Amicus Curiae Brief — Gonzales v. Oregon

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—_— gr eee

Supreme Court, U.S.

FILED

No. 04-623 JUL 18 2005

IN THE

Supreme Court of the United States

ALBERTO R. GONZALES,

ATTORNEY GENERAL, ET AL.,

Petitioners,

Vv.

STATE OF OREGON, ET AL.,

Respondents.

On Writ of Certiorari to the

United States Court of Appeals

for the Ninth Circuit

BRIEF OF THE AMERICAN PUBLIC HEALTH

ASSOCIATION AS AMICUS CURIAE

IN SUPPORT OF RESPONDENTS

SEAN H. DONAHUE DAVID T. GOLDBERG

2000 L. Street, Suite 808 Counsel of Record

Washington, DC 20036 99 Hudson Street, 8th Fl

(202) 466-2234 New York, N.Y. 10013

(212) 334-8813

DANIEL N. ABRAHAMSON

Drug Policy Alliance,

Office of Legal Affairs

717 Washington St.

Oakland, CA 94607

(510) 208-7711

Attorneys for Amicus Curiae

SN a a a a a ED

TABLE OF CONTENTS

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Interest of Amicus Curiae ............cccccccccccces l

CE l

TSE SE ee AY Sr a Oe 3

I. It Is Impossible To Construe The CSA

As Vesting The Attorney General With

The Broad Power Claimed ....................... 3

Congress Did Not Confer The Authority

On Which The Directive Is Premised ........... 3

The Meaning of “legitimacy” Must Be Anchored

To The Statute’s Text And Purposes ........... 10

The 1984 Amendment Did Not Confer

Power To Overrule State Policy Judgments

Unrelated To Controlled Substances ........... 13

The CSA Must Be Read As Preserving

States’ Role In Matters of Public Health

a cceuecees 14

Public Health Is Served By Legal Principles

Allowing Experimentation And Diversity

Ee 14

. Oregon’s Law Is A Legitimate and

Important Policy “Experiment” ............... 17

C. The Extent and Benefits of Regulatory

Diversity Is Significant ...........-.50-0eee-

D. Congress Dic Not Intend The CSA

To Standardize Medical Practice

Neslomuitia . ow ccccccccsccscessuseeeeee

Ill. Sustaining The Assertion of Authority Would

Interfere With Proper Health Care ................

A. The Directive Will Worsen Existing, Serious

Inadequacies in End-of-Life Care .............

B. The Authority Claimed, If Approved,

Would Chill Legitimate Medical Practice

And Distort the Process By Which

Controversial Policy Questions Are Resolved .. . .

CONCLUSION ... ce ccccnccccccvccccvcesesesecss

TABLE OF AUTHORITIES

CASES

Alden v. Maine, 527 U.S. 706 (1999) .............--. 16

Bates v Dow Agrosciences, LLC,

125 S. Ct. 1788 (2005)... eee cece eee e eee. 4,14

BMW N. America v. Gore, 517 U.S. 559 (1996) ........ 21

California Retail Liquor Dealers Ass'n. v.

Midcal Aluminum, Inc., 445 U.S. 97 (1980) ........... 15

Chevron U.S.A. Inc. v. NRDC, Inc., 467 U.S. 837 (1984) .. 6

Crandon v. United States 494 U.S. 152 (1990) ........ 6,7

Conant v. Walters, 309 F.3d 629 (9th Cir. 2002)........ 25

FDA v. Brown & Williamson Tobacco Corp.,

EE EEE 4

Garcia v. San Antonio Metro. Transit Auth.,

ELIE EE 16

Gonzales v. Raich, 125 S. Ct. 2197 (2005) ............ 24

Gregory v. Ashcroft, 501 U.S. 452 (1991) .......... 15,16

In re Harline, 65 Fed. Reg. 5,665 (Feb. 4,2000) ........ 9

Hillsborough County v. Automated Med. Labs., Inc.,

SIE UD. FE CIGD oc cvcscccccccessvccsnssecesess 20

Linder v United States, 268 U.S. 5(1925) ............. 14

McCulloch v. Maryland, 19 U.S. 316 (1819) .......... 16

Medtronic v. Lohr, 518 U.S. 470 (1996) ........... 15, 16

Mississippi Band of Choctaw Indians v. Holyfield,

GED UD. FOCI oc ccccccccccccccesccccsccceccse 21

New State Ice Co. v. Liebmann,

TED GS. TEBE ccvcccccccscccccevecess 16, 17, 24

Pegram v. Herdrich, 530 U.S. 211 (2000) ....... 4, 14, 15

Rush Prudential HMO, Inc. v. Moran,

SE ES ccc cunencubuneseeeeveds 12, 15, 21

Solid Waste Agency of Northern Cook County v.

Army Corps of Engineers, 531 U.S. 159 (2001) ... 4, 14, 16

Tesauro v. Perrige,

650 A.2d 1079 (Pa. Super. Ct. 1994) ...........-54.. 22

Tobash v. Jones, 213 A.2d 588 (Pa. 1965) ........... 22

Thompson v. Western States Med. Ctr.,

) FR 0 re Tri ere ee 10, 25

United States v. Bass, 404 U.S. 336 (1971) ... 4, 14, 15, 16

United States v. Lopez, 514 U.S. 549 (1995) .......... 16

-iv-

United States v. Moore, 423 U.S. 122 (1975) ...... passim

United States v. Rosenberg,

ree 23

United States v. Oakland Cannabis

Buyers’ Cooperative, 532 U.S. 483 (2001) ......... 23, 24

United States v. Touby, 500 U.S. 160 (1991) ........... 6

Vacco v. Quill, 521 U.S. 793 (1997) ............. passim

Washington v. Glucksberg, 521 U.S 702 (1997) .... passim

Webb v. United States, 249 U.S. 96 (1919) ............. 4

STATUTES AND LEGISLATIVE MATERIALS

Be Ok ostcvdscceguecssdsnwanees 5, 6, 21

BP ED hiedauiresedieseddbuwndeuenee bas 6

a CE bGdonedneksuetiuseeiesiadas 5, 9, 26

ED Cita wduivedbei ad oineneohuuaie 6

Se ED no hac eed i cedsivdddeekdasers 6, 8, 24

PPE déddd duvucwedekuntstvededkaeuel 21

Se ET ccdaddcouesdebueadedsectusneicci 6,7

Se ED ankdsddvensdndesocubcenacsiecee 8, 23

Be es BOD cs cccccccecccccccsesesecods 5, 7, 14, 23

NN OI ov cccacnindsdekdeaiiedizeies 6

iy oo 1d heeweuneuenis 15

Pe 20

HLR. Rep. 91-1444 (1970) ........00.. cece eee sees 5,8

H.R. Rep. 93-884 (1974)... 0... ccc cece ceeeeeeeeees 6

ee ee 30

FEDERAL ADMINISTRATIVE MATERIALS

21 CIR. © CSBGBD. 2c ccccccccsccsccccccses 6, 7, 26

37 Fed. Reg. 16,505 (1972) .... nce cccccccccccccces 15

51 Fed. Reg. 17,476 (May 13, 1986) ..............4.. 9

58 Fed. Reg. 4,898 (Jan. 19, 1993) ............-0505, 13

66 Fed. Reg. 56,607 (Nov. 9, 2001) .............. passim

Exec. Order 13,237 (Nov. 28, 2001) ...........-5-045. 4

STATE STATUTES AND REGULATIONS

Cal. Health & Safety Code § 24185 ...............4.. 20

Cal. Health & Safety Code §125300 ................. 20

Mich. Comp. Laws § 333.16274 .................45.

ee ED 6 neeesneceetcdncctcncesececen

Pees Ge, GEG GBB cc ccccccccccccccccescces

SN OP IS deb cuccconccdcnaseceecnees

es OP UES cccvececcdiecccccsdcessecs

OTHER AUTHORITIES

Acupuncture as Illegal Practice of Medicine,

AMA Council on Ethical & Jud. Affairs, Physician

Participation in Capital Punishment,

PE g cdddueudadsss ninsecscnuees

APHA Policy 8123: Death With Dignity ..............

Bernabei et al., Management of Pain

in Elderly Patients with Cancer,

ee ee

Boumil & Elias,

The Law of Medical Liability (1995) .................

Carson et al., The Impact of Laws on HIV and STD

Prevention, 30 J. L. Med. Eth. 139 (2002).............

