ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS AND WASHINGTON LEGAL FOUNDATION, APPELLANTS v. ANDREW VON ESCHENBACH, IN HIS OFFICIAL CAPACITY AS COMMISSIONER, FOOD AND DRUG ADMINISTRATION AND MICHAEL O. LEAVITT, IN HIS OFFICIAL CAPACITY AS SECRETARY, U.S. DEPT. OF HEALTH AND HUMAN SERVICES, APPELLEES
No. 04-5350
United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued March 1, 2007 Decided August 7, 2007
Appeal from the United States District Court for the District of Columbia (No. 03cv01601)
Brian P. Brooks and Arthur W.S. Duff were on the brief for amici curiae John E. Calfee, et al. in support of appellants.
Jonathan F. Cohn, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General, Jeffrey A. Taylor, U.S. Attorney, Jeffrey S. Bucholtz, Principal Deputy Assistant Attorney General, Michael J. Ryan and Rhonda C. Fields, Assistant U.S. Attorneys, Mark B. Stern and Scott R. McIntosh, Attorneys, Daniel Meron, General Counsel, U.S. Department of Health and Human Services, Eric M. Blumberg, Deputy Chief Counsel for Litigation, and Karen E. Schifter, Associate Chief Counsel. R. Craig Lawrence, Assistant U.S. Attorney, entered an appearance.
Samuel D. Turner was on the brief for amici curiae American Society of Clinical Oncology, et al. in support of appellees.
William B. Schultz was on the brief for amici curiae National Organization for Rare Disorders, et al. in support of appellees.
Before: GINSBURG, Chief Judge, SENTELLE, HENDERSON, RANDOLPH, ROGERS, TATEL, GARLAND, BROWN, GRIFFITH, and KAVANAUGH, Circuit Judges.
Opinion for the Court filed by Circuit Judge GRIFFITH.
Dissenting opinion filed by Circuit Judge ROGERS, with whom Chief Judge GINSBURG joins.
GRIFFITH, Circuit Judge: 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, see Washington v. Glucksberg, 521 U.S. 702, 720-21 (1997) (quoting Moore v. East Cleveland, 431 U.S. 494, 503 (1977) (plurality opinion)), we affirm the judgment of the district court.
I.
A.
The Abigail Alliance for Better Access to Developmental Drugs (the “Alliance“) is an organization of terminally ill patients and their supporters that seeks expanded access to experimental drugs for the terminally ill. The Food, Drug, and Cosmetic Act (“FDCA” or “Act“), however, generally prohibits access to new drugs unless and until they have been approved by the Food and Drug Administration (“FDA“). See
But before a sponsor can even begin human testing, it must submit for the FDA‘s approval an investigational new drug application (“IND“), see
Clinical testing for safety and effectiveness requires three or sometimes four phases. See
Phase III studies are expanded clinical trials of several hundred to several thousand subjects designed to “gather ... additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician
labeling.”
Terminally ill patients need not, however, always await the results of the clinical testing process. The FDA and Congress have created several programs designed to
B.
Concluding that the FDA‘s current process for early access to new drugs was inadequate to meet the needs of its terminally ill members, the Alliance submitted its own proposals to the FDA. Those proposals culminated in a “citizen petition” to the FDA, see
The FDA never responded to the Alliance‘s citizen petition, but did respond to the Alliance‘s earlier submissions. After noting that a number of senior FDA officials
Relying upon its experience exercising its scientific and medical judgment in creating its regulations for experimental drugs and, in certain circumstances, exceptions to those regulations for the terminally ill, the FDA noted that “a reasonably precise estimate of response rate” and “enough experience to detect serious adverse effects” are “critical” in determining when experimental drugs should be made available. Id. For example, most experimental cancer drugs “have potentially lethal toxicity, with potentially large effects on a patient‘s remaining quality of life.” Id. Accordingly, “it does not serve patients well to make drugs too widely available before there is a reasonable assessment of such risks to guide patient decisions, and experience in managing them.” Id. at 4-5. The FDA concluded that accepting the Alliance‘s proposal “would upset the appropriate balance that [it is] seeking to maintain, by giving almost total weight to the goal of early availability and giving little recognition to the importance of marketing drugs with reasonable knowledge for patients and physicians of their likely clinical benefit and their toxicity.” Id. at 5.
Having thus been rejected by the FDA, the Alliance turned to the courts, arguing that the United States Constitution provides a right of access to experimental drugs for its members. In a complaint that mirrored much of its earlier submissions to the FDA, the Alliance argued that the FDA‘s lengthy clinical trials, combined with the “FDA‘s restrictions on pre-approval availability[,] amount to a death sentence for these [terminally ill] patients.” Am. Compl. ¶¶ 15-17. Nor, the Alliance argues, are the FDA‘s exceptions to the clinical testing process sufficient to provide the terminally ill the access they need because they “are small, when they exist at all,” and the ban on profits prevents many drug sponsors from participating. Id. ¶ 18.
“Terminally ill patients,” in the Alliance‘s view, “are typically willing to assume risks . . . .” Id. ¶ 19. Before the district court, the Alliance argued that the Constitution guarantees them the right to do so. The district court rejected that argument, holding that “there is no constitutional right of access to unapproved drugs.” Abigail Alliance for Better Access to Developmental Drugs v. McClellan, No. 03-1601, 2004 WL 3777340, at *1 (D.D.C. Aug. 30, 2004). A divided panel of this Court reversed, concluding that “where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient‘s informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause.” Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 445 F.3d 470, 486 (D.C. Cir. 2006). We vacated that decision and granted rehearing en banc. See Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, No. 04-5350 (D.C. Cir. Nov. 21, 2006).
As framed by the Alliance, we now consider:
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.
Appellants’ Br. at 1.5 That is, we must determine whether terminally ill patients have a fundamental right to experimental drugs that have passed Phase I clinical testing. If such a right exists, the Alliance argues that both
where there is an unreasonable risk of injury) and
II.
The Due Process Clause of the Fifth Amendment provides that “[n]o person shall be ... deprived of life, liberty, or property, without due process of law.”
