No Constitutional Right to Drugs:

The U.S. Court of Appeals for the D.C. Circuit has just released its long-awaited en banc decision in Abigail Alliance v. Eschenbach. As anticipated, the Court held 8-2, against the Abigail Alliance for Better Access to Developmental Drugs. The majority opinion, written by Judge Griffith, begins:

This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective. The district court held there is no such right. A divided panel of this Court held there is. 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 Rogers, joined by Chief Judge Ginsburg, dissented.

For some earlier posts on this case see here. More to follow.

UPDATE: For more past blogging on the case, see Randy Barnett's posts here and this post from Glenn Cohen (who worked on the case) from Prawfsblawg.

Some Thoughts on Abigail Alliance:

Here are some of my initial thoughts and reactions to the majority opinion in today's decision in Abigail Alliance v. Eschenbach. Next I'll post some thoughts and reactions on the dissent.

Abigail Alliance argues that terminally ill patients are typically willing to assume the risks of taking drugs that have not gone all the way through the approval process, and that this choice should be theirs to make, not the government's. I am exceptionally sympathetic to this claim as a policy matter, but I have trouble making the leap to their constitutional claim. It is tempting to adopt a "presumption of liberty" in cases like this, but such a presumption carries a risk of its own. Every time a court holds that a fundamental right is protected by the Constitution, it effectively removes this issue from the democratic process -- indeed, that is the point. This serves to protect rights, but it also functions to insulate erroneously recognized rights from correction. So, despite by strong libertarian leanings, I am more reluctant than many libertarians to read rights into the Constitution.

The question before the court, as framed by Abigail Alliance, was:

Whether the liberty protected by the Due Process Clause embraces the right of a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor, whether to seek access to investigational medications that the [FDA] concedes are safe and promising enough for substantial human testing.
At one level, Abigail Alliance's claim is for a constitutional right to life -- or right to take actions that may save one's life -- that imposes limits on the government's ability to prohibit a patient's access to new drugs. On the other hand, it is the drug company that must submit itself to the approval process, and terminally ill patients certainly have no constitutional right to drugs that have not yet been placed on the market by their manufacturers. If due to liability concerns or for some other reason manufacturers were not willing to make unapproved drugs available even if the FDA lifted its rules, terminally ill patients would be out of luck. Furthermore, any regulatory scheme that limits the ability of producers to sell or market products without government approval necessarily limits the ability of consumers to purchase such goods. Both parties to the potential transaction have their liberty constrained by such a rule. Nonetheless, such rules are quite common today.

In what strikes me as an important footnote (fn5), the majority rejects the dissent's effort to frame the issue as whether there is a "right to save one's life," as opposed to a"right to access experimental and unproven drugs in an attempt to save one's life." Accepting the former would be problematic, the majority maintains, because

If the asserted right is so broad that it protects a person's efforts to save his life, it might subject to strict scrutiny any government action that would affect the means by which he sought to do so, no matter how remote the chance of success.
Perhaps, but all this would mean is that such government actions are subject to strict scrutiny. Insofar as the government can demonstrate that FDA drug regulation is still necessary to protect the public at large from unsafe drugs, the regulatory scheme could still be upheld.

I think the majority is on fiarly strong legal ground in suggesting that it is a bit late in the game to suggest that the federal government's power to regulate pharmaceuticals is constrained by a fundamental right to potentially life-saving medical treatment.

our Nation's history evidences increasing regulation of drugs as both the ability of government to address these risks has increased and the risks associated with drugs have become apparent. Similarly, our legal traditions of allowing a necessity defense, prohibiting intentional interference with rescue, and recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process. . . .

Our Nation's history and traditions have consistently demonstrated that the democratic branches are better suited to decide the proper balance between the uncertain risks and benefits of medical technology, and are entitled to deference in doing so.

As much as I might like it if the federal government were barred from adopting regulatory schemes to protect us consumers from ourselves, such a principle would cut a whole swath out of the federal regulatory state.

