that summary judgment not be granted to defendants and ask that they be permitted to conduct discovery in order to ensure that the administrative record is complete and was not improperly influenced by DoD. Defendants ask this Court to grant summary judgment in their favor.
4 The parties consented to keeping the Preliminary Injunction in place with regard to the six Doe plaintiffs. Subsequently, at a Motions Hearing on March 15, 2004, the Court vacated its injunction as to the six Doe plaintiffs though the parties agreed that the six Doe plaintiffs would not be required to submit to the vaccination while this lawsuit was pending.
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 14 of 41
III. Standard of Review Pending before this Court are cross motions for summary
judgment. Summary judgment is granted pursuant to Federal Rule of Civil Procedure 56 only when there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). The Court views the evidence in the light most favorable to the nonmoving party, according the party the benefit of all reasonable inferences. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). Thus, in ruling on cross motions for summary judgment, the Court will grant summary judgment only if one of the moving parties is entitled to judgment as a matter of law upon material facts that are not in dispute. See Rhoads v. McFerran, 517 F.2d 66, 67 (2d Cir. 1975).
There are no genuine material facts that preclude judgment in this matter. If the FDA’s Final Rule and Order categorizing AVA as safe and effective for protection against inhalation anthrax was issued in accordance with the relevant law, then DoD’s AVIP is lawful; conversely, if FDA’s Final Rule and Order is invalid, the AVIP is unlawful absent informed consent or a Presidential waiver.
Under the Administrative Procedure Act, a reviewing court may hold unlawful and set aside final agency action found to be “arbitrary, capricious, an abuse of discretion, or otherwise not
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 15 of 41
in accordance with the law,” or “without observance of procedure required by law.” 5 U.S.C. § 706(2).
This Court is mindful that the standard of review for agency action is highly deferential. See American Public Communications Council v. FCC, 215 F.3d 51, 61 (D.C. Cir. 2000); Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 216 (D.D.C. 1996). Ordinary deference may be heightened even further in cases involving scientific or technical decisions. See Serono Labs., Inc., v. Shalala, 158 F.3d 1313, 1320 (D.C. Cir. 1998) (noting that an agency is entitled to a “high level of deference” when its regulatory determination rests on its “evaluation [] of scientific data within its area of expertise”). The “determination whether a drug is generally recognized as safe and effective within the meaning of [the FDCA] necessarily implicates complex chemical and pharmacological considerations.” Weinberger v. Bentex Pharms, Inc., 412 U.S. 645, 654 (1973). FDA’s “judgment as to what is required to ascertain the safety and efficacy of drugs” thus falls “‘squarely within the ambit of FDA’s expertise and merit[s] deference from’ the courts.” Bristol-Myers, 923 F. Supp. at 220 (quoting Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir.), cert denied, 516 U.S. 907 (1995)).
Although FDA’s scientific expertise is due great deference, it is well within this Court’s scope of authority to ensure that
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the agency adheres to its own procedural requirements. See Service v. Dulles, 354 U.S. 363 (1957) (seminal case standing for the proposition that judicial review is available to ensure that agencies comply with their own voluntarily-promulgated regulations, even where Congress has given the agency “absolute discretion” over the administrative action in question). See also Rodway v. United States Dept. of Agric., 514 F.2d 809, 81314 (D.C. Cir. 1975) (requiring the agency to comply with its own regulations “making the procedural requirements of [the APA] applicable” because “it is, of course, well settled that validly issued administrative regulations have the force and effect of law”) (citing Morton v. Ruiz, 415 U.S. 199, 235 (1974); Vitarelli v. Seaton, 359 U.S. 535, 539-540 (1959); Service, 354 U.S. at 388). In this case, the Court focuses not on FDA’s substantive-and highly technical--determinations regarding the safety of AVA, but rather on whether or not the Agency observed the relevant “procedure required by law.”
IV. Discussion A. Standing The party asserting jurisdiction always has the burden to
prove standing. FW/PBS Inc. v. City of Dallas, 492 U.S. 21, 23 (1990). To have standing, a plaintiff must allege: (1) an “actual or imminent” injury-in-fact; (2) “fairly . . .
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 17 of 41
trace[able] to the challenged action of the defendant”; and (3) “likely” to be “redressed by a favorable decision.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). At the summary judgment stage, “the plaintiff can no longer rest on . . . ‘mere allegations’,” but must “‘set forth’ by affidavit or other evidence ‘specific facts’” establishing standing. Lujan, 504 U.S. at 561 (quoting Fed. R. Civ. P. 56(e)).
The Court has recognized that in order to establish injury plaintiffs must demonstrate that they have taken, or have been ordered imminently to take, the anthrax vaccine. See Doe, 297 F. Supp. 2d at 130-31. While defendants argue that plaintiffs have presented no “specific facts” in support of these claims, the Court accepts and credits the sworn affidavit of plaintiffs’ counsel. Thus, plaintiffs have standing to challenge the FDA’s actions.
B. The Status of FDA’s December 30, 2003 Issuance At the outset, the parties dispute whether the FDA’s December 30, 2003 issuance, labeled a “Final Rule and Order,” was in fact a Final Rule or a Final Order.5 The Court will address this issue in the first instance. The APA defines two broad, normally mutually exclusive
5 Defendants claim that while part of the issuance is a Rule, the part that is relevant to AVA is an Order. Tr. 5/25/04 at 38.
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 18 of 41
categories of agency action - rules and orders. See Bowen v.
Georgetown Univ. Hosp., 488 U.S. 204, 216 (1988)(Scalia, J.,
concurring) (distinction between rules and orders is “the entire dichotomy upon which the most significant portions of the APA are based”). The APA defines a “rule” as:
the whole or a part of an agency statement of general or partial applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency and includes the approval or prescription for the future of rates, wages, corporate or financial structures or reorganization thereof, prices, facilities, appliances, services, or allowance therefor or of valuation, costs, or accounting, or practices bearing on any of the foregoing. 5 U.S.C. § 551(4). “[R]ule making,” which can be formal or informal, is the “agency process for formulating, amending, or
repealing a rule.” Id. at § 551(5).
When promulgating a substantive rule, an agency must comply
with the notice-and-comment requirements of 5 U.S.C. § 553. See
5 U.S.C. § 553(b). Notice and comment requires that an agency provide notice of a proposed rulemaking, and that notice must include “either the terms or substance of the proposed rule or a description of the subjects and issues involved.” 5 U.S.C. § 553(b). Once a proposed rule is issued, the agency must “give interested persons an opportunity to participate in the rulemaking through submissions of written data, views, or arguments.” 5 U.S.C. § 553(c).
The APA defines an “order” as:
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 19 of 41
the whole or a part of a final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other then rule making but including licensing. Id. at § 551(6). “Adjudication,” which can also be formal or informal, is the “agency process for the formulation of an order.” Id. at § 551(7). Plaintiffs claim that in conducting its review of AVA, FDA acted in a manner consistent with the exercise of rulemaking and that it was not until the present litigation that defendants sought to recast the AVA certification process.6 Plaintiffs allege that FDA’s rulemaking denied affected parties the opportunity to effectively participate in the process, and that the Final Rule should be invalidated and remanded to the agency. Defendants argue that a decision by FDA to place a biological product in Category I, thereby confirming its license, falls squarely within the definition of an “order” for purposes of the APA. See 5 U.S.C. § 551(6). Defendants note that Section 601.25 itself refers to FDA’s determination as an “order.” See 21 C.F.R. § 601.25(f). Defendants observe that FDA’s process for licensing biological products is not itself subject to rulemaking requirements. See, e.g., 42 U.S.C. § 262(a)(2)(A)(“[t]he
6 Plaintiffs note that the original notice of final agency action that appeared in the Federal Register on January 5, 2004 described FDA’s actions as a “Final Rule.” The words “and Order” were added by hand. Until that final agency action, FDA and DoD spokespersons have consistently referred to this determination concerning AVA as a “Final Rule.” See Pls.’ Reply Brief 6-7.
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Secretary shall establish, by regulation, requirements for approval, suspension, and revocation of biologics licenses”); 21 C.F.R. §§ 601.2 - 601.9. Thus, defendants note that were AVA a new biological product for which the manufacturer was seeking an initial license, FDA would not be required by the APA’s rulemaking provision to publish its licensing decision for notice and comment.
Moreover, defendants allege that FDA’s decision placing AVA in Category I bears none of the hallmarks of a “rule.” It does not “implement, interpret, or prescribe law or policy.” 5 U.S.C. § 551(4). Instead, defendants claim, the decision merely applies already-existing legal standards to specific facts - the hallmark of adjudication. Defendants note that the decision has no “future effect” (5 U.S.C. § 551(4)); it merely determines the “past and present rights and liabilities” of AVA’s manufacturer with respect to an already-issued license. See Bowen, 488 U.S. at 219 (Scalia, J., concurring); see also Goodman v. FCC, 182 F.3d 987, 994 (D.C. Cir. 1999). Defendants submit that consistent with Section 601.25(g), FDA referred to its licensing decision as a “Final Order” in several places. See Final Rule and Order at 257.
Plaintiffs claim that FDA has considered determinations like the one issued regarding AVA as rulemaking subject to judicial review. In Contact Lens Manufacturers Ass’n v. FDA, a commercial
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association sued FDA over its decision to classify contact lenses according to the product’s safety and effectiveness. 766 F.2d 592, 594 (D.C. Cir. 1985). In describing the safety and effectiveness of the lenses, FDA utilized a three class categorization system. Contact lens manufacturers whose products had been placed in Class III lobbied to reverse FDA’s proposal to stop a transfer of a category of lenses from Class III to Class I. Plaintiffs claim that the determination made by FDA with regard to the products’ status are virtually identical to the determination at issue here. Nevertheless, FDA provided extensive comment periods, and even a public hearing. Id. at 596-7.
In Cutler v. Hayes, FDA engaged in a comprehensive review of the safety and effectiveness of all over-the-counter drugs. 818 F.2d 879 (D.C. Cir. 1987). In doing so, FDA used a process, again, virtually identical to the one at issue here. To start, advisory review panels of experts were appointed to analyze existing test data and make recommendations in the form of monographs. Id. at 884. FDA reviewed the monographs, published them in the Federal Register, opened the period for public comment, and made a final recommendation, which was also open for public comment. Id. FDA then promulgated a determination classifying the drug as either Category I (safe and effective), Category II (not generally recognized as safe and effective), or
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Category III (data is insufficient to classify as I or II). In making its determination, FDA invited public comment twice.
Defendants acknowledge that FDA did provide interested parties an opportunity to comment on its Proposed Order categorizing AVA as a Category I product. Defendants argue that while agencies have discretion to employ “extra procedural devices,” the court may not second guess the agency’s decision
not to do so. See Vermont Yankee Nuclear Power Corp. v. Natural
Resources Defense Council, Inc. 435 U.S. 519, 545 (1978).
The D.C. Circuit has explained that when determining whether agency action is rulemaking or adjudicating:
the focus is not on whether the particular proceeding involved trial-type devices but instead turns on the nature of the decision to be reached in the proceeding. Rulemaking is prospective in scope and nonaccusatory in form, directed to the implementation of general policy concerns into legal standards. Adjudication, on the other hand, is “individual in impact and condemnatory in purpose,” directed to the determination of the legal status of a particular person or practices through the application of preexisting legal standards.
FTC v. Brigadier Industries Corp., 613 F.2d 1110, 1117 (D.C. Cir.
1979). It appears to the Court that the agency held AVA up to a
pre-determined standard and made a judgment as to whether to classify AVA as safe and effective or otherwise. This suggests to this Court that FDA has issued an order. However, Section 601.25(g) and (i) instruct the agency to take comments for 90 days. While orders typically fall outside the confines of APA
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rulemaking, see 5 U.S.C. § 553, here, the Court is confronted
with a situation where the agency decided that notice and comment regarding the proposed order was the correct course of action. This procedure is not without precedent.7
In Contact Lens Manufacturers, the FDA reviewed products for
safety and efficacy, provided opportunity for public input through the notice-and-comment process and public hearings, and published an Order as is evidenced by the D.C. Circuit’s labeling
of its review as a “Petition for Review of an Order of the Food
and Drug Administration.” 766 F.2d at 593 (emphasis added).
Cutler also provided an opportunity for the public to submit
comments following the publication of a proposed order. See 818
F.2d at 884. Thus, the Court is persuaded that the December 30, 2003 issuance was an order. While orders do not ordinarily require notice and comment, the plain meaning of Section 601.25 of FDA’s regulations requires notice and comment on the classification of the biologics in question:
7 The Court is perplexed by the fact that both parties have looked at Contact Lens Manufacturers and Cutler and asserted that rulemaking took place. See Tr.5/25/04 (by counsel for defendants “Let me cut to the chase, Contact Lens involved what was a rule. It wasn’t an order because it dealt with a broad category.” The Court: “So it’s the government view that it was a rule that was being challenged?” Counsel: “That was a rule.” The Court: “And not an Order?” Counsel: “And unquestionably not an order.”); see also Pls.’ Reply at 4 (“A review of comparable FDA determinations [alluding to Contact Lens Manufactures and Cutler] demonstrates that this type of FDA action constitutes rulemaking subject to public comment.”
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(4) The full report or reports of the panel to the Commissioner of Food and Drug. The summary minutes of the panel meeting or meetings shall be made available to interested persons upon request. Any interested person may within 90 days after publication of the proposed order in the Federal Register, file with the Hearing Clerk of the Food and Drug Administration written comments in quintuplicate. . . . (g) Final order. After reviewing the comments, the Commissioner of Food and Drugs shall publish in the Federal Register a final order on the matters covered in the proposed order.
21 C.F.R. § 601.25(f)(4) & (g). This requirement is also
reflected in FDA’s Final Rule and Order:
In accordance with § 601.25, after reviewing the conclusions and recommendations of the review panel, FDA would publish in the Federal Register a proposed order . . . After reviewing public comments, FDA would publish a final order on the matters covered in the proposed order.
69 Fed. Reg. 255.
Notice and comment gives interested parties an opportunity
to participate through the submission of data, views and
arguments.8 See Vermont Yankee Nuclear Power Corp. v. Natural
Resources Defense Council, Inc., 435 U.S. 519 (1978). Notice
and comment also ensures fairness to all parties and provides a
well-developed record - something this case is severely lacking.
See Sprint Corp v. FCC, 315 F.3d 369 (D.C. Cir. 2003); see also
Tr. 5/25/04 at 2 (by the Court “Let me just say at the outset
8 It appears to the Court that the FDA was concerned about representation of divergent views as section 601.25(a) notes that the advisory review panels “shall include persons from lists submitted by organizations representing professional, consumer, and industry interests. Such persons shall represent a wide divergence of responsible medical and scientific opinion.”
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that the administrative record in this case is one of the most confusing, jumbled records this Court has ever seen. Indeed, the only thing that is clear is that confusion abounds.”).
Although defendants are correct that the courts may not compel an agency to employ “extra procedural devices,” this Court shall compel an agency to follow the procedures set forth in its own regulations. In this case, FDA’s regulations require it to: (1) publish a proposed order in the Federal Register after considering the expert panel’s recommendations; (2) provide 90 days for interested persons to file written comments on the proposal; and (3) publish a final order on the matters covered in the proposed order. See 21 C.F.R. § 601.25 (f)(4) & (g). Thus, this Court will concentrate its review on the sufficiency of FDA’s compliance with these procedures. To guide its analysis, the Court will look to the substantial body of existing case law that gives meaning to what is meant by “notice and comment” under the APA.
C. Procedural Challenges to FDA’s Final Rule and Order 1. Studies Outside the Comment Period
The public was invited to submit comments on the Proposed Order for 90 days, from December 13, 1985, until the period closed on March 13, 1986. However, eighteen years later when the Final Rule and Order was published, FDA relied on studies
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and data that were not in existence at the conclusion of the comment period. Plaintiffs argue that the D.C. Circuit has frowned on this practice, noting that “[a]n agency commits serious procedural error when it fails to reveal portions of the technical basis for a proposed rule in time to allow for meaningful commentary.” Conn. Light & Power Co. v. Nuclear Regulatory Comm’n, 673 F.2d 525, 530-31 (D.C. Cir. 1982). It is clear that when an agency relies on studies or data after the comment period has ended, no meaningful commentary on such data is possible. See American Iron & Steel Inst. v. OSHA, 939 F.2d 975, 1009-10 (D.C. Cir. 1991); Small Refiner Lead Phase-Down Task Force v. EPA, 705 F.2d 506, 540-41 (D.C. Cir. 1983); Sierra Club v. Costle, 657 F.2d 298, 398 (D.C. Cir. 1981).
In American Iron & Steel, OSHA relied on a professional industry analysis that was completed after the comment period had ended in evaluating the economic feasibility of certain workplace exposure levels. The D.C. Circuit held that “reliance on the [post-comment period data] without providing an opportunity for comment was improper,” and the court vacated the portion of the regulation that relied on the late data. See 939 F.2d at 1010.
Here, plaintiffs argue that FDA relied on at least four extensive studies that commenced and concluded after the comment period ended. See 69 Fed. Reg. at 265-66. For example, FDA
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cites and relies on a report on the anthrax vaccine issued by the Institute of Medicine (“IOM”) in 2002 - sixteen years after the comment period ended. Id. at 259-60. In issuing its report, the IOM evaluated “all available data, both published and unpublished” on the anthrax vaccine, specifically focusing on three studies from 1996, 1998, and 2001. Id. at 260 & n.5.
Moreover, plaintiffs note that of the 4,209 pages in the administrative record, approximately 2,653 (63%) post-date 1986. Plaintiffs allege that persons who submitted comments in late 1985 and early 1986 were deprived of the opportunity to comment on these studies. Plaintiffs argue that this procedural flaw is so fundamental as to require the invalidation of FDA’s Final Rule and Order.
2. Deviations From The Proposed Rule While “a final rule need not be identical to the original proposed rule,” when the final rule “deviates too sharply from the proposal, affected parties will be deprived of notice and an opportunity to respond to the proposal.” AFL-CIO v. Donavan, 757 F.2d 330, 338 (D.C. Cir. 1985). The test is whether the final rule is a “logical outgrowth” of the proposed rule. If “a new round of notice and comment would provide the first opportunity for interested parties to offer comments that could persuade the agency to modify its rule,” then the final rule is
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not a “logical outgrowth.” American Water Works Assoc. v. EPA, 40 F.3d 1266, 1274 (D.C. Cir. 1994). See also Nat’l Mining Assoc. v. Mine Safety & Health Admin., 116 F.3d 520, 531 (D.C. Cir. 1997).
In Shell Oil Co. v. EPA, plaintiffs asserted that the EPA’s Final Rule contained a definition of “hazardous waste” that was much broader than the definition contained in the proposed rule and, as a result, they claimed not to have notice of the definition that was finally adopted. 950 F.2d 741, 748 (D.C. Cir. 1991). EPA argued that it intended to include the broader aspects of the definition, and that interested parties should have anticipated the substance of the final rule. Id. at 74950. In setting aside the rule and remanding it to the EPA, the D.C. Circuit held that an agency’s “unexpressed intention cannot convert a final rule into a ‘logical outgrowth’ that the public should have anticipated. Interested parties cannot be expected to divine the EPA’s unspoken thoughts.” Id. at 751-52.
Defendants argue that FDA’s Final Rule and Order is identical to what it proposed in 1985 - to place AVA in Category I. Compare Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed. Reg. 51,002, 51,104 (Dec. 13, 1985) with Final Rule and Order at 259. They claim that plaintiffs’ position is based on a misunderstanding of the Expert Panel’s recommendation. Defendants state that when the
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Panel issued its report, AVA was indicated for persons at risk to exposure to the anthrax bacterium and its label did not specify a route of exposure. See 50 Fed. Reg. at 51,059.
Moreover, defendants contend that the Panel recommended Category I notwithstanding the Panel’s alleged erroneous belief that the Brachman study did not assess the protective effect of the vaccine against inhalation anthrax. Defendants claim that this “framed . . . for discussion” whether AVA should be placed in Category I for use against inhalation anthrax. See Omnipoint Corp. v. FCC, 78 F.3d 620, 631 (D.C. Cir. 1996). Thus, defendants argue that FDA provided adequate “opportunities for interested parties to offer comments that could persuade the agency to modify its rule.” See American Water Works, 40 F.3d at 1274.
However, the Court finds that the public has never been afforded an opportunity to comment on the safety and efficacy of AVA as it pertains to inhalation anthrax. FDA’s Proposed Order (though called a “Proposed Rule” when published) only contained the Panel’s assessment of AVA. It found that the anthrax vaccine was safe and effective in “the limited circumstances for which this vaccine is employed.” 50 Fed. Reg. at 51,059. At that time, the vaccine was employed for use by “certain occupational groups,” mainly “individuals in industrial settings” who worked with animal furs, hides and hairs. 50 Fed.
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 30 of 41
Reg. at 51,058. The vaccine’s use was intended to be for
“protection against cutaneous anthrax in fully immunized
subjects.” 50 Fed. Reg. at 51,059. The Panel concluded that,
“no meaningful assessment of the [the vaccine’s] value against
inhalation anthrax is possible.” Id. It was under this premise
that the public was on notice to submit comments.
Interested parties in 1985 could not have anticipated that
FDA would permit the vaccine to be used for inhalation anthrax
as a result of exposure through a biological attack.9 In 1985
there would have been no reason to submit comments on the
vaccine’s use against other routes of exposure for the
population at large; indeed, not a single comment was received
on anthrax in response to the Proposed Rule.
Now, for the first time, eighteen years later, FDA’s Final
9 Defendants’ counsel conceded as much in response to a question by the Court: “But it’s absolutely right, Your Honor, that the possibility of weaponized anthrax was not in the minds of the advisory panel and probably not in the minds of the FDA.” Tr. 5/25/04 at 69.
Lending further support to the notion that the Expert Panel did not consider mass inhalational anthrax exposure is the Panel’s own comment:
Anthrax vaccine poses no serious special problems other than the fact that its efficacy against inhalation anthrax is not well documented. This question is not amenable to study due to the low incidence and sporadic occurrence of the disease. In fact, the industrial setting in which the studies above were conducted is vanishing, precluding any further clinical studies. In any event, further studies on this vaccine would receive low priority for available funding. 50 Fed. Reg. 51,058.
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Rule and Order asserts that FDA “does not agree with the Panel report,” and believes that “the vaccine is indicated for active immunization against [anthrax], independent of the route of exposure,” and that the vaccine will “protect humans against . . . inhalation anthrax.” 69 Fed. Reg. at 259-60.
The Court finds that this significant post-comment expansion of the scope of FDA’s inquiry deprived the public of a meaningful opportunity to submit comments and participate in the administrative process mandated by law. Because “a new round of notice and comment would provide the first opportunity for interested parties to offer comments that could persuade” the FDA to change its position with regard to the use of AVA against inhalation anthrax, the Agency’s Final Rule and Order is by no means a “logical outgrowth” of the 1985 Proposed Rule. See American Water Works, 40 F.3d at 1274. This failure to provide for a meaningful opportunity to comment, as required by FDA’s own regulations, violates the APA. See 5 U.S.C. § 706(2).
While vacatur is the normal remedy for an APA violation, a plaintiff must “show prejudice from an agency’s procedural violation.” City of Waukesha v. EPA, 320 F.3d 228, 246 (D.C. Cir. 2003). For a plaintiff to establish prejudice on the basis of a “logical outgrowth” argument, a plaintiff generally must show (1) that, “had proper notice been provided, they would have submitted additional, different comments that could have
31

