LeFevre v. Secretary, Dept. of Veterans Affairs, 94-7050

• Decision Date: 15 September 1995
• Docket Number: No. 94-7050,94-7050
• Parties: Jennie R. LEFEVRE, Sally M. Hill, Frederick L. Rada and Mary Christina Veldman, Petitioners, v. SECRETARY, DEPARTMENT OF VETERANS AFFAIRS, Respondent. Federal Circuit
• Court: U.S. Court of Appeals — Federal Circuit

Page 1191

66 F.3d 1191

Jennie R. LEFEVRE, Sally M. Hill, Frederick L. Rada and Mary

Christina Veldman, Petitioners, v. SECRETARY, DEPARTMENT OF VETERANS AFFAIRS, Respondent.

No. 94-7050.

United States Court of Appeals,

Federal Circuit.

Sept. 15, 1995.

Rehearing Denied Oct. 13, 1995.

Frank W. Hunger, Assistant Attorney General, Department of Justice, Washington, DC, Henry A. Azar, Jr., Department of Justice, Civil Division, Washington, DC, argued, for respondent. With him on the brief was Theodore C. Hirt. Of counsel was David J. Barrans, Staff Attorney and Richard J. Hipolit, Deputy Assistant General Counsel, Department of Veterans Affairs, Washington, DC.

Gershon M. Ratner, National Veterans Legal Services Project, Washington, DC, argued for petitioners.

Before RICH and MICHEL, Circuit Judges, and FRIEDMAN, Senior Circuit Judge.

FRIEDMAN, Senior Circuit Judge.

The issue on the merits is the validity of the determination of the Secretary of Veterans Affairs, pursuant to the Agent Orange Act of 1991, 38 U.S.C. Sec. 1116 (Supp.V.1993) (the 1991 Act), not to create a presumption that prostate cancer, liver cancer, and nose cancer are connected to exposure to herbicides in Vietnam, which would be applied in determining eligibility for disability and survivor's benefits. The Secretary contends that under the 1991 Act we do not have jurisdiction to review his determination. We hold that we have jurisdiction, and affirm his determination.

I.

A. In 1984, Congress recognized that it would be virtually impossible to determine on a case-by-case basis whether exposure to herbicides in Vietnam caused a disease in a particular veteran. 130 Cong.Rec. 13,159 (remarks of Senator Simpson). It therefore decided to require the Secretary to create or reject a presumption-of-service connection for particular diseases, based upon the statistical probability of such connection, as reflected in scientific studies of the relationship between those diseases and exposure to herbicides and the incidence of those diseases in persons and animals subject to herbicide exposure. Id. at 13,157-59; See Veterans' Dioxin and Radiation Exposure Compensation Act of 1984, Pub.L. No. 98-542, 98 Stat. 2725 (1984 Act).

By 1991 Congress had concluded that the Secretary's administration of the 1984 Act had created doubt about the way the Act was being applied. A Senate Committee report on the 1991 Act stated:

A number of reviews of the scientific literature on the effects of exposure to dioxin have been carried out under contract with VA and published by VA pursuant to the mandate in [the 1984 Act].... General acceptance of these reviews has been impaired because of concern that VA may have exerted influence on their content. Although the Committee does not share such a concern, it nevertheless recognizes that the perception of a possibility of some taint does exist and cannot be dismissed out of hand. Other than these reviews, the Committee is unaware of any other unified analysis of the results obtained from studies on the effects of dioxin exposure or of any up-to-date analysis.

S.Rep. No. 101-82, 101st Cong., 1st Sess. 41 (1989).

Congress therefore enacted the 1991 Act to provide

a review, by an entity completely independent of VA, that will yield unified compilation and analysis of the results from the various scientific studies.

In order to accomplish this result, the Committee bill would provide for an independent contract scientific organization--the National Academy of Sciences unless NAS is unwilling to undertake this effort--to undertake a comprehensive review and evaluation of all of the scientific evidence, literature, and studies--including the Selected Cancers (SC) Study being carried out by CDC--pertaining to the adverse health effects in humans or other animals of exposure to dioxin and other substances in herbicides used in Vietnam.

Id. at 42.

