# Petition for Writ of Certiorari — Gonzales v. Oregon

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0051%3A02

## Record

- **Collection:** Supreme Court brief
- **Document type:** Petition for Writ of Certiorari
- **Published:** January 1, 2006
- **Citation:** 546 U.S. 243

## Text

NOV 9 ~ 2004
No.

In the Supreme Court of the Anited States

JOHN ASHCROFT, ATTORNEY GENERAL, ET AL.,
PETITIONERS

v.

STATE OF OREGON, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

PAUL D. CLEMENT

Acting Solicitor General
Counsel of Record

PETER D. KEISLER
Assistant Attorney General

EDWIN S. KNEEDLER
Deputy Solicitor General

GREGORY G. KATSAS
Deputy Assistant Attorney
General

DOUGLAS HALLWARD-DRIEMEIER
Assistant to the Solicitor
General

MARK B. STERN
JONATHAN H. LEVY
Attorneys

Department of Justice

Washington, D.C. 20530-0001
(202) 514-2217

Yi

QUESTION PRESENTED

Whether the Attorney General has permissibly construed
the Controlled Substances Act, 21 U.S.C. 801 et seq., and its
implementing regulations to prohibit the distribution of fed-
erally controlled substances for the purpose of facilitating an
individual’s suicide, regardless of a state law purporting to
authorize such distribution.

(I)

II

PARTIES TO THE PROCEEDING

Petitioners are John Ashcroft, Attorney General of the
United States; Karen Tandy, Administrator of the Drug En-
forcement Administration; Kenneth W. McGee, Assistant
Special Agent-in-Charge of the Portland Office of the Drug
Enforcement Administration; the United States of America;
the United States Department of Justice; and the Drug En-
forcement Administration.

Respondents are the State of Oregon, Peter A. Ras-
mussen, David Malcolm Hochhalter, Richard Holmes, James
Romney, Melissa Bush, and John Doe #1.

TABLE OF CONTENTS

Page
Opinions below 1
Jurisdiction 1
Statutory provisions involved 2
Statement 2
Reasons for granting the petition 9

I. The Ninth Circuit erred in holding that a single
State’s law rendered invalid the Attorney General's
reasonable interpretation of the Controlled Sub-
stances Act and its implementing regulations to bar
the of controlled substances to facilitate suicide .......... 11
A. The Attorney General's reasonable interpretation
of the comprehensive federal statute must
prevail over he determination by a particular
State that departs radically from long-accepted

legal and ethical norms ll
B. The Ninth Circuit’s reliance on Gregory v.

Ashcroft and related principles to defeat the

application of federal law to the private conduct

of dispensing drugs is fundamentally flawed ......... 20

II. The Court of Appeals’ decision warrants review
because it conflicts with decisions of this Court
and improperly allows states to dictate the content

of federal law 26
Conclusion 28
TABLE OF AUTHORITIES

Cases:
Alliance for Cannabis Therapeutics v. DEA, 15 F.3d
1131 (D.C. Cir. 1994) 16-17
Auer v. Robbins, 519 U.S. 452 (1997) 12

(IID)

Cases—Continued: Page

United States v. Oakland Cannabis Buyers’ Coop.:
190 F.3d 1109 (9th Cir. 1999), rev'd, 582 U.S.

IV
Cases—Continued: Page
Chevron U.S.A. Inc. v. Natural Res. Def. Council,

Inc., 467 U.S. 837 (1984) 11-12
Dickerson v. New Banner Inst., Inc., 460 U.S. 108

(1983) 19
Gately v. Massachusetts, 2 F.3d 1221 (ist Cir.

1993) 21
Gregory v. Ashcroft, 501 U.S. 452 (1991) 10, 20, 21
Hammer v. Dagenhart, 247 U.S. 251 (1918) 22
Jerome v. United States, 318 U.S. 101 (1943) ................... 18
Linder v. United States, 268 U.S. 5 (1925) 20, 22
Minor v. United States, 396 U.S. 87 (1969) 22
Mississippi Band of Choctaw Indians v. Holyfield,

490 U.S. 30 (1989) 8, 18
NLRB v. Natural Gas Util. Dist., 402 U.S. 600

(1971) 20
NLRB v. Randolph Elec. Membership Corp., 343

F.2d 60 (4th Cir. 1965) 20
Raich v. Ashcroft, 352 F.3d 1222 (9th Cir. 2003),

cert. granted, 124 S. Ct. 2909 (2004) 26
Reina v. United States, 364 U.S. 507 (1960) 22
Solid Waste Agency v. United States Army Corps

of Eng’rs, 531 U.S. 159 (2001) x
Thomas Jefferson Univ. v. Shalala, 512 U.S. 504

(1994) 12
United States v. Daniel, 3 F 3d 775 (4th Cir. 1993),

cert. denied, 510 U.S. 1130 (1994) 18
United States v. Darby, 312 U.S. 100 (1941) 22
United States v. Lot 5, Fox Grove, 23 F.3d 359

(11th Cir. 1994), cert. denied, 513 U.S. 1076

(1995) 21
United States v. Moore, 423 U.S. 122 (1975) 3, 4, 9,

14, 17-18, 22, 25
United States v. Norris, 780 F.2d 1207 (5th Cir.
1986) 18

483 (2001) 26
532 U.S. 483 (2001) 6, 10, 15, 16, 22
United States v. Pelzer, 312 U.S. 399 (1941) 19
United States v. Turley, 352 U.S. 407 (1957) 18
United States v. Vamos, 797 F.2d 1146 (2d Cir.
1986), cert. denied, 479 U.S. 1036 (1987) 18
Washington v. Glucksberg, 521 U.S. 702 (1997) ........ 7, 12, 13
Constitution, statute and regulations:
U.S. Const. Art. I, § 8, Cl. 3 (Commerce Clause) ................ 26
Controlled Substances Act, Pub. L. No. 91-513,
Tit. I1, 84 Stat. 1242 (21 U.S.C. 801 et seq.) 2
21 U.S.C. 801(1) 13, 24
21 U.S.C. 801(2) 23
21 U.S.C. 801(6) 19
21 U.S.C. 802(10) ... 2
21 U.S.C. 802(21) ‘2,14
21 U.S.C. 811 4
21 U.S.C. 811(a) 14, 16
21 U.S.C. 812 4
21 U.S.C. 812(b) 14, 15
21 U.S.C. 812(b)\(1) 16
21 U.S.C. 812(b)(1B) 3, 6, 10, 14
21 U.S.C. 812(b)(2)(5) 14
21 U.S.C. 812(b2XB) 3
21 U.S.C. 812(b3\B) 3
21 U.S.C. 812(b)(4\(B) 3
21 U.S.C. 812(b)(5B) 3
21 U.S.C. 812(¢) 3
21 U.S.C. 821 4
21 U.S.C. 822(a\(2) 2
21 U.S.C. 822(b) 2
21 U.S.C. 823(a\(1) 14, 24

