Reply Brief — Gonzales v. Oregon

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No. 04-623

Jn the Supreme Court of the United States

ALBERTO R. GONZALES, ATTORNEY GENERAL. ET AL..

PETITIONERS

STATE OF OREGON, ET AL.

ON WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

REPLY BRIEF FOR THE PETITIONERS

PAUL D. CLEMENT

Solicitor General

Counsel of Record

De partie nt of Justice

Washington, DC. 205.20-0001

(02) 915-2717

TABLE OF CONTENTS

I. The Attorney General reasonably concluded that

assisting a person’s suicide is not a “legitimate

medical purpose” for which drugs can be distributed

under the Controlled Substances Act

A. The Attorney General’s interpretive rule is

reasonable and is entitled to deference

B. The CSA establishes a uniform national

standard for distributing controlled

substances

Il. There is no requirement of a clear statement

applicable here

A. A presumption against federal preemption

does not apply because the CSA does not

preempt the DWDA

B. Because the CSA, as interpreted by the

Attorney General, is clearly constitutional,

the doctrine of constitutional avoidance does

not apply

C. There is no requirement that Congress make

a particularly “clear statement” whenever it

addresses an issue that is also within “traditional

state authority”

TABLE OF AUTHORITIES

Cases:

Alaska Dep't of Envtl. Conservation v. EPA,

540 U.S. 461 (2004)

Auer v. Robbins, 519 U.S. 452 (1997)

Babbitt v. Sweet Home Chapter of Cmtys. for a

Great Or., 515 U.S. 687 (1995)

Barnhart v. Walton, 535 U.S. 212 (2002)

(I)

Page

11

11

14

16

II

Cases—Continued: Page

California Div. of Labor Standards Enforcement v.

Dillingham Constr., N_A., 519 U.S. 316 (1997) ...cccccceeees 17

Caron vy. United States, 514 U.S. 308 (1998) ...........c0000 13,19

Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837

(1984) 2,3

Chicago & N.W. Transp. Co. v. Kalo Brick & Tile

Co., 450 U.S. 311 (1981) 12

Christensen v. Harris County, 519 U.S. 576

(2000) 4

Cipollone v. Liggett Group, Inc., 505 U.S. 504

(1992) 13

City of Edmonds vy. Oxford House, Inc., 514

U.S. 725 (1995) 17

Department of Revenue v. ACF Indus., Inc., 510

US. 3382 (1994) ..... 13

Dickerson v. New Banner Inst., Inc., 460 U.S. 103

(1983) 13

Edward J. DeBartolo Corp. v. Florida Gulf

Coast Bldg. & Constr. Trades Council, 485 U.S.

568 (1988) 18

Elk Grove Unified Sch. Dist. v. Newdow, 124

S. Ct. 2301 (2004) 19

Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1 (1824) ......cceseeee 12

Gregory v. Ashcroft, 501 U.S. 452 (1991) 17

Gonzalez v. Raich, 1258. Ct. 2195 (2004) 2, 3, 7,

%, 11, 14, 15, 16

Hillsborough County v. Automated Med. Labs.,

Inc., 471 U.S. 707 (1985) 17

Hisquierdo v. Hisquierdo, 439 U.S. 572 (1979) ..ecccccceeeee 17

Hodel v. Virginia Surface Mining & Reclamation

Ass'n, 452 U.S. 264 (1981) 17

Hyland v. Fukuda, 580 F.2d 977 (9th Cir.

1978) 12

Jerome v. United States, 318 US. 101 (1943) 20... cece 19

Ill

Cases—Continued: Page

Jin Fuey Moy v. United States, 254 U.S. 189

(1920) 3

Jones v. United States, 529 U.S. 848 (2000) .....000 13,18

Kane v. Kulongoski, 871 P.2d 993 (Or. 1994) ............000+ = 12

Lambert v. Yellowley, 272 U.S. 581 (1926) 19

Linder v. United States, 268 U.S. 5 (1925) 19

Lottery Case, 188 U.S. 321 (1903) 15

Martin v. OSHRC, 499 U.S. 144 (1991) 2

Mississippi Bank of Choctaw Indians v. Holyfield,

490 U.S. 30 (1989) 18, 19

National Cable & Telecomm. Ass'n v. Brand X

Internet Servs., 125 S. Ct. 2688 (2005) 5

Raygor v. Santa Fe Elevator Corp., 331 US. 218

(1947) 18

Robertson v. Methow Valley Citizens Council,

490 U.S. 382 (1989) 1

Rush Prudential HMO, Inc. v. Moran, 536 US.

355 (2002) 17

Shatz v. United States Dep't of Justice, 873 F 2d

1089 (8th Cir. 1989) 10

Solid Waste Agency v. United States Army Corps.

of Eng’rs, 531 U.S. 159 (2001) 18

Thomas Jefferson Univ. v. Shalala, 512 U.S. 504

(1994) 1,2

United States v. Bass, 404 U.S. 336 (1971) 13, 18

United States v. Behrmann, 258 U.S. 281 (1922) ............. 3

United States v. Darby, 312 U.S. 100 (194)) ............... 13, 15,

16, 18

United States v. Lopez, 514 U.S. 549 (1995) 18

United States v. Mead Corp., 538 US. 213

(2001) 4

United States v. Moore, 423 U.S. 122 (1975) ......... 2,3,8,15

United States v. Oakland Cannabis Buyers’ Coop.,

582 U.S. 488 (2001) 3,7

IV V

Cases—Continued: Page Statutes and regulations—Continued: Page

Verizon Communications, Inc. v. FCC, 535 U.S. 21 U.S.C. 823(f)(4) 10

467 (2002) 14 21 U.S.C. &823(f5) 10

Webb v. United States, 249 U.S. 96 (1919) 3 21 U.S.C. S23(gX1) ae >.