Rejecting Abigail Alliance's claims necessarily means that there are people whose lives would have been saved had they had access to unapproved drugs. We don't know how many, but we can be quite certain the number is greater than zero. (Whether the net number of lives saved is negative or positive, however, is a separate question.) The delay between when a new drug is developed and when it is finally approved necessarily has consequences. If there are people who will be helped by a newly approved drug, then there are people who were not helped during the time it took for the drug to be approved. In the case of a life-saving drug, this means that there will be people whose lives could have been saved had the drug been approved earlier. More extensive testing and a prolonged approval process may help avoid the approval of a dangerous drug, but it also delays the benefits of a beneficial drug. There are health costs -- and potentially lives lost -- on both sides of the equation. One of the things that is interesting about this litigation is that it raises the questions the extent to which the Constitution constrains how a regulatory agency balances these trade-offs.

Jessie Hill on Abigail Alliance:

My colleague Jessie Hill, who has a forthcoming article on whether there is a constitutional right to make medical treatment decisions for oneself, offers the following thoughts about the Abigail Alliance decision.

It would probably be a gross understatement to say that most legal scholars will not be shocked by today's en banc decision in Abigail Alliance v. von Eschenbach. Yet, as I argue in a forthcoming article in the Texas Law Review (entitled "The Constitutional Right to Make Medical Treatment Decisions: A Tale of Two Doctrines"), there is ample support for the dissent's view that a long line of cases, including not only Roe v. Wade and Stenberg v. Carhart, but also Carhart v. Gonzales, and even, I might add, Jacobson v. Massachusetts, appear to recognize that the Constitution forbids government interference with individuals' attempts to protect their own health. The Abigail Alliance majority, however, points to cases denying access to medical marijuana and the unapproved cancer drug laetrile, and it distinguishes the abortion cases on the ground that here, there is "no proven therapeutic effect" for the forbidden medical treatment.

No proven therapeutic effect? In both Stenberg v. Carhart and Carhart v. Gonzales, the therapeutic value of the outlawed abortion procedure was hotly disputed. What is interesting about those cases is that the Court nonetheless allowed the plaintiffs to introduce evidence of medical efficacy, rather than simply deferring to the legislature's view. In the cases cited by the Abigail Alliance majority, by contrast, courts largely deferred to the legislature without considering any further medical evidence.

In my article, I argue that the question of how much deference should be given to the government when it finds medical facts is the key one lurking behind many cases dealing with the right to choose particular medical treatments, and it is one that is given insufficient attention by the courts. Rather, courts tend to reflexively view the issue as invoking government's traditional power to protect the public and, like the majority here, defer to the government's medical fact finding (which I refer to as the "public health" approach); or, alternatively, they view the issue as one growing directly out of the abortion and contraception cases and, like the dissent, at least carefully consider challengers' medical evidence challenging the government's evidence (which I refer to as the "autonomy" approach). In Abigail Alliance, there may be very good reasons for deferring to an administrative agency like the FDA regarding its view of the medical facts. Even if the result in Abigail Alliance may be the right one, however, it seems that the majority and dissent just talked past each other because of their failure to address the underlying disagreement over the appropriateness of deference -- in other words, who (doctors, administrative agencies, legislatures, courts) gets to decide whether a treatment in fact has sufficient therapeutic benefit.

Judge Rogers' Abigail Alliance Dissent:

Judge Judith Rogers' dissent in Abigail Alliance is quite strong. It also may be the only time she and Chief Judge Douglas Ginsburg find themselves allied against the rest of their court. Although I somewhat skeptical of the dissent's claims, I think it is worth quoting from the opening of her 29-page opinion at length.

Today, the court rejects the claim that terminally ill patients who have exhausted all government approved treatment options have a fundamental right to access investigational new drugs. The court's opinion reflects a flawed conception of the right claimed by the Abigail Alliance for Better Access to Developmental Drugs and a stunning misunderstanding of the stakes. The court shifts the inquiry required by Washington v. Glucksberg, 521 U.S. 702 (1997), by changing the nature of the right, by conflating the right with the deprivation, and by prematurely advancing countervailing government interests. The court fails to come to grips with the Nation's history and traditions, which reflect deep respect and protection for the right to preserve life, a corollary to the right to life enshrined in the Constitution. The court confuses this liberty interest with the manner in which the Alliance alleges that the liberty has been deprived, namely by denying terminally ill patients access to investigational medications under the narrow conditions described by the Alliance. The court conflates the inquiry as to whether a fundamental right exists at all with whether the government has demonstrated a compelling interest, when strictly scrutinized, rendering its restrictive policy constitutional.

These missteps lead the court to rely upon how rights and liberties have been limited and restricted — addressing regulations to prevent fraud in the sale of misbranded and adulterated medications or safety restrictions applicable to all medicines for any palliative purpose — which says little about the historic importance of the underlying right of a person to save her own life. . . .

