Doe v. Shalala

862 F. Supp. 1421, 1994 WL 525897
CourtDistrict Court, D. Maryland
DecidedSeptember 26, 1994
DocketCiv. PJM 94-1703
StatusPublished
Cited by7 cases

This text of 862 F. Supp. 1421 (Doe v. Shalala) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Doe v. Shalala, 862 F. Supp. 1421, 1994 WL 525897 (D. Md. 1994).

Opinion

OPINION

MESSITTE, District Judge.

I.

Plaintiffs in this suit seek to enjoin the activity of the National Institutes' of Health (NIH) Human Embryo Research Panel (Panel) on the grounds that the membership of the Panel is not “fairly balanced” within the meaning of the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2, § 5(b)(2) and on the further grounds that Section 101 of the NIH Revitalization Act of 1993 (Revitalization Act), 42 U.S.C. § 289a-l, violates the U.S. Constitution. More immediately, their objective is to prevent the Panel from holding any meetings or making any recommendations to NIH or the Secretary of Health and Human Services with regard to the issue of human fetal research. The matter comes before the Court in the form of a Motion for Preliminary Injunction, anticipating the imminent publication by the Panel of its report and recommendations.

The Court holds that Plaintiffs lack standing to litigate these claims and, particularly insofar as the claims are based on the Federal Advisory Committee Act, that the matter is non-justiciable. Accordingly, the Court finds no need to engage in the usual preliminary injunction analysis and will proceed directly to dismiss Plaintiffs’ suit. 1

II.

Would-be Plaintiff Mary Doe is an unnamed baby girl who, according to the Amended Complaint, is “a pre-born child in being as a human embryo.” She is allegedly one of more than 20,000 such embryos ex útero located in various in vitro laboratories within the United States. Plaintiff International Foundation for Genetic Research (The Michael Fund) is a non-profit organization whose primary purpose is to sponsor research involving the genetic disorder known as Down’s Syndrome and similar inborn chromosomal disorders. Plaintiff Michael *1424 Policastro, after whom The Michael Fund was named, is 24 years of age and suffers from Down’s Syndrome. Defendants, in addition to the Secretary of U.S. Department of Health and Human Services and NIH, are the Department of Health and Human Services, the Director of NIH individually, the NIH Human Embryo Research Panel and the individual members of the Panel.

The Panel whose activities are challenged in this proceeding came into existence following the enactment of the NIH Revitalization Act of 1993, P.L. No. 103-43, codified at 42 U.S.C. § 281 et seq. Consideration of pertinent provisions of the Act will illuminate the nature of the litigation.

Under the Act, the Secretary of HHS may not withhold federal funds for clinical research “because of ethical considerations” unless she first convenes an ethics advisory board (EAB) which, in accordance with certain prescribed procedures, studies such considerations, and either (1) recommends, by majority vote, because of ethical considerations, that the Secretary withhold funds for their proposed research or (2) recommends, by majority vote, because of ethical considerations, that the Secretary not withhold funds for the proposed research, but the Secretary finds the recommendation to be arbitrary and capricious. See 42 U.S.C. § 289a-l(b). This law amended existing federal regulations governing research on human embryos, which required such research to be reviewed by an EAB before such research might proceed. See 45 C.F.R. § 46.204(d). Because prior presidential administrations apparently chose not to appoint an EAB, no funding for such research had in fact been approved. What the new law did was to reverse the conditions for in vitro fertilization research: it could go forward unless disapproved. Previously it could not go forward unless approved.

Nothing in the new law appears to require the Secretary of HHS to appoint an EAB. 2 The law merely sets forth the procedures the Secretary must follow if and when she chooses to convene an EAB: Under the Act, she must first publish a statement in the Federal Register announcing her intention to convene the board, which must include a request that interested individuals submit recommendations “specifying the particular individuals who should be appointed to the advisory board involved.” The Secretary must then consider these recommendations in making appointments to the EAB. See 42 U.S.C. § 289a-l(b)(4)(A) and (B). The EAB must be composed of no fewer than 14 nor more than 20 members “who are not officers or employees of the United States” and who are “individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research.” It must also be composed of at least one attorney, one ethicist, one practicing physician, one theologian, and no fewer than & but 1 no more than X of “scientists with substantial accomplishments in biomedical or behavioral research.” 42 U.S.C. § 289.a-l(b)(5)(C). An appointed member serves “for the life of the board” and can only be removed by the Secretary “for neglect of duty or malfeasancé or for other good cause shown.” 42 U.S.C. § 289a-1(b)(5)(D) and (E).

Not later than 180 days after an EAB is convened, it is required to submit to the Secretary and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the United States Senate a report describing its findings regarding the proposed research project or projects and making recommendations as to whether the Secretary should or should not withhold funds for such project or projects on ethical grounds. 42 U.S.C. § 289a-l(b)(5)(B)(ii).

With the passage of the Revitalization Act, NIH in fact received a number of appliea *1425 tions seeking financial support of research involving human embryos. During the fall of 1993, therefore, Secretary Shalala, acting pursuant to the law, decided to convene and appoint an EAB, to be known as the NIH Human Embryo Research Panel. 3 The Panel was charged by the Secretary with addressing the moral and ethical issues raised by the use of human embryos in research and with developing “guidelines” as to which areas of research involving human embryos would be acceptable for funding, which would require additional review, and which would be unacceptable for federal support.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Physicians For Social Responsibility v. Wheeler
359 F. Supp. 3d 27 (D.C. Circuit, 2019)
Doe v. Obama
670 F. Supp. 2d 435 (D. Maryland, 2009)
Sherley v. Sebelius
District of Columbia, 2009
Center for Law & Education v. United States Department of Education
209 F. Supp. 2d 102 (District of Columbia, 2002)

Cite This Page — Counsel Stack

Bluebook (online)
862 F. Supp. 1421, 1994 WL 525897, Counsel Stack Legal Research, https://law.counselstack.com/opinion/doe-v-shalala-mdd-1994.