Thursday, December 06, 2018

What Would the SCOTUS Say About a Human Gene Editing Ban?

by Michael C. Dorf

The recent news that Chinese scientist He Jiankui claimed to have created twin girls with genes edited to give them resistance to HIV infection sparked great interest and sharp criticism. Did he actually do it? Did his university know? Why didn't he follow ordinary scientific protocols? Was it ethical? And now, ominously, where is he?

Those are all important questions, no doubt, but as a constitutional lawyer they raised a different question for me. The first "test-tube baby" was born forty years ago. In the intervening years, a host of legal questions involving IVF, egg donation, surrogacy, and other forms of assisted reproductive technology (ART) have arisen. State laws and state court decisions address many of these questions. And yet, despite tackling other contentious issues involving human reproduction, sexuality, and family formation, the SCOTUS has been almost completely absent from this debate.

I don't intend that observation as a criticism. One can legitimately worry about over-constitutionalization of policy questions that are better addressed through public debate, legislation, and state court litigation that has a less permanent and more local quality than a Supreme Court decision. Nonetheless, the result is at least a little curious on its face. Over the last four decades, the Supreme Court has not exactly been shy about constitutionalizing issues--in ways that liberals and conservatives each dislike, depending on the issue. Why not at least a handful of ART rulings, even if only to deny recognition to a constitutional right to any particular ART?

I don't have a clear understanding of why the Court has avoided this area, so I will leave it as an exercise for the reader. Meanwhile, I want to flag how I think the argument will go if and when one of these cases eventually makes it to the SCOTUS.

For concreteness, let's imagine a case based on the recent events. Suppose that geneticists and doctors working under more conventional conditions and controls perfect human embryonic gene editing that eliminates what would otherwise be a genetic condition with a serious adverse impact on a person's life.

In many circumstances, we might think that actually altering genes is unnecessary. If, say, the father and mother are both carriers for such a condition, then the technology that permits gene editing even more readily permits screening to ensure that the embryos implanted do not have copies of the condition-carrying gene. But we can imagine cases more like the recent newsworthy event.

Suppose that there is some condition in which even one copy of the offending gene renders a person's life difficult, because it renders her susceptible to serious infection or injury. The precise details are not important to my example. Let's simply suppose that a couple are unwilling to produce a child without the gene editing because of the medical risks to that child, that this decision is widely understood to be reasonable in light of the those risks, and that there is a doctor who is willing and highly qualified to perform the well-tested (in other countries) method for the gene editing. However, let's assume that a federal statute or regulation adopted pursuant to a clear delegation of rule making authority forbids human gene editing. Do the couple have a constitutional right to employ the doctor's services?

On the liberty side, it is easy to make a strong case for such a right. Roe v. Wade contains considerable language about the right of a patient to make medical decisions in connection with her doctor without undue interference from the state. Subsequent decisions narrow the abortion right somewhat, but mostly because they recognize a greater state interest in promoting fetal life, an interest that the state cannot plausibly assert against the couple in my hypothetical example. Meanwhile, older cases such as Skinner and Griswold--which would almost certainly remain good law even if the Court were to overturn the abortion decisions--give effect to a right to make decisions about whether to become a parent.

If we conceptualized the couple as asserting a right to become parents without undue interference from the state, their claim is pretty strong. But despite the doctor-praising language in Roe and despite a long tradition of what Prof. Lewis Grossman aptly calls "American health libertarianism," the Court would appear unlikely to vindicate such a right if the basis for the prohibition were some plausible determination by the regulatory authorities that gene editing poses unacceptable risks.

The unanimous 1979 ruling in US v. Rutherford is informative. The FDA had found that Laetrile was not a safe and effective cancer treatment. Terminally ill cancer patients sought to enjoin the enforcement of the prohibition. The Court, in a fairly curt opinion by Justice Marshall for a unanimous Court, said that the statute did not contain an implicit exception for terminally ill patients. Although the Court did not formally reach the constitutional objection, its failure to engage in constitutional avoidance and its rhetoric more broadly indicated that the Court would not have found a constitutional right if it did reach the question. Writing as though the issue was whether to allow opticians to successfully challenge a law favoring optometrists and ophthalmologists, Justice Marshall said: "Under our constitutional framework, federal courts do not sit as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy."

The Court again decided only on statutory grounds when it faced a 2001 claim that the federal Controlled Substances Act should be construed to permit an exception for medical marijuana. And again it unanimously rejected the claim. Together, the Laetrile and marijuana cases strongly suggest that the Court will defer to agency expertise with respect to claims of a right to medical decision making.

And that's not unreasonable. Exceptions to the FDA's safety and effectiveness testing regime make it very difficult to test a drug's safety and effectiveness. For terminal patients we might not worry much about safety, but we should worry about effectiveness. If everyone who is terminal or has some other sympathetic claim gets to use a drug before effectiveness has been shown, then no one will volunteer for clinical trials. Why risk getting the placebo when you get a shot at the experimental treatment? So it's not just a matter of deferring to expertise. There's also something to be said in these cases for the integrity of the safety-and-efficacy regime as a whole.

Some of these issues surfaced as objections during debate over the recently enacted Right to Try Act. They were ultimately not sufficient to block the legislation, but that doesn't mean that a contrary legislative judgment would be unconstitutional.

But what if the government's reason for banning gene editing is not a fear that it is ineffective or unsafe (or, what amounts to the same thing, that under something like a precautionary principle, its risks are unknown)? What if, instead, the government cites moral interests, such as revulsion at eugenics? I tend to think that the government would not cite such concerns standing alone, especially because it is almost always possible to point to some health risk or efficacy concern and then obtain deferential review. But for the purpose of the exercise, it is worth considering a moral justification standing alone.

The Supreme Court has said in cases like Lawrence v. Texas that a mere government assertion of an interest in morality does not suffice to overcome a fundamental right. That sparked pushback from Justice Scalia and others. Don't moral judgments undergird most of our laws? That's true, but I think that the disclaimer about morality in Lawrence (and occasionally in other cases) must be understood to refer to a particular kind of moral claim -- namely, that government can forbid some activity that does not cause any concrete harm on the ground that it violates traditional (invariably religious) conceptions of immorality. In other words, while government may restrict actions that cause harm, it may not restrict otherwise harmless actions on the ground that they are sins.

Much more can be said about the scope of the limit on government's ability to restrict basic liberties on moral grounds, but here I want to note that moral revulsion at eugenics falls into a kind of gray zone. It is not a traditional moral view like the view that certain sexual acts are sinful. Nor is it "traditional." It is a fairly recent moral sentiment. Many members of the American elite (most famously Oliver Wendell Holmes, Jr.) were enthusiastic believers in eugenics until the Nazis gave it a very bad image. While I share some of the revulsion against eugenics for that reason, it is not clear to me that this is an entirely rational belief rather than a kind of guilt by association. After all, one can draw a principled distinction between, on one hand, tinkering with genes to allow a couple to produce a healthy baby when otherwise they could not, and, on the other hand, sterilizing or exterminating millions of people on the ground that they belong to an inferior race.

To the extent that revulsion against eugenics is rational, I think it rests on two sorts of judgments. First, there could be a practical worry about slippery slopes. If we allow gene editing to eliminate susceptibility to disease, will the next step be gene editing to create taller, smarter, more beautiful children? And will that in turn lead to restrictions on who can reproduce?

A second and related sort of judgment rests on a concern about symbolic meaning. Even before we go sliding down the slippery slope, any kind of gene editing could send a signal about the relative worth or lack of worth of people whose genes have not been edited.

Absent more, I'm not sure that either of the foregoing interests would suffice to justify a complete ban on gene editing if it were subject to strict scrutiny. But I also have a hard time imagining the Court as currently configured striking down a ban on gene editing. A more likely path to upholding such a ban would be for the Court to say that there is no substantive due process right to use gene editing and that therefore a ban on it need only satisfy rational basis scrutiny. It's possible that the newly very conservative Court would say the same thing about all ARTs. Hostility to substantive due process--especially with respect to "new" rights--appears to be widely shared among judicial conservatives.

Accordingly, I think a state ban or a federal statutory ban on human gene editing would likely survive a constitutional challenge in the SCOTUS. A federal regulation banning it might be on shakier ground, depending on the scope and wording of the statutory delegation of power to the relevant regulatory agency. Rutherford was decided in an era of strong deference to the regulatory state. Insofar as contemporary conservatives distrust regulatory agencies, a challenge to an administrative ban on gene editing could pit two contemporary conservative inclinations against one another: hostility to agency administrative action versus hostility to substantive due process.

For any of these scenarios to play out, however, the Court must first abandon its decades-long approach to ARTs by entering the fray.

2 comments:

t jones said...

Of course, it could be said that contemporary conservatives (at least those on the Court) are hostile to agency regulation they disagree with. How that would play out in an ART case thus requires an additional level of analysis.

Joe said...

Has the lower courts dealt with ART? For instance, after failing on Commerce Clause grounds, the 9CA rejected a liberty claim to use medical marijuana.

In her dissent in Gonzles v. Carhart, RBG argued: "Thus, legal challenges to undue restrictions on abortion procedures do not seek to vindicate some generalized notion of privacy; rather, they center on a woman’s autonomy to determine her life’s course, and thus to enjoy equal citizenship stature."

I think the citation in Lawrence v. Texas to "morality" is not some absolutist reference in application either since as noted in some sense lots of laws on the book in some fashion have "moral" grounds. OTOH, they usually can be phrased in a different way. Thus, e.g., incest laws can be defended on grounds of familial harmony, concerns of consent and other reasons.

I think the government interest likely to be raised here is the issue of safety of the particular medical procedure. Abortion, e.g., was flagged as safety than childbirth. The balance there might be complicated but the sense of realism of the Trump Court accepting the underlining right is well taken. There is also the complication that it affects a future constitutional person that will be born. An abortion ends the existence of an embryo. Issues of fetal surgery etc. also might raise this concern.