Amicus Curiae Brief — Gonzales v. Oregon

No. 04-623

IN THE

Supreme Court of the United States

ALBERTO R. GONZALEZ, ATTORNEY GENERAL

OF THE UNITED STATES, ET AL.

Vv.

PETITIONERS,

STATE OF OREGON, ET AL.,

RESPONDENTS.

On Writ of Certiorari to the

United States Court of Appeals for the Ninth Circuit

BRIEF OF FOCUS ON THE FAMILY AND THE

FAMILY RESEARCH COUNCIL

AS AMICI CURIAE, SUPPORTING PETITIONERS

STEPHEN W. REED

35 N. Lake Ave.

Pasadena, CA 91101

(626) 449-4521

PATRICK A. TRUEMAN

801 G. Street NW

Washington D.C. 20001

(202) 393-2100

WILLIAM WAGNER

NELSON P. MILLER

Counsel of Record

COOLEY LAW SCHOOL

300 South Capitol

Lansing, MI 48933

(517) 371-5140

TABLE OF CONTENTS

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THE COURT OF APPEALS ERRED IN GRANTING

OREGON’S REQUEST TO ENJOIN THE UNITED STATES

FROM ENFORCING THE FEDERAL CONTROLLED

_ A. Congress, Pursuant to its Enumerated Powers in

Article I of the United States Constitution, May

Regulate the Dispensing of Controlled Substances by

Physicians and Other Medical Professionals ............4

B. The Federal Controlled Substances Act Preempts

the Oregon Law Authorizing Doctors to Dispense

Drugs to Assist Killing a Human Being ....................7

C. Dispensing Controlled Substances to Assist

Suicide Is Not a Traditional State Medical Practice

D. The Attorney General Acted within His Statutory

il

E. Enjoining the United States from Protecting

the Citizenry against Dispensing Drugs to Kill a

Person, Creates a Culture of Death with Serious

SEES ee oa a 19

EE Sh eR eed 24

ili

TABLE OF AUTHORITIES

Cases:

Boggs v. Boggs, 520 U.S.833 (1997) ....ccccccccccceeeeereeees 10

Gade v. National Solid Waste

Management Assn., 505 U.S. 98 (1992) ......cccccccccceeeees 10

Hisquierdo v. Hisquierdo, 439 U.S. 572 (1979) ....... 3,10

Hodel v. Indiana, 452 U.S. 314, 323-324 (1981) .......... 5

United States v. Steele, 147 F.3d 1316 (11" Cir.

1998)(en banc) (and cases cited therein), cert. denied,

Steele v. United States, 528 U.S. 933 (1999)............... 7,8

United States v. Darby, 312 U.S. 100 (1941) ............. 5,7

United States v. Lopez, 514 U.S. 549 (1995) .........cc00 5

United States v. Moore,

LTE Gl) eee § FS

United States v. Morrison, 529 U.S. 598 (2000) ........... 5

Washington v. Glucksberg, 521 U.S. 702 (1997)......... 22

Ashcroft v. Oregon, (court of appeals opinion, filed

May 26, 2004 -- Pet. App.).........ccccccssesseeesees 11,14,18,20

Oregon v Ashcroft, (district court opinion

OT, GND ncriceccinenennenencetneensenenmnssnsenessonnet 8

iv

Constitution, statutes, and regulations:

of RB. FO RR SX . 5 nena 4

SFR FURR ee 5

ee I GY WT cceespieidiicindiciiaesiesdiiiaislidamtieaeaaiaianes 39,24

Or. Rev. Stat. §§ 127.800 er seg. (2003) .............. 000.7

Health Insurance Portability and Accountability Act,

Pub. L. No. 104-191, 110 Stat. 1936 (1996) .............13

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21 CFR § 306.04(a) (1973) (re-designated as 21 CFR §

tT) ee 4,8,10,11,14,17,18

Pet. App. 100a (AG Order no. 2534-2001,

ee 4,11,14,18

Miscellaneous:

Sissella Bok, Physician-Assisted Suicide, in Euthanasia

and Physician-Assisted Suicide 139 (Gerald Dworkin,

60h, Cig Ce cercctenstecintntinnnnninanisial 20

Kathleen Foley, and Herbert Hendin, The Case Against

Assisted Suicide, For the Right to End-of-Life Care

(Foley & Hendin, eds 2002).............:c000000 12,20,21,22,23

Brief of the American Medical Assn., American Nurses

Assn., American Psychiatric Assn., et al., as Amicus

Curiae in Support of Petitioners at 5, Glucksberg

(No. 96-110), available in 1996 WL 56263............. 12,13

vi

H.R. Rep. No. 1444,

91st Cong., 2d Sess. Pt. 1 (1970) oo... ccccceeeceeeeeeees &,

Memorandum for the Attorney General,

(June 27, 2001 -- Pet. App.) ............ poneenmmmeseaiannaeitd 8,16

l

INTEREST OF AMICI CURIAE

This amicus curiae brief is filed on behalf of Focus

on the Family and the Family Research Council. '

Focus on the Family is a non-profit religious

corporation committed to strengthening the emotional,

psychological, and spiritual health of children and their

families in the United States and throughout the world.

