User:BD2412/Military anthrax cases

Anthrax Vaccinations Halted Again, United Press International, October 28, 2004

Rempfer v. Von Eschenbach (2008)
Rempfer v. Von Eschenbach, 535 F.Supp.2d 99 (D.D.C., 2008)

535 F.Supp.2d 99 Thomas REMPFER, et al., Plaintiffs, v. Andrew C. VON ESCHENBACH, Commissioner Food and Drug Administration, et al., Defendants. Civil Action No. 06-2131 (KMC). United States District Court, District of Columbia. February 29, 2008. Page 100 COPYRIGHT MATERIAL OMITTED Page 101 John J. Michels, Jr., McGuire Woods, LLP, Chicago, IL, Mark S. Zaid, Mark S. Zaid, PC, Washington, DC, for Plaintiffs. Jeffrey Michael Smith, U.S. Department of Justice, Washington, DC, for Defendants. MEMORANDUM OPINION ROSEMARY M. COLLYER, District Judge. Plaintiffs1 are military personnel subject to orders to take Anthrax Vaccine Adsorbed ("AVA"), the only vaccine in the U.S. licensed as a prophylactic against anthrax. They brought this suit against the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and the Department of Defense (DoD)2 (collectively "Defendants"), challenging (1) the FDA's Final Order, see 70 Fed.Reg. 75,180 (Dec. 19, 2005), which determined that AVA is safe and effective and hot misbranded,3 and (2) the DoD's decision to reinstate mandatory AVA inoculations. Plaintiffs do not contend that Page 102 AVA is unsafe or misbranded; instead they allege that there is insufficient evidence that AVA is effective to prevent anthrax infection acquired through inhalation. Defendants move to dismiss. Upon reviewing the pleadings and the administrative record and in deference to the FDA's evaluation of scientific data, Defendants' motion will be granted. I. BACKGROUND Anthrax is a bacterial disease caused by spores of Bacillus anthracis. Anthrax spores can cause infection through three routes: skin contact (cutaneous), ingestion, and inhalation. Without antibiotic treatment, inhalation anthrax has the highest fatality rate — estimated to be 45% to 90%. A.R. at 639 (04 AR, Vol. 3).4 Cutaneous anthrax has an estimated 20% fatality rate, and gastrointestinal anthrax has an estimated fatality rate of 25% to 60%. Id. at 638-39. In the U.S., there were eighteen cases of inhalations anthrax from 1900 to October 2001,5 mostly occurring in textile mill workers. Id. at 639. Sixteen of those cases were fatal. Then, from October 4, 2001 to December 5, 2001, there were eleven cases of inhalation anthrax, five of which were fatal. Id. The 2001 cases were all linked to intentional dissemination. Id. Regardless of the route of exposure, anthrax is toxic to the body in the same way. The "virulence components" of anthrax include an anitphagocytic capsule and three proteins: protective antigen, lethal factor, and edema factor. The combination of protective antigen with lethal factor causes the formation of cytotoxic lethal toxin, and the combination of protective antigen with edema factor results in edema toxin. Id. In 1965, DoD contracted with the Michigan Department of Public Health ("MDPH") to produce an anthrax vaccine. A.R. 3647-52 (04 AR, Vol. 13). Before the MDPH contact, DoD had contracted with Merck Sharpe & Dohme to produce an anthrax vaccine and prior to that the Army had produced a vaccine (the "original vaccine" or the "DoD vaccine"). In 1966, the Center for Disease Control ("CDC") filed with the National Institute for Health ("NIH") a "Notice of Claimed Investigational Exemption" for the anthrax vaccine. Under this investigational new drug application, the CDC began an "open label study" to collect safety data on the MDPH vaccine; the study continued from year to year and the CDC provided annual progress reports to the NIH. The next year, MDPH filed a product license application with the NIH for the vaccine it was producing for DoD. During the licensing process, the MDPH vaccine was named AVA. The NIH licensed AVA in 1970.6 The NIH-approved package insert recommended Page 103 AVA immunization for individuals with a risk of exposure to anthrax, those who come into contact with animal hides, bonemeal, and fur, especially goat hair. A.R. 3291 (04 AR, Vol. 12). The labeling did not recommend immunization fee limited to any particular route of exposure. A.R. 3291-92 (04 AR, Vol. 12). AVA was licensed to be given in a six dose regimen: three inoculations, each two weeks apart, and then three more given at six, twelve, and eighteen month intervals thereafter. In 1973, the FDA announced a safety and effectiveness review for various vaccines, including AVA, and solicited data and information. 38 Fed.Reg. 5,358 (Feb. 28, 1973). The Panel that conducted the review issued a report in 1980. See A.R. 0001-0600 (04 AR, Vol. 1-2). In 1985, the FDA published the Panel's report and a proposed order relating to matters in the report. See 50 Fed.Reg. 51,002, (Dec. 13, 2005). As to AVA, the FDA agreed with the Panel's recommended that AVA be categorized as safe, effective, and not misbranded. 70 Fed.Reg. at 75,182; see 50 Fed.Reg. at 51,059.7 To determine whether AVA was effective, the Panel considered: (1) a controlled human field study conducted by Drs. Brachman, Gold, Plotkin, Fekety, Werrin, and Ingraham in the 1950s (the "Brachman Study"), see A.R. 3732-3745 (04 AR, Vol. 13), and (2) surveillance data collected by the CDC. See 50 Fed.Reg. at 51,058. The Brachman Study involved 1,249 workers in four textile mills that processed raw imported goat hair, a group at risk for anthrax infection.8 Slee AR 3732-33 (04 AR, Vol. 13). The workers were divided into three groups: one received the anthrax vaccine; one received a placebo; and one was simply monitored for anthrax infection; Id. at 3732; 50 Fed.Reg. at 51,058. There were 26 cases of anthrax during the study period, five of which were individuals infected through inhalation. See AR 3734 (04 AR, Vol. 13); id. at 3736 (Table 4). None of the individuals with inhalation anthrax had taken the vaccine, two were in the placebo group, and three were in the observation group. The remaining twenty-one infected workers contracted cutaneous anthrax. Of those, three had taken the vaccine (although two had not been fully inoculated) fifteen were in the placebo group, and three were in the observation group. Id. Based on these facts, the Brachman Study concluded the effectiveness of the vaccine at 92.5%, comparing the vaccine group with the placebo group and combining the inhalation and Page 104 cutaneous cases. Id. at 3737. The rate of effectiveness did not include data from the group that was simply monitored. Id.; A.R. 1381 at n. 9 (04 AR, Vol. 6). Although the Panel relied on the Brachman Study, the Panel found that the study demonstrated effectiveness only against cutaneous anthrax because the inhalation cases "occurred too infrequently to assess the protective effect of [the] vaccine against this form of the disease." Fed. Reg. at 51,058. "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." Id. Even so, the Panel found the vaccine to be safe and effective for the limited circumstances for which it is employed. Id. Further, the Panel did not recommend any change in the "recommendations for use" section of the AVA label, which recommended AVA for immunization against anthrax, without any specification regarding route of exposure.9 In addition to the Brachman Study, the Panel relied on the CDC surveillance data as evidence of effectiveness as follows: [The data] were summarized for the period between 1962 to 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. Id. Thus, based on the CDC surveillance data and the Brachman Study, the Panel found "substantial evidence of safety and effectiveness for this product [AVA]." Id. at 51,059. In March of 1998, DoD implemented the Anthrax Vaccine Immunization Program to protect service personnel at risk of contracting anthrax. Congress then directed DoD to contract with the National Research Council to study the safety and effectiveness of AVA. A.R. 3324 (04 AR, Vol. 12). As a result, the Institute of Medicine's Committee to Assess the Safety and Efficacy of the Anthrax Vaccine (the "IOM Committee") conducted an independent study over the course of two years. AR. 3303-583 (04 AR, Vol. 12). The IOM Committee10sought, reviewed, and weighed "[a]ll available data." Id. at 3309. The Committee issued a report finding, "As indicated by evidence from studies in both humans and animals, the committee concluded that AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax," and it is "reasonably safe." Id. at 3323. In its 2005 Final Order, the FDA agreed with the report of the IOM Committee and its finding that AVA was effective. 70 Fed.Reg. at 75,183. The FDA disagreed Page 105 with the Panel's 1985 opinion that the Brachman Study did not have sufficient data to demonstrate the effectiveness of AVA against inhalation anthrax. The FDA explained: We do not agree with the Panel's statement that the protection [provided by AVA] was limited to cutaneous anthrax cases. The Brachman [S]tudy's comparison between anthrax cases in the placebo and vaccine groups included both inhalation and cutaneous anthrax cases, Accordingly, the calculated effectiveness of the vaccine to prevent both types of anthrax disease combined was 92.5 percent (Iower 95 percent confidence interval = 65 percent) as described in the Brachman, et al. report. Id. See also A.R. 3736 (04 AR, Vol. 13 (Table 4)); id. at 3740-41 (Table 8). The FDA noted that the CDC surveillance data supported the Brachman Study's findings regarding the effectiveness of AVA.11 The FDA received numerous comments relating to its Order. Comments supportive of AVA licensure included a submission by a researcher who discussed in detail "how the pathology of cutaneous and inhalation anthrax at the cellular level is fundamentally the same, i.e., dependent on the actions of anthrax toxin, such that cytotoxic activities are blocked by antibodies produced in response to AVA in the same manner despite the route of exposure." 70 Fed.Reg. at 75,185. Comments against licensure included the same objections that Plaintiffs raise here. The FDA concluded, "After review of the comments and finding no additional scientific evidence to alter the proposed categorization, FDA accepts the Panel's recommendation ... and determines AVA to be safe and effective and not misbranded." Id. at 75,182. Counts I, II, and III of the First Amended Complaint challenge the FDA's Final Order. Plaintiffs seek temporary and permanent injunctive relief from DoD's anthrax vaccination program, alleging that the FDA's finding that AVA was effective against inhalation anthraxwas arbitrary and capricious in violation of the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701 et seq. In Count IV, Plaintiffs seek a declaratory judgment that AVA is being administered in violation of 10 U.S.C. § 1107. Defendants seek dismissal of Counts I, II, and III based on failure to state a claim and on Count IV based on lack subject matter jurisdiction due to lack of standing. Plaintiffs oppose. II. STANDARD OF REVIEW A. Failure to State a Claim A motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) challenges the adequacy of a complaint on its face, testing whether a plaintiff has properly stated a claim. Although a complaint "does not need detailed factual allegations, a plaintiff's obligation to provide the `grounds' of his `entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not da" Bell Atl. Corp. v. Twombly, ___ U.S. ___-___ ___, 127 S.Ct. 1955, 1964-65, 167 L.Ed.2d 929 (2007) (internal citations omitted). The court must treat the complaint's factual allegations — including mixed questions of law and fact — as true, drawing all reasonable inferences in the plaintiff's favor, Macharia v. United States, 334 F.3d 61, Page 106 64, 67 (D.C.Cir.2003); Holy Land Found, for Relief & Dev. v. Ashcroft, 333 F.3d 156, 165 (D.C.Cir.2003), and the facts alleged "must be enough to raise a right to relief above the speculative level," Twombly, 127 S.Ct. at 1965. But the court need not accept as true inferences unsupported by facts set out in the complaint or legal conclusions cast as factual allegations. Browning v. Clinton, 292 F.3d 235, 242 (D.C.Cir.2002). B. Lack of Subject Matter Jurisdiction Federal courts are courts of limited jurisdiction and the law presumes that "a cause lies outside this limited jurisdiction." Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994). Because subject matter jurisdiction is an Article III as well as a statutory requirement, "no action of the parties can confer subject-matter jurisdiction upon a federal court." Akinseye v. District of Columbia, 339 F.3d 970, 971 (D.C.Cir.2003). On a motion to dismiss for lack of subject-matter jurisdiction pursuant to Rule 12(b)(1), the plaintiff bears the burden of establishing that the court has subject matter jurisdiction. Evans v. B.F. Perkins Co., 166 F.3d 642, 647 (4th Cir. 1999); see also McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 182-83, 56 S.Ct. 780, 80 L.Ed. 1135 (1936). Because subject matter jurisdiction focuses on the court's power to hear the claim, however, the court must give the plaintiffs factual allegations closer scrutiny when resolving a Rule 12(b)(1) motion than would be required for a Rule 12(b)(6) motion for failure to state a claim. Macharia v. United States, 334 F.3d 61, 64, 69 (D.C.Cir.2003). To determine whether it has jurisdiction over the claim, the court may consider materials outside the pleadings. Herbert v. Nat'l Acad. of Scis., 974 F.2d 192, 197 (D.C.Cir.1992). C. APA Review The APA requires a reviewing court to set aside an agency action that is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A); Tourus Records, Inc. v. Drug Enforcement Admin., 259 F.3d 731, 736 (D.C.Cir.2001). In making this inquiry, the reviewing court "must consider whether the [agency's] decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment." Marsh v. Oregon Natural Res. Council, 490 U.S. 360, 378,109 S.Ct. 1851,104 L.Ed.2d 377 (1989) (internal quotation marks and citation omitted). At a minimum, the agency must have considered relevant data and articulated an explanation establishing a "rational connection between the facts found and the choice made." Bowen v. Am. Hosp. Ass'n, 476 U.S. 610, 626, 106 S.Ct. 2101, 90 L.Ed.2d 584 (1986); see also Pub. Citizen, Inc. v. Fed. Aviation Admin., 988 F.2d 186, 197 (D.C.Cir.1993) ("The requirement that agency action not be arbitrary or capricious includes a requirement that the agency adequately explain its result."). An agency action usually is arbitrary or capricious if       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. Motor Vehicle Mfrs. Ass'n of U.S. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983); see also County of Los Angeles v. Shalala, 192 F.3d 1005, 1021 (D.C.Cir.1999) ("Where the agency has failed to provide a reasoned explanation, or where the record belies the Page 107 agency's conclusion, [the court] must undo its action."). As the Supreme Court has explained, "the, scope of review under the `arbitrary and capricious' standard is narrow and a court is not to substitute its judgment for that of the agency." Motor Vehicle Mfrs. Ass'n, 463 U.S. at 43, 103 S.Ct. 2856; see 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."). Rather, the agency action under review is "entitled to a presumption of regularity" and the court must consider only whether the agency decision was based on relevant factors and whether there has been a clear error of judgment. Citizens to Pres. Overton Park, Inc. v. Volpe, 401 U.S. 402, 415, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971), abrogated on other grounds by Califano v. Sanders, 430 U.S. 99, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977). In cases involving scientific or technical decisions within the agency's area of expertise, the agency is entitled to a "high level of deference." Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1320 (D.C.Cir.1998). When confronted with subject matter characterized by scientific and technological uncertainty, courts "must proceed with particular caution, avoiding all temptation to direct the agency in a choice between rational alternatives." Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166, 177 (D.D.C.2000). Judges are not "scientists independently capable of assessing the validity of the agency's determination"; instead of making an independent assessment, courts must hold the agency to the standards of rationality required by the APA. Serono Labs., 158 F.3d at 1327; accord Troy Corp. v. Browner, 120 F.3d 277, 283 (D.C.Cir. 1997) ("we review scientific judgments of the agency [the EPA] hot 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."). The determination of whether a drug is effective "necessarily implicates complex chemical and pharmacological considerations." Weinberger v. Bentex Pharms., Inc., 412 U.S. 645, 654, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973). The FDA's judgments regarding efficacy fall within the FDA's expertise and thus such judgments merit deference from the courts. Bristol-Myers Squibb Co. v. Shalala, 923 F.Supp. 212, 220 (D.D.C.1996). Further, the "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 Labs., Inc. v. FDA 942 F.Supp. 19, 25 (D.D.C.1996). In reviewing an administration action such as the FDA's Final Order at issue here, the role of the district court is to "sit as ah appellate tribunal" and review the case as a matter of law. Marshall County Health Care Auth. v. Shalala, 988 F.2d 1221, 1226 (D.C.Cir.1993). Such review is limited to the administrative record, and "not some new record made initially in the reviewing court." Camp v. Pitts, 411 U.S. 138, 142, 93 S.Ct. 1241, 36 L.Ed.2d 106 (1973); accord Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166, 177 (D.D.C. 2000). Thus, here the Court reviews the pleadings and the administrative record; the Court may not review any new materials submitted by either party. III. ANALYSIS Counts I through III each challenge the FDA's finding that AVA is effective. The standards for the FDA and its Panels to apply in evaluating safety, effectiveness, and labeling are set forth in 21 C.F.R. Page 108 § 601.25(d). Effectiveness is defined as follows: Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological or other effect of the biologic 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. Id. Such controlled clinical 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. A. Counts I and II       Plaintiffs' allegations in Counts I and II of the First Amended Complaint are overlapping. In Count I, Plaintiffs assert that the FDA relied on flawed scientific studies, the Brachman Study and the CDC safety surveillance data, to find that AVA was effective. First Am. Compl. ¶¶ 69-75. In Count II, Plaintiffs assert that there were too few incidents of inhalation anthrax in the Brachman Study to substantiate the vaccine's effectiveness.12 Id. ¶¶ 90-92.       