Chin et al., Legalized Physician-Assisted Suicide

in Oregon — The First Year's Experience,

340 New Eng. J. Med. 577 (1999) ............ 0000 0e

-vii-

Clark, Separation of Powers as a Safeguard

of Federalism, 79 Texas L. Rev. 1321 (2001) .......... 16

Cleeland et al., Pain Management in Minority Patients

With Cancer, 127 Annals Internal Med. 813 (1997) .... 27

Cohen, Holistic Health Care: Including Alternative

and Complementary Medicine In Insurance

and Regulatory Schemes, 38 Ariz. L. Rev 83 (1996) .... 19

Davidson, Pain and Opiophobia,

40 Healthcare Forum J. 64 (1997). .............0555. 29

Emergency Contraception Pharmacy Program,

Emergency Contraception (http://www.ec-help.org) .... . 20

Farber-Langendoen & Karlawish, Should Assisted

Suicide Be Only Physician Assisted ?,

Annals Internal Med., Mar. 21, 2000 ................. 10

Federation of State Medical Boards of the United States,

Model Policy for the Use of Controlled Substances

for the Treatment of Pain (2004) ... 0... 6.6 ccc cece 29

Ganzini et al., Oregon Physicians’ Attitudes About

and Experiences With End-of-Life Care Since

The Passage of the Oregon Death With Dignity Act,

ee EEE 9 6. 6.6:49.50640000000000660006% 18

Gostin, Public Health Theory and Practice in the

Constitutional Design, 11 Health Matrix 265 (2001) ... 17

Groopman, Separating Death From Agony, N.Y. Times,

8 FF Aree eer er ree 28

Haugen, Pain Relief for the Dying: The Unwelcome

Intervention of the Criminal Law, ;

23 Wm. Mitchell L. Rev. 325 (1997) ..............

Hill, Government Regulatory Influences on Opioid

Prescribing and Their Impact on the Treatment

of Pain of Nonmalignant Origin,

11 J. Pain & Symptom Mgmt. 287 (1996) ..........

Hedberg et al., Five Years of Legal Physician-Assisted

Suicide in Oregon, 348 New Eng. J. Med. 961 (2003) ...

Hodge, The Role of New Federalism and

Public Health Law, 12 J.L. & Health 30 (1998) .....

Hyman, Pain Management and Disciplinary Action:

How Medical Boards Can Remove Barriers to

Effective Treatment, 24 J.L. Med. & Ethics 338 (1996) ..

Institute of Medicine, Approaching Death:

Improving Care at the End of Life

(Field & Cassel, eds. 1997) ..... 0.0.0... c cece

Johnson, Disciplinary Actions and Pain Relief:

An Analysis of the Pain Relief Act,

24 J.L. Med. & Ethics 319(1996)..... 0.0... ...0008.

Kapp, Treating Medical Charts Near the End

of Life: How Legal Anxieties Inhibit Good Patient

Deaths, 28 U. Tol. L. Rev. 521 (1997) .............

Kimsma, Euthanasia and Euthanizing Drugs

in The Netherlands, in Drug Use in Assisted Suicide

and Euthanasia (Battin & Lipman eds., 1996) ........

-ix-

Martino, Jn Search of a New Ethic for Treating

Patients with Chronic Pain: What Can Medical

Boards Do?, 26 J.L. Med. & Ethics 332 (1998) ..... 27, 28

Meier et al, A National Survey of Physician-Assisted

Suicide and Euthanasia in the United States,

338 N Eng. J. Med. 1193 (2001) ..........0cceeeeees 26

Midwives Alliance of North America, Direct-Entry

Midwidery State-byState-Legal Status

(Http://www.mana.org/statechart.html) ............... 19

Morgan, American Opiophobia: A Customary

Underutilization of Opioid Analgesics,

in Controversies in Alcoholism and Substance Abuse

EE a cl odideeheewasdneesves 25

National Conf. Of State Legislatures, State Laws on

Heart Attacks, Cardiac Arrest & Defibrillators

(http://www.ncsl.org/programs/health/aed.htm) ........ 19

National Institutes of Health, Acupuncture:

NIH Consensus Statement 15(5):1-34 (1997) .......... 19

9 Oxford English Dictionary (2d ed. 1989) ............ 1]

Oken, Curing Healthcare Providers’ Failure to

Administer Opiods in the Treatment of Severe Pain, 23

CE Bt Ge ao 6b. 0 bk Web dse Se ctceebecn 25

Portenoy, Opioid Therapy for Chronic

Nonmalignant Pain: Clinicians’ Perspective,

24 J.L. Med. & Ethics 296 (1996) ............0000 00s 29

The Random House Dictionary of the English Language

SD dtb6ek o5dnddeneesuecnuawensureesdeue 1]

Sabatino, Removing Legal Obstacles to Effective Pain

Management, NAELA Q., Spring 2001 ............... 27

Schwartz, Where Everybody Knows Your Name: lowa's

Policy of Name-Based HIV Reporting, 7 J. Race & Gender

PT Gnu ciceeecudecudde kesssdewsduedes 19

SUPPORT Principal Investigators, A Controlled Trial to

Improve Care for Seriously Ill Hospitalized Patients,

sd esac ducensdécesedees 27

Teno et al., Persistent Pain in Nursing Home

Residents, 285 JAMA 2081 (2001) ...............05. 27

Von Roenn et al., Physician Attitudes and

Practices in Cancer Pain Management,

119 Annals Internal Med. 121 (1993) ................ 27

Whitney et al, Views of U.S. Physicians and

Members of the AMA House of Delegates on Physician-

Assisted Suicide, 16 J. Gen. Intern. Med. 290 (2001) .... 12

-xi-

Interest of Amicus Curiae

Founded in 1872, the American Public Health Association

(APHA) is the oldest, largest and most diverse organization of

public health professionals in the world. The association aims

to protect all Americans and their communities from

preventable, serious health threats and strives to assure

community-based health promotion and disease prevention

activities and preventive health services are universally

accessible in the United States. APHA represents a broad array

of health providers, educators, environmentalists, policy-makers

and health officials at all levels working both within and

outside governmental organizations and educational

institutions.

Based on the values of health, equity, diversity,

empowerment, integrity, dignity, and knowledge for individuals

and communities, APHA advocates the conditions for a healthy

society, promotes the scientific and professional foundation of

public health practice and policy, and supports its members in

promoting and protecting environmental and community health.

In the context of treatment refusal, APHA has recognized

that “to the seriously ill and infirm, death is not only a distinct

possibility, but sometimes preferable to any alternative,” and

that health care policy “should not blindly stress the

continuation of life.” APHA Policy 8123: Death With Dignity.

APHA does not take a position on whether Oregon’s law is

wise policy. APHA believes, however, that sustaining the

Attorney General’s Directive would adversely affect the public

health and submits this brief to set forth its concerns.

Summary of Argument

Although this case arises from the Attorney General’s

attempt to pretermit State-level policies respecting physician-

“No counsel for any party authored any part of this brief. No person or

entity other than Amicus and its counsel made a monetary contribution

toward submission of this brief, which is filed with the parties’ written

consent.

assisted suicide, the authority asserted would sweep much

further. Underlying the Directive is a claim that Congress

delegated to the Attorney General broad powers to regulate the

practice of medicine — and to take action against a physician for

prescribing a controlled drug in the course of a medical practice

the Attorney General disapproves of, even if the practice is

affirmatively authorized and closely regulated by the licensing

State, and even if the grounds for objection are unrelated to the

possibility that drugs will be diverted or abused.

It is not only implausible that Congress would vest such a

power in the Attorney General — but impossible to construe the

statute he points to, the Controlled Substances Act (CSA), as

having conferred it. Everything about that statute attests that it

was enacted to address a nationally important, but discrete

public health problem: the diversion and abuse of certain drugs.

And everything in the Act’s text and structure confirms that the

Attorney General’s responsibility is confined to assuring that

Congress’s means of addressing the problem - a closed

distribution system — would operate effectively.

The regulatory regime the Attorney General asks the Court

to approve also ignores the important and conspicuous public

health benefits that result from entrusting matters of medical

regulation and health policy to State-level resolution. As the

opinions in Glucksberg and Quill eloquently attest, this long-

established allocation of decision making power is working

exceptionally well with respect to the very issue that is the

subject of the Directive. The text of the CSA indicates that

Congress meant to preserve the benefits of State regulation, and

nothing in the Act’s text or structure suggests that, by

recognizing the intrastate dimension of the national drug

trafficking problem, Congress intended to establish — or permit

— a system of uniform medical practice regulation, under the

Attorney General.

The Directive — and the assertion of power underlying it —

carry further public health dangers. As this Court has

recognized, patients are harmed when physicians are deterred

from providing care in accord with their professional judgment

— and the possibility of intervention by law enforcement agents

has a uniquely potent distorting effect on medical practice.

These deterrent effects are of special concern because

inappropriate undertreatment with controlled drugs, and

inadequate pain relief for those who are terminally ill, are

recognized to be public health problems of the first order. By

establishing a broad and ill-defined federal law enforcement

role in fields of medical practice where there is no suggestion

of drug diversion or illicit physician behavior — and no claim

that States are defaulting on their closed system responsibilities

— the Attorney General’s construction of the statute could only

impede the provision of legitimate, medically appropriate care.

