Gonzales - v - Oregon

Doctrine: Even if a drug falls within the Controlled Substances Act, a doctor can prescribe it for a patient if it is allowed in the context of assisted suicide for terminally ill individuals under state law.


Facts:
1.      Oregon became the first State to legalize assisted suicide when voters approved a ballot measure enacting the Oregon Death With Dignity Act (ODWDA). ODWDA exempts from civil or criminal liability state-licensed physicians who, in compliance with the specific safeguards in ODWDA, dispense or prescribe a lethal dose of drugs upon the request of a terminally ill patient.
2.      The drugs Oregon physicians prescribe under ODWDA are regulated under a federal statute, the Controlled Substances Act (CSA or Act). The CSA allows these particular drugs to be available only by a written prescription from a registered physician.
3.      On November 9, 2001, without consulting Oregon or apparently anyone outside his Department, the Attorney General issued an Interpretive Rule announcing his intent to restrict the use of controlled substances for physician-assisted suicide.
4.      The United States District Court for the District of Oregon entered a permanent injunction against the Interpretive Rule’s enforcement.
5.       A divided panel of the Court of Appeals for the Ninth Circuit granted the petitions for review and held the Interpretive Rule invalid. 

Issue: Whether or not the Controlled Substances Act allows the United States Attorney General to prohibit doctors from prescribing regulated drugs for use in physician-assisted suicide, notwithstanding a state law permitting the procedure.
Held: NO!

Ratio:
-          CSA creates a comprehensive, closed regulatory regime criminalizing the unauthorized manufacture, distribution, dispensing, and possession of substances classified in any of the Act’s five schedules. The Act places substances in one of five schedules based on their potential for abuse or dependence, their accepted medical use, and their accepted safety for use under medical supervision.
-          Congress classified a host of substances when it enacted the CSA, but the statute permits the Attorney General to add, remove, or reschedule substances. He may do so, however, only after making particular findings, and on scientific and medical matters he is required to accept the findings of the Secretary of Health and Human Services (Secretary).
-          To prevent diversion of controlled substances with medical uses, the CSA regulates the activity of physicians. To issue lawful prescriptions of drugs, physicians must “obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him.” 
-          When deciding whether a practitioner’s registration is in the public interest, the Attorney General “shall” consider:
a)      The recommendation of the appropriate State licensing board or professional disciplinary authority.
b)      The applicant’s experience in dispensing,
or conducting research with respect to controlled
substances.
c)      The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
d)      Compliance with applicable State, Federal, or local laws relating to controlled substances.
e)      Such other conduct which may threaten the public health and safety.
-          The Attorney General has rulemaking power to fulfill his duties under the CSA. The specific respects in which he is authorized to make rules, however, instruct that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.
-          The Interpretive Rule is an interpretation of the substantive federal law requirements for a valid prescription. The Interpretive Rule thus purports to declare that using controlled substances for physician-assisted suicide is a crime, an authority that goes well beyond the Attorney General’s statutory power to register or deregister.
-          Oregon’s regime is an example of the state regulation of medical practice that the CSA presupposes. Rather than simply decriminalizing assisted suicide, ODWDA limits its exercise to the attending physicians of terminally ill patients, physicians who must be licensed by Oregon’s Board of Medical Examiners.
-          The statute gives attending physicians a central role, requiring them to provide prognoses and prescriptions, give information about palliative alternatives and counseling, and ensure patients are competent and acting voluntarily. Any eligible patient must also get a second opinion from another registered physician, and the statute’s safeguards require physicians to keep and submit to inspection detailed records of their actions.
-          The prescription requirement is better understood as a provision that ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. The provision also bars doctors from peddling to patients who crave the drugs for those prohibited uses.
-          The Government’s interpretation of the prescription requirement fails under the objection that the Attorney General is an unlikely recipient of such broad authority, given the Secretary’s primacy in shaping medical policy under the CSA, and the statute’s otherwise careful allocation of decision making powers.

Note: I made this case digest when I was still a law student. The ones posted on my blog were not due for submission as part of any academic requirement. I want to remind you that there is no substitute to reading the full text of the case! Use at your own risk.