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 32 of 41
invalidated the rationale for the revised rule;” or (2) that “the agency has entirely failed to comply with the notice-andcomment requirements, and the agency has offered no persuasive evidence that possible objections to its final rules have been given sufficient consideration.” Id.
Defendants argue that plaintiffs cannot make the first showing because FDA did consider and reject arguments against the rationale for its effectiveness determination in the course of responding to the citizen petition. See, e.g., A.R. 1376-85. In its Final Rule and Order, FDA expressly referred to the citizen petition and its response. See FDA Rule and Order at 259 n.2. Further, defendants claim that FDA’s citizen petition response provides “persuasive evidence” that it considered fully “possible objections” to the Order. See City of Waukesha, 320 F.3d at 246.
However, the Court is not persuaded. While some individuals may have submitted comments as part of a citizen petition, it is clear to this Court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency. Airborne exposure to anthrax was not an indication under the licensing contemplated by the 1985 Proposed Rule and a new notice-and-comment period would be the first opportunity that interested parties would have to
32

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 33 of 41
challenge the vaccine’s efficacy against such exposure. Thus, the Final Rule and Order shall be vacated and
remanded to the agency for reconsideration following an appropriate notice-and-comment period in accordance with the APA, the Agency’s own regulations, and this Memorandum Opinion and Order.10
V. Scope of Injunction Having vacated and remanded FDA’s Final Rule and Order, the
posture of this case reverts back to where it was on December 22, 2003, when this Court granted plaintiffs’ Motion for a Preliminary Injunction. Thus, for all the reasons stated in this Court’s December 22, 2003 opinion, including Congress’s prohibition on forced inoculations with “investigational” drugs, see 10 U.S.C. § 1107, the Court shall now issue a permanent injunction. Unless and until FDA follows the correct procedures to certify AVA as a safe and effective drug for its intended use, defendant DoD may no longer subject military personnel to involuntary anthrax vaccinations absent informed consent or a Presidential waiver.
10 Because the Court is granting plaintiffs’ Motion for Summary Judgment, this Memorandum Opinion does not address plaintiffs’ alternative argument for discovery or defendants’ Motion for Summary Judgment. Moreover, since the Court’s holding is based on procedural grounds, the Court does not reach plaintiffs’ numerous substantive challenges to FDA’s Final Rule and Order.
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In the days after the Court issued its injunction, there was much discussion concerning whether the injunction applied to the six Doe plaintiffs or whether the injunction applied to all persons affected by the DoD’s involuntary anthrax program. Because it is inevitable that this concern will be raised again, the Court shall address it now.11
Traditionally, "[l]itigation is conducted by and on behalf of the individual named parties only." Califano v. Yamasaki, 442 U.S. 682, 700-01 (1979). This general rule is based on the fundamental principles of due process and prudential standing. See, e.g., Allen v. Wright, 468 U.S. 737, 751 (1984)(noting "the general prohibition on a litigant's raising another person's legal rights"); Singleton v. Wulff, 428 U.S. 106, 113-14 (1976) ("[C]ourts should not adjudicate [the] rights [of third persons] unnecessarily, and it may be that in fact the holders of those rights either do not wish to assert them, or will be able to enjoy them regardless of whether the in-court litigant is successful or not.").
However, the Court notes that this litigation concerns the lawful status of the anthrax vaccine. Having found that the vaccine’s use without informed consent or a Presidential waiver
11 The parties briefed this issue in early 2004 which culminated in a Motions Hearing on March 15, 2004. At that time, the Court expressed its concern that a finding on this issue would have resulted in an advisory opinion. Thus, the Court denied the motion without prejudice.
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 35 of 41
is unlawful, this Court would be remiss to find that a conflict exists between service members who think that the DoD should be required to follow the law and those service members who think otherwise.
The Fourth, Fifth, Ninth, and D.C. Circuits have held that an injunction can benefit parties other than the parties to the litigation. See, e.g., National Mining Ass’n, et. al., v. U.S. Army Corps of Engineers, et. al., 145 F.3d 1399 (D.C. Cir. 1998); Bresgal v. Brock, 843 F.2d 1163 (9th Cir. 1987); Evans v. Harnett County Bd. of Educ., 684 F.2d 304 (4th Cir. 1982); Meyer v. Brown & Root Construction Co., 661 F.2d 369 (5th Cir. 1981). The Supreme Court has implicitly agreed with this proposition. Lujan v. National Wildlife Federation, 497 U.S. 871, 913 (1990).
“There is no general requirement that an injunction affect only the parties in the suit. Where, as here, an injunction is warranted by a finding of defendants’ outrageous unlawful practices, the injunction is not prohibited merely because it confers benefits upon individuals who were not named plaintiffs or members of a formally certified class.” McCargo v. Vaughn, 778 F. Supp. 1341, 1342 (E.D. Pa. 1991). A district court has “broad power to restrain acts which are of the same type or class as unlawful acts which the court has found to have been committed or whose commission in the future, unless enjoined,
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 36 of 41
may fairly be anticipated from the defendant’s conduct in the past.” N.L.R.B. v. Express Publ’g Co., 312 U.S. 426, 435 (1941).
The D.C. Circuit has found that when agency “regulations are unlawful, the ordinary result is that the rules are vacated – not that their application to the individual petitioner is proscribed.” National Mining Ass’n, 145 F.3d at 1409 (citation omitted). In National Mining Ass’n, the district court invalidated a Corps of Engineers regulation and entered an injunction prohibiting the Corps and the Environmental Protection Agency from enforcing the regulation nationwide. 145 F.3d at 1408. The D.C. Circuit upheld that nationwide application, notwithstanding the fact that non-parties to the litigation would specifically be affected. Id. at 1409-10.
Government-wide injunctive relief for plaintiffs and all individuals similarly situated can be entirely appropriate and it is “well-supported by precedent, as courts frequently enjoin enforcement of regulations ultimately held to be invalid.” Sanjour v. United States EPA, 7 F. Supp. 2d 14, 17 (D.D.C. 1998). See, e.g., Harmon v. Thornburgh, 878 F.2d 484, 495 n.21 (D.C. Cir. 1989)(court decision invalidating unlawful agency regulation applies beyond just individual petitioners); Planned Parenthood Fed’n of Amer., Inc., v. Heckler, 712 F.2d 650 (D.C. Cir. 1983)(affirming final injunction prohibiting enforcement of
36

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 37 of 41
invalidated regulations); Dimension Fin. Corp. v. Board of
Governors of the Fed. Reserve Sys., 744 F.2d 1402 (10th Cir.
1984)(enjoining Board from enforcing or implementing invalid
regulations) aff’d, 474 U.S. 361 (1986); Service Employees Int’l
Union v. General Servs. Admin., 830 F. Supp. 5 (D.D.C.
1993)(invalidating GSA regulation and enjoining further
enforcement of the rule).
The Supreme Court has also embraced this view. Although
written as part of a dissent, the D.C. Circuit has noted that it
expressed the views of all nine Justices. Justice Blackmun
wrote:
The Administrative Procedure Act permits suit to be brought by any person ‘adversely affected or aggrieved by agency action.’ In some cases, the ‘agency action’ will consist of a rule of broad applicability; and if the plaintiff prevails, the result is that the rule is invalidated, not simply that the court forbids its application to a particular individual. Under these circumstances, a single plaintiff, so long as he is injured by the rule, may obtain ‘programmatic’ relief that affects the rights of parties not before the court. On the other hand, if a generally lawful policy is applied in an illegal manner on a particular occasion, one who is injured is not thereby entitled to challenge other applications of the rule.
Lujan, 497 U.S. at 913 (Blackmum, J. dissenting)(citation
omitted). See also id. at 890 n.2 (majority opinion)(noting
that under the APA, successful challenge by aggrieved individual
can affect the entire agency program)(as cited in National
Mining Ass’n, 145 F.3d at 1409).
However, defendants are correct in asserting that National
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 38 of 41
Mining Ass’n did not address a mandatory rule that requires district courts to issue nationwide injunctions as a matter of law in all cases where agency regulations are invalidated. Rather, the appropriate scope is in the court's discretion. See 145 F.3d at 1408-09 (noting the district court's "discretion in awarding injunctive relief" and holding that when "a reviewing court determines that agency regulations are unlawful, the ordinary result is that the rules are vacated"). Courts retain discretion to decline granting an injunction even where there is a conceded violation of law. See Weinberger v. Romero-Barcelo, 456 U.S. 305, 312-13 (1982).
Defendants attempt to distinguish National Mining Ass’n from the present case by noting that the injunction there prohibited the enforcement by an agency of its own broadly applicable regulation deemed by the court to be facially invalid. See 145 F.3d at 1408. Here, plaintiffs seek an injunction that would prohibit DoD from taking action with respect to individual members of the military. Defendants claims that this is much broader than the injunction in National Mining Ass’n.12
12 Defendants also challenge the stability of National Mining Ass’n in the D.C. Circuit. Defendants note that the D.C. Circuit has recently questioned the viability of National Mining Ass’n for overlooking a key Supreme Court case in considering which test to apply to determine the merits of plaintiff's facial challenge. See Amfac Resorts v. United States Dep't of Interior, 282 F.3d 818, 826-27 (D.C. Cir. 2002) rev'd on other grounds, 538
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Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 39 of 41
Defendants note that the relief in National Mining Ass’n was also understandable in light of the broad representation of the plaintiffs before the court there. That case involved a challenge brought by several trade associations on behalf of their members. 145 F.3d at 1401. Defendants claim that the trade associations represented a much broader cross-section of affected parties than the six Doe plaintiffs.
However, it appears to this Court that the Court is faced with precisely the circumstances described by Justice Blackmun in his discussion of “programmatic relief.” See also Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191, 212 (D.D.C. 2002)(noting that National Mining Ass’n stands for the “proposition that a nationwide injunction invalidating an agency rule of broad applicability is appropriate even where a single plaintiff has challenged the legality of the rule”). Thus, the injunction issued today shall apply to all persons subject to DoD’s involuntary anthrax inoculation program and not just the six Doe plaintiffs.
U.S. 803 (2003); National Mining Ass'n v. United States Dep't of Interior, 251 F.3d 1007, 1010 (D.C. Cir. 2001). However, in Amfac Resorts, the D.C. Circuit "called into question its holding regarding the dredging regulation." Id. at 826-27. Thus, the D.C. Circuit reconsideration of the standard it applied in its analysis of a constitutional challenge to the dredging regulation does not suggest that program-wide relief cannot be extended to non-plaintiffs.
39