First, Plaintiffs allege that the FDA's reliance on the Brachman Study was improper because the study was not "well-controlled" as required by 21 C.F.R. § 601.25(d)(2). The FDA, in its scientific judgment, has found that the Brachman Study was well-controlled. See 70 Fed. Reg. at 75,182. This judgment is supported by the record. The Brachman Study was a field study that compared the results in an inoculated group against the results in a placebo control group, and thus by its very definition was a controlled study. AR 3734 (04 AR, Vol. 13); id. at 3736 (Table 4). Plaintiffs argue that in 1969 when the NIH reviewed the effectiveness of AVA (the MDPH vaccine), the NIH noted that the studies "did not provide control data whereby the effectiveness of the vaccine could be evaluated." AR. 3629-30 (04 AR, Vol. 13). In fact, the NIH did not refer to the Brachman Study at all, as the Brachman Study used the earlier version of the vaccine (the DoD vaccine), not the MDPH vaccine that the NIH was reviewing at the time.13 The NIH documents that Plaintiffs cite discuss data generated from uncontrolled studies of the MDPH vaccine. The NIH was referring to the "Talladega" non-controlled epidemiological data and other uncontrolled studies listed at A.R. 3607-16 (04 AR, Vol. 13). See A.R. 3634 (04 AR, Vol. 13) ("The lack of cases of anthrax in an uncontrolled population of approximately 600 persons in the Talladega mill can hardly be accepted as scientific evidence for the efficacy of the vaccine."). In a 1969 letter from the CDC to the NIH, the CDC director indicated, "[t]here have been no controlled evaluation studies with the Page 109 Michigan [MDPH] anthrax product as was done by Dr. Philip Brachman using the [original/DoD] vaccine." A.R. 1375 (04 AR, Vol. 6). Second, Plaintiffs allege that the FDA should not have combined statistics regarding cutaneous anthrax cases with inhalation anthrax cases when it evaluated the Brachman Study data. They argue that "modern statistical analysis of Brachman data reveals that there is no statistical correlation between vaccination, with AVA and inhalation anthrax protection." Pls.' Resp. at 15. Plaintiffs, in essence, argue that cutaneous and inhalation anthrax are different outcomes and must be tested for separately. If inhalation anthrax had been tested separately in the Brachman Study, the numbers would not have been sufficient for a statistical analysis — the two cases in the placebo group compared to no cases in the vaccinated group were just too few to be statistically significant. However, the FDA, again in its scientific expertise, determined that the contraction of the anthrax disease was the proper out-come to be tested, regardless of the route of exposure. The Brachman Study compared the incidence of anthrax in a control group with the incidence in an inoculated group and determined that the vaccine was 92.5% effective against anthrax, combining both cutaneous and inhalation anthrax cases. The FDA determined that this type of statistical analysis was appropriate because the vaccine counteracts the anthrax bacteria in the same manner, no matter how the anthrax was contracted. Regardless of the route of infection the anthrax bacteria produces the same toxins and the vaccine acts against those toxins in the same manner. The FDA fully explained its analysis: The inclusion of both cutaneous and inhalation cases of anthrax in the analysis of the Brachman [S]tudy was appropriate because it was not possible to predict the route of exposure (cutaneous versus inhalation) that would occur within the environmental setting of the woolen mills. With regard to the known pathophysiology of anthrax, the signs and symptoms of disease arise due to the production of toxins by anthrax bacteria growing within the infected individual. The toxins produced by anthrax bacteria do not vary based on route of exposure. The antibodies produced in response to Vaccination contribute to the protection of the vaccinated individual by neutralizing the activities of those toxins. Thus, AVA elicits an antibody response to disrupt the cytotoxic effects of toxins produced by anthrax bacteria, regardless of the route of infection. 70 Fed.Reg. at 75,187. Third, Plaintiffs contend that the fact that inhalation anthrax is more deadly than cutaneous anthrax shows that the bacteria acts differently depending on the route of infection. Pls.' Resp. at 7. Plaintiffs cite no support for this proposition. FDA has explained that inhalation anthrax has a higher fatality rate than cutaneous anthrax because it generally results in a systemic infection whereas cutaneous anthrax generally results in a localized infection. See, e.g., AR. 3363-64 (04 AR, Vo. 12). Fourth, Plaintiffs contend that the FDA improperly relied on (1) the CDC surveillance data and (2) animal studies. In making a finding of effectiveness, the FDA can rely on a controlled clinical study such as the Brachman Study, and the controlled clinical study may be "corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing." 21 C.F.R. § 601.25(d)(2). "Isolated case reports, random experience, and reports Page 110 lacking the details which permit scientific evaluation will not be considered." Id. Under this regulation, the FDA considered the CDC surveillance data as "reports of significant human experience during marketing." Similarly, the FDA found that studies in human and animal models cited in the IOM report supported the conclusion that AVA was effective against anthrax regardless of the route of exposure. 70 Fed.Reg. at 75,183. For example, the IOM Committee noted that the pathology of anthrax in macaques "best mimics that seen in humans after inhalation exposure," A.R. 3385 (04 AR, Vol. 12), and concluded that AVA is effective in protecting macaques from inhalation exposure to the strains of anthrax tested. Id. at 3389. Pursuant to section 601.25(d)(2), the FCA cited the IOM's conclusions from animal studies to corroborate the Brachman Study. The FDA's interpretation of its own regulation, as permitting corroboration by the CDC surveillance data and animal studies, was not plainly erroneous and must be afforded deference. Berlex Labs., 942 F.Supp. at 25 (the FDA's interpretation of its own regulations should be paid special deference because of its scientific expertise). Accordingly, the FDA's reliance on the CDC surveillance data and animal studies as corroborating evidence was proper. B. Count III In Count III, Plaintiffs assert that the current AVA vaccine, manufactured by the MDPH, was never tested and thus the FDA cannot attest to its efficacy; the Brachman Study tested the original DoD vaccine manufactured by the Army. The FDA may base its approval on studies done with a prior version of a vaccine if it finds that the two versions are comparable in terms of safety and effectiveness. Products may be comparable, so long as the manufacturers have shared critical manufacturing process information. A.R. 1399-1406 (04 AR, Vol. 6) (FDA comparability policy). Here, the FDA found that AVA and the original vaccine were comparable under "FDA's long-standing approach to comparability," which permits a manufacturer to make manufacturing changes in producing a product "without performing additional clinical studies to demonstrate the safety and effectiveness of the similar product if data regarding the manufacturing changes support the conclusion that the versions are comparable." 70 Fed.Reg. at 74,184. Applying this approach and after reviewing the development of AVA, the FDA found AVA and the original vaccine were comparable. Id. "[C]linical data comparing the safety and immunogenicity of [AVA] vaccine with [the original] vaccine. reveal[ed] that the serological responses to [AVA] and [the original] vaccine were similar with respect to peak antibody response and seropositivity." Id. The FDA concluded that the two versions of the vaccine "are comparable in their ability to protect test animals ... and their ability to elicit similar immune responses in humans" and thus the data from test studies of the original vaccine could be used to approve AVA. Id. Plaintiffs argue that the FDA may not compare AVA and the original vaccine because the comparability policy only applies to products made by a single manufacturer and AVA and the original vaccine were made by different manufacturers. First Am. Compl. ¶ 99. The FDA comparability policy does not state that it is limited to products made by a single manufacturer. Further, Plaintiffs claim that the FDA simply "declared" AVA and the original vaccine to be comparable as part of this litigation, that the FDA did not make a legitimate finding of comparability. This claim is not borne out by the record. As quoted above, the FDA reviewed the development Page 111 of the anthrax vaccine and examined the clinical data comparing the safety and injmunogenicity of AVA and the original vaccine. See A.R. 3698-3705 (AR 04, Vol. 13) (clinical data). As the FDA noted in its Final Order, "after a manufacturing change, a manufacturer may use data gathered with a previous version of its product to support the effectiveness of a comparable version of the same product." 70 Fed.Reg. at 75,184; see also A.R. 1383-84 (04 AR, Vol. 6) (the FDA's 2002 statement that the DoD vaccine is comparable to the BioPort [aka AVA] vaccine). In sum, the FDA's determination of comparability, based on its review of scientific data, is supported by the record. C. Count IV       In March of 1998, DoD implemented the Anthrax Vaccine Immunization Program ("AVIP") to protect service personnel, at risk of contracting anthrax. Pursuant to this Program, DoD has inoculated active duty and reserve members of the armed forces against anthraxwith AVA, via the recommended the six dose regimen: three inoculations, each two weeks apart, and then three more inoculations at six, twelve, and eighteen month intervals thereafter. See First Am. Compl. ¶¶ 10 & 25. In July of 2000, DoD suspended the AVIP due to a shortage of AVA. Id. ¶ 58. Thus, immunization was interrupted for those military personnel who had not completed the six dose regimen at the time the AVIP was suspended. On October 16, 2006, DoD announced the resumption of the AVIP for military personnel and "emergency-essential" DoD civilians and contractors. Id. ¶ 48. Plaintiffs allege: As part of this suspension, DoD announced that members of the Armed Forces who had received at least one of the sequences 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. Id. ¶¶ 59; see also id. ¶ 61 & 63 (DoD requires individuals who had their doses deferred must continue with the next dose in the series when directed.) Id. ¶ 61.       Thus, Plaintiffs claim that some military personnel will be subject to mandatory immunization under a modified drug regimen schedule that was not approved by the FDA. Because DoD intends to follow a vaccination schedule (for personnel whose vaccineregimen was interrupted) which is inconsistent with AVA's FDA-approved inoculation schedule, in those cases AVA is a drug allegedly unapproved for its applied/intended use. Id. ¶ 107. Under 10 U.S.C. § 1107, drugs unapproved for their applied uses may not be given to members of the Armed Forces without their informed consent except in the case of a Presidential waiver. Plaintiffs allege that they have not consented to unapproved anthrax inoculation by the DoD. Id. ¶ 111.       Although Plaintiffs allege that for certain military personnel DoD approved a vaccination schedule inconsistent with product instructions, Plaintiffs have not alleged that they themselves have been, or imminently will be, subjected to such a vaccination schedule and thus they lack standing to bring this claim. To withstand a motion to dismiss for lack of standing, a plaintiff must 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, 231,110 S.Ct. 596, 107 L.Ed.2d 603 (1990). The Page 112 facts alleged "must be enough to raise a right to relief above the speculative level." Twombly, 127 S.Ct. at 1965. To assert standing, an Article III jurisdictional requirement, a plaintiff must allege: (1) an actual or imminent injury in fact; (2) fairly traceable to the challenged action of the defendant; (3) likely to be redressed by a favorable decision. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). Because Plaintiffs have not alleged that they have suffered, or imminently will suffer, an injury due to an off-label inoculation schedule, they lack standing to bring this claim and the Court lacks jurisdiction over it. Count IV will be dismissed.14 IV. CONCLUSION For the reasons explained above, the Court will dismiss Counts I, II, and III, Plaintiffs' APA challenge to the FDA's Final Order. After examining the available scientific data and interpreting the data pursuant to its regulations, the FDA applied its expertise and found that AVA is effective for immunization against anthrax, whether the infection was acquired by inhalation or cutaneously. The FDA did not act arbitrarily or capriciously. It considered the relevant data and articulated an explanation establishing a "rational connection between the facts found and the choice made." Bowen, 476 U.S. at 626, 106 S.Ct. 2101. The Court will not substitute its own judgment when the FDA made no clear error of judgment. See Overton Park, 401 U.S. at 415-16, 91 S.Ct. 814 (the court must consider only whether the agency decision was based on relevant factors and whether there has been a clear error of judgment). In addition, the Court will dismiss Count IV because Plaintiffs lack standing to make a claim of off-label use under 10 U.S.C. § 1107. Accordingly, Defendants' motion to dismiss15 will be granted. Counts I, II, and III will be dismissed for failure to state a claim, and Count IV will be dismissed for lack of standing. A memorializing order accompanies this Memorandum Opinion. --- Notes: 1. Plaintiffs are: Thomas Rempfer, Joshua Cohen, Gareth Harris, Kevin Ferrara, Shameka Edwards, Eric Gearhart, Michael Palmer, and James Hailstone. 2. The complaint names, in their official capacities, the following: Andrew Von Eschenbach, Commissioner, FDA; Mike Leavitt, Secretary, HHS; and Robert Gates, Secretary, DoD. The FDA is an agent of HHS. 3. Plaintiffs' counsel here instituted prior, litigation, Doe v. Rumsfeld, Civ. No. 03-707 (D.D.C.), related to AVA. In that suit, six John and Jane Doe plaintiffs sought to challenge the DoD's immunization program. The court enjoined DoD from inoculating service members, finding that the vaccine was not properly licensed since the FDA had not made a final decision regarding, the investigational status of AVA. Doe v. Rumsfeld, 297 F.Supp.2d 119, 131 (D.D.C.2003). Soon after, the FDA issued a final order classifying AVA as safe and effective; as a result the injunction was stayed. Doe v. Rumsfeld, 297 F.Supp.2d 200, 201 (D.D.C.2004). The Doe plaintiffs then amended their complaint to challenge the FDA's final order. The Court, on cross motions for summary judgment, then determined that the FDA had issued the final order without proper notice and comment. The FDA withdrew the final order and proceeded with notice and comment. The FDA then issued a new Final Order, 70 Fed.Reg. 75,180, the one at issue here. 4. "A.R." refers to the Administrative Record consisting of 4209 pages originally filed in 2004, see Doe v. Rumsfeld, Civ. No. 03-707 (D.D.C.), plus an additional 20,000 pages. The record first filed in 2004 has been refiled here in 15 volumes on a single CD; these documents are secondarily cited as "(04 AR, Vol. ___)". The additional 20,000 pages were filed here in 3 volumes on 3 CDs. 5. The last case reported in this period occurred in 1976. 6. The committee from the NIH that recommended granting the license application based its recommendation on the following: the CPC safety data, potency data, from lab tests using AVA in guinea pigs, and additional standards relating to production and potency testing. While the committee noted that MDPH's vaccine had not been used in a controlled field trial, the original vaccine was used in a controlled study. Because the original vaccine and the MDPH vaccine were comparable, the FDA determined that the controlled study could be relied upon for proof of AVA's effectiveness. See text infra regarding Count III of the First Amended Complaint. 7. There is a two-stage process for reviewing biological products licensed prior to July 1, 1972, such as AVA. See 21 C.F.R. § 601.25. First, the FDA Commissioner appoints a Panel of experts to review the safety, effectiveness, and labeling of the biological product at issue and to produce an advisory report. Id. § 601.25(a) & (e). Second, the Commissioner publishes the report and a proposed order in the Federal Register and solicits comments. Id. § 601.25(f). After reviewing the comments, the FDA publishes a final order, which constitutes final agency action from which appeal may lie to the courts. Id. § 601.25(g) & (i). 8. In order to conduct a study of the effectiveness of the vaccine, the study required a "well defined, .exposed, susceptible population among whom cases of anthraxwere reported with some regularity." See A.R. 3732 (04 AR, Vol. 13). This type of population could only be found in the U.S. in certain types of textile mills. Id. When the Panel submitted its report in 1980, this type of industry was "vanishing, precluding any further clinical studies." 50 Fed.Reg. at 51,058. 9. In the Final Order, discussed infra, the FDA found that the Panel's conclusion that the Brachman study demonstrated effectiveness only against cutaneous anthraxdue to the low incidence of inhalation cases was in error, and that in fact the Brachman Study calculated the vaccine's effectiveness against cutaneous and inhalation anthrax. See A.R. 3736 (04 AR, Vol. 13) (Table 4); id. at 3740-41 (Table 8). 10. The IOM Committee was composed of ten experts from respected institutions such as Harvard University and the University of Pennsylvania School of Medicine. Their collective knowledge included expertise in microbiology, epidemiology, biostatistics, immunology, and health surveillance, as well as vaccine research, development, manufacture, evaluation, and post-marketing surveillance of adverse events. A.R. 3325 (04 AR, Vol. 12). 11. The FDA also agreed with the Panel that the safety of AVA was demonstrated by the CDC open label safety study (described supra) that was initiated in 1966. 70 Fed.Reg. at 75,183 & 75,188. The CDC open label safety study should not be confused with the CDC surveillance data which corroborated the Brachman Study's findings regarding AVA's effectiveness. 12. In Count II, Plaintiffs also assert that at the time AVA was licensed in 1970 under the Public Health Service Act ("PHSA"), 42 U.S.C. §§ 201 et seq., it was found to be "potent" as required by the PHSA and it was not found to be "effective" as was required starting in 1972 under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq. The fact that in 1970 there was ho finding of effectiveness is not relevant because in 2005 the FDA in its Final Order did find that AVA is effective. See 70 Fed.Reg. 75,180. It is this finding of effectiveness that Plaintiffs challenge in this lawsuit. 13. The FDA concluded in its Final Order that these versions of the vaccine in fact are comparable. See discussion of Count III, infra. 14. Although none of the Plaintiffs is a civilian, Plaintiffs assert that civilian DoD employees and DoD contractors should be covered by 10 U.S.C. § 1107. Pls.' Resp. at 22. Section 1107 expressly applies only to members of the armed forces. 10 U.S.C. § 1107 (this section applies when "the Secretary of Defense requests or requires a member of the armed forces to receive an investigational new drug or a drug unapproved for its applied use"). Even if a civilian were a named plaintiff in this suit, no claim could be stated under section 1107 on behalf of a civilian. 15. Defendants' motion to dismiss [Dkt. #15] was dismissed without prejudice by Minute Entry Order on August 3, 2007. Defendants renewed their motion to dismiss without amendment by filing a notice of such renewal [Dkt. # 29] on September 17, 2007.