21 U.S.C. 823(f) 2, 3, 8, 14, 24, 25

VI

Statute and regulations: Page

21 U.S.C. 823(f(3) 8-9
21 U.S.C. 823(f\4) 8-9, 25
21 U.S.C. 823(fK5) 9, 2, 25
21 U.S.C. 824aX4) 2
21 U.S.C. 829 3,4, 14
21 U.S.C. 82%a) 14
21 U.S.C. 82%c) 14
21 U.S.C. 830(b3)( Ai) 15
21 U.S.C. 841(aX(1) 2,3
21 U.S.C. 871(b)
21 U.S.C. 877
21 U.S.C. 908

Harrison Act of 1914, ch. 1, 38 Stat. 785

21 U.S.C. 352(j)

21 U.S.C. 355(d)

42 U.S.C. 257a (1970)
42 U.S.C. 290bb-2a
42 U.S.C. 1320a-7(a)
42 U.S.C. 1320a-7(b\6\B)
42 U.S.C. 1320¢-H(a\(1)
42 U.S.C. 1320c-K(b)
42 U.S.C. 1395y(ay(1)(A) (2000 & Supp. I 2001) .................
Cal. Health & Safety Code § 11362.5(b)(1)(A) (West
Supp. 2001)
Death With Dignity Act, Or. Rev. Stat. $§ 127.800
et seq. (2003)
§ 127.300
§ 127.300(11)
§ 127.815
§ 127.815(d)
§ 127.820
§ 127.885(1)

» #
ananaaoann & BSSSSRBKKVNVEawe

Vil

Statute and regulations—Continued:

21 C.F.R.:
Section 1306.04

Section 1306.04(a) 4, 15,17

Section 1308.12(e)
28 C.F.R. 0.100(b)

Miscellaneous:

66 Fed. Reg. 56,607 (2001)
H.R. Rep. No. 1444, 91st Cong., 2d Sess. Pt. 1(1970) .........

http://www.dhs.state.or.us/publichealth/chs/pas/ar-tbl-4.
cfm

Letter from Janet Reno, Attorney General of the
United States, to Henry J. Hyde, Chairman, Com-
mittee on the Judiciary, U.S. House of Representatives
(June 5, 1998)

Health & Human Servs., Medicare Benefit Policy
Manual (visited Nov. 5, 2004) ................-

Kevin F. O'Malley et al., Federal Jury Practice and
Instructions (Criminal) (5th ed. 2000)

17

18

In the Supreme Court of the Gnited States

No.

JOHN ASHCROFT, ATTORNEY GENERAL, ET AL.,
PETITIONERS

v.

STATE OF OREGON, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

The Acting Solicitor General, on behalf of the Attorney
General of the United States and the other federal parties,
respectfully petitions for a writ of certiorari to review the
judgment of the United States Court of Appeals for the
Ninth Circuit in this case.

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-63a) is
reported at 368 F.3d 1118. The order of the district court
granting respondents’ motion for a preliminary injunction
(Pet. App. 64a-97a) is reported at 192 F. Supp. 2d 1077.

JURISDICTION

The judgment of the court of appeals was entered on May
26, 2004. A petition for rehearing was denied on August 11,

(1)

2004 (Pet. App. 98a-99a). The jurisdiction of this Court is
invoked under 28 U.S.C. 1254(1).

STATUTORY PROVISIONS INVOLVED

Relevant provisions of the Controlled Substances Act
(CSA or Act), Pub. L. No. 91-513, Tit. II, 84 Stat. 1242 (21
U.S.C. 801 et seq.) and the implementing regulation, 21
C.F.R. 1306.04, are set out in an appendix to this petition.
Pet. App. 149a-161a. The relevant provisions of the Oregon
Death with Dignity Act, Or. Rev. Stat. §§ 127.800 et seq.
(2003), are also set out in the appendix. Pet. App. 162a-165a.

STATEMENT

1. a. The Controlled Substances Act, 21 U.S.C. 801
et seq., establishes a comprehensive federal scheme to regu-
late controlled substances. The CSA makes it unlawful to
“manufacture, distribute, or dispense, or possess with intent
to manufacture, distribute, or dispense” any controlled
substance, “le]xcept as authorized by [21 U.S.C. 801 et seq.].”
21 U.S.C. 841(a)(1). Physicians and other practitioners who
dispense’ controlled substances must “obtain from the
Attorney General a registration.” 21 U.S.C. 822(a)(2). They
may dispense controlled substances only “in the course of
professional practice or research,” 21 U.S.C. 802(21), and
only “to the extent authorized by their registration and in
conformity with the other provisions of [the CSA],” 21
U.S.C. 822(b).

The CSA authorizes the Attorney General to deny or re-
voke the registration of a practitioner “if he determines that
the issuance of such registration would be inconsistent with
the public interest.” 21 U.S.C. 823(f), 824(a)(4). In deter-
mining the “public interest” for registration purposes, the

1 Under the CSA, the term “dispense” includes the issuance of a pre-
scription by a practitioner as well as delivering a controlled substance
directly to a patient. 21 U.S.C. 802(10).

Attorney General considers a number of factors including
the registrant’s compliance with federal, state, and local laws
relating to controlled substances, 21 U.S.C. 823(f)(3) and (4),
and “such other conduct which may threaten the public
health and safety.” 21 U.S.C. 823(f)(5). In addition, a
physician who dispenses controlled substances outside the
“accepted limits” of medical practice is subject to prose-
cution under 21 U.S.C. 841(a)(1). United States v. Moore,
423 U.S. 122, 142 (1975).

Under the CSA, each controlled substance is placed in one
of five schedules, depending on whether the substance has a
currently accepted medical use in treatment in the United
States and the relative abuse potential of the substance. The
Act imposes varying regulatory restrictions on controlled
substances depending on the applicable schedule. Sub-
stances in Schedule I—the most restricted schedule—have
“no currently accepted medical use in treatment in the
United States,” 21 U.S.C. 812(b)(1)(B), and may not be pre-
scribed by a physician. 21 U.S.C. 829. Human consumption
of Schedule I controlled substances is permissible only in a
research setting where the research has been approved by
the Food and Drug Administration and the researcher has
obtained from the Drug Enforcement Administration (DEA)
a registration authorizing the specific research protocol. 21
U.S.C. 823(f). Substances in Schedules II through V have a
“currently accepted medical use in treatment in the United
States,” 21 U.S.C. 812(b)(2)(B), (3)(B), (4)(B) and (5)(B)), and
therefore may be dispensed for medical use. 21 U.S.C. 829.

When the CSA was enacted in 1970, Congress made an
initial assignment of controlled substances to the schedules it
believed appropriate. 21 U.S.C. 812(c). Congress authorized
the Attorney General, in consultation with the Secretary of
Health and Human Services, to add or remove substances or
to transfer substances from one schedule to another based
upon statutory criteria that take into account changes in

medical and scientific understanding and shifts in patterns of
abuse. 21 U.S.C. 811, 812. In addition, Congress provided
the Attorney General with broad authority to promulgate
“rules and regulations * * * relating to the registration and
control of the manufacture, distribution, and dispensing of
controlled substances,” 21 U.S.C. 821, and “any rules, regula-
tions, and procedures which he may deem necessary and ap-
propriate for the efficient execution of his functions” under
the CSA, 21 U.S.C. 871(b). The Attorney General has dele-
gated his functions under the Act to the Administrator of
DEA. 28 C.F.R. 0.100(b).

