There are few people who can say a major historical event has happened inside of them. Brian Madeux is one of them.

Some context: Madeux has a rare genetic condition called Hunter syndrome, a disease caused by a missing chromosome in his DNA. Without that chromosome, Madeux’s body cannot break down complex sugar molecules, leaving them build up in the body and damage organs. However, about four months ago, scientists in California injected gene editing tools designed to allow his liver to break down these molecules into Madeux’s left arm. This trial represents the first time a living human being’s genetic code has been directly modified inside their body, and is a landmark in research on human genome editing.

However, this accomplishment should also prompt some reflection among lawyers. Although genome editing offers the possibility of significant medical benefits, it has detractors who question both whether genome editing is “playing God” and whether the potential future risks of genome editing outweigh the benefits. Whether, and if so, how, human genome editing should be regulated is a significant question that the legal community has only recently begun to grapple with.

One immediate obstacle efforts to regulate human genome editing will face is the possibility of constitutional challenges of state regulation. In the context of reproductive rights, the Supreme Court has recognized that the liberty components of the Due Process Clauses of the Fifth and Fourteenth Amendments protect a woman’s right to make certain important medical decisions, including about abortion. This recognition has been founded, at least in part, on the notion that the Constitution protects bodily autonomy from state interference. Arguably, modification of DNA to cure serious genetic conditions falls within this set of protections.

The primary challenge for proponents of a constitutional right to gene modification will likely be that the federal courts have not been particularly receptive to arguments based on purported constitutional rights to make medical decisions outside of the context of reproductive liberty. For example, lower courts have rejected constitutional challenges based on the Due Process Clauses by cancer patients seeking to use treatments that have not been FDA approved and by patients seeking to use medical marijuana. This suggests that the bodily autonomy right described in the Court’s abortion jurisprudence is distinctly limited.

Where the courts will end up on this question is not entirely clear. However, given that human gene editing is no longer a matter of speculation but is an actual present reality, legal scholars should give this issue more attention.

Nigel Halliday



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