More States See Legislation That Conditions Abortion Rights on the Genetic Status of the Fetus

The ongoing legal battles over the scope of reproductive rights protected by the 14th Amendment  – with claims of constitutionally protected values of liberty and privacy invoked – continue, going back to the signature case of Roe v. Wade in 1973 and furthered tailored by Planned Parenthood v. Casey (1992), among other cases. Other arguments for the protection of reproductive autonomy are grounded in gender equality. Fast forwarding to the rapidly developing technological landscape of genetic testing, reproductive medicine has steadily refined the options available for prenatal testing to provide prospective parents with ever more accurate – and earlier obtained – medical information. The most dramatic development has been the availability of non-invasive prenatal diagnosis (NIPD) that relies on obtaining fetal DNA (cell-free detal DNA, cffDNA) from maternal blood as early as 4 weeks into gestation and to test for a number of genetic/chromosomal disorders, including Down syndrome (attributed to the presence of an extra chromosome 21, leading to a trisomy). NIPD has reduced the need for invasive procedures, such as chorionic villi sampling and/or amniocentesis. As prenatal testing becomes more sophisticated, an ongoing political battle rages over whether abortion rights should be restricted based on the intent or rationale of the mother for seeking the procedure. This has led to both state and federal efforts to restrict abortion when it is sought on the basis of gender, race or genetic anomaly (e.g., Down syndrome). Currently, a bill, HB 135, is pending in Ohio that would ban any abortion that is sought sought because prenatal testing reveals Down syndrome. North Dakota enacted a similar bill in 2013 (that same bill would have prohibited abortions about as early as 6 weeks; that portion was struck down by the Eighth Circuit in July of this year). To date, there are no reports of enforcement of these selective bans on abortion. Yet they raise not only the most obvious legal issue of whether such laws impinge on the constitutional right enshrined by Roe (or present the “undue burden” prohibited in Casey). They raise a novel issue of whether the legal rights accorded to the mother can vary according to genetic status of a fetus. Beyond that, express litigation over the constitutional concerns of the fetus itself would lead into the legal personhood legal battles that have been fought already (and overwhelmingly seen the defeat of attempted personhood ballot initiatives and legislation) (see earlier posts here and here). Thus, an indirect genetically-determined legal climate of maternal rights emerges if these laws work as intended – with the twist that the relevant genetic information is derived from the fetus. While is appears that these laws are unworkable as a practical matter, these bills can formally require the provider to question the mother about her motives and can impose felony charges on a physician violating the ban. The Ohio bill is likely to pass, and join the North Dakota bill alone in targeting maternal rights on the basis of a fetal genetic anomaly. Proponents of these bills have argued that, for example, the current climate of genetic testing only encourages the elimination of offspring with detectable genetic abnormalities, with the result that Down syndrome births become increasingly uncommon, and they invoke a kind of disability discrimination argument in support of these measures (however, that leads back to the fetal personhood debate). Opponents argue that the Roe-based constitutional right to seek an abortion – while certainly cabined by many modern legislative limitations – is not conditioned on maternal motive or the genetic status of the fetus, but is simply motivated by a desire to limit women's reproductive choices.

Three-Parent Assisted Reproductive Technology Nears Approval in U.K.

The U.K. House of Commons approved a bill this week that would allow the use of a novel assisted reproductive technology (ART) to proceed. In current media coverage, the technique has been called three-parent reproduction, and it has been developed to offer a route to reproduction for women who are likely to transmit genetically inherited mitochondrial disease. Offspring inherit their mitochondria from the egg of the mother, and can be at risk from any mitochondrial disease that has occurred to the mother or the maternal family. The proposed intervention is known as mitochondrial replacement therapy. The three parents are the father and two mother donors: the nucleus is removed from the egg of the intended but genetically impaired parent and it is inserted into the egg of a healthy female donor, whose mitochondria are not defective. The reengineered egg undergoes in vitro fertilization with the father’s sperm, and is then implanted. This week, the U.K. House of Commons approved the use of the 3-parent mitochondrial replacement technique, in amending the Human Fertilisation and Embryology Act of 2008. The House of Lords is expected to follow suit. Unlike the U.S., the U.K. has an oversight body for ART – the Human Fertilisation and Embryology Authority (HFEA) -  which regulates fertility treatments and other reproductive technologies. The U.S. has no specific regulatory agency targeting reproductive technologies, but the FDA claims a regulatory role based on its general regulation of reproductive tissues in commerce (eggs, sperm) and the agency did shut down earlier work using MRT in the late 1990's. In the U.S. the FDA and the Institute of Medicine (IOM) are considering whether the technique should be approved for use in the U.S: 

An FDA Advisory Committee (AC) met on February 25 and 26, 2014, to discuss the science regarding assisted reproductive methods involving genetic modification of eggs and zygotes for the prevention of  mitochondrial disease. FDA has requested that the Institute of Medicine produce a consensus report regarding the ethical and social policy issues related to genetic modification of eggs and zygotes to prevent transmission of mitochondrial disease.

The FDA committee agreed that any proposed clinical trials with humans could be premature:

The Committee generally agreed that there is not sufficient animal data (particularly with regard to follow-up of offspring) to support the use of the mitochondrial manipulation technologies in first-in-human clinical trials. It was also acknowledged that the use of somatic cell nuclear transfer (SCNT) following by intracytoplasmic sperm injection (ICSI) had to be weighed against alternative methods for preventing the transmission of mitochondrial diseases to offspring, including adoption, oocyte donation, and cytoplasmic/mitochondrial transfer. 

The IOM began its study last month, holding its first meeting on the subject. In general, the U.S. is lagging behind the U.K. in considering official approval of this technique; in 1978, in vitro fertilization was first used in the UK before it migrated to the U.S. soon afterward. To date, there are pro and con views on whether MRT could be a viable option for prospective parents. Critics point to safety concerns as well as fears regarding a slippery slope toward allowing other genetic interventions to produce either healthier or “better” offspring. Supporters of MRT point out that the technique offers women with mitochondrial disease to have children that are genetically related but free of the genetic defect imparting serious disease. My own view is that there might be latent genetic incompatibilities that would not be overtly evident but perhaps manifest developmentally or subtly in a way that comprises the health of an MRT-derived offspring. Looking at regulatory moves in the future, there is always the possibility of legislative action that would either allow or prohibit the use of the technique – it’s too early to have such initiatives started, but such moves would echo ongoing Congressional and state responses to the possibility of human reproductive cloning that emerged in 1997, following the creation of the cloned sheep, Dolly.

Federal Court Rejects Claim by Guatemalan Victims of U.S. Medical Experiments

A federal district court has rejected a legal claim by individuals in Guatamala who asserted their right to compensation for the unethical medical experimentation that was carried out by U.S. researchers in the 1940’s (Garcia v. Sebelius, Dist. D.C., 2012). The researchers from the U.S. Public Health Service exposed the plaintiffs to sexually transmitted diseases (syphilis, gonorrhea) to create research subjects. No informed consent or bioethical standards were used to conduct these studies; the participants were institutionalized (prisons, hospitals, etc.) and had little control over the conditions of their confinement. The legal claim was filed under the Alien Tort Statute, which provides a mechanism for aliens to file legal claims for violations of international law or treaties in U.S. courts. The statute has been used extensively to assert human rights claims in a variety of international settings; nonetheless, the scope of the statute is still hotly contested (see upcoming Kiobel v. Royal Dutch Petroleum, to be heard in the Fall 2012 term). The specific legal issue in the Guatamala case was whether the government, would face liability under the Federal Tort Claims Act (FTCA), which does expose government employees to liability when their acts are which ordinarily concedes a waiver of sovereign immunity by virtue of the existence of the statute for caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, nonetheless would escape lliability due to an exception for activities conducted in a foreign country. Although the plaintiffs asked the court to carve out an exception to that clause in this case, the court rejected that argument: “Here, the plaintiffs' Alien Tort Statute claims all arise out of injuries suffered in Guatemala, and the claims are thus barred by the FTCA's foreign country exception.”  The court further noted, that despite its inability to grant relief, the U.S. government has conceded the severe injustices of this case and has declared its intention to provide redress.  Indeed, the State Department issued an official apology in 2010: “We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices.” The Presidential Commission on Bioethical Issues also issued a report (discussed here). No official compensation scheme has been announced by the U.S. government.