Wickard vy. Filburn, 317 US. 111 (1942) 16 21 USC. 824 u

Will v. Michigan Dep't of State Police, 491 US 3 USC. Sta) »

aie : >» Se ee 21 U.S.C. 824(a)(2) (1970) 9

58 (1989) ....... saqneneueenennesnensnnes —_ 18 21 U.S.C. 830(b\(3)A)ii) 7

Constitution, statutes and regulations: 21 U.S.C. 903 12

; Dealth with Dignity Act, Or. Rev. Stat. $$ 127.800

U.S. Const. et seq. (2003) 2

Art. IV, $4 .. 17 21 C.F.R. 1306.04 7, 10

aa “4 ea ag oo 17 21 C.F.R. 1306.04(a) 1

ministrative ure ~9 USL, .

BEDMBMA) ccceene 4 Miscellaneous:

Fair Labor Standards Act of 1988, 29 U.S.C. 201 AMA, Current Opinions of the Council of Ethical

et SEQ. .... 13 and Judicial Affairs, Opinion No. E-2.211,

Revenue Act of Feb. 24, 1919, § 1006, 40 Stat. 1131 ccs. 2 Physician-Assisted Suicide (last visit Aug. 25, 2005)

PROTECT Act, Pub. L. No. 108-21, Tit. L, § 105(a), <http/iwww sme-esen.org/ama/pablentogory/priat/

117 Stat. 654 (to be codified at 18 U.S.C. 2423(b)) ccc... 16 _ Sana -

USS tee ~ 36 Fed. Reg. 4948 (1971) 1

pa ’ 36 Fed. Reg. 7777 (1971) 1

18 USC. 195%a) 16 36 Fed. Reg. 7799 (1971) 1

8 USC. SMD. a H.R. Rep. No. 1444, 91st Cong., 2d Sess. (1970) .cvcsonen 3

USC seem) ; S. Rep. No. 225, 98th Cong., Ist Sess. (1983) 10

21 U.S.C. 811(b) 4,5

21 USC. 81Ke). 5

21 USC. 81KeX1) 5

21 USC. 811(ex4) 5

21 USC. X1Mex5) 5

21 U.S.C. 812(b\1)45) 7

21 US.C. 812(b\1,B) 3

21 USC. 812(b\1XC) ..... 3

21 US.C. x2 11

21 USC. 82%ay1) 7

21 USC. s2xf - 7,9,10,11

9

21 USC. 824(f) (1970) .....

I. THE ATTORNEY GENERAL REASONABLY CON-

CLUDED THAT ASSISTING A PERSON’S SUICIDE

IS NOT A “LEGITIMATE MEDICAL PURPOSE”

FOR WHICH DRUGS CAN BE DISTRIBUTED UN-

DER THE CONTROLLED SUBSTANCES ACT

A. The Attorney General's Interpretive Rule Is Reason-

able And Is Entitled To Deference

1. Respondents challenge the Attorney General’s regula-

tory interpretation that dispensing drugs for the purpose of

hastening a person’s death is not within “the usual course of

professional treatment” or for a “legitimate medical pur-

pose” within the meaning of the longstanding regulation that

establishes the prerequisites for a lawful prescription under

the Controlled Substances Act. See 21 C.F.R. 1306.04(a).

The Attorney General’s interpretation of his own regulation

is “controlling unless ‘plainly erroneous or inconsistent with

the regulation.’” Auer v. Robbins, 519 U.S. 452, 461 (1997)

(quoting Robertson v. Methow Valley Citizens Council, 490

U.S. 332, 359 (1989)); Thomas Jefferson Univ. v. Shalala, 512

U.S. 504, 512 (1994). That precondition for deference is am-

ply satisfied here. The Attorney General’s interpretation of

the regulation is supported by the thrust of the Act it im-

plements (which combats drug abuse, including overdoses),

this Court’s decisions under the Harrison Act and the CSA,

the ordinary meaning of the terms “medical” and “medicine,”

centuries of tradition, federal law in other contexts, the po-

sition of 49 States, and the judgment of the American Medi-

cal Association that assisting suicide is “fundamentally in-

compatible” with a physician’s role as healer. See Gov't Br.

21-24; p. 19, infra.

Patient-respondents suggest (at 9-12) that the Attorney

General's interpretation is not entitled to deference under

Auer because it was not issued after notice-and-comment

rulemaking. That contention is mistaken. The underlying

regulation the Attorney General interpreted was issued

though notice and comment, 36 Fed. Reg. 4948, 7777, 7799

(1)

2

(1971), and respondents do not challenge the regulation’s va-

lidity under Chevron. Nor could they because the regulation

is firmly supported by the longstanding requirement—

dating to the Harrison Act, which, as amended, excepted

from its scope drugs obtained pursuant to “a prescription,

written for legitimate medical uses,” Revenue Act of Feb.

24, 1919, § 1006, 40 Stat. 1131, and reaffirmed in the CSA and

United States v. Moore, 423 U.S. 122 (1975)—that a pre-

scription must be for an accepted medical purpose in

treatment, not for a non-medical purpose such as maintain-

ing the habit of an addict. And there is no independent re-

quirement that the interpretation of a notice-and-comment

regulation also be the product of notice and comment. Such

interpretations rarely follow notice and comment, and indeed

Auer and its predecessors involved interpretations that

were not the product of notice and comment. See Auer, 519

U.S. at 462; Thomas Jefferson Univ., 512 U.S. at 510, 512;

Martin v. OSHRC, 499 U.S. 144, 156-157 (1991). Accord-

ingly, the regulation itself is concededly valid and the

Attorney General's interpretation of it plainly qualifies for

Auer deference. That is a sufficient basis to decide this case

and reverse the decision below.

2. The Attorney General's rule is equally valid, however,

even if respondents are somehow permitted to ignore the

regulation and Awer and their suit is viewed as one chal-

lenging an interpretation of the Act itself. The interpreta-

tion embraced in the Attorney General’s rule reflects an en-

tirely reasonable construction of the Act, and therefore must

be upheld under Chevron.

