Issues
Whether the Controlled Substance Act authorizes the Attorney General to decide that physician-assisted suicide does not serve a "legitimate medical purpose," thereby nullifying an Oregon statute permitting this particular practice in some circumstances.
Congress enacted the Controlled Substance Act ("CSA") in 1970 as part of a comprehensive federal scheme to regulate and control certain drugs and other substances. A 1984 Amendment to the Act authorized the Attorney General to prohibit medical practitioners' use of a controlled substance if that use was "inconsistent with the public interest." 21 U.S.C. § 824(a)(4). In 2001, Attorney General Ashcroft determined that Oregon physicians' use of a federally registered controlled substance to facilitate physician-assisted suicide was not a legitimate medical purpose, despite an Oregon statute which authorized such use. In Oregon's suit, brought to enjoin Ashcroft from giving any legal effect to his directive, the District Court ruled for Oregon and issued a permanent injunction, and the Court of Appeals for the Ninth Circuit affirmed. Oregon argues that since states traditionally regulate medical practices, Gonzales (the new Attorney General, replacing Ashcroft) must show that Congress expressly intended to authorize the Attorney General to make such a determination. Gonzales argues that the Attorney General's reasonable interpretation of a federal regulation is entitled to deference, even without a clear statement of legislative intent, and that Ashcroft's interpretation of the CSA is reasonable. In the alternative, Gonzales argues that Ashcroft's interpretation is consistent with Congress's intent in passing the CSA and the 1984 Amendment. This case will decide the fate the Oregon statute by either expanding or limiting the federal government's authority over traditionally state-regulated medical practices. This case also has far-reaching moral and ethical implications that go beyond the scope of states' rights.
Questions as Framed for the Court by the Parties
Whether the Attorney General has permissibly construed the Controlled Substance Act, 21 U.S.C. 801 et seq., and its implementing regulations to prohibit the distribution of federally controlled substances for the purpose of facilitating an individual's suicide, regardless of state law purporting to authorize such distribution.
Facts
In 1970, Congress passed the Controlled Substance Act ("CSA") as part of a comprehensive federal scheme to regulate and control certain drugs and other substances. Under the CSA, physicians who prescribe controlled substances are considered "practitioners" who "dispense" controlled substances. 21 U.S.C. § 802(10) and (21). In order to obtain authorization to dispense such controlled substances, practitioners must register with the Attorney General and obtain a Drug Enforcement Agency ("DEA") certificate of registration. 21 U.S.C. § 822. In 1971, the then Administrator of the DEA adopted formal regulations for implementing the CSA, providing in part that "[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 C.F.R. § 1306.04.
The CSA has undergone many amendments since its enactment. Pertinent to this case, the 1984 amendments empowered the Attorney General to deny, suspend, or revoke a practitioner's DEA registration if the Attorney General "determines that the issuance of such registration would be inconsistent with the public interest." 21 U.S.C. § 823(f) ; see also 21 U.S.C. § 824(a)(1)(4).
In 1994, against this backdrop of federal regulations, Oregon enacted the Oregon Death with Dignity Act ("the Oregon Act"). See 3 Or. Rev. Stat. § 127.800 (1994). The Oregon Act provides a detailed procedure by which, upon a patient's request, physicians may prescribe lethal doses of a controlled substance to competent, terminally ill adult patients who, according to reasonable medical judgment, are within six months of dying. See §§ 127.805–885.
In July of 1997, several members of Congress sent letters to the Administrator of the DEA, urging him to declare that physician-assisted suicide violated the CSA. See Oregon v. Ashcroft , 368 F.3d 1118, 1123 (9th Cir. 2004). These letters included a memorandum that suggested an interpretation of the CSA that would render assisted suicide illegal. See Id. A few months later, the DEA Administrator indeed announced that physician-assisted suicide was not a "legitimate medical purpose" under the CSA and, accordingly, that the DEA had the authority to prosecute physicians who wrote prescriptions facilitating suicide. Id. Soon afterwards, the Department of Justice ("DOJ") reviewed the issue and the then U.S. Attorney General, Janet Reno ("Reno"), announced that the CSA did not mandate the DEA to prosecute physicians who acted in full compliance with the Oregon Act. See Id.
In 2001, the appointment of a new U.S. Attorney General, John Ashcroft ("Ashcroft"), brought a change of perspective. See Id. Ashcroft reversed Reno's position by issuing the Ashcroft Directive, a report in which Ashcroft concluded that "assisting suicide is not a legitimate medical purpose within the meaning of 21 C.F.R. § 1306.04 (2001)." Oregon, 368 at 1123 (citing 66 Fed. Reg. 56,607 ).
On November 7, 2001, Plaintiff, State of Oregon ("Oregon"), commenced this action by filing a complaint for declaratory and injunctive relief, together with a motion for a temporary restraining order to enjoin Ashcroft from giving any legal effect to the Ashcroft Directive. See Oregon v. Ashcroft, 192 F.Supp. 2d 1077, 1084 (D. Ore. 2002). After a full hearing on the matter in March of 2002, the District Court concluded that Ashcroft did not have the authority to override a state's decision concerning what constitutes "legitimate medical practice" and that Ashcroft exceeded his authority under the CSA in implementing the Ashcroft Directive. Id. at 1084. The Court then entered a Permanent Injunction. Id. Ashcroft appealed to the Ninth Circuit, which ordered affirmed the District Court. See Oregon v. Ashcroft, 368 F.3d at 1131.
Analysis
Statutory Interpretation of the Controlled Substances Act
The Court's decision in Gonzales v. Oregon, 368 F.3d 1118 (9th Cir. 2004), cert. granted, 125 S. Ct. 1299 (2005) will depend on how the Court interprets the CSA, 21 U.S.C. 801 et seq. The Court will examine the text of the CSA to determine whether or not the Attorney General has misread the language or the scope of the statute. The language at issue in the CSA refers to the restriction of controlled substances for "legitimate medical purposes" because this forms the basis for the Attorney General's interpretive ruling. 21 U.S.C. § 823.
Gonzales argues that distributing drugs for physician-assisted suicide is not a legitimate use of controlled substances. Reply Brief for the Petitioners at 12, Gonzales v. Oregon, No. 04-623 (August 25, 2005). Rather, Gonzales maintains that the use of controlled substances for such purposes violates the essence of the CSA and constitutes drug misuse. Id. at 45. Relying on the general purpose of the CSA, Gonzales first points to the fact that the statute was implemented to prevent the diversion of controlled substances from legal means to illegal channels. Id. at 45. He argues that the Oregon Act's authorization of controlled substances to end life rather than to preserve it is an inherently illegitimate use. Reply Id. at 19. This interpretation of the Oregon Act, 3 Or. Rev. Stat. §127.800 (1994), allows the Attorney General to subject Oregon physicians to criminal prosecution. Reply Brief for the Petitioners at 3, Gonzales v. Oregon, No. 04-623 (August 25, 2005). By pointing to the practices adopted in all the other states and to the fact that the medical community has not entirely accepted physician-assisted suicide as an acceptable medical practice, the Attorney General can make a strong case against the Oregon Act, Oregon being the only state allowing for physician-assisted suicide. Id. at 12.
Alternatively, Oregon might succeed in convincing the Court that the Attorney General has misconstrued the text of the CSA to override the will of the people of Oregon. Reply Brief for Respondent State of Oregon at 11, Gonzales v. Oregon, No. 04-623 (July 15, 2005). Oregon can support this argument by highlighting that the language of the CSA does not address the drugs at issue and also by focusing on the legislative impetus behind the act. Id. at 41. Clearly, Congress was concerned about the diversion of federally registered, controlled substances from legal purposes to illegal markets. Id. at 14-15. However, Oregon rejects the notion that CSA was enacted to prevent the state from regulating its own physicians' distribution of controlled substances to the terminally ill because this activity falls outside the range of activities that Congress prohibits through amendment to the CSA. Id. at 36-38.
Oregon's argument could expose the Attorney General's interpretation as legally incompatible with both the words and purpose of the CSA by demonstrating that typical drug addiction and general misuse is substantially different from what the Oregon Act allows. Id. at 14-15. The Oregon Act allows physicians to prescribe a controlled substance for a limited purpose—ending the suffering of the terminally ill. The Oregon Act was not drafted to create an illegitimate channel for commonly abused drugs. Id. at 18-19. Neither Oregon's physicians nor its terminally ill appear to have any interest in the resale of these controlled substances, and it would be very difficult to use the Oregon Act as a loophole to legally abuse narcotics due to strict state regulations. Id. at 18-19. Oregon argues that the Attorney General cannot show that its statute has led to increased drug trafficking or misuse of controlled substances within the state. Id. at 23.
Alternative Administrative Grounds for Justifying the Attorney General's Interpretation
Should the Attorney General fail to persuade the Court that he has acted within the scope of Congressional intent, he can still argue that his ruling should receive deference under the principles of administrative law. Gonzales may thus argue that his threatened action against the Oregon Act deserves substantial deference because it would fall within the purview of the Office of Attorney General. Reply Brief for the Petitioners at 21, Gonzales v. Oregon, No. 04-623 (August 25, 2005). There is a fine line between enforcing agency policy and creating law, and the Attorney General would have a harder time doing the latter while still arguing for substantial deference. Reply Brief for Respondent State of Oregon at 30-31, Gonzales v. Oregon, No. 04-623 (July 15, 2005).
The Attorney General also argues that the 1984 Amendment has left questions of inconsistency concerning "public interest" to his discretion, not that of the Secretary of Health and Human Services. Reply Brief for the Petitioners at 46-49, Gonzales v. Oregon, No. 04-623 (August 25, 2005). He points to the fact that the language of the CSA explicitly mentions the Attorney General and omits reference to the Secretary of Health and Human Services when delegating certain enforcement responsibilities. Id. at 46-49. Oregon, however, questions vesting such profound discretion over the use of controlled substances in the Attorney General rather than the Secretary of Health and Human services, suggesting that joint decision-making is preferable. Reply Brief for Respondent State of Oregon at 24, 41 Gonzales v. Oregon, No. 04-623 (July 15, 2005).
With respect to enforcement of agency policy, Oregon could counter that the Attorney General's reading of the CSA creates new law. Id. at 30-31. Oregon fears that adopting the Attorney General's interpretation of "a genuine medical use" would grant him the authority to remove the regulation of controlled substances from state legislatures altogether. Id. at 16.
The Attorney General maintains that the CSA authorizes one uniform national standard for monitoring all controlled substances. Reply Brief for the Petitioners at 24-27, Gonzales v. Oregon, No. 04-623 (August 25, 2005). However, the Court cannot ignore Oregon's argument that the CSA is being used to regulate illicit narcotics and to undermine state law which permits physicians to use the most practical means for physician-assisted suicide. Reply Brief for Respondent State of Oregon at 18-19, Gonzales v. Oregon, No. 04-623 (July 15, 2005). However, if the Supreme Court disagrees, then the Attorney General's interpretation should receive judicial respect since state law cannot completely frustrate the CSA's legitimate aims. Reply Brief for the Petitioners at 44, Gonzales v. Oregon, No. 04-623 (August 25, 2005).
Judicial Precedent Respecting the States' Assisted Suicide Choices
Oregon relies heavily on Washington v. Glucksberg (96-110) 521 U.S. 702 (1997), as judicial precedent for respecting the Oregon Act, even though that case upheld a state prohibition on physician-assisted suicide. Oregon argues that Glucksberg stands for the proposition that the choice to prohibit or permit physician-assisted suicide is better left to the states, largely due to the fact that the issue implicates their traditional police powers. Reply Brief for Respondent State of Oregon at 9, 40, Gonzales v. Oregon, No. 04-623 (July 15, 2005). States' police powers allow them to police the general welfare of their citizens, particularly in an area like medical practice. If the Court finds that the CSA authorizes the Attorney General to displace the Oregon Act within the context of physician-assisted suicide, this could open the doorway for the Attorney General to use the CSA in more expansive ways to further negate conflicting state law relating to narcotics. Reply Brief for Respondent State of Oregon at 41 Gonzales v. Oregon, No. 04-623 (July 15, 2005).
Federal Law Displacing State Law
Oregon must persuade the Court that enabling physicians to distribute controlled substances for physician-assisted suicide is a legitimate medical practice subject to state authority, as this would undercut the Attorney General's reliance on the uniformity of federal law over the Oregon Act. Id. at 38-39. The Attorney General will also have to overcome a presumption against state preemption, which is a general principle that federal law should not displace state law. Id. at 20-21. The presumption against preemption recognizes that the federal government should respect states' democratic choices and individual autonomy. Id. at 20-21. However, this principle may not be sufficient to carry the day for either side.
Discussion
Gonzales v. Oregon (formerly Oregon v. Ashcroft ), 368 F.3d 1118 (9th Cir. 2004), cert. granted, 125 S. Ct. 1299 (2005), requires the Supreme Court to decide whether the CSA permits the Attorney General to prohibit a state-approved practice of physician-assisted suicide. The answer will turn on close analysis of the language and legislative history of the CSA.
Oregon emphasizes that states have traditionally regulated medical practices and that regulation of assisted suicide should be no exception to this tradition. See Brief for Respondent State of Oregon at 27-28, Gonzales v. Oregon, No. 04-623 (July 15, 2005). Accordingly, Alberto Gonzales ("Gonzales" who replaced Ashcroft as Attorney General) has a heavy burden of showing that Congress clearly intended to give the Attorney General the power to invalidate the Oregon Act. Id . Oregon points to Congressional records and language in the CSA to support its assertion that Congress did not intend the result found in the Ashcroft Directive. Id . Gonzales argues that the U.S. Attorney General does not need to show that Congress clearly intended to grant her/him such authorization so long as her/his interpretation of the CSA is reasonable. Reply Brief for the Petitioners at 11, Gonzales v. Oregon, No. 04-623 (August 25, 2005). In this case, Gonzales argues that it was reasonable for Ashcroft to conclude that substances used to facilitate suicide, rather than to treat diseases, are not used for a legitimate medical purpose. Id. at 3.
At the very least, this case will decide the fate of the Oregon Act and whether physicians will be faced with criminal charges should they disobey the Ashcroft Directive. In doing so, the Court will either expand the Attorney General's authority to regulate medical practices under the CSA or limit her/his authority and reaffirm state sovereignty over medical practices. But beyond the narrow, statutory dimension of this case, Gonzales v. Oregon raises many moral and policy-related concerns that go beyond the scope of the CSA and states' rights.
Direct Effect on the Oregon Act
Gonzales supporters argue that a ruling for Gonzales will not nullify the Oregon Act, but will rather limit Oregon's physicians' choice of drugs. Brief Amici Curiae for the International Task Force on Euthanasia and Assisted Suicide at 6-7, Gonzales v. Oregon, No. 04-623 (May 9, 2005). After all, the Oregon Act does not specify that physicians must use federally controlled substances in assisting suicide; in fact, some evidence suggests that the sleeping pills used by Oregon's physicians may not even be the optimal drugs for assisted-suicide. Id .
The physicians who have joined the suit alongside Oregon, however, insist that a victory for Ashcroft will effectively render the Oregon Act useless. Brief for Respondents Peter A. Rasmussen, M.D., and David M. Hochalter at 17-18,Gonzales v. Oregon, No. 04-623 (July 21, 2005). Oregon asserts that all doctors who have aided patients under the Oregon Act have used the federally controlled substances in question and insist that forbidding physicians from using these substances would eliminate "the most effective and humane means of easing death." Brief for Respondent State of Oregon at 18-19.