Sustaining the Directive would also adversely affect the

process by which difficult, controversial, and profound policy

decisions are made. Experimentation, evidence-gathering, and

persuasion at the State level and in Congress are difficult;

“interpretive rules,” by contrast, may issue — as this one largely

did — without the involvement or even awareness of those with

opposing views and those most directly affected. Given the

many matters that engender comparably strong objections (and

that also happen to include administration of controlled drugs)

sustaining the assertion of authority here would surely make

pursuit of similar administrative declarations of “illegitimacy”

the first resort — and the pull and haul of the lawmaking process

the Constitution contemplates, 2 distant second choice.

ARGUMENT

I. It Is Impossible To Construe The CSA As Vesting The

Attorney General With The Broad Power Claimed

A. In Enacting The CSA, Congress Did Not Confer The

Authority On Which The Directive Is Premised

Although the Directive addresses the specific practice of

physicians’ assisting terminally ill patients to hasten death, the

power claimed would extend to any practice in which

controlled substances are prescribed — and would include

authority to pass judgment on controversial matters of medical

practice and ethics, irrespective of whether the controversy (or

the Attorney General’s objection) has anything to do with the

use of controlled (as opposed to other) substances. Moreover,

the Attorney General would be empowered to bring within the

ambit of federal criminal law medical practices affirmatively

authorized and actively supervised by the licensing State.

Not only must this assertion of authority reckon with the

presumption that Congress does not intend drastically to alter

the federal/State balance in matters, historically entrusted to the

States, see, e.g., United States v. Bass, 404 U.S. 336, 349

(1971); Bates v Dow Agrosciences, LLC, 125 S. Ct. 1788,1801

(2005), Pegram v. Herdrich, 530 U.S. 211, 237 (2000), but it

must overcome the fundamental implausibility that Congress

would delegate power to resolve large and momentous

questions cf ethical and medical legitimacy, see SWANCC v.

Army Corps of Eng’rs, 531 U.S. 159, 172 (2001); FDA v.

Brown & Williamson Tobacco Corp., 529 U.S. 120,133 (2000),

let alone to an official with no recognized expertise in matters

of public health or medical practice.'

Far from “manifesting” an intent to confer such

extraordinary authority, the text and structure of the CSA rule

out the construction advanced, and make clear that Congress

intended a more limited, but still vital responsibility for the

Attorney General: maintaining the “closed system” for

‘In fact, the federal government rarely undertakes even to examine

questions of such complexity and moment — let alone answer them

definitively for the Nation — without involving those in fields whose

knowledge and experience span a far broader range than does the Attorney

General's. See, e.g., Exec. Order 13,237 (Nov. 28, 2001)§ 3(a) (President's

Council on Bioethics “shall include members drawn from the fields of

science and medicine, law and government, philosophy and theology, and

other areas of the humanities and social sciences”); see also id. § 2(a)(5)(c)

(noting “the complex and often competing moral positions” on issues and

directing Council to resist “an overriding concern to find consensus”).

distributing certain drugs, H.R. Rep. 91-1444 at 6 (1970), and

assuring that individuals who would subvert or undermine that

system do not succeed.

Thus, instead of evincing intent to centralize authority over

medical practice, the CSA includes an express disclaimer of

broad preemptive effect, 21 U.S.C. § 903, and expressly affirms

the States’ longstanding role as regulators of medical practice

within their borders. See id. § 802(21) (defining “practitioner”

to include “a physician * * * licensed by * * * the jurisdiction

in which he practices to distribute [or] dispense * * * a

controlled substance in the course of professional practice’’). In

fact, until Congress amended the Act in 1984, the Attorney

General was not even permitted to deny registration based on a

practitioner’s active, improper dispensing of controlled drugs,

unless the licensing State took decisive disciplinary action (or

he was convicted of a felony). See United States v. Moore, 423

U.S. 122, 141n.19 (1975) (registration was “a matter of right”

for individual “engaged in activities involving these drugs

which are authorized or permitted under State law’’’) (quoting

H.R. Rep. 91-1444 at 23).

Nor do the statutory text and structure detract from the

intuitive unlikelihood of the notion that Congress would vest

the Attorney General (or the DEA, as designee) with authority

to make plenary, nationwide judgments concerning difficult,

even profound questions of medical practice “under the CSA.”

Rather, the statute’s terms and legislative history attest to

Congress’s concern about the Attorney General’s involvement

in even mundane medical decision making. See, e.g.,21 U.S.C.

§ 811(b) (“The recommendations of the [HHS] Secretary * * *

shall be binding on the Attorney General as to such scientific

and medical matters, and if the Secretary recommends that a

drug or other substance not be controlled, the Attorney General

shall not control the drug or other substance”). In the one

instance when Congress authorized formulation of federal

standards of “professional practice” — with respect to “the

medical treatment of * * * narcotic addition,” 4Z U.S.C. §

290bb — it entrusted that responsibility to the HHS [then HEW]

Secretary. See H.R. Rep. 93-884 (1974) (“All decisions of a

medical nature are to be made by the Secretary. Law

enforcement decisions respecting the security of stocks of

narcotic drugs and the maintenance of records on such drugs are

to be made by the Attorney General”).

Indeed, the narrow lawmaking powers Congress did confer

on the Attorney General are carefully cabined. Title 2] U.S.C.

§ 811(a) requires that decisions to place substances on the

federal schedules be made through formal rulemaking pursuant

to the Administrative Procedure Act; § 811(c) specifies the

eight factors that must be considered in scheduling a drug; and

21 U.S.C. § 812(b) specifies findings that must be made before

he may assign a drug to a particular schedule. See generally

United States v. Touby, 500 U.S. 160, 166 (1991).

The Attorney General nonetheless contends that the

structure of the CSA supports an overarching “legitimate

medical practice” limitation, and that the authority asserted

here, to pass judgment on what is “legitimate” “under the

CSA,” is essentially the same one recognized in Moore (and in

earlier cases sustaining convictions of physicians under

predecessor statutes).

At the outset, the phrase the Attorney General most

thoroughly parses and identifies as the principal source of

authority for the Directive — “legitimate medical purpose” —

derives from a Justice Department regulation, see 21 C.F.R. §

1306.04(a), not the text of the relevant statutory provision.

Compare 21 U.S.C. § 802(21); id. § 829(a)-(b) (exempting

prescriptions “in the course of professional practice” from the

Act’s reach); see Chevron U.S.A. Inc. v. NRDC, Inc., 467 U.S.

837 (1984) (ambiguous language in a statute may be treated as

a delegation by Congress of interpretive authority to the agency

administering the law); but cf. Crandon v. United States 494

U.S. 152, 177 (1990) (Scalia, J., concurring) (for purposes of

deference, prosecutor does not “administer” the criminal statute

under which she proceeds). Moreover, that regulation, by its

terms, addresses only what qualifies as a “valid prescription,”

21 C.F.R. § 1306.04(a), under the CSA — though Congress

expressly provided that physicians may dispense controlled

substances directly to patients without a written prescription.

See 21 U.S.C. § 829(a), (b).’

But accepting, as Moore did, that Congress contemplated

keeping “medical practice within accepted limits,” 423 U.S. at

142, in order to prevent drug trafficking, does not establish that

the statute should be construed as conferring a plenary power

to decide that particular medical practices are not “legitimate”

— and then treat as federal drug offenders doctors who prescribe

controlled drugs in the course of the Attorney-General-

disapproved practice.

The Court in Moore did not defer to an administrative

definition of what constitutes proper medical practice: the case

was a criminal prosecution, see Crandon; and the government

assumed the burden of proof, which it carried by presenting

“expert medical testimony,” 505 F.2d at 426 (McKinnon, J.,

dissenting), that the defendant had completely abandoned his

professional responsibility to his “patients.” There was no

claim that Moore’s conduct — prescribing “some 800,000

methadone tablets” over a four-month period, 423 U.S. at 126,

and charging patients “according to the number of tablets

desired,” id. at 143 — was affirmatively authorized under State

[District of Columbia] law.’

? Although Oregon law requires a written prescription, it cannot fairly

be said that this “exception” is “not relevant here,” Pet.Br.3. It highlights the

unsoundness of the Attorney General’s construction: if the provision were

intended to authorize overruling policy choices like Oregon's, it is hard to

understand why Congress would have the Attorney General's power depend

on whether a State’s implementing legislation required a written prescription

— with States that opted against such a patient-protective requirement

ag norm latitude. Cf. 21 U.S.C. § 903.

nature of the prosecution's evidentiary burden was not decided by

The “illegitimacy” at issue in Moore was the very one that

Congress sought to combat in enacting the CSA: selling

controlled drugs, “‘primarily for the profits to be derived

therefrom,”” id. at 135 (quoting H.R. Rep. 91-1444 at 10), to

those seeking them for their prohibited properties. See id. at

143 (defendant “acted as a large-scale ‘pusher’ not as a

physician”). The authority to prosecute was a necessary

incident of Congress’s recognition, expressed in the text of the

statute, that the closed system for distributing these particular

drugs would be defeated if doctors were permitted to exploit

their privileged position within the system, to cater the very

demand the law was enacted to suppress.

