THE TRIAL OF AMERICAN STEM CELL RESEARCH—DISMISSED?
By Don C. Reed
As you recall, the lawsuit against America’s new stem cell guidelines (Sherley et al vs. Sebelius et al, filed August 19, 2009) was moving forward; until resolved, all federal funding of embryonic stem cell research was shut down.
Research delayed is research denied. Every day the opposition can tie us up in court is a victory for them, and another day for people like my son to remain paralyzed, and my sister suffer cancer, and millions more good folks: their cures delayed, their hopes denied.
The plaintiffs had made their case, arguing that embryonic stem cell research should not be funded. Our side (the defendants) responded—asking for the case to be thrown out.
Everything depended on “standing”: could those making the complaint show some injury they had received (or would receive) from the new stem cell research guidelines?
Without legal standing, there can be no case.
But there were five sets of plaintiffs; if even one had a legitimate grievance, the suit could go forward, the research funding would remain blocked for the length of the trial—and in California, a similar lawsuit had tied up the funding for our beautiful stem cell research program for two years…
So here we go. For each plaintiff I will quote the official description, claim of injury, some court comments, my own views– and the judge’s decision.
1. Nightlight Christian Adoptions, (Nightlight) “… an adoption agency that helps individuals adopt human embryos that are being stored in fertilization clinics.”
Looking it up on the web, I found Nightlight is a fee-charging nonprofit, which helps childless couples obtain blastocysts from In Vitro Fertility (IVF) clinics. Nightlight appears to be either part of a company called Snowflakes, or closely associated with them. They are not shy about charging fees.
Here are some of their cost estimates:
“Program fees: Snowflakes Program fee: $8,000;
Nightlight home study fee is $2,600;
Fertility clinic frozen embryo transfer fees $3,000-$5,000.
Total Fees $12,000–$16,000.” (the possibility of additional charges is made clear.)
Alleged Injury: “Nightlight alleges that the (new) guidelines will cause a decrease in the number of embryos available for adoption.”
The court commented: “This alleged injury does not satisfy the “injury in fact” requirement because it is speculative and dependent upon third party conduct. The guidelines do not mandate a decrease in the number of embryos available for adoption. Rather, the guidelines allow funding for hesc research on embryos that were donated “by individuals who sought reproductive treatment,, and who gave voluntary written consent (their emphasis) for the embryos to be used for research purposes.”
By my non-lawyer understanding, “third party” means someone not named in the lawsuit. This is important because it is the new guidelines that are being sued– and nothing in the guidelines orders a decrease in the number of embryos. The decision (whether the blastocysts shall be frozen and stored, destroyed, given away or donated to research) remains exactly where it should be: with the un-named third party—the donors.
And the Judge’s official finding?
“Accordingly, the Court finds that Nightlight lacks standing (emphasis added) because its alleged injury is “mere unadorned speculation as to the existence of a relationship between the guidelines and the third party conduct.” Indeed, if Nightlight suffers any injury at all, it will be because of the choices of third parties not before this court, and not because of the guidelines.”
If this were baseball, that would be strike one—but it would take five strikes to put the anti-research team out of the game.
2. Shayne and Tina Nelson, William and Patricia Flynn: “The Nelsons and Flynns are clients of Nightlight who seek to adopt human embryos in the future.”
These folks had children through the IVF process, with the help of Nightlight, adopting (and implanting) left-over blastocysts. I am glad for them. Most couples want a child. I have two, and they are treasures to me. That is why I will fight to protect them, and that includes not allowing politics to block research for cure.
Alleged Injury: “The Nelsons and Flynns, who each have had a child through the adoption of an embryo from Nightlight, allege they are seeking to adopt additional human embryos. They contend the guidelines injure them by “jeopardizing the likelihood that embryos will become available in a timely manner for adoption and implantation.”
Apparently, the four clients of Nightlight worry that the new guidelines mean they will have less blastocysts to choose from, if they decide to have another child through IVF, with the help of Nightlight. Presently, there are about 450,000 blastocysts frozen in storage. How many choices are required?
“The Court finds that the Nelsons and Flynns have not alleged a concrete and imminent injury… the guidelines do not regulate embryonic adoption… neither the Nelsons nor the Flynns allege…guidelines have erected any barriers to their efforts to adopt an embryo.”
