Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)

As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here  I want to raise a different question. Would such a recommendation be unconstitutional?

If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test?

One question is whether the concern for germ line consequences is a sufficiently important government interest? If this were rational basis review, the lowest tier of scrutiny, the answer would be an easy yes. But is the risk data so compelling that we think it is an interest satisfying this higher tier of scrutiny? After all the UK did not adopt a similar requirement in its legislation. This inquiry will also lead us to interesting questions about whether the state is constitutionally justified in trying to “protect” our future generations going forward by restricting reproductive options, a topic I touch on briefly here. If the consequence of germ line transmission was, let’s say hypothetically, a disease for future children or lower IQ or something like that several generations down the road is that the kind of thing the government is entitled to use as a basis for limiting reproductive options?

If it can meet the first part of the test, that is it is sufficiently important of an interest. I think the substantial relation piece would be easier for the government. That said, others even better versed in the science than I may think there are alternatives the FDA would need to consider and rule out.

There is also a very interesting question lurking in the background of all this: Is this the kind of discrimination that activates the equal protection clause at all? The “disfavored” class, females, is disfavored such that it does not come into existence at all. Does the Equal Protection clause consider potential people amongst the class to whom it extends its protection? One might be tempted to say no, but that answer might yield some counter-intuitive results. For example, it would suggest an attempt to eradicate from the future populations an entire race through legal restrictions on reproduction would not be an Equal Protection violation, which seems counter-intuitive. In such a case perhaps one might argue that the violation is of the Equal Protection rights of the parents not the children, but if that is true couldn’t one say the same thing in the gender/MRT context?

Lots more to think about…

I. Glenn Cohen

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

2 thoughts to “Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)”

  1. Glenn, in your view, does the Equal Protection Clause operate identically in the pre- approval (Research under IND) stage as it does (or would) in post-approval clinical context?

    1. Thanks Alta. Great question!
      Here are my quick thoughts (but would love others to weigh in who know more about this aspect of constitutional litigation).

      Take the easiest case. Congress passed a law that makes it a crime to do MRT with female embryos. That’s going to raise an equal protection issue (though not clear how it would come out as I suggest in my comment online).

      Ok next easiest. FDA approves the technology only for the male embryos and has enforcement power to bring actions against off label use for female embryos. It seems to me one might raise an EP challenge to the enforcement action if one was aggrieved by it but I can’t name a case with the same configuration to be sure (also you would nnow better than I if they could even go after the off label use in this case, and given the recent case law there may also be First Amendment issues with pursuing such an enforcement action).

      Next case. At IND phase the FDA will only accept data using male embryos but post approval does not use enforcement authority against those who use it for female embryos. Well now my question is who would have standing to bring the equal protection challenge? No woman seeking to use MRT is aggrieved. And the EP claim does not seem to “belong” to the IND applicant but instead the downstream user. So this strikes me as the hardest context in which to litigate.

      Of course “raising an Equal Protection issue” is not the same as meaning a court will find merit in it. So that is a separate challenge.

      But again great question and (I know you were on the committee) great report!

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