By contrast, the “illegitimacy” asserted here — and the

power claimed — are untethered from the text, structure, and

purposes of the statute. Although the Attorney General invokes

his “ability to administer the Act’s comprehensive national

scheme for controlling dangerous substances,” Pet.Br.14, there

is NO suggestion that controlled drugs prescribed in compliance

with Oregon law are likely, let alone especially likely, to be

diverted outside legitimate channels: given the substantial

additional regulation the State imposes, the opposite is surely

the case. Likewise, given that the relevant patient population is

limited to individuals at an advanced stage of terminal illness,

it is nearly certain that the considerations that trigger control

under the statute, see 21 U.S.C. § 812(b)(2) — apply with less

force in DWDA prescriptions than in other instances where

physicians prescribe Schedule II drugs in professional practice.‘

this Court in Moore, which addressed whether a rogue doctor could be

charged under § 841. As explained infra, see n.11, even if the opinion’s

quotation of the jury instructions could be understood as approval, those

instructions were — at best —- ambiguous on precisely the point the Attorney

General asserts they were “clear.”

“While the Attorney General emphasizes the frequency with which

terms such as “medical use,” “treatment,” and “treatment with severe

restrictions” appear in the subsections of § 812, the power claimed draws

no distinction between substances on the various schedules or between drugs

subject to “severe restrictions,” id. § 812(b)(2)(B), and those which are not.

Likewise, notwithstanding assertions that helping terminally

ill patients hasten their deaths is not a “proper use of a

controlled substance,” Pet.Br.11, and is illegitimate “for

purposes of the CSA,” Pet.Br.26 (emphasis added), the Attorney

General does not suggest that prescribing a controlled substance

to a patient who seeks to hasten death is “illegitimate” in the

same sense that prescribing morphine to an addict would be, see

Webb v. United States, 249 U.S. 96 (1919). The “illegitimacy”

the Attorney General identifies has nothing to do with the

particular substances prescribed — or with the particular

pharmacological characteristics of those drugs. Cf. In re

Harline, 65 Fed. Reg. 5,665, 5,670 (Feb. 4, 2000) (noting

diversity of medical opinion as to “when it is appropriate to use

controlled substances in the treatment of weight control”).°

Thus, the Attorney General acknowledges that “doctors in

Oregon [who] dispense substances other than those regulated

under the CSA to hasten their patients’ deaths,” are beyond the

Directive’s reach, Pet.Br.43; see 21 U.S.C. § 811(b), but does

not suggest any medical distinction between those doctors’

conduct and that which the Direct.ve governs.

Two significant conclusions follow. First, it is hard to

imagine that a Congress that opposed physician assistance of

the kind Oregon has authorized — or even one that simply

intended to confer on the Attorney General the authority to

regulate medical practices (for reasons unrelated to drug

diversion) — would so limit his power to stop practices he has

determined to be “[ilJlegitimate.”

Treating substances interchangeably is incongruous with the Act's stringent,

schedule-driven limitations on the controls the Attorney General may impose

— and on whether he can impose controls at all. See id. § 811(b).

*The regulatory treatment of Marinol (Pet.Br. 30) is no precedent for the

power claimed here. The DEA action occurred in the context of a decision

rescheduling a particular drug — determined to have “a currently accepted

medical use with severe restrictions,” 51 Fed. Reg. at 17,476, and, as

Petitioners’ Brief explains, the restriction was based on “a significant risk”

particular to that drug, id. at 17,477, i.e., that it would be widely sought on

account of its chemical similarity to marijuana, a Schedule I drug.

More important, although the Directive is described as

embodying a “broad consensus,” Pet.Br.18, none of the

authorities cited opposes the “practice” of “assisted suicide

[with controlled substances]” -— or indicates that the

pharmacological properties (or legal status) of the particular

drug a doctor prescribes is relevant to, let alone determinative

of, the “legitimacy” of the practice Oregon authorizes. Indeed,

there are strong reasons to expect that many who oppose the

Oregon law based on conceptions about doctors’ proper “role,”

see id., would reject the Directive’s implication: i.e., that

Oregon physicians who do so help their terminally ill patients

should confine themselves to substances that do not appear on

the federal schedules — even when, as a matter of professional

judgment, they believe that these other medications are not in

their patients’ best interests.°

B. The Meaning of “Ilegitimacy” Must Be Anchored To

The Statute’s Text And Purposes

Moore and other cases cited by the Attorney General

establish that the meaning of “legitimacy” under the CSA

should be defined — and limited — by that which Congress

recognized as “‘illegitimate”: doctors’ “trafficking” or

“pushing” drugs (or enabling others to do so). So construed,

the Attorney General has all the power needed to accomplish

the Act’s objectives and fulfill the responsibilities Congress

entrusted to him, without compromising States’ power to

regulate medical practice, or terminating debate and

experimentation in the field of public health — or unnecessarily

°As the Court of Appeals observed, “controlled substances provide the

best and most reliable means for terminally ill patients to painlessly take

their own lives.” 368 F.3d at 1123 n.5 (citing Kimsma, Euthanasia and

Euthanizing Drugs in The Netherlands, in Drug Use in Assisted Suicide and

Euthanasia 193 (Battin & Lipman eds., 1996); Farber-Langendoen &

Karlawish, Should Assisted Suicide Be Only Physician Assisted?, Annals

Internal Med., Mar. 21, 2000, at 482)). Cf. Thompson v. Western States

Med. Ctr., 535 U.S. 357, 374 (2002) (assuming that physicians do not

prescribe “unnecessary medications”).

deterring legitimate, beneficial medical practice. See infra.

By contrast, the Attorney General’s efforts - in the

Directive itself and his defense of it in this Court — to formulate

a definition of medical “legitimacy” narrow enough to rule out

the Oregon-sanctioned practice raises serious problems.

It would seem unrealistic in any event to expect that

questions that have engaged, challenged, and divided the

Nation’s foremost bioethicists —- and engendered “earnest and

profound debate,” 521 U.S. at 735, among its citizenry and

health care professionals — could be settled through resort to the

dictionary, see Pet.Br.18. But more troubling is the guidance

that the Attorney General purports to derive from those sources.

Applied literally, the cited definitions would exclude entire

fields of professional practice — and many medical procedures

that are regularly performed, with controlled substances. For

example, fertility treatments and cosmetic surgery (and

nontherapeutic abortions) are often found not to entail “the

cure, alleviation, and prevention of disease * * * [or] the

restoration and preservation of health,” Pet.Br.19 (quoting 9

Oxford English Dictionary 549 (2d ed. 1989)).

Even worse, such dictionary definitions reflect assumptions

about the “ends of medicine” that not only are controversial, but

are, in important ways, a cause of what all recognize to be a

serious public health problem. It is precisely because

prescribing pain medication to those who are terminal ill does

not “‘restor[e] or preserv[e] health or due physical condition,’”

Pet.Br.19 (quoting The Random House Dictionary of the

English Language 1194 (2d ed. 1987)), that medical training,

focused on curing disease, long neglected to educate physicians

about palliative care. See Institute of Medicine, Approaching

Death: Improving Care at the End of Life 207 (Field & Cassel,

eds. 1997) (“Deficiencies in * * * education for end-of-life care

reflect a medical culture that defines death as failure and —

ignores care for dying people as a source of professional

accomplishment and personal meaning”).

Defining “illegitimacy” under the CSA with reference to

legal standards governing “medical necessity” in the insurance

reimbursement context, see Pet.Br.42, is equally ill-considered.

Reimbursement denials carry no intimation of a practice’s

“illegitimacy.” Rather, the rules governing medical necessity

— which are decidedly nonuniform among the States, see Rush

Prudential HMO, Inc. v. Moran, 536 U.S. 355 (2002) — more

often reflect determinations that scarce funds should be first

allocated to procedures needed to “restore [policyholders’]

health.” Of course, many doctors perform procedures despite

the unavailability of third-party reimbursement.

Nor does “consensus” (Pet.Br.11) distinguish the subject

matter of the Directive from other medical practices on which

the Attorney General might have strong views. Even accepting

that Congress was interested in suppressing State diversity, but

see infra, there is, as explained above, no consensus in the

medical community supporting the regime the Directive would

implement — in which Oregon physicians would be permitted to

“dispense substances other than those regulated under the CSA

to hasten their patients’ deaths,” Pet.Br.35, but would be

harshly penalized for prescribing a controlled substance.

Even at a higher level of generality, opinion is decidedly

less one-sided than portrayed. See Whitney et al, Views of U.S.