In the end, it is startling that the oft-limited rights to marry, to fornicate, to have children, to control the education and upbringing of children, 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 have all been deemed fundamental rights covered, although not always protected, by the Due Process Clause, but the right to try to save one's life is left out in the cold despite its textual anchor in the right to life. This alone is reason the court should pause about refusing to put the FDA to its proof when it denies terminal patients with no alternative therapy the only option they have left, regardless of whether that option may be a long-shot with high risks. . . .

It bears outlining the history and common law basis for the Alliance's claim in order to demonstrate, once again, that the history and traditions of this Nation support the right of a terminal patient, and not the government, to make this fundamentally personal choice involving her own life. Because judicial precedents and the historical record require strict scrutiny before upsetting rights of this magnitude, the FDA must demonstrate a compelling governmental interest before its policy restricting access can survive.

Whether or not one agrees with Judge Rogers' conclusions, it is hard to deny that the right at issue here would seem to fit well among those unenumerated rights the Supreme Court has recognized before. Indeed, some right to voluntarily submit to medical treatment without government approval would seem to be a stronger candidate for constitutional protection than some of the other rights that have found court favor in the past. As I noted before the original panel opinion sought to vindicate the right asserted here without relying upon the Supreme Court's still-controversial sexual liberty and abortion cases, focusing instead on the narrower test established in Glucksberg. In the end, I am not sure the dissent's arguments in Abigail Alliance carry the day, but I think Judge Rogers makes a good go of it.

More on Abigail Alliance:

Lyle Denniston discusses the case at SCOTUSBlog here, and the AP covers the decision here.

There's also more commentary at Hit & Run, OpenMarket, and the Drug Law Blog.

UPDATE: Briefs, updates and other materials related to the case are available on the Washington Legal Foundation website here.

A Practitioner's Perspective on Abigail Alliance:

Private attorneys Mark Hermann and Jim Beck have an extensive post at the Drug and Device Law blog discussing some of the practical implications of the Abigail Alliance litigation. Among other things, their post helps explain why drug manufacturers did not support the Alliance's claims. Here's a taste of their comments:

The recognition of a constitutional right of access to entirely unapproved drugs would create a Catch-22 legal environment where, on the one hand a company definitely should provide warnings -- if only to protect itself from liability -- but the law absolutely forbids giving them.

Plainly, in addressing the claim of a broad, vague new constitutional right, neither side in Abigail Alliance gave much thought to the practicalities of the situation. In order to satisfy that right, would the manufacturer of an experimental drug be forever locked into providing it, even after it had decided not to proceed with commercialization? FDA good manufacturing practices are pretty strict. Unless manufacturing is turned over to some fly-by-night foreign operation (which nobody advocates), to keep a production process going for a minuscule population claiming constitutional entitlement is not a cheap proposition. So from a purely monetary standpoint, we're pleased that no new constitutional right is going to interfere with our clients' ability to allocate their limited resources available for research in favor of those drugs in the pipeline that appear to have the most promise.

Isn't that putting the crass commercial interests of drug companies ahead of the needs of desperately ill people? Well, if it is, then we're in good company -- eight of ten DC circuit court judges agree with us. Not bad for a couple of tort lawyers whose only real familiarity with constitutional law is limited to preemption and the First Amendment.

Further, we don't think so, for two reasons: (1) forcing an uneconomic reallocation of research dollars will ultimately result in fewer FDA approvable "safe and effective" drugs being discovered, something that would wind up hurting many more people than a few unapproved drugs could possibly help; and (2) creating an uncertain, litigation-charged environment around experimental drugs that might cure fatal diseases would have any number of unintended consequences -- from making enrollment in clinical trials more difficult, to driving the conduct of such trials out of the country altogether.

Nor does it hurt that we're defense lawyers, and this kind of pejorative rhetoric is something we've had thrown at us in practically every case we have to defend.

All of this is why, in the end, we think that notwithstanding some questionable reasoning, the court got it right. These plaintiffs, like so many others, have fallen prey to judicial triumphalism -- the notion that litigation and court decisions are the best way to solve any and all societal problems. The solution isn't for courts to create another undefined constitutional right enforceable through amorphous litigation. Rather, Congress should legislate, and the FDA should regulate to create an environment in which experimental drugs can be available for terminally ill patients under rational and economically sensible criteria, and in which drug companies can provide such drugs without the risk of being sued or being subject to administrative sanction.

