54 F.3d 789 (D.C. Cir. 1995), 93-5404, American Legion v. Derwinski
|Docket Nº:||93-5404, 94-5013.|
|Citation:||54 F.3d 789|
|Party Name:||The AMERICAN LEGION, Appellant, v. Edward DERWINSKI, Secretary, Department of Veterans Affairs; Donna E. Shalala, Secretary, Department of Health and Human Services; William L. Roper, M.D., Director, Centers for Disease Control; Vernon N. Houk, Director, Center for Environmental Health and Injury Control Center; United States of America, Appellees.|
|Case Date:||April 25, 1995|
|Court:||United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit|
[Copyrighted Material Omitted]
Argued Feb. 2, 1995.
Gershon M. Ratner argued the cause for appellants. With him on briefs were Mark A. Venuti and Ron Simon. Barton F. Stichman entered an appearance for appellants.
Jonathan R. Siegel, U.S. Dept. of Justice, argued the cause for appellees. With him on brief were Frank W. Hunger, Asst. Atty. Gen., Eric H. Holder, Jr., U.S. Atty., and Robert S. Greenspan, U.S. Dept. of Justice.
Before: EDWARDS, Chief Judge, and RANDOLPH and ROGERS, Circuit Judges.
Opinion for the court filed by Circuit Judge ROGERS.
ROGERS, Circuit Judge:
The American Legion and others appeal from the grant of summary judgment rejecting their challenge to the decision of the Secretary of Veterans Affairs to abandon a congressionally mandated epidemiological study of the effects of exposure to dioxin, a by-product of Agent Orange and other herbicides, on Vietnam veterans. 1 The district court ruled that the Secretary had acted within his discretion in abandoning the Agent Orange Study, which the Secretary had commissioned the Centers for Disease Control to design and conduct, after determining that sampling problems made it unlikely that the investigation would yield scientifically valid results. American Legion v. Derwinski, 827 F.Supp. 805, 812-14 (D.D.C.1993). Appellants contend that the Secretary erroneously relied on a repealed standard as the basis for abandoning the study and violated the statute by halting the study before submitting a mandated report of health results to Congress; alternatively, they challenge as arbitrary and capricious the Secretary's conclusion that a scientifically valid study was impossible. Finding these contentions unpersuasive, we affirm.
As background to appellants' contentions, we first outline the statute and the Secretary's efforts to implement the statutory directive for an epidemiological study on the effects of exposure to dioxins during the Vietnam conflict.
A. The Statute. In enacting the Veterans' Health Programs Extension and Improvement Act of 1979, Pub.L. No. 96-151,
93 Stat. 1092 (codified as amended at 38 U.S.C. Sec. 219 note (1988)), reprinted as amended in 38 U.S.C.A. Sec. 527 note (1991) (the "1979 Act"), Congress sought to determine by means of an epidemiological study the health effects of exposure to Agent Orange and other herbicides on Vietnam veterans. 2 Id. Sec. 307; see also S.REP. NO. 260, 96th Cong., 1st Sess. 36-40 (1979) ("1979 S.REP."), reprinted in relevant part in 1979 U.S.C.C.A.N. 1894, 1922-1926. These herbicides, which the United States military used during the Vietnam conflict, contain varying amounts of dioxins--also referred to as TCDD 3--which studies have suggested can cause harmful health effects in laboratory animals and consequently led to concern about similar effects in humans. 4 Congress sought to determine whether Vietnam veterans had suffered such adverse health effects as a result of their military service and, if so, to compensate them for their injuries. See 1979 S.REP. at 38-40.
The 1979 Act directed the Secretary to conduct an epidemiological study pursuant to a protocol approved by the director of the congressional Office of Technology Assessment ("OTA"). 1979 Act Sec. 307(a)(2)(A)(i). The statute also required the director of OTA to oversee the conduct of the study and report its oversight activities to the appropriate congressional committees. Id. Sec. 307(a)(2). Further, as part of the effort to ensure that the study was "scientifically valid and ... conducted with efficiency and objectivity," the 1979 Act directed the President to coordinate the Secretary's study with any other Federal governmental studies on the effects of dioxins. Id. Sec. 307(c). The 1979 Act expressly required, however, that the Secretary continue the study only "for as long after the submission of [his first] report [to Congress on 'the results thus far obtained under the study'] ... as the [Secretary] may determine reasonable in light of the possibility of developing through such study significant new information on the long-term adverse health effects of exposure to dioxins." Id. Sec. 307(a)(3), (b)(2).