Physicians and Members of the AMA House of Delegates on

Physician-Assisted Suicide, 16 J. Gen. Intern. Med. 290 (2001)

(45% of physicians surveyed answered that physician assistance

should “definitely” or “probably” be legal). And although

Glucksberg and Quill made quite clear that proponents of

physician assistance do not have legal tradition on their side,

see Pet.Br.22 (citing Glucksberg, 521 U.S. at 710-719); but cf.

id. at 716 (noting “many significant changes in state laws and

in the attitudes these laws reflect”), it is jarring to see the

opinions in those cases — which evinced respect for Oregon’s

side of the “debate” and presented the DWDA’s possible

implementation as a constitutionally benign development —

cited as supporting the proposition that “strik[ing] the * * *

balance,” id. at 736 (O’Connor, J., concurring), in favor of

patient self-determination is facially “illegitimate.”

C. The 1984 Amendment Did Not Confer Power To

Overrule State Policy Judgments Unrelated To

Controlled Substances

Nor can Congress’s 1984 amendment of the CSA (see

Pet.Br.34) plausibly be construed as conferring the sweeping

powers asserted by the Attorney General. First, that measure’s

enactment calls attention to a basic problem in the Attorney

General’s principal claim: it is not easily understood why a

Legislature that intended to authorize the Attorney General to

overrule affirmative State policy judgments on grounds

unrelated to drug-diversion and abuse (via the purported

“delegation” of power to judge “medical legitimacy”) would

have enacted a law making a State’s inaction against an

individual practitioner who was, in fact, diverting controlled

drugs, binding on the Attorney General, see p.5, supra.

More important, the text, structure, and legislative history

of the law, passed as the “Dangerous Drug Diversion Control

Act,” make clear that Congress intended the Attorney General

to “continue to give deference to the opinions of state licensing

"It bears mention that the Justice Department has elsewhere refused to

adopt precisely the same understanding of “medical practice” that is asserted

to require overruling of Oregon’s judgment. Many of the same organizations

whose condemnation of “physician-assisted suicide” the Directive relies

upon have denounced physician involvement in administering capital

punishment as “illegitimate” — on the same ground, i.e., as contrary to the

physician’s role as “healer,” see AMA Council on Ethical & Jud. Affairs,

Physician Participation in Capital Punishment, 270 JAMA 365 (1993). But

the Justice Department has disagreed. See 58 Fed. Reg. 4,898 (Jan. 19,

1993) (declining to bar physician participation). While there is plainly no

inherent contradiction in supporting capital punishment while opposing

Oregon’s approach to decisional autonomy at the end of life as a policy

matter, this inconsistency highlights that disagreement with Oregon — which

does not sound in drug control or law enforcement — also does not reflect a

consistently adhered-to conception of “legitimate medical practice.”

authorities, S. Rep. 98-225 at 262 (1984), and that the measure

was addressed at a particular “weakness” in the then-existing

enforcement system, id. Making registration entirely dependent

on enforcement actions by often-overburdened and slow-

moving State authorities, Congress recognized, raised

intolerable risks that practitioners engaged in acts inimical to

federal and State anti-diversion policy would remain entitled,

as of right, to dispense controlled substances until State

regulators took action, see id.

Il. The CSA Must Be Read As Preserving States’ Role In

Matters of Public Health And Medical Practice

A. Public Health Is Served By Legal Principles Allowing

Experimentation And Diversity At the State Level

That “the CSA is binding federal law” (Pet.Br.41) does not

cast light on the legal question actually presented here: whether

States retain their historic power to regulate medical practice up

to the point that doing so would conflict with Congress’s drug

control concerns, or whether the CSA endows the Attorney

General with plenary power over all medical practice “with

controlled substances,” with States limited to authorizing those

practices which the Attorney General does not object to.

Not only is the former construction far more sensible as a

matter of text, structure and legislative intent, see 21 U.S. §

903, but it draws strong support from this Court’s precedents,

which (1) establish that medical regulation (and public health)

has traditionally — and consistently — been a matter of State

concern, see, e.g., Pegram, 530 U.S. at 237; Linder v. United

States, 268 U.S. 5, 18 (1925), and (2) require that federal laws

be construed so as to preserve, rather than displace, State

authority “in areas of traditional state regulation,” unless a

contrary congressional intent is manifest, Bates, 125 S. Ct. at

1801; Bass, 404 U.S. at 349 (1971); SWANCC, 531 U.S. at 172.

Beyond the irony of invoking the spirit of the Lochner

dissents -— which championed State autonomy and

experimentation — in defense of the Directive, the Attorney

General’s suggestion (Pet.Br.37, 40) that these rules are relics

of a bygone constitutional era is puzzling. The States’ primary

role in regulating medical practice — and this Court’s

recognition of it — did not stop with Linder. See, e.g., Pegram;

Medtronic v. Lohr, 518 U.S. 470, 475 (1996); Rush Prudential,

536 U.S. at 386. Nor has this understanding been idiosyncratic

to the judicial branch. See 42 U.S.C. § 1395 (“Nothing in

{Medicare program] shall be construed to authorize any Federal

officer or employee to exercise any supervision or control over

the practice of medicine or the manner in which medical

services are provided”); 37 Fed. Reg. 16,503, 16,504 (1972)

(“[I]t is clear that Congress did not intend the [FDA] to regulate

or interfere with the practice of medicine”).

And as the decisions cited above attest, it is not possible to

describe the modern Court’s hesitancy to enforce categorical,

constitutional limitations on congressional power as a rejection

of the legal relevance of the historic distribution of

responsibility. Rather, doctrinal develapments evidence a shift

in the means by which respect for the Constitution’s federal

structure is expressed: i.e., increasingly through rules of

Statutory interpretation, which assure that States are not

divested of their historic responsibilities without evidence of an

deliberate congressional decision to alter the balance. See Bass,

404 U.S. at 349 (“the requirement of clear statement assures

that the legislature has in fact faced and intended” the

consequences for federal system).*

®There is a threshold problem with the Attorney General’s attempted

canon-by-canon refutation — see Pet.Br.44 (asserting inapplicability of anti-

preemption presumption); id. at 37 (asserting inapplicability of Gregory

rule): even if those rules did not govern, this Court has held (in cases not

cited in Petitioners’ Brief) that a construction fundamentally altering the

federal-State balance — that does not formally preempt State law or directly

regulate State governments — is also disfavored. See, e.g., Bass, 404 U.S.

at 349; cf. California Retail Liquor Dealers Ass'n. v. Midcal Aluminum,

Inc., 445 U.S. 97 (1980) (federalism concerns require antitrust exception for

private anticompetitive conduct that is “clearly authorized” and “actively

supervised” by State).

More important are the reasons why the Court has not

embraced a presumption in favor of displacement. “Treat[ing]

the States as * * * joint participants in the governance of the

Nation,” Alden v. Maine, 527 U.S. 706, 748 (1999), “preserves

to the people numerous advantages,” Gregory v. Ashcroft, 501

U.S. 452, 458 (1991):

It assures a decentralized government that will be more

sensitive to the diverse needs of a heterogenous society; it

increases opportunity for citizen involvement in democratic

processes; it allows for more innovation and

experimentation in government; and it makes government

more responsive by putting the States in competition for a

mobile citizenry.

Id. See also New State Ice Co. v. Liebmann, 285 U.S. 262, 311

(1932) (Brandeis, J., dissenting).’

Equally important, while the various federalism-based canons are not

identical, neither are they, as this argument presupposes, a set of discrete,

disconnected rules. There is no principled reason why an interpretation of

federal law that made an Oregon law literally inoperative should be

disfavored, but one which “merely” subjected individuals to criminal

punishment for carrying out the State’s affirmative policy judgment should

raise no similar judicial caution. In “sensitive areas,” Bass, 404 U.S. at 349,

such formalisms do not usually control. See McCulloch v. Maryland, 19

U.S. 316, 431 (1819) (“the power to tax involves the power to destroy”).

%One principal rationale for the trend toward restraint in constitutional

adjudication — recognition of the ways in which State interests are protected

through the Constitution’s lawmaking process, see Garcia v. San Antonio

Metro. Transit Auth., 469 U.S. 528, 552 (1985); United States v. Lopez, 514

U.S. 549, 577 (1995) (Kennedy, J., concurring) — helps explain the more

stringent clear statement rule of SWANCC. Although Congress is not barred

entirely from delegating preemptive power to an administrative agency, see

Medtronic, 518 U.S. at 495, Congress, not the Executive, must consider the

costs to the federal system. See generally Clark, Separation of Powers as a

Safeguard of Federalism, 79 Texas L. Rev. 1321, 1393 (2001).

This case supplies a vivid illustration of what should not happen in a

system of government where the States’ distinctive constitutional status is

taken seriously — and of why the SWANCC rule is sound. Although the

Attorney General recognizes that Congress imposed stringent procedural

limitations on his power to make even minor scheduling decisions — or

These advantages fully characterize the allocation of

responsibility over public health, which not only permits

recognition of differences in “health needs across the nation,”

Hodge, The Role of New Federalism and Public Health Law, 12

J.L. & Health 309, 356 (1998), and the benefits of policy

experimentation, see Gostin, Public Health Theory and

Practice in the Constitutional Design, 11 Health Matrix 265,

287 (2001) — but also permits a plurality of approaches on

matters where disagreement has significant moral, as well as

empirical, dimensions.

