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Constitutional Flaw?
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Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no."1 In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals for the District of Columbia Circuit said "yes" (with one dissent).2 But when the full appeals court reconsidered the panel's decision, it said "no" (with two dissents).3

Where in the Constitution might such a right be found? If anywhere, in the fifth amendment's due process clause: "No person shall be . . . deprived of life, liberty, or property, without due process of law." This clause might seem only to impose procedural limits on how the government may take your life, liberty, or property. Nevertheless, twice in American history the Supreme Court has believed that the clause imposes substantive as well as procedural limits—that the clause limits what government may do as well as how it may do it.

The first period of "substantive due process" was the opening decades of the twentieth century, when the Court announced a person's right "to his personal liberty, . . . to enter into those contracts . . . which may seem to him appropriate." For example, New York sought to protect bakers' lungs by forbidding their employers to make them work more than sixty hours a week. The Court thought the statute "an unreasonable, unnecessary, and arbitrary interference with the right of the individual to his personal liberty" because bakers are "equal in intelligence and capacity to men in other trades" and can "assert their rights and care for themselves without the protecting arm of the state, interfering with their independence of judgment and of action. They are in no sense wards of the state."4

The second period of substantive due process began roughly with Roe v. Wade and continues today.5 The scope of today's clause is cloudy and controversial, but on one view it embodies a right to make important intimate decisions, like choices about abortion, contraception, marrying, and raising children.

Both versions of substantive due process protect individual autonomy as contemporaneously understood. But most law limits someone's autonomy in some way. Is most law really made unconstitutional by this expansive interpretation of the due process clause?

Of course not. For one thing, government may infringe any constitutional right with adequate justification. As Justice Holmes famously said, "The most stringent protection of free speech would not protect a man falsely shouting fire in a theater and causing a panic." But infringements of constitutional rights must generally meet a forbidding standard of justification. Can the Court really subject all legislation to that high standard?

Of course not. So the Court (somewhat erratically) uses a sorting device. When the government infringes a "fundamental" right, it must meet an onerous standard of justification—the infringement must be "necessary" to serve a "compelling state interest." Where the right is not fundamental, the government need only show that its infringement is "rationally related" to a "legitimate state interest." These terms are marvelously vague, but they are almost (in the law's cant) "outcome determinative." In practice, the government can rarely show a compelling state interest and can almost always show a legitimate state interest.

What makes a right "fundamental"? In Washington v. Glucksberg (the assisted suicide case), the Court said that first it "carefully" defines the right.6 Second, it asks whether the right is "'deeply rooted in this Nation's history and tradition' . . . and 'implicit in the concept of ordered liberty,' such that 'neither liberty nor justice would exist if they were sacrificed.'"

So is the Abigail Alliance right "fundamental"? The Food, Drug and Cosmetic Act requires that the FDA approve new drugs, ordinarily in three phases. "A Phase I study usually consists of twenty to eighty subjects and is 'designed to determine the...



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