The 1991 Act directed the Secretary to seek to enter into an agreement with the National Academy of Science (the Academy or NAS), an independent non-profit, non-governmental scientific organization, under which the Academy would "review and summarize the scientific evidence and assess the strength thereof, concerning the association between exposure to an herbicide used in support of military operations in Vietnam," and "each disease suspected to be associated with such exposure." 38 U.S.C. Sec. 1116, Note, Sec. 3(c). The agreement was to require the Academy to transmit to the Secretary written reports over ten years, the first within 18 months and the remaining ones at least every two years. Id., Note Sec. 3(g)(1).

Under the 1991 Act the Academy is directed, "[f]or each disease reviewed," to

determine (to the extent that available scientific data permit meaningful determinations)--

(A) whether a statistical association with herbicide exposure exists, taking into account the strength of the scientific evidence and the appropriateness of the statistical and epidemiological methods used to detect the association;

(B) the increased risk of the disease among those exposed to herbicides during service in the Republic of Vietnam during the Vietnam era; and

(C) whether there exists a plausible biological mechanism or other evidence of a causal relationship between herbicide exposure and the disease.

(2) the Academy shall include in its reports under subsection (g) a full discussion of the scientific evidence and reasoning that led to its conclusions under this subsection.

Id., Note Sec. 3(d).

Within 60 days of receiving the Academy's report, the Secretary is to determine whether a "positive association existed between (A) the exposure of humans to an herbicide agent, and (B) the occurrence of a disease in humans...." 38 U.S.C. Sec. 1116(b)(1). There is such a positive association "if the credible evidence for the association is equal to or outweighs the credible evidence against the association." 38 U.S.C. Sec. 1116(b)(3). If the Secretary determines, "on the basis of sound medical and scientific evidence," that such positive association exists, he is required to establish a presumption of service connection for the disease. 38 U.S.C. Sec. 1116(b)(1).

In making his determinations, the Secretary is required to "take into account" the Academy's report and "all other sound medical and scientific information and analysis available to the Secretary." 38 U.S.C. Sec. 1116(b)(2). "In evaluating any study for the purpose of making such determinations, the Secretary shall take into consideration whether the results are statistically significant, are capable of replication, and withstand peer review." Id.

B. Pursuant to its agreement with the Secretary, the Academy conducted an extensive investigation in which it "review[ed] and summarize[d] the strength of the scientific evidence concerning the association between herbicide exposure during Vietnam service and each disease or condition suspected to be associated with such exposure." The result was a 764 page Report, which exhaustively reviewed the scientific evidence regarding the association between exposure to herbicides and various diseases. The Academy made no new studies, but reviewed existing evidence including various epidemiological studies and studies of biologic plausibility. The latter is biological evidence, usually from animal testing, that a particular agent is associated with a particular disease. The Report was based on the Academy's review of more than 6000 abstracts of scientific or medical articles, approximately 230 of which were given detailed analysis.

The Academy summarized the extent of the evidence of association between herbicide exposure and 31 specific health problems by placing each disease in one of four categories. The first category, diseases for which the scientific evidence constituted "Sufficient Evidence of an Association" "Between Specific Health Problems and Exposure to Herbicides," contained five diseases, none of which is at issue in this case. The second category was:

Limited/Suggestive Evidence of an Association: Evidence is suggestive of an association between herbicides and the outcome but is limited because chance, bias, and confounding could not be ruled out with confidence. For example, at least one high-quality study shows a positive association, but the results of other studies are inconsistent.

The Report placed three types of cancer in this category, one of which, prostate cancer, is at issue here.

The third category was:

Inadequate/Insufficient Evidence to Determine Whether an Association Exists: The available studies are insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of an association. For example, studies fail to control for confounding, have inadequate exposure assessment, or fail to address latency.

The Report placed 20 diseases in this category. Two of them--hepatobiliary (liver) and nasal/nasopharyngeal (nose) cancer--are at issue here.

The fourth category, "Limited/Suggested Evidence of No Association," contains 4 types of cancer. None of these is here involved.

The Report noted that the Academy "was charged with reviewing the scientific evidence, rather than making recommendations regarding DVA policy, and [placement of the diseases in categories] is not intended to imply or suggest any policy decisions, which must rest with the Secretary."

The Report also considered separately whether exposure to herbicides increased risk for Vietnam veterans for each of the diseases. It concluded that "it is not possible for the Academy to quantify the degree of risk likely to have been experienced by Vietnam veterans because of their exposure to herbicides in Vietnam," "[g]iven the large uncertainties that remain about the magnitude of potential risk from exposure to herbicides in the occupational, environmental, and veterans studies that have been reviewed, inadequate control for important confounders in these studies,...