Mydlarz v. Comm'r of Soc. Sec. (E.D. Mich., 2017)
Mydlarz v. Comm'r of Soc. Sec. (E.D. Mich., 2017)

DAVID MYDLARZ,1 Plaintiff, v. COMMISSIONER OF SOCIAL SECURITY, Defendant.

Civil Action No. 17-10116

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION

December 12, 2017

Magistrate Judge David R. Grand

OPINION AND ORDER DENYING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT [14], GRANTING IN PART PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT [13], AND REMANDING THE CASE TO THE ALJ FOR FURTHER PROCEEDINGS

I. Background

Plaintiff David Mydlarz ("Mydlarz") brings this action pursuant to 42 U.S.C. § 405(g), challenging the final decision of Defendant Commissioner of Social Security ("Commissioner") denying his application for Disability Insurance Benefits ("DIB") under the Social Security Act (the "Act"). Both parties have filed summary judgment motions. (Docs. #13, #14). On February 23, 2017, the parties consented to the undersigned's authority to conduct all proceedings and enter a final judgment. (Doc. #8). A hearing was held on December 12, 2017, where counsel for both parties appeared by telephone.

Mydlarz alleges disability as a result of various conditions, and Administrative Law Judge Kari Deming (the "ALJ") found that Mydlarz suffers from the following severe impairments: insulin-dependent diabetes mellitus with neuropathy and retinopathy; scoliosis with lumbago (i.e., with back pain) and a single level (L4-L5 disc bulge); depressive disorder; anxiety

Page 2

disorder; and insomnia. (Tr. 18). The ALJ ultimately determined that Mydlarz retains the residual functional capacity ("RFC") to perform light work with additional exertional and non-exertional limitations, including being able to change from sitting to standing every 45 minutes; no more than frequently balancing and stooping, and occasionally climbing, kneeling, crawling, and crouching; no exposure to workplace hazards or environmental conditions like extreme heat, cold, humidity, etc.; engage in simple, routine tasks that are goal-oriented, rather than production-paced; and engage in no more than frequent interaction with the public, co-workers, and supervisors. (Tr. 21). The ALJ then found that because a substantial number of jobs exist in the national economy that could be performed by a person with this RFC, Mydlarz is not disabled under the Act. (Tr. 25-26).

Mydlarz's appeal to this Court followed, and he argues that the ALJ erred in failing to adequately discuss the medical record, make a credibility determination, and support the RFC with record evidence.

II. Applicable Legal Standards

Under the Act, DIB are available only for those who have a "disability." See Colvin v. Barnhart, 475 F.3d 727, 730 (6th Cir. 2007). The Act defines "disability" as the:

inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months. 42 U.S.C. § 423(d)(1)(A). The Commissioner's regulations provide that a disability is to be determined through the application of a five-step sequential analysis:

Step One: If the claimant is currently engaged in substantial gainful activity, benefits are denied without further analysis.

Step Two: If the claimant does not have a severe impairment or combination of impairments that "significantly limits . . . physical or mental ability to do basic work activities," benefits are denied without Page 3

further analysis.

Step Three: If the claimant is not performing substantial gainful activity, has a severe impairment that is expected to last for at least twelve months, and the severe impairment meets or equals one of the impairments listed in the regulations, the claimant is conclusively presumed to be disabled regardless of age, education, or work experience.

Step Four: If the claimant is able to perform his or her past relevant work, benefits are denied without further analysis.

Step Five: Even if the claimant is unable to perform his or her past relevant work, if other work exists in the national economy that the claimant can perform, in view of his or her age, education, and work experience, benefits are denied. Scheuneman v. Comm'r of Soc. Sec., 2011 WL 6937331, at *7 (E.D. Mich. Dec. 6, 2011) (citing 20 C.F.R. § 416.920); see also Heston v. Comm'r of Soc. Sec., 245 F.3d 528, 534 (6th Cir. 2001). "The burden of proof is on the claimant throughout the first four steps . . . . If the analysis reaches the fifth step without a finding that claimant is not disabled, the burden transfers to the [defendant]." Preslar v. Sec'y of Health & Human Servs., 14 F.3d 1107, 1110 (6th Cir. 1994).

The District Court has jurisdiction to review the Commissioner's final administrative decision pursuant to 42 U.S.C. § 405(g). Judicial review under this statute is limited in that the court "must affirm the Commissioner's conclusions absent a determination that the Commissioner has failed to apply the correct legal standard or has made findings of fact unsupported by substantial evidence in the record." Longworth v. Comm'r of Soc. Sec., 402 F.3d 591, 595 (6th Cir. 2005) (internal citations omitted); Rabbers v. Comm'r of Soc. Sec., 582 F.3d 647, 654 (6th Cir. 2009) ("[I]f an agency has failed to adhere to its own procedures, we will not remand for further administrative proceedings unless the claimant has been prejudiced on the merits or deprived of substantial rights because of the agency's procedural lapses.") (internal quotations omitted). Substantial evidence is "more than a scintilla of evidence but less than a preponderance; it is such relevant evidence as a reasonable mind might accept as adequate to

Page 4

support a conclusion." Rogers v. Comm'r of Soc. Sec., 486 F.3d 234, 241 (6th Cir. 2007) (internal quotations omitted). In deciding whether substantial evidence supports the ALJ's decision, the court does "not try the case de novo, resolve conflicts in evidence or decide questions of credibility." Bass v. McMahon, 499 F.3d 506, 509 (6th Cir. 2007); Rogers, 486 F.3d at 247 ("It is of course for the ALJ, and not the reviewing court, to evaluate the credibility of witnesses, including that of the claimant.").

When reviewing the Commissioner's factual findings, the court is limited to an examination of the record and must consider the record as a whole. Bass, 499 F.3d at 512-13; Wyatt v. Sec'y of Health & Human Servs., 974 F.2d 680, 683 (6th Cir. 1992). The court "may look to any evidence in the record, regardless of whether it has been cited by the Appeals Council," or in this case, the ALJ. Heston, 245 F.3d at 535; Walker v. Sec'y of Health & Human Servs., 884 F.2d 241, 245 (6th Cir. 1989). There is no requirement, however, that either the ALJ or the court discuss every piece of evidence in the administrative record. See Kornecky v. Comm'r of Soc. Sec., 167 F. App'x 496, 508 (6th Cir. 2006) ("[A]n ALJ can consider all evidence without directly addressing in his written decision every piece of evidence submitted by a party.") (internal quotations omitted). If the Commissioner's decision is supported by substantial evidence, "it must be affirmed even if the reviewing court would decide the matter differently and even if substantial evidence also supports the opposite conclusion." Cutlip v. Sec'y of Health & Human Servs., 25 F.3d 284, 286 (6th Cir. 1994) (internal citations omitted); Blakley v. Comm'r of Soc. Sec., 581 F.3d 399, 406 (6th Cir. 2009) ("[I]f substantial evidence supports the ALJ's decision, this Court defers to that finding 'even if there is substantial evidence in the record that would have supported an opposite conclusion.'").

Page 5

III. Analysis

Mydlarz has been diagnosed with Diabetes Mellitus, allegedly as a result of an Anthrax vaccine he was required to have administered when he was with the Marines. As the Court explained on the record, at least with respect to the more recent time period, which may satisfy the 12-month durational disability requirement, the ALJ's analysis did not meaningfully address numerous medical records that belie her conclusions that Mydlarz "regularly denies fatigue," has only "mild to moderate difficulties" in social functioning, and most importantly, could function in a regular 40 hour/week work setting on an ongoing basis. In these respects, the Court highlights the following mental health treatment records:

• Tr. 812 - "Veteran states he becomes hopeless due to diabetes and struggles with eating on a daily basis...He also worries constantly about his blood sugars and states he hates to eat as it makes him nauseous. In the past, he tried, Ambien and Trazadone without any relief."

• Tr. 817 - "Mood: Anxious . . . Veteran [] was referred from BCT for worsen[ing] symptoms of depression. Veteran reports that he has been struggling with depression after returning home from deployment to Iraq and finding out he has Type I diabetes."

• Tr. 822-23 - "[Mydlarz reported] lack of interest, depressed mood, difficulty sleeping, variable appetite, low energy, difficulty concentrating, feeling nervous/anxious, and having worrisome thoughts. In addition, the veteran reported having unmanaged type I diabetes, which is a current stressor. He described his current mood as 'numb.' . . . Given the nature of the veteran's concerns and the severity of his symptoms, a mental health consult was placed."

• Tr. 867 - "[Mydlarz] relates his illness to his diabetes...He also notes he limits his social life staying in one place at home because it is safe. He is anxious when away from home . . . He recognizes that his diabetes causes him to 'neglect to live.'"

• Tr. 870 - "Mydlarz has consistently indicated that he isolates at home and does not enjoy social activity. Much of his issue relates to his medical condition and fear that he would become ill or embarrass himself by [] having a diabetes related seizure. . . . He maintained a flat affect throughout the visit . . ." This note also references the therapist having to "force" Mydlarz to engage socially. Page 6

• Tr. 871 - "According to the veteran, 'I hate diabetes. It is exhausting and it limits what [I] [sic] can do...Mydlarz perefers [sic] to isolate at home. He anticipates becoming embarrassed if he shows the IBS or vomiting symptomatic while away from home."

• Tr. 873-874 - "further query found that the veteran's medical condition has a profound influence on his comfort engaging in life away from home. According to him, 'I get fatigued, sick, want to vomit . . . It appears that he is a 'victim' of his diabetes to a point where he has given up. Therapy will continue to encourage social involvement within his limits. . . Little progress is noted as veteran's medical condition is perceived by the veteran as setting him up for failure. In turn he prefers to do nothing believing it is 'safer to stay inside.'"

• Tr. 881 - "[Mydlarz] presents with complaints of poor motivation and lethargy. He states, 'I have no goals right now.' He describes significant sleep impairment ..." • Tr. 885 - "symptoms of depression started approximately five years ago in the context of developing diabetes. . . His mood and disposition remain depressed and tired..."

• Tr. 890 - "Affect was flat, mood was blunted . . . he gets sick and is frequently tired or fatigued...Mydlarz identified social withdrawal as an issue."

• Tr. 910 - "Fatigue still present. Ability to concentrate is rather affected and he attributes it in part to fluctuation in blood sugar." Accordingly, the Court cannot find that the ALJ's RFC determination is supported by substantial evidence, and remand is appropriate. On remand the ALJ should thoroughly discuss Mydlarz's mental health2 treatment records and their relevance to his ultimate RFC. In addition, on remand the ALJ should re-assess Mydlarz's credibility, including by considering all of the facts and circumstances of his travel in the spring of 2016 (e.g., Tr. 867), and their consistency with the other record evidence in this case.

IV. Conclusion

For the foregoing reasons, and those set forth on the record, the Court DENIES the Commissioner's motion for summary judgment (Doc. #14); GRANTS IN PART Mydlarz's

Page 7

motion for summary judgment (Doc. #13) to the extent it seeks remand and DENIES IN PART that motion to the extent it seeks an award of benefits; and, pursuant to sentence four of 42 U.S.C. § 405(g), REMANDS this case to the ALJ for further proceedings consistent with this opinion.

IT IS SO ORDERED.

Dated: December 12, 2017 Ann Arbor, Michigan

s/David R. Grand DAVID R. GRAND United States Magistrate Judge

Bates v. Donley (2013)
Bates v. Donley, 935 F.Supp.2d 14 (D.D.C., 2013)

935 F.Supp.2d 14

Sonnie G. BATES, Plaintiff, v. Michael B. DONLEY, Secretary of the Air Force, Defendant.

Civil No. 11–1589 (RCL).

United States District Court, District of Columbia.

March 27, 2013.

[935 F.Supp.2d 16]

David Patrick Sheldon, Law Office of David P. Sheldon, Washington, DC, for Plaintiff.

Peter Bryce, U.S. Department of Justice, Washington, DC, for Defendant.

MEMORANDUM OPINION

ROYCE C. LAMBERTH, Chief Judge. Plaintiff Sonnie Bates sues Michael Donley, Secretary of the Air Force (“Secretary” or “defendant”), seeking review of the Air Force Board for the Correction of Military Records' (“AFBCMR” or “Board”) decision not to correct or remove disciplinary records from plaintiff's file. Plaintiff was an Air Force Major who in 1999 refused an order to take an anthrax vaccine because of concerns about its health effects. In 2000, facing continuing disciplinary proceedings, plaintiff resigned from the Air Force, receiving a general (under honorable conditions) discharge.