As such rights are not set forth in the language of the Constitution, the Supreme Court has cautioned against expanding the substantive rights protected by the Due Process Clause “because guideposts for responsible decisionmaking in this unchartered area are scarce and open-ended.” Collins v. Harker Heights, 503 U.S. 115, 125 (1992) (citing Regents of Univ. of Mich. v. Ewing, 474 U.S. 214, 225-26 (1985)). There is an additional and substantial concern that courts must also consider: “By extending constitutional protection to an asserted right or liberty interest, we, to a great extent, place the matter outside the arena of public debate and legislative action.”
Glucksberg, 521 U.S. at 720. Thus, the Supreme Court has directed courts to “exercise the utmost care whenever we are asked to break new ground in this field, lest the liberty protected by the Due Process Clause be subtly transformed into the policy preferences of the [courts’ members].” Id. (quotation marks and citations omitted); see Moore, 431 U.S. at 502 (“As the history of the Lochner era demonstrates, there is reason for concern lest the only limits to such judicial intervention become the predilections of those who happen at the time to be Members of this Court.“) (footnote omitted).
In Glucksberg, the Supreme Court described its “established method of substantive-due-process analysis” as having “two primary features.” Glucksberg, 521 U.S. at 720.
First, we have regularly observed that the Due Process Clause specially protects those fundamental rights and liberties which are, objectively, 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. Second, we have required in substantive-due-process cases a careful description of the asserted fundamental liberty interest.
Id. at 720-21 (quotation marks and citations omitted).
We will assume arguendo that the Alliance‘s description of its asserted right would satisfy Glucksberg‘s “careful
description” requirement.6 Looking to whether the Alliance has demonstrated
A.
“We begin, as we do in all due process cases, by examining our Nation‘s history, legal traditions, and practices.”
Glucksberg, 521 U.S. at 710. The Alliance argues that its right can be found in our history and legal traditions because “the government never interfered with the judgment of individual doctors about the medical efficacy of particular drugs until 1962,” i.e., when major amendments were made to the Food, Drug, and Cosmetic Act. Appellants’ Br. at 44 (emphasis added); see id. at 23 (“[T]he common law consistently left judgments about the efficacy of medical treatments in the hands of individual doctors and their patients. Governmental review of the effectiveness of drugs did not exist in this country at all until 1962 . . . .“) (emphasis added).
The Alliance has little to say, however, about our Nation‘s history of regulating the safety of drugs. The Alliance‘s effort to focus on efficacy regulation ignores one simple fact: it is unlawful for the Alliance to procure experimental drugs not only because they have not been proven effective, but because they have not been proven safe. Although the Alliance contends that it only wants drugs that “are safe and promising enough for substantial human testing,” id. at 1, i.e., drugs that have passed Phase I testing, current law bans access to an experimental drug on safety grounds until it has successfully completed all phases of testing. See
Examining, as we are required to do under Glucksberg, our Nation‘s history, legal traditions, and practice with respect to the regulation of drugs for efficacy and safety, we conclude that our Nation has long expressed interest in drug regulation, calibrating its response in terms of the capabilities to determine the risks associated with both drug safety and efficacy.
Drug regulation in the United States7 began with the Colonies and States when
become “dangerous and intolerable.” EDWARD KREMERS, KREMERS AND URDANG‘S HISTORY OF PHARMACY 158 (4th ed. 1976).8 The Territory of Orleans (Louisiana) passed an act in 1808 requiring a diploma and an examination before permitting pharmacists to dispense drugs; Louisiana also prohibited the sale of deteriorated drugs and restricted the sale of poisons. Id. at 182-84, 214; see David L. Cowen, The Development of State Pharmaceutical Law, PHARMACY IN HISTORY, Vol. 37 No. 2, 1995, at 54 (noting that the 1808 act prohibited the sale of drugs that were “injured, moulded, discomposed, or sophisticated” and placed restrictions on the sale of “any suspicious or dangerous remedy“). South Carolina enacted legislation in 1817 requiring pharmacists to obtain licenses, KREMERS, supra, at 184, 214, followed by Georgia in 1825 and Alabama in 1852, id. at 214. By 1870, at least twenty-five states or territories had statutes regulating adulteration (impure drugs), and a few others had laws addressing poisons. Id. at 216. In the early history of our Nation, we observe not a tradition of protecting a right of access to drugs, but rather governments responding to the risks of new compounds as they become aware of and able to address those risks. See Cowen, supra, at 56 (“The history of state laws pertaining to pharmacy obviously reflect[s] the development of pharmacy scientifically, professionally, and economically.“).
Nor were the States the only regulators of access to drugs. Although early federal regulation was not extensive, perhaps
because “[n]ot until interstate commerce began its great expansion after the Civil War did the need for Federal rule-making become widely realized,” Wallace F. Janssen, Outline of the History of U.S. Drug Regulation and Labeling, 36 FOOD DRUG COSM. L.J. 420, 425 (1981), there are early examples of federal government intervention. In 1848, the Import Drug Act, ch. 70, 9 Stat. 237 (1848), banned “imported adulterated drugs” after a Congressional committee concluded that “this country had become the grand mart and receptacle of all the refuse [drug] merchandise ... , not only from the European warehouses, but from the whole Eastern world.” Wesley J. Heath,
The current regime of federal drug regulation began to take shape with the Food, Drug, and Cosmetic Act of 1938. See
We end our historical analysis where the Alliance would prefer it begin—with the 1962 Amendments to the FDCA. Undoubtedly, as the Alliance argues at length, Congress amended the FDCA in 1962 to explicitly require that the FDA only approve drugs deemed effective for public use. See Drug Amendments of 1962, Pub. L. No. 87-781, § 102, 76 Stat. 780, 781 (1962). Thus, the Alliance argues that, prior to 1962, patients were free to make their own decisions whether a drug might be effective.10 But even assuming arguendo that efficacy
regulation began in 1962, the Alliance‘s argument ignores our Nation‘s history of drug safety regulation described above. Nor can the Alliance override current FDA regulations simply by insisting that drugs which have completed Phase I testing are safe enough for terminally ill patients. Current law bars public access to drugs undergoing clinical testing on safety
But even setting the safety issue to one side, the Alliance‘s argument that effectiveness was not required before 1962 also fails under closer scrutiny. First, as a matter of history, at least some drug regulation prior to 1962 addressed efficacy. More importantly, an arguably limited history of efficacy regulation prior to 1962 does not establish a fundamental right of access to unproven drugs. The amendments made to the
It was not just advances in statistics and clinical trials, however, that improved governments’ ability to regulate access to drugs. The ability of scientists to “detect, identify, and understand” the components of various drugs has contributed to “new regulatory approaches [that] would not have been feasible and could never have occurred” without these scientific advances. Peter Barton Hutt, The Importance of Analytical Chemistry to Food and Drug Regulation, 38 VAND. L. REV. 479, 487 (1985). Further, the need for efficacy regulation became more pressing “[a]fter World War II [as] the number of drugs available, the range of diseases and conditions amenable to drug therapy, and the power of drugs all increased dramatically.” PETER TEMIN, TAKING YOUR MEDICINE: DRUG REGULATION IN THE UNITED STATES 5 (1980).