The CSA makes clear in its very first section that it per-

mits the distribution of controlled substances only for “le-

gitimate medical purposes”—those intended to “maintain the

health and general welfare of the American people,” 21

U.S.C. 801(1). The Act’s clearly stated purpose is to enhance

and maintain life, not to end it. This Court’s decisions under

the Harrison Act, which the CSA was intended to streng-

then, Gonzales v. Raich, 125 S. Ct. 2195, 2202-2203 (2005),

3

made that central principle clear more than 80 years ago.

See Webb v. United States, 249 U.S. 96, 99-100 (1919) (To call

a doctor’s order for morphine that was “not * * * issued

* * * in the course of professional treatment in the

attempted cure of the habit” “a physician’s prescription

would be so plain a perversion of meaning that no discussion

of the subject is required.”) (emphasis added); accord Jin

Fuey Moy v. United States, 254 U.S. 189, 194 (1920); United

States v. Behrman, 258 U.S. 280, 286, 288-289 (1922). And

this Court followed the interpretation of those cases in

Moore, 423 U.S. at 132, in a prosecution under the CSA.

Moreover, the CSA directs that substances be scheduled

according to whether they have a “currently accepted medi-

cal use in treatment” and an “accepted safety for use * * *

under medical supervision.” 21 U.S.C. 812(b)(1)(B) and (C)

(emphasis added). There can be little doubt that a substance

that had no utility in curing, treating, or alleviating disease,

but was perfectly suited to causing a painless death, would

be placed among the substances in schedule I as one having

“no currently accepted medical use in treatment in the

United States,” 21 U.S.C. 812(b)(1)(B). That scheduling

decision would be made as a matter of federal law, and would

bind physicians, even if state law were to the contrary.

Raich, 125 S. Ct. at 2211-2213; United States v. Oakland

Cannabis Buyers’ Coop., 532 U.S. 483, 486, 492-493 (2001).

While the schedule II substances prescribed under Oregon’s

Death with Dignity Act (DWDA), Or. Rev. Stat. §§ 127.800

et seq. (2003), do have some accepted medical uses,

facilitating suicide is not one of them. A prescription issued

for that purpose therefore is not for a legitimate medical

purpose under the Act. The legislative history of the CSA

confirms that using controlled substances to commit suicide

is “misuse” under the CSA and a critical aspect of the pat-

tern of abuse—including overdoses—that the Act was

enacted to prevent. H.R. Rep. No. 1444, 91st Cong., 2d Sess.

35 (1970). This interpretation of the Act is eminently rea-

sonable and therefore is controlling under Chevron.

4

3. That validity of the Attorney General’s interpretation

of the Act is unaffected by the fact that it was not issued af-

ter notice and comment. This Court has made clear that no-

tice-and-comment rulemaking is not a prerequisite for

Chevron deference. Barnhart v. Walton, 535 U.S. 212, 219-

220, 221-222 (2002). And any such inflexible requirement

would be contrary to the Administrative Procedure Act, the

basic statutory framework for judicial review of agency

action, which specifically exempts interpretive rules from

the requirement of notice and comment. See 5 U.S.C.

553(b)3)(A).

The patient-respondents’ other objections to deference (at

10-28) are without merit. Respondents first object to the

interpretation as “informal.” See Patient Br. 11. But the in-

terpretive rule was issued by the Attorney General himself,

after considering the lengthy legal analysis of the Office of

Legal Counsel, and his determination was published in the

Federal Register. Pet. App. 100a-105a; id. at 106a-148a. No

greater formality could be expected. This case therefore is a

far cry from the cases the patient-respondents cite: United

States v. Mead Corp., 533 U.S. 218, 233 (2001) (“46 different

* * * offices issue 10,000 to 15,000” rulings per year);

Alaska Depurtment of Environmental Conservation, 540

U.S. 461, 487 (2004) (“internal guidance memorandum”);

Christensen v. Harris County, 529 U.S. 576, 587 (2000)

(opinion letter).

The patient-respondents also contend (at 13-15) that the

Attorney General's rule is not entitled to deference because

he lacks medical expertise. They cite the role assigned to

the Secretary of Health and Human Services in the CSA

with respect to the scheduling of controlled substances. /d.

at 15 (citing 21 U.S.C. 811(b)). But as the practitioner-

respondents realize (at 20-33), this case does not implicate

the authority to schedule controlled substances, which may

touch upon technical scientific and medical matters. Rather,

it presents a legal question for the Attorney General to re-

solve by interpreting one of his own regulations and the

5

provisions of the CSA it implements. Nor is there anything

anomalous about a scheme that requires broader input on

the ultimate question of scheduling a drug than on a decision

that particular practices are abusive or illegitimate. In cases

such as Webb and Moore, the Court sustained criminal prose-

cutions initiated by the Department of Justice based on the

Department’s judgment that the prescriptions were

improper, with no suggestion that prior approval by some

other federal agency was required.

Even as to scheduling, respondents overstate the role of

the Secretary. His views are binding on the Attorney Gen-

eral only as to “such scientific and medical matters” as are

specifically referred to the Secretary in the scheduling proc-

ess. See 21 U.S.C. 811(b) and (c). The statute makes clear-

that the Secretary’s comments about a substance’s “poten-

tial for abuse,” “pattern of abuse,” or “significance of abuse,”

21 U.S.C. 811(b), (¢)(1), (4) and (5), are binding on the Attor-

ney General only as to any “scientific and medical considera-

tions,” 21 U.S.C. 811(b). Congress thus recognized that even

in the scheduling process, determinations about a sub-

stance’s “abuse” may not be scientific or medical in nature,

but might instead involve legal or other considerations that

are for the Attorney General to resolve.

Respondents also emphasize that the interpretive rule at

issue here is contrary to the views of the preceding Attorney

General. Patient Br. 16, 21-22, 27-28. This Court’s recent

decision in National Cable & Telecommunications Ass’n v.

Brand X Internet Services, 125 S. Ct. 2688 (2005), provides a

complete legal answer to that argument. “Agency inconsis-

tency is not a basis for declining to analyze the agency’s in-

terpretation under the Chevron framework.” Id. at 2699. In

addition, the position of the Attorney General that respon-

dents challenge, unlike the views of his predecessor set forth

in a letter to Members of Congress, took the form of agency

action, after a thorough legal analysis, published in the Fed-

eral Register.

6

Finally, respondents object (Patient Br. 16-19, 20-21, 30-

35) that the thorough analysis on which the Attorney Gen-

eral’s decision was based did not discuss Oregon’s experience

under the DWDA or other views supportive of assisted sui-

cide as a policy matter. But, because that analysis focused

on what constitutes a “legitimate medical purpose” as a /egal

mutter and on the judgment that suicide, including physi-

cian-assisted suicide, is itself harmful to public health and

safety, Oregon’s data concerning the experience of persons

who receive drugs and commit suicide as permitted by the

DWDA were irrelevant. The patient-respondents’ other

evidence consists of a few opinion polls, the support of spe-

cialized professional groups and associations, and recent le-

gal developments in a few foreign countries. Patient Br. 30-

35. Even respondents concede that, at most, that evidence

indicates that public opinion is “divided” on this issue, Pa-

tient Br. 30.'

B. The CSA Establishes A Uniform National Standard

For Distributing Controlled Substances

Apart from their challenge to the Attorney General’s in-

terpretation on deference grounds, respondents offer three

statutory arguments why the CSA should be construed to

take the determination out of federal hands altogether and

make state law the arbiter of whether distribution of a drug

is ,or a “legitimate medical purpose” under the CSA. None

is persuasive.

! Certain of respondents’ amici, but not respondents, argue that the

Attorney General's interpretive ruling should be rejected because of the

“rule of lenity.” Briffault Br. 19-22. In Babbitt v. Sweet Home Chapter of

Communities for a Great Oregon, 515 U.S. 687 (1995), the Court rejected

the suggestion “that the rule of lenity should provide the standard for

reviewing facial challenges to administrative regulations whenever the

governing statute authorizes criminal enforcement.” Jd. at 704 n.18.

There is no question that the Attorney General's interpretive rule gives

“| jadequate notice of potential liability” to practitioners if they use their

federal registration to assist someone to commit suicide. /bid. The rule of

lenity is therefore inapplicable.

7

1. Practitioner-respondents argue (at 13-14, 23) that it is

the statutory phrase “in the course of professional practice,”

21 U.S.C. 802(21), rather than the regulatory phrase “legiti-

mate medical purpose,” 21 C.F.R. 1306.04, that governs, and

that the former necessarily incorporates medical practice

under state law. That argument simply ignores the fact that

the CSA itself uses the term “legitimate” to modify “medical

purpose” or medical “use” in at least four different provi-

sions, including the Act’s very first declaration of congres-

sional purpose, 21 U.S.C. 801(1). See also 21 U.S.C.

830(b)(3)(A)(ii) (defining “valid prescription” as one “issued

for a legitimate medical purpose”), 823(a)(1), 823(f). It also

ignores the absence of any language even in “the course of

professional practice” phrase that ties it to practice in a par-

ticular state or locality.

More broadly, the practitioners fail to grasp that the CSA

does not merely regulate the conduct of doctors in particular

localities; it imposes affirmative nationwide duties on the At-

torney General to act based upon his determination whether

an asserted medical purpose is “legitimate” or “accepted.”

For example, the Attorney General must schedule sub-

stances according to whether they have a “currently ac-

cepted medical use in treatment in the United States,” 21

U.S.C. 812(b)(1)-(5) (emphasis added), and must regulate the

manufacture of controlled substances to ensure “an adequate

and uninterrupted supply” for “legitimate medical, scientific,

research and industrial purposes,” 21 U.S.C. 823(a)(1). It is

untenable, especially in light of this Court’s recent decision

in Raich upholding the CSA’s blanket prohibition on mari-

juana use despite California’s recognition of its medicinal

utility, to maintain that the Attorney General is constrained

to adopt a particular State’s policy regarding what is an “ac-

cepted” or “legitimate” medical purpose or use. 125 S. Ct. at

2211; Oakland Cannabis, 532 U.S. at 486, 492-493. The At-

torney General would not need to remove a drug froia

schedule I because one State recognized an idiosyncratic use

for an otherwise banned substance. There is no more reason

8

for the Attorney General to have to treat a prescription that

would be unlawful and improper as a matter of federal law in

49 States as legitimate because of the idiosyncratic view of a

single State. That would be true of a State that purported to

allow prescriptions of the sort at issue in Moore, and is no

less true of a State that allows prescriptions for a use (facili-

tating a lethal overdose) that amounts to abuse in 49 States

and as a matter of federal law.

2. Alternatively, the practitioner-respondents argue (at

25) that Congress was concerned only with doctors “di-

verting drugs outside of legitimate channels.” To the extent

respondents mean that Congress was not concerned with the

purposes for which a doctor prescribes medicine to a patient,

except to the extent the patient might resell the drugs out-

side “legitimate channels,” that contention is simply wrong.

As the Court recognized in Raich, “the CSA is a comprehen-

sive regulatory regime specifically designed to regulate

which controlled substances can be utilized for medicinal

purposes, and in what manner,” 125 S. Ct. at 2211 (emphasis

added). See Moore, 423 U.S. at 143 (CSA establishes “limits

on free experimentation with drugs” by physicians). Indeed,

diversion from legitimate uses to illegitimate uses via oth-

erwise legitimate channels (e.g., prescriptions from a doctor

to a patient) was a primary concern of the Harrison Act

prosecutions and Moore. Similarly in this case, the diversion

‘ of schedule II substances from legitimate uses as medicine to

what in every other State and under federal law amounts to

abuse and the facilitation of a lethal overdose is diversion for

purposes of the CSA

* Moreover, Oregon’s representation (at 23 n.9) that prescriptions

under DWDA pose no risk of diversion to others is not borne out. A lethal

dose under DWDA is approximately 90 to 100 times the therapeutic dose.

Oregon Br. 43. And it appears that a high percentage of persons for whom

a lethal dose is prescribed do not end up taking the prescribed drugs,

Patient Br. 39, thus leaving a large quantity of strictly regulated schedule

I] substances unaccounted for and outside the CSA’s closed system.