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 40 of 41
VI. Conclusion This Court has an obligation to ensure that FDA follow the
law in order to carry out its vital role in protecting the public’s health and safety. By refusing to give the American public an opportunity to submit meaningful comments on the anthrax vaccine’s classification, the agency violated the Administrative Procedure Act. While the policy of submitting comments on an agency’s proposed order may be unusual, it is the course the agency chose to take and this Court shall ensure that the agency follows through on its commitment to the public.
Congress has prohibited the administration of investigational drugs to service members without their consent. This Court will not permit the government to circumvent this requirement. The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all - public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this Court shall compel FDA to follow.
Accordingly, it is by the Court hereby ORDERED that Plaintiff’s Motion for Summary Judgment is GRANTED. The FDA’s Final Rule and Order is vacated and shall be remanded to the agency for reconsideration in accordance with this Memorandum Opinion and Order. Unless and until FDA
40

Case 1:03-cv-00707-EGS Document 59 Filed 10/27/04 Page 41 of 41

properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting defendants’ use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug within the meaning of 10 U.S.C. § 1107. Accordingly, the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a Presidential waiver; and it is further
ORDERED that, in light of the finding with regard to Plaintiffs’ Motion for Summary Judgment, Defendants’ Motion for Summary Judgment is DENIED.
A separate Order and Judgment accompanies this Memorandum Opinion.

Signed:

Emmet G. Sullivan United States District Judge October 27, 2004

41

 
 Case 1:03-cv-00707-EGS Document 66 Filed 02/04/05 Page 1 of 13

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Case 1:03-cv-00707-EGS Document 66 Filed 02/04/05 Page 4 of 13
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Case 1:03-cv-00707-EGS Document 66 Filed 02/04/05 Page 6 of 13
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Case 1:03-cv-00707-EGS Document 66 Filed 02/04/05 Page 7 of 13
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 Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 1 of 11

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

JOHN DOE # 1 et al., Plaintiffs, v.
DONALD H. RUMSFELD et al., Defendants.

)

)

)

)

Civil Action No. 1:03CV00707

)

)

)

)

)

PLAINTIFFS’ OPPOSITION TO DEFENDANTS' EMERGENCY MOTION TO MODIFY INJUNCTION

Plaintiffs John and Jane Does #1-6 oppose the granting of the Defendants' motion

at this time because it is fundamentally at odds with the express terms of the Court's

injunction. Moreover, the Defendants’ motion, in its present form, effectively removes

the careful lawful protections that the Court recognized existed specifically with relation

to the use of the Anthrax Vaccine Adsorbed ("AVA").

FACTUAL POSTURE

This Court permanently enjoined the involuntary administration of anthrax

vaccine absent a presidential waiver on October 27, 2004. The Court determined that the

Defendant Department of Defense (“DoD”) had for six years administered AVA as an

investigational new drug to service members and DoD civilians in violation of 10 U.S.C.

§ 1107 (2004). Absent providing informed consent in a voluntary program, or without the

required presidential waiver of informed consent, the Defendants were prohibited from

continuing a mandatory vaccination program.

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 2 of 11
As described more fully in the Government's Motion and attachments, the Defendants responded to the Court's action by invoking the provisions of the Project Bioshield Act, 21 U.S.C. § 360bb-3, in an effort to restart the Anthrax Vaccine Immunization Program ("AVIP").1 Following a hurried review of a DoD request, the Secretary of Health and Human Services ("HHS") authorized "emergency" use of the AVA under the terms of a specific use authorization. See 70 Fed. Reg. 5450, 5450-55. Among other things, this Emergency Use Authorization ("EUA") allegedly allows service members to refuse inoculation with no adverse consequences.
As part of the EUA requirements, the acting HHS Commissioner approved a socalled “tri-fold brochure” to be provided to each service member and civilian selected for vaccination by DoD. Although this Court's injunction required informed consent by service members prior to vaccination, the EUA does not provide for informed consent. Moreover, Defendants' counsel freely stated that the DoD does not believe informed consent is necessary, and that the information being provided via the tri-fold brochure falls short of an informed consent standard. See Transcript of Hearing of February 14, 2004, at 4-5 (“Tr.”), attached as Exhibit “1”; Tri-fold brochure, attached as Exhibit “2”.2
Pursuant to this new, improved and consensual AVIP, Defendants now seek an amendment of this Court's injunction to allow them to continue vaccinations with a vaccine that is unapproved for its intended use and still in investigational status. While
1 In fact, Defendants' counsel admitted at the status conference on February 14, 2005, that the reason the Defendants sought the emergency use authorization at issue here was because of this Court's injunction. See Tr. at 19. 2 Although the Acting HHS Secretary stated that the tri-fold brochure was "approved" by FDA on February 2, 2005, it was clear from the Defendants' attorney’s statements at the status hearing that this is not the case. In fact, final approval by FDA of the tri-fold brochure apparently did not occur until several days after the hearing on this matter.
2

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 3 of 11
Plaintiffs applaud Defendants' belated recognition that this program should be a voluntary
one, the so-called "voluntary" aspect of the proposed AVIP falls well short of what is
required under the terms of the injunction. The shortcomings are particularly troubling
given DoD’s admitted inability to comply with the original terms of the injunction in that
an unknown number of service members continued to received AVA after October 27, 2004.3
ARGUMENT
I. THE TRI-FOLD BROCHURE DOES NOT MEET THE REQUIREMENTS OF INFORMED CONSENT UNDER THE LAW OR THE LANGUAGE OF THIS COURT’S PERMANENT INJUNCTION
In light of what Defendants propose regarding individual notice to service
members affected by AVIP, the additional requirements for informed consent for the
military, promulgated under the Federal Food, Drug and Cosmetic Act (21 U.S.C.
355(i)(4)) and its supporting regulations, are not particularly onerous. See 21 CFR
§§ 5.20-27. The notice requirements for a written informed consent form are contained
in 21 CFR § 50.25 and include:
o A description of any reasonably foreseeable risks or discomforts to the subject;
o A description of any benefits to the subject or to others doing the research;
o Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to subject;
3 Plaintiffs also ask the Court to note that the government represented from the very beginning of this litigation that a voluntary program was incompatible with the most basic requirements of military readiness. See Defendants' Opposition to Plaintiffs' Motion for a Temporary Injunction at 4, 35-36 (filed April 9, 2003). As recently as January 2004, Defendants' counsel continued with that sentiment. See Transcript of Hearing, January 14, 2004, at 30-31, attached as Exhibit “3”. The Defendants’ sudden conversion on this issue is, accordingly, suspect.
3

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 4 of 11
o Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect such records;
o Contact information for answers to pertinent questions about the research and the subject’s rights and whom to contact in the event of research-related injury;
o A statement that the participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that subject may discontinue participation at any time without penalty.
In the current context, Plaintiffs note that the tri-fold brochure appears to comply with some of the regulatory requirements, but with several crucial exceptions. Chief among the omissions is a mechanism for tracking compliance with the education and information requirements of the EUA. Informed consent under the DoD regulations requires some form of documentation that the individual soldier or civilian who has been properly advised of the risks and benefits associated with the vaccination actually consents. Consent is documented by the individual's signing and dating a consent form. 21 CFR § 50.27.
There are no provisions in the tri-fold brochure for such documentation, nor have the Defendants proposed such an option.
Defendants plan on distributing the tri-fold brochures on an individual basis to every service member or civilian employee slated to take AVA. Under the circumstances, modifying the brochure to include a signature line with text indicating that the service member has read and understands her rights under the terms of the EUA does not seem particularly onerous.
4

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 5 of 11
Plaintiffs also request that Defendants be required to file copies of signed forms in the service member or civilian's medical records, as well as providing those who consent with a copy of the signed form for their own personal medical files. Again, given the relatively minimal administrative burden such a record-keeping requirement entails, this should not prove particularly onerous. Moreover, a signed record of consent would be of direct benefit both to the Defendants and the service members, given the apparent inability of the government to track shot records, shot sequences, or even shot administration for service members. See Defendants’ Response to Court’s Order of January 26, 2005 at 2-3; Tr. at 12-13.
A. Other Substantive Issues with the Tri-Fold Brochure. Plaintiffs also note these additional shortcomings in the brochure and suggest the following modifications: 1. Although the brochure ostensibly raises the issue of long-term side-effects, there is no description of such effects anywhere in the brochure. In fact, long-term side effects are discussed in the product insert; and a similar description should be included in the brochure. Specifically, the AVA license insert, a document approved by the FDA, notes that approximately 6% of reported reactions to the vaccine were listed as "serious," which are defined as events resulting in death, hospitalization, permanent disability, or are life threatening. The license insert also contains an exhaustive list of "infrequently" reported adverse events including such things as asthma, aplastic anemia, lymphoma, collagen vascular disease, lupus, multiple sclerosis, renal failure and liver abscess. See Product insert, 31 Jan. 2002, at 5-6, attached as Exhibit “4”. At a minimum, these long-
5

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 6 of 11
term effects should be provided to the service member to aid in later diagnosis should future health problems arise.
2. There should be a substantially stronger warning concerning the use of the vaccine for pregnant women. Specifically, the third paragraph under the "What if I'm Pregnant?" section should be moved so that it is the first paragraph in the sequence, and the sentence beginning, "Pregnant women should not be vaccinated against anthrax ...," should be boldfaced.
3. The front cover of the brochure should note that the vaccine is being used in an unapproved manner under the terms of an emergency use authorization.
4. The bullet point concerning a reported 92.5% effective rate is incorrect and misleading. In fact, the study cited in the brochure stated that inhalation anthrax (which is the focus of the entire AVIP) occurred too infrequently for the vaccine's effectiveness to be measured. See Brachman Study, FDA Administrative Record Concerning the AVA, at 3732-45; FDA Expert Panel Report, 50 Fed. Reg. at 51,058.
5. Given the identified risk of heart problems resulting from the vaccine, there should be a boldfaced warning prominently displayed in the brochure alerting soldiers of the need to respond immediately to certain symptoms associated with myocardiatis, cardiomyopathy, and atrial fibrillation.
6. The statement that the vaccine has been "FDA licensed to prevent anthrax since 1970," is misleading because it is quite clear from this Court's ruling that the vaccine has not been licensed to prevent inhalation (or gastrointestinal) anthrax. This statement should be corrected.
6

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 7 of 11
7. Notwithstanding the fact the vaccinations are to be voluntary and refusal is not to be punished, the brochure engages in both explicit and implicit coercion with its comments such as:
If you get infected with anthrax, your loss could endanger other people in your unit who depend on you. If you get infected with anthrax, it could endanger your mission. The consequences of refusing anthrax vaccine include that you will be more vulnerable to lethal anthrax infection. Your loss could threaten the lives of others in your unit who depend on you, and could jeopardize the success of your mission. These comments are incompatible with the requirements of informed consent. They demonstrate DoD’s unwillingness to simply allow servicemembers the dignity of making an informed choice absent repeated implied threats and statements designed to minimize the potential for soldiers opting out of the vaccination program. The presence of these statements is positive proof that the need for a balanced assessment of the AVA’s risks is more than theoretical. Some or all of this information will not fit on the current tri-fold brochure. However, there is a substantial amount of redundant or incorrect information on the inside cover and center of the brochure which could be eliminated to provide for an acknowledgement, signature and date line, as well as product insert information. At a minimum, the brochure needs to provide more specific information concerning possible health side effects such as those listed in the product insert and provide an acknowledgement line so that it is possible to adequately determine who has consented to
7

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 8 of 11
vaccination. Without these relatively simple adjustments, the so-called "voluntary"
nature of the program becomes meaningless.4
II. THE EMERGENCY USE AUTHORIZATION HAS BEEN IMPROPERLY ISSUED BY THE DEPARTMENT OF DEFENSE
It is undisputed that the triggering event for the EUA was not some escalated
threat of anthrax use against U.S. forces, but rather this Court's issuance of a permanent
injunction. See Tr. at 14. Thus, the very nature of the so-called "emergency" triggering
the decision by the Secretary of HHS is, at best, illusory. Indeed, this concern has been
raised by Members of Congress, including those who participated in the drafting of
Project BioShield. See Exhibit “5”.
In addition, the statute plainly requires the Secretary of Defense to determine that
there is a military emergency, or a significant potential for a military emergency.
4 As touched upon earlier, the Court should note that the DoD’s historic and continuing hostility to any kind of an informed consent requirement for service members involved in one of its vaccination programs is well documented. At the time of the Persian Gulf War, for example, DoD sought a waiver of requirements for informed consent for the use of Pyridostigmine Bromide (“PGB”) and Botulinum Toxoid. Although representatives of FDA indicated that these drugs were clearly investigational, DoD representatives informed FDA that DoD leadership did not want to abide by informed consent regulations. DoD advised FDA that the secretary of the military departments could dictate the use of unapproved FDA-regulated products as needed. See Senate Report 103-97, Dec. 8, 1994, Notes 79 and 80. Although DoD later represented to FDA that the use of the investigational drugs in question would be voluntary, post-war interviews indicated that upwards of 80% to 90% of the soldiers who took the drugs were told at the time that they had no choice. Id., at Notes 84, 85. In addition, where there was an education and notice requirement in place, as with the use of PGB, it was clear that DoD failed to provide the required notice. See Friedman, M.A., Lead Deputy Commissioner, Food and Drug Administration, letter to E.D. Martin, Acting Assistant Secretary of Defense (Health Affairs), July 22, 1997, attached as Exhibit “6”. Given this record of a previous voluntary program, it does not seem unwise for the Court to impose a signature and acknowledgement requirement for the voluntary AVIP. See also Declaration of Dr. Jonathan Moreno at ¶¶12-19, attached as Exhibit “7”. Dr Moreno, a nationally recognized expert in bioethics, notes that the DoD brochure does not meet any commonly understood standard of informed consent, and is, in fact, coercive to an unacceptable degree. Id.
8

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 9 of 11
21 U.S.C. § 360bbb-3(b)(1)(B). However, in this case, the determination of such a military emergency, and the request to the Secretary of HHS was not made by the Secretary of Defense, but by a Deputy Secretary of Defense. See Defendants' Emergency Motion to Modify Injunction (filed February 4, 2005), at Exhibit 4.
It is undisputed that the provisions for issuing an EUA do not state that the Secretary of Defense or his designee can make the requisite determination and request, but only the "Secretary of Defense". While Defendants will presumably rely on the provisions of 10 U.S.C. § 113(d), which allows the Secretary of Defense to perform his functions through or with the aid of his designees unless specifically prohibited by law, it is clear from the nature of the Project Bioshield amendments that Congress expected EUA authority to remain with the cabinet secretaries. See e.g., Exhibit “5”.
For example, it is the Secretary of Health and Human Services that issues the EUA with or without (under his discretion) consultation with other federal entities. Moreover, it appears from the language of the statute that the Secretary of HHS can waive the informed consent requirements for a drug unapproved for its unintended use. See 21 U.S.C. § 360bbb-3(e)(2)(A)("the secretary shall, to the extent practicable given the circumstances of the emergency" establish the requirements, including the option to accept or refuse administration of the product, relating to the EUA for the product).
Under these circumstances, it appears that Congress was providing substantial power to the Executive Branch to deal with a true national emergency, namely a biological warfare attack on the United States or its armed forces. The casual disregard of that requirement, especially under the circumstances present before the Court today,
9

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 10 of 11

argue strongly in favor of maintaining the determination and request authority at the

secretary level.