States remain free to enact their own laws relating to con-
trolled substances, such as their own criminal penalties, but
state laws are preempted to the extent of any “positive con-
flict” between a provision of state law and the CSA such that
the two “cannot consistently stand together.” 21 U.S.C. 903.

b. When the CSA became effective in 1971, DEA’s
predecessor (the Bureau of Narcotics and Dangerous Drugs)
issued regulations through notice-and-comment rulemaking
to implement the Act. One of those regulations, now found
at 21 C.F.R. 1306.04(a), requires that a prescription for a
controlled substance “must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual
course of his professional practice.” A purported prescrip-
tion that is not issued “in the usual course of professional
treatment or in legitimate and authorized research” does not
qualify as a “prescription” for purposes of 21 U.S.C. 829 and,
if issued knowingly, will subject the practitioner “to the pen-
alties provided for violations of the provisions of law relating
to controlled substances.” 21 C.F.R. 1306.04(a). As this
Court indicated in Moore, this legitimate medical purpose
requirement is implicit in various provisions of the CSA,
such as 21 U.S.C. 829, but is made explicit by virtue of the
implementing regulation, 21 C.F.R. 1306.04(a). See Moore,
423 U.S. at 137-139 & n.13.

2. In November 1994, Oregon voters passed a ballot ini-
tiative referred to as the Oregon Death with Dignity Act
(DWDA), Or. Rev. Stat. §§ 127.800 et seg. (2003). The
DWDA allows the prescribing and dispensing of “medica-
tion” for the purpose of enabling an individual with a termi-
nal disease to commit suicide. Jd. § 127.800(11). It requires
the physician prescribing or dispensing the lethal substance
to ensure that the patient is a resident of Oregon, is compe-
tent, has a terminal disease, and is making a voluntary and
informed decision to obtain the drugs for the purpose of
ending his or her life. See id. §§ 127.800, 127.815. A second
physician must also verify most of those facts. /d.
§§ 127.815(d), 127.820. The DWDA provides that a physician
who prescribes or dispenses a lethal amount or combination
of drugs in accordance with the DWDA shall not, for that
reason, “be subject to civil or criminal liability or profes-
sional disciplinary action.” Jd. § 127.885(1). Oregon is the
only State in the Union that purports to authorize physician-
assisted suicide.

3. In 2001, the Attorney General sought an opinion from
the Office of Legal Counsel (OLC) in the Department of Jus-
tice on the question whether a prescription for a drug to as-
sist in a person’s suicide, as contemplated in Oregon’s
DWDA, is a valid prescription pursuant to the CSA and its
implementing regulation.2 On June 27, 2001, OLC issued a
memorandum concluding that “assisting in suicide is not a

2 No interpretive rule had previously been issued by the Attorney
General on this subject. The Administrator of the DEA had previously
concluded that assisting suicide in accordance with the DWDA would
violate the CSA, E.R. 17, but then-Attorney General Janet Reno reached
a different conclusion, see Pet. App. 109a (quoting Letter from Janet
Reno, Attorney General of the United States, to Henry J. Hyde, Chair-
man, Committee on the Judiciary, U.S. House of Representatives (June 5,
1998)). Neither of those previous documents was published in the Federal
Register.

‘legitimate medical purpose’ that would justify a physician’s
dispensing controlled substances consistent with the CSA.”
Pet. App. 130a; see id. at 106a-148a.

The OLC memorandum explained that “(t]he CSA
establishes a uniform, nation-wide statutory scheme for
regulating the distribution of controlled substances,” Pet.
App. 130a, and that this Court had held, in United States v.
Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483 (2001),
that a California voter initiative purporting to recognize a
medical use for marijuana could not provide the basis for an
implied “medical necessity” exception or defense in the CSA
in the face of Congress’s placement of marijuana on Schedule
I, which is reserved for substances with “no currently
accepted medical use in treatment in the United States,” 21
U.S.C. 812(b)(1)(B). Pet. App. 131la-133a. The OLC memo-
randum concluded that Oregon’s ballot initiative likewise
could not immunize a physician from prosecution or loss of
registration under the CSA, if the Attorney General deter-
mined, pursuant to the regulatory authority granted to him
in the CSA, that assisting an individual to commit suicide
does not constitute a “legitimate medical purpose” for which
controlled substances may be prescribed. /d. at 133a-134a.

The OLC memorandum also canvassed the views of medi-
cal and nursing associations, federal and state law, and judi-
cial opinions and concluded, based on that review, that de-
spite the Oregon voters’ approval, physician-assisted suicide
is not a “legitimate medical purpose.” The memorandum
noted that “state law and policy, with the sole exception of
Oregon’s, emphatically oppose assisted suicide,” Pet. App.
117a, and that federal law likewise prohibits such conduct in
federal medical facilities and denies federal financial assis-
tance in support of it, id. at 119a-122a. For example, the
memorandum noted that the Health Care Financing Admini-
stration in the Department of Health and Human Services
had determined that physician-assisted suicide is not eligible

for reimbursement under Medicare because it is “not rea-
sonable and necessary to the diagnosis and treatment of dis-
ease or injury.” /d. at 120a-121a (internal quotation marks
omitted).* In addition, the OLC memorandum reviewed the
position of leading organizations of the medical profession,
including the American Medical Association, American
Nurses Association, and American Psychiatric Association,
all of which took the view that physician-assisted suicide was
“fundamentally incompatible with the physician’s role as
healer.” Jd. at 124a (quoting AMA Br. at 5, Washington v.
Glucksberg, 521 U.S. 702 (1997) (No. 96-110)).

On November 9, 2001, the Attorney General published an
interpretive rule in the Federal Register (66 Fed. Reg.
56,607 (2001)), that adopted the analysis of the OLC
Memorandum. Pet. App. 100a-105a. The Attorney General
determined that “assisting suicide is not a ‘legitimate
medical purpose’ within the meaning of 21 CFR
§ 1306.04,” and therefore that “prescribing, dispensing, or
administering federally controlled substances to assist
suicide violates the CSA.” Id. at 102a. The Attorney
General made clear that these conclusions “appl{y] regard-
less of whether state law authorizes or permits such conduct
by practitioners or others.” bid.