Focus on the Family’s Founder and Chairman, Dr.

James Dobson, a distinguished child psychologist, is the

author of numerous books, pamphlets, and papers on child

development, education, marriage, and society. Focus on the

Family and Dr. Dobson have been at the forefront of the pro-

life movement and have spoken and written extensively

concerning individual and societal dangers associated with

assisted suicide. Focus on the Family has participated as

amicus curiae on numerous briefs to this Court and others in

cases addressing issues of life. It regularly lobbies Congress

and state legislatures concerning matters associated with the

sanctity and preservation of life. See www.family.org.

Family Research Council is a non-profit, research

and educational organization dedicated to articulating and

advancing a family-centered philosophy of public life. FRC

is a voice for the pro-family movement in Washington, D.C.,

and provides policy analysis, legislative assistance, and

research for pro-life and pro-family organizations. It also

' In accordance with Supreme Court Rule 37(6), amici certify that this

brief was authored entirely by Counsel of Record for amici and that no

part of the brief was authored by any attorney for a party. The Alliance

Defense Fund provided a monetary contribution to the preparation or

submission of this brief; no other person or entity other than amici curiae

or their counsel provided a monetary contribution to the preparation or

submission of this brief.

2

seeks to educate legislators on issues that affect American

families.

In addition to providing policy research and analysis

for the legislative, executive, and judicial branches of the

federal government, FRC works to inform the news media,

the academic community, business leaders, and the general

public about family issues that affect the nation. FRC

publishes and disseminates resource materials, legal

memoranda, and public policy studies on pro-family issues.

These publications include discussions on the problems and

legal controversies surrounding assisted suicide. See

www.frc.org. Its research, publications, and films on the

impact of assisted suicide have been distributed to thousands

of scholars, students, organizations, and citizens. FRC’s legal

and public policy experts are continually sought out by

members of Congress and state legislators for assistance and

advice on matters of bioethics and issues relating to assisted

suicide.

FRC has participated in numerous amicus curiae

briefs in the United States Supreme Court and federal courts,

including cases involving pro-life issues.

Focus on the Family and Family Research Council

work to preserve and protect the family and have particular

knowledge about the social and legal impact of assisted

suicide that will be helpful to the Court in this case.

Petitioner and Respondents, through their counsel of

record, consented to the filing of this Brief of Amici Curiae

in support of Petitioner. Their letters of consent are on file

with the Clerk of the Court.

3

SUMMARY OF THE ARGUMENT

The issues in this case implicate important federalism

concerns vital to proper constitutional governance under the

rule of law.

The appellate court’s analysis, granting Oregon’s

request to enjoin the United States from enforcing the

Federal Controlled Substances Act (CSA), is incompatible

with the Supremacy Clause in Article VI of the United States

Constitution. Mutually exclusive provisions of the Federal

CSA and Oregon law make it impossible for a dispensing

physician to comply with both. In such situations, this Court

has deemed the state law preempted—even where a

distinctive state interest is at stake. See, e.g., Hisquierdo v.

Hisquierdo, 439 U.S. 572, 581 (1979) (finding state

community property law preempted by federal military pay

law). Thus, even without considering the Attorney General’s

reasonable interpretation of the CSA’s implementing

regulation, the two statutes here conflict to the extent they

cannot consistently stand together.

The CSA, as interpreted by the Attorney General,

does not interfere with Oregon’s regulation of a traditional

state function. The Oregon law authorizes and protects a

non-traditional, deadly practice, using federally controlled

substances—a practice condemned by the American Medical

Association and our nation’s leading health care provider

associations. This deadly practice cannot be a traditional

state function as Oregon professes it to be. As such, Oregon

has no right to prevent federal enforcement of the applicable

federal drug laws under the CSA.

The Attorney General’s interpretive rule confirmed

that dispensing controlled substances to assist suicide

violates the CSA, and merely verified that assisting suicide is

4

not a “legitimate medical purpose” within the meaning of 21

C.F.R. 1306.04. Pet. App. 100a (AG Order no. 2534-2001).

When this interpretation of the CSA’s implementing

regulation is added into the analysis, federal preemption is

irrefutable. In promulgating this interpretive rule concerning

the dispensing of controlled substances, the Attorney

General acted within the scope of his statutory authority.

Finally, enjoining the United States from protecting

the citizenry against dispensing drugs to kill a human being

creates a culture of death with serious implications.

Amici, therefore, urge this Court to reverse the

decision of the United States Court of Appeals for the Ninth

Circuit.

ARGUMENT

THE COURT OF APPEALS ERRED IN GRANTING OREGON’S

REQUEST TO ENJOIN THE UNITED STATES FROM ENFORCING

THE FEDERAL CONTROLLED SUBSTANCES ACT (CSA)

The issues in this case implicate important federalism

concerns vital to proper constitutional governance under the

rule of law.

A. CONGRESS, PURSUANT TO ITS ENUMERATED POWERS

IN ARTICLE I OF THE UNITED STATES CONSTITUTION, MAY

REGULATE THE DISPENSING OF CONTROLLED SUBSTANCES

BY PHYSICIANS AND OTHER MEDICAL PROFESSIONALS

Article I, of the United States Constitution, vests in

Congress the power "[t]o regulate Commerce ... among the

several States," U.S. Const. art. I, § 8, cl. 3. Additionally, the

2 21 U.S.C. §§ 801 er seg.

5

Necessary and Proper Clause, empowers Congress to enact

laws reasonably necessary to carry out its power under the

Commerce Clause. /d. at cl. 18.

This Court has held that "Congress’s commerce

authority includes the power to regulate those activities

having a substantial relation to interstate commerce, . . . 1.€.,

those activities that substantially affect interstate commerce."

See United States v. Morrison, 529 U.S. 598, 609 (2000)

(quoting United States v. Lopez, 514 U.S. 549, 558-59

(1995)). See also United States v. Darby, 312 U.S. 100, 118

(1941). Congress properly exercised such Article | powers

when enacting the Federal Controlled Substances Act.

Under a "rational basis" standard, broad deference is

due to congressional judgments concerning whether drug

dispensing activity by physicians substantially affects

interstate commerce. See Lopez, 5/4 U.S. at 557. Likewise,

such broad deference applies to whether Congress’s

regulation of drugs is reasonably necessary to carry out its

legislative purpose under the Commerce Clause. Id. Here,

it is clear that Congress’s purpose in enacting the Controlled

Substances Act was to comprehensively regulate the market

of such substances. A House Report expressly stated that

Congress promulgated the law in order "to deal in a

comprehensive fashion with the growing menace of drug

abuse in the United States . . . through providing more

effective means for law enforcement aspects of drug abuse

prevention and control." H.R. Rep. No. 91-1444, Pt. 1, at 1

(1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4567.

> "A court may invalidate legislation enacted under the Commerce Clause

only if it is clear that there is no rational basis for a congressional finding

that the regulated activity affects interstate commerce, or that there is no

reasonable connection between the regulatory means selected and the

asserted ends." Hodel v. Indiana, 452 U.S. 314, 323-24 (1981).

6

When it enacted the Federal Controlled Substances

Act, Congress made the following findings and statements:

(1) Many of the drugs included within this

subchapter have a useful and legitimate

medical purpose and are necessary to

maintain the health and general welfare of the

American people.

(2) The illegal . . . distribution, and possession

and improper use of controlled substances

have a substantial and detrimental effect on

the health and general welfare of the

American people. (emphasis added)

(3) A major portion of the traffic in controlled

substances flows through interstate and

foreign commerce. Incidents of the traffic

which are not an integral part of the interstate

or foreign flow, such as manufacture, local

distribution, and possession, nonetheless have

a substantial and direct effect upon interstate

commerce.... 21 U.S.C. § 801.

From these and its other findings, Congress could reasonably

assume that the dispensing of drugs substantially affects

interstate drug commerce. It is also reasonable that federal

regulation of such an activity is necessary to accomplish the

congressional purpose of regulating drug commerce.

Congress properly, therefore, could conclude that regulation

of drug-dispensing activity is a reasonably necessary way to

achieve its purpose of comprehensively regulating the

interstate market in controlled substances. Including

improper drug-dispensing activity for lethal purposes within

the CSA’s coverage furthers its legitimate objective. Indeed,

excepting such activity undermines clear legislative intent to

j

regulate the drug market comprehensively in a manner which

protects public health and safety.*

Moreover, no_ constitutional provision limits

Congress from using its powers under Article I to regulate

commerce in connection with medical matters. See Darby,

312 U.S. at 115-17 (1941) (renouncing earlier doctrines

holding that Congress could not utilize the commerce power

to achieve legitimate objectives relating to the health and

welfare of the nation); and see generally, United States v.

Steele, 147 F.3d 1316, (11™ Cir. 1998) (en banc) (and cases

cited therein), cert. denied, Steele v. United States, 528 U.S.

933 (1999)(upholding a conviction of a physician under the

CSA for dispensing drugs outside professional limits).

B. THE FEDERAL CONTROLLED SUBSTANCES ACT

PREEMPTS THE OREGON LAW AUTHORIZING DOCTORS

TO DISPENSE DRUGS TO ASSIST KILLING A HUