New limit on rights of the dying heads to Court
on Aug 7, 2007 at 2:59 pm
In a ruling that will now be appealed to the Supreme Court, the D.C. Circuit Court on Tuesday refused to recognize a new constitutional right for dying patients to have access to experimental drugs not yet cleared by the government for general public use. The en banc, 8-2 decision exposed a deep rift within the Circuit Court on how to define a newly claimed constitutional right. The majority treated the issue as a narrow claim to a right to have access to experimental drugs not yet found to be safe, while the dissenters argued that nothing less than “a right to save one’s life” was at stake.
The ruling came in Abigail Alliance, et al., v. Eschenbach, et al. (Circuit docket 04-5350). The ruling can be found on the “All Opinions” page of the Circuit Court, under that docket number for Tuesday’s date, at this site. (Howard Bashman has a direct link to the opinion on the How Appealing blog.)
The Alliance — formally, the Abigail Alliance for Better Access to Developmental Drugs — has been engaging in a years-long dispute with the Food and Drug Administration over early access to new drugs when terminally ill patients have run out of other treatment options. The Alliance seeks access for such patients to new drugs that have cleared FDA’s so-called “Phase I” review — that is, after FDA had found a new drug to be safe enough to justify continued human testing. This may be months, or years perhaps, before such a drug is actually cleared for commercial marketing after a finding that it is safe and effective. FDA not only has refused to relax access rules for such patients, but also bars profits by any drugmaker from selling experimental drugs. After failing to get access through FDA, the Alliance (named for a University of Virginia student who died of cancer in 2001 at age 21) along with the Washington Legal Foundation sued FDA in federal court. The District Court dismissed the claim three years ago.
A three-judge panel of the D.C. Circuit, in a 2-1 ruling in May 2006, found a constitutional right under the Due Process Clause for “terminally ill patients to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational new 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 on a substantial number of human beings.” The majority opinion, written by Circuit Judge Judith W. Rogers, found support for that right in the Supreme Court’s 1990 decision establishing a right to refuse life-sustaining medical treatment (Cruzan v. Missouri Department of Health).
Last November, however, the en banc Circuit Court vacated that decision, and ordered rehearing, leading to Tuesday’s ruling, written by Circuit Judge Thomas B. Griffith (who had dissented in the panel decision). Circuit Judge Rogers, joined by Chief Circuit Judge Douglas H. Ginsburg, who was in the panel majority, dissented.
“Because we conclude that there is no fundamental right ‘deeply rooted in this Nation’s history and tradition’ of access to experimental drugs for the terminally ill,…we affirm the judgment of the District Court,” Judge Griffith wrote at the opening of a 36-page opinion. Judging the FDA’s policy by a rational basis standard, the Court upheld it.
Frank Burroughs of Fredericksburg, Va., who was Abigail’s father and who now is president of the Abigail Alliance, said Tuesday that “we will be going forward” with a petition for review in the Supreme Court. “Most of the judges [on the Circuit Court] tragically missed the merits of the case,” resulting in a “terribly flawed” ruling, he contended. (He noted that the Alliance is also seeking a legislative solution in Congress, but that no bill has yet cleared a committee.)
Judge Griffith’s opinion suggested that even the Alliance’s description of the right it was seeking — keyed to current FDA policy — was constitutionally flawed, raising these questions: “How can a constitutional right be defined by an administrative regulation that is subject to change? Would an FDA decision requiring increased testing for safety and efficacy before the commencement of human clinical trials affect the Alliance’s constitutional right? Moreover, we find it difficult to imagine how a right inextricably entangled with the details of shifting administration regulations could be ‘deeply rooted in this Nation’s history and tradition and implicit in the concept of ordered liberty’ ‘” — the standard a claimed right must meet before it can be recognized under the Due Process Clause.
To the dissenters’ argument that the right being sought was actually “a right to try to save one’s life,” the majority countered that a right that broad “might subject to strict scrutiny any government action that would affect the means by which [a person] sought to do so, no matter how remote the chance of success.” In the end, Judge Griffith wrote, “this case is about the right to access experimental and unproven drugs in an attempt to save one’s life.” That does not have a firm foundation in history or tradition, he concluded.
The dissenters said that the Court should have focused on the claim of a fundamental right, not on whether the government has deprived terminally ill patients of such a right. Once a right is found, a court can then judge whether its deprivation was justified, the dissenters said, arguing that the majority had conflated the two inquiries. Focusing upon how a right or liberty has been limited or restricted in the past, Judge Rogers wrote, “says little about the historic importance of the underlying right of a person to save her own life.” It is that basic right, she argued, that the Alliance was seeking to establish.