Hermann and Beck also suggest that a recognition of a constitutional right to experimental drugs would lead to lawsuits against drug manufacturers from terminally ill patients demanding access to experimental drugs. While I have no doubt such cases would be filed — and they cite examples of such cases that have already been brought — I also have little doubt that drug manufacturers would prevail in such suits. Drug companies are not state actors. Legal recognition of a constitutional right that limits the government's ability to deny access to certain drugs does not create any affirmative obligations on drug manufacturers. I certainly understand why drug manufacturers would be wary of such suits — after all, even suits with little merit can be costly to defend against — I just don't think such suits would ever be successful.

UPDATE: I mistakenly attributed the post at Drug and Device Law blog to only one of the blog's two contributors, when it should have been attributed to both of them. I've corrected the error.

Roger Pilon on Abigail Alliance:

The Cato Institute's Roger Pilon takes to the WSJ editorial page to lambaste the D.C. Circuit's Abigail Alliance decision.

Judge Thomas Griffith, who had dissented in the earlier opinion but wrote now for the majority, recast the right at issue as "the right to access experimental and unproven drugs in an attempt to save one's life." Through such "tragic wordplay," as the dissent put it, the right ceases to be "fundamental," under Supreme Court precedents, because it is "not deeply rooted in the Nation's history and traditions."

So described, the right is not "deeply rooted," of course, because the very idea of "experimental and unproven drugs" implies a regulatory regime like the FDA, and that is a recent development. Yet as the dissent detailed, for most of our history individuals were free to take whatever drugs they wanted without a doctor's prescription. It was only in 1951 that Congress created a category of prescription drugs. Then in 1962 it began requiring drug companies to conduct extensive tests to ensure drug "efficacy," which led to long delays for drug approval and to the deaths of countless patients who would gladly have borne the unknown risks for a chance at life.

As a legal matter, what Judge Griffith achieved with his linguistic legerdemain was a shift in the burden of proof: No longer would the government need to justify its restrictions; the dying would have to try to overcome those restrictions. But that would be impossible because now the court would no longer strictly scrutinize the government's rationale. Rather, it would apply a "rational basis" test under which the government would win as long as it had any reason for restricting access. Deference so complete, the dissent noted, amounts to nothing less than "judicial abdication."

Plainly, the issues here go well beyond this case, which is doubtless why the court decided to rehear it en banc. And they go beyond liberal and conservative as well, as the mixed seven who joined Judge Griffith's opinion should indicate. What we have here, arguably, is a revolt of sorts by Judge Rogers and Chief Judge Ginsburg against what passes today for "constitutional law." Reducing that revolt to a simple question: Under a Constitution that expressly protects the right to life, how did we get to where government can effectively restrict the right, and the courts will do nothing?

. . . liberal jurists could rule against Abigail Alliance to ensure the dominance of the regulatory regime. Conservative jurists, viewing that regime as "settled law," could do likewise to avoid even the appearance of judicial activism. The approach of liberals is understandable: Long ago they abandoned the written for the "living" Constitution, which enables ad hoc adjudication, the rule of law notwithstanding. The approach of conservative "originalists," however, is less easily explained, since they purport to take the Constitution seriously.

For those without a WSJ Online subscription, Pilon's op-ed is also available on the Cato website here.

Abigail Alliance -- The Practitioners Respond:

Attorneys Jim Beck and Mark Hermann reply to the comment thread at this post critiquing their commentary on Abigail Alliance. They write in part:

We realize that no court has yet found a drug company to be a state actor in this context, but, until now, no one had created an environment in which scores of intelligent, motivated plaintiffs' counsel would be pursuing multiple theories to try to achieve that result. As our full post (not just the excerpt posted on Volokh) discussed, even without the constitutional right there's already been litigation -- so far unsuccessful, to be sure -- seeking to force drug companies to provide experimental drugs when they've decided to terminate clinical trials. This isn't some paranoid fantasy, as some of the Volokh commentators suggest.

If a court were to create a constitutional right for terminally ill patients to ingest experimental drugs, cases asserting that right will (quite properly) hold immense emotional appeal for the plaintiffs. Lawyers will line up left and right to take those cases, and judges will bend over backwards to find a remedy. We're litigators, that's something we know. . . .

