Rempfer v. Sharfstein

• Decision Date: 29 September 2009
• Docket Number: No. 08-5117.,08-5117.
• Citation: 583 F.3d 860
• Parties: Thomas REMPFER, U.S. Air Force, et al., Appellants v. Joshua M. SHARFSTEIN, MD, acting Commissioner, Food and Drug Administration, et al., Appellees.
• Court: U.S. Court of Appeals — District of Columbia Circuit

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.

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 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 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 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...