True, a lack of government interference throughout history might be some evidence that a right is deeply rooted. But standing alone, it cannot be enough. If it were, it would be easy to employ such a
B.
The Alliance next turns to several common law doctrines, arguing that barring access to experimental drugs for terminally ill patients is “inconsistent with the way that our legal tradition treats persons in all other life-threatening situations.” Appellants’ Br. at 31. Specifically, the Alliance argues that three doctrines—(1) the doctrine of necessity; (2) the tort of intentional interference with rescue; and (3) the right to self-defense—each support the recognition of a right to self-preservation. Such a right to self-preservation, the Alliance believes, would permit “persons in mortal peril . . . to try to save their own lives, even if the chosen means would otherwise be illegal or involve enormous risks.” Id. at 32. Specifically, in this case, the Alliance believes that a right to self-preservation would give the terminally ill a constitutionally protected right of access to experimental drugs.13
Looking first to the Alliance‘s necessity argument, the Alliance invokes the common law doctrine, which “traditionally covered the situation where physical forces beyond the actor‘s control rendered illegal conduct the lesser of two evils.” United States v. Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483, 490 (2001) (quoting United States v. Bailey, 444 U.S. 394, 410 (1980)). The Alliance offers, however, little detail about how necessity would apply to its case. See Appellants’ Br. at 37. (E.g., would terminally ill patients have a right to force drug companies to provide them with experimental drugs?) Nonetheless, the Supreme Court‘s analysis of the common law doctrine of necessity in Oakland leaves little room for the Alliance‘s argument that common law necessity could justify overriding the
In Oakland, a group of patients seeking access to marijuana for medicinal purposes argued that “because necessity was a defense at common law, medical necessity should be read into the
The Supreme Court rejected that argument because “[u]nder any conception of legal necessity, one principle is clear: The defense cannot succeed when the legislature itself has made a determination of values,” id. at 491 (quotation marks omitted). Although the Court limited its analysis to the statutory issue and did not address the defendant‘s constitutional arguments, see id. at 494, the learning of Oakland is clear. Congress may limit or even eliminate a necessity defense that might otherwise be available. That is precisely what the
The Alliance next invokes the tort of intentional interference with lifesaving efforts, which the Restatement of Torts defines as “intentionally prevent[ing] a third person from giving to another aid necessary to his bodily security.” RESTATEMENT (FIRST) OF TORTS § 326 (emphasis added). But that is not this case. The Alliance seeks access to drugs that are experimental and have not been shown to be safe, let alone effective at (or “necessary” for) prolonging life.15 Indeed, the
Finally, the Alliance looks to traditional self-defense principles to support its proposed constitutional right. The common law doctrine of self-defense provides that “[o]ne who is not the aggressor . . . is justified in using a reasonable amount of force against his adversary when he reasonably believes (a) that he is in immediate danger of unlawful bodily harm from his adversary and (b) that the use of such force is necessary to avoid this danger.” 2 WAYNE R. LAFAVE, SUBSTANTIVE CRIMINAL LAW § 10.4 (2d ed. 2003). Self-defense typically arises when a victim is being attacked by an aggressor and uses reasonable force to overcome immediate danger. The Alliance argues that self-defense permits victims to assume two types of risk: (1) the risk that the victim will kill the attacker; and (2) the risk that “[f]ighting back may dramatically increase the . . . harm” to the victim. Appellants’ Br. at 35-36. So, the argument goes, if victims of crimes are allowed to assume these risks in defending their lives, terminally ill patients should also be allowed to assume the risk that an experimental drug may hasten their deaths.
That self-defense principles should be applied in the medical context is evidenced, the Alliance argues, by the Supreme Court‘s abortion jurisprudence. The Alliance does not look to the “right of personal privacy” addressed in Roe v. Wade, 410 U.S. 113, 152 (1973). Instead, the Alliance argues that Roe “recognized another, entirely separate right to abortion: a woman‘s right to abort a fetus at any stage of a pregnancy if doing so is necessary to preserve her life or health.” Appellants’ Br. at 39 (emphasis in original).16 “That right,” the Alliance argues, “is grounded in traditional self-defense principles rather than privacy. . . .” Id. Applying that concept here, the Alliance argues that because its terminally ill members are in immediate danger of harm from cancer, they can use whatever medical means are necessary to defend themselves. Thus, they argue, even if a medical treatment might otherwise be prohibited by law, the doctrine of self-defense justifies access to that treatment, just as self-defense justifies an assault victim using physical force otherwise prohibited by law.
This analogy also fails because this case is not about using reasonable force to defend
III.