9

After criminal prosecutions such as Moore confirmed the

basic legal distinction under the CSA between legitimate

medical treatment of addicts and illicit dispensing of drugs to

maintain an addict’s habit, the Act was amended to provide

for the Secretary to articulate more specific criteria for when

a physician can prescribe narcotic drugs to patients for

“maintenance treatment or detoxification treatment.” 21

U.S.C. 823(g)(1); see Gov’t Br. 33-34. But that mechanism

for fleshing out the established legal standard in a particular

context simply confirms that the CSA itself more generally

embodies a basic federal statutory limitation on what consti-

tutes a “legitimate medical purpose.” If prescribing con-

trolled substances to sustain addiction during life is not such

a purpose, then a fortiori prescribing drugs to cause death

crosses the statutory line. No medical or scientific expertise

of the Secretary is required for the Attorney General to re-

solve that basic question of statutory interpretation.

3. Respondents contend that the CSA’s reference to

state licensing decisions in 21 U.S.C. 823(f) indicates a con-

gresrional intent that state, rather than federal, law provide

the sole reference point for determining whether a particular

physician’s dispensing of drugs is permissible under the

CSA. Practitioner Br. 29-33; Oregon Br. 35-38. Section

823(f) governs the granting of federal registration to dis-

pense controlled substances, not the conduct of physicians

after they are registered. Gov’t Br. 34-35. Nonetheless, its

history is instructive. When the CSA was adopted, Con-

gress piggybacked on state licensing boards to determine

who would obtain a federal registration in the first instance.

See 21 U.S.C. 823(f) (1970). But even then the State’s

licensing decision was not dispositive with respect to federal

registration, because registration could be revoked if the

registrant was convicted of a felony under the CSA or any

other law of the United States (or of any State) relating to a

controlled substance. 21 U.S.C. 824(a)(2) (1970). Neither

Section 823(f) nor any other provision of the CSA was ever

understood to require that the federal government await a

10

determination by a state licensing board before prosecuting

a doctor under the CSA or revoking the federal registration

based on a conviction. Gov't Br. 31-33.

Significantly, moreover, Congress amended the Act in

1984 to allow the Attorney General to deny, suspend, or re-

voke a practitioner’s registration on other federal grounds as

well. See 21 U.S.C. 823(f), 824(a). Now, the Attorney Gen-

eral must also consider “(t]he applicant’s experience in dis-

pensing * * * controlled substances,” “[c]ompliance with

applicable State, Federal, or local laws relating to controlled

substances,” and “{s]uch other conduct which may threaten

the public health and safety.” 21 U.S.C. 823(f)(2), (4), and (5).

Congress revised the earlier provisions in part because

States were not adequately regulating physicians’ abuses of

their prescription-writing authority. See S. Rep. No. 225,

98th Cong., Ist Sess. 262 (1983) (noting that it “may clearly

be contrary to the public interest” to require federal regis-

tration of any practitioner licensed under state law); id. at

266. Thus, the 1984 amendments granted the Attorney Gen-

eral considerably broader authority to take administrative

action on independent federal grounds. It is also clear that

the references to violations of federal, state, or local law are

in the disjunctive and that any one of the enumerated factors

in Section 823(f) can be dispositive. See, e.g., Shatz v. United

States Dep't of Justice, 873 F.2d 1089 (8th Cir. 1989). It is

clear, for example, that the Attorney General may now re-

voke the registration of a physician who engages in improper

prescription practices of the sort involved in Moore, without

waiting for a federal criminal conviction much less a state-

law conviction or action by state registration authorities.

The patient-respondents suggest (at 42-44) that the At-

torney General’s interpretive rule violates Section 823(f) be-

cause it gives insufficient weight to Oregon law. The Attor-

ney General's rule is not, however, an application of the reg-

istration provisions in Section 823(f), but an interpretation of

the substantive federal law requirements (under 21 C.F.R.

1306.04) for a valid prescription. Because compliance with

11

federal law, viz the CSA (including the prescription require-

ment), is itself a consideration in registration decisions under

Section 823(f), the interpretive rule puts registrants on

notice of an important determination of the Attorney

General regarding federal law that could affect their regis-

trations. In short, Sections 823 and 824 make clear that a

doctor can lose his or her federal license by violating state

law, local law or federal law. A doctor might lose federal

registration based on violations of state laws that have no

federal analog because the state-law violation may demon-

strate indirectly that a doctor is unfit for federal-law pur-

poses. A violation of federal law demonstrates unfitness

more directly and can occur even if state law does not regu-

late or criminalize the conduct.

Il. THERE IS NO REQUIREMENT OF A CLEAR

STATEMENT APPLICABLE HERE

For the reasons stated above, the Attorney General's

ruling is clearly sound under normal rules of statutory con-

struction. Respondents urge, however, that the usual princi-

ples do not apply here. Rather, they contend that the CSA

can restrict conduct that state law would permit only if the

statute contains a “clear statement” to that effect. This

Court has already recognized that the CSA reflects a com-

prehensive regime that does not need to yield just because a

State has chosen to remove state-law prohibitions on certain

conduct independently prohibited by federal law. Raich, 125

S. Ct. at 2203. And respondents cannot point to any author-

ity requiring federal authorities to identify a “clear state-

ment” of legislative intent before applying a comprehensive

scheme to such conduct.

A. A Presumption Against Federal Preemption Does

Not Apply Because The CSA Does Not Preempt The

DWDA

Oregon contends that a “presumption against preemption”

applies—and a “clear statement” is required—whenever a

federal regulation would “prevent” a more permissive “state

12

law from operating as state lawmakers intended.” Oregon

Br. 20-21. That argument is flatly wrong and, if accepted,

would dramatically alter the relationship between state and

federal law.

Respondents’ reliance on the presumption against pre-

emption suffers a singular flaw: This is not a preemption

case. Preemption refers to those circumstances in which

“the Supremacy Clause invalidates state laws that ‘interfere

with or are contrary to the laws of Congress.’” Chicago &

N.W. Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317

(1981) (quoting Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211

(1824)). The combined effect of federal law and the Suprem-

acy Clause renders such state statutes unconstitutional. The

CSA does not preempt Oregon law. The CSA prohibits phy-

sicians from prescribing federally-controlled substances for

the purpose of assisting a person to commit suicide. The

DWDA removes pre-existing state-law sanctions on facili-

tating suicide in certain circumstances. See Kane v. Kulon-

goski, 871 P.2d 993, 998 (Or. 1994). Nothing in the CSA in-

validates the DWDA or prevents the use of means other

than federally-controlled substances for the commission of

When “Congress has chosen to prohibit an act which [the

State] has chosen not to prohibit; there is no conflict,” Hy-

land v. Fukuda, 580 F.2d 977, 981 (9th Cir. 1978), and any

presumption against preemption is therefore inapposite. Re-

spondents’ reliance (Oregon Br. 26-27; Practitioner Br. 45-

46) on the CSA's preemption clause, 21 U.S.C. 903, is thus

misplaced. That provision clarifies Congress’s intent not to

preempt the entire field of controlled substances. But, since

the Attorney General's interpretive ruling does not “pre-

empt” Oregon law in any way, let alone the field, Section 903

is simply irrelevant.

What Oregon actually proposes (Br. 20-21), then, is a radi-

cal new presumption that would effectively invert the Su-

premacy Clause and, in the absence of a clear statement, bar

federal regulation whenever it would “frustrat(e]” a State’s

13

choice to permit conduct that federal law prohibits. That

proposition has no support in the cases Oregon cites,’ and

would either completely invert the constitutional relation-

ship between the federal and state governments or at a mini-

mum resurrect the cramped notions of federal power that

the Court definitively rejected in United States v. Darby,

312 U.S. 100 (1941). In Darby, the respondent challenged

the Fair Labor Standards Act of 1938, 29 U.S.C. 201 et seq.,

on the ground that it “undertakes to regulate wages and

hours within the state contrary to the policy of the state

which has elected to leave them unregulated.” 312 U.S. at

114. The Court rejected that contention, ruling that Con-

gress is “free to exclude from commerce” conduct that “it

may conceive to be injurious to the public health, morals or

welfare, even though the state has not sought to regulate

their use.” bid.

Although Darby concerned Congress’s constitutional

authority, other cases reject the same proposition as a mat-

ter of statutory construction. For example, in Caron v.

United States, 524 U.S. 308 (1998), the Court interpreted a

federal statute to prohibit an individual from possessing ri-

fles and shotguns, id. at 316-317, even though the State spe-

cifically allowed such possession, id. at 311. Similarly, in

Dickerson v. New Banner Institute Inc., 460 U.S. 103 (1983),

the Court held that, for purposes of federal gun laws, the de-

terminations whether an individual had been “convicted” in

state court and whether that conviction had later been nulli-

fied were “question{s) of federal, not state, law,” id. at 111-

112, even though the respondent’s gun rights might have

been restored as a matter of state law, id. at 114 n.9.

* Two of those cases, Jones v. United States, 529 U.S. 848 (2000), and

United States v. Bass, 404 U.S. 336 (1971), involved the doctrine of consti-

tutional avoidance, which we address below. See pp. 14-16, infra. The

other two involved classic questions of preemption. See Department of

Revenne v. ACF Indus., Inc., 510 U.S. 332, 335-336 (1994); Cipollone v.

Liggett Group, Inc., 505 U.S. 504, 508 (1992).

14

B. Because The CSA, As Interpreted By The Attorney

General, Is Clearly Constitutional, The Doctrine Of

Constitutional Avoidance Does Not Apply

Respondents invoke the doctrine of constitutional avoid-

ance, under which courts prefer an interpretation of an am-

biguous statute that avoids “a serious constitutional ques-

tion.” Verizon Communications, Inc. v. FCC, 535 U.S. 467,

523 (2002). Oregon Br. 42; see Patient Br. 23; Practitioner

Br. 47-50. As explained above, however, the CSA is not am-

biguous. Nor is its constitutionality, as interpreted by the

Attorney General, doubtful.

Respondents’ contention that Congress lacks authority

under the Commerce Clause to regulate the distribution of

schedule II controlled substances in Oregon is foreclosed, a

fortiori, by this Court’s decision in Raich, which rejected a

Commerce Clause challenge to Congress's authority to regu-

late even the home cultivation and consumption of mari-

juana, including marijuana that is to be used for purported

medicinal purposes on the basis of a physician’s recommen-

dation as authorized by state law. 125 S. Ct. at 2207. The

class of conduct at issue in Raich was “purely intrastate ac-

tivity that is not itself ‘commercial,’ in that it is not produced

for sale.” Jd. at 2206. Here, by contrast, the CSA directly

regulates the commerce between physician and patient or

pharmacist and customer in schedule II controlled sub-

stances that, by Oregon's own admission (Br. 43 & n.18), are

produced commercially and have, in all likelihood, “traveled

in interstate commerce.”

Respondents assert that the Attorney General's interpre-

tive rule is nonetheless unconstitutional because there is no

evidence that controlled substances prescribed under the

DWDA “have or will enter into the stream of illicit com-

merce.” Practitioner Br. 49 (emphasis added). But that ar-

gument is both circular and unpersuasive. The prescription

of drugs for the purpose of enabling a person to take his own

life is “illicit” under the CSA, and its legality and consequent

regulation (to an extent) under Oregon law does not diminish

15

federal authority. Raich, 125 S. Ct. at 2213 n.38; id. at 2219-

2220 (Scalia, J., concurring in the judgment). Nor, in any

event, is Congress’s Commerce Clause authority limited by

the licit or illicit nature of the activity regulated. The CSA is

equally constitutional in its prohibition of schedule I sub-

stances and its regulation of sometimes lawful schedule II

substances. Oregon also errs in suggesting that because a

relatively small number of individuals can avail themselves

of the DWDA, the total amount of drugs at issue is too “in-

significant” for Congress to regulate. Oregon Br. 45.