Federal Uniformity v. State Sovereignty
Some medical practitioners argue that uniform federal regulation of medical practices is essential to curb the recent increase of abuse of pharmaceutical drugs. Brief Amicus Curiae of the Catholic Medical Association at 5-7, Gonzales v. Oregon, No. 04-623 (May 11, 2005). From their perspective, a victory for Oregon would not only compound this problem but also rob the federal government of all regulatory power over drugs which are regulated by state legislation. Id. at 8. Many lobbyist groups insist that it is the federal government's responsibility to outlaw a medical practice which has never been considered legitimate in the United States and which only one state has legalized. Brief Amicus Curiae of the International Task Force on Euthanasia and Assisted Suicide at 10, 14-15. Oregon's supporters, however, point to statistics that reflect a growing consensus among the medical and legal professions, and among Americans generally, that they consider physician-assisted suicide to be appropriate in some circumstances. Brief for the Patients-Respondents at 30-33, Gonzales v. Oregon, No. 04-623 (July 21, 2005). Furthermore, several states, regardless of their legislative stance on physician-assisted suicide, support Oregon's position that regulation of medical practices must remain at the state level in order to ensure that states can advance those medical procedures that its own citizens choose to support. Brief of the States of California, et al. at 3-4, 6-8 Gonzales v. Oregon, No. 04-623 (July 21, 2005).
Moral Dimension
Some argue that a victory for Oregon would enable "enterprising purveyors of death", alluding to Dr. Kevorkian and the like, to capitalize on the suffering of the terminally ill by marketing lethal substances to physicians and patients. Brief Amicus Curiae of the Catholic Medical Association at 9-10. Others believe that a victory for Oregon will result in a domino effect of unethical practices, not unlike the Netherlands' experience with legalized assisted suicide—an experiment which evolved to encompass infants, minors, and the mentally ill. Brief Amicus Curiae of the International Task Force on Euthanasia and Assisted Suicide at 21-25.
Some of Oregon's academic supporters believe that a victory for Gonzales would eliminate a unique opportunity to gather the empirical data necessary to either legitimize or disqualify the fears associated with assisted-suicide. Amicus Brief for Professors of Law Richard Briffault, et al. at 24-25,Gonzales v. Oregon, No. 04-623 (July 18, 2005). Other Oregon supporters argue that such fear is irrational since it disregards seven years of data that Oregon has already complied with regards to the Oregon Act, which reveals no evidence of abuse. Brief of Autonomy, Inc. and Cascade Aids Project as Amici Curiae at 10-12,Gonzales v. Oregon, No. 04-623 (July 21, 2005). Furthermore, the Oregon Act itself addresses fear of abuse by including a myriad of safeguards in the form of requirements and procedures for both physicians and patients. Id. at 12-14.
The Supreme Court is not likely to pass judgment on the ethical and moral issues that stimulate much of the impetus and public interest behind this case. More likely, the Court will address the statutory questions involving the scope of the CSA, the Attorney General's authority, and Oregon's sovereignty over a particular medical practice. It is the ethical dimension, however, that is likely to remain at the forefront of this case's historical significance.
Conclusion
On its face, Gonzales v. Oregon (formerly Oregon v. Ashcroft ), 368 F.3d 1118 (9th Cir. 2004), cert. granted, 125 S. Ct. 1299 (2005),is an intriguing case because it presents a clash of federal and state spheres of influence. On the one hand, the Attorney General has taken the position that Oregon's decision to permit physicians to distribute controlled substances for physician-assisted suicide is contrary to federal law. On the other hand, Oregon argues that the Attorney General has misinterpreted the CSA to invalidate state law that represents the democratic choice of the people of Oregon in the medical arena. These views present two different perspectives of the concept of federalism, while also implicating serious moral and policy concerns. Given framing of the central issues, the Court will not likely address this question on policy or moral grounds. The plain language of the CSA, Congressional intent and administrative law will all inform the Court's decision. The Court will likely avoid such slippery slope issues if favor of uniformity in the implementation of the CSA, perhaps a more preferable outcome to variable multi-state regulation. The safe route to resolving this case with the minimal amount of controversy suggests that change may be on the horizon for the Oregon Act.Written by:
Galit Avitan
Nick Wimbush