May 3, 2006 1:26PM

A Right to Experimental Drugs? Yes. No. Maybe.

The D.C. Circuit recently ruled that "a terminally ill, mentally competent adult patient’s informed access to potentially life-saving . . . new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause." You can read more about it here.

 I want to raise a question about the way others are characterizing the case.

Following some of the language of the D.C. Circuit’s opinion, Jonathan Adler and Orin Kerr describe the case as a decision that recognizes a new "right to experimental drugs." This characterization makes the case sound quite revolutionary. And it raises an interesting problem about how to talk about substantive due process cases. Compare common descriptions of Cruzan v. Director, Missouri Department of Health. There, the Supreme Court upheld a state law that, in effect, prohibited withdrawal of life support from a vegetative patient despite her previously expressed wish to die when in such a condition. (The law forced a surrogate to prove the patient's wishes by heightened evidence.) But the Court also held that patients have a protected liberty interest in “refusing unwanted medical treatment.” Why then did it uphold state law? Because the Court held that the state interests outweighed the liberty interest at issue on the facts of the case.

Cruzan defies easy categorization. It’s variously described as a case that (1) left the right to die “unanswered”; or (2) recognized a “right to die.” This D.C. Circuit case also defies easy categorization. Relying on the logic of Cruzan, the D.C. Circuit held that patients have a liberty interest in control over their use of life-saving drugs protected by the Due Process Clause. But, whether the state has a sufficiently strong interest to override the liberty interest remains an open question, which the trial court must now consider. Like the state regs in Cruzan, the FDA regulations will be upheld if the government can show the regs serve a narrowly tailored “compelling interest”--what lawyers call “strict scrutiny.” (One way the FDA may try to do so, suggested by Cruzan, is to show that the regs somehow protect patients who don’t understand the risks involved--perhaps by attempting to show that terminally ill patients are poor judges of unknown risks and therefore at high risk of manipulation by doctors and pharmaceutical companies during Phase I trials. See this article for notes toward such an argument.)

In short, you shouldn’t assume that strict scrutiny is always fatal in fact. “Strict scrutiny” tests appear throughout constitutional law, and they are applied with different degrees of rigor: more exacting in some free speech cases, less exacting in equal protection cases. If Cruzan is any evidence, the “strict scrutiny test” applied in the field of substantive due process is a weaker variety. Perhaps there are important differences between the FDA regs here and state regs upheld in Cruzan. But on the face of things, it's possible the endgame of this decision may leave room for government regulation---or even uphold the FDA regs in their entirety.

This is one reason why I think the Supreme Court--if the case were to be appealed--would be wise to wait until the trial court has balanced the state interests and the liberty interest recognized by the D.C. Circuit. And it is also a reason why pundits should be cautious about describing the case’s real-world effect. The real action in this case may be yet to come.