Although it has not addressed the precise constitutional argument urged by the Alliance, we find it highly significant that the Supreme Court has rejected several similar challenges to the
Because the Alliance‘s claimed right is not fundamental, the Alliance‘s claim of a right of access to experimental drugs is subject only to rational basis scrutiny. See Glucksberg, 521 U.S. at 722 (noting that “a challenged state action [must] implicate a fundamental right” to avoid rational basis review). The rational basis test requires that the Alliance prove that the government‘s restrictions bear no rational relationship to a legitimate state interest. See, e.g., Harrah Indep. Sch. Dist. v. Martin, 440 U.S. 194, 198 (1979); Glucksberg, 521 U.S. at 735. The challenged policy “need not be in every respect logically consistent with its aims to be constitutional. It is enough that there is an evil at hand for correction, and that it might be thought that the particular legislative measure was a rational way to correct it.” Williamson v. Lee Optical of Okla., Inc., 348 U.S. 483, 487-88 (1955).20
The Alliance acknowledges the risk inherent in taking experimental drugs. See Am. Compl. ¶ 19 (“Terminally ill patients are typically willing to assume risks . . . .“). The Alliance would rather that individual patients make decisions about this risk than have the
Applying the rational basis standard to the Alliance‘s complaint, we cannot say that the government‘s interest does not bear a rational relation to a legitimate state interest. That conclusion is compelled by the Supreme Court‘s decision in United States v. Rutherford, 442 U.S. 544 (1979). In that
Although terminally ill patients desperately need curative treatments, as Rutherford holds, their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit. Thus, we must conclude that, prior to distribution of a drug outside of controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug. We therefore hold that the
Although in the Alliance‘s view the
We must assume that, when the statute in question was passed, the legislature . . . was not unaware of these opposing theories, and was compelled, of necessity, to choose between them. It was not compelled to commit a matter involving the public health and safety to the final decision of a court or jury. It is no part of the function of a court or a jury to determine which one of two modes was likely to be the most effective for the protection of the public against disease.
Jacobson v. Massachusetts, 197 U.S. 11, 30 (1905); see also Gonzales v. Carhart, 127 S. Ct. 1610, 1636 (2007) (“The Court has given state and federal legislatures wide discretion to pass legislation in areas where there is medical and scientific uncertainty.“); cf. Greenwood v. United States, 350 U.S. 366, 375-76 (1956) (“The only certain thing that can be said about the present state of knowledge and therapy is that science has not reached finality of judgment . . . . Certainly, denial of constitutional power to Congress in dealing with a situation like this ought not to rest on dogmatic adherence to one view or another on controversial psychiatric issues.“). Consistent with that precedent, our holding today ensures that this debate among the Alliance, the
V.
For the foregoing reasons, the judgment of the district court is affirmed.
So ordered.
ROGERS, Circuit Judge, with whom Chief Judge GINSBURG joins, dissenting: 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. Likewise, in its treatment of the common law doctrines of necessity, interference with rescue, and self defense, the court points to evolved limitations on those doctrines while ignoring the core concerns that animate them, namely the special importance of life and attempts to preserve it. That the ultimate protection of such varying attempts to save life is cabined by the precedents—regarding what constitutes “necessity,” the related “necessity” of any aid being given to a third party, and the “reasonable” and “necessary” limitations on any force used in self-defense—does not suggest the absence of an underlying right to attempt to protect life, but rather the recognition of competing governmental interests that in various circumstances justify the deprivation of or a limitation upon the right.
The common law doctrines remain good evidence of a history and tradition of protecting life and attempts to preserve life as a deep-seated personal right. That the right may be and has been denied in the face of compelling governmental interests is no reason for conflating the two stages of the analysis and looking only to the results of past cases in order to avoid the analysis prescribed by the Supreme Court in Glucksberg, 521 U.S. at 720-21. Contrary to today‘s view of the court and the Federal Drug Administration (“FDA“), nothing in the prior opinion of the court would give “total weight” to the interests of the terminal patients or deny the
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
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
I.
The
A.
The Glucksberg analysis begins with a “‘careful description’ of the asserted fundamental liberty interest.” 521 U.S. at 721-23. As the court‘s opinion in this case demonstrates, the description of the right is of crucial importance—too broad and a right becomes all-encompassing and impossible to evaluate; too narrow and a right appears trivial. See Abigail Alliance I, 445 F.3d at 477. The court asserts that “[t]his case is about whether there is a constitutional right to assume ‘enormous risks’ in pursuit of potentially life-saving drugs.” Op. at 28 (emphasis in original) (citation omitted). This description can be characterized as “careful” only if the objective of Glucksberg analysis is to produce abstractions that
shield a court from acknowledging the rights underlying a party‘s claims. As the court notes, fundamental rights cannot be “solely based upon ‘abstract concepts of personal autonomy.‘” Op. at 23 n.13 (quoting Glucksberg, 521 U.S. at 725). However, were it impermissible to draw any inferences from a broader right to a narrower right, nearly all of the Supreme Court‘s substantive due process case law would be out of bounds. See, e.g., Moore, 431 U.S. at 503 (extrapolating specific right to determine extended family living arrangements from broader constitutional protection for “the sanctity of the family“); Roe v. Wade, 410 U.S. 113 (1973) (identifying specific right to terminate a pregnancy from broader right to privacy); Griswold v. Connecticut, 381 U.S. 479, 484-86 (1965) (inferring specific right to use contraception from general right to be free from intrusion into “sacred precincts of marital bedrooms“). In any event, the Alliance‘s liberty claims are not grounded in the abstract notion of personal autonomy but rather in the specific right to act to save one‘s own life.
The court fundamentally misunderstands the right claimed by the Alliance and trivially casts it as a function of the regulatory scheme. See Op. at 14 n.6. But the Alliance should not be penalized for anticipating a justification for infringing the right that might survive strict scrutiny. Applying the court‘s reasoning today, had “Jane Roe” been prescient enough to claim a right to abort a pre-viable fetus by a procedure that is demonstrably safer than all other alternatives, cf. Gonzales v. Carhart, 127 S. Ct. 1610, 1638 (2007), she would have failed to show a fundamental right to an abortion.2 Again, the claimed fundamental right is to attempt to preserve one‘s life; whether the risks associated with doing so justify restraining that right is properly considered only after the right is deemed fundamental. Under Glucksberg, the court‘s analysis should begin with an assessment of whether the right to attempt to preserve life can be found in the Nation‘s history and tradition. See Abigail Alliance I, 445 F.3d at 479. A
- The heritage of this right predates the Founding. Samuel Adams referred to “the duty of self preservation” as “the first law of nature.” Samuel Adams, The Rights of the Colonists: Report of the Committee of Correspondence to the Boston Town Meeting, 7 OLD SOUTH LEAFLETS 417 (No. 173) (Burt Franklin 1970) (1772). The common law‘s eminent commentator, William Blackstone, wrote of three “principal or primary articles” historically comprising “the rights of all mankind.” First among these was “[t]he right of personal security . . . in a person‘s legal and uninterrupted enjoyment of his life, his limbs, his body, [and] his health.” WILLIAM BLACKSTONE, 1 COMMENTARIES *129. Blackstone described the guarantee of “[t]he preservation of a man‘s health from such practices as may prejudice or annoy it.” Id. at *134. This right included the right to self-defense and the right to self-preservation. “For whatever is done by a man to save either life or member, is looked upon as done upon the highest necessity and compulsion.” Id. at *130.