B. Oregon’s Law Is A Legitimate and Important Policy

“Experiment”

Oregon’s law exemplifies these benefits. In Glucksberg and

Quill, the Court described the continuing State-'evel debate

“about the morality, legality, and practicality of physician-

assisted suicide” as a paradigm of what “should [occur] in a

democratic society,” 521 U.S. at 735. Justice O’Connor’s

opinion invoked States’ “extensive and serious evaluation” as

a ground for restraint on the constitutional question presented,

see id. at 737, and Justice Souter noted that the Court’s

judgment would allow “experimentation [to] be attempted in

some of the States,” id. at 787, which, in turn would “confirm[]

or discredit[] the concerns” about possible abuse, id.

Consistent with these expectations, Oregon’s decision to

strike a different “balance” — to serve as a “laboratory” for the

“novel social * * * experiment,” of regulated physician-

assisted suicide, New State Ice, 285 U.S. at 311 — has catalyzed

deliberation and action elsewhere, and its experience under the

DWDA has informed the public discussion of the subject and

promoted the reasoned development of public health policy.

By imposing recordkeeping requirements, see Or. Rev. Stat.

§ 127.855, and issuing detailed annual reports, id. § 127.865,

revoke the registration of a single practitioner, he did not even give Oregon

meaningful notice that the rule, purporting to nullify the verdict of two State

referenda, was in the offing, let alone afford an opportunity to be heard.

which include demographic information about the patients who

have obtained prescriptions and results of interviews with

prescribing physicians concerning their patients’ circumstances

and reasons for requesting prescriptions, Oregon has enabled

research on empirical questions that have long figured centrally

in the policy debate. For example, researchers have

consistently found that experience in Oregon does not bear out

concerns that physician-assistance “would be disproportionately

chosen by or forced on terminally ill patients who were poor,

uneducated, uninsured, or fearful of the financial consequences

of their illness.” Chin et al., Legalized Physician-Assisted

Suicide in Oregon — The First Year’s Experience, 340 New

Eng. J. Med. 577, 582 (1999); accord Hedberg et al., Five Years

of Legal Physician-Assisted Suicide in Oregon, 348 New Eng.

J. Med. 961 (2003)."°

C. The Extent and Benefits of Regulatory Diversity Are

Significant

The Attorney General’s brief, focused narrowly on a single

development in a single mode of health regulation — the eclipse

of the “locality rule” in medical malpractice litigation

(Pet.Br.36), but see.p. 21, infra — does not begin to capture the

extent and importance of ongoing State-level innovation,

experimentation, and diversity in health law and policy.

Professional licensure laws continue to reflect substantial

interstate differences: “Arizona recognizes and licenses the

professions of chiropractic, acupuncture, naturopathy, and

homeopathy. The States of Oregon and Utah recognize and

license practitioners of chiropractic, acupuncture, and

Research has also cast doubt on predictions that the Act's

implementation would adversely affect other aspects of health care for the

dying, finding, for example, that a high proportion of Oregon doctors had

made efforts to improve their knowledge of pain medications and their

recognition of depression and other psychiatric disorders, and were referring

more patients to hospice care. See Ganzini et al., Oregon Physicians’

Attitudes About and Experiences With End-of-Life Care Since The Passage

of the Oregon Death With Dignity Act, 285 JAMA 2363 (2001).

er ee ee ee

naturopathy. The States of Alabama, Illinois, Indiana,

Michigan, Minnesota, Mississippi, North Carolina, Oklahoma,

South Dakota, and Wyoming, recognize and license only

physicians, surgeons and chiropractors.” Cohen, Holistic

Health Care: Including Alternative and Complementary

Medicine In Insurance and Regulatory Schemes, 38 Ariz. L.

Rev 83 (1996). Midwifery is prohibited in 14 States and the

District of Columbia, see http://www.mana.org/statechart.html,

while 10 of the 36 States that permit it provide for Medicaid

reimbursement.

On the other hand, experiences in “vanguard” States have

influenced important changes in the mainstream. For example,

acupuncture, once marginalized, has been shown to be effective

enough for the National Institutes of Health to call for its

expanded use in “conventional medicine,” Acupuncture: NIH

Consensus Statement 15(5): 1-34 (1997); compare Acupuncture

as Illegal Practice of Medicine, 72 A.L.R.3d 1257 (1976).

In some health areas, a single State’s innovative policy will

meet with rapid acceptance. In 1997, Florida, recognizing the

life-saving benefits of defibrillators for people suffering cardiac

arrest, was the first State to enact a law broadly encouraging

public access to such devices. By mid-2001, all fifty States had

adopted similar measures. See http://www.ncsl.org/programs/

health/aed.htm. By contrast, other controversial medical

practice questions have divided the States for decades. See,

e.g., Cohen, 38 Ariz. L. Rev. at 117 (discussing differing

States’ responses to EDTA chelation treatment).

States have played the central role in fighting emergent

health threats, most prominently the HIV epidemic, see Carson

et al., The Impact of Laws on HIV and STD Prevention, 30 J. L.

Med. Eth. 139 (2002), staking out significantly different, often

controversial, policy approaches. Compare id. at 141 (asserting

health benefits of “name-based reporting”) with Schwartz,

Where Everybody Knows Your Name: lowa’s Policy of Name-

Based HIV Reporting, 7 J. Race & Gender Just. 387 (2003)

(criticizing such policies on public health grounds).

And States have likewise taken nonuniform approaches to

important developments in reproductive medicine, see Nat'l

Conf. State Legislatures, 50-State Summary of Laws Related To

Insurance Coverage for Infertility Therapy (describing States’

regulation of in-vitro-fertilization); see also

http://www.ec-help.org (noting that six States permit women to

obtain emergency contraception directly from pharmacies).

The impassioned, ongoing debate over stem cell research

have led some States to enact prohibitions on the practice of

“therapeutic cloning,” while two have passed laws affirmatively

encouraging it. Compare, e.g., N.D. Cent. Code § 12.1-39;

Mich. Comp. Laws § 333.16274 with Cal. Health & Safety

Code §§ 24185, 125300; N.J. Stat. § 26:2Z-2.

Finally, as Glucksberg recognized, 521 U.S. at 716, States

have played a primary, dynamic — but not monolithic — role in

addressing the legal, ethical, and medical issues involving end-

of-life care and decisionmaking, cf. 42 U.S.C. § 1395cc(f).

And they are playing an important role in responding to

developments in pain medicine and in addressing documented

problems of inappropriate undertreatment. See, e.g., Tarzian,

Achieving the Right Balance in Oversight of Physician Opioid

Prescribing for Pain: The Role of State Medical Boards 31 J.L.

Med. & Ethics 21, 23 (2003) (“In 1999, the Oregon Medical

Board was the first in the nation to discipline a physician for

failure to prescribe adequate pain relief medication”).

D. Congress Did Not Intend The CSA To Standardize

Medical Practice Nationwide

While the Attorney General insists that Congress should be

“presumed” to have intended to standardize medical practice

(with controlled substances) throughout the United States, the

mere fact that the CSA is national in scope (and paramount in

cases of “positive conflict” with State law) does not mean that

Congress intended to broadly repudiate this beneficial State

nonuniformity, see Hillsborough County v. Automated Med.

Labs., Inc., 471 U.S. 707, 719 (1985) (that “every subject that

merits congressional legislation is, by definition, a subject of

national concern [does not] * * * * mean * * * that every

federal statute ousts all related state law”), and the CSA’s

textual indications are plainly “to the contrary,” Mississippi

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

As a matter of law and fact, the Act contemplates extensive

variation in medical practice from State-to-State, and expressly

references State law in both the key definitional section, 21

U.S.C. § 802(21), and the other provision the Attorney General

invokes, id. § 823(f). Indeed, even the provisions cited as

evidence of an intent to impose uniformity support the opposite

conclusion. Thus, the 1984 amendment, while denying

dispositive effect to State nonenforcement, contemplated that

“deference” to State decision making would remain the norm,

see p.13, supra. And while the Act’s drug treatment provisions,

see Pet.Br.33, do contemplate federally-formulated standards

“of professional practice” in that one area, such an express and

specific indication argues against treating silence in the rest of

the Act as a broad mandate for national standards. Indeed, that

specific authority involves a field of practice, dispensing

scheduled drugs to drug-dependent patients, where the statute’ s

core concerns are uniquely implicated — and even then,

Congress took care to limit the Attorney General’s role in

medical decisionmaking, see p.6, supra.

Nor is there any tension between preserving State authority

over medical practice and the trend away from the “locality

rule” in medical malpractice lawsuits (Pet.Br.36). As explained

above, malpractice law represents a single strand of State health

care regulation — and, three decades after the CSA, there

remains substantial diversity among States even in that field.

