quarta-feira, 15 de setembro de 2010

A Legal Review of Sherley v. Sebelius and Obama's Embryonic Stem Cell Research Policy


by Margaret Datiles, Esq., Associate Fellow in Law

In Culture of Life Foundation

I. Introduction

In his August 24, 2010 order in
Sherley v. Sebelius [1], U.S. district court Judge Royce Lamberth declared that the Obama Administration’s new embryonic stem cell research policy is illegal because it violates the plain language and intent of the Dickey-Wicker Amendment. For a short time, all federally-funded embryonic stem cell (ESCR) research was halted.

With the
Sherley v. Sebelius case pending, a possible appeal on the horizon, and congressmen introducing legislation to override Dickey before the November elections, the existence of a ban on the use of federal funds for destructive ESCR appears to hang upon a thread. However, the solid legal reasoning behind Judge Lamberth’s preliminary injunction, the overall public opposition to taxpayer funded ESCR, and other factors may indicate the opposite.

This article will discuss the district court’s interpretation of the Dickey-Wicker Amendment and other issues affecting the political landscape for ESCR research funding. Let us begin with a brief summary of important dates and events relevant to the current legal situation:

II. Legal Timeline for Embryonic Stem Cell Research

- December 2, 1994: President Bill Clinton announces that federal funding should not be allocated to destructive ESCR.
- January 26, 1996: Congress enacts the Dickey-Wicker Amendment [2], which prohibits the use of federal funds for research involving the creation, destruction or endangerment of human embryos.
- August 9, 2001: President George W. Bush announces his policy prohibiting the use of federal funds for research on human embryonic stem cell lines derived after August 9, 2001 [3]. The policy was subsequently formalized via executive order [4].
- March 9, 2009: President Obama overturns Bush’s restrictions by executive order by allowing the National Institutes of Health (NIH) to conduct federally-funded ESCR and by mandating NIH to implement new policy guidelines for stem cell research, including ESCR [5].
- Fiscal Years 2009 and 2010: Approximately $143 million and $137 million in federal funds were appropriated by NIH for embryonic stem cell research.
- August 23, 2010: U.S. District Court of the District of Columbia issues a preliminary injunction against Obama’s new stem cell policy because it violates the Dickey-Wicker Amendment, thereby putting a hold on all federal funding for ESCR and stopping all current research projects.
- September 9, 2010: U.S. Court of Appeals for the District of Columbia lifts the preliminary injunction until Monday, September 20th , 2010. Until then, federally-funded ESCR may resume. On September 20th, the Court will decide if the injunction will be reinstated. Argument briefs for both parties are also due on that day.

III. The U.S. District Court’s Interpretation of the Dickey-Wicker Amendment

The Dickey-Wicker Amendment states that the use of federal funds is prohibited for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero” under applicable law [6].

The Obama Administration sought to skirt around the provisions of the Dickey-Wicker Amendment by arguing that the destruction of a human embryo takes place prior to the research, and therefore the research “does not involve nor result in an embryo’s destruction.” [7]

In court, the Obama Administration argued that the term “research” in Dickey is ambiguous. It insisted that the meaning of the term “research” is so vague that the congressional intent of Dickey is unclear. The argument was that in this situation deference should be given to NIH’s interpretation of the statute – that is, that the prohibited “research” does not refer to the all of the steps and developments of a particular investigation, but rather refers only to the “piece of research” where the embryo is destroyed.

Judge Lamberth held this distinction meaningless. He found that the definition of the term “research” is not vague, that the congressional intent of Dickey is evident, and therefore the NIH Stem Cell Guidelines’ definition of “research” as a “piece of research” is not to be applied.

Lamberth agreed with the Plaintiffs’ argument that the plain meaning of the statute is to be followed. The “plain meaning” rule is a legal doctrine which provides that laws must be interpreted according to the ordinary, literal meaning of its terms, unless the statute explicitly provides otherwise. [8]

The Court noted that the Health and Human Services research laws on “Protection of Human Subjects” [9] defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (emphasis added). As this common definition of research is supported by the language of the statute, the Court concluded that this definition (and not NIH’s definition of research as “a piece of research”) is to be applied.

If Congress had wanted to prohibit funding only for the step of research where the embryo is destroyed, it would have written the statute that way. But since it did not, “the language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed” (emphasis added).

In particular, the Court clarified that “ESC research necessarily depends upon the destruction of a human embryo.” The destruction of an embryo “is an integral step in conducting ESC research…If one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment” (emphasis added).