4. The State of Oregon and others challenged the inter-
pretive rule in the United States District Court for the Dis-
trict of Oregon. That court held the interpretive rule invalid
and enjoined its application. Pet. App. 64a-97a. The Attor-
ney General and the other federal parties appealed. The
court of appeals first held that the district court had lacked

3 The Health Care Financing Administration is now called the Centers
for Medicare and Medicaid Services (CMS). CMS maintains this policy at
present, and it is currently reflected in the Health & Human Servs.,
Medicare Benefit Policy Manual, ch. 16, § 20 (visited Nov. 5, 2004)
.

jurisdiction over respondents’ suit. /d. at 2a-3a & n.1, 56a-
6la. Instead, the court of appeals treated the action as a
petition for review under 21 U.S.C. 877 that had been
mistakenly filed in district court and transferred to the court
of appeals. Pet. App. 2a-3a & n.1. On the merits, a divided
panel granted the petitions for review.

a. The majority concluded that the interpretive rule was
invalid absent an “unmistakably clear” indication of congres-
sional intent to regulate physician-assisted suicide, because,
in the majority’s view, the rule “invokes the outer limits of
Congress’ power” by altering “the usual constitutional bal-
ance between the States and the Federal Government.” Pet.
App. 12a-13a (quoting Solid Waste Agency v. United States
Army Corps of Eng’rs, 531 U.S. 159, 172-173 (2001), and
Gregory v. Ashcroft, 501 U.S. 452, 461 (1991) (internal quotes
omitted)). The court also held that the interpretive rule
violated “the plain language of the CSA,” id. at 13a, which,
according to the majority, (1) only addresses “drug abuse,”
id. at 13a-14a, (2) entrusts medical decisions to the Secretary
of Health and Human Services (not the Attorney General),
id. at 15a, and (3) requires the Attorney General to address
all five statutory factors in Section 823(f) that are relevant to
registration of a physician under the CSA, including, in
particular, whether the physician’s conduct complies with
state law, before adopting an interpretive rule such as the
one here at issue, id. at 16a. The panel granted the petitions
for review and “continued” the district court’s injunction. Jd.
at 25a.

b. Senior Judge Wallace dissented. Pet. App. 25a-63a.
He relied upon the presumption that Congress does not
make the application of federal statutes dependent on state
law, id. at 36a (citing Mississippi Band of Choctaw Indians
v. Holyfield, 490 U.S. 30, 43 (1989)), and noted that, while a
physician’s compliance with state law is relevant under the
CSA in determining whether his or her registration would

be consistent with the public interest, id. at 37a (citing 21
U.S.C. 823(f\(3) and (4)), other factors, including whether the
physician’s conduct “may threaten the public health and
safety,” are not dependent on state law, ibid. (citing 21
U.S.C. 823(f)(5)). The dissent further noted that, while the
Secretary of Health and Human Services is specifically
delegated certain functions under the CSA, responsibility
under the Act for determining whether a physician’s regis-
tration serves the public interest is assigned to the Attorney
General alone. /d. at 39a-40a. The dissent also rejected the
majority’s suggestion that application of the CSA to the dis-
pensing of controlled substances to assist suicide is at the
limits of Congress’s power or would alter federal-state rela-
tions, id. at 45a, and pointed out that, to the contrary, Con-
gress’s authority under the Commerce Clause to regulate
the distribution of controlled substances is well-established,
id. at 49a-50a. Finally, the dissent observed that the
Attorney General’s conclusion that physician-assisted suicide
is not a legitimate medical purpose is well supported by an
“overwhelming historical, legal, and medical consensus.” /d.
at 56a.

c. The court of appeals denied the government’s petition
for rehearing or rehearing en banc. Pet. App. 98a-99a

REASONS FOR GRANTING THE PETITION

The Ninth Circuit held in this case that the Attorney Gen-
eral’s ability to administer and enforce the Controlled Sub-
stances Act is subordinate to the views of each of the 50
States regarding the permissible uses of scheduled sub-
stances. That holding is erroneous and stands the proper
relationship between the federal and state governments
under the Constitution on its head. Moreover, the court of
appeals’ ruling conflicts with this Court’s recognition in
United States v. Moore, 423 U.S. 122 (1975), that a
physician's prescription violates the CSA unless made “in

10

the usual course of a professional practice and in accordance
with a standard of medical practice generally recognized and
accepted in the United States,” id. at 139 (emphasis added).
The court of ajypeals’ ruling also conflicts with this Court’s
more recent decision in United States v. Oakland Cannabis
Buyers’ Cooperative, 532 U.S. 483 (2001), which gave effect
to the determination set forth in the CSA that marijuana has
“no currently accepted medical use in treatment in the
United States,” 21 U.S.C. 812(b)(1"3", in the face of a State’s
contrary determination of that disputed medical question,
532 U.S. at 486, 493.

The court of appeals reached this erroneous result only by
misconstruing and dramatically expanding the scope of this
Court’s decision in Gregory v. Ashcroft, 501 U.S. 452 (1991),
and by finding, contrary to this Court’s well-established ju-
risprudence, that federal regulation of the distribution of
controlled substances alters the usual constitutional balance
between the States and the federal government because of
its effect on the practice of medicine. By relying on constitu-
tional avoidance principles to avoid a plainly reasonable in-
terpretation of the CSA by the Attorney General, the court
of appeals’ holding threatens to undermine federal authority
to regulate in numerous other areas that may have an effect
on the practice of medicine. This Court’s review is war-
ranted to correct this serious misconception of the relative
powers of state and federal governments under the Consti-
tution and the CSA.

11

I. THE NINTH CIRCUIT ERRED IN HOLDING
THAT A SINGLE STATE’S LAW RENDERED
INVALID THE ATTORNEY GENERAL’S REASON-
ABLE INTERPRETATION OF THE CONTROLLED
SUBSTANCES ACT AND ITS IMPLEMENTING
REGULATIONS TO BAR THE DISPENSING OF
CONTROLLED SUBSTANCES TO FACILITATE

A. The Attorney General's Reasonable Interpretation
Of The Comprehensive Federal Statute Must Pre-
vail Over The Determination By A Particular State

That Departs Radically From Long-Accepted Legal
And Ethical Norms

The court of appeals acknowledged that the CSA prohibits
practitioners from prescribing or dispensing controlled sub-
stances except for a “legitimate medical purpose” and “in the
usual course of professional treatment.” Pet. App. 5a (quot-
ing 21 C.F.R. 1306.04). Thus, as the court of appeals recog-
nized, the issue presented in this case is “who gets to de-
cide,” id. at 9a, whether a practitioner’s conduct comports
with that federal requirement under the CSA—the Attorney
General, pursuant to a uniform national standard, or each of
the 50 States, according to 50 different views regarding the
proper use of controlled substances. The text and structure
of the CSA, as well as general principles of federalism, com-
pel the conclusion that the CSA, and the Attorney General’s
"ERRNO heneeeeneenpt ta Ry gS

1. In the interpretive ruling under challenge here, the
Attorney General concluded that dispensing drugs to assist
another individual in taking his or her life does not constitute
a “legitimate medical purpose” in the course of medical
“treatment.” 21 C.F.R. 1306.04(a). Because the Attorney
General has primary responsibility for enforcing the CSA,
his interpretation of the Act is entitled to deference under

12

Chevron U.S.A. Inc. v. Natural Resources Defense Council,
Inc., 467 U.S. 837, 843-844 (1984), and his interpretation of
his own regulation is entitled to even greater deference un-
der Auer v. Robbins, 519 U.S. 452, 461 (1997), and Thomas
Jefferson University v. Shalala, 512 U.S. 504, 512 (1994).
The Attorney General clearly acted reasonably in concluding
that dispensing drugs to assist a person to commit suicide is
not for a “legitimate medical purpose” or for “treatment”
within the meaning of the CSA and his implementing
regulation.