“(Where the class of activities is regulated and that class is

within the reach of federal power, the courts have no power

to excise, as trivial, individual instances of the class.” Raich,

125 S. Ct. at 2209 (quotation marks omitted). It is the class-

of activities that Congress has forbidden—not the class of ac-

tivities that state law decriminalizes—that must have the

requisite impact on interstate commerce, and that standard

is satisfied here, just as it was in Raich. Id. at 2208.

Oregon contends that Congress’s power under the Com-

merce Clause is limited to regulating the “commercial as-

pects” of a transaction, and that it cannot make the applica-

tion of federal law turn on “a physician's or patient’s inten-

tions about the ultimate use of the drugs” at issue. Oregon

Br. 43-44. However, the Court made clear long ago that

Congress’s Commerce Clause power is not limited to some

narrow category of concerns about the “commercial aspects”

of transactions, but may be exercised, based on Congress’s

“own conception of public policy,” to prohibit what it “may

conceive to be injurious to the public health, morals or wel-

fare.” Darby, 312 U.S. at 114; see also The Lottery Case, 188

U.S. 321, 354 (1903). There is nothing unusual, let alone con-

stitutionally suspect, about federal laws that regulate con-

duct based on the actor’s purpose or intent. In Moore, for

example, the Court upheld a physician’s conviction under the

CSA precisely because he had prescribed methadone to feed

his patients’ habits, rather than for “detoxification pur-

poses,” the only purpose allowed under the Act. 423 U.S. at

16

144-145. Nor does the fact that a physician acts “pursuant to

affirmative state law,” Oregon Br. 47, shield his activity from

Congress's constitutional reach, for “state action cannot cir-

cumscribe Congress’ plenary commerce power.” Raich, 125

S. Ct. at 2213; Wickard v. Filburn, 317 U.S. 111, 124 (1942);

Darby, 312 U.S. at 114. Indeed, the logic of respondents’

Commerce Clause argument is that the federal government

lacks the authority to revoke a doctor’s license for prescrib-

ing controlled substances for purposes of assisting suicide

not just in Oregon, but in the 49 States that prohibit the con-

duct.

C. There Is No Requirement That Congress Make A Par-

ticularly “Clear Statement” Whenever It Addresses

An Issue That Is Also Within “Traditional State

Authority”

Respondents finally suggest that a clear statement is nec-

essary because the CSA, as interpreted by the Attorney

General, “would intrude upon the historic powers of the

States” and “alter the usual state-federal balance.” Oregon

Br. 28, 30 (quotation marks omitted). See Practitioner Br.

47-50; Patient Br. 23-24. That proposition is singularly inap-

posite here: the federal government has regulated the distri-

bution of controlled substances for 90 years, Raich, 125

S. Ct. at 2202, whereas, prior to 1994, no State had ever pur-

ported to allow physicians to dispense controlled substances

for the purpose of assisting a person’s suicide.

More broadly, Oregon asserts (Br. 34 & n.15) that a “clear

statement” is required whenever federal regulation would

have an impact on “States’ regulation of the health, welfare,

and comfort of their citizens.” But that category of state

authority encompasses everything not forbidden by the Con-

4 Similarly, federal law prohibits interstate travel only when done

with specified intent, such as “for the purpose of engaging in any illicit

sexual conduct with another person,” PROTECT Act, Pub. L. 108-21, Title

1, $ 105(a), 117 Stat. 654 (to be codified at 18 U.S.C. 2423(b)), with intent to

commit murder for hire, 18 U.S.C. 1958(a), with intent to avoid prosecu-

tion, 18 U.S.C. 1073, and with intent to incite a riot, 18 U.S.C. 2101(a\(1).

17

stitution. See Hodel v. Virginia Surface Mining & Reclama-

tion Ass'n, 452 U.S. 264, 311 (1981). Respondents’ broad

anti-federal-regulation presumption therefore would mark a

sea-change in the Court’s jurisprudence. None of the cases

cited by respondents (Oregon Br. 27-34, 38-42) support such

a sweeping rule.

Oregon primarily relies (Br. 31-34) on Gregory v. Ashcroft,

501 U.S. 452 (1991), but Gregory stands for no such proposi-

tion. The question presented was one of federal preemption

of state law—whether the federal Age Discrimination in

Employment Act prohibited Missouri from enforcing a state

constitutional requirement that judges retire at seventy.

See id. at 455, 460. Moreover, because the state law at issue

concerned “(t]he authority of the people of the States to

determine the qualifications of their government officials,”

preemption by federal law would have encroached upon

“how a State defines itself as a sovereign” and presented a

“potential constitutional problem,” under the Guarantee

Clause, U.S. Const., Art. IV, § 4, and the Tenth Amendment.

Gregory, 501 U.S. at 460, 463-464; see City of Edmonds v.

Oxford House, Inc., 514 U.S. 725, 732 n.5 (1995) (emphasizing

that Missouri's interest in setting the qualifications of judi-

cial office went “beyond an area traditionally regulated by

the States,” to the core of state sovereignty) (quoting

Gregory, 501 U.S. at 460) (emphasis added). This case impli-

cates neither basis for triggering a clear-statement require-

ment.

Oregon contends (Br. 31-34) that, even if Gregory is not

directly applicable, other decisions have applied Gregory's

clear statement requirement more broadly. But the other

cases Oregon cites are likewise inapposite. Most are yet fur-

ther examples of the presumption against preemption of

state law in particular contexts.’ Others are instances of the

® See, eg., Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 359

(2002); California Div. of Labor Standards Enforcement v. Dillingham

Constr., N.A., Inc., 519 U.S. 316, 319 (1997); Hillsborough County v.

Automated Med. Labs., Inc., 471 U.S. 707, 714-715 (1985); Hisquierdo v.