CONCLUSION

In response to this Court's October 27, 2004 permanent injunction (which the

government consistently refers to as nothing more than a "pause" in its AVIP literature),

Defendants instituted a course of action that, in retrospect, can only be considered

extraordinary. Defendants did nothing less than manufacture an emergency request under

the cover of a statute designed to respond to a real or imminent biological attack on the

United States, and now collude to end-run the Court's injunction. Given that Defendants

have failed to comply with that injunction and in light of DoD’s conduct, it seems only

prudent and proper that Defendants be required to follow at least a minimum of

procedural care in the administration of an investigational/unapproved vaccine on even a

voluntary basis.

Plaintiffs urge the Court to deny Defendants' motion without prejudice so that

they can return with a workable program that accommodates the rights and interests of

service members and civilians, or that the Court grant the motion but with the

modifications to the notice requirements as set forth above.

Date: February 28, 2005

Respectfully submitted,

/s/ ______________________________ Mark S. Zaid, Esq. D.C. Bar #440532 Krieger & Zaid, PLLC 1747 Pennsylvania Avenue, N.W. Suite 300 Washington, D.C. 20006 (202) 454-2809

10

Case 1:03-cv-00707-EGS Document 70 Filed 02/28/05 Page 11 of 11 John J. Michels, Jr., Esq. D.C. Bar #457575 McGUIREWOODS LLP 77 W. Wacker, Suite 4400 Chicago, Illinois 60601 (312) 849-8150 Attorney For The Plaintiffs
11

 
 Case 1:03-cv-00707-EGS Document 76 Filed 03/10/05 Page 1 of 15

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96+*+'("'+O"$+7%$"0/%$$+'7+*"(."(/+"PGA4"9$%&'(&))*"%6+"%((+89(&'7"%'"+'-M%6.1'-"(/+")1'-%8+'(%$ 6+31&6+8+'(*").6"L6&'7&'7"%"0$%&8"&'")+-+6%$"0.16(E""Q+0%1*+"9$%&'(&))*"/%;+"'.("&-+'(&)&+-"%"*&'7$+ 0%*+"(/%("O.1$-"%$$.O"(/+8"(."L59%**"(/.*+"L%*&0"6+31&6+8+'(*4"9%6(&01$%6$5"&'"%"0$.*+-"0%*+4"(/+&6 %((+89("(."L..(*(6%9"'+O"$+7%$"0$%&8*"&'"(/+"'%66.O"0.')&'+*".)"(/+*+"R1$+"=K>L?"96.0++-&'7* */.1$-"L+"6+S+0(+-E" !!" #$%&#'!()*+,&-'*.$/'%&0%%#1&#$%&233+!.2-+%&+%42+
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F/0"*9$"0$)+/'+")80$)(P"(4+;1++$(J"*9$":/10*"+9/18("'/*"$D$'"0$);9"*9$".$04*+"/&"*9$+$ ;/'*$'*4/'+"G$;)1+$"*9$P")0$"3$88"G$P/'("*9$"+;/6$"/&"*9$+$"60/;$$(4'?+")'("G$;)1+$"68)4'*4&&+ 9)D$"'/*"($./'+*0)*$("*9$40"+*)'(4'?"*/"G04'?"+1;9";9)88$'?$+"/0"$D$'")"60/6$0";)1+$"/&");*4/'H" Q$;)1+$"*9$"+4R"%/$"68)4'*4&&+"*9$.+$8D$+")0$"1')G8$"*/";/'*$'("*9)*"*9$P")0$")*"04+S"/&"G81'($04'? 4'*/");;$6*)';$"/&")'")'*90)R"4'/;18)*4/'"1'($0"*9$"TUVJ"*9$40"($.)'(+"&/0")((4*4/')8 4'&/0.)*4/'"4'"*9$"*04@&/8("G0/;910$J")'("&/0"+1668$.$'*)8"60/;$(10$+J"0$60$+$'*"4.60/6$0 )**$.6*+"*/")(D)';$"*9$"61*)*4D$"4'*$0$+*+"/&"*940("6)0*4$+"'/*"G$&/0$"*9$":/10*H""W9$")G+$';$"/& +*)'(4'?"&/0"*9$"+4R"%/$"68)4'*4&&+"4+"/'8P"6)0*"/&"*9$"60/G8$.J")+"*9$"/'8P"60/6$0"3)P"*9$"%/$ 68)4'*4&&+";/18("6106/0*"*/"0$60$+$'*")G+$'*".$.G$0+"/&"*9$"V0.$("F/0;$+"39/"3488"0$;$4D$"/&&$0+ /&"4'/;18)*4/'"4+"*/"/G*)4'";$0*4&4;)*4/'"/&")";8)++"1'($0"F$($0)8"=18$"/&":4D48"70/;$(10$"KXY) 60/;$(10$"68)4'*4&&+"9)D$"&)48$("*/"4'D/S$"4'"*94+"84*4?)*4/'H!""-/0$/D$0J")+"60$D4/1+8P"$R68)4'$(J 4'")'P"60/6$0";8)++");*4/'";/.68)4'*"*9$"68)4'*4&&+"3/18("G$"34*9/1*")"D)84(";)1+$"/&");*4/'J G$;)1+$"*9$"($*$0.4')*4/'"/&"*9$"4'&/0.)*4/'"*/"G$"60/D4($("1'($0")'"TUV"4+"$R60$++8P ;/..4**$("*/")?$';P"(4+;0$*4/'"GP"+*)*1*$H""W/"0$;)88J"+$;*4/'"!ZME4N"/&"*9$"FF%:V"$R684;4*8P +*)*$+"*9)*");*4/'+"*)S$'"1'($0"*9$")1*9/04*P"/&"+$;*4/'"!ZM"GP"*9$"#$;0$*)0P"/&"[[#"/0"*9$ #$;0$*)0P"/&"%$&$'+$"\)0$";/..4**$("*/")?$';P"(4+;0$*4/'H]""K^"UH#H:H"_"XZLGGG@XE4NH""V'("*9$ $+*)G84+9.$'*"/&";/'(4*4/'+"/'")'"TUVJ"4';81(4'?"*9$"4'&/0.)*4/'"*/"G$"60/D4($("*/"4'(4D4(1)8 0$;464$'*+J"4+"68)4'8P")'")1*9/04*P";/..4**$("*/"[[#"1'($0"*9$"+*)*1*$H""#$$"_"XZLGGG@XE$NH" `4D$'"*94+";8$)0"*$R*1)8";/..4*.$'*"*/")?$';P"(4+;0$*4/'J"*9$0$"4+"'/"G)+4+"&/0"68)4'*4&&+"*/
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 Case 1:03-cv-00707-EGS Document 90 Filed 04/06/05 Page 1 of 3

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

_________________________________

)

JOHN DOE #1, et al,

)

)

Plaintiffs, )

)

v.

) Civil Action No. 03-707 (EGS)

)

DONALD H. RUMSFELD, et al

)

)

Defendants. )

_________________________________)

ORDER

On October 27, 2004, this Court issued an order permanently enjoining the military’s anthrax vaccine program. Specifically, the Court held, “Unless and until FDA classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting defendants’ use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug within the meaning of 10 U.S.C. § 1107. Accordingly, the involuntary anthrax vaccine program, as applied to all persons, is rendered illegal absent informed consent or a Presidential waiver.”
Defendants have now filed an Emergency Motion to Modify the Injunction, seeking clarification that there exists a third option - an alternative to informed consent or a Presidential waiver - by which defendants can administer AVA to service members even in the absence of FDA approval of the drug: that is, pursuant to an Emergency Use Authorization (“EUA”) under the

Case 1:03-cv-00707-EGS Document 90 Filed 04/06/05 Page 2 of 3
Project BioShield Act of 2004, 21 U.S.C.A. § 360bbb-3. In enacting the EUA provision, Congress appears to have
authorized the use of unapproved drugs or the unapproved use of approved drugs based on a declaration of emergency by the Secretary of Health and Human Services, which in turn is based on “a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological or nuclear agent or agents.” 21 U.S.C.A. § 360bbb3(b)(1)(B).
Without ruling on the lawfulness or merits of any EUA, upon consideration of the defendants’ motion, the opposition and replies thereto, the amicus curiae brief, the arguments heard in open court on March 21, 2005, and the draft language jointly submitted by the parties in this case, it is hereby
ORDERED that the defendants’ Motion to Modify the Injunction is GRANTED; it is further
ORDERED that the Court’s injunction of October 27, 2004, is modified by the addition of the following language: “This injunction, however, shall not preclude defendants from administering AVA, on a voluntary basis, pursuant to the terms of a lawful emergency use authorization (“EUA”) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, without prejudice to a future challenge to the validity of any such EUA.

Case 1:03-cv-00707-EGS Document 90 Filed 04/06/05 Page 3 of 3

The Court expressly makes no finding as to the lawfulness of any specific EUA that has been or may be approved by the Department of Health and Human Services.”

Signed:

Emmet G. Sullivan United States District Judge April 6, 2005

 
 USCA Case #04-5440 Document #948693 Filed: 02/09/2006 Page 1 of 2

United S tates Court of A ppeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

No. 04-5440
JOHN DOE,1 THROUGH 4; JANE DOE, 1 THROUGH 2; AND OTHER SIMILARLY SITUATED INDIVIDUALS,
APPELLEES
v.
DONALD H. RUMSFELD, SECRETARY OF DEFENSE, ET AL., APPELLANTS

September Term, 2005
FILED ON: FEBRUARY 9, 2006 [948693]

Appeal from the United States District Court for the District of Columbia (No. 03cv00707)

Before: RANDOLPH, TATEL, and GRIFFITH, Circuit Judges.
J U D G M E N T
This case was considered on the record from the United States District Court for the District of Columbia and on the briefs and arguments of the parties. It is
ORDERED AND ADJUDGED that the case be remanded to the district court because the appeal is moot. At issue here is—or rather, was—the validity of a permanent injunction forbidding the Department of Defense from administering anthrax vaccine adsorbed (AVA) to members of the military without their consent. By its own terms, that injunction remained in effect “[u]nless and until FDA classifies AVA as a safe and effective drug for its intended use.” Doe v. Rumsfeld, No. 03-707 (D.D.C. Oct. 27, 2004) (order granting plaintiffs’ motion for summary judgment) (“Summ. J. Order”). In its order of December 19, 2005, FDA did just that, namely, classified AVA as “safe and effective and not misbranded.” Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order, 70 Fed. Reg. 75,180, 75,182 (Dec. 19, 2005).
By its own terms, then, the injunction has dissolved, and this case no longer presents a live

USCA Case #04-5440 Document #948693 Filed: 02/09/2006 Page 2 of 2
controversy on which we may pass judgment. See Nat’l Black Police Ass’n v. District of Columbia, 108 F.3d 346, 349 (D.C. Cir. 1997) (“a live controversy must exist at all stages of review”). Although the parties still dispute whether AVA’s original 1970 license takes it outside the definition of “drug unapproved for its applied use” within the meaning of 10 U.S.C. § 1107(g)(2), resolving that issue would have no practical effect on the now-dissolved injunction, and we have “no power to . . . decide questions that cannot affect the rights of litigants in the case before [us].” Nat’l Black Police Ass’n, 108 F.3d at 349 (internal quotation marks removed).
The government argues that the case is not moot because the district court’s final order “encompasses a declaration that the vaccine’s 1970 license does not extend to inhalation anthrax.” Reply to Opp’n to Appellant’s Mot. to Govern Further Proceedings 2. As we read the district court’s order, however, it never granted such declaratory relief, nor any other relief except the injunction. See Summ. J. Order.
In the event we find the case moot, the government urges us to vacate the district court’s opinion. We decline to do so, and instead remand with instructions to the district court to consider that request. See U.S. Bancorp Mortgage Co. v. Bonner Mall P’ship, 513 U.S. 18, 29 (1994) (“a court of appeals presented with a request for vacatur of a district-court judgment may remand the case with instructions that the district court consider the request”).
Pursuant to D.C. Circuit Rule 36, this disposition will not be published. The clerk is directed to withhold issuance of the mandate herein until seven days after resolution of any timely petition for rehearing or rehearing en banc. See Fed. R. App. P. 41(b); D.C. Cir. R. 41.
Per Curiam FOR THE COURT: Mark J. Langer, Clerk
BY: Michael C. McGrail Deputy Clerk

 
 Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 1 of 19
APPEAL, CLOSED, TYPE−D
U.S. District Court District of Columbia (Washington, DC) CIVIL DOCKET FOR CASE #: 1:03−cv−00707−EGS

JOHN DOE et al v. RUMSFELD et al Assigned to: Judge Emmet G. Sullivan Case in other court: USCA−DC, 04−05440 Cause: 05:702 Administrative Procedure Act Plaintiff JOHN DOE 1 through 4
Plaintiff JANE DOE 1 through 2; Other similarly situated individuals

Date Filed: 03/18/2003 Date Terminated: 01/25/2008 Jury Demand: None Nature of Suit: 890 Other Statutory Actions Jurisdiction: U.S. Government Defendant
represented by Mark S. Zaid MARK S. ZAID, P.C. 1250 Connecticut Avenue, NW Suite 200 Washington, DC 20036 (202) 454−2809 Fax: (202) 330−5610 Email: Mark@MarkZaid.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
John J. Michels , Jr. MCGUIRE WOODS, LLP 77 West Wacker Drive Suite 4100 Chicago, IL 60601−1604 (312) 849−8150 Fax: (312) 849−8151 Email: jmichels@mcguirewoods.com ATTORNEY TO BE NOTICED
represented by Mark S. Zaid (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
John J. Michels , Jr. (See above for address) ATTORNEY TO BE NOTICED

V.
Defendant
DONALD H. RUMSFELD Secretary of Defense

represented by Ronald James Wiltsie U.S. DEPARTMENT OF JUSTICE Federal Programs Branch 20 Massachusetts Avenue, NW Washington, DC 20530−0001 (202) 307−1401 Fax: (202) 616−8470 Email: ronald.wiltsie@usdoj.gov LEAD ATTORNEY ATTORNEY TO BE NOTICED
Andrew H. Tannenbaum U.S. DEPARTMENT OF JUSTICE Civil Division, Federal Programs Branch

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 2 of 19

P.O. Box 883 20 Massachusetts Ave., NW Washington, DC 20044 (202) 514−4263 Fax: (202) 616−8202 Email: andrew.tannenbaum@usdoj.gov ATTORNEY TO BE NOTICED

Craig M. Blackwell US DEPT OF JUSTICE−CIVIL DIVISION Ben Franklin Station P.O. Box 883 Washington, DC 2044 (202) 616−0679 Fax: (202) 616−8470 Email: craig.blackwell@usdoj.gov ATTORNEY TO BE NOTICED