Indeed, the Attorney General’s conclusion is the position
maintained by 49 States, the federal government, and
leading associations of the medical profession. As the Court
noted in Washington v. Glucksberg, 521 U.S. 702 (1997), “[iJjn
almost every State—indeed, in almost every western
democracy—it is a crime to assist a suicide.” Jd. at 710.
With specific reference to Oregon’s DWDA, the Court made
clear that the Oregon statute was contrary both to
longstanding historical practices and to contemporary trends
in the law. Jd. at 717-718. Thus, contrary to the dominant
theme of the court of appeals’ decision, the Attorney General
did not ignore the laws of the States in interpreting the CSA
to bar the dispensing of controlled substances to facilitate
suicide. His interpretation is consistent with the position of
the overwhelming majority of the States.

Numerous health care experts have agreed that physi-
cian-assisted suicide is not a legitimate medical treatment.
In Glucksberg, the Court noted that New York State’s Task
Force on Life and the Law—a commission composed of doc-
tors, ethicists, lawyers, religious leaders and interested lay-
persons—had unanimously concluded that “[ljegalizing
assisted suicide and euthanasia would pose profound risks to
many individuals who are ill and vulnerable. . . . [T)he
potential dangers of this dramatic change in public policy
would outweigh any benefit that might be achieved.” 521

13

U.S. at 719 (quotation marks and citation omitted).
Likewise, as the OLC memorandum noted, the American
Medical Association, American Nurses Association, and
American Psychiatric Association filed a joint brief in
Glucksberg taking the position that physician-assisted
suicide is “fundamentally incompatible with the physician’s
role as healer.” Pet. App. 124a (quoting AMA Br. at 5,
Washington v. Glucksberg, 521 U.S. 702 (1997) (No. 96-110)).
Within the federal government as well, the Department of
Health and Human Services’ Health Care Financing
Administration similarly has determined that physician-
assisted suicide is not eligible for reimbursement under
Medicare because it is “not reasonable and necessary to the
diagnosis and treatment of disease or injury.” Pet. App.
120a-121a (internal quotes omitted).

There can be no question, then, that the Attorney Gen-
eral’s interpretive ruling is consistent with the prevailing
views regarding medical practice and on that basis is, at the
very least, reasonable and entitled to deference.

2. It is also clear, from the text and structure of the CSA,
that the Attorney General’s responsibility for enforcing the
CSA required him to resolve the question whether the use of
controlled substances to facilitate suicide is a “legitimate
medical purpose” for “treatment.” The principle that con-
trolled substances may be dispensed only for a “legitimate
medical purpose” in “treatment” is central to the CSA and is
reflected throughout its provisions. The starting point of the
Act (indeed, its first provision) is the recognition that
“{mJany of the drugs included within this subchapter have a
useful and legitimate medical purpose and are necessary to
maintain the health and general welfare of the American
people.” 21 U.S.C. 801(1). The federal regulatory scheme is
built upon the dual principles that the dispensing of
controlled substances should be allowed for such “legitimate

14

medical purposes” but that distribution for illegitimate
purposes should be prohibited.

The Attorney General is charged under the CSA, 21
U.S.C. 811(a), with assigning a controlled substance to the
appropriate “schedule” according to whether it has a “cur-
rently accepted medical use in treatment in the United
States,” 21 U.S.C. 812(b), as well as with ensuring that there
is an “adequate * * * supply” of Schedule I and Schedule II
substances “for legitimate medical, scientific, research, and
industrial purposes,” 21 U.S.C. 823(a)(1). Those substances
for which the Attorney General has determined there is “no
currently accepted medical use in treatment in the United
States” are placed in Schedule I, 21 U.S.C. 812(b)(1)(B), and
may not be prescribed or dispensed except pursuant to a re-
search protocol speifically approved by the Attorney Gen-
eral and the Secretary of Health and Human Services with
respect to the medical merits of the proposal and its security
against diverting the substance from “legitimate medical or
scientific use,” 21 U.S.C. 823(f). Substances in other Sched-
ules may be dispensed by practitioners only because they
have “a currently accepted medical use in treatment in
the United States,” 21 U.S.C. 812(b)(2)-(5), and a legitimate
“medical use” in “treatment” therefore is a prerequisite to
such dispensing.

Other provisions of the Act also confine a practitioner’s
latitude in dispensing drugs on Schedules II through V to le-
gitimate medical uses in the course of treatment. See, ¢.g.,
21 U.S.C. 829(c) (“No controlled substance in schedule V
which is a drug may be distributed or dispensed other than
for a medical purpose.”); Moore, 423 U.S. at 137 n.13 (indi-
cating that the same requirement is implicit in 21 U.S.C.
829(a) for Schedule II substances). The Act authorizes the
prescription of controlled substances only by a practitioner
acting “in the course of professional practice or research,” 21
U.S.C. 802(21), and, as a general matter, only by written

15

“prescription,” 21 U.S.C. 829. The Attorney General's
unchallenged regulation clarifies that a prescription, to be
valid, must be “for a legitimate medical purpose” and issued
“in the usual course of professional treatment or in legiti-
mate and authorized research.” 21 C.F.R. 1306.04(a).
Certain reporting requirements imposed by the CSA
similarly define a “valid prescription” as one “issued for a
legitimate medical purpose by an individual practitioner
* * * acting in the usual course of the practitioner’s
professional practice,” 21 U.S.C. 830(b)(3)(A)(ii).

3. a. The centrality of the concepts of “legitimate
medical purpose” and medical “treatment” in the text and
structure of the CSA leaves no doubt that those standards
are to be established and enforced at the federal, rather than
state, level. This Court’s decisions confirm that conclusion.
There is no question, for example, that the determination
whether a drug has a “currently accepted medical use in
treatment in the United States,” for purposes of scheduling
the substance under 21 U.S.C. 812(b), is a federal decision
that is binding on the States, rather than vice-versa. In Oak-
land Cannabis, the voters in California had passed a ballot
initiative that established, for purposes of state law, that
seriously ill Californians could “use marijuana for medical
purposes.” 532 U.S. at 486 (quoting Cal. Health & Safety
Code Ann. § 11362.5(b)(1)(A) (West Supp. 2001)). None-
theless, this Court rejected the marijuana cooperative’s reli-
ance on the state law as supporting a “medical necessity” de-
fense to prosecution under the CSA. The Court held that
such a defense would be inconsistent with Congress’s find-
ing, in classifying marijuana in Schedule I, that it has “no
currently accepted medical use in treatment in the United
States.” Jd. at 492. See id. at 493 (notwithstanding state
law, “Congress has made a determination that marijuana has
no medical benefits worthy of an exception,” and the Court

16

could not “override a legislative determination” to that ef-
fect).

Although Congress, rather than the Attorney General,
made the determination whether marijuana has a generally
accepted medical use in treatment, a determination by the
Attorney General would be no less binding on the States.
The CSA expressly grants the Attorney General authority
to assign substances to the appropriate schedule, and to
move substances—including those originally classified by
Congress—among schedules. 21 U.S.C. 811(a). In fact, in
Oakland Cannabis, the Court specifically recognized
that “[t]he Attorney General can include a drug in schedule I
* * * if the drug ‘has no currently accepted medical use in
treatment in the United States,’” 532 U.S. at 492 (quoting 21
U.S.C. 812(b)(1)), and one issue raised in the case was
whether Congress’s assignment »f marijuana to Schedule I,
without making specific findings a»out its medical useful-
ness, was entitled to as much deference as the Attorney
General's assignment would be. Ibid. The Court specifically
rejected the challenge to Congress’s classification of
marijuana, holding that “the statute consistently treats all
schedule I drugs alike,” whether placed there by Congress
or the Attorney General. Jd. at 492-493.

