Patent Baristas

The U.S. Court of Appeals for the District of Columbia has lifted the injunction on federal funding of embryonic stem-cell research. The ban was set last year by a federal judge who said all embryonic stem-cell research at the National Institutes of Health amounted to destruction of embryos, in violation of congressional spending laws.  Sherley, et al. v. Kathleen Sebelius, et al., U.S. Court of Appeals for the District of Columbia Circuit (10-5287).

The opinion by Circuit Judge GINSBURG. Dissenting opinion filed by Circuit Judge HENDERSON.

Two scientists brought this suit to enjoin the National Institutes of Health from funding research using human embryonic stem cells (ESCs) pursuant to the NIH’s 2009 Guidelines. The district court granted their motion for a preliminary injunction, concluding they were likely to succeed in showing the Guidelines violated the Dickey-Wicker Amendment, an appropriations rider that bars federal funding for research in which a human embryo is destroyed.

Dickey-Wicker prohibits the NIH from funding:

(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 45 C.F.R. 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).  Pub. L. No. 111-117.

The DC Circuit court concluded the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.

Stem cells have the potential of yielding treatments for a wide range of afflictions because scientists can cause them to function as any one of a number of specific types of cell. Generally, there considered two different classes of human stem cells: adult stem cells, which are somewhat specialized, and ESCs, which are pluripotent, meaning they can develop into nearly any of the 200 types of human cell.

ESCs can be found only in a human embryo; isolating an ESC requires removing the “inner cell mass” of the embryo, a process that destroys the embryo. The stem cells among the 30 or so cells in the inner cell mass are then placed in a culture, where they will divide continuously without differentiating, thus forming a “stem cell line” of identical cells.
Drs. Sherley and Deisher and a number of others filed this suit in August 2009 and moved the district court for a preliminary injunction.

The text of Dickey-Wicker bars federal funding specifically for “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 uteros.” The district court held that, because an embryo had to be destroyed in order to yield an ESC, any later research project that uses an ESC is necessarily “research” in which the embryo is destroyed.

The Government argued the text is not an unambiguous ban on research using embryonic stem cells because Dickey-Wicker is written in the present tense, addressing research in which embryos “are” destroyed, not research for which embryos “were destroyed.” The DC Court decided that the use of the present tense in a statute strongly suggests it does not extend to past actions.

The plaintiffs argued that because research using an ESC includes derivation of the ESC, the derivation does not predate but is an integral part of the research.

Under Chevron, the court must uphold the NIH’s interpretation of Dickey-Wicker if it isreasonable. The NIH determined Dickey-Wicker does not bar its funding a project using an ESC that was previously derived because a stem cell is not an embryo and cannot develop into a human being. The plaintiffs argued the NIH is not entitled to deference because it never offered an interpretation of the term research.

The Government pointed out at oral argument that “stem cells are not pre-labeled cells that you can simply extract,” and argued “the scientific process” of derivation, in which cells are “extracted and put into mediums where [they] can grow” before being examined and chemically treated, “itself involves experimentation.

The DC Circuit held that:

Rather than rely upon that account of derivation qualifying as research, let us assume for the sake of the plaintiffs’ argument derivation involves no scientific inquiry; it does not follow that the NIH may define derivation as “research” only if or insofar as the derivation is tethered to some later project using the derived cells. Although an understanding of “research” that includes the derivation of stem cells is not the ordinary reading of that term, it is surely as sensible as the plaintiffs’ alternative, in which the derivation of a cell line is deemed part of every one of the scores if not hundreds of subsequent research projects — although pursued by different scientists, perhaps many years later — to use one of the derived cells.

Furthermore, the district court decided that the “balance of hardships weighs in favor of an injunction” because, for ESC researchers, “the injunction would simply preserve the status quo and would not interfere with their ability to obtain private funding.”  On the other hand, the court thought it certain that increased competition would “threaten [the plaintiffs’] very livelihood.”

The DC Circuit thought differently:

[A] preliminary injunction would in fact upend the status quo. …  it is necessarily uncertain whether invalidating the Guidelines would result in the plaintiffs getting any more grant money from the NIH. Accordingly, we cannot say that, if the plaintiffs are to litigate this case without the benefit of interim relief, then the 2009 Guidelines will place a significant additional burden upon their ability to secure funding for their research.

The hardship a preliminary injunction would impose upon ESC researchers, by contrast, would be certain and substantial. The injunction entered by the district court would preclude the NIH from funding new ESC projects it has or would have deemed meritorious, thereby inevitably denying other scientists funds they would have received.

All this is to say the balance of equities tilts against granting a preliminary injunction. That, combined with our conclusion the plaintiffs have not shown they are likely to succeed on the merits, leads us to hold the district court abused its discretion in awarding preliminary injunctive relief.

Circuit Judge Henderson dissented

The majority opinion has taken a straightforward case of statutory construction and produced a result that would make Rube Goldberg tip his hat. Breaking the simple noun “research” into “temporal” bits, Maj. Op. at 5, 6, 16, narrowing the verb phrase “are destroyed” to an unintended scope, id. at 11, dismissing the definition section of implementing regulations promulgated by the Department of Health and Human Services (HHS) (in case the plain meaning of “research” were not plain enough), id. at 11 n.*, my colleagues perform linguistic jujitsu. I must therefore respectfully dissent.