This principle is of early vintage, for “Anglo-American law starts with the premise of thorough-going self determination.” Natanson v. Kline, 350 P.2d 1093, 1104 (Kan. 1960). Long before regulation of the efficacy of medications was contemplated by the federal government, courts recognized with “universal acquiescence” that “the free citizen‘s first and greatest right, which underlies all others,” is “the right to the inviolability of his person, in other words, his right to himself.” Pratt v. Davis, 118 Ill. App. 161, 166 (1905), aff‘d, 79 N.E. 562 (Ill. 1906). So too, this court has recognized “the concept, fundamental in American jurisprudence, that ‘[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body.‘” Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir. 1972) (alteration in original) (quoting Schloendorff v. Soc‘y of N.Y. Hosp., 105 N.E. 92, 93 (1914) (Cardozo, J.)).
- This historical entitlement recognized in the legal tradition of this Nation is reflected in rights recognized at common law that are retained by an individual. Most notably, the right of self-defense enforces the right of a person facing death to take reasonable steps to protect her own life. Although this right is not unqualified, self-defense has been described as “an inherent right of man, older than states or Constitutions.” People v. Pignatoro, 136 N.Y.S. 155, 160 (Magis. Ct. 1911). The privilege extends, of course, to repelling the attacks of aggressors, see, e.g., Brown v. United States, 256 U.S. 335, 343-44 (1921); cf. Montana v. Egelhoff, 518 U.S. 37, 56 (1996) (plurality opinion), but also protects incursions into the property of others, see, e.g., Ploof v. Putnam, 71 A. 188, 189 (Vt. 1908) (“This doctrine of necessity applies with special force to the preservation of human life. . . . One may sacrifice the personal property of another to save his life or the lives of his fellows.” (citation omitted)); Mouse‘s Case, 12 Co. Rep. 63, 77 Eng. Rep. 1341, 1342 (K.B. 1609) (deciding that it is lawful to throw overboard property of another for safety of lives of passengers); RESTATEMENT OF TORTS § 197 (1934). See generally George C. Christie, The Defense of Necessity Considered from the Legal and Moral Points of View, 48 DUKE L.J. 975 (1996). Although the concept of self-defense is most often thought of in terms of the response to an assault by another human being, its premise compels the same response in the face of other forms
of aggression against life and limb, whether the aggressor be an animal3 or a diseased cell within one‘s body. There is, accordingly, no reason to think that the efforts of Alliance members to repel their terminal diseases do not implicate this concept.
Aside from asserting that this case is not about efforts to preserve one‘s life, but rather the “right to assume any level of risk,” the court further avoids the doctrines of self-defense and necessity by asserting that Congress can override the common law. See Op. at 26. This is true but irrelevant. It was also true in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990), in which the Supreme Court discussed the fundamental right to refuse life-sustaining medical treatment, id. at 278. When the Court recognized that the common law tort of battery supported the fundamental right to refuse medical treatment, id. at 269, it did not constitutionalize the tort of battery. Similarly, recognizing that necessity has historically been protected does not constitutionalize the doctrine of necessity. Yet the court resists the implications of the historical protection for actions prompted by necessity out of an unwarranted fear that acknowledging the historical record will constitutionalize the common law. See Op. at 22-23, 26. In so doing, it forgets the second part of the Glucksberg inquiry. A tradition of protection does not alone establish a fundamental right. The subsequent determination of whether a right is “implicit in the concept of ordered liberty” invalidates the court‘s fears of a slippery slope.
The common law also recognized the right of protection against interference with rescue. This right is infrequently invoked, but as early as 1889, it was acknowledged by the highest court of the State of Maryland, which explained that even prolongation of a fading life was not to be obstructed:
Surely the law does not authorize the husband to say to his wife: “You shall die of the cancer; you cannot be cured, and a surgical operation affording only temporary relief, will result in useless expense.” The husband had no power to withhold from his wife the medical assistance which her case might require.
State v. Housekeeper, 16 A. 382, 383-84 (Md. 1889). The Restatement of Torts, published in 1934, generalized this point of law: “One who, without a privilege to do so, intentionally prevents a third person from giving to another aid necessary to his bodily security, is liable for bodily harm caused to the other by the absence of aid which he has prevented the third person from giving.” RESTATEMENT OF TORTS § 326; see also id. § 327 (negligence); RESTATEMENT (SECOND) OF TORTS §§ 326, 327; W. PAGE KEETON ET AL., PROSSER AND KEETON ON THE LAW OF TORTS 382 (5th ed. 1984). This common law rule is firmly grounded.4 By interposing itself
The common law protection, of course, is for rescues that are reasonably necessary. In an effort to distinguish this historical protection, the court relies upon the fact that the new investigational drugs “have not been shown to be safe, let alone effective at (or ‘necessary’ for) prolonging life.” Op. at 25. But this confuses what is necessary with what is sufficient. This is not a case about elective medical treatments. Without access, Alliance members will die. No doubt the deceased members of the Alliance who were denied access to experimental drugs that were subsequently approved by the FDA would have been surprised to learn that these drugs, under the court‘s analysis, were unnecessary to the preservation of their lives. See Br. of Appellants at 31 n.15; Reply Br. of Appellants at 23. See generally Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 469 F.3d 129 (D.C. Cir. 2006) (“Abigail Alliance II“). Thus, the court‘s apparent understanding of the meaning of “necessity” is manifestly flawed. See Op. at 25 n.15. By the court‘s reasoning, it is not “necessary” for the driver of a car that is hurtling toward a cliff to press the brake because we “cannot know until after” he has done so whether the car will stop in time. Alliance members, like the endangered driver, will perish without remedial steps. The question presented in this case is not whether investigational drugs are necessary to a terminally ill patient who has exhausted conventional treatment options — they are — but who will make the subsequent decision about using these medications, the patient with her doctor or the government. Moreover, as Prosser and Keeton have explained, “[t]he principle [that one may not prevent aid by others] has been carried even to the length of holding that there is liability for interfering with the possibility of such aid.” KEETON ET AL., supra, at 382.