Just as California’s ballot initiative purporting to recog-
nize a “use [for] marijuana for medical purposes,” Cal.
Health & Safety Code § 11362.5(b)(1)(A) (West Supp. 2001),
did not compel recognition in Oakland Cannabis of an
exception to the currently applicable rule under the CSA
that a Schedule I substance has no “currently accepted
medical use in treatment in the United States,” neither
would the state law be binding on the Attorney General for
purposes of compelling him to reclassify marijuana to a
different schedule under the CSA. Rather, such a determi-
nation must be based upon an independent federal assess-
ment of the medical and scientific evidence and, if supported

17

by substantial evidence, is binding upon the entire Nation
for purposes of the CSA. See Alliance for Cannabis Thera-
peutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) (upholding
DEA’s refusal to reschedule marijuana as supported by sub-
stantial evidence). As the D.C. Circuit held in Alliance for
Cannabis, “only rigorous scientific proof can satisfy the
CSA’s ‘currently accepted medical use’ requirement.” Jd. at
1137. There is no basis in the CSA for substituting a ballot
initiative, such as California voters’ approval of medical
marijuana or Oregon voters’ endorsement of physician-
assisted suicide, for the requisite “rigorous scientific proof”
regarding a substance’s “accepted medical use.”

Nor is there any reason to conclude, as the Ninth Circuit
in this case did, that the Attorney General’s determination
whether a particular use of a controlled substance consti-
tutes a “legitimate medical use” “in the usual course of pro-
fessional treatment,” 21 C.F.R. 1306.04(a), is any less binding
in the States for purposes of the CSA than his determination
whether a substance has any accepted medical use. If, as is
evident from Oakland Cannabis, the Attorney General
could reclassify the Schedule II substances used by Oregon
physicians to assist suicide* to Schedule I if the medical and
scientific evidence warranted—despite the passage of the
assisted suicide initiative in Oregon—then he likewise can
determine that, while those Schedule II substances have
other generally accepted medical uses in treatment,
deliberately assisting a person to commit suicide is not one.

This Court’s dec’sion in Moore strongly supports that con-
clusion. Moore involved the prosecution of a physician who

4 According to the Oregon Department of Human Services, the three
drugs dispensed pursuant to the DWDA are secobarbital, pentobar-
bital, and amobarbital, all of which are Schedule II depressants. See
http://www.dhs.state.or.us/publichealth/chs/pas/ar-tbl-4.cfm; 21 C.F.R.
1308.12(e).

18

prescribed large quantities of methadone tablets with little
or no medical assessment or supervision. See 423 U.S. at
126. He was convicted under the CSA for prescribing con-
trolled substances outside the usual course of his profes-
sional practice. This Court held that the CSA was intended
to limit a physician’s distribution of controlled substances to
actions “as a physician” and in the course of “professional
practice.” 423 U.S. at 140, 141. The Court made clear that
Moore’s conviction, which it affirmed, was based on a uni-
form nationwide standard for deciding whether the
prescriptions were valid and permissible under the CSA:
whether they were “in accordance with a standard of medical
practice generally recognized and accepted in the United
States.” Id. at 139 (quoting jury instructions) (emphasis
added).”

b. The conclusion evident from the text and structure of
the CSA—that Congress intended the Act to be applied in a
uniform manner across the Nation—is further confirmed by
the well-established principle of statutory construction that,
“in the absence of a plain indication to the contrary, . . .
Congress when it enacts a statute is not making the applica-
tion of the federal act dependent on state law.” Mississippi
Band of Choctaw Indians v. Holyfield, 490 U.S. 30, 43, 47
(1989) (quoting Jerome v. United States, 318 U.S. 101, 104
(1943), and holding that the word “domicile” used in a federal
law should have a uniform meaning and is not defined by

® With the exception of the decision below, the courts of appeals have
followed Moore and applied a national standard for professional practice
under the CSA. See United States v. Vamos, 797 F.2d 1146, 1151 (2d Cir.
1986) (standard of professional practice “generally recognized and
accepted in the United States”), cert. denied, 479 U.S. 1036 (1987); United
States v. Norris, 780 F.2d 1207, 1209 & n.2 (5th Cir. 1986) (same); United
States v. Daniel, 3 F.3d 775, 778 (4th Cir. 1993) (same), cert. denied, 510
U.S. 1130 (1994); Kevin F. O’Malley et al., Federal Jury Practice and
Instructions (Criminal) § 64.16, at 423 (5th ed. 2000) (same).

19

state law). See United States v. Turley, 352 U.S. 407 (1957)
(word “stolen,” used in federal criminal statute, has a uni-
form nationwide meaning and is not defined by state law);
United States v. Pelzer, 312 U.S. 399 (1941) (same for phrase
“future interests” in federal tax statute). Nothing in either
the CSA or its implementing regulation makes the definition
of “legitimate medical purpose” depend upon state law. To
the contrary, there are strong indications, as Moore and
Oakland Cannabis recognize, that Congress did not intend
the concepts of legitimate medical purpose, medical treat-
ment, or public health and safety to be determined solely by
reference to state law.

The Mississippi Band presumption is particularly appro-
priate with respect to the CSA. Congress made clear that it
intended the CSA to establish a national, comprehensive,
and uniform law governing the use of controlled substances
in this country. The need for national control was so great
that Congress specifically found it necessary to regulate
purely intrastate conduct relating to controlled substances.
See 21 U.S.C. 801(6) (finding that “[flederal control of the
intrastate incidents of the traffic in controlled substances is
essential to the effective control of the interstate incidents of
such traffic”). Thus, as in Mississippi Band, the application
of federal law must not (and does not) depend on state law
because “the application of federal legislation is nationwide
and at times the federal program would be impaired if state
law were to control.” Dickerson v. New Banner Inst., Inc.,
460 U.S. 103, 119-120 (1983). If, for example, one State’s vot-
ers were of the view that marijuana has a medical use in
treating mild depression, and that view was binding on the
Attorney General for purposes of scheduling and ensuring
adequate supplies for legitimate medical uses, the federal
scheme to control the lines of distribution of that
drug—including in other States that did not share the mav-
erick view—would be severely undermined. The CSA’s

20

scheme to control all manufacturing, possession, and distri-
bution of any scheduled drug unquestionably constitutes
“federal legislation, administered by a national agency, in-
tended to solve a national problem on a national scale,” the
success of which cannot depend upon the vagaries of state
law. NLRB v. Naturai Gas Util. Dist., 402 U.S. 600, 603-604
(1971) (quoting NLRB v. Randolph Elec. Membership Corp.,
343 F.2d 60, 63 (4th Cir. 1965)).

