By Mark Moller
Special to washingtonpost.com
Tuesday, May 9, 2006 12:00 AM
On May 2, a three judge panel of the D.C. Circuit recognized that "a terminally ill, mentally competent adult patient's informed access to potentially life-saving . . . new drugs . . . warrants protection under the Due Process Clause." The decision stemmed from a case challenging FDA regulations, which require experimental drugs to go through a lengthy series of FDA managed clinical trials before they are available to patients. That red tape can be a death sentence for patients in dire need, whose lives may well depend on access to the new medicine.
Following some of the language of the D.C. Circuit's opinion, law professor-bloggers Jonathan Adler and Orin Kerr then described the case as a decision that recognizes a new "right to experimental drugs." A Washington Post editorial went further, charging that the D.C. Circuit pulled this right to experimental drugs "out of thin air," "call[ing] into question the whole fabric of drug regulation."
Let's take a deep breath. It's far from clear that the case will change the status quo a single jot or tittle.
To see what I mean, take a look at Cruzan v. Director, Missouri Department of Health, one of the key Supreme Court precedents cited in the D.C. Circuit's decision. The D.C. Circuit's decision could well turn out to be another Cruzan, where, in a landmark decision, the Supreme Court recognized that patients do indeed have a constitutional right to "refuse unwanted medical treatment." But the Court upheld the state's law anyway, ruling that Missouri's law was justified by its "unqualified interest in the preservation of human life."
Cruzan defies categorization: Its reasoning sounded radical, but its concrete outcome-- upholding Missouri law-- was anything but.
Like Cruzan, the D.C. Circuit's decision defies easy categorization. Yes, the D.C. Circuit held that patients have a constitutional right to access life-saving drugs. But, as in Cruzan, that's just the first step. Like the Missouri law in Cruzan, the FDA regulations will be upheld if the government can show these regulations serve an important state interest that outweighs sick patients' interests. This balancing test is what lawyers call "strict scrutiny."
One way the FDA may survive "strict scrutiny" is to show that the regulations somehow protect against use of drugs by patients who don't understand the risks involved. There's a rich debate about how people factor risks into their decision-making. Some psychologists claim people's assessment of risk can be shaped by how it is presented. (In one study, discussed by Dana Ziker in the Duke Journal of Law and Technology, 80% of students asked whether a "colorless, odorless, tasteless" chemical called dihydrogen monoxide that "causes thousands of deaths every year" should be banned said it should. Dihydrogen monoxide is a fancy name for ordinary water (H20).) Some studies also suggest that people may be poor judges of low probability, unknown, or difficult to quantify risks, which are of course inherent in the use of largely untested experimental drugs. The FDA therefore might argue that during early stages of clinical trials, patients simply don't have the information they need to assess risks and make an informed decision. The FDA's "expert" assessment, its lawyers might argue, can help correct this problem.
If courts accepted such an argument, it would be a travesty: dying people should surely be able to make up their own minds about these things. But my point is this: you shouldn't assume that strict scrutiny is always fatal in fact. The government has clever lawyers. "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 to regulations that impinge on "liberty interests" is a weaker variety -- especially where the state can come up with a plausible argument that its regulation helps protect vulnerable people's welfare. Thus, it's possible the endgame of this decision may leave room for government regulation -- including upholding the FDA regulations in their entirety. It's a revolution in embryo only.
This is one reason why the Supreme Court (and the full D.C. Circuit) would be wise to wait to review the decision until the trial court has balanced the state interests and the liberty interest recognized by the D.C. Circuit. That way we will better understand the implications of recognizing a liberty interest in the complex area of health and safety regulation. And it is also a reason why pundits should be cautious about describing the decision's import. The real action in this case is yet to come.
Mark Moller is a senior fellow at the Cato Institute and editor in chief of the Cato Supreme Court Review.