The 1979 Act initially called for an epidemiological study of veterans who "were exposed to" dioxins during the Vietnam conflict. Id. Sec. 307(a)(1) (amended 1981). From the outset, a major obstacle to completion of the study was the identification of veterans, other than "Ranch Hands" who did the actual spraying, who had been exposed to Agent Orange during their service in Vietnam. S.REP. NO. 89, 97th Cong., 1st Sess. 25 (1981) ("1981 S.REP."). To address this problem, Congress amended the statute in 1981 to require a study of veterans' health effects that "may result" from exposure to dioxins. Veterans' Health Care, Training, and Small Business Loan Act of 1981, Pub.L. 97-72 Sec. 401(a)(1), 95 Stat. 1061 (1981) (codified at 38 U.S.C. Sec. 219 note (1988)), reprinted in 38 U.S.C.A. Sec. 527 note ("1981 Amendments"). The 1981 Amendments also expanded the scope of the study to examine health effects that may have resulted from other factors in the overall Vietnam experience, "including exposure to other herbicides, chemicals, medications, or environmental hazards or conditions." Id. According to the Senate Report, the amendments were intended to "allow the Secretary to begin the study of the health status of these veterans by identifying a population of veterans who served in Vietnam, without first having to determine whether each was, without question, exposed to Agent Orange in Vietnam." 1981 S.REP. at 26.
B. The Health Study Protocol and Pilot Study. Following enactment of the 1981 Amendments, the Secretary entered into a contract with the Centers for Disease Control ("the Center") to design a protocol for the epidemiological investigation. The Center's
Health Study Protocol, completed in November 1983, proposed three studies to evaluate the health of Vietnam veterans, one of which was the "Agent Orange" Study, designed to examine the effects of exposure to Agent Orange and other herbicides on veterans' health. See United States Department of Health and Human Services, Public Health Service, Centers for Disease Control, Protocol for Epidemiologic Studies of the Health of Vietnam Veterans (November 1983) at 1, 6-9 ("Health Study Protocol"). 5 To isolate the effects of dioxin exposure, the Center needed to distinguish between groups of Vietnam veterans who were similar except for their level of dioxin exposure. See supra n. 2. The Health Study Protocol proposed to use military records to divide a sample of Vietnam veterans into those who were likely exposed to herbicides in Vietnam and those likely not exposed and then to compare the health of the two cohorts. Health Study Protocol at 6-7, 10-15. The Center planned to review battalion journal files and morning reports to locate companies at various times during the Vietnam conflict and to determine the presence or absence of individuals within the company. Utilizing herbicide usage reports such as aircraft spraying records to estimate the location and timing of herbicide applications, the Center planned to fit veterans into the "likely exposed" or "likely not exposed" cohort "according to the measure of their company's distance in time and space from any herbicide applications." Id. at 6. To measure the possible health effects of dioxins, the Center would then compare the medical histories of "likely exposed" and "likely not exposed" veterans based on review of mortality records, health interviews, medical examinations, and laboratory tests. Id. at 20-25.
The Health Study Protocol cautioned that certain "obstacles" prevented the Center from adopting the "ideal" design for an Agent Orange cohort study, which would have compared one group free from all exposure to another group subjected to "meaningful" exposure to herbicides. These obstacles included the difficulty of defining "meaningful exposure" and the uncertainty about whether exposed veterans were comparable to unexposed veterans in other characteristics that might affect health. Most significant for purposes of these appeals, the Protocol noted that the "uneven quality" of the military records, including gaps in company records and errors in herbicide usage records, meant that "the categorization of individuals with respect to their potential for herbicide exposure will be uncertain and will forever remain so." Id. at 6. The Health Study Protocol concluded that "[s]ince many of the proposed procedures are untested, modification, indeed even a recommendation not to proceed with an Agent Orange Study, may be required...." Id. at 11.
The Center's initial review, conducted from 1983 to 1986, confirmed its concern that inadequacies in the military documentation would likely make...
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