FINDING: “Accordingly, the Nelsons and Flynns do not have standing.” (Strike two…)
3. Embryos “The Embryos consist of all individual human embryos that were created for reproductive purposes, but are no longer needed for those purposes.”
Alleged Injury: “The embryos, through Nightlight, contend that their lives will face a recurring risk of destruction as a result of the guidelines.”
I hardly know where to start: “The embryos…contend…” Talking blastocysts? This is more than just foolishness. This is a subtle attempt at deception, like the anti-research propagandist who talked about embryonic stem cells, while behind him was a huge picture of a baby in the womb. They know the research is about cells, cells, nothing but cells, but they use words which plant a false picture in the minds of the listeners.
Even the word “embryo” is to my mind prejudicial, because it implies a baby in a womb, which is false; we are talking about bits of tissue smaller than the point of a pin– and not in the woman’s body. No blastocyst can ever become a child, unless it is implanted in the womb. No mother, no child; this is not rocket science.
And what amazing arrogance in this claim… How could any organization claim the right to decide what is best for every unused IVF embryo in the world?
A great deal is at stake here, as the Court noted:
“This case…concerns whether an embryo qualifies as a person (emphasis added)… The Supreme Court has stated that “the unborn have never been recognized in the law as persons…”
This is vital. If a blastocyst (the first linkage of microscopic sperm and egg) can be declared a full human under law, the entire field of embryonic stem cell research becomes illegal, as does every woman’s right to choose to terminate her pregnancy—ever. The In Vitro Fertility process would be illegal, and many forms of birth control.
This is the Religious Right’s personhood concept: their attempt to get every blastocyst declared a legal person, with standing in a court of law. If they win on “personhood”, our hopes and dreams for embryonic stem cell research are gone.
But the judge spoke out clear and plain, no translation required: “The Court finds… that the embryos are not “persons” under the law, and thereby do not have standing.”
We must remember this. We are fighting to save real people’s lives, not potential ones. A droplet of sperm may contain the beginnings of a million lives, but that does not mean each one should be protected under law.
The exact time when tissue becomes a person has been argued for centuries. Is it viability, when a child can live on its own, outside the womb? That is the official definition, according to American law. Or, as the Catholic Saint Thomas Aquinas opined, does life begin at the “quickening”, when the mother first feels the baby stirring in her womb? Earlier? Later?
“Personhood” wants humanity declared at the joining of sperm and egg—even in a Petri dish of salt water, outside the womb, when there is no possibility it could become a child.
What’s next, are we going to say that new life begins at the twinkle in Dad’s eye?
But while we can argue forever about that definition, there is no debate about the personhood of my son Roman, who is paralyzed, or my sister Barbara, who has cancer. They are full human beings, protected by the law of this land. Their right to life is guaranteed under the Constitution– and must not be jeopardized by political games, which could block research to heal disease or disabilities which blight their lives.
FINDING: “Accordingly, the Court concludes that the embryos lack standing because they are not persons under the law.” (Strike 3 of 5…)
4. Christian Medical Association, (CMA) a non-profit which “strives to improve the ethical standards of health care in the United States and abroad”.
Note: The CMA appears to be part of a larger group, the 2,400 member Christian Medical and Dental Association (CMDA). If that assumption is correct, (I could not find the CMA listed as a separate organization) I am not sure why the CMA sued, while their parent organization did not. Perhaps they disagree; I do not know. (I do know, however, that even some of the nation’s most conservative Christians no longer worry about this issue. A poll was taken at a recent Values Voters Summit, the ultimate conservative gathering, put on by the Family Research Council. When 5,000 values voters were asked to list their issues of concern, less than 1 (one) per cent listed “early embryo research”.)
Alleged Injury: “CMA alleges that it will suffer injury because: the guidelines will frustrate CMA’s purpose and require CMA to devote significant resources to address and counteract the grave ethical problems posed by illegal public funding of embryo research.”
This is an amazing claim, when you think about it. If a “frustration” argument was allowed, it would open the door for lawsuits against probably every law ever passed.
The Court stated: “Frustration of purpose is not a sufficient injury to establish standing….allegations that frustrate an organization’s objectives is “an abstract concern that does not impart standing.”
Finding: “Accordingly, the Court finds that CMA lacks standing.” (Strike 4…)
5. Drs. James L. Sherley and Theresa Deisher, adult stem cell researchers.
“Drs. Sherley and Deisher specialize in adult stem cell research and plan to seek NIH funding for adult stem cell research in the future. In addition, Dr. Sherley has one proposal currently pending.”
Alleged Injury: Drs. Sherley and Deisher contend that the new guidelines will “result in increased competition for limited federal funding and will thereby injure their ability to successfully compete for… NIH stem cell research funds.”
To me, this sounds like they want a monopoly on what type of research gets funded. During the Bush Administration, adult stem cell research was heavily favored; seven times more money given to it than embryonic; even under the Obama Administration, adult stem cell research appears likely to receive triple the funding of embryonic. Personally, I favor a level playing field, where the quality of science will decide.
“ The Court finds that increased competition for funding is an insufficient injury to impart standing… The guidelines neither prevent nor hinder either doctor’s opportunity to compete for funding. Indeed, Drs. Sherley and Deisher’s proposals for adult stem cell research can receive funding, if they survive the review process all applicants undergo…
“… the guidelines will not “almost surely cause (Drs. Sherley and Deisher) to lose” funding… The application process to receive NIH funding is extremely competitive. Only about 22% of applications receive NIH funding… Even if the guidelines did not exist, Drs. Sherley and Deisher are not assured of receiving funding…”
Finding: “Accordingly the court concludes … that Drs. Sherley and Deisher lack standing.” (Strike 5!)
“Conclusion: For the reasons set forth above, the Court finds that plaintiffs lack standing and will grant defendants Motion 22 to dismiss. A separate order shall issue this date.
“Signed by Royce C. Lamberth, Chief Judge, on October 27, 2009”
So did we win?
Yes.
Will they appeal? No way of knowing, of course, but probably they will.
I am sure they believe in their side as thoroughly as we believe in ours.
We won’t give up; neither will they.
Until cures come.
P.S. Below is the Court’s decision on the case. I two-finger-typed the Judge’s decision below, so you can read as much or as little as you like of it. It is essentially complete, but I left out document references, etc. You can find the original on the web, just Google it. (For my two previous articles on this subject, go to www.stemcellbattles.com)
United States District Court for the District of Columbia
James Sherley et al, Plaintiffs, v. Kathleen Sebelius, et al Cic. No. 1;009-cv-1575 RCL
Memorandum Opinion
This matter comes before the court on defendants’ Motion to Dismiss. Plaintiffs brought this suit to enjoin the defendants from taking further actions to implement and apply the guidelines promulgated by the National institute of Health (NIH) that provide for public funding of human embryonic stem cell (hesc) research. Defendants motion states, among other things, that plaintiffs lack standing. This court agrees with defendants and finds that plaintiffs lack standing. Accordingly, the Court will grant Defendants motion to dismiss.
- Background
Plaintiffs are Drs. James L. Sherley and Theresa Deisher, Nightlight Christian Adoptions (Nightlight), Embryos, Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association (CMA), Drs. Sherley and Deisher specialize in adult stem cell research and plan to seek NIH funding for adult stem cell research in the future. In addition, Dr. Sherley has one proposal currently pending. Nightlight is an adoption agency that helps individuals adopt human embryos that are being stored in fertilization clinics. The Embryos consist of all individual human embryos that were created for reproductive purposes, but are no longer needed for those purposes. The Nelsons and Flynns are clients of Nightlight who seek to adopt human embryos in the future. CMA is a non-profit association of doctors that strives to improve the ethical standards of health care in the United States and abroad. Together, plaintiffs seek to enjoin defendants “from applying the Guidelines (promulgated by NIH) or otherwise funding research involving the destruction of human embryonic stem cells.”
On March 9, 2009, President Obama issued Exec. Order (which) removed President Bush’s limitations on hesc research. In addition, the Order directed NIH to issue new guidelines to allow hesc research to the extent permitted by law.
After a notice and comment period, NIH issued the final guidelines on July 7, 2009. Under the guidelines, for an applicant to conduct research on hESC derived from embryos donated on or after the effective date of the guidelines, the applicant must either limit his or her research to cell lines posted on an NIH registry, or submit an assurance of compliance with part A of the Guidelines (which) ensure that the proposed research involves only hesc that are no longer needed for reproductive purposes and were voluntarily donated to be used for research purposes. For an applicant to conduct research on hesc derived from embryos donated before the effective date of the guidelines, the applicant must either show compliance with part A of the guidelines, or submit materials to an advisory committee, which will make recommendations concerning the eligibility for NIH funding.
Plaintiffs allege that the guidelines, by allowing NIH to fund hesc research , will cause them irreparable harm. Specifically, Drs. Sherley and Deisher contend that the new guidelines will “result in increased competition for limited federal funding and will thereby injure their ability to scccessfully compete for… NIH stem cell research funds,.” Nightlight alleges that the guidelines will cause a decrease in the number of embryos available for adoption. The embryos, through Nightlight, contend that their lives will face a recurring risk of destruction as a result of the guidelines. The Nelsons and Flynns maintain that the guidelines will “jeopardize the likelihood that embryos will become available” for them to adopt in the future. Finally, CMA alleges that the guidelines will frustrate its purpose and require it to expend significant resources to combat the ethical problems posed by hESC research.
- Discussion.
Defendants move to dismiss plaintiffs’ complaint on the grounds that this Court lacks subject-matter jurisdiction, or, in the alternative, that plaintiffs have failed to state a claim upon which relief could be granted. The Court finds that it lacks subject-matter jurisdiction because subjects do not have standing. Therefore, the Court need not address defendants’ additional arguments.
- Legal Standard
Federal courts are courts of limited jurisdiction. When a defendant files a motion to dismiss for lack of subject-matter jurisdiction pursuant to Rule 12 (b) 1, the plaintiff must demonstrate by a preponderance of evidence that the court has subject-matter jurisdiction. The Court must accept all the factual allegations in the complaint as true and draw all reasonable inferences in the plaintiff’s favor. Furthermore the court may consider material outside of the pleadings in its effort to determine whether the court has jurisdiction in the case.
A court lacks subject-matter jurisdiction if the plaintiff fails to establish standing. (“The party invoking federal jurisdiction bears the burden of establishing standing.”) To have constitutional standing the plaintiff must demonstrate 1. an injury in fact; 2. causation: and 3. redressability. An injury in fact is “an invasion of a legally protected interest which (a) concrete and particularized … and actual or imminent, not conjectural or hypothetical. (internal citations and quotations omitted)
“When a plaintiff’s asserted injury arises from the Government’s regulation of a third party that is not before the court, it becomes ‘substantially more difficult ‘ to establish standing ….. The court, however, will not dismiss a complaint brought by multiple plaintiffs if one of the plaintiffs has standing. (the presence of one party with standing is sufficient to satisfy articles III”s case-or-controversy requirement”
- Plaintiffs lack standing
CMA: CMA alleges that it will suffer injury because: the guidelines will frustrate CMA’s purpose and require CMA to devote significant resources to address and counteract the grave ethical problems posed by illegal public funding of embryo research. Frustration of purpose is not a sufficient injury to establish standing…. allegations that frustrate an organization’s objectives is “an abstract concern that does not impart standing.” Indeed, plaintiffs do not argue in their opposition that this injury is sufficient for standing purposes. Accordingly, the Court finds that CMA lacks standing.
Nightlight: Nightlight contends that it will suffer injury because the guidelines will cause a decrease in the number of embryos available for adoption. This alleged injury does not satisfy the “injury in fact” requirement because it is speculative and dependent upon third party conduct. The guidelines do not mandate a decrease in the number if embryos available for adoption. Rather, the guidelines allow funding for hesc research on embryos on embryos that were donated “by individuals who sought reproductive treatment,, and who gave voluntary written consent (their emphasis) for the embryos to be used for research purposes.” Thus, for Nightlight to suffer an injury, potential embryo donors have to choose to donate their embryos for research, and not for adoption.
The choice, however, is not simply whether to donate embryos for research or for adoption. The donors must choose between continuing to store the embryos, discarding them, donating them for research, or giving them to an adoption agency involved in embryonic adoption.
Accordingly, the Court finds that Nightlight lacks standing because its alleged injury is “mere unadorned speculation as to the existence of a relationship between the guidelines and the third party conduct.” Indeed, if Nightlight suffers any injury at all, it will be because of the choices of third parties not before this court, and not because of the guidelines.