B. The Ninth Circuit’s Reliance On Gregory v. Ashcroft
And Related Principles To Defeat The Application Of
The CSA To Private Conduct In Dispensing Drugs Is
Fundamentally Flawed

1. The court of appeals failed to follow Oakland Canna-
bis, Moore, and Mississippi Band, and instead concluded
that this Court’s decision in Gregory v. Ashcroft, 501 U.S.
452 (1991), compelled a holding that state law controls the
question whether a physician’s conduct is for a legitimate
medical purpose under the CSA. The court of appeals even
went so far as to conclude that the Attorney General’s
interpretive ruling that dispensing a federally controlled
substance to assist a person to commit suicide is not
permitted under the CSA “invokes the outer limits of
Congress’s power by encroaching on state authority to
regulate medical practice.” Pet. App. 12a (citing Linder v.
United States, 268 U.S. 5, 18 (1925)). Because, in the court of
appeals’ view, the effect of the CSA on Oregon law “alter[s]
the usual constitutional balance between the States and the
Federal Government” by exercising control over “an area of
law traditionally reserved for state authority,” id. at lla
(quoting Gregory, 501 U.S. at 461 (additional internal quotes
omitted)), the court required that the CSA make
“unmistakably clear” the Attorney General’s authority to
adopt the interpretive rule, ibid.

21

The court of appeals’ conclusion that federal regulation of
the distribution of controlled substances “alter[s] the usual
constitutional balance between the States and the Federal
Government” in a manner that requires an “unmistakably
clear” statement by Congress fundamentally misunder-
stands the constitutional rule. The decision in Gregory
turned on the fact that the federal statute at issue threat-
ened to intrude upon a State’s determination of the qualifica-
tions of its own judges, which this Court characterized as a
constitutionally protected “decision of the most fundamental
sort for a sovereign entity.” 501 U.S. at 460. As the courts
of appeals have recognized, Gregory must be limited to such
basic threats to state sovereignty. See United States v. Lot
5, Fox Grove, 23 F.3d 359, 362 (11th Cir. 1994) (noting that
“the Gregory plain statement preemption rule is limited to
federal laws impacting a state’s self-identification as a
sovereignty”), cert. denied, 513 U.S. 1076 (1995); Gately v.
Massachusetts, 2 F.3d 1221, 1230 (1st Cir. 1993) (noting that
Gregory is limited to protecting “a core function going to the
‘heart of representative government”). The Gregory
principle does not apply to the effect an Act of Congress may
have on a State’s views about private conduct that is
otherwise within the scope of Congress’s power to regulate.
Furthermore, there is no merit to the court of appeals’
notion that the application of the CSA here encroaches on
“an area of law traditionally reserved for state authority,”
Pet. App. lla, because, as Glucksberg, makes clear, there is
no tradition of States authorizing physician-assisted suicide,
521 U.S. at 710.

The court of appeals’ suggestion that Congress’s regula-
tion of the distribution of controlled substances in these cir-
cumstances raises significant constitutional problems also
flies in the face of history and this Court’s precedent. Con-
gress has regulated prescriptions for controlled substances
nationwide for almost a century under the CSA and its pre-

22

decessor, the Harrison Act of 1914, ch. 1, 38 Stat. 785. The
court of appeals cited Linder as authority for the proposition
that “direct control of medical practice in the states is
beyond the power of the federal government,” Pet. App. 10a,
and for the further conclusion that the Attorney General’s
interpretive ruling “invokes the outer limits of Congress’
power by encroaching on sta‘ » authority to regulate medical
practice,” id. at 12a. Notaviy, the Court’s Lochner-era
decision in Linder relied upon the then-prevailing view, ar-
ticulated in such cases as Hammer v. Dagenhart, 247 U.S.
251 (1918), that Congress could not employ its enumerated
powers to accomplish more general purposes relating to
health and welfare that were believed to be the exclusive
province of the States. Linder, 268 U.S. at 17 (citing
Hammer, among others, for the proposition that “an act of
Congress ostensibly enacted under power granted by the
Constitution, not naturally and reasonably adapted to the
effective exercise of such power but solely to the achieve-
ment of something plainly within power reserved to the
States, is invalid and cannot be enforced”). That holding of
Hammer was expressly overruled in United States v. Darby,
312 U.S. 100, 115-117 (1941), which upheld the authority of
Congress to regulate interstate commerce for the purpose of
improving the working conditions of laborers, id. at 115.
Moreover, this Court’s subsequent decisions establish that
Linder’s suggestion that the federal government could not
supplant wholesale the States’ “control of medical practice”
does not preclude federal regulation of interstate commerce
in controlled substances despite the effects such regulation
may have on unorthodox practices by physicians. See Oak-
land Cannabis, 532 U.S. at 492-493 (upholding CSA deter-
mination that marijuana lacked an acceptable medical use);
Moore, 423 U.S. at 143 (affirming federal criminal conviction
of physician engaged in unauthorized “experiment(al] * * *
theory of detoxification”); Minor v. United States, 396 U.S.

23

87, 98 n.13 (1969) (ban on sale of narcotics is within Con-
gress’s constitutional power); Reina v. United States, 364
U.S. 507, 511 (1960) (Congress had “undoubted power to en-
act the narcotics laws”).

Thus the court of appeals erred in concluding that the At-

torney General’s adoption of a national rule regarding the
distribution of controlled substances to facilitate suicide up-
set the usual balance between the state and federal govern-
ments.
2. The other reasons the court of appeals gave in support
of its holding are likewise flawed and are, to a significant de-
gree, infected with the court of appeals’ erroneous view that
Gregory's clear statement rule provided the applicable stan-
dard. Under the appropriate framework of affording Chev-
ron deference to the Attorney General’s construction of the
CSA, rather than Gregory’s reverse presumption, none of
the court of appeals’ other points undermines the reason-
ableness of the Attorney General’s interpretive ruling.

a. The court of appeals erred, for example, in relying on
the notion that Congress intended “to limit federal authority
under the CSA to the field of drug abuse,” Pet. App. 14a, and
that the CSA’s “legitimate medical purpose” requirement
must be construed to address that concern alone. In the first
place, the taking of drugs to commit suicide is “drug abuse,”
and prohibiting the dispensing of a drug to facilitate suicide
therefore falls within the purposes of the Act even as the
court of appeals understood them. Moreover, Congress ex-
pressly stated broad goals in enacting the CSA, which was
designed to combat “illegal importation, manufacture, distri-
bution, and possession and improper use of controlled sub-
stances.” 21 U.S.C. 801(2) (emphasis added). There is no
doubt that Congress viewed the use of controlled substances
to commit suicide to be a form of improper use. Congress
specifically referred to the “[mlJisuse of a drug in suicides and
attempted suicides,” and noted that “injuries resulting from

24

unsupervised use are regarded ~s indicative of a drug’s
potential for abuse.” H.R. Rep. No. 1444, 91st Cong., 2d
Sess. Pt. 1., at 35 (1970). See id. at 34 (potential for abuse
indicated by “evidence that individuals are taking the drug
* * * in amounts sufficient to create a hazard to their
health”); 21 U.S.C. 801(1) (noting congressional purpose “to
maintain the health and general welfare of the American
people”); 21 U.S.C. 823(f)(5) (requiring the Attorney General
to consider threats to “the public health and safety” in
issuing and revoking registrations to physicians to distribute
controlled substances).