Defendant
TOMMY THOMPSON Secretary of Health and Human Services

represented by Ronald James Wiltsie (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Andrew H. Tannenbaum (See above for address) ATTORNEY TO BE NOTICED

Craig M. Blackwell (See above for address) ATTORNEY TO BE NOTICED

Defendant MARK B. MCCLELLAN

represented by Ronald James Wiltsie (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Andrew H. Tannenbaum (See above for address) ATTORNEY TO BE NOTICED

Craig M. Blackwell (See above for address) ATTORNEY TO BE NOTICED

Movant
MILITARY VACCINE EDUCATION CENTER

represented by Kenneth T. Levine NELSON LEVINE DELUCA &HORST Four Sentry Parkway Suite 300 Blue Bell, PA 19422 (610) 862−6570 Fax: (610) 862−6501 Email: klevine@nldhlaw.com LEAD ATTORNEY ATTORNEY TO BE NOTICED

Martin Henry Karo NELSON LEVINE DELUCA &HORST Four Sentry Parkway Blue Bell, PA 19422

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 3 of 19

(610) 6500 Email: mkaro@nldhlaw.com TERMINATED: 11/20/2007 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Movant
NATIONAL GULF WAR RESOURCE CENTER

represented by Kenneth T. Levine (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED

Martin Henry Karo (See above for address) TERMINATED: 11/20/2007 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Movant
NATIONAL VACCINE INFORMATION CENTER

represented by Martin Henry Karo (See above for address) TERMINATED: 11/20/2007 LEAD ATTORNEY ATTORNEY TO BE NOTICED

Kenneth T. Levine (See above for address) ATTORNEY TO BE NOTICED

Date Filed 03/18/2003 03/18/2003
03/18/2003 03/18/2003 03/18/2003 03/21/2003 03/25/2003 03/27/2003
04/01/2003

# Docket Text
SUMMONS (5) Issued as to MARK B. MCCLELLAN ; DONALD H. RUMSFELD ; TOMMY THOMPSON, U.S. Attorney and U.S. Attorney General (td, ) (Entered: 03/21/2003)
1 MOTION (Ex Parte) for Leave to File complaint using "John Does" and "Jane Does" and counsel's address in violation of LCVR 5.1(e) and to seal declaration of Mark S. Zaid by JANE DOE, JOHN DOE;attachment (affidavit, filed under seal. (td, ) Modified on 6/18/2003 (zstewart−payneb, ). (Entered: 03/21/2003)
2 ORDER granting re 1 plaintiff's Motion for Leave to File complaint. Signed by Judge Thomas F. Hogan on 03/18/03. (td, ) (Entered: 03/21/2003)
3 COMPLAINT against MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Filing fee $ 150.) , filed by JANE DOE, JOHN DOE.(td, ) (Entered: 03/21/2003)
4 MOTION for Preliminary Injunction, MOTION for Temporary Restraining Order by JANE DOE, JOHN DOE. (td, ) (Entered: 03/21/2003)
Status Hearing set for 3/25/2003 10:30 AM in Courtroom 1 before Emmet G. Sullivan.. Signed by Judge Emmet G. Sullivan on 03/21/03. (td, ) (Entered: 03/21/2003)
Set/Reset Hearings: Status Conference reset for 3/27/2003 11:30 AM in Courtroom 1 before Emmet G. Sullivan. (clv, ) (Entered: 03/25/2003)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Status Conference held on 3/27/2003. Motion Hearing set for 5/8/2003 10:00 AM in Courtroom 1 before Emmet G. Sullivan. chambers to electronically issue an order;(Court Reporter Frank Rangus.) (clv, ) (Entered: 03/27/2003)
5 SCHEDULING ORDER. Signed by Judge Emmet G. Sullivan on April 1, 2003. (lcegs1) (Entered: 04/01/2003)

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04/09/2003
04/09/2003
04/11/2003 04/21/2003
04/25/2003 04/25/2003 04/25/2003
04/28/2003 05/19/2003 05/20/2003
05/23/2003 05/28/2003 06/19/2003
06/19/2003
06/26/2003
07/08/2003 07/08/2003

6 Memorandum in opposition to motion re 4 filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Affidavit Grabenstein Declaration# 2 Affidavit Goodman Declaration# 3 Affidavit AsstSecDef Letter)(Wiltsie, Ronald) (Entered: 04/09/2003)
7 NOTICE by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON Regarding Filing Exhibits Attached to Defendants' Opposition to Plaintiffs' Motion for a Preliminary Injunction (Wiltsie, Ronald) (Entered: 04/09/2003)
8 Consent MOTION for Extension of Time to File Response/Reply by JOHN DOE. (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 04/11/2003)
NOTICE: The Court directs counsel in this case to contact the Court by telephone at 12:30 pm. on Friday, April 25, in order to discuss further proceedings in this matter. Signed by Judge Emmet G. Sullivan on April 21, 2003. (lcegs1) (Entered: 04/21/2003)
ORDER finding as moot 8 Motion for Extension of Time to File Response/Reply. Signed by Judge Emmet G. Sullivan on April 25, 2003. (lcegs1) (Entered: 04/25/2003)
9 ORDER continuing hearing on pending motions until May 20, 2003 at 10:30 a.m. Signed by Judge Emmet G. Sullivan on April 25, 2003. (lcegs1) (Entered: 04/25/2003)
10 REPLY in support of motion re 4 Preliminary Injunction filed by JOHN DOE. (Attachments: # 1 Exhibit FDA Meeting Minutes# 2 Exhibit Bioport 1998 IND Supplemental# 3 Exhibit December 17, 1997 Meeting Memo# 4 Exhibit CDC Anthrax Information)(Zaid, Mark) (Entered: 04/25/2003)
11 ORDER continuing motions hearing to 5/20/03 at 10:30 a.m. Signed by Judge Emmet G. Sullivan on April 28, 2003. (lcegs1) (Entered: 04/28/2003)
Set/Reset Hearings: Motion Hearing set for 5/20/2003 03:00 PM in Courtroom 1 before Emmet G. Sullivan. (lcegs1) (Entered: 05/19/2003)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Motion Hearing held on 5/20/2003 re 4 MOTION for Preliminary Injunction MOTION for Temporary Restraining Order filed by JOHN DOE, JANE DOE.; motion heard and taken under advisement; counsel to submit order; (Court Reporter Jon Hundley, Miller.) (clv, ) (Entered: 05/20/2003)
12 MOTION to Seal Document by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 05/23/2003)
13 NOTICE OF TRANSCRIPT FILED for dates May 20, 2003; Court Reporter: John Hundley, Miller Reporting. (td, ) (Entered: 05/30/2003)
14 ENTERED IN ERROR. . . .Joint MOTION for Protective Order by JANE DOE, JOHN DOE, MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) Modified on 6/19/2003 (td, ). (Entered: 06/19/2003)
15 STIPULATION for Protective Order for the Trade Secrets and Confidential Proprietary Information of BioPort Corporation by JANE DOE, JOHN DOE, MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 06/19/2003)
16 STIPULATED PROTECTIVE ORDER FOR THE TRADE SECRETS AND CONFIDENTIAL PROPERIETARY INFORMATION OF BIOPORT CORPORATION . Signed by Judge Emmet G. Sullivan on June 25, 2003. (clv, ) (Entered: 06/26/2003)
17 ORDER granting defendants' motion to file document under seal. Signed by Judge Emmet G. Sullivan on 7/1/03. (clv, ) (Entered: 07/08/2003)
134 EXHIBIT the last document filed in the Food and DRug Administration's file BB−IND 6847 by MARK B. MCCLELLAN, DONALD H. RUMSFELD,

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 5 of 19

12/22/2003 12/24/2003
12/30/2003 12/30/2003 12/30/2003 12/30/2003 12/31/2003 12/31/2003
12/31/2003 01/02/2004

TOMMY THOMPSON 12 MOTION to Seal Document filed by DONALD H. RUMSFELD,, TOMMY THOMPSON,, MARK B. MCCLELLAN,; (SEALED) (td, ) (Entered: 08/03/2006)
18 ORDER granting 4 Plaintiff's Motion for Preliminary Injunction and setting forth instructions to parties. Signed by Judge Emmet G. Sullivan on December 22, 2003. (lcegs1) (Entered: 12/22/2003)
19 First MOTION Clarification or in the Alternative for Reconsideration re 18 Order on Motion for Preliminary Injunction, Order on Motion for TRO, MOTION for Reconsideration re 18 Order on Motion for Preliminary Injunction, Order on Motion for TRO by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 12/24/2003)
20 First MOTION for Extension of Time to Respond to Defendants' Motion for Clarification by JANE DOE, JOHN DOE. (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 12/30/2003)
MINUTE ORDER The Court, sua sponte, directs that a Response, if any, to Plaintiff's Motion for Extension of Time shall be filed by no later than 12:00 p.m. on December 31, 2003. A Reply, if any, shall be filed by no later than 3:00 p.m. on December 31, 2003. Signed by Judge Emmet G. Sullivan on December 30, 2003. (lcegs1) (Entered: 12/30/2003)
21 MOTION to Expedite, MOTION to Stay Preliminary Injunction, MOTION to Vacate Preliminary Injunction by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Exhibit One# 2 Exhibit Two# 3 Exhibit Three# 4 Exhibit Four# 5 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 12/30/2003)
22 MOTION to Expedite Defendants' Pending Motion for a Clarification or in the Alternative for Reconsideration by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 12/30/2003)
23 Memorandum in opposition to motion re 20 an Extension of Time in Which to Respond to Defendants' Motion for a Clarification or in the Alternative for Reconsideration filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 12/31/2003)
MINUTE ORDER granting 20 Plaintiffs' Motion for Extension of Time and granting 22 Defendants' Motion to Expedite Review of the pending motions. Plaintiffs shall file Responses to Defendants' Motion for Clarification or in the alternative for Reconsideration and Defendants' Motion to Vacate the Preliminary Injunction and for a Stay by no later than 4:00 p.m. January 9, 2004. Any Replies to the pending motions shall be filed by 4:00 p.m. January 12, 2004. The Court, sua sponte, schedules a Motions Hearing for all pending motions at 10:00 a.m. on January 14, 2004. Plaintiffs are excused from filing a Reply to their Motion for Extension of Time. Signed by Judge Emmet G. Sullivan on December 31, 2003. (lcegs1, ) (Entered: 12/31/2003)
Set/Reset Hearings: Motion Hearing set for 1/14/2004 10:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (lcegs1) (Entered: 12/31/2003)
24 Emergency MOTION For Immediate Administrative Stay Pending Disposition Of Defendants' Motions re 19 First MOTION Clarification or in the Alternative for Reconsideration re 18 Order on Motion for Preliminary Injunction, Order on Motion for TRO MOTION for Reconsideration re 18 Order on Motion for Preliminary Injunction, Order on Motion for TRO MOTION for Reconsideration re 18 Order on Motion for Preliminary Injunction, Order on Motion for TRO, 21 MOTION to Expedite MOTION to Stay Preliminary Injunction MOTION to Stay Preliminary Injunction MOTION to Vacate Preliminary Injunction MOTION to Vacate Preliminary Injunction, 22 MOTION to Expedite Defendants' Pending Motion for a Clarification or in the Alternative for Reconsideration by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON.

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01/04/2004 01/05/2004
01/05/2004 01/06/2004
01/07/2004 01/13/2004 01/14/2004 01/14/2004 01/16/2004 01/16/2004 01/16/2004 01/26/2004

(Attachments: # 1)(Wiltsie, Ronald) (Entered: 01/02/2004)
25 Memorandum in opposition to motion re 24 Emergency Motion for Immediate Administrative Stay filed by JANE DOE, JOHN DOE. (Zaid, Mark) (Entered: 01/04/2004)
MINUTE ORDER Defendants are directed to file a Reply to Plaintiffs' Response to Defendants' Emergency Motion for Immediate Administrative Stay Pending Disposition of Defendants' Motions by no later than 4:00 p.m. on January 6, 2004. Defendants are directed not to repeat any previously made arguements. A Motions Hearing to hear ONLY the Motion to Stay will be held January 7, 2004 at 12:30 p.m. Signed by Judge Emmet G. Sullivan on January 5, 2004. (lcegs1) (Entered: 01/05/2004)
26 REPLY in support of motion re 24 Immediate Administrative Stay Pending Disposition of Defendants' Motions filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 01/05/2004)
27 ENTERED IN ERROR. . . .NOTICE by JANE DOE, JOHN DOE of Filing of First Amended Complaint (Attachments: # 1 Exhibit Exhibit 1 − Original Complaint# 2 Exhibit Exhibit 2 − First Amended Complaint# 3 Exhibit Attachment A − Anthrax Vaccine Adsorbed product insert# 4 Exhibit Attachment B − 2002 Anthrax Vaccine Adsorbed Product Insert# 5 Exhibit Attachment C − RFP DAMD17−85−R−0078# 6 Exhibit Attachment D − FDA Response to Citizen Petition# 7 Exhibit Attachment E − Federal Register, December 13, 1985# 8 Exhibit Attachment F − Testimony of Nancy Kingsbury, GAO# 9 Exhibit Attachment G − October 5, 1995 License Amendment Plan# 10 Exhibit Attachment H − Minutes of October 20, 1995 Meeting# 11 Exhibit Attachment I − Comparative Study# 12 Exhibit Attachment J − September 20, 1996, MBPI Letter to Dr. Kathryn C. Zoon# 13 Exhibit Attachment K − IND Introductory Statement# 14 Exhibit Attachment L − FDA letter of December 13, 1996# 15 Exhibit Attachment M − Industrial Capabilities Assessment# 16 Exhibit Attachment N − IND Application Supplements# 17 Exhibit Attachment O − Indemnification Agreement# 18 Exhibit Attachment P − September 29, 1999 Letter to Bailey# 19 Exhibit Attachment Q − August 6, 2002, AVIP Memorandum)(Zaid, Mark) Modified on 1/9/2004 (td, ). (Entered: 01/06/2004)
28 ORDER granting 24 Motion to Stay the Injunction as Applied to Persons Other than the Named Parties. Signed by Judge Emmet G. Sullivan on January 7, 2004. (lcegs1) (Entered: 01/07/2004)
29 Joint MOTION Joint Proposal Regarding Further Proceedings by JANE DOE, JOHN DOE, MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 01/13/2004)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Motion Hearing held on 1/14/2004 Motion Hearing set for 3/15/2004 10:00 AM in Courtroom 1 before Judge Judge Emmet G. Sullivan. and May 18, 2004 at 10:00(Court Reporter Frank Rangus.) (clv, ) (Entered: 01/14/2004)
MINUTE ORDER Parties are directed to confer and submit a joint proposed order memorializing the scheduling established at the January 14, 2004 Status Hearing. Signed by Emmet G. Sullivan on January 14, 2004. (lcegs1) (Entered: 01/14/2004)
30 ORDER setting the schedule for further proceedings. Signed by Judge Emmet G. Sullivan on January 16, 2004. (lcegs1) (Entered: 01/16/2004)
Set/Reset Hearings: Motion Hearing set for 3/15/2004 10:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (lcegs1) (Entered: 01/16/2004)
Set/Reset Hearings: Motion Hearing set for 5/18/2004 10:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (lcegs1) (Entered: 01/16/2004)
31 MOTION Determine that Class Certification is not Required for Program−Wide Injunctive Relief by JANE DOE, JOHN DOE. (Attachments: # 1 Memorandum of Law# 2 Text of Proposed Order)(Zaid, Mark) (Entered: 01/26/2004)

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02/02/2004 02/02/2004 02/02/2004 02/02/2004 02/02/2004 02/09/2004
02/10/2004 02/10/2004 02/10/2004 02/11/2004 02/17/2004
02/25/2004
02/26/2004
02/26/2004 02/26/2004 02/27/2004 03/03/2004

MINUTE ORDER The Motions Hearing previously scheduled for May 18, 2004 has been continued until May 25, 2004 at 10:00 a.m. in Courtroom One. Signed by Judge Emmet G. Sullivan on February 2, 2004. (lcegs1) (Entered: 02/02/2004)
Set/Reset Hearings: Motion Hearing set for 5/25/2004 10:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (lcegs1) (Entered: 02/02/2004)
32 ENTERED IN ERROR. . . .NOTICE by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON of Filing of the Administrative Record (Wiltsie, Ronald) Modified on 2/3/2004 (td, ). (Entered: 02/02/2004)
33 ADMINISTRATIVE RECORD by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (td, ) (Entered: 02/03/2004)
DOCUMENT NO. 32 filed by defendant's has been Entered In Error and correctly reentered as document number 33(td, ) (Entered: 02/03/2004)
34 Memorandum in opposition to motion re 31 to Determine that Class Certification is Not Required for Program−Wide Injunctive Relief filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Tannenbaum, Andrew) (Entered: 02/09/2004)
35 MOTION to Seal Accompanying Unopposed Motion To Place Document Under Seal by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 02/10/2004)
36 MOTION to Place Document Under Seal by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 02/10/2004)
37 MOTION to Seal accompaning unopposed motion to place document under seal; EXHIBIT (SEALED; Unopposed Motion) by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (td, ) (Entered: 02/13/2004)
MINUTE ORDER granting 35 Defendant's Motion to Seal, granting 36 Defendant's Motion to Place Documents to Seal. Signed by Judge Emmet G. Sullivan on February 11, 2004. (lcegs1) (Entered: 02/11/2004)
38 REPLY in support of motion re 31 Program Wide Injunctive Relief filed by JANE DOE, JOHN DOE. (Attachments: # 1 Exhibit Hartford Courant Article# 2 Exhibit Army Briefing# 3 Exhibit Financial Times Article)(Zaid, Mark) (Entered: 02/17/2004)
39 ENTERED IN ERROR. . . .Consent MOTION for Protective Order For The Trade Secrets And Confidential Proprietary Information Of BioPort Corporation by JANE DOE, JOHN DOE, MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) Modified on 2/26/2004 (td, ). (Entered: 02/25/2004)
40 STIPULATION Protective Order For The Trade Secrets And Confidential Proprietary Information Of BioPort Corporation by JANE DOE, JOHN DOE, MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 02/26/2004)
DOCUMENT NO. 39 has been Entered In Error and counsel has been instructed to refile said document as a stipulation.(td, ) (Entered: 02/26/2004)
MINUTE ORDER The Court accepts 40 the Consent Stipulation of the parties. Signed by Judge Emmet G. Sullivan on February 26, 2004. (lcegs1) (Entered: 02/26/2004)
41 NOTICE OF TRANSCRIPT FILED for dates 1/14/02; Court Reporter: Frank J. Rangus. (td, ) (Entered: 03/03/2004)
42 MOTION for Summary Judgment and supporting memorandum of points and authorities by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order proposed order# 2 local rule 7.1(h) statement of material facts)(Blackwell, Craig) (Entered: 03/03/2004)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 8 of 19

03/03/2004 03/03/2004 03/12/2004 03/16/2004
03/31/2004 03/31/2004 04/07/2004
04/07/2004 04/13/2004 04/13/2004 04/21/2004 04/21/2004 05/25/2004

43 MOTION for Summary Judgment and Permanent Injunctive Relief Or, In The Alternative, Discovery by JANE DOE, JOHN DOE. (Attachments: # 1 Memorandum of Law# 2 Exhibit FDA Final Rule# 3 Exhibit CT Attorney General Letter to FDA# 4 Exhibit Missing Documents# 5 Exhibit BG Caine E−mails# 6 Text of Proposed Order)(Zaid, Mark) (Entered: 03/03/2004)
44 NOTICE by JANE DOE, JOHN DOE re 43 MOTION for Summary Judgment and Permanent Injunctive Relief Or, In The Alternative, Discovery of Filing (Attachments: # 1 Statement of Material Facts)(Zaid, Mark) (Entered: 03/03/2004)
MINUTE ENTRY − Due to the Trial in progress before the Court, the hearing on pending motions is rescheduled from 10:00 a.m. to 11:30 a.m. on 3/15/04. Set/Reset Hearings: Motion Hearing set for 3/15/2004 11:30 AM before Judge Judge Emmet G. Sullivan. (GK, ) (Entered: 03/12/2004)
45 ORDER denying without prejudice 31 Plaintiffs' Motion to determine that class certification is not required for program−wide injunctive relief, denying as moot 19 Defendants' Motion for Clarification, denying as moot 19 Defendants' Motion for Reconsideration, denying as moot 21 Defendants' Motion to Expedite, denying as moot 21 Defendants' Motion to Stay the Preliminary Injunction, denying as moot 21 Defendants' Motion to Vacate the Preliminay Injuncton and vacating the Court's January 7, 2004 Injunction with regard to the six Doe plaintiffs. Signed by Judge Emmet G. Sullivan on March 16, 2004. (lcegs1) (Entered: 03/16/2004)
46 Consent MOTION for Extension of Time to File Response/Reply by JANE DOE, JOHN DOE. (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 03/31/2004)
MINUTE ORDER granting 46 the Consent Motion for Extension of Time to File Responses and Replies re 42 Defendants' MOTION for Summary Judgment and 43 Plaintiffs' MOTION for Summary Judgment. Responses are due by no later than 4/7/2004. Replies are due by no later than 4/21/2004. Signed by Judge Emmet G. Sullivan on March 31, 2004. (lcegs1) (Entered: 03/31/2004)
47 Memorandum in opposition to motion re 42 Defendants Request for Summary Judgment filed by JANE DOE, JOHN DOE. (Attachments: # 1 Exhibit Exhibit "1" − Schumm Declaration# 2 Exhibit Exhibit "1−A" − Statistical Analysis# 3 Exhibit Exhbit "1−B" − AVA and Gulf War Syndrome# 4 Exhibit Exhibit "1−C" − Comments on IOM Report# 5 Exhibit Exhibit "1−D" − Efficacy Memo# 6 Exhibit Exhibit "1−E" − Pittman Memo# 7 Exhibit Exhibit "1−F" − MDPH Visit# 8 Exhibit Exhibit "1−G" − MDPH Submission# 9 Exhibit Plaintiffs Response to Defs Statement of Material Facts)(Zaid, Mark) (Entered: 04/07/2004)
48 Memorandum in opposition to motion re 43 plaintiffs' motion for summary judgment filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 response to plaintiffs' statement of material facts# 2 Text of Proposed Order)(Blackwell, Craig) (Entered: 04/07/2004)
Set/Reset Hearings: Motion Hearing set for 5/25/2004 10:00 AM in Courtroom 1 before Judge Judge Emmet G. Sullivan. (clv, ) (Entered: 04/13/2004)
49 NOTICE by JANE DOE, JOHN DOE of Filing of Sealed Letter (Zaid, Mark) (Entered: 04/13/2004)
50 REPLY to opposition to motion re 42 defendants' motion for summary judgment filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Blackwell, Craig) (Entered: 04/21/2004)
51 REPLY to opposition to motion re 43 Plaintiffs' Motion for Summary Judgment Or, Alternatively, For Discovery filed by JANE DOE, JOHN DOE. (Attachments: # 1 Exhibit 1 − FDA Handwritten Fed Reg Notice)(Zaid, Mark) (Entered: 04/21/2004)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Motion Hearing held on 5/25/2004; motions heard and taken under advisement; (Court Reporter Elaine Merchant.) (clv, ) (Entered: 05/25/2004)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 9 of 19

05/26/2004
06/07/2004 06/07/2004
06/25/2004 07/09/2004 07/12/2004 07/14/2004 07/14/2004 10/27/2004 10/27/2004 10/27/2004 10/27/2004 10/28/2004 11/28/2004
12/13/2004

MINUTE ORDER The parties are directed to file a response to the following questions by no later than June 7, 2004: (1) What is the statutory authority for 21 C.F.R. 601.25? (2) Explain how 21 C.F.R. 601.25 is related to section 355(h) of the Federal Food, Drug &Cosmetic Act, 21 U.S.C. 301, et seq, which directs appeals of agency Orders to the Court of Appeals. (3) Explain the relevance of Contact Lens Manufacturers Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), which is styled a "Petition for Review of an Order of the Food &Drug Administration." (4) Are you aware of any cases in which a district court judge has remanded an Order to an agency? Signed by Judge Emmet G. Sullivan on May 26, 2004. (lcegs1) (Entered: 05/26/2004)
52 RESPONSE to the Court's May 26 Order by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Tannenbaum, Andrew) (Entered: 06/07/2004)
53 RESPONSE to Court's May 26, 2004 Order filed by JANE DOE, JOHN DOE. (Attachments: # 1 Exhibit 1 − Sammie Young Declaration# 2 Exhibit 1A − 1993 Congressional Record# 3 Exhibit 1B − 1980 Citizen Petition# 4 Exhibit 1C − 1972 GAO Report# 5 Exhibit 1D − 2002 GAO Report)(Zaid, Mark) (Entered: 06/07/2004)
54 MOTION to Strike by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Tannenbaum, Andrew) (Entered: 06/25/2004)
55 Unopposed MOTION for Extension of Time to File Response/Reply as to 54 MOTION to Strike by JANE DOE, JOHN DOE. (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 07/09/2004)
MINUTE ORDER granting 55 the Unopposed Motion for Extension of Time to File Response re 54 the Government's MOTION to Strike. Response due by 7/14/2004. Signed by Judge Emmet G. Sullivan on July 12, 2004. (lcegs1) (Entered: 07/12/2004)
56 Memorandum in opposition to motion re 54 Striking Young Declaration filed by JANE DOE, JOHN DOE. (Zaid, Mark) (Entered: 07/14/2004)
57 NOTICE OF TRANSCRIPT FILED for motion held on dates May 25, 2004; Court Reporter: Elaine A. Merchant. (jf, ) (Entered: 07/19/2004)
58 ENTERED IN ERROR. . . .ORDER denying 42 Defendants' Motion for Summary Judgment, granting 43 Plaintiffs' Motion for Summary Judgment. Signed by Judge Emmet G. Sullivan on October 27, 2004. (lcegs1) Modified on 10/27/2004 (td, ). (Entered: 10/27/2004)
59 MEMORANDUM OPINION. Signed by Judge Emmet G. Sullivan on October 27, 2004. (lcegs1) (Entered: 10/27/2004)
DOCUMENT NO. 58 was Entered In Error and chambers will refile Order on Motion for Summary Judgment, (td, ) (Entered: 10/27/2004)
60 ORDER denying 42 Defendants' Motion for Summary Judgment, granting 43 Plaintiffs' Motion for Summary Judgment. Signed by Judge Emmet G. Sullivan on October 27, 2004. (lcegs2) (Entered: 10/27/2004)
61 CLERK'S JUDGMENT in favor of plaintiff against defendant. Signed by Judge Emmet G. Sullivan's Courtroom Deputy, Carol Votteler on October 27, 2004. (clv, ) (Entered: 10/28/2004)
62 MOTION for Attorney Fees and Costs by JANE DOE, JOHN DOE. (Attachments: # 1 Exhibit A − Original Complaint# 2 Exhibit B − Court Opinion, Oct 27, 2004# 3 Exhibit C − Declaration of John J. Michels, Jr., Esq.# 4 Exhibit D − Statement of Attorneys Fees and Costs# 5 Exhibit E − Dr. Schumm Invoice# 6 Text of Proposed Order)(Zaid, Mark) (Entered: 11/28/2004)
63 Joint MOTION to Continue To Hold Plaintiffs' Motion for Attorneys' Fees in Abeyance by JANE DOE, JOHN DOE, MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 12/13/2004)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 10 of 19

12/13/2004
12/23/2004 12/23/2004 01/03/2005 01/26/2005 02/01/2005 02/04/2005
02/08/2005 02/09/2005 02/14/2005
02/14/2005

MINUTE ORDER granting 63 Joint Motion to Continue to Hold Plaintiffs' Motion for Attorneys' Fees and Costs in Abeyance. Upon consideration of the joint motion, it is hereby ordered that the motion is granted and the Plaintiffs' pending motion for attorneys' fees and costs will be held in abeyance until either the expiration of Defendants' period to notice an appeal or the final resolution of this matter pursuant to any appeal that is taken. Signed by Judge Emmet G. Sullivan on December 13, 2004. (lcegs1) (Entered: 12/13/2004)
64 NOTICE OF APPEAL as to 60 Order, 61 Clerk's Judgment by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (lc, ) (Entered: 12/27/2004)
Transmission of Notice of Appeal and Docket Sheet to US Court of Appeals re 64 Notice of Appeal (lc, ) (Entered: 12/27/2004)
USCA Case Number 04−5440 for 64 Notice of Appeal filed by DONALD H. RUMSFELD,, TOMMY THOMPSON,, MARK B. MCCLELLAN,. (lc, ) (Entered: 01/11/2005)
MINUTE ORDER. The Court, sua sponte, directs the defendants to file by no later than February 1, 2005, a pleading describing the manner in which defendants are complying with the Court's Order of October 27, 2004. Signed by Judge Emmet G. Sullivan on January 26, 2005. (lcegs1) (Entered: 01/26/2005)
65 RESPONSE to The Court's Minute Order Of January 26, 2005 filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Exhibit One# 2 Exhibit Two)(Wiltsie, Ronald) (Entered: 02/01/2005)
66 Emergency MOTION to Amend/Correct 60 Order /Modify Injunction by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Exhibit 1 (Letter from Dr. Lester M. Crawford, D.V.M., PhD., FDA, to Dr. William Winkenwerder, Assistant Secretary of Defense for Health Affairs (Jan. 27, 2005))# 2 Exhibit 2 (70 Fed. Reg. 5452, 5452−−56)# 3 Exhibit 3 (Declaration of Emergency Pursuant to 21 U.S.C. 360bbb−3(b), Tommy G. Thompson, Secretary of Health and Human Services (Jan. 14, 2005))# 4 Exhibit 4 (Letter from Paul Wolfowitz, Deputy Secretary of Defense, to the Honorable Tommy G. Thompson, Secretary of Health and Human Services (Dec. 10, 2004))# 5 Exhibit 5 (70 Fed. Reg. 5450, 5450−−51))(Tannenbaum, Andrew) (Entered: 02/04/2005)
MINUTE ORDER. The Court, sua sponte, schedules a Status Conference for 2/14/2005 at 11:00 am to discuss future proceedings in this case. Signed by Judge Emmet G. Sullivan on February 8, 2005. (lcegs1) (Entered: 02/08/2005)
Set/Reset Hearings: Status Conference set for 2/14/2005 11:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (clv, ) (Entered: 02/09/2005)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Status Conference held on 2/14/2005. Defendants to Respond to the Court's Order to Show Cause by 2/28/2005. Plaintiffs given until 2/28/2005 to file Opposition to Motion of Defendants to Modify Injunction. Defendants to file a Reply by 3/10/2005. A Show Cause Hearing set for 3/10/2005 at 10:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (Court Reporter Elaine Merchang.) (jwd) (Entered: 02/14/2005)
67 ORDER memorializing the briefing schedule, pursuant to proceedings held in open court on February 14, 2005. The defendant's response to the Court's Order to Show Cause shall be filed by no later than February 28, 2005; plaintiffs shall file a response to defendants' emergency motion to modify the injunction by no later than February 28, 2005; plaintiffs' reply to the defendant's response to the Court's order to show cause shall be filed by no later than March 10, 2005; defendants' reply to plaintiffs' opposition to defendants' motion to modify the injunction shall be filed by no later than March 10, 2005. It is further ORDERED that a hearing on the Court's Order to Show Cause and the Defendants' Motion to Modify the Injunction shall be held on March 21, 2005 at 10:00 am in Courtroom One. Signed by Judge Emmet G. Sullivan on February 14, 2005. (lcegs1) (Entered: 02/14/2005)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 11 of 19

02/22/2005 02/28/2005
02/28/2005 03/01/2005
03/07/2005 03/08/2005 03/08/2005 03/08/2005 03/08/2005
03/09/2005 03/09/2005

68 TRANSCRIPT of Proceedings held on 2/14/05 before Judge Sullivan. Court Reporter: Elaine A. Merchant. The public may view the document in the Clerk's Office between the hours of 9:00 a.m. and 4:00 p.m, Monday through Friday. (td, ) (Entered: 02/24/2005)
69 RESPONSE TO ORDER TO SHOW CAUSE by DONALD H. RUMSFELD. (Attachments: # 1 Exhibit A (Second Declaration of Col. Steven Jones)# 2 Exhibit 1 to Second Jones Decl.# 3 Exhibit 2 to Second Jones Decl.# 4 Exhibit 3 to Second Jones Decl.# 5 Exhibit 4 to Second Jones Decl.# 6 Exhibit 5 to Second Jones Decl.# 7 Exhibit 6 to Second Jones Decl.# 8 Exhibit 7 to Second Jones Decl.# 9 Exhibit 8 to Second Jones Decl.# 10 Exhibit 9 to Second Jones Decl.# 11 Exhibit 10 to Second Jones Decl.# 12 Exhibit 11 to Second Jones Decl.# 13 Exhibit 12 to Second Jones Decl.# 14 Exhibit 13 to Second Jones Decl.# 15 Exhibit B (Transcript of Feb. 14, 2005 Hearing))(Tannenbaum, Andrew) (Entered: 02/28/2005)
70 Memorandum in opposition to motion re 66 Modification of Injunction filed by JOHN DOE, JANE DOE. (Attachments: # 1 Exhibit 1 − Transcript Feb 14 2005# 2 Exhibit 2 − Tri−Fold Brochure# 3 Exhibit Transcript − Jan 14 2004# 4 Exhibit 4 − Product Insert# 5 Exhibit 5 − Congressional Letters# 6 Exhibit 6 − HHS Letter to DoD# 7 Exhibit 7 − Dr. Moreno Declaration)(Zaid, Mark) (Entered: 02/28/2005)
71 MOTION for Leave to File Amicus Brief by MILITARY VACCINE EDUCATION CENTER, NATIONAL GULF WAR RESOURCE CENTER, NATIONAL VACCINE INFORMATION CENTER. (Attachments: # 1 Text of Proposed Order # 2 Exhibit A−Amicus Brief# 3 Exhibit B−Declaration of Meryl Nass MD# 4 Exhibit C−2003 VAERS AVA Data# 5 Exhibit D−2004 VAERS AVA Data# 6 Exhibit E−Piel Testimony# 7 Exhibit F−Rovet Testimony# 8 Exhibit G−DCIS 11/20/02 Memo# 9 Exhibit H−Declaration of Steve Turney# 10 Exhibit I−Declaration of Richard Poplin# 11 Exhibit J−AVA Efficacy Statements# 12 Exhibit K−Declaration of Virginia Shemeley# 13 Exhibit L−Declaration of Lavester Brown# 14 Exhibit M−Declaration of Bridget Savage# 15 Exhibit N−3/30/01 Mississippi AG Letter# 16 Exhibit O−Declaration of Luis Hernandez# 17 Exhibit P−Declaraion of Eddie Norman# 18 Exhibit Q−8/10/01 Aldrich Chu Memo# 19 Exhibit R−Winkenwerder Mtg Memo 1/14/02# 20 Exhibit S−Declaration of Sammie Young)(nmw, ) (Entered: 03/07/2005)
MINUTE ORDER. The parties are directed to file any response to 71 the motion for leave to file an amicus curiae submission by the National Vaccine Information Center, the National Gulf War Resource Center, and the Military Vaccine Information Center, Inc. by no later than 4:00 pm on 3/8/2005. Signed by Judge Emmet G. Sullivan on March 7, 2005. (lcegs1) (Entered: 03/07/2005)
Set/Reset Deadlines: Responsesto the Motion for leave to file an amicus curiae submission due by due by 4:00 p.m. on 3/8/2005 (clv, ) (Entered: 03/08/2005)
72 RESPONSE to Court's Minute Order of March 7, 2005 filed by JOHN DOE, JANE DOE. (Zaid, Mark) (Entered: 03/08/2005)
73 Memorandum in opposition to motion re 71 for leave to file amicus brief filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Tannenbaum, Andrew) (Entered: 03/08/2005)
MINUTE ORDER granting 71 Motion for Leave to File Amicus Brief. Upon consideration of the Motion for Leave to File Amicus Brief, the Defendants' Opposition thereto, and the Plaintiffs' Consent thereto, it is hereby ORDERED that the motion is GRANTED. The parties are afforded an opportunity to respond to the amicus submission by no later than noon on 3/11/05. Amici and/or the parties shall file any replies to responses by no later than noon on 3/14/05. Signed by Judge Emmet G. Sullivan on March 8, 2005. (lcegs1) (Entered: 03/08/2005)
74 MOTION to Appoint Counsel Pro Hac Vice by NATIONAL VACCINE INFORMATION CENTER. (Attachments: # 1 # 2)(Karo, Martin) (Entered: 03/09/2005)
MINUTE ORDER granting 74 Motion for Admission Pro Hac Vice of Kenneth T. Levine. Signed by Judge Emmet G. Sullivan on March 9, 2005. (lcegs1) (Entered: 03/09/2005)

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03/09/2005
03/10/2005
03/10/2005 03/11/2005 03/14/2005 03/14/2005 03/21/2005
03/21/2005
03/22/2005 03/23/2005 03/31/2005
04/01/2005
04/04/2005 04/04/2005 04/04/2005 04/04/2005 04/05/2005

75 NOTICE of Addendum to the Second Declaration of Colonel Steven P. Jones by DONALD H. RUMSFELD (Attachments: # 1 Addendum to the Second Declaration of Colonel Steven P. Jones)(Tannenbaum, Andrew) (Entered: 03/09/2005)
76 REPLY to opposition to motion re 66 to Modify Injunction filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Exhibit 1# 2 Exhibit 2)(Tannenbaum, Andrew) (Entered: 03/10/2005)
77 RESPONSE to Court's Order to Show Cause Dated February 14, 2005 filed by JOHN DOE, JANE DOE. (Attachments: # 1 Exhibit 1 − SECDEF Oct 27, 2004 Memo# 2 Exhibit 2 − FDA Correspondence)(Zaid, Mark) (Entered: 03/10/2005)
78 RESPONSE to 71 Amicus Curiae Brief filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Tannenbaum, Andrew) (Entered: 03/11/2005)
79 REPLY Brief Opposing Emergency Motion to Modify Injunction filed by NATIONAL VACCINE INFORMATION CENTER. (Levine, Kenneth) (Entered: 03/14/2005)
80 NOTICE of Appearance by Kenneth T. Levine on behalf of NATIONAL VACCINE INFORMATION CENTER (Levine, Kenneth) (Entered: 03/14/2005)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Show Cause Hearing held on 3/21/2005. Show Cause Hearing set for 4/1/2005 10:00 AM in Courtroom 1 before Judge Emmet G. Sullivan. (Court Reporter Jon Hundley, Miller.) (clv, ) (Entered: 03/21/2005)
81 NOTICE of Filing Of Congressional Correspondence by JOHN DOE, JANE DOE (Attachments: # 1 Exhibit A − Congressman Chris Shays Correspondence# 2 Exhibit B − HHS Response To Congressman Shays)(Zaid, Mark) (Entered: 03/21/2005)
82 NOTICE by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Wiltsie, Ronald) (Entered: 03/22/2005)
83 NOTICE of Clarification by DONALD H. RUMSFELD (Tannenbaum, Andrew) (Entered: 03/23/2005)
MINUTE ORDER. The Court, sua sponte, directs the defendants to be prepared to inform the Court exactly how many, if any, military personnel have been unlawfully administered AVA since the March 21, 2005 hearing. Signed by Judge Emmet G. Sullivan on March 31, 2005. (lcegs1) (Entered: 03/31/2005)
Minute Entry for proceedings held before Judge Emmet G. Sullivan: Show Cause Hearing Resumed on 4/1/2005. Motion of Defendants to Modify the Court's 10/27/2004 Injunction, granted. Counsel for defendants to provide the Court with Weekly Reports regarding inoculation prohiobited by the Court's 10/27/2004 injunction. Cour stayed the issuance of it's order until noon, Monday, April 1, 2005. (Court Reporter Elaine Merchant.) (jwd, ) (Entered: 04/01/2005)
84 NOTICE of Appearance by John J. Michels on behalf of all plaintiffs (Michels, John) (Entered: 04/04/2005)
85 NOTICE by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Tannenbaum, Andrew) (Entered: 04/04/2005)
86 NOTICE by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Tannenbaum, Andrew) (Entered: 04/04/2005)
87 RESPONSE to Defendants' "Notice" of a Submission by Defendant, Dept. of Defense, to Defendant, Food and Drug Administration filed by JOHN DOE, JANE DOE. (Michels, John) (Entered: 04/04/2005)
88 ORDER. Signed by Judge Emmet G. Sullivan on April 5, 2005. (lcegs1) (Entered: 04/05/2005)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 13 of 19

04/06/2005 04/06/2005 04/13/2005
04/21/2005
04/22/2005 04/22/2005
04/25/2005
04/25/2005
04/29/2005 05/06/2005 05/13/2005 05/20/2005 05/27/2005 06/03/2005 06/10/2005 06/17/2005 06/24/2005 07/01/2005

89 NOTICE by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Tannenbaum, Andrew) (Entered: 04/06/2005)
90 ORDER granting 66 Defendant's Emergency Motion to Modify Injunction. Signed by Judge Emmet G. Sullivan on April 6, 2005. (lcegs1) (Entered: 04/06/2005)
91 TRANSCRIPT of Show−Cause Hearing held on March 21, 2005 before Judge Emmet G. Sullivan. Court Reporter: Jon Hundley (MILLER). The public may view the document in the Clerk's Office between the hours of 9:00 a.m. and 4:00 p.m, Monday through Friday. (jf, ) (Entered: 04/14/2005)
MINUTE ORDER. Defendants are directed to show cause by no later than noon on 4/25/05 why they should not be held in contempt for failure to comply with this Court's order, issued in open court on 4/1/05, instructing Defendant DOD to file weekly reports regarding unlawful inoculations administered in violation of this Court's October 27, 2004 injunction. Signed by Judge Emmet G. Sullivan on April 21, 2005. (lcegs1) (Entered: 04/21/2005)
92 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Affidavit COL S. Jones)(Wiltsie, Ronald) (Entered: 04/22/2005)
93 Emergency MOTION to Vacate The Order to Show Cause or, In the Alternative, For An Extension To Respond by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Notice of Weekly Report# 2 Affidavit COL S. Jones# 3 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 04/22/2005)
MINUTE ORDER granting 93 Motion to Vacate. Upon consideration of defendants' Emergency Unopposed Motion to Vacate the Order to Show Cause or, in the alternative, For An Extension To Respond, it is herby ORDERED that theMotion is GRANTED. Signed by Judge Emmet G. Sullivan on April 25, 2005. (lcegs1) (Entered: 04/25/2005)
95 TRANSCRIPT of Proceedings held on 4/1/05 before Judge Emmet G. Sullivan. Court Reporter: Elaine A. Merchant. The public may view the document in the Clerk's Office between the hours of 9:00 a.m. and 4:00 p.m, Monday through Friday. (td, ) (Entered: 05/02/2005)
94 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 04/29/2005)
96 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 05/06/2005)
97 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 05/13/2005)
98 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 05/20/2005)
99 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 05/27/2005)
100 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 06/03/2005)
101 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 06/10/2005)
102 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 06/17/2005)
103 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 06/24/2005)
104 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 07/01/2005)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 14 of 19

07/08/2005 07/15/2005 07/22/2005 07/28/2005 08/05/2005 08/12/2005 08/19/2005 08/26/2005 08/30/2005
09/02/2005 09/08/2005 09/16/2005 09/23/2005 09/30/2005 10/07/2005 10/14/2005 10/21/2005

105 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Affidavit of Weekly Report)(Wiltsie, Ronald) (Entered: 07/08/2005)
106 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Affidavit of Col Grabenstein)(Wiltsie, Ronald) (Entered: 07/15/2005)
107 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Affidavit COL John Grabenstein)(Wiltsie, Ronald) (Entered: 07/22/2005)
108 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Exhibit Declaration of COL Grabenstein)(Wiltsie, Ronald) (Entered: 07/28/2005)
109 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Blackwell, Craig) (Entered: 08/05/2005)
110 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Exhibit)(Wiltsie, Ronald) (Entered: 08/12/2005)
111 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 08/19/2005)
112 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 08/26/2005)
MINUTE ORDER. Pursuant to the defendants' weekly report filed July 22, 2005, informing the Court that an involuntary anthrax vaccination was administered at a U.S. military medical clinic in Iraq, in violation of this Court's injunction, and in light of the steps that the commanding officer of that medical unit has taken to avoid additional involuntary vaccinations, the Court, sua sponte, hereby ORDERS that the instructions given by memorandum to members of that medical unit be distributed by no later than September 15, 2005, to all medical staff administering vaccines. Specifically, those instructions, according to defendants' July 22, 2005 filing, are "If administering Anthrax Vaccination ensure the patient has signed in, received training and trifold, understand [sic] the right to refuse, and states they want to receive the Anthrax Vaccine. Immediately prior to administration of the Anthrax Vaccination (once site and vaccine are prepared) ask the patient 'Do you want to receive the Anthrax Vaccination?' If the patient confirms, administer." Signed by Judge Emmet G. Sullivan on August 30, 2005. (lcegs1) (Entered: 08/30/2005)
113 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Affidavit Col Grabenstein)(Wiltsie, Ronald) (Entered: 09/02/2005)
114 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 09/08/2005)
115 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 09/16/2005)
116 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 09/23/2005)
117 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 09/30/2005)
118 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 10/07/2005)
119 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 10/14/2005)
120 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 10/21/2005)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 15 of 19

10/28/2005 11/04/2005 11/10/2005 11/18/2005 11/23/2005 12/02/2005 12/09/2005 12/16/2005 12/23/2005
12/23/2005 04/06/2006
05/04/2006
05/05/2006 06/20/2006 06/21/2006
07/20/2006 07/21/2006 07/21/2006

121 NOTICE of Weekly Report by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Exhibit Weekly Report Declaration)(Wiltsie, Ronald) (Entered: 10/28/2005)
122 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 11/04/2005)
123 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 11/10/2005)
124 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 11/18/2005)
125 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 11/23/2005)
126 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 12/02/2005)
127 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 12/09/2005)
128 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 12/16/2005)
129 NOTICE OF PUBLICATION OF FDA ORDER by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Exhibit FDA Order# 2 Exhibit Motion to Govern Further Proceedings In Court of Appeals)(Wiltsie, Ronald) (Entered: 12/23/2005)
130 NOTICE of Weekly Report by DONALD H. RUMSFELD (Attachments: # 1 Weekly Report Declaration)(Tannenbaum, Andrew) (Entered: 12/23/2005)
131 USCA JUDGMENT (certified copy) as to 64 Notice of Appeal filed by DONALD H. RUMSFELD,, TOMMY THOMPSON,, MARK B. MCCLELLAN; It is hereby ordered and adjudged that the case be remanded to the District Court because the appeal is moot; USCA#04−5440 (jsc) (Entered: 04/20/2006)
MINUTE ORDER. At the request of counsel for the parties, a status hearing is scheduled for June 27, 2006 at 11:00 a.m. in Courtroom 24A. Counsel are directed to filed a joint proposal for further proceedings no later than June 23, 2006. If counsel cannot agree on a joint proposal, counsel may submit their recommendations separately. Signed by Judge Emmet G. Sullivan on May 4, 2006. (lcegs1) (Entered: 05/04/2006)
Set Deadlines/Hearings: Proposal for further proceedings due by 6/23/2006. Status Conference set for 6/27/2006 11:00 AM in Courtroom 24A before Judge Emmet G. Sullivan. (clv, ) (Entered: 05/05/2006)
132 Unopposed MOTION to Continue Status Conference by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 06/20/2006)
MINUTE ORDER granting 132 Motion to Continue. The status conference scheduled for June 27 is rescheduled to begin at 12:00 p.m. on July 25, 2006 in Courtroom 24A. The status report is now due July 20, 2006. Signed by Judge Emmet G. Sullivan on June 21, 2006. (lcegs1) (Entered: 06/21/2006)
133 STATUS REPORT Joint Proposals for Further Proceedings by MARK B. MCCLELLAN, JOHN DOE, JANE DOE, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 07/20/2006)
MINUTE ORDER. The Status Hearing scheduled for July 25, 2006 is continued to August 9, 2006 at 11:30 a.m. Signed by Judge Emmet G. Sullivan on July 21, 2006. (lcegs1) (Entered: 07/21/2006)
Set/Reset Hearings: Status Conference set for 7/25/06 has been reset for 8/9/2006 11:30 AM in Courtroom 24A before Judge Emmet G. Sullivan. (adc) (Entered: 07/21/2006)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 16 of 19