Throughout its discussion of self-defense and interference with rescue, the court recognizes that common law rights are not unlimited but fails to acknowledge that the evolved limitations on hallowed rights do not undercut the core concerns that animate them — here, the special importance of life and attempts to preserve it. That the ultimate protection of such varying attempts to save life is cabined by precedents discussing “necessity” speaks not to the absence of an underlying right to attempt to protect life but rather to the recognition of competing governmental interests that in various circumstances justify the deprivation of or a limitation upon the right. Whether similar countervailing interests exist in this case is a question bearing on the resolution of strict scrutiny analysis, not on whether it should apply.
- Although the Supreme Court has not squarely addressed the right to use potentially life-saving medications, it has developed a sizable body of law regarding the right to a potentially life-saving medical procedure when the life or health of a pregnant woman is on the line. In Roe, 410 U.S. at 164-65, and again in Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 846, 880 (1992), the
Court held that even after fetal viability, a state cannot constitutionally proscribe abortion “where it is necessary, in appropriate medical judgment, for the preservation of the life or health of the mother,” Roe, 410 U.S. at 164-65; Casey, 505 U.S. at 879 (plurality opinion); accord Ayotte v. Planned Parenthood of N. New Eng., 546 U.S. 320, 327-28 (2006). In so doing, the Court acknowledged the tradition of “preserving the life of the mother,” Roe, 410 U.S. at 137 (quoting Rex v. Bourne, [1939] 1 K.B. 687 (Crim. App.)), both in the common law, see id., and in early state statutes, see id. at 138 (citing “model” legislation enacted in New York in 1828).
In Stenberg v. Carhart, 530 U.S. 914 (2000), the Supreme Court squarely addressed whether a state may ban a particular medical procedure in cases where a patient‘s health or life is endangered. The Court held that “the governing standard requires an exception ‘where it is necessary, in appropriate medical judgment for the preservation of the life or health of the mother.‘” Id. at 931 (quoting Casey, 505 U.S. at 879). There, the State of Nebraska could not constitutionally ban particular abortion procedures, notwithstanding the state‘s “interest in the potentiality of human life,” id. at 930, even though the state claimed that there were adequate alternatives, id. at 931-32. Here, the situation is even starker: The Alliance‘s terminally ill members have no remaining alternatives except the medications to which the FDA denies them access. This Term all nine justices of the Supreme Court agreed that controlling precedents forbid the government from banning an abortion procedure “if it ‘subject[ed] [women] to significant health risks,‘” Gonzales v. Carhart, 127 S. Ct. at 1635 (quoting Ayotte, 546 U.S. at 328) (alterations in original); accord id. at 1641-42 (Ginsburg, J., with whom Stevens, Souter, and Breyer, JJ., join, dissenting), and the Court repeatedly emphasized the availability of safe alternative procedures before approving the ban, see id. at 1636, 1637, 1638. The right sought by the Alliance pertains only to those for whom no such alternatives exist.
Consequently, for the court to conclude that the Supreme Court has not already decided that medical self-preservation is fundamental, the court is forced to conclude that when a patient‘s life is on the line, medical procedures like abortion are to be analyzed differently than medical treatments consisting of prescription medications. To draw this distinction, the FDA offers only the empty assertion that “the right to abort a fetus to save the life or health of the mother is simply an aspect of the underlying constitutional right of abortion recognized in Roe.” Brief for Appellees at 39. This ipse dixit cannot be reconciled with the fact that a woman‘s right to end a life-threatening pregnancy has long been uncontroversial in the face of state statutory prohibitions against abortion and distinct from the considerations that otherwise bear on the procedure. “The criminal abortion laws passed in every state by 1880 made exceptions for therapeutic abortions performed in order to save a woman‘s life.” LESLIE J. REAGAN, WHEN ABORTION WAS A CRIME 5 (1997). Reaching farther back into history, as the Supreme Court discussed in Roe:
The Ephesian, Soranos, often described as the greatest of the ancient gynecologists, appears to have been generally opposed to Rome‘s prevailing free-abortion practices. He found it necessary to think first of the life of the mother, and he resorted to abortion when, upon this standard, he felt the procedure advisable.
410 U.S. at 130. This approach continued into the modern era. When England imposed criminal sanctions for abortion in 1861, it provided no explicit exception for pregnancies that endanger the life or health of a mother. Offenses Against the Person Act of 1861, 24 & 25 Vict., c. 100, § 59. Nonetheless, an English court determined that the statute could not include procedures necessary to save the woman‘s life, because “as in the case of homicide, so also in the case where an unborn child is killed, there may be justification for the act.” Bourne, [1939] 1 K.B. at 690. This history suggests, contrary to the FDA‘s view, that a woman‘s right to an abortion as an act of medical self-defense is independent from her right to an abortion based upon her right to make deeply personal decisions, see Casey, 505 U.S. at 581.
The court chooses not to distinguish the abortion cases on this flimsy basis but its approach is no less startling. The court holds that because the Alliance seeks access only to “potentially life-saving drugs,” Op. at 28 (emphasis in original), the abortion cases are distinguishable. Nowhere in the Supreme Court‘s jurisprudence has it intimated that the government may ban procedures that represent a patient‘s only chance of survival because they might not be successful. The fundamental right does not accrue only upon a demonstration of surefire actualization; the trigger is the necessity, which is crucially different from the sufficiency to which the court repeatedly refers. Indeed, in Stenberg, the Supreme Court addressed the level of medical consensus needed for a procedure to become protected, holding that procedures supported by “substantial medical authority” could not be proscribed. See 530 U.S. at 938. The Court was careful not to require medical unanimity, see id. at 937, or even “general medical studies,” see id. at 935, like those required for FDA approval of investigational new drugs for commercial marketing, see
Although the FDA does not contend that its approval process reflects the Stenberg standard, the court nonetheless makes the wholly unsupported assertion that “the collective judgment of the scientific and medical communities [is] expressed through the FDA‘s clinical testing process.” Op. at 26. To the contrary, the Alliance specifically alleges in attachments to its complaint that the FDA has denied terminally ill Alliance members access to investigational new drugs “reported to have great potential,” Decl. of Carole Steele ¶ 3, and acknowledged by the “medical community” as “far and away superior to anything then available,” Decl. of Victoria Jean Doran ¶ 2. At this stage of the proceedings, the court is required to accept the Alliance‘s allegations as true. See, e.g., Broudy v. Mather, 460 F.3d 106, 116 (D.C. Cir. 2006). Thus, there are situations where a terminally ill patient seeks access to a new medication that has not yet been approved by the FDA for commercial marketing but that has been recognized by the medical community as that patient‘s best chance to survive. In such instances, the Fifth Amendment guarantee of due process protects the terminally ill patient‘s pursuit of those medications.