Cf. Rush Prudential, 536 U.S. at 386 (“standards of reasonable

medical care” are “quintessent ally state-law” matters); BMW

N. America v. Gore, 517 U.S. 559, 615 (1996) (Ginsburg, J.,

dissenting). And this development’s significance is readily

overstated: many jurisdictions that no longer require injured

plaintiffs to produce testimony of local expert witnesses, see M.

Boumil & C. Elias, The Law of Medical Liability 30 (1995),

continue to adhere to the “respected minority” doctrine — under

which liability may not be imposed for noncompliance with the

predominant view of proper practice, if the conduct is supported

by any “competent medical authority, subscribed to by

reputable, respectable and reasonable medical experts * * * in

the field,” Tobash v. Jones, 213 A.2d 588, 592 (Pa. 1965).

The Attorney General’s other policy argument — that

nonuniform standards of medical practice hamper prosecution

of rogue doctors — is largely beside the point. For the reasons

explained in Part I, even if it were clear that a single federal

standard applied in cases charging doctors with “large scale

drug trafficking,” that would not establish the necessity or

desirability of — let alone a congressional preference for -

national uniformity as to the “legitimacy” of every medical

practice that happened to involve controlled substances.

But even on that limited point, the case for national

uniformity is not airtight. There does not seem much basis for

concern that a jury would acquit a doctor, proved by the

government to be selling drugs in contravention of widely

accepted standards, based solely on the defendant’s “own

view,” Pet.Br.35, of acceptable State practice. Cf. Tesauro v.

Perrige, 650 A.2d 1079, 1082 (Pa. Super. Ct. 1994)

(malpractice defendant bears burden of producing “adequate

factual support for his claim that there are a considerable

number of professionals who agree with the treatment”). By the

same token, it is not obvious that a jury instructed as were those

in the cases cited approvingly in the Attorney General’s brief

(Pet.Br.31) would convict a physician, in the rare instance

where his conduct strictly complied with a “state statutory law

governing the particular matter in question,” id. at 35; in such

an instance, it presumably would be hard for the Government

to carry its burden of proving that the physician was not acting

“in good faith,” see, e.g., United States v. Rosenberg, 515 F.2d

190, 198 (9th Cir.1975), and there would be strong arguments

against mounting a prosecution at all."’

Nor do the Court’s recent decisions in “medical marijuana”

cases support construing the CSA as enacting a national

medical practice regulation — or a preemptive ban on assisted

suicide. First, the legal issue presented here is nothing like the

one decided in United States v. Oakland Cannabis Buyers’

Cooperative, 532 U.S. 483 (2001) (“OCBC’”), which held that

a federal court’s recognition of a “medical necessity” defense

to a marijuana distribution charge would be precluded by the

Statutory determination that that the drug has no “accepted

medical use.” See id. at 483; cf. Moore, 423 U.S. at 142

(authority “under the CSA to dispense * * * Schedule I drugs *

* * does not follow automatically from state registration as it

does with respect to drugs in Schedules II through V, all of

which have some accepted medical use”). OCBC recognized

that a State law that purported to overrule the federal ban on

distribution of marijuana would not only be in “positive

conflict,” 21 U.S.C. § 903, with that drug’s placement on

Schedule I, but also in tension with the statutory structure,

which relies on centralized scheduling decisions, guided by

' However rare such situations may be, Pet.Br.35, the exercise of power

at issue here obviously does entail overruling “state statutory law governing

the particular matter in question, "id.

The question actnally presented in Moore was whether a physician could

ever be prosecuted under § 841 — not the standard for establishing guilt —

but it is not at all “clear that Moore’s conviction * * * was based on a

uniform nationwide standard” (Pet. Br.31). As quoted in the opinion, the

jury instruction directed that compliance “with a standard of medical

practice generally recognized and accepted in the United States,” 423 U.S.

at 139 (emphasis added), would preclude conviction; and “the jury was

instructed that Dr. Moore could not be convicted if he merely made ‘an

honest effort’ to prescribe for detoxification in compliance with an accepted

standard of medical practice,” id. at 143 n.20 (emphasis added); see also

id. at 126 (“The Government's position [was] that Dr. Moore’s conduct was

inconsistent with all accepted methods of treating addicts’”’).

specific congressionally-identified factors, to determine whether

— and subject to which controls — a substance may be

distributed.’

Here, there is no “positive conflict” — or even implied

conflict — between Oregon’s exercise of its historic powers and

any congressional determination, let alone any affront to the

scheme of substance-based scheduling and controls that

Congress enacted. This case does not involve enforcement of

a federal prohibition “duplicative” of or “parallel” to a repealed

State law, see Pet.Br.44: the Attorney General effectively

claims power under the CSA to create a crime of “assisted-

suicide [with a controlled substance].”"

III. Sustaining The Assertion of Authority Would Interfere

With Proper Health Care

There are important public health reasons why even the

powers Congress did confer on the Attorney General must be

clearly and narrowly defined and sensitively exercised. As

Congress, this Court, and others have often recognized, patients

'2The suggestion (Pet.Br.29) that OCBC recognized the Attorney

General’s power to displace State laws to be greater than Congress's

misreads the decision. Respondents in OCBC did not claim that the

Attorney General had especially broad power under the CSA; their

contention, rejected in the relevant opinion passage, was that because the

mandatory § 812(b) criteria are binding only in an administrative scheduling,

Congress’s placement of marijuana on schedule I did not literally establish

~ as a lawful DEA classification necessarily would — that the drug had been

determined to “lack accepted medical use.”

'3Gonzales v. Raich, 125 S. Ct. 2197 (2005), which addressed

Congress’s power under the Constitution to regulate intrastate marijuana

possession for medical purposes, is of no more help to the Attorney General

— and even less relevant. That decision proceeded from the premise that

Congress had in fact prohibited Respondents’ conduct by enacting the CSA,

and then held that the decision to do so — supported by unquestioned power

over interstate trafficking in marijuana and by findings that regulation of

local activity was necessary to make the national prohibition effective — were

within its Article I power. Cf. New State Ice, 285 U.S. at 311 (Brandeis, J “

dissenting) (emphasizing value of State experimentation that poses no “risk

to the rest of the country”).

are ill-served when their doctors are deterred from practicing

medicine in accordance with professional judgment — or from

providing care at all. See Moore, 423 U.S. at 143 (noting

presidential commission findings that “‘fear of prosecution”

leads “many physicians [to] * * * shun addicts as patients” or

provide them inappropriate care); Conant v. Walters, 309 F.3d

629, 640 n.2 (9th Cir. 2002) (Kozinski, J., concurring)

(“‘[P]hysicians are particularly easily deterred by the threat of

governmental investigation and/or sanction from engaging in

conduct that is entirely lawful and medically appropriate’”’)

(quoting expert report); cf. Thompson, 535 U.S. at 374

(recognizing benefits to patients of permitting physicians to

prescribe compounded drugs and “off-label” uses).

The dangers of such deterrence are especially acute where

controlled substances are involved. Not only does prescribing

such medications subject the practitioner to far greater

governmental scrutiny (heightening concerns about possible

investigations and enforcement actions, see infra), but many

individual physicians, like the rest of society, harbor inaccurate

assumptions about the risks such drugs pose, see Oken, Curing

Healthcare Providers’ Failure to Administer Opiods in the

Treatment of Severe Pain, 23 Cardozo L. Rev. 1917, 1938

(2002); Morgan, American Opiophobia: A Customary

Underutilization of Opioid Analgesics, in Controversies in

Alcoholism and Substance Abuse (Stimmel, ed. 1986) at 171,

and professional training historically did not treat their principal

benefit — relieving patients’ pain — as an important part of

doctors’ medical treatment responsibilities, see p. 10, supra.

For these reasons, the Directive and the construction of the

Act on which it rests — which would grant the Attorney General

broad and ill-defined power to investigate, discipline, and

prosecute doctors for actions taken in good faith, in accord with

professional judgment and State law, in situations where there

is not even a suggestion of drug diversion — represent, from a

public health perspective, a long step in the wrong direction.

A. The Directive Will Worsen Existing, Serious

Inadequacies in End-of-Life Care

Both in Oregon and elsewhere, the Directive would

negatively affect care in a field of medical practice — care for

the terminally ill — in which legitimate concerns about drug

diversion and addiction are at their nadir, and in which very

serious inadequacies have already widely recognized.

As noted above, see p. 9, supra, the Directive’s operation in

Oregon would be troubling even on its own terms. Because it

is limited to controlled substances, see § 81 1(b); Pet.Br.43, the

Directive apparently would not stand in the way of Oregon

physicians’ pursuing the objected-to “aim[]” (Pet.Br.19), by

means that the physician does not believe — and the Attorney

General does not suggest — are more medically appropriate."