Embryos. Nightlight also seeks to proceed in this complaint on behalf of all embryos created for reproductive purposes that are no longer needed for such purposes. The complaint alleges the embryos face the risk of imminent injury, i.e. destruction, as result of the NIH guidelines. The Court finds, however, that the embryos are not “persons” under the law, and there(by) do not have standing. (my emphasis)
Plaintiffs’ reliance on Hatch v. Riggs Natl. Bank, 361, F.2d 559, 566 (D.C. Cir. 1966) for the proposition that embryos qualify as persons and should have a guardian ad litem appointed to represent their interest is misplaced. “Hatch” concerned the “interests of unborn and/or otherwise unascertainable beneficiaries of a trust.” An unborn’s legal interest in a trust has been recognized for centuries. See Roe v. Wade, 410 U.S. 114, 162, (1973) (noting that historically guardians at litem have been appointed to represent property interests of the unborn that are “contingent upon live birth”). This case, however, does not concern whether an embryo qualifies as a person in order to enforce a trust. Rather, it concerns whether an embryo qualifies as a person in order to assert a liberty interest. The Supreme Court has stated that “the unborn have never been recognized in the law as persons in the whole sense” and that they have no right to life protected under the Fourteenth Amendment…Accordingly, the Court concludes that the embryos lack standing because they are not persons under the law…
The Nelsons and Flynns, who each have had a child through the adoption of an embryo from Nightlight, allege they are seeking to adopt additional human embryos. They contend the guidelines injure them by “jeopardizing the likelihood that embryos will become available in a timely manner for adoption and implantation.”
The Court finds that the Nelsons and Flynns have not alleged a concrete and imminent injury. As discussed with Nightlight, the allegation that fewer embryos will be available for adoption is speculative and dependent upon third parties. Moreover, the guidelines do not regulate embryonic adoption, and neither the Nelsons nor the Flynns allege that the guidelines have erected any barriers to their efforts to adopt an embryo. Accordingly, the Nelsons and Flynns do not have standing.
Drs. Sherley and Deisher allege that the guidelines “will result in increased competition for limited federal funding and will thereby injure (their) ability to compete successfully for….NIH stem cell research funds. “ The Court finds that increased competition for funding is an insufficient injury to impart standing.
Drs. Sherley and Deisher contend that they have standing under the “competitor standing” doctrine. Under the competitor standing doctrine, a plaintiff “suffers constitutional injury in fact when agencies lift regulatory restrictions on their competitors or otherwise allow increased competition.”
The competitor standing doctrine is not applicable to the facts of this case. The Supreme Court has held that the competitor standing doctrine applies only “when the particular statutory provision (or regulation) involved… reflects a legislative purpose to protect a competitive interest.” Here, Drs. Sherley and Deisher have not demonstrated that they have a protected competitive interest in receiving NIH funding. Their only protected interest is their opportunity to compete with other applicants for limited NIH funding… The guidelines neither prevent nor hinder either doctors opportunity to compete for funding. Indeed, Drs. Sherley and Deisher’s proposals for adult stem cell research can receive funding if they survive the two-tier review process that all applicants undergo.
In addition, the cases relied upon by Dr. Sherley and Deisher are readily distinguishable. In both cases, the competitor standing doctrine applied where the petitioners were active participants in the strictly regulated economic markets of energy, communication, and banking. … Drs. Sherley and Deisher, however, are not participants in strictly regulated economic markets. They are applicants for research grants… As stated above, Drs. Sherley and Deisher may still receive funding.
Last, even if the competitive standing doctrine did apply, Drs. Sherley and Deisher would not have standing because the guidelines will not “almost surely cause (Drs. Sherley and Deisher) to lose” funding…The application process to receive NIH funding is extremely competitive. Only about 22% of applications receive NIH funding. Thus, even if the guidelines did not exist, Drs. Sherley and Deisher are not assured of receiving funding for adult stem cell research.
Accordingly the court concludes that the competitor standing doctrine does not apply and that Drs. Sherley and Deisher lack standing.
- Conclusion: For the reasons set forth above, the Court finds that plaintiffs lack standing and will grant defendants Motion 22 to dismiss. A separate order shall issue this date.
Signed by Royce C. Lamberth, Chief Judge, on October 27, 2009