We appreciate the constitutional subtleties involved in all of this, but, frankly, the companies put at the center of the fray -- those who invent and manufacture the drugs -- will spend years litigating their way out of this trap, if courts choose to create it. And even when they win, they lose, both in terms of $$$ spent on yet another way of keeping lawyers busy billing time, and in terms of bad publicity.

In my own defense, I would note that I acknowledged that suits of the sort Beck and Hermann (and their clients) fear have already been filed, and that drug companies' near-certain victory against such suits does not make them any less expensive to litigate. As I wrote: "I certainly understand why drug manufacturers would be wary of such suits — after all, even suits with little merit can be costly to defend against — I just don't think such suits would ever be successful."

Abigail Alliance and therapeutic cloning

What is most interesting about Rogers' dissent in Abigail Alliance (which in its essentials was the original panel's majority opinion) is that it would interpret a historical record showing a lack of regulation as evidence of a "tradition" supporting unrestricted liberty. (The dissent is correct that the historical record of regulation laid out by the majority shows only a tradition of prohibiting fraud, not a tradition of regulation to ensure efficacy and/or safety.) This move, if it had ultimately carried the day, would have provided support for finding a fundamental right of unimpeded access to new technologies, because there is no historical tradition of regulating these technologies.

I've thought about this argument in the context of attempts by Congressional conservatives to pass a law that would prohibit therapeutic cloning, the technique by which scientists seek to create an embryo with the genome of an adult cell and then harvest embryonic stem cells for research. No one has been able to make this process work in humans yet, but most scientists think it is possible and will be perfected sooner rather than later. The ultimate goal of therapeutic cloning is to one day be able to take a skin cell from a patient, create an embryonic stem cell line with the patient's genome, and then create individualized stem cell treatments that won't subject the patient to the problem of immune system rejection.

Would a Congressional prohibition of therapeutic cloning infringe a fundamental right? If we were to interpret a historical absence of regulation as equivalent to a history of affirmative support for an individual freedom, perhaps so: there is no tradition of the states or the federal government attempting to prevent anyone from seeking the health benefits of therapeutic cloning!

The Rogers' approach never had much of chance to survive review by either the en banc Circuit or the Supreme Court (although I am surprised that she and Ginsburg couldn't garner even one additional vote when the D.C. Circuit heard the case en banc). Here's an excerpt discussing the original panel decision from my forthcoming book, Stem Cell Century: Law and Policy for a Breakthrough Technology (which will be published by Yale University Press this fall):

As a practical matter, it seems unlikely that the U.S. Supreme Court would either uphold the D.C. Circuit [panel] ruling in Abigail Alliance or determine that the due process clause provides patients with a right to seek therapeutic cloning. The majority of justices currently serving on the U.S. Supreme Court have, in previous opinions, articulated a relatively narrow view of the substantive due process doctrine. Under this prevailing perspective, the only rights protected by the due process clause that are not explicitly enumerated in the Constitution are those specific rights that have been traditionally been recognized as such in Anglo-American law. In Washington v. Glucksberg, for example, the Court refused to recognize physician-assisted suicide as fundamental right under the due process clause, leaving legislatures to prohibit the practice if they see fit. The Court majority relied mainly on the observation that the practice of assisted suicide — and, indeed, suicide in general — enjoyed no historical tradition of support in the United States, or support in Great Britain prior to the American Revolution. More generally, the Court pronounced that substantive rights under the due process clause must be "deeply rooted in this Nation's history and tradition" and stated that constitutional rights cannot be "simply deduced from abstract concepts of personal autonomy."

The Abigail Alliance [panel] attempted to inoculate itself against the current Supreme Court's negative view of unenumerated rights by claiming that there is a "long-standing tradition in our Nation that would protect individual access to potentially life-saving medication." The factual support for this claim provided in the Abigail Alliance opinion is the lack of regulation of pharmaceuticals prior to the twentieth century, rather than any evidence of governmental recognition of an affirmative right. This approach turns the reasoning of Glucksberg on its head, shifting the burden of proof on the question of historical tradition from individuals claiming a right to government actors denying the existence of any such right, and it is not likely to be accepted by the Supreme Court's current majority.

For more on the policy and constitutional issues concerning therapeutic cloning, see my article Stem Cell Research and the Cloning Wars, 18 Stan. L. & Pol. Rev. 161 (2007), available on my SSRN page, or preorder the book on Amazon!