b. The court of appeals also cited the role of the Secre-
tary of Health and Human Services as a reason why the At-
torney General was not ihe appropriate officer within the
federal government to make determinations under the CSA
that affect the practice of medicine. Pet. App. 15a. While it
is true that the CSA assigns certain functions with respect
to its implementation to the Secretary, the Attorney General
shares a role in many of those functions. E.g., 21 U.S.C.
823(f) (assigning to both the Secretary and Attorney General
roles in assessing proposed research projects relating to
Schedule I drugs). Many other responsibilities under the
CSA that require making determinations respecting the le-
gitimate medical use of substances are assigned to the At-
torney General alone. E.g., 21 U.S.C. 823(a)(1) (Attorney
General to ensure adequate supply of Schedule II substances
for “legitimate medical * * * purposes”); 21 U.S.C. 823(f)(5)
(listing “the public health and safety” among factors the At-
torney General may consider in determining whether to re-
voke a practitioner’s registration under the CSA). In any
event, the determination whether dispensing drugs to facili-
tate suicide constitutes a “legitimate medical purpose” turns
on an interpretation of the CSA and a regulation of the
Attorney General, and does not require an assessment of

25

medical or scientific evidence of the sort that the CSA has
assigned to the Secretary.*

c. The court of appeals’ conclusion that the Attorney
General violated 21 U.S.C. 823(f) by failing to consider all of
the factors addressed in that section is also flawed. As an
initial matter, Section 823(f) applies, by its terms, only to ac-
tions by the Attorney General to deny or revoke a CSA reg-
istration. The Attorney General’s ruling at issue here is not
such a denial or revocation. It is, rather, an interpretation of
the substantive provisions of the Act, violation of which may
in turn lead to a revocation of registration. In any event,
Section 823(f) requires the Attorney General to consider a
number of factors, including not only compliance with state
laws, 21 U.S.C. 823(f)(4), but others, such as “{clompliance
with applicable * * * Federal * * * laws relating to
controlled substances,” 21 U.S.C. 823(f)(4), and any threat to
“the public health and safety,” 21 U.S.C. 823(f)(5), that
plainly call for an independent determination by the
Attorney General. The court of appeals’ ruling would
preclude the Attorney General from exercising his statutory
responsibility to ascertain whether a physician’s registration
is consistent with the public interest by making one
factor—compliance with state law—determinative of that
question. Indeed the court of appeals would make state law
determinative of the question whether dispensing drugs to
facilitate suicide even violates the CSA to begin with. There

® The court of appeals cited (Pet. App. 15a) this Court’s reference in
Moore to the Secretary’s function in determining “the appropriate
methods of professional practice in the medical treatment of . . . narcotic
addiction.” 423 U.S. at 144 (quoting 42 U.S.C. 257a (1970) (auventiy 42
U.S.C. 290bb-2a)). That provision is not directly at issue here, and the fact
that certain health-related determinations are assigned to the Secretary
does not negate the Attorney General's independent responsibilities under
the CSA to ensure that controlled substances are prescribed only for a
“legitimate medical purpose.”

26

is no support in the statute’s text for those extraordinary

conclusions.

Il. THE COURT OF APPEALS’ DECISION WAR-
RANTS REVIEW BECAUSE IT CONFLICTS WITH
DECISIONS OF THIS COURT AND IMPROPERLY
ALLOWS STATES TO DICTATE THE CONTENT
OF FEDERAL LAW.

The court of appeals’ decision warrants review by this
Court. The holding below is yet another in a series of deci-
sions in which the Ninth Circuit has undermined the federal
government’s ability to enforce the comprehensive federal
law to control dangerous substances by subordinating fed-
eral authority to that of the States. In Oakland Cannabis,
the Ninth Circuit held that in light of California’s medical
marijuana initiative, the United States could not enforce the
CSA against individuals who purport to use marijuana for
medical purposes, despite the federal determination in the
CSA itself that no generally accepted medical use exists for
marijuana. United States v. Oakland Cannabis Buyers’
Coop., 190 F.3d 1109, 1111, 1114 (9th Cir. 1999), rev'd, 532
U.S. 483 (2001). More recently, in Raich v. Ashcroft, 352
F.3d 1222 (2003), cert. granted, 124 S. Ct. 2909 (2004), the
Ninth Circuit held that Congress could not, pursuant to the
Commerce Clause (U.S. Const. Art. 1, § 8, Cl. 3), regulate
“the intrastate, noncommercial cultivation and possession of
cannabis for personal medical purposes as recommended by
a patient’s physician pursuant to valid California state law,”
because, in the court’s view, that sub-class of activity did not
have a sufficient impact on interstate commerce. 352 F.3d at
1228, 1231.

The Ninth Circuit’s decision in this case is equally dismis-
sive of the comprehensive federal regulatory scheme. It
makes that scheme for controlling substances depend not on
a uniform national standard, but on the vagaries of each
State’s notions of what constitutes a “legit‘mate medical

27

purpose” or “treatment,” no matter how far outside the
mainstream of accepted medical practice a particular State’s
views may be.

Moreover, the reasoning by which the court of appeals
reached that conclusion is dramatic in its potential seope—as
evidenced by its reliance on a Lochner-era case as defining
the limits on Congress’s authority to regulate matters that
may indirectly affect the practice of medicine. The court of
appeals’ failure to apply this Court’s presumption of national
uniformity established in Mississippi Band and its
invocation, instead, of the Gregory v. Ashcroft clear state-
ment rule based on the mere fact that the practice of
medicine is implicated could have far-reaching consequences
if applied to other federal statutory schemes. E.g., 21 U.S.C.
355(d) (requiring FDA to deny application for new drug if
not safe and effective for its intended purpose); 21 U.S.C.
352(j) (drug is “misbranded” if “it is dangerous to health
when used in the dosage or manner, or with the frequency or
duration prescribed, recommended, or suggested in the la-
beling thereof”); 42 U.S.C. 1320a-7(a) and (b)(6)(B) (author-
izing Secretary to exclude from participation in “any Federal
health care program” a doctor (or anyone else) who furnishes
services “substantially in excess of the needs of * * * pa-
tients,” regardless of whether those patients were eligible
for or participated in any federal programs); 42 U.S.C. 1320c-
5(a)(1) and (b) (requiring any “health care practitioner” par-
ticipating in Medicare to provide only “medically necessary”
services to Medicare beneficiaries, and allowing the Secre-
tary to bar violators from participating in the Medicare pro-
gram); 42 U.S.C. 1395y(a)(1)(A) (2000 & Supp. I 2001)
(authorizing Medicare to reimburse only “reasonable and
necessary” medical services).

In short, Congress often attaches consequences under
federal statutes to a determination by a federal official re-
garding what constitutes proper, necessary, safe, or effective

28

medical care. The uniform application of such statutory
schemes is cast into doubt by the court of appeals’ decision in
this case.

CONCLUSION
The petition for a writ of certiorari should be granted.
Respectfully submitted.

PAUL D. CLEMENT
Acting Solicitor General

PETER D. KEISLER
Assistant Attorney General

EDWIN S. KNEEDLER
Deputy Solicitor General
GREGORY G. KATSAS
Deputy Assistant Attorney
General

DOUGLAS HALLWARD-DRIEMEIER
Assistant to the Solicitor
General

MARK B. STERN
JONATHAN H. LEVY

Attorneys

NOVEMBER 2004

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0051%3A02. Public record. Not legal advice.