Judge Lamberth issued the preliminary injunction against Obama’s stem cell policy on the grounds that, since the policy violates the clear language of Dickey, the Plaintiffs have a substantial likelihood of winning the case on the merits. [10]

IV. Legislative Challenges to Dickey-Wicker

In recognition of the credibility of Judge Lamberth’s interpretation of Dickey and the possibility that Obama’s policy will be ultimately struck as illegal, Democrats – in both the House and Senate – are scrambling to pass legislation that will repeal Dickey. If such legislation is enacted, any pending case involving Dickey will be rendered moot, and any decisions invalidating Obama’s policy will be overturned.

Sen. Arlen Specter has just introduced a bill, S. 3766, to authorize federal funding of ESCR in the Senate. Rep. Diane DeGette introduced a similar bill in the House. The DeGette bill, H.R. 4808, provides in part that the government “shall conduct and support research that utilizes human stem cells, including human embryonic stem cells.” After gaining the support of Republican Rep. Mike Castle, DeGette intends to re-introduce the bill jointly with Castle as a primary sponsor. In addition, Democratic Sen. Tom Harkin, will be holding a hearing this Thursday, September 16th, on his own bill supporting ESCR in the Senate Labor-HHS-Education Appropriations Subcommittee.

With the November elections fast-approaching, supporters of these bills are aware that their chances of repealing Dickey will plummet in the event of a landslide election of pro-life Republicans.

V. Other Considerations

Other influential factors working against the legalization of federally funded ESCR include the fact that the American public opposes the idea. A Rasmussen poll (taken the week Judge Lamberth granted the preliminary injunction) indicated that 57% of Americans oppose taxpayer funded ESCR, with only 33% favoring it. In addition, the overwhelming success of adult stem cell research and the failure of ESCR in treating patients draw attention to the priority and promise of adult stem cell research over ESCR.

VI. Conclusion

In short, Judge Lamberth concluded that Obama’s stem cell policy clearly violates the plain language of the Dickey-Wicker Amendment because it authorizes funding for research wherein the destruction of a human embryo is the first and necessary step.

This leaves the Obama Administration with two ways to fight back: (1) it can proceed with the lawsuit, followed by an appeal (since it has already been established that the Plaintiffs have a substantial likelihood of success); and (2) it can focus on pushing legislation through Congress to repeal Dickey.

However, with strong evidence of a clean pro-life win in the trial court and the impending surge of newly-elected pro-life congressmen, the Obama Administration may only have a matter of weeks to claim victory on the issue of federal funding of destructive embryonic stem cell research.


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Notes

1. Dr. James L. Sherley, et al., v. Kathleen Sebelius, et al., U.S. District Court for the District of Columbia, Civ. No. 1:09-cv-1575 (RCL) (2010).
2. The Dickey-Wicker Amendment is an appropriations bill rider that first appeared in the Balanced Budget Downpayment Act, Pub. L. No. 104-99, § 128, 110 Stat. 26, 34 (1996). Congress has included the rider in every Health and Human Services appropriations bill since 1996.
3. Address to Nation on Stem Cell Research from Crawford Texas, 37 Weekly Compl. Pres. Doc. 1149 (Aug. 9, 2001).
4. Exec. Order No. 13,435, 72 Fed. Reg. 34,591 (June 20, 2007).
5. Exec. Order No. 13,505, 74 Fed. Reg. 10,667 (Mar. 9, 2009) (NIH “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law,” and the agency must “issue a new NIH guidance on such research that is consistent with this order.”)
6. Id. at note 2.
7. The National Institutes of Health Guidelines for Human Stem Cell Research (NIH Guidelines) created after President Obama’s executive order attempted to draw a distinction “between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which Federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo’s destruction, for which Federal funding is prohibited.” 74 Fed. Reg. at 32, 173 (2009).
8. In addition, the plain meaning rule need not be applied if such a reading would result in a cruel or absurd result. When a term is vague, a judge may use legislative history and purpose to find meanings. Adherence to these legal principles is necessary to maintain the judicial branch’s role as an interpreter – and not a creator – of the law.
9. 45 C.F.R. § 46.102(d).
10. A preliminary injunction may be granted when the party seeking the injunction has shown (1) a substantial likelihood of success on the merits of the case, (2) the party will suffer irreparable injury without the injunction, (3) an injunction would not substantially injure others, and (4) an injunction would further public interest. If the party has a very strong showing for one of these factors, they need not have a strong showing for the others.