New limit on rights of the dying heads to Court
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.
I would be surprised to see cert granted in this case.
Conservatives on the Court are generally hostile to the creation of new rights, especially when they interfere with the operations of a pro-typically technocratic administrative agency in a situation where Congress has the power to act. So they have no reason to grant certiorari in order to reverse the D.C. Circuit, and hearing a case that affirms the status quo would likely be considered a waste of time on a small docket.
Liberals on the Court, knowing that to grant cert is likely to affirm the D.C. Circuit, have no reason to prevent the law from evolving in other circuits.
Proponents of “a right to save one’s life” would have a stronger case in, for example, a defense to a controlled substances act or unlicensed practice of medicine prosecution involving an experimental drug or procedure that was working at the time, than in this case. This case really involves a right to have the government get out of the way of third party efforts to invent drugs with which you could save your life, notwithstanding a regulatory scheme that has some rational basis, which is a considerably more attenuated matter.
Comment by Andrew Oh-Willeke — August 7, 2007 @ 8:10 pm
While I hate to quibble with your generally excellent reporting, Mr. Denniston’s careful and detailed account of this decision is disserved by the headline, “NEW LIMIT on rights of dying heads to Court.” This suggests that the Court of Appeals decision cut back on some preexisting, recognized right. For whatever the merits of petitioners’ claims, that is not correct. Rather, as Mr. Denniston’s topic sentence accurately explains, it is the petitioners who are seeking “new” or at least heretofore unknown) “limits” on the FDA’s authority over drugs. As Mr. Denniston put the matter: “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.” Mr. Denniston’s description is more accurate. The FDA has had and exercised the regulatory authority at issue in the case for a long time. There is no court decision or other positive law recognizing the limit on this authority claimed by petitioners. Thus, for whatever the merits of petitioners’ claims, the court of appeals did not impose some “new limit” of its own on dying persons’ rights but rather refused to overturn on constitutional grounds a preexisting limit on their rights resulting from the FDA’s exercise of regulatory authority granted by statute.
Comment by Lee Liberman Otis — August 8, 2007 @ 7:08 pm
The court’s decision certainly looks like a new limit on the right to live to me. (By “right to live,” I am referring to the right to “life” expressly mentioned in the text of the Fifth Amendment, not a made-up right emanating in the penumbra and waiting to be discovered by an activist judge).
The idea that terminally ill people, who are going to die anyway, can be prevented from voluntarily contracting with a drug-maker to buy an experimental drug that is their last, best hope for survival (and has passed an initial safety review) is bonkers, and would have struck the founding fathers as ludicrous and government despotism run amok.
The Court’s opinion eviscerating the right to live is fully of shoddy reasoning. The Court claims its decision does not infringe patients’ constitutional right to life, even though the FDA bans drugs that doctors view as the last, best hope for their patients, because “the collective judgment of the scientific and medical community is expressed through the FDA’s clinical testing process.”
As former FDA official Henry Miller has noted, survey after survey has shown that doctors think the FDA is too slow in approving drugs, as critics of the court’s decision have noted. Doctors emphatically DO NOT view the FDA’s ponderous processes as reflecting the “collective judgment of the scientific and medical community.”
Indeed, the plaintiffs submitted affidavits from doctors that promising drugs existed for their patients that the FDA was blocking, making their patients’ death inevitable. The court ignored these affidavits, and similar allegations in the plaintiffs’ complaint, in granting a motion to dismiss their challenge (which was contrary to Rule 12(b)(6)).
The FDA is accountable to politicians, not the medical or scientific communities, and it thus has every institutional incentive to delay approval of needed drugs, rather than implementing the judgment of the scientific or medical communities.
No FDA bureaucrat has ever been fired for delaying approval of life-saving drugs. By contrast, FDA officials know they are sure to be chastised by publicity-seeking congressmen in the rare case in which the FDA approves a drug too soon that turns out to have unanticipated safety risks.
As the dissent pointed out, it is deeply ironic that the federal courts have recognized a host of rights not mentioned in the text of the Constitution, such as the rights “to perform varied sexual acts in private and to control one’s own body even if it results in one’s own death or the death of a fetus,” even while “the right to save one’s life is left out in the cold despite its textual anchor in the right to life.”