08/03/2006 09/07/2006
09/07/2006
10/31/2006
12/11/2006 12/12/2006 12/12/2006 01/04/2007 01/05/2007 01/08/2007 01/24/2007 01/25/2007 01/29/2007

Set/Reset Hearings: Status Conference is now set for 9/7/2006 10:00 AM in Courtroom 24A before Judge Emmet G. Sullivan. THE STATUS HEARING PREVIOUSLY SCHEDULED FOR 8/9/06 IS VACATED DUE TO CHANGES IN THE COURT'S CALENDAR. (clv, ) (Entered: 08/03/2006)
Minute Entry for proceedings held before Judge Emmet G. Sullivan : Status Conference held on 9/7/2006. Motion for Attorney Fees denied. Motions due by 10/31/2006. Responses due by 12/15/2006 Replies due by 1/11/2007. Status Conference set for 1/31/2007 10:30 AM in Courtroom 24A before Judge Emmet G. Sullivan. OTBP(Court Reporter ELAINE MERCHAN.) (clv, ) (Entered: 09/07/2006)
MINUTE ORDER denying 62 Motion for Attorney Fees. For the reasons stated in open court today, September 7, 2006, the plaintiffs' motion for attorneys' fees is denied without prejudice. The plaintiffs' new motion for attorneys' fees, to reflect all work to date, shall be filed no later than October 31, 2006. The defendants' response is due no later than December 15, 2006. The plaintiffs' reply is due no later than January 11, 2007. A status hearing is scheduled in Courtroom 24A for January 31, 2007, at 10:30am.Pursuant to representations made at today's hearing, plaintiffs are directed to release under seal the names of the individual plaintiffs to the government.Signed by Judge Emmet G. Sullivan on 9/7/06. (lcegs1) (Entered: 09/07/2006)
135 MOTION for Attorney Fees by JOHN DOE, JANE DOE. (Attachments: # 1 Exhibit A − Complaint# 2 Appendix B − 2003 Decision# 3 Exhibit C − First Amended Complaint# 4 Exhibit D − Oct 2004 Decision# 5 Exhibit E − Affidavit of John J. Michels, Esq.# 6 Exhibit F − Billing Records# 7 Exhibit Ex G − Declaration of Mark S. Zaid, Esq.# 8 Exhibit H − Schumm Time# 9 Text of Proposed Order)(Zaid, Mark) (Entered: 10/31/2006)
136 Unopposed MOTION for Extension of Time to Respond to Plaintiffs' Amended Petition for Attorneys' Fees by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 12/11/2006)
MINUTE ORDER granting 136 Unopposed Motion for Extension of Time to Respond. Defendants' response to plaintiffs' motion for attorney fees is due no later than January 5, 2007. Plaintiffs' reply is due no later than February 1, 2007. Signed by Judge Emmet G. Sullivan on December 12, 2006. (lcegs1) (Entered: 12/12/2006)
Set/Reset Deadlines: Responses due by 1/5/2007 Replies due by 2/1/2007. (clv, ) (Entered: 12/12/2006)
137 Consent MOTION for Extension of Time to File Response/Reply as to 135 MOTION for Attorney Fees by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Tannenbaum, Andrew) (Entered: 01/04/2007)
MINUTE ORDER granting 137 Consent Motion for Extension of Time to File Response. Defendants' response to plaintiffs' motion for attorneys' fees is due no later than February 5, 2007. Signed by Judge Emmet G. Sullivan on January 5, 2007. (lcegs1) (Entered: 01/05/2007)
Set/Reset Deadlines: Responses due by 2/5/2007 (clv, ) (Entered: 01/08/2007)
138 Consent MOTION for Protective Order Regarding Disclosure of the Doe Plaintiffs' Names by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 01/24/2007)
139 PROTECTIVE ORDER setting forth procedures for handling confidential material; allowing designated material to be filed under seal. Signed by Judge Emmet G. Sullivan on 1/24/07. (clv, ) (Entered: 01/25/2007)
MINUTE ORDER. Due to the modified schedule for the briefing of plaintiffs' motion for attorneys' fees, the Court sua sponte orders that the status hearing scheduled for January 31 is VACATED. The status hearing is rescheduled to February 14, 2007, at 9:30 am. Signed by Judge Emmet G. Sullivan on January 29,

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 17 of 19

01/30/2007 02/05/2007 02/07/2007 02/12/2007 02/12/2007
02/13/2007 02/13/2007 02/26/2007 02/28/2007
02/28/2007 04/02/2007 04/06/2007
04/06/2007 04/20/2007 08/21/2007
08/21/2007 08/21/2007

2007. (lcegs1) (Entered: 01/29/2007)
Set/Reset Hearings: Status Conference set for 2/14/2007 09:30 AM in Courtroom 24A before Judge Emmet G. Sullivan. (clv, ) (Entered: 01/30/2007)
140 Memorandum in opposition to re 135 MOTION for Attorney Fees filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Exhibit)(Wiltsie, Ronald) (Entered: 02/05/2007)
Set/Reset Hearings: Status Conference is now set for 2/16/2007 11:30 AM in Courtroom 24A before Judge Emmet G. Sullivan. PLEASE NOTE THE DATE CHANGE. (clv, ) (Entered: 02/07/2007)
141 Unopposed MOTION for Extension of Time to File Response/Reply as to 135 MOTION for Attorney Fees by JOHN DOE, JANE DOE. (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 02/12/2007)
MINUTE ORDER granting 141 Consent Motion for Extension of Time to File Response/Reply. Plaintiffs' reply regarding 135 their motion for attorney fees is due no later than February 26, 2007. In addition, the status hearing scheduled for February 16 is hereby VACATED. The status hearing is rescheduled for March 15, 2007, at 12:15 pm. Signed by Judge Emmet G. Sullivan on February 12, 2007. (lcegs1) (Entered: 02/12/2007)
Set Deadlines/Hearings: Status Conference set for 3/15/2007 12:15 PM in Courtroom 24A before Judge Emmet G. Sullivan. (clv, ) (Entered: 02/13/2007)
Set/Reset Deadlines: Replies due by 2/26/2007. (clv, ) (Entered: 02/13/2007)
142 Unopposed MOTION for Extension of Time to File Response/Reply as to 135 MOTION for Attorney Fees by JOHN DOE, JANE DOE. (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 02/26/2007)
MINUTE ORDER granting 142 Consent Motion for Extension of Time to File Response/Reply. Plaintiffs' reply regarding 135 their motion for attorney fees is due no later than March 19, 2007. In addition, the status hearing scheduled for March 15 is hereby VACATED. Signed by Judge Emmet G. Sullivan on February 28, 2007. (lcegs1) (Entered: 02/28/2007)
Set/Reset Deadlines: Replies due by 3/19/2007. (clv, ) (Entered: 02/28/2007)
143 MOTION for Extension of Time Nunc Pro Tunc to File Response/Reply as to 135 MOTION for Attorney Fees by JOHN DOE, JANE DOE (Attachments: # 1 Text of Proposed Order)(nmw, ) (Entered: 04/04/2007)
MINUTE ORDER granting 143 Unopposed Motion for Extension of Time to File Reply. Plaintiffs' reply regarding 135 their motion for attorney fees is due no later than April 20, 2007. Signed by Judge Emmet G. Sullivan on April 6, 2007. (lcegs1) (Entered: 04/06/2007)
Set/Reset Deadlines: Replies due by 4/20/2007. (clv, ) (Entered: 04/06/2007)
144 REPLY to opposition to motion re 135 MOTION for Attorney Fees filed by JOHN DOE, JANE DOE. (Attachments: # 1 Exhibit 1 − Declaration of Mark S. Zaid, Esq.)(Zaid, Mark) (Entered: 04/20/2007)
145 ORDER denying without prejudice 135 Plaintiffs' Motion for Attorney Fees and directing that plaintiff file an amended motion for attorney fees or the parties jointly submit a status report and recommendation for future proceedings by no later than September 28, 2007. See accompanying Memorandum Opinion. Signed by Judge Emmet G. Sullivan on August 21, 2007. (lcegs1) Additional attachment(s) added on 8/21/2007 (lcegs1, ). (Entered: 08/21/2007)
NOTICE OF CORRECTED DOCKET ENTRY re 145 : Correct Order on Motion for Attorney Fees filed in place of mis−filed document. (lcegs1) (Entered: 08/21/2007)
146 MEMORANDUM OPINION. Signed by Judge Emmet G. Sullivan on August 21, 2007. (lcegs1) (Entered: 08/21/2007)

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 18 of 19

08/21/2007 09/28/2007
10/04/2007 10/05/2007
10/09/2007 10/14/2007 10/16/2007
10/17/2007 10/26/2007
11/05/2007 11/06/2007 11/07/2007 11/18/2007 11/20/2007
11/29/2007 12/03/2007

Set/Reset Deadlines: Status Report due by 9/28/2007. (clv, ) (Entered: 08/21/2007)
147 Amended MOTION for Attorney Fees and Costs by JOHN DOE, JANE DOE (Attachments: # 1 Exhibit 1 − Michels Declaration# 2 Exhibit 1A − McGuireWoods Billing Entries# 3 Exhibit 1B − McGuireWoods Resumes# 4 Exhibit 2 − Zaid Declaration# 5 Exhibit 2A − Zaid Billing Entries# 6 Text of Proposed Order)(Zaid, Mark) (Entered: 09/28/2007)
148 Unopposed MOTION for Extension of Time to File Response/Reply to Plaintiffs' Amended Attorneys Fee Petition by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON (Attachments: # 1 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 10/04/2007)
MINUTE ORDER granting 148 defendants' Unopposed Motion for Extension of Time to file response re 147 plaintiffs' Amended Motion for Attorney Fees and Costs. Defendants shall file their response by no later than October 26, 2007. Furthermore, the joint status report due on September 28, 2007 shall be filed by no later than Oct. 14, 2007. Signed by Judge Emmet G. Sullivan on October 5, 2007. (lcegs1) (Entered: 10/05/2007)
Set/Reset Deadlines: Responses due by 10/26/2007,Status Report due by 10/14/2007. (clv, ) (Entered: 10/09/2007)
149 STATUS REPORT by JOHN DOE. (Zaid, Mark) (Entered: 10/14/2007)
MINUTE ORDER. In the event that defendants elect not to oppose plaintiffs' Amended Petition for Attorney's Fees and Costs, the parties are directed to submit a joint report and recommendation for further proceedings by Oct. 31, 2007. Signed by Judge Emmet G. Sullivan on October 16, 2007. (lcegs1) (Entered: 10/16/2007)
Set/Reset Deadlines: Status Report due by 10/31/2007. (clv, ) (Entered: 10/17/2007)
150 Memorandum in opposition to re 147 Amended MOTION for Attorney Fees and Costs filed by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Attachments: # 1 Exhibit Table of Remaining Vague Entries# 2 Exhibit Bates v. Rumsfeld Slip Opinion# 3 Exhibit Bates v. Rumsfeld Docket# 4 Exhibit New Entries# 5 Exhibit Summary Table# 6 Text of Proposed Order)(Wiltsie, Ronald) (Entered: 10/26/2007)
151 Consent MOTION for Extension of Time to File Response/Reply to Defendants' Opposition to Plaintiffs' Amended Motion for Attorneys Fees and Costs by JOHN DOE, JANE DOE (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 11/05/2007)
MINUTE ORDER granting 151 Plaintiffs' Consent Motion for Extension of Time to File Reply re 147 plaintiffs' Amended Motion for Attorney Fees and Costs.Plaintiffs' reply is due by no later than November 19, 2007. Signed by Judge Emmet G. Sullivan on November 6, 2007. (lcegs1) (Entered: 11/06/2007)
Set/Reset Deadlines: Replies due by 11/19/2007. (clv, ) (Entered: 11/07/2007)
152 Unopposed MOTION for Extension of Time to File Response/Reply as to 147 Amended MOTION for Attorney Fees and Costs by JOHN DOE, JANE DOE (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 11/18/2007)
MINUTE ORDER granting 152 plaintiffs' Unopposed Motion for Extension of Time to File Reply Brief in response to defendants' opposition to 147 plaintiffs' Amended Motion for Attorney Fees and Costs. Plaintiffs' reply is due by no later than November 30, 2007. Signed by Judge Emmet G. Sullivan on November 20, 2007. (lcegs1) (Entered: 11/20/2007)
153 Consent MOTION for Extension of Time to File Response/Reply as to 147 Amended MOTION for Attorney Fees and Costs by JOHN DOE, JANE DOE (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 11/29/2007)
MINUTE ORDER granting 153 Consent Motion for Extension of Time to File Reply re 147 Amended MOTION for Attorney Fees and Costs. Reply due by

Case: 1:03-cv-707 As of: 10/04/2011 06:39 PM EDT 19 of 19

12/04/2007 12/14/2007 12/14/2007 12/14/2007 12/24/2007 12/26/2007 12/26/2007 01/25/2008
02/25/2008

12/14/2007. Signed by Judge Emmet G. Sullivan on December 3, 2007. (AS) (Entered: 12/03/2007)
Set/Reset Deadlines: Replies due by 12/14/2007. (clv, ) (Entered: 12/04/2007)
154 Consent MOTION for Extension of Time to File Response/Reply as to 147 Amended MOTION for Attorney Fees and Costs by JOHN DOE, JANE DOE (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 12/14/2007)
MINUTE ORDER granting 154 Consent Motion for Extension of Time to File Reply in Support of 147 Amended MOTION for Attorney Fees. Replies due by 12/28/2007. Signed by Judge Emmet G. Sullivan on December 14, 2007. (AS) (Entered: 12/14/2007)
Set/Reset Deadlines: Replies due by 12/28/2007. (clv, ) (Entered: 12/14/2007)
155 Consent MOTION for Extension of Time to File Response/Reply as to 147 Amended MOTION for Attorney Fees and Costs by JOHN DOE, JANE DOE (Attachments: # 1 Text of Proposed Order)(Zaid, Mark) (Entered: 12/24/2007)
MINUTE ORDER granting 155 plaintiffs' consent Motion for Extension of Time to File Reply re 147 plaintiffs' Amended Motion for Attorney Fees and Costs. Plaintiffs' reply is due by no later than January 28, 2008. Signed by Judge Emmet G. Sullivan on December 26, 2007. (lcegs1) (Entered: 12/26/2007)
Set/Reset Deadlines: Replies due by 1/28/2008. (clv, ) (Entered: 12/26/2007)
MINUTE ORDER. The Court having been informed by counsel for the parties that all remaining issues in this matter have been resolved, it is HEREBY ORDERED that this case shall be removed from the active calendar of the Court and it is FURTHER ORDERED that within thirty (30) days from the date of this Order, a praecipe shall be filed with the Court informing the Court that this case is SETTLED AND DISMISSED WITH PREJUDICE; and it is FURTHER ORDERED that in the unlikely event a settlement on the issue of attorneys' fees and costs is not reached, the parties are instructed to contact the Court to reinstate the matter to the active calendar. Signed by Judge Emmet G. Sullivan on January 25, 2008. (AS, ) (Entered: 01/25/2008)
156 STIPULATION of Dismissal by MARK B. MCCLELLAN, DONALD H. RUMSFELD, TOMMY THOMPSON. (Wiltsie, Ronald) (Entered: 02/25/2008)