18

-doctrine of constitutional avoidance." And two involved the

presumption that Congress does not intend to abrogate the

States’ sovereign immunity—a core aspect of state sover-

eignty.' None of those canons of construction is implicated

by the application of the CSA to commercial transactions in

controlled substances among physicians, pharmacists, and

their customers, even if, as in Raich, the CSA prohibits

transactions that state law would allow.

Respondents’ inability to cite examples of the Court’s ap-

plying a clear-statement rule merely because federal law

regulates private conduct in a manner more restrictive than

state law is not surprising. Giving effect to more stringent

federal law does not “alter the usual state-federal balance,”

Oregon Br. 30. Rather, that is the usual state-federal bal-

ance under the Constitution, which permits Congress to leg-

islate according to “its own conception of public policy.”

Darby, 312 U.S. at 114. Thus, as we discussed in our opening

brief, the “general assumption” is that the terms of a federal

statute do not depend upon state law but instead should be

given “uniform nationwide application.” Mississippi Band of

Choctaw Indians v. Holyfield, 490 U.S. 30, 43 (1989).

The Court has, moreover, applied the presumption of fed-

eral uniformity to statutes that legislate in areas within

“traditional state regulatory powers,” Oregon Br. 28. In

Mississippi Band itself, the Court held that a uniform fed-

eral definition should be given to the ambiguous term “domi-

cile” in the Indian Child Welfare Act, even though the sub-

Hisquierdo, 439 U.S. 572, 581, 590 (1979); Rice v. Santa Fe Elevator Corp.,

331 U.S. 218, 236 (1947).

6 See, e.g., Raygor v. Regents of the Univ. of Minn., 534 U.S. 533, 543-

544 (2002); Solid Waste Agency v. United States Army Corps of Eng’rs,

531 U.S. 159, 172-173 (2001); Jones v. United States, 529 U.S. 848, 857-858

(2000); Edward J. DeBartolo Corp. v. Florida Gulf Coast Bldg. & Constr.

Trades Council, 485 U.S. 568, 575 (1988); United States v. Bass, 404 U.S.

336, 339 n.4 (1971). See also United States v. Lopez, 514 U.S. 549, 562

(1995) (characterizing Bass as an example of constitutional avoidance).

7 See Raygor, 534 U.S. at 543; Will v. Michigan Dep't of State Police,

491 U.S. 58 (1989).

19

ject matter—family law, specifically child custody—is near

the epicenter of conduct traditionally regulated by the

States. See Elk Grove Unified School Dist. v. Newdow, 124

S. Ct. 2301, 2309 (2004)." Likewise, in Caron the Court gave

a uniform federal meaning to the gun statute in light of the

federal government’s “interest in a single, national, protec-

tive policy, broader than required by state law.” 524 U.S. at

316.

Respondents cite numerous cases that comment on the

States’ historic role in regulating medicine (Practitioner Br.

44; Oregon Br. 47 & n.22; Patient Br. 24 n.11), but none—

apart from long-ago-overruled language in Linder v. Un.ied

States, 268 U.S. 5 (1925), see Gov’t Br. 40-41—suggests that

a federal law concerning medicine is somehow more suspect:

than statutes in other areas like family law or gun possession

that States have also traditionally regulated. And the

Court’s decisions in Raich and Oakland Cannabis positively

refute that proposition specifically with respect to the CSA.

See also Lambert v. Yellowley, 272 U.S 581, 596 (1926)

(“(Tjhere is no right to practice medicine which is not

subordinate to * * * the power of Congress to make laws

necessary and proper” to its constitutional authority.).

Although respondents refer repeatedly to the tradition of

state regulation of medicine, the DWDA and its approach to

assisted suicide does not resemble any traditional regulation

of “medicine.” Assisting in a person’s suicide is, as the

American Medical Association ethics guidelines recognize,

“fundamentally incompatible with the physician’s role as

healer.” AMA, Current Opinions of the Council of Ethical

* Oregon characterizes (at 16 n.7) Mississippi Band as involving a

“clearly demonstrated [congressional] intent to displace state court juris-

diction.” But that is not how the Court described its own reasoning.

Rather, the opinion states that “[wle start * * * with the general

assumption that ‘in the absence of a plain indication to the contrary, . . .

Congress when it enacts a statute is not making the application of the

federal act dependent upon state law.’” 490 U.S. at 43 (emphasis added)

(quoting Jerome v. United States, 318 U.S. 101, 104 (1943)).

20

and Judicial Affairs, Opinion No. E-2.211, Physician-As-

sisted Suicide, (last visited Aug. 25, 2005) <http://www.ama-

assn.org/ama/pub/category/print/ 8459.html>. Moreover, the

DWDA regulates assisted suicide differently from Oregon’s

own regulation of medicine. The DWDA’s allowance of pre-

scriptions for assisted suicide, while prohibiting physicians

from actually administering the lethal drugs (see Oregon Br.

2, Practitioner Br. 15), which presumably reflects Oregon’s

own apparent discomfort with the idea of physicians directly

causing death, is unique. Respondents point to no other cir-

cumsiance, and we are aware of none, in which a doctor “may

prescribe, but not administer,” a substance. Oregon Br. 2.

That simply does not happen when the controlled substance

is being dispensed as “medicine.” Moreover, that anomaly

only underscores that the DWDA relies not on the physi-

cian’s medical knowledge (the lethal substances and the re-

quired dosages have been well publicized in Oregon’s DWDA

reports, see Oregon Br. 43 & n.20.), but on the physician’s

federal-law status as a distributor of schedule II substances.

The Attorney General’s interpretation thus represents not

an effort to reverse a state-law judgment about assisted sui-

cide (which remains valid in Oregon to the extent is does not

involve federally-controlled substances), but an effort to pre-

vent a State from commandeering a federal-licensee’s ability

to dispense schedule II substances for ends that are contrary

to federal law and bear little resemblance to traditional

medicine.

* + + Y *

For the foregoing reasons and those stated in the opening

brief, the judgment of the court of appeals should be re-

versed.

Respectfully submitted.

PAUL D. CLEMENT

Solicitor General

AUGUST 2005