There is, then, no merit to the FDA‘s suggestion adopted by the court that in the medical context there can be no deeply rooted privilege to attempt to save one‘s
B.
Against this substantial historical record demonstrating the deep roots of the right to preserve one‘s own life, it is no coincidence that neither the court nor the FDA can marshal evidence from the early history of the Nation demonstrating that the federal government or any state thought to restrain the terminally ill from accessing medical treatments and procedures that had not proven unsafe but were of unknown efficacy. Still, the court asserts that “a lack of government interference . . . cannot be enough” to demonstrate that a right is deeply rooted. This reasoning is misguided.
First, the most fundamental rights are those that no government of the people would contemplate abridging — it is doubtful that many courts or legislatures have discussed whether the government can determine whether we are allowed to breathe air, but this does not make our access to oxygen any less grounded in history. Cf.
Second, the Supreme Court‘s statements on fundamental rights do not support the court‘s conclusion. In Glucksberg itself, the Supreme Court determined that the claimed right to assisted suicide was not deeply rooted because “for over 700 years, the Anglo-American common-law tradition has punished or otherwise disapproved of both suicide and assisting suicide.” 521 U.S. at 711. In the Court‘s words: “[W]e are confronted with a consistent and almost universal tradition that has long rejected the asserted right, and continues explicitly to reject it today, even for terminally ill, mentally competent adults.” Id. at 723. But the Supreme Court did not say, as the FDA argued and this court appears to agree, that a right can be fundamental only if it has been acknowledged by statute or decisional law. A plurality of the Supreme Court said the opposite in Michael H. v. Gerald D., 491 U.S. 110, 122 n.2 (1989), in observing that historical “protection need not take the form of an explicit constitutional provision or statutory guarantee, but it must at least exclude . . . a societal tradition of enacting laws denying the interest.”
Fourth, in the alternative, the court shifts the target and looks to historical evidence of regulation for safety. The court claims that post-Phase I testing is designed not only to test a drug‘s efficacy but also to continue monitoring its safety. Op. at 15. As support, the court lists instances in which drugs have been removed from the market after Phase I because of safety concerns. See id. at 20 n.11. This inquiry confuses the right to save one‘s life with the alleged deprivation, which here occurs by means of an agency policy. Whether the FDA policy actually impermissibly infringes upon the asserted right is a factual question that is not properly resolved at the motion-to-dismiss stage when all reasonable inferences must be drawn to the plaintiff‘s benefit, see, e.g., Broudy, 460 F.3d at 116.5
Furthermore, safety restrictions are applicable
By redirecting its inquiry, the court conveniently avoids the sparse history of drug regulation for efficacy. See Abigail Alliance I, 445 F.3d at 481-83. Prior to 1906, there was essentially no drug regulation in the United States save protections against fraud and adulteration.6 In 1906, Congress enacted the Pure Food and Drug Act (“1906 Act“), ch. 3915, 34 Stat. 768 (repealed 1938), which prohibited misbranded and adulterated foods or drugs from entering interstate commerce, id. § 2, 34 Stat. at 768, and prohibited false and misleading labeling, id. § 8, 34 Stat. at 770. For a small number of particularly dangerous drugs, the 1906 Act required the labels to identify the drug‘s ingredients and quantities. Id. The statute also authorized the Bureau of Chemistry, a predecessor of the FDA, to seize nonconforming goods and to recommend federal prosecution of those who violated the 1906 Act. Id. § 4, 34 Stat. at 769. The 1906 Act did not, however, limit individual access to new drugs or regulate therapeutic claims by drug manufacturers. Cf. United States v. Johnson, 221 U.S. 488 (1911). It thus appears that a patient still could obtain access to any new drug for medicinal use, even if the drug had no therapeutic benefit, albeit subject to the controls placed on narcotics by the Harrison Narcotic Act of 1914, ch. 1, 38 Stat. 785.7
Only in 1962 did Congress require drug manufacturers to provide empirical evidence of the effectiveness of a drug as opposed to evidence of the drug‘s safety.11 The Kefauver-Harris Amendments, Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified in scattered sections of
Despite the increased federal scrutiny of new drugs, important aspects of patient access to drugs are unregulated by the government and appear always to have been unregulated. The “FDA‘s regulatory authority . . . extends to manufacturers of drugs but not to the physicians who dispense them.”14 Thus, a doctor may — and
For more than half of this Nation‘s history, then, until the enactment of the 1906 Act, a person could obtain access to any new drug without any government interference whatsoever. Even after enactment of the FDCA in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs’ efficacy. Rather, at that time, the FDA could interrupt the sale of new drugs only if it determined that the new drug was unsafe. Government regulation of such drugs premised on concern over a new drug‘s efficacy, as opposed to its safety, is of very recent origin. Even today, a patient may use a drug for unapproved purposes where the drug may be unsafe or ineffective for the off-label purpose. In short, encumbrances on the treatment decisions of a patient and her physician lack the historical pedigree of the rights that the Alliance seeks to vindicate.