Beginning in 2003, Judge Emmet Sullivan of the U.S. District Court for the District of Columbia heard a case, Doe v. Rumsfeld, regarding the legality of the military's anthrax vaccine program. Judge Sullivan prospectively enjoined the armed forces from administering the vaccine until the Food and Drug Administration (“FDA”) completed proper rulemaking. Before the D.C. Circuit could rule on the merits of Judge Sullivan's order, the FDA enacted a valid final rule that dissolved Judge Sullivan's injunction. Plaintiff was not a party to this case, and Judge Sullivan did not order any retrospective or declaratory relief. Other courts have come to different conclusions as to the vaccine's legality.

In November 2008, plaintiff submitted an application to the AFBCMR, seeking correction of his records in light of Doe. After receiving seven advisory opinions and considering plaintiff's submissions, the AFBCMR denied plaintiff's request to change his disciplinary and personnel records. Thereafter, plaintiff brought suit in this Court, challenging the actions of the AFBCMR.

[935 F.Supp.2d 17]

Before the Court is defendant's Motion to Dismiss, Jan. 31, 2012, ECF No. 5. Upon consideration of the defendant's motion; the plaintiff's Opposition, Apr. 16, 2012, ECF No. 8; the defendant's Reply thereto, May 7, 2012, ECF No. 10; the applicable law; and the record herein, the Court shall convert defendant's motion into a motion for summary judgment under Federal Rule of Civil Procedure 12(d), and grant defendant summary judgment.

I. BACKGROUND For the purposes of this Opinion, the Court takes as true the facts alleged in plaintiff's Complaint. See, e.g., Kowal v. MCI Commc'ns Corp., 16 F.3d 1271, 1276 (D.C.Cir.1994). Furthermore, when faced with a motion to dismiss in the APA context, a court may consider the administrative record and public documents without converting the motion into a motion for summary judgment, Rempfer v. Sharfstein, 583 F.3d 860, 865 (D.C.Cir.2009), or it may convert the motion into a motion for summary judgment under Rule 12(d), Marshall Cnty. Health Care Auth. v. Shalala, 988 F.2d 1221, 1226 & n. 5 (D.C.Cir.1993). Therefore, the Court draws the background facts from plaintiff's Complaint and the submitted administrative record. Pl.'s Compl., Sept. 2, 2011, ECF No. 1; Admin. Record of Proceedings Before AFBCMR (“AR”), Nov. 8, 2011, ECF Nos. 5–1–6.

A. Factual Background to the Anthrax Vaccination Program In December 1997, the Department of Defense (“DoD”) initiated the Anthrax Vaccine Immunization Program (“AVIP”). Compl. ¶ 11. The program went into effect in March 1998, and under the AVIP, members of the Armed Forces at risk of anthrax exposure were required to submit to mandatory vaccination. Id. ¶¶ 11, 13.

Through this program, the DoD administered a vaccine known as Anthrax Vaccine Absorbed (“AVA”). Id. ¶ 13. In 1970, the National Institutes of Health (“NIH”)—the agency responsible for licensing biologic products at the time—licensed AVA for use against anthrax. In 1972, Congress transferred responsibility for licensing biologics to the Food and Drug Administration (“FDA”). See AR 99 ( Anthrax Vaccine Safety and Efficacy Issues: Hearing Before the H. Comm. on Gov't Reform, 106th Cong. 1 (1999) (statement of Kwai–Cheung Chan, Dir., Special Studies & Evaluations, Nat'l Sec. & Int'l Affairs Div., GAO)). After notice and comment rulemaking, the FDA issued a final order explicitly finding AVA efficacious against inhalation anthrax in December 2005. See Compl. ¶ 50.

In 1998, Congress passed 10 U.S.C. § 1107, restricting the administration of investigational or unapproved drugs to military personnel. Under the law, the DoD may not require a member of the armed services to receive an “investigational new drug or a drug unapproved for its applied use,” 10 U.S.C. § 1107(a)(1), without the informed consent of the service member or a presidential waiver, 10 U.S.C. § 1107(f)(1). Pursuant to this law, in September 1999 the President signed Executive Order 13139, stating that “[b]efore administering an investigational drug to members of the Armed Forces, the ... [DoD] must obtain informed consent from each individual unless the Secretary can justify to the President a need for a waiver of informed consent [.]” 64 Fed.Reg. 54,175 (Sept. 30, 1999). According to the plaintiff, the DoD did not secure informed consent of service members or seek a Presidential waiver before administering AVA. See, e.g., Compl. ¶ 53.

B. Plaintiff's Refusal to Take the Anthrax Vaccine and Related Discipline Plaintiff Sonnie Bates entered the active duty Air Force in September 1986 as a

[935 F.Supp.2d 18]

Second Lieutenant; by April 1998, plaintiff achieved the rank of Major. Compl. ¶ 8. Plaintiff states that he had “amassed an exemplary military record as both an aviator and officer,” Pl.'s Opp'n 5. He cites an impressive record of accomplishments, commendations, and awards. Compl. ¶¶ 9–10.

In October 1999, the plaintiff told his squadron commander at the Dover Air Force Base, Lt. Col. David Smith, that he was considering not taking the anthrax vaccine. His opposition was based on his observations of sick squadron personnel. At that time, the Air Force required all personnel training to become a C–5 pilot, including the plaintiff, to take the anthrax vaccine. Lt. Col. Smith advised the plaintiff to share his concerns with the Wing Flight Surgeon and Area Defense Counsel. AR 163; Compl. ¶ 22.

On November 8, 1999, Lt. Col. Smith told plaintiff that he would be expected to take the vaccination before his first operational mission. On November 16 and 17, plaintiff advised the squadron Readiness Flight Commander and the Squadron Director of Operations that he decided not to take AVA. On November 18, plaintiff submitted a request for resignation under Air Force Instruction (“AFI”) 36–3207, Separating Commissioned Officers. On the same date, the plaintiff gave his Squadron Director of Operations a letter stating that he had completed all training requirements except the anthrax vaccination, and explained his lingering concerns over the product quality and safety of the AVA. AR 163; Compl. ¶¶ 24–26.

On November 19, 1999, the plaintiff was removed from his next operational mission because of his failure to take the anthrax immunization. On November 22, Lt. Col. Smith counseled plaintiff on his failure to be “mission ready,” removed him from all squadron duties, assigned plaintiff to the Operations Group, and ordered the plaintiff to meet with the Flight Surgeon, chaplain, and his military defense attorney. AR 163; Compl. ¶¶ 27–28. The next day, Lt. Col. Smith met with plaintiff and plaintiff's spouse; during that meeting, Lt. Col. Smith asked plaintiff to put his objections to the AVIP in writing, and told plaintiff that he would try to educate him further regarding his concerns. On November 24, plaintiff submitted a two-page letter detailing his objections to the AVIP. On November 30, plaintiff met with Col. Harvey R. Crowder, Chief, Preventative Division, Air Force Medical Operations Agency, to discuss his concerns. AR 164; Compl. ¶¶ 29–31.

On December 1, 1999, plaintiff was given a written order to be inoculated with the anthrax vaccine by December 3rd. In response, plaintiff submitted a letter from Dr. J.B. Classen advising plaintiff not to take the vaccine. Dr. Classen based his advice on a review of plaintiff's family history and his research on autoimmunity. Plaintiff went to Andrews Air Force Base on December 3 to meet with Col. Bernardo Villacis, Senior Consultant, Allergy Clinic, and discussed the assertions Dr. Classen made in his letter. After plaintiff returned from Andrews AFB without taking the vaccine, Lt. Col. Smith told plaintiff that an on-call medic would be available throughout the weekend if plaintiff changed his mind. AR 164; Compl. ¶¶ 32–33.

Plaintiff did not take the vaccination, and on December 8, 1999, Brigadier General F. Randall Starbuck, Air Force Vice Commander, offered plaintiff a Uniform Code of Military Justice (“UCMJ”) Article 15 (nonjudicial punishment) for willfully disobeying a lawful order to take the AVA. Plaintiff initially elected trial by court-martial, but later waived his right to a UCMJ Article 32 hearing and submitted a

[935 F.Supp.2d 19]

request to change his election and accept the offer of nonjudicial punishment. Plaintiff also requested, and was granted, a personal hearing with Brigadier General Starbuck. AR 164; Compl. ¶¶ 34–36.

On February 21, 2000, plaintiff submitted a response to the Article 15 proceedings. Plaintiff stated that he believed that the anthrax vaccine was unsafe and linked to illness. On November 28, Brigadier General Starbuck determined that plaintiff had committed the offense, and imposed punishment consisting of forfeiture of $3200 in pay and the placement of a Letter of Reprimand in plaintiff's official file. Plaintiff did not appeal this decision. On March 9, 2000, a legal review found the nonjudicial punishment legally sufficient, and an additional supervisory review concurred. AR 164; Compl. ¶¶ 37–38.

On March 8, 2000, the Air Force notified plaintiff of an action initiated under AFI 36–3206, Administrative Discharge Procedures for Commissioned Officers, for commission of a serious offense under UCMJ Article 90, specifically for willfully disobeying the lawful command of a superior officer. On March 10, plaintiff submitted AF Form 780, Officer Separation Actions, tending his resignation per AFI 32–3207 because he could not support the AVIP. On March 30, plaintiff was discharged per AFI 36–3206 with a general (under honorable conditions) discharge and a separation code of BKQ (indicating “misconduct—commission of a serious offense”). Plaintiff did not appeal his discharge characterization or separation code. See AR 164; Compl. ¶¶ 39–42.

C. Later Proceedings and Challenges A few years after plaintiff left the Air Force, Judge Emmet Sullivan of the United States District Court for the District of Columbia heard a legal challenge to the AVIP. In Doe v. Rumsfeld (“ Doe I ”), 297 F.Supp.2d 119, 135 (D.D.C.2003), Judge Sullivan ruled that, with regard to immunization from inhalation anthrax, AVA was an investigational drug being used for an unapproved purpose in violation of 10 U.S.C. § 1107. Judge Sullivan found that the FDA had not properly licensed the AVA for use against inhalation anthrax. He then granted the Doe plaintiffs' request for a preliminary injunction and enjoined the AVIP. Id.

Shortly after the Doe I injunction, the FDA issued a final rule and order finding that AVA was safe and effective “independent of the route of exposure.” 69 Fed.Reg. 255, 260 (Jan. 5, 2004). Judge Sullivan, nonetheless, vacated the FDA's rule and order because the FDA failed to follow the required notice and comment procedures. Doe v. Rumsfeld (“ Doe II ”), 341 F.Supp.2d 1, 16 (D.D.C.2004). Finding a clear statutory prohibition on inoculation with investigational drugs, Judge Sullivan issued a permanent injunction on AVIP until the FDA certified AVA through the proper procedures. Id. at 16. In December 2005, the FDA issued a new final order explicitly finding AVA efficacious against inhalation anthrax, causing the D.C. Circuit to conclude that the injunction against the vaccination program had dissolved on its own terms. Doe v. Rumsfeld (“ Doe IV ”), 172 Fed.Appx. 327, 327 (D.C.Cir.2006).

After the Doe litigation put the legality of the AVIP in doubt, plaintiff sought relief from the Air Force Board for the Correction of Military Records. On November 8, 2008, plaintiff submitted an application to the AFBCMR requesting several changes be made to his Air Force file, in order to correct for the perceived injustice of being disciplined for refusing to take the AVA. Compl. ¶¶ 52–53; AR 14–15. The plaintiff, relying on Doe and a later case,

[935 F.Supp.2d 20]

Rempfer v. AFBCMR, 538 F.Supp.2d 200 (D.D.C.2008), argued that “from the time [he] was punished and separated from the Air Force in 2000—until December 2005—an order to submit to the anthrax vaccination was illegal!” AR 18.

Following plaintiff's submission, the Board forwarded his application for seven advisory opinions. Compl. ¶ 56. The seven advisory opinions all recommended denying plaintiff's request. See id. ¶¶ 57–63. The Board received a legal opinion by the Air Force Legal Operations Agency, Military Justice Division (“AFLOA/JAJM” or “JAJM”). The JAJM advisory opinion thoroughly considered plaintiff's arguments based on Rempfer and Doe. First, the opinion distinguished Rempfer, which plaintiff argues elaborates on Doe and makes clear that pre–2005 orders to take the AVA were illegal. The JAJM opinion noted that the Rempfer court “pointed out that ‘other courts have affirmed the legality of pre–2005 orders subjecting military personnel to involuntary anthrax vaccination,’ ” AR 166 (quoting Rempfer, 538 F.Supp.2d at 210), and that the Rempfer court did not take a position on whether the AFBCMR should consider itself bound by Doe v. Rumsfeld, AR 166.

Next, the JAJM opinion distinguished Doe, noting that Doe only concerned prospective, injunctive relief and did not concern whether prior inoculation orders were illegal. AR 166–67. JAJM found more persuasive the holding of the Court of Appeals for the Armed Forces in United States v. Kisala, 64 M.J. 50 (C.A.A.F.2006). Kisala, according to the JAJM, “spoke directly to the issue raised by the applicant.” AR 166. In Kisala, an army specialist refused a written order to take the AVA. Explaining its reliance on Kisala, the JAJM opinion stated:

The Court in Kisala described how it had long ago “recognized the foundational principle of military discipline ... obedience to lawful orders.” Kisala at 51. It pointed out that “an order is presumed to be lawful, and a subordinate disobeys an order at his own peril.” Id. at 52. The Court then summarized the specialist's challenge as trying to “overcome [the] presumption of the lawfulness of the order to receive the vaccine.” Id. ....

Just as applicant did indirectly through the Rempfer case, the specialist [in Kisala] relied upon Doe to show that the AVA was not lawful for use as intended by the AVIP. The Kisala Court pointed out that, in dealing with the presumption that an order is lawful, the service member challenging the order bears the burden of demonstrating the illegality. Id. at 53. After analyzing the licensing process for the vaccination and pointing out that the burden on the service member challenging the rule from the FDA is high, the Court found that the specialist had not established that the vaccine is an investigational new drug or a drug unapproved for its applied use. Id. at 54–55. Therefore, use of the AVA did not require a presidential waiver of informed consent to be used on military members. The Court concluded that the specialist had failed to overcome the presumption of the lawfulness of the orders and, therefore, it affirmed the findings and sentence as adjudged. Id.

The facts in Kisala and the applicant's case are identical except for the fact that the applicant did not face a court-martial for his offense and received much less serious consequences because of that fact. A ruling of the Court of Appeals of the Armed Forces is binding on all courts-martial and other military justice actions for all armed services. Therefore, since the applicant has used the same argument as the specialist in Kisala, the same outcome for the applicant's

[935 F.Supp.2d 21]

case must result from applying the reasoning used in Kisala on applicant's situation. The applicant has not overcome the presumption of lawfulness of the order he was given on 3 December 1999. Therefore, the Article 15 based on failure to obey that order is legally sufficient

The applicant has cited to Rempfer, which was decided after Kisala. However, Rempfer is not on point for the applicant's case since it does not directly address the issue of the presumption of the lawfulness of the order given to the applicant. Moreover, even if the rulings in Kisala and Rempfer were in exact opposition to one another, military legal authorities would be bound to follow the Kisala decision unless and until that decision was overturned or overruled by the Court of Appeals of the Armed Forces or the United States Supreme Court.

AR 167. Therefore, the JAJM recommended denial of plaintiff's application.

On August 14, 2009, the AFBCMR forwarded the advisory opinions to plaintiff and gave him 30 days from the date of the letter to comment on the advisory opinions or provide any additional evidence. Compl. ¶ 64. The plaintiff responded to the JAJM's advisory opinion, arguing that Kisala did not “somehow trump[ ] the decision of a Federal District Court—a court of competent jurisdiction which construed the legality of the AVIP program.” AR 185. He reiterated his arguments based on Doe and Rempfer. He argued that the Court of Appeals for the Armed Forces, which issued Kisala, “is neither an appellate court to which the Federal District Court must answer, nor is it competent to rule on the legality of FDA regulations nor any Executive Orders as they pertain to FDA regulations.” Id.

In early 2010, the Board requested and received two supplemental advisory opinions. See Compl. ¶¶ 66–67.1 The supplemental JAJM opinion again recommended denial of plaintiff's application, and responded to plaintiff's rebuttal argument about Kisala not “trumping” Doe:

It may be true that the Court of Appeals for the Armed Forces does not “trump” a Federal District Court. It is also true that a Federal District Court does not “trump” the Court of Appeals for the Armed Forces on questions of military law. We remain convinced that the order was lawful within the body of mandatory military law precedents that we must follow in our military justice system.

The failure of the FDA to properly authorize the use of the vaccine—a fact not known to either the commander or the applicant at the time of the order, did not invalidate the order at the time it was given to the applicant. The fact that a subsequent revelation of improper rulemaking interrupted the administration of the vaccine program until the rulemaking was properly completed had no impact on the legality of the order.

AR 179–80. The Board asked the Judge Advocate General of the Air Force (“JAA”)

[935 F.Supp.2d 22]

for a supplemental opinion on “the extent of the remedies requested by the applicant assuming the disciplinary action is removed from the records.” See AR 189. However, instead of providing an opinion on that issue, the JAA responded: “We emphatically do not, and cannot responsibly discuss—even hypothetically—a remedy for which there is absolutely no underlying error or injustice.” Id. The JAA then proceeded with a fervent analysis “as to why this applicant's request must be denied in its entirety.” Id. The JAA opinion specifically responded to plaintiff's reliance on Doe and Rempfer and noted that a “variety of pre-Doe v. Rumsfeld authorities [ ] concluded the AVIP was legal.” AR 191 (citing Mazares v. Dep't of the Navy, 302 F.3d 1382, 1385 (Fed.Cir.2002); O'Neil v. Sec. of the Navy, 76 F.Supp.2d 641, 645 (W.D.Pa.1999)). The JAA also stated that the Kisala decision was more on point than Doe, since Kisala actually addressed the presumption that military orders are legal. Id.

By letter dated April 16, 2010, the plaintiff responded to the JAJM and JAA supplemental opinions. Compl. ¶ 77. In that letter, the plaintiff called the supplemental opinions “unresponsive, argumentative, and wholly improper and irresponsible.” AR 198. He reiterated his arguments that the Board should follow Doe and Rempfer rather than Kisala. AR 198–203.

The AFCMR convened on April 23, 2010, and denied plaintiff's application. Compl. ¶ 80. The Board relied on advisory opinions, detailed supra, when it concluded that “[i]nsufficient relevant evidence has been presented to demonstrate the existence of an error or injustice.” AR 10. The plaintiff then brought suit in this Court, challenging the decision of the AFBCMR under the Administrative Procedure Act, 5 U.S.C. § 701 et seq. Complaint, Sept. 2, 2011, ECF No. 1. The Court now considers the defendant's Motion to Dismiss, Jan. 31, 2012, ECF No. 5.

II. LEGAL STANDARD The defendant has moved for dismissal under Federal Rule of Civil Procedure 12(b)(6). However, Rule 12(d) provides that “if, on a motion under Rule 12(b)(6) ..., matters outside the pleadings are presented to and not excluded by the court, the motion must be treated as one for summary judgment under Rule 56. All parties must be given a reasonable opportunity to present all the material that is pertinent to the motion.” Fed.R.Civ.P. 12(d). Because the parties have relied on material outside the pleadings (namely, the administrative record), the Court deems it appropriate to treat the defendant's motion to dismiss as a motion for summary judgment. See Shalala, 988 F.2d at 1226 & n. 5 (noting that a district court considering a Rule 12(b)(6) motion “can consult the [administrative] record to answer the legal question[s] before the court,” but that “[i]t is probably the better practice for a district court always to convert to summary judgment.”).

“Summary judgment is the proper mechanism for deciding, as a matter of law, whether an agency action is supported by the administrative record and consistent with the APA standard of review.” Loma Linda Univ. Med. Ctr. v. Sebelius, 684 F.Supp.2d 42, 52 (D.D.C.2010) (citing Stuttering Found. of Am. v. Springer, 498 F.Supp.2d 203, 207 (D.D.C.2007)); see also Richards v. INS, 554 F.2d 1173, 1177 & n. 28 (D.C.Cir.1977). Due to the court's limited role in reviewing the administrative record, the typical summary judgment standards of Rule 56 are not applicable. Stuttering, 498 F.Supp.2d at 207. Rather, “[u]nder the APA, it is the role of the agency to resolve factual issues to arrive at a decision that is supported by the administrative

[935 F.Supp.2d 23]

record, whereas ‘the function of the district court is to determine whether or not as a matter of law the evidence in the administrative record permitted the agency to make the decision it did.’ ” Id. (quoting Occidental Eng'g Co. v. INS, 753 F.2d 766, 769–70 (9th Cir.1985)).

III. ANALYSIS The Court considers two arguments for granting defendant summary judgment. First, the defendant challenges the action as time-barred under the law of the Federal Circuit, which defendant says has exclusive appellate jurisdiction over the case since the Complaint is based in part on the Little Tucker Act. The guidance from the D.C. Circuit is not clear on this point, and the Court will proceed to consider plaintiff's claims under the APA—although an appellate court may find this first argument a sufficient grounds for dismissal.

Second, when the Court considers plaintiff's APA challenge, the facts do not indicate that the AFBCMR's decision was arbitrary, capricious, or unlawful. The Court should apply a strongly deferential application of the arbitrary and capricious standard to decisions of the AFBCMR. However, even under “standard” APA deference, the well-reasoned and thorough decision of the AFBCMR withstands judicial review

The Court notes at the outset the similarity between this case and a recently decided case before Judge Reggie Walton. In Martin v. Donley, 886 F.Supp.2d 1, 5–6 (D.D.C.2012), plaintiff Martin was a former member of the Air Force reserves who refused to take the anthrax vaccination in 2000. The Air Force initiated discharge procedures against Martin for willfully disobeying a lawful order, and Martin resigned facing involuntary discharge. In 2008, Martin challenged his discharge designation before the AFBCMR, claiming the inoculation order was illegal under Doe v. Rumsfeld. When the AFBCMR denied Martin's request, he challenged this action in the U.S. District Court for the District of Columbia. Id. at 5–7. Judge Walton decided that the AFBCMR came to a reasoned decision and was entitled to summary judgment.

Martin and the present case are virtually identical. In both cases, the same lawyers have represented each side—resulting in substantial similarities in the briefs.2 The actions were filed on the same day and bear consecutive case numbers. Compare Complaint, Sept. 2, 2011, No. 11–cv–1590 ( Martin), ECF No. 1, with Complaint, Sept. 2, 2011, No. 11–cv–1589 ( Bates ), ECF No. 1. The facts, in all important aspects, are indistinguishable. The plaintiff, when asking the AFBCMR and this Court to follow Doe instead of Kisala, stressed the importance of following the legal and factual findings of the United States District Court for the District of Columbia. See, e.g., Pl.'s Opp'n 31 (“Considering that Kisala's holdings directly contradict ... rulings by Article III courts competent to decide such issues as the legality of the Vaccine ... it was not reasonable for the AFBCMR to ignore federal court precedent and adopt the CAAF case.”). While plaintiff is wrong about the precedential effect of district court opinions, he is right to suggest that the well-reasoned holdings of a colleague have a strong persuasive effect. Therefore, this Court is guided by Judge Walton's sound approach in Martin and will come to the same result for many of the same reasons.

A. The Court Will Treat Plaintiff's Claims as Arising Under the APA First, the defendant argues that despite plaintiff's attempts to frame his action as arising under the APA, the fact that plaintiff requests damages capped at $10,000 invokes this Court's jurisdiction under the Little Tucker Act. Def.'s Mot. to Dismiss 13–14. The Little Tucker Act, 28 U.S.C. § 1346(a)(2), gives district courts concurrent jurisdiction with the Court of Federal Claims over any civil action against the United States for damages not exceeding $10,000. Defendant argues that since plaintiff requests damages in the form of “back pay and allowances” not exceeding $10,000, Compl. ¶¶ 5, (H), the plaintiff has availed himself of the Court's concurrent jurisdiction under the Little Tucker Act, Def.'s Mot. to Dismiss 14. Therefore, exclusive appellate jurisdiction for the entire action would rest in the Federal Circuit; and, applying the law of the Federal Circuit, plaintiff's action would be time-barred. See Def.'s Mot. to Dismiss 14–15.

The Court concedes that Circuit precedent on this issue is not completely clear. The Court finds guidance from Judge Walton's opinion in Martin v. Donley, 886 F.Supp.2d 1. Like the present case, Martin's complaint cited the APA—not the Little Tucker Act—and included a similar waiver of “any right or entitlement to recover monetary damages greater than $10,000 in this action.” Id. at 9. As in this case, the defendant claimed this waiver availed the Court of its jurisdiction under the Little Tucker Act and meant the action was time-barred under the precedent of the Federal Circuit. Judge Walton provided an excellent and detailed analysis of the Court's jurisdiction to proceed under the APA, which this Court will not belabor here. Judge Walton concluded:

After carefully weighing the “relative importance of the [plaintiff's] monetary recovery,” Bublitz [ v. Brownlee], 309 F.Supp.2d [1, 8 (D.D.C.2008) ], which, as noted, cannot exceed $10,000, ... against the valuable equitable relief sought, the Court determines that the plaintiff's claims in this case are not “in essence” for money damages. Thus, the plaintiff's claims are not predicated on the Tucker Act; rather, the plaintiff has pleaded APA claims, which the Court may review pursuant to its federal question jurisdiction.

Id. at 10. Considering the similarities between this case and Martin, and the persuasiveness of Judge Walton's approach, this Court finds that Bates' claims are predicated on the APA and will consider the merits of his APA challenge.

B. Plaintiff's APA Challenge of the AFBCMR's Decision Cannot Prevail Plaintiff does not—and cannot, because of timeliness problems—directly challenge his discharge or Article 15 nonjudicial punishment. Plaintiff is time barred from

[935 F.Supp.2d 25]

challenging any of the defendant's actions during 1999–2000 related to the AVIP and disciplining plaintiff for refusing to take the AVA. Plaintiff may only challenge the AFBCMR's denial of plaintiff's record correction request. See Rempfer, 538 F.Supp.2d at 203–04 (service member who was discharged for refusing order to take anthrax vaccine cannot directly challenge discharge, as the action was brought more than six years after the date of the discharge; service member can only challenge the AFBCMR's denial of his corrections request).

1. Under the APA, the Court Owes Significant Deference to the AFBCMR The Court must consider what deference it owes to the decision of the AFBCMR. At times, plaintiff proceeds as if this Court can review, de novo, the Air Force's disciplinary actions. However, the Court is several steps removed from those decisions. The issue is not whether the AVIP program, or the Air Force's order that plaintiff be immunized, was contrary to law. The issue is not whether the Air Force's actions in disciplining and discharging the plaintiff were arbitrary and capricious, or contrary to law. The only question is whether the AFBCMR acted in accordance with § 706 of the APA; the Court may not substitute its own judgment for that of the AFBCMR when the Board has come to a reasoned decision after considering all relevant factors.

While decisions of the AFBCMR are “reviewable under the APA,” these decisions are reviewable by “an unusually deferential application of the ‘arbitrary or capricious' standard.” Kreis v. Sec'y of Air Force, 866 F.2d 1508, 1514 (D.C.Cir.1989). The D.C. Circuit elaborated:

Nominally, of course, the terms of § 706 of the APA apply alike to all agency actions subject to review thereunder. In practice, however, the question whether a particular action is arbitrary or capricious must turn on the extent to which the relevant statute, or other source of law, constrains agency action. While the broad grant of discretion implicated here does not entirely foreclose review of the Secretary's action, the way in which the statute frames the issue for review does substantially restrict the authority of the reviewing court to upset the Secretary's determination. It is simply more difficult to say that the Secretary has acted arbitrarily if he is authorized to act “ when he considers it necessary to correct an error or remove an injustice,” 10 U.S.C. § 1552(a) (emphasis added), than it is if he is required to act whenever a court determines that certain objective conditions are met, i.e., that there has been an error or injustice.

The Secretary may, in other words, have a reason for considering that it is not necessary to alter an applicant's military record in order to correct even an undisputed error or to remove even a conceded injustice. Drawing upon our own experience, we can readily envision the Secretary, for example, exercising his discretion not to correct an error upon which nothing turns by reason of mootness, lack of harm to the person in question, or inability by such correction to redress the harm claimed. Afield of our experience, we can imagine that the alteration of a record may correct one injustice only to commit another, or perhaps only to incur some other equally significant institutional cost. All such balancing of considerations is to be done by the Secretary, free of judicial second-guessing. Such determinations are well within his discretion.

Id. The Circuit concluded that while the Secretary's exercise of discretion to correct military records “is not to be utterly

[935 F.Supp.2d 26]

unreviewable,” “[p]erhaps only the most egregious decisions may be prevented under such a deferential standard of review.” Id. at 1514–15. The court's role is to determine whether the Secretary has “give[n] a reason [for his decision] that a court can measure, albeit with all due deference, against the ‘arbitrary and capricious' standard of the APA.” Id.

Accordingly, the Board's decision “need not be ‘a model of analytic precision,’ ” but “[it] ‘must minimally contain a rational connection between the facts found and the choice made.’ ” Wilhelmus v. Geren, 796 F.Supp.2d 157, 163 (D.D.C.2011) (quoting Dickson v. Sec'y of Defense, 68 F.3d 1396, 1404 (D.C.Cir.1995)). In this way, the deferential standard ensures that a court does not “substitute its judgment for that of the agency,” Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983), or “supply a reasoned basis for the agency's decisions that the agency itself has not offered,” P.R. Higher Educ. Assistance Corp. v. Riley, 10 F.3d 847, 850 (D.C.Cir.1993) (internal citation omitted). Rather, “the court ... ensure[s] that the agency ‘examined the relevant data and articulate[d] a satisfactory explanation for its action,’ ” Calloway v. Brownlee, 366 F.Supp.2d 43, 54 (D.D.C.2005) (citing Riley, 10 F.3d at 850), by limiting its review to “the administrative record already in existence [and] not some new record made initially in the reviewing court,” Wilhelmus, 796 F.Supp.2d at 161;see also Camp v. Pitts, 411 U.S. 138, 93 S.Ct. 1241, 36 L.Ed.2d 106 (1973).

2. The Court Cannot Grant Most of the Relief Requested by Plaintiff The Court cannot order much of the relief plaintiff requests. The Court cannot order the Board to modify plaintiff's records to remove mentions of discipline and change his discharge status, Compl. ¶¶ (A)-(F); order “Special Selection Boards ... to be held to determine Plaintiff's promotion eligibility,” id. ¶ (G); or order the Board to credit plaintiff with back pay and allowances and allow plaintiff to complete Squadron Officer School and Air Command Staff College, id. ¶¶ (H), (I). Even if the Court found that the AFBCMR's decision violated the APA, the Court would vacate and remand the Board's decision; the Court would not tell the Board how to decide on remand. SeeKreis, 866 F.2d at 1512 (“The court would only require the Secretary, on remand, to explain more fully the reasoning behind his decision and ... to apply the correct legal standard. The Secretary would remain free, following his reevaluation, to reaffirm his original determination[.]”); Rempfer, 538 F.Supp.2d at 210 (while remanding decision of AFBCMR for failure to consider effect of Doe v. Rumsfeld, stating that the impact of Doe litigation on plaintiffs' “claims before the AFBCMR is not [clear]” and taking “no position on whether the AFBCMR ought consider itself bound by Doe's legal and factual conclusions” when considering issue on remand).

3. The AFBCMR's Decision Did Not Violate the APA Reviewing the administrative record submitted by the AFBCMR, the Court finds that the Board offered a thorough, well-reasoned explanation of its denial of plaintiff's request. The Board weighed all relevant factors, including the Doe and Rempfer litigation cited by plaintiff, and responded to all of the plaintiff's salient arguments. See AR 2–13 (Record of Proceeding, AFBCMR). The Board solicited and relied on several detailed advisory opinions, which explored in greater detail the legal and factual basis of plaintiff's request. See AR 14–203 (documents

[935 F.Supp.2d 27]

AFBCMR considered). As the discussion in Part I.C. supra shows, the Board thoroughly considered all of plaintiff's arguments and provided a well-supported opinion. The Board's decision appears to be procedurally valid, and plaintiff has not shown that the process by which the AFBCMR came to its conclusion was unjust, arbitrary, or unlawful. Since the Board offered an exhaustive justification for its decision, the Court will not repeat all of the reasons the Board proffered. The Court, however, will address plaintiff's central arguments that the Board's decision is infirm.

Plaintiff argues that “clear, binding decisions in this jurisdiction [ ] unequivocally found that AVA was an investigational drug within the meaning of 10 U.S.C. § 1107 and that pre–2005 military orders to involuntarily inoculate service members were illegal.” Pl.'s Opp'n 24. Doe litigation halted the AVIP from 2003 to December 2005 because Judge Sullivan found the AVA was an investigational drug under 10 U.S.C. § 1107. Doe I, 297 F.Supp.2d at 125. In Rempfer v. AFBCMR, Judge Robertson vacated and remanded a denial of a records correction request because the Board did not consider the effect of Doe. 538 F.Supp.2d at 210. Plaintiff argues that, taken together, Doe and Rempfer hold that it was illegal before 2005 to order any service member to take the anthrax vaccine. The Board's failure to follow clear and binding precedent, plaintiff argues, means the Board's decision was arbitrary, capricious, and contrary to law.

Contrary to plaintiff's protestations, Doe is not “binding” on the AFBCMR. The Doe litigation only awarded prospective, injunctive relief—not any declaratory relief or damages. It did not discuss whether prior orders to take the anthrax vaccine were illegal. See Doe I, 297 F.Supp.2d at 125. The D.C. Circuit did not affirm the reasoning of Doe—the Circuit mooted the appeal because a final, procedurally-valid FDA rule found the AVA safe and efficacious, and the Circuit explicitly declined to opine on whether Doe was decided correctly. Doe IV, 172 Fed.Appx. at 328 (“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.” (internal quotation marks omitted)).

Plaintiff argues that the AFBCMR improperly relied on the Court of Military Appeal's Kisala decision, which held that military orders to take the AVA were legal, despite the Doe litigation. See Pl.'s Opp'n 27–32; AR 185 (discussing Kisala, 64 M.J. at 53–54). While the Board may not have been required to follow Kisala's reasoning, it was not required to follow Doe either. Several courts have come to different conclusions regarding the legality of the AVIP and military orders to be inoculated. See, e.g., Mazares, 302 F.3d at 1385;O'Neil, 76 F.Supp.2d at 645. The AFBCMR considered this conflicting authority and came to a reasoned decision to follow Kisala. See, e.g., AR 9–11, 166–67, 187–96. Since a decision of a federal district court does not necessarily “trump” a decision of the Court of Military Appeals, it was not arbitrary or capricious for the Board to find Kisala's reasoning more persuasive.

Although Doe does not directly speak to the legality of the AVIP prior to 2005, the plaintiff relies heavily on Rempfer to argue that the 1999 order was illegal. See, e.g., AR 14–15, 185. Plaintiff repeatedly quotes the following language:

[935 F.Supp.2d 28]

Taken as a whole, Judge Sullivan's decisions in Doe v. Rumsfeld conclude that, prior to the FDA's December 2005 rulemaking, it was a violation of federal law for military personnel to be subjected to involuntary AVA inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax.

Rempfer v. AFBCMR, 538 F.Supp.2d at 210. The plaintiff's use of Rempfer is borderline disingenuous. Directly following the above-quoted language, Rempfer continued:

While the undisturbed factual and legal findings of the Doe litigation are clear, their impact on [plaintiffs'] claims before the AFBCMR is not. Other courts have affirmed the legality of pre—2005 orders subjecting military personnel to involuntary anthrax vaccination, although they did so without giving detailed consideration to the implications of the FDA's licensing requirements.

On remand, the Board must reach the issue and explain its conclusions about the merits of plaintiffs' constructive discharge claims and their accompanying demands for compensatory relief. This Court does not assume that the AFBCMR must necessarily pass on the legality of pre–2005 involuntary AVA vaccination in order to decide plaintiffs' constructive discharge claims. Should the Board address that underlying question on remand, this Court takes no position on whether the AFBCMR ought consider itself bound by Doe's legal and factual conclusions.

Id. (citations omitted). Rempfer only found that the AFBCMR needed to consider Doe—not that the Board needed to agree with Doe. In the present case, the AFBCMR considered Doe, weighed it against contrary authority, and concluded that it was not “bound by Doe's legal and factual conclusions.” Id. The Court can only make sure that the Board considered all relevant factors; it cannot require the Board to follow Doe's reasoning rather than Kisala's.

As discussed supra, this case is almost identical to Martin v. Donley. In that case, Judge Walton rejected an APA challenge to the AFBCMR's denial of plaintiff's request to change his discharge classification. As in this case, Martin was disciplined for failing to obey an order to be inoculated under the AVIP. And as in this case, Martin later claimed that the inoculation order was illegal under Doe v. Rumsfeld. Judge Walton decided that the defendant was entitled to summary judgment on plaintiffs' APA claims, stating:

[T]he Court is not persuaded that the Board for Correction acted arbitrarily or capriciously in concluding that “the order to submit to the vaccination program was not illegal,” and that it should “defer to the Court of Appeals for the Armed Forces in [United States v. Kisala, 64 M.J. 50 (2006) ].” Def.'s Mem. at 10. The parties agree, and the Administrative Record is clear, that before the Board for Correction made its final ruling it sought the recommendations of nine advisory opinions from various offices in the Air Force, as well as from the Air Force Administrative Law Division. Compl. ¶ 47, 59; see also Def.'s Mem. at 10; A.R., Ex. A (May 13, 2010 R. of Proceedings) at 10–11. After consulting these opinions, the Board for Correction decided not to second-guess the military court's decision on a “basic legal issue” of military justice. A.R., Ex. A (May 13, 2010 R. of Proceedings) at 10–11. In the alternative, the Board for Correction concluded that even if it were to undertake its own review of the legality of the vaccination program order it

[935 F.Supp.2d 29]

was “not convinced the order was illegal.” Id. at 11. The Board for Correction then gave several justifications for why it would not invalidate the order, relying heavily on the analysis in the advisory opinions. Id. A reasoned decision is certainly not the type of “egregious decision[ ]” the Court should undo. See Kreis, 866 F.2d at 1515. In fact, the Court finds that the Board for Correction's decision is supported by substantial evidence. See Kight v. U.S., 850 F.Supp.2d 165, 168–69, 174–75 (D.D.C.2012) (setting forth standard of review requiring determination only whether conclusion is supported by substantial evidence); Walker v. Shannon, 848 F.Supp. 250, 255 (D.D.C.1994). Because a review of the Board for Correction's decision is not intended to “reweigh[ ] ... the evidence,” id., and because the deferential standard of review prohibits a court from “substitut[ing] its judgment for that of the [Board for Correction],” Motor Vehicle Mfrs. Ass'n, 463 U.S. at 43, 103 S.Ct. 2856, the Court is satisfied that the Board for Correction's decision sufficiently contains a “rational connection between the facts ... and the choice made,” Dickson, 68 F.3d 1396.

Martin, 886 F.Supp.2d at 11–12. This Court finds the rationale of Martin persuasive, and its facts—in all relevant regards—indistinguishable. Therefore, the Court will follow Judge Walton's lead and grant defendant summary judgment on plaintiff's APA challenge.

IV. CONCLUSION This case is not about whether the Air Force conducted its immunization program in accordance with the law. It is not about whether the vaccine used was properly licensed for protection against inhalation anthrax exposure. It is not even about whether the Air Force properly disciplined Mr. Bates for refusing to comply with an order to take the anthrax vaccine.

Like the plaintiffs in Doe v. Rumsfeld, Mr. Bates could have requested an injunction against the Air Force's vaccine program, had he thought it contrary to law. Mr. Bates could have, within the six-year statute of limitations, directly challenged his discipline and discharge under the Administrative Procedure Act.

Instead, Mr. Bates waited eight years to ask the Air Force Board for the Correction of Military Records to change his records and effectively “undo” the effects of his earlier discipline. After thorough consideration, the Board exercised its discretion to decline Mr. Bates' request. Mr. Bates then challenged that denial to this Court under the APA.

Therefore, this case is only about whether the AFBCMR violated the requirements of the APA in denying Mr. Bates' request. In this posture, the Court defers strongly to the informed judgments of the Board and does not simply displace the Board's judgments in favor of its own. The only pertinent question is whether the Board's action was arbitrary, capricious, unsupported by substantial evidence, or contrary to law. The AFBCMR considered the appropriate factors and evidence and came to a reasoned decision. The Court cannot disturb that decision simply because it could have decided differently.

My colleague, Judge Reggie Walton, recently resolved a case with strikingly similar facts and legal issues. This Court finds Judge Walton's well-reasoned approach in Martin v. Donley persuasive and bases much of its current decision on how Judge Walton resolved Martin.

For the reasons stated above, the Court will convert defendant's Motion to Dismiss into a motion for summary judgment and grant the defendant summary judgment.

[935 F.Supp.2d 30]

This constitutes final judgment in this action, and the Court will dismiss this case with prejudice.

A separate Order accompanying this Memorandum Opinion shall issue this date.

Notes:

1. Plaintiff presents an extended discussion, in paragraphs 68–72 of his Complaint, regarding the Board's concerns about completing its investigation within the allotted 18–month period, giving the plaintiff 30 days to respond to revised advisory opinions, and completing the process before the Board's next scheduled meeting. This discussion is irrelevant. Plaintiff admits that the “date of the panel was subsequently postponed due to availability issues” and concerns about procedural irregularity or giving the plaintiff enough time to respond were made “moot.” Compl. ¶ 72. Plaintiff does not seem to argue seriously that the AFBCMR's decision was procedurally defective.

2. The filings in the two cases repeat verbatim many of the same legal arguments, and all of the key filings in the cases were filed around the same day. Compare Complaint, Sept. 2, 2011, No. 11–cv–1590 ( Martin ), ECF No. 1, with Complaint, Sept. 2, 2011, No. 11–cv–1589 ( Bates ), ECF No. 1; compare Def.'s Mot. to Dismiss, Feb. 3, 2012, No. 11–cv–1590 ( Martin ), ECF No. 4, with Def.'s Mot. to Dismiss, Jan 31, 2012, No. 11–cv–1589 ( Bates ), ECF No. 5; compare Pl.'s Opp'n to Def.'s Mot. to Dismiss, Apr. 16, 2012, No. 11–cv–1590 ( Martin ), ECF No. 7, with Pl.'s Opp'n to Def.'s Mot. to Dismiss, Apr. 16, 2012, No. 11–cv–1579 ( Bates ), ECF No. 8; compare Def.'s Reply, May 7, 2012, No. 11–cv–1590 ( Martin ), ECF No. 9, with Def.'s Reply, May 7, 2012, No. 11–cv–1590 ( Martin ), ECF No. 9.

The commonality of counsel does not mean Martin has any preclusive or res judicata effect in the present case. But it enhances the similarities between Martin and Bates. Not only do the two cases have virtually indistinguishable facts, Judge Walton considered many of the same legal arguments when he decided Martin.

Rempfer v. Sharfstein (2009)
Rempfer v. Sharfstein, 583 F.3d 860 (D.C. Cir., 2009)

583 F.3d 860

Thomas REMPFER, U.S. Air Force, et al., Appellants v. Joshua M. SHARFSTEIN, MD, acting Commissioner, Food and Drug Administration, et al., Appellees.

No. 08-5117.

United States Court of Appeals, District of Columbia Circuit.

Argued April 20, 2009.

Decided September 29, 2009. [583 F.3d 861]

Appeal from the United States District Court for the District of Columbia (No. 1:06-cv-02131-RMC).

John J. Michels Jr. argued the cause for appellants. With him on the briefs was Mark S. Zaid.

Melissa N. Patterson, Attorney, U.S. Department of Justice, argued the cause for appellees. With her on the brief were Michael F. Hertz, Acting Assistant Attorney General, Jeffrey A. Taylor, U.S. Attorney, and Mark B. Stern, Attorney. R. Craig Lawrence, Assistant U.S. Attorney, entered an appearance.

Before: HENDERSON, TATEL, and GARLAND, Circuit Judges.

Opinion for the Court filed by Circuit Judge GARLAND.

GARLAND, Circuit Judge:

Pursuant to the Department of Defense's Anthrax Vaccine Immunization Program, members of the armed forces may be ordered to submit to inoculation against anthrax disease. Eight servicemembers brought suit in district court to challenge the Food and Drug Administration's approval of the anthrax vaccine and to enjoin the Defense Department from administering it. The district court dismissed

[583 F.3d 862]

three counts of the complaint on the merits and dismissed a fourth count because the plaintiffs lack standing to make it. We affirm.

I Anthrax is an acute bacterial disease caused by infection with spores of Bacillus anthracis. It can be contracted through three routes of exposure: by skin contact (cutaneously), by inhalation, and by ingestion. From 1954-1959, a clinical study led by Dr. Philip Brachman tested an anthrax vaccine produced by the Department of Defense (DOD). See Philip S. Brachman et al., Field Evaluation of a Human Anthrax Vaccine, 52 AM. J. PUB. HEALTH 632 (1962) [hereinafter Brachman Study]. Dr. Brachman studied 1249 textile workers exposed to imported goat hair, dividing the population into a vaccine group, a placebo group, and an observational (no treatment) group. Id. at 634, 638.1 During the study, 26 cases of anthrax occurred: 21 contracted cutaneously and 5 by inhalation. Id. at 638. Three of the cutaneous cases occurred in the vaccine group; the remainder, and all inhalation cases, occurred in the placebo and observational groups. Id. The study calculated that the vaccine was 92.5 percent effective (lower 95 percent confidence limit = 65 percent). Id. at 644. The study noted, however, that the small number of inhalation cases "makes the data less significant in showing effectiveness of the vaccine" with respect to that "form of the disease." Id. at 643.

DOD subsequently contracted with Merck, Sharpe, & Dohme to develop a new version of the vaccine for large-scale production. See Food and Drug Administration (FDA), Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order, 70 Fed.Reg. 75,180, 75,192 (Dec. 19, 2005) [hereinafter 2005 Final Order]. Later, it entered into a similar contract with the Michigan Department of Public Health (MDPH), the relevant division of which is now operated by the BioPort Corporation. Id. at 75,181, 75,182, 75,192, 75,197. MDPH/BioPort produced and continues to produce the current generation of the vaccine, known as Anthrax Vaccine Adsorbed (AVA). Id. at 75,192.

Prior to 1972, the National Institutes of Health (NIH) was the agency responsible for the licensing of biological products. See 2005 Final Order, 70 Fed.Reg. at 75,181. In 1970, NIH issued a license for AVA. As labeled, the vaccine was to be administered in a six-shot sequence, with specified intervals between each inoculation. Id. at 75,184.

In 1972, responsibility for licensing biological products was transferred from NIH to the FDA. Id. at 75,181. The FDA

[583 F.3d 863]

then issued procedures for determining that products previously licensed by NIH "are safe, effective, and not misbranded." Procedures for Review of Safety, Effectiveness and Labeling, 38 Fed.Reg. 4319, 4321 (Feb. 13, 1973) (codified as amended at 21 C.F.R. § 601.25). Under those procedures, the FDA appoints an independent advisory panel to report on covered products. See 21 C.F.R. § 601.25(a), (e). After reviewing the panel's recommendations, the FDA makes its own determination, which it publishes as a proposed order along with the panel's report. See id. § 601.25(f). After receiving and reviewing comments, the FDA publishes a final order. See id. § 601.25(g).

In 1973, the FDA announced that advisory panels would review the safety and effectiveness of several vaccines previously licensed by NIH, including AVA. Biological Products; Bacterial Vaccines and Toxoids with Standards of Potency, Single or in Combination; Safety, Effectiveness and Labeling Review; Request for Data Information, 38 Fed.Reg. 5358 (Feb. 28, 1973). In 1980, an advisory panel submitted a report finding that the "best evidence for the efficacy of anthrax vaccine comes from [the] placebo-controlled field trial conducted by Brachman." Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed.Reg. 51,002, 51,058 (Dec. 13, 1985). Although the panel concluded that "inhalation anthrax occurred too infrequently [in the Brachman Study] to assess the protective effect of vaccine against this form of the disease," it recommended categorizing AVA as "safe and effective under the limited circumstances for which [it] is employed." Id. at 51,058, 51,059. In 1985, the FDA issued a proposed order classifying AVA as "safe and effective and not misbranded," id. at 51,104, but it did not issue a final order, see 2005 Final Order, 70 Fed.Reg. at 75,182.

In 1998, DOD implemented the Anthrax Vaccine Immunization Program (AVIP), which subjected members of the Armed Forces at risk of anthrax exposure to mandatory administration of AVA. See id. at 75,183. Thereafter, Congress directed DOD to support an independent examination of AVA by the Institute of Medicine of the National Academy of Sciences. Id.; see H.R.Rep. No. 106-371, at 256 (1999) (Conf.Rep.). A committee convened by the Institute conducted the study, examined "all available data," and concluded that, "[a]s indicated by evidence from studies in both humans and animals, ... AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax." COMM. TO ASSESS THE SAFETY AND EFFICACY OF THE ANTHRAX VACCINE, INSTITUTE OF MEDICINE, THE ANTHRAX VACCINE: IS IT SAFE? DOES IT WORK? 1-2 (2002) (J.A. 140-41) [hereinafter Institute of Medicine Report].

Meanwhile, in July 2000, a shortage of the vaccine resulted in a temporary suspension of DOD's vaccination program, causing servicemembers who had begun the six-dose regimen to miss scheduled shots. First Am. Compl. ¶¶ 58, 59, 61; Rempfer v. Von Eschenbach, 535 F.Supp.2d 99, 111 (D.D.C.2008). According to the plaintiffs, when the suspension ended in 2002, DOD announced that personnel whose vaccination series had been interrupted would not repeat any doses already received but would instead continue with the next dose in the series. First Am. Compl. ¶¶ 63-64.

Six servicemembers sought to enjoin the vaccination program in 2003. Doe v. Rumsfeld, 297 F.Supp.2d 119, 123, 130 (D.D.C.2003). Although they did not dispute that AVA had been approved as safe and effective against cutaneous anthrax, they argued that it was not a licensed

[583 F.3d 864]

vaccine for inhalational anthrax. Id. As a consequence, they maintained, 10 U.S.C. § 1107(f)(1) barred administration of the vaccine without either informed consent or a Presidential waiver.2

Finding a likelihood of success on this claim, the district court issued the requested preliminary injunction in December 2003. Doe, 297 F.Supp.2d at 135. Days later, the FDA finalized the order it had proposed in 1985, but revised it to specify that AVA was safe and effective "independent of the route of exposure." Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 69 Fed.Reg. 255, 260, 257-59 (Jan. 5, 2004). The district court vacated that order for failure to comply with the notice-and-comment requirements of the Administrative Procedure Act (APA), 5 U.S.C. § 553. Doe v. Rumsfeld, 341 F.Supp.2d 1 (D.D.C. 2004). The court then issued a permanent injunction — "unless and until FDA follows the correct procedures to certify AVA" as safe and effective — against "involuntary anthrax vaccinations absent informed consent or a Presidential waiver." Id. at 16. The government filed an appeal in this court.

In December 2004, the FDA issued a new proposed order for comment. Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 69 Fed.Reg. 78,281 (Dec. 29, 2004). After reviewing the comments, the FDA issued a new final order on December 19, 2005, again classifying AVA as safe and effective in the prevention of anthrax regardless of the route of exposure. 2005 Final Order, 70 Fed.Reg. 75,180. In February 2006, a panel of this court concluded that, because issuance of the new order caused the permanent injunction to dissolve "[b]y its own terms," the government's appeal was moot. Doe v. Rumsfeld, 172 Fed.Appx. 327, 328 (D.C.Cir.2006). In October 2006, DOD announced resumption of the mandatory immunization program. First Am. Compl. ¶ 48.

Thereafter, the plaintiffs in the case now before us — eight servicemembers subject to mandatory inoculation orders — initiated new proceedings in the district court challenging the FDA's 2005 final order. First Am. Compl. ¶¶ 1-8. They also sought to enjoin DOD from deviating from the recommended six-shot schedule for servicemembers whose vaccinations DOD had suspended between 2000 and 2002. The plaintiffs alleged that any such deviation would violate 10 U.S.C. § 1107(f)(1). Id. ¶¶ 102-12; see supra note 2. The district court resolved the only issue raised by the plaintiffs' three claims against the FDA — whether the agency's reliance on the Brachman Study to establish the vaccine's effectiveness against anthrax was arbitrary or capricious under the APA — in favor of the agency. Rempfer, 535 F.Supp.2d 99. It also dismissed the plaintiffs' claim against DOD for lack of standing based on the plaintiffs' failure to allege that they had been or would be subjected to off-schedule inoculations. Id.

We review the district court's APA ruling de novo, "as if the agency's decision

[583 F.3d 865]

`had been appealed to this court directly.'" Gerber v. Norton, 294 F.3d 173, 178 (D.C.Cir.2002) (quoting Dr. Pepper/Seven-Up Cos. v. FTC, 991 F.2d 859, 862 (D.C.Cir.1993)). We also review de novo the district court's dismissal of the claim against DOD for lack of standing. Muir v. Navy Fed. Credit Union, 529 F.3d 1100, 1105 (D.C.Cir.2008).

II The plaintiffs' principal challenge is to the FDA's determination that the anthrax vaccine is effective.3 More specifically, they fault the FDA's reliance on the Brachman Study in making that determination. They argue that reliance on that study was improper because: 1) it cannot support a finding of effectiveness against anthrax contracted by inhalation; and 2) it cannot support a finding of effectiveness for the current generation of the anthrax vaccine. The plaintiffs do not contest the vaccine's safety.

We will consider both arguments, but first pause to correct the plaintiffs' misperception regarding the nature of the district court's review, and of ours, under the APA. The plaintiffs repeatedly insist that the district court was obliged to deny the government's motion to dismiss because they had raised genuine issues of material fact and hence were entitled to discovery to flesh out their claims. But "when a party seeks review of agency action under the APA [before a district court], the district judge sits as an appellate tribunal." Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1083 (D.C.Cir. 2001). "The entire case on review is a question of law," and the "complaint, properly read, actually presents no factual allegations, but rather only arguments about the legal conclusion to be drawn about the agency action." Marshall County Health Care Auth. v. Shalala, 988 F.2d 1221, 1226 (D.C.Cir.1993).4 Consequently, challengers are "not ... ordinarily entitled to augment the agency's record with either discovery or testimony presented in the district court," and there is "no inherent barrier to reaching the merits" at the motion to dismiss stage. Id. Our review, like that of the district court, is based on the agency record and limited to determining whether the agency acted arbitrarily or capriciously. See 5 U.S.C. § 706.

A The plaintiffs first object that, because the Brachman Study included few cases of anthrax contracted by inhalation, it cannot support a conclusion of effectiveness against that route of exposure. We grant the plaintiffs' premise but disagree with their conclusion.

The FDA does not dispute that, if "the cases of inhalation anthrax reported in the course of the Brachman study [are] analyzed separately, [they] are too few to support a meaningful statistical conclusion." 2005 Final Order, 70 Fed.Reg. at 75,183. But this simply directs us to the

[583 F.3d 866]

underlying issue: should "inhalational anthrax" be analyzed separately? That question cannot, as appellants assume, be answered as an abstract question of statistical method. Rather, it must be answered as a matter of scientific judgment. To illustrate: if the route-of-exposure distinction were replaced with a time-of-exposure distinction, no one would insist that "morning anthrax" must be analyzed separately from "afternoon anthrax." Yet categorizing cases by time seems arbitrary not because time of exposure is any less measurable a distinction than route of exposure, but because time seems unlikely — as a scientific matter — to be relevant to vaccine effectiveness.

Of course, in comparison to time of exposure, it is not as self-evident that route of exposure is unlikely to be relevant. After all, Dr. Brachman did flag the route-of-exposure distinction half a century ago. Moreover, the FDA agrees that, as a general matter, "the route of exposure to an infectious agent may potentially have an impact on the effectiveness of a vaccine." Id. at 75,187.

But in the case of the anthrax vaccine, the FDA's scientific judgment is that route of exposure is not relevant to the vaccine's effectiveness. The reason, the agency explains, is as follows:

With regard to the known pathophysiology of anthrax, the signs and symptoms of disease arise due to the production of toxins by anthrax bacteria growing within the infected individual. The toxins produced by anthrax bacteria do not vary based on the route of exposure. The antibodies produced in response to vaccination contribute to the protection of the vaccinated individual by neutralizing the activities of those toxins. Thus, AVA elicits an antibody response to disrupt the cytotoxic effects of toxins produced by anthrax bacteria, regardless of the route of infection.

2005 Final Order, 70 Fed.Reg. at 75,187 (emphasis added). In other words, AVA responds to anthrax in the same way regardless of how the disease enters the body. Thus, for purposes of establishing AVA's effectiveness, the inhalational versus cutaneous distinction is one without a difference, and there is no need to treat them separately in interpreting the Brachman Study. This, the FDA explains, is why it disagrees with the 1980 advisory panel's statement that inhalation anthrax occurred too infrequently in the Brachman Study to provide a basis for assessing the efficacy of AVA against that form of the disease. Id. at 75,183; see 38 Fed.Reg. at 4321 (stating that "the report of each panel is advisory to the Commissioner, who has the final authority to accept or to reject the conclusions and recommendations of the panel").

As the FDA further notes, its judgment in this respect is in accord with the report of the committee of experts charged by the Institute of Medicine with conducting an independent review. 2005 Final Order, 70 Fed.Reg. at 75,183. The committee found that "laboratory experiments indicate that AVA provides effective protection against inhalational challenge in rabbits and macaques, the animal models in which the disease is most reflective of the disease in humans." Institute of Medicine Report, at 10. And the committee concluded that, "[a]s indicated by evidence from studies in both humans and animals, ... AVA, as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax." Id. at 2.5

[583 F.3d 867]

At bottom, the plaintiffs' claim that the Brachman Study establishes nothing in regard to "inhalational anthrax" relies on the proposition that route of exposure is scientifically relevant. But the FDA's contrary determination is a scientific judgment within its "area of expertise," the kind of judgment to which this court gives a "high level of deference." A.L. Pharma, Inc. v. Shalala, 62 F.3d 1484, 1490 (D.C.Cir.1995); see Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1320 (D.C.Cir. 1998). Moreover, as the plaintiffs themselves concede, there is no scientific evidence in the administrative record to contradict that judgment. See Oral Argument Recording at 35:03.6 In the absence of such evidence, we must defer to the FDA's judgment that AVA is effective regardless of the route of exposure.

B The plaintiffs' other principal contention is that, because the Brachman Study used an earlier generation of the anthrax vaccine, it cannot establish the effectiveness of the current version. We again grant the premise but reject the conclusion.

The fact that manufacturing changes occur during the course of vaccine production is not unique to AVA, and the FDA has an established protocol for analyzing such changes: "[A] manufacturer may make manufacturing changes in a product without performing additional clinical studies to demonstrate the safety and effectiveness of the similar product if data regarding the manufacturing changes support the conclusion that the versions are comparable." 2005 Final Order, 70 Fed.Reg. at 75,184. The plaintiffs maintain that "there is no evidence within the Administrative Record that the FDA ever compared the different anthrax vaccines and efficacy data to reach the conclusion that the vaccines are comparable." Appellants' Br. 43. But that is simply incorrect, because the FDA did make the requisite comparability determination.

As the FDA explained in its 2005 Final Order, it "reviewed the historical development of AVA and conclude[d] that DOD directed the development of the vaccine, including its formulation and manufacturing process, from the vaccine used in the Brachman study ... to the vaccine that was ultimately licensed and manufactured by BioPort." 2005 Final Order, 70 Fed. Reg. at 75,184. "All three versions of anthrax vaccine," the agency determined, "were tested in animals and demonstrated to protect test animals ... against challenge with virulent [anthrax] spores." Id. In addition, "clinical data comparing the safety and immunogenicity of [AVA] with [the DOD] vaccine ... reveal that the serological responses to [AVA] and [the

[583 F.3d 868]

DOD] vaccine were similar with respect to peak antibody response and seropositivity." Id. That is, human blood serum showed similar antibody production in response to the different versions of the vaccine. Id. at 75,184, 75,192-93. The FDA also found that the two versions were "comparable in their ability to protect test animals." Id. at 75,184. On this basis, the agency concluded that the two vaccines were comparable and that the Brachman Study could therefore be used to approve AVA. Id.

Once again, we are presented with a scientific judgment by the FDA to which we owe considerable deference. And once again, the plaintiffs fail to proffer any scientific evidence to rebut it. Our conclusion must therefore be the same as above: the FDA did not act arbitrarily or capriciously in resting a finding of effectiveness on the results of the Brachman Study.7

III Finally, we address the plaintiffs' claim that DOD is subjecting military personnel to mandatory immunization on an unapproved schedule of inoculations. The district court dismissed this claim on the ground that the plaintiffs lack standing to raise it. "To establish constitutional standing, a plaintiff must show an injury in fact that is fairly traceable to the challenged conduct and that will likely be redressed by a favorable decision on the merits." Muir, 529 F.3d at 1105 (citing Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992)). The district court concluded that the plaintiffs have not alleged the constitutionally requisite injury in fact, and we agree.

The plaintiffs' complaint alleges that DOD began its program of mandatory inoculation in 1998, suspended it for some period during 2000-02 due to a supply shortage, and then resumed the program without correcting for the interruption in the recommended six-shot dosage schedule. First Am. Compl. ¶¶ 10, 58-64. The plaintiffs do not allege that servicemembers who were or will be inoculated for the first time under the post-2002 regime will have their inoculations interrupted and restarted off schedule. Nor do they claim that DOD is otherwise stopping and restarting the shot sequences. Rather, they allege that "`[p]ersonnel whose vaccination series was interrupted during the p[re]vious AVIP slowdown .... will just continue with the next dose in the series.'" First Am. Compl. ¶ 63 (emphasis added) (quoting an Air Force statement).

As the district court noted, the plaintiffs have "not alleged that they themselves have been, or imminently will be, subjected to such [an interrupted] vaccination schedule." Rempfer, 535 F.Supp.2d at 111. The complaint does not allege that the inoculation sequence of any of the plaintiffs was actually interrupted by the 2000-02 AVIP suspension. Nor have the plaintiffs filed an affidavit to that effect. At oral argument, the plaintiffs insisted that they are under no obligation to make such an allegation. See Oral Argument Recording at 15:35-48.

The plaintiffs are wrong. "[I]t is the burden of the party who seeks the exercise of jurisdiction in his favor clearly

[583 F.3d 869]

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, 110 S.Ct. 596, 107 L.Ed.2d 603 (1990) (internal quotations and citations omitted). Thus, the plaintiffs "must `allege ... facts essential to show jurisdiction. If [they] fai[l] to make the necessary allegations, [they have] no standing.'" Id. (quoting McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 189, 56 S.Ct. 780, 80 L.Ed. 1135 (1936)) (alterations and omissions in original). Plaintiffs have failed to make the necessary allegation here, and they therefore lack standing to raise this challenge.

IV For the foregoing reasons, the judgment of the district court is

Affirmed.

---

Notes:

1. As the FDA explained: The Brachman Study's "selected population was at risk because the mill workers routinely handled anthrax-infected animal materials. Prior to vaccination, the yearly average number of human anthrax infections among workers in these mills was 1.2 cases per every 100 employees." Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order, 70 Fed.Reg. 75,180, 75,186 (Dec. 19, 2005). By the mid-1980s, this industrial setting was "vanishing, precluding any further clinical studies." Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review, 50 Fed.Reg. 51,002, 51,058 (Dec. 13, 1985). Today, "due to the significant health risks associated with exposure to anthrax spores, it would not be ethical to actively expose human study subjects to B. anthracis spores in order to assess the effectiveness of an anthrax vaccine in a controlled clinical trial. Furthermore, naturally occurring anthrax is now so rare that a field study of vaccine effectiveness is no longer feasible in the United States." 70 Fed.Reg. at 75,192.

2. The statute provides:

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 member's participation in a particular military operation, the requirement 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. The President may grant such a waiver only if the President determines, in writing, that obtaining consent is not in the interests of national security.

10 U.S.C. § 1107(f)(1).

3. "Effectiveness means 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).

4. See Am. Bioscience, 269 F.3d at 1083 (noting that, "when reviewing agency action[,] the question of whether the agency acted in an arbitrary and capricious manner is a legal one which the district court can resolve on the agency record, regardless of whether it is presented in the context of a motion for judgment on the pleadings or in a motion for summary judgment").

5. The FDA found additional support for the effectiveness of the vaccine in epidemiological data "on the occurrence of anthrax disease in at-risk industrial settings collected by the [Centers for Disease Control and Prevention] and summarized for the years 1962 to 1974." 2005 Final Order, 70 Fed.Reg. at 75,183. The FDA noted that unvaccinated persons within the at-risk populations had been infected by anthrax during that period, but that "no cases have occurred in fully vaccinated subjects while the risk of infection has continued." Id.

6. At oral argument, plaintiffs' counsel pointed to one piece of evidence purportedly contradicting the FDA's judgment — a declaration the plaintiffs filed in the district court. See J.A. 212. The declaration was not submitted to the FDA during the administrative proceedings and was not mentioned in the plaintiffs' appellate briefs. It is therefore outside the scope of our review on two accounts. See Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971) (holding that review is generally limited to the "record that was before the [agency] at the time [it] made [its] decision"); Ark Las Vegas Rest. Corp. v. NLRB, 334 F.3d 99, 108 n. 4 (D.C.Cir.2003) (holding that arguments raised for the first time at oral argument are waived).

7. Scattered throughout the plaintiffs' briefs are a number of additional arguments criticizing the Brachman Study. Because those arguments are raised "only summarily, without explanation or reasoning," they are waived. City of Waukesha v. EPA, 320 F.3d 228, 251 n. 22 (D.C.Cir.2003). In any event, we agree with the carefully considered opinion of the district court that those additional challenges lack merit. See Rempfer, 535 F.Supp.2d at 108-11.

---

Mazares v. Department of Navy (2002)
Mazares v. Department of Navy, 302 F.3d 1382 (Fed. Cir., 2002)

302 F.3d 1382

Joseph V. MAZARES, Jr., Petitioner, v. DEPARTMENT OF THE NAVY, Respondent. Michael R. Testman, Petitioner, v. Department of the Navy, Respondent.

No. 01-3337.

No. 01-3338.

United States Court of Appeals, Federal Circuit.

September 11, 2002. Sam S. Sheldon, Cozen O'Connor, of San Diego, CA, argued for petitioners.

Steven J. Abelson, Attorney, Commercial Litigation Branch, Civil Division, Department of Justice, of Washington, DC, argued for respondent. With him on the brief were Robert D. McCallum, Jr., Assistant Attorney General; David M. Cohen, Director; and Franklin E. White, Jr., Assistant Director. Of counsel on the brief was Charna J. Swedarsky, Associate Counsel for Litigation, Office of Counsel, Military Sealift Command, Department of the Navy, of Washington, DC. Of counsel was Sandra Patterson-Jackson, Office of Counsel, Military Sealift Command, Department of the Navy, of Virginia Beach, VA.

Before RADER, Circuit Judge, FRIEDMAN, Senior Circuit Judge, and GAJARSA, Circuit Judge.

FRIEDMAN, Senior Circuit Judge.

The Department of the Navy removed two civilian seamen it employed aboard a naval ship because they disobeyed an order to be vaccinated against anthrax. The Merit Systems Protection Board ("Board") upheld both removals. So do we.

I A. The facts found by the Board's administrative judge are not disputed.

The petitioners Mazares and Testman were employed by the Military Sealift

Page 1383

Command aboard the naval ship Kilauea. The crew was approximately eighty percent civilian mariners (known in Navy lexicon as CIVMARs) and twenty percent military personnel. The Kilauea carried ammunition, which it supplied to an aircraft carrier operating in the western Pacific Ocean.

The Kilauea was headed for a port in Korea, where it was scheduled to undergo a major overhaul. Because Korea was considered a high-risk area for biological weapons, the Commander of the Military Sealift Command ordered that all members of the crew, civilian and military, be vaccinated against anthrax.

The chief mate, who was the immediate supervisor of Mazares and Testman, ordered them to report to the Medical Services Officer to be vaccinated. He told them that if they had "questions" they should ask the Medical Officer. They refused to take the vaccination.

The next day they and the chief mate met with the captain. He stated that he was just carrying out his instructions in requiring the vaccination, and warned them that if they failed to take the vaccine, they would be charged with "violating an order." He stated they would meet again in one week.

During the next week the chief mate repeatedly urged them to take the vaccine, but they continued to refuse. At the end of the week, when they still refused, he told them he had "orders" from the captain to "sign [them] off the ship."

B. They were both then transferred from the ship and repatriated to California. The Navy then instituted removal proceedings against them.

In response to the notices of proposed removal, each of them admitted he had received the vaccination order and disobeyed it, but offered justifications for his conduct that, he asserted, entitled him to a medical waiver. (The Navy permits vaccination requirements to be waived for medical reasons.) Mazares stated that he suffered from asbestosis and had been exposed to Agent Orange during his military service in Vietnam. Testman stated that he previously had received the first two doses of the series required for anthrax vaccination, and that each time he had suffered headaches and body pains (he continued to work nevertheless).

The Navy cancelled the proposed removals and investigated Mazares's and Testman's claims. It concluded, however, that neither of them was entitled to a medical waiver of the vaccination requirement and, after full administrative proceedings, removed both of them "for failure to obey a direct order to receive mandatory injections of an anthrax immunization vaccine."

Mazares and Testman each appealed his removal to the Board. The same administrative judge heard both cases. In his initial decisions, which became final when the Board refused to review them, the administrative judge upheld the removals.

In detailed opinions, he held that the Navy had proved by preponderant evidence its charges that Mazares and Testman "willfully and intentionally refused the order of a superior officer." He rejected their contention that the order was unauthorized, finding that the Navy "had full authority to order the appellant[s] to submit to anthrax vaccination, and immediate vaccination became a requirement of the appellant's CIVMAR position when KILAUEA was ordered to land in Korea, which had been designated a high-threat area." He noted that their "subjective fear of vaccination was not sufficient to

Page 1384

excuse [their] failure to obey a direct order." The administrative judge "conclude[d] that the vaccination orders were lawful, and the agency had a right to have them obeyed."

Finally, the administrative judge upheld the penalty of removal. He concluded that the officer who selected the penalty "considered the relevant factors and exercised his discretion within tolerable limits of reasonableness. Under the circumstances, I cannot find that his choice of penalty was so excessive as to be an abuse of discretion, or that it exceeds the maximum reasonable penalty under the circumstances." (citations omitted).

II Mazares and Testman here challenge their removals on two grounds. They contend (A) that the order to receive the anthrax vaccine was unauthorized and therefore they could not be punished for disobeying it, and (B) that the penalty of removal was excessive.

A. Their challenge to the validity of the orders rests primarily upon a one-page March 30, 1999, memorandum from the Assistant Secretary of Defense to the Secretaries of the Army, Navy, and Air Force. The subject of the memorandum was "Change to Anthrax Vaccine Immunization Program (AVIP) Operation Procedure (One Day Policy) Schedule." They rely upon the first paragraph of the memorandum, which stated:

Effective immediately, the AVIP will be applied to all U.S. military personnel and Department of Defense (DoD) emergency essential civilian employees and contractor personnel assigned, deployed or on temporary duty in the high threat areas and contiguous waters of South-west Asia (Kuwait, Saudi Arabia, Bahrain, Jordan, Qatar, Oman, UAE, Yemen, and Israel) and the Korean Peninsula for any period of time. Prior to entry into the designated high threat areas these personnel must initiate vaccination against anthrax in accordance with the prescribed Immunization schedule. Ideally, personnel should receive at least the first three vaccinations in the series. In those rare circumstances when an Individual is not able to take or continue with the anthrax vaccination for medical or administrative reasons, they will be evaluated for deployability in accordance with Service criteria. Neither this policy nor the requirement to participate in AVIP is applicable to civilian employees or contractor personnel who are not designated as emergency essential.

Since it is conceded that Mazares and Testman have not been designated as "emergency essential" employees, they contend that the captain of the Kilauea had no authority to order them to receive the anthrax vaccine. They particularly stress the last section of the first paragraph, which states that "[n]either this policy nor the requirement to participate in AVIP is applicable to civilian employees or contractor personnel who are not designated as emergency essential."

As this court recently stated, although in a different context, "[a] `policy' is just that, however. It indicates the standards an agency generally will follow in conducting its operations. It is not, however, a black letter rule that the agency is required to follow in all cases without regard to the circumstances of the particular situation before it." Brehmer v. Fed. Aviation Admin., 294 F.3d 1344, 1348 (Fed.Cir.2002).

Page 1385

Those words are equally applicable to the present case.

The memorandum states the general policy the services are to follow in administering the anthrax vaccine to military and civilian personnel and the policy is inapplicable to non-"emergency essential" civilian employees. It does not, however, either explicitly or by necessary implication, prohibit anthrax vaccination of such civilian employees, i.e., those who are not designated "emergency essential." It states only that the Department's general policy providing for anthrax vaccination does not cover those employees.

There is ample authority in the appropriate Navy regulations and directives for the Navy 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. In a written policy that antedated the March 30, 1999, memorandum upon which Mazares and Testman rely, the Department of Defense provided for the immunization of personnel expected to enter certain "high-threat areas" — referring to areas "in the proximity of a nation or nations considered to pose a potential biological threat to DoD personnel by the Chairman of the Joint Chiefs of Staff in consultation with the Commanders of the Unified Commands and the Director, DIA." DoD Directive 6205.3, "DoD Immunization Program for Biological Warfare Defense" (Nov. 26, 1993). The Secretary of the Navy then issued an instruction that authorized immunization against biological threats for all "alert forces," including civilian mariners. The Department of the Navy also issued an instruction specifically relating to anthrax, which authorized mandatory vaccination for "Federal civilian employees and other groups having status equivalent to deployable forces serving under the auspices of the [Department of the Navy].... [I]n certain instances, anthrax immunization might be determined by the appropriate authority to be a condition of [civilian] employment."

Finally, the Commander of the Military Sealift Command issued an order dated October 14, 1999, that stated that "[t]he basic immunization series for deployable Naval Forces, including anthrax, is a requirement for all MSC CIVMARs unless medically waived." This order directed also that immunization was to begin immediately for those personnel "subject to deployment into high threat areas for any length of time." It was pursuant to this order, a copy of which was sent to the Kilauea, that the captain of that vessel ordered Mazares and Testman to be given the anthrax vaccination.

The military has broad authority and discretion in dealing with its personnel, both military and civilian, including the protection of their health. The Navy did not exceed its authority or otherwise abuse its discretion by ordering Mazares and Testman to undergo anthrax vaccination.

B. The penalty of removal was neither unauthorized nor excessive. The misconduct for which Mazares and Testman were removed was "failure to obey a direct order to receive mandatory injections of an anthrax immunization vaccine." That misconduct constituted insubordination, which this court defines as a "willful and intentional refusal to obey an authorized order of a superior officer which the officer is entitled to have obeyed." Bieber v. Dep't of the Army, 287 F.3d 1358, 1364 (Fed.Cir.2002).

Page 1386

Insubordination is a serious offense that disrupts the work place and interferes with and threatens the ability of the work force to perform its duties. Its adverse impact is particularly serious in the military, where prompt obedience to lawful orders is essential, especially aboard a ship. In this case, there was a clear and unjustified refusal to obey the lawful order of a superior. There can be no question that the removal of Mazares and Testman was "for such cause as will promote the efficiency of the service." 5 U.S.C. § 7513 (2000).

"Our statutory scope of review [of penalties] is narrow. Determination of an appropriate penalty is a matter committed primarily to the sound discretion of the employing agency." Connolly v. Dep't of Justice, 766 F.2d 507, 514 (Fed.Cir.1985) (citing Miguel v. Dep't of the Army, 727 F.2d 1081, 1083 (Fed.Cir.1984)). See also Brown v. Dep't of the Navy, 229 F.3d 1356 (Fed.Cir.2000). Unless the penalty is totally unwarranted or grossly disproportionate to the misconduct, we will not overturn it. See Mings v. Dep't of Justice, 813 F.2d 384, 390 (Fed.Cir.1987); Miguel v. Dep't of the Army, 727 F.2d 1081, 1083 (Fed.Cir.1984).

Here, as the Board noted, the agency considered all the relevant factors set forth in Douglas v. Veterans Admin., 5 MSPB 313, 5 M.S.P.R. 280 (1981), in deciding to remove Mazares and Testman. The agency "considered" the employees' fifteen and eleven years, respectively, of "honorable and dedicated service," their prior "naval status" and their "excellent evaluations." The deciding officer stated that although each of them had been an "outstanding" civilian mariner, he found that "there is no basis for your failure to receive mandatory injections of the anthrax immunization vaccine." He also explained: "I have lost confidence in your ability to perform at a satisfactory level due to your refusal to take the anthrax vaccine. Also, the nature of the offense causes me to question your reliability and weakens my confidence in your ability to carry out your duties ... during future missions where this vaccine is required."

The Board correctly determined that the agency-imposed penalty of removal did not "exceed[] the maximum reasonable penalty under the circumstances."

CONCLUSION The decision of the Board is AFFIRMED.