The Directive’s most serious adverse effects, however,

would be in jurisdictions where traditional bans remain in

effect. Notwithstanding the oblique assertion that increased

enforcement activity outside Oregon is not “portend[ed], the

Directive plainly declares an intention to regulate end-of-life

care throughout the Nation, i.e., “regardless of whether state

law authorizes or permits [assisting suicide] by practitioners or

others and regardless of the condition of the person whose

suicide is assisted,” 66 Fed. Reg. at 56,608, threatening

physicians who provide “illegitimate” assistance to terminally

ill patients with “the penalties provided for violations of * * *

law relating to controlled substances,” 21 C.F.R. § 1306.04(a).

The impact of this unprecedented assertion of authority

“To the extent that the Directive is intended to dissuade States

otherwise inclined to follow Oregon's course from doing so, its implications

are also potentially perverse. In view of evidence that physician assistance

occurs throughout the country, see Meier et al, A National Survey of

Physician-Assisted Suicide and Euthanasia in the United States, 338 N. Eng.

J. Med. 1193 (2001), the Directive would give jurisdictions where the

practice is tacitly accepted (but legally prohibited) strong incentive to remain

beneath the Attorney General's “radar” — thereby denying patients the formal

safeguards and public scrutiny that formal regimes like Oregon's provide.

must be understood in light of the already serious problem it

would aggravate — inadequate palliative care for the terminally

ill. Even absent the Directive, “[t]oo many dying people suffer

from pain * * * that clinicians could * * * relieve with existing

* * * therapies.” Approaching Death at 2. The consensus view

across a variety of disciplines is that undertreatment of pain is

a pervasive public health problem. See Martino, Jn Search of

a New Ethic for Treating Patients with Chronic Pain: What

Can Medical Boards Do?, 26 J.L. Med. & Ethics 332 (1998).'°

As courts and researchers have recognized, this

phenomenon is not primarily explained by a lack of available

medications — or by “legal barriers to obtaining medication

** * to alleviate * * * suffering,” Glucksberg, 521 U.S. at 736-

37 (O’Connor, J., concurring), so much as by “reluctance of

health care practitioners to use narcotic analgesics fully for

therapeutic purposes.” Martino, 26 J.L. Med. & Ethics at 333.

As noted, see p. 25, supra, this reluctance is partly attributable

to a professional culture that long neglected the importance of

palliative care — and to doctors’ own misconceptions about drug

dependence — but it is significantly driven by apprehensions

about the prospect of governmental investigation, legal

sanctions, and the attendant professional stigma.'®

'SStudies have found that 41.2% of the 2.2 million residents of U.S.

nursing homes have “persistent pain,” Teno et al., Persistent Pain in Nursing

Home Residents, 285 JAMA 2081 (2001); that large percentages of

terminally ill patients spend their last days in moderate to severe pain, see A

Controlled Trial to Improve Care for Seriously Ill Hospitalized Patients, 274

JAMA 1591 (1995); that significant numbers of elderly cancer patients in

nursing homes received no analgesics at all, Bernabei et al., Management of

Pain in Elderly Patients with Cancer, 279 JAMA 1877 (1998); and that

minority patients are at special risk of undertreatment, see Cleeland et al.,

Pain Management in Minority Patients With Cancer, 127 Annals Internal

Med. 813 (1997); see also Von Roenn et al., Physician Attitudes and

Practices in Cancer Pain Management, \19 Annals Internal Med. 121

(1993) (86% of physicians responded that the majority of cancer patients

with pain were undermedicated).

See, e.g., Sabatino, Removing Legal Obstacles to Effective Pain

Management, NAELA Q., Spring 200i, at 15, 19; Johnson, Disciplinary

Cases involving the terminally ill present special challenges,

because drugs, if applied in certain dosages, can hasten death:

“The threat of prosecution, the possibility of being labeled

another Kevorkian, and the risk of losing prescribing or practice

privileges are all strong incentives to say no, even in instances

where the use of high doses of opioids is not only the

legitimate, but also the most humane course of action,”

Martino, 26 J.L. Med. & Ethics at 337; see Haugen, Pain Relief

for the Dying: The Unwelcome Intervention of the Criminal

Law, 23 Wm. Mitchell L. Rev. 325 (1997); Kapp, Treating

Medical Charts Near the End of Life: How Legal Anxieties

Inhibit Good Patient Deaths, 28 U. Tol. L. Rev. 521 (1997).

Even though the Directive includes language professing

recognition of the “important medical, ethical, and legal

distinctions between intentionally causing a patient’s death and

providing sufficient dosages of pain medication necessary to

eliminate or alleviate pain,” 66 Fed. Reg. at 56,608, it can only

aggravate these concerns. That language falls conspicuously

short of recognizing a safe harbor (as some State laws have) for

prescribing drugs that have the “double effect” of hastening

death, see Glucksberg, 521 U.S. at 780 n.15 (Souter, J.,

concurring); indeed, nothing in the Directive indicates that the

Attorney General would not investigate a physician who was in

compliance with his or her State’s provision. Even in those

jurisdictions, physicians fearful of having their “intent” misread

may refrain from administering (appropriately) high doses of

pain medication to their terminally ill patients. See Groopman,

Separating Death From Agony, N.Y. Times, Nov. 9, 2001, at

A21 (describing as “medically impossible” to “dissociate

intentionally ameliorating a dying patient’s agony from

intentionally shortening the time left to live”).

Actions and Pain Relief: An Analysis of the Pain Relief Act, 24 J.L. Med. &

Ethics 319, 320 (1996); Hill, Government Regulatory Influences on Opioid

Prescribing and Their Impact on the Treatment of Pain of Nonmalignant

Origin, 11 J. Pain & Symptom Mgmt. 287, 288 (1996).

The Directive would increase these deterrents vastly, by

vesting medically untrained law enforcement agents with

authority to ascertain a physician’s “motive” in caring for a

deceased patient; by raising the stakes of such investigations;

and by heightening the danger that those making such

inherently delicate judgments would apply conflicting

standards.

B. The Authority Claimed, If Approved, Would Chill

Legitimate Medical Practice And Distort the Process By

Which Controversial Policy Questions Are Resolved

Sustaining the Attorney General’s construction of the statute

would not merely affect the subject matter of the Directive, but

would enable a federal law enforcement presence in matters, far

removed from the concerns that led to enactment of the CSA,

that have always been for State resolution.

The construction of the statute advanced in this Court would

also authorize actions against doctors for prescribing pain

medication for patients who are not terminally ill, even when

done in full, good faith compliance with “state statutory law

governing the particular matter in question.” Pet.Br.35

(emphasis added). As researchers have found, the tendency to

undertreat severe pain of those not in the late stages of terminal

disease is likely a more pervasive — and harder to solve —

problem than is inadequate care at the end of life.'”

"Not only has end-of-life care received more focused policy attention,

but many doctors’ reluctance to prescribe potentially dependency-inducing

medication is especially pronounced for patients with chronic pain, and the

standards of proper care for management of such pain are less well-

established. See Portenoy, Opioid Therapy for Chronic Nonmalignant Pain:

Clinicians’ Perspective, 24 J.L. Med. & Ethics 296 (1996); Davidson, Pain

and Opiophobia, 40 Healthcare Forum J. 64 (1997); Hyman, Pain

Management and Disciplinary Action: How Medical Boards Can Remove

Barriers to Effective Treatment, 24 J.L. Med. & Ethics 338 (1996). See

Federation of State Medical Boards of the United States, Model Policy for

the Use of Controlled Substances for the Treatment of Pain (2004)

(recognizing undertreatment of pain to be a “serious public health problem

and citing doctors’ “perception that prescribing adequate amounts of

Moreover, as explained above (pp. 10-11), the Attorney

General’s efforts to articulate a definition of “illegitimacy” not

limited to “closed system” concerns would bring prescription of

controlled substances in the course of any experimental or

nontherapeutic medical procedure within the ambit of the CSA

— with the Attorney General’s available grounds for proceeding

against a doctor (or overruling a State) not limited to reasons of

drug control or even medical appropriateness.

It is no answer that the Attorney General might not attempt

such further assertions of power. First, as just described, the

threat of conviction is not needed to distort doctors’ choices —

in ways that disserve patients (and the Directive itself would

hardly have been a foreseeable development from the vantage

point of Glucksberg and Quill). But whether or not similar

“interpretive rules” were ultimately to issue, the process for

resolving difficult questions of policy and morality would be

skewed, encouraging those who object to novel and

controversial practices to bypass State-level (and even

congressional) debate and ask the Attorney General to “stay

experimentation” at the earliest possible stage (when a fully

contrary “consensus” could most plausibly be claimed).

Such a regime would be inimical to the public health, and

it is not what should happen in “a democratic society,”

Glucksberg, 521 U.S. at 735.

Conclusion

The judgment of the Court of Appeals should be affirmed.

controlled substances will result in unnecessary scrutiny by regulatory

authorities” as a contributing cause).

Respectfully submitted,