Instead of confronting this history, the court relies on statutory restrictions that address misbranded or adulterated drugs, sales of poisons, and fraudulent curative claims, see Op. at 17-18 & n.8, government restrictions that are not inconsistent with the right of a person to attempt to save her own life. None of the cited restrictions, focusing largely on the licensing of pharmacists, suggest a physician could not prescribe a new medication for a terminal patient. While Congress has imposed increased responsibilities on the drug industry and the FDA upon evidence of tragic consequences of some new drugs as a result of new technology, see Abigail Alliance I, 445 F.3d at 482, the FDA does not regulate physicians, id. at 483, and off-label prescription of medications is a long-standing practice that has not been outlawed, id. Elsewhere the court relies on straw men that are either acknowledged by the court to be irrelevant, Op. at 17 n.8 (an incident in 1630 not the result of “legislative or regulatory intervention“); or are in fact irrelevant, id. at 30 n.18 (discussing “affirmative access claim[s]” even though the Alliance makes no such claim); or are speculative, id. at 21 n.12 (noting “a more plausible explanation for the limited efficacy regulation“); see also Amicus Br. for Economists John E. Calfee et al. This analysis hardly overcomes the history and Constitutional recognition of the underlying right to life that the Alliance claims.
The common law traditions protecting necessity, forbidding interference with rescue, and supporting self-defense, and the Supreme Court‘s validation of the fundamental
II.
For a right to be fundamental, the Glucksberg analysis requires that it also be “‘implicit in the concept of ordered liberty,’ such that ‘neither liberty nor justice would exist if they were sacrificed,‘” Glucksberg, 521 U.S. at 721 (quoting Palko, 302 U.S. at 325, 326). The Supreme Court has explained that this expression “encompasses and protects the personal intimacies of the home, the family, marriage, motherhood, procreation, and child rearing.” Paris Adult Theatre I v. Slaton, 413 U.S. 49, 65 (1973). It also safeguards the “freedom of thought and speech,” Palko, 302 U.S. at 326, and “[t]he security of one‘s privacy against arbitrary intrusion by the police,” Wolf v. Colorado, 338 U.S. 25, 27-28 (1949), overruled on other grounds by Mapp v. Ohio, 367 U.S. 643 (1961). In the context of criminal trials, matters “implicit in the concept of ordered liberty” include “the right to counsel at trial,” Teague v. Lane, 489 U.S. 288, 311 (1989) (plurality opinion) (quoting Mackey v. United States, 401 U.S. 667, 693-94 (1971) (opinion of Harlan, J.)); the presumption that “all are innocent until the state has proved them to be guilty,” United States v. Salerno, 481 U.S. 739, 763 (1987); and “[t]he principle that a State may not knowingly use false evidence, including false testimony, to obtain a tainted conviction,” Napue v. Illinois, 360 U.S. 264, 269 (1959).
Unlike Glucksberg‘s historical inquiry, this step assesses whether the Alliance‘s claimed right is a component of the “compendious expression for all those rights which the courts must enforce because they are basic to our free society.” Wolf, 338 U.S. at 27. As Justice Frankfurter wrote, these rights create “a realm of sanctuary surrounding every individual and infrangible, save in a very limited class of circumstances, by the agents of government.” Monroe v. Pape, 365 U.S. 167, 208-09 (1961) (Frankfurter, J., dissenting), maj. op. overruled by Monell v. Dep‘t of Soc. Servs., 436 U.S. 658 (1978).
Setting aside the textual anchor of the Alliance‘s claim in the right to life, the claimed right also falls squarely within the realm of rights implicit in ordered liberty. The core of liberty is autonomy. As Professor Charles Fried writes, “[l]iberty is the exercise of our powers as self-conscious, judging individuals, individuals who in making our own lives cannot be responsible to anyone . . . else except as we choose to be.” CHARLES FRIED, MODERN LIBERTY 180 (2007). It is difficult to imagine any context in which this liberty interest would be stronger than in trying to save one‘s own life. Cf. BRIAN CLARK, WHOSE LIFE IS IT ANYWAY? (1978).
The Supreme Court engaged in similar analysis in Cruzan. In evaluating the claim that due process protects a person‘s right to refuse life-sustaining treatment, the Court reasoned that “it cannot be disputed that the Due Process Clause protects
In summary, there is no logic to be found, in view of oft-limited rights considered inherent in the nature of ordered liberty, see Abigail Alliance II, 469 F.3d at 136-37, in the conclusion that the right to save one‘s life is unprotected notwithstanding the specific protection afforded life in the Fifth Amendment to the Constitution.
III.
For these reasons, I have serious disagreements with the court‘s assessment of the Alliance‘s claim to a fundamental right protected by the Fifth Amendment to the Constitution. It is no more than tragic wordplay to suggest that the Alliance‘s liberty claim to potentially life prolonging medications, when no other government approved alternatives exist, does not involve a corollary to the right to life enshrined in the Fifth Amendment to the Constitution. See Op. at 11 n.5. Denying a terminally ill patient her only chance to survive without even a strict showing of governmental necessity presupposes a dangerous brand of paternalism. As the court phrases it, because “[w]e . . . cannot know until the clinical testing process has been completed that these drugs are necessary,” Op. at 25 n.15 (emphasis added), the terminally ill patient, informed by her physician, is denied a right to decide whether to bear those risks in an attempt to preserve her life. Such intervention is directly at odds with this Nation‘s history and traditions giving recognition to individual self-determination and autonomy where one‘s own life is at stake and should extend no further than the result in this case. Because the right of a terminally ill patient to access potentially life-saving investigational medications satisfies the Glucksberg test, I would remand this case for the district court to assess in the first instance whether there exists a compelling governmental interest, narrowly tailored, to overcome the Alliance‘s interest. Flores, 507 U.S. at 302. Accordingly, I respectfully dissent.
Notes
A person may assert self-defense rights against animals. See, e.g., People v. Lee, 32 Cal. Rptr. 3d 745, 754-55 (Ct. App. 2005); Credit v. Brown, 10 Johns. 365 (N.Y. Sup. Ct. 1813).The Secretary shall make appointments to each panel ... so that each panel shall consist of—
(A) members who are qualified by training and experience to evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as clinical and administrative medicine, pharmacy, pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;
(C) a representative of consumer interests, and a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel; and
(D) two or more members who are specialists or have other expertise in the particular disease or condition for which the drug under review is proposed to be indicated.
Expanded Access to Investigational Drugs, 71 Fed. Reg. 75,147-01, 75,147 (Dec. 14, 2006).propos[ed] to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The proposed rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies.