Sherley v. Sebelius
776 F. Supp. 2d 1
D.D.C.2011Background
- Plaintiffs allege NIH Guidelines for Human Stem Cell Research violate the Dickey-Wicker Amendment and were enacted in violation of the APA.
- District Court previously dismissed for lack of standing; the D.C. Circuit reversed on standing and reinstated the preliminary injunction, which the Circuit later vacated on appeal.
- Guidelines authorize NIH funding for embryonic stem cell research despite Dickey-Wicker’s prohibition on funding for embryos being destroyed; dispute centers on the meaning of 'research' and what constitutes 'in which' embryos are destroyed or subjected to risk.
- Presidential policy shifts: Bush (2001) restricted funding to existing lines; Obama (2009) Executive Order directed NIH to fund embryonic stem cell research consistent with law and to issue new guidelines.
- NIH final Guidelines issued July 7, 2009 with donor informed consent and embryo-source restrictions; the agency maintained that embryonic stem cell research does not involve embryos or destroy embryos, justifying funding under Dickey-Wicker.
- On remand, the Court analyzes standing and the Dickey-Wicker claims under Chevron deference, and concludes for defendants on summary judgment after considering APA arguments.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing | Sherley and Deisher have an actual ongoing injury from increased competition for NIH funds. | Plaintiffs fail to show concrete injury or active competition impact. | Plaintiffs have Article III standing. |
| Dickey-Wicker: is embryonic stem cell research 'research in which a human embryo is destroyed'? | Any funding of embryonic stem cell research falls within the prohibition as the research participates in the destruction of embryos. | NIH interprets 'research' narrowly; embryonic stem cell research does not involve embryos or destruction. | NIH interpretation is permissible; funding Embryonic stem cell research is not barred. |
| Dickey-Wicker: is embryonic stem cell research 'research in which embryos are knowingly subjected to risk of injury or death'? | Funding any embryonic research that risks embryos contradicts the 'knowingly subjected' clause. | The 'in which' construction limits to research involving embryos; derivation or future risk not within the research. | NIH interpretation is permissible; not barred by the risk language. |
| Chevron deference to NIH interpretation | NIH has not provided a clear, authoritative interpretation warranting deference. | NIH’s interpretation is reasonable and implicit in the Guidelines; court should defer. | NIH interpretation entitled to Chevron deference; consistent with the statute. |
| APA notice-and-comment compliance | NIH ignored significant public comments opposing embryonic stem cell funding. | Executive Order 13,505 directed guidelines; comments opposing funding would conflict with law; procedural compliance satisfied. | APA claims fail; NIH reasonably construed and followed the order and rulemaking requirements. |
Key Cases Cited
- Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011) (ambiguous 'research' term; deference to NIH interpretation; standing framework)
- Sherley v. Sebelius, 610 F.3d 69 (D.C. Cir. 2010) (competitor standing: increased competition injures plaintiffs now)
- Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (U.S. 1984) (two-step deferential framework for agency interpretations)
- University of Texas v. Camenisch, 451 U.S. 390 (U.S. 1981) (law-of-the-case/mandate considerations; context of preliminary rulings)
- La. Energy & Power Auth. v. FERC, 141 F.3d 364 (D.C. Cir. 1998) (competitor standing; injury in fact from increased competition)