The court majority attempted to distinguish away those other rights recognized by the courts, like the right to refuse unwanted medical treatment even when that results in one’s death, by claiming that a ban on experimental drugs involves “affirmative access” to a “commercial good” rather than the “freedom” from “forced medical treatment.”
That is an absurd distinction. If the judges in the court majority were denied the right to use their own money to buy food, and thus condemned to starvation, no one would argue that their right to live was not infringed merely because buying food involves “affirmative access” to a “commercial good.”
Most constitutional rights necessarily involve “access” to a “commercial good.” A newspaper can’t exercise its First Amendment right to publish unless it is allowed to buy “commercial goods” like newsprint and paper from willing sellers. A political candidate can’t communicate with voters without spending money on ads. And it is well-established that the First Amendment protects “access” to such “commercial goods.”
The plaintiffs didn’t seek welfare or any affirmative entitlement from the government. All they sought was the right to voluntarily contract with private sellers to obtain life-saving drugs.
Comment by Hans Bader — August 9, 2007 @ 11:13 am
I didn’t mean to be arguing one way or the other on what should happen here and I wasn’t suggesting it’s not a limit. I was only pointing out 1)that it’s not a limit imposed by the Court of Appeals, but rather one imposed by the FDA; and 2) it assuredly is not a NEW limit.
Comment by Lee Liberman Otis — August 9, 2007 @ 12:36 pm
The idea that terminally ill people, who are going to die anyway, can be prevented from voluntarily contracting with a drug-maker to buy an experimental drug that is their last, best hope for survival (and has passed an initial safety review) is bonkers, and would have struck the founding fathers as ludicrous and government despotism run amok.
Why, then, don’t women have the liberty to contract voluntarily with doctors to remove an unwanted fetal parasite?
Comment by Jacques McKenzie — August 9, 2007 @ 4:15 pm
Messrs Bader, McKenzie,
1. There *is* a downside to allowing free contract between patients and drug companies. That downside is disruption of an orderly process that identifies from the chemicals tested the few safe, effective agents and discards the many toxic or ineffective agents. Disruption of the FDA testing process by allowing use of drugs that have survived Phase 1 testing would delay or abort identification of useful agents that actually are effective cancer chemotherapy drugs. Such disruption would harm a vast, though somewhat inchoate, class of people who will get cancer and would benefit from identification of useful drugs. This population has rights as well. It is probably true that the current cancer drug approval program will deliver a greater benefit to tmore cancer patients than would release of post-Phase 1 agents. It seems to be a narrowly structured to serve the important government interest of identifying effectivce treatments for cancer.
2. Assuming, arguendo, a right to self defense that encompasses some sort of right of patients to access treatment, Abagail is be a bad case to assert that right. First, substances that survive Phase I screening are not “safe.” Rather, they are safe enough to be used in further testing at the dose identified in the Phase 2 trial. Many of these substances are subsequently found to be too dangerous to use clinically. Second, the vast majority of these agents are not “drugs,” if drugs are agents that provide a therapeutic effect. The vast majority are found not to be effective. Rather, they are chemicals that have a finite but small chance of possessing properties that would allow them to be used as drugs. The FDA has a program to systematically demonstrate or refute the possibility that these substances are drugs. Agents that survive Phase 2 testing are better suited to test Mr. Bader’s proposition.
3. The analogy to abortion is weird. Termination of pregnancy, (whether or not you think is appropriate) clearly has the effect on the mother and fetus that the mother and doctor intend. It is a widely used procedure whose effects and complications are well understood. A better analogy would be whether a doctor should be allowed to give a pregnant woman, for the purpose of terminating her pregnancy, a chemical that had been used in a few hundred rodents and feser than 50 people (in escalating dosages). It is stipulated that the agent didn’t kill the 3 to 5 people who received it at the proposed dosage, and that succeeded in aborting some pregnancies in some of the rodents. That is what these Phase 1 agents comprise.
–Allan Jacobs
Comment by Ajacobs — August 9, 2007 @ 4:58 pm