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Rempfer v. Eschenbach

February 29, 2008


The opinion of the court was delivered by: Rosemary M. Collyer United States District Judge


Plaintiffs*fn1 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)*fn2 (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 not misbranded,*fn3 and (2) the DoD's decision to reinstate mandatory AVA inoculations. Plaintiffs do not contend that 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.


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).*fn4 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,*fn5 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.*fn6 The NIH-approved package insert recommended 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 be 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.*fn7

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.*fn8 See 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 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.*fn9

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. A.R. 3303-583 (04 AR, Vol. 12). The IOM Committee*fn10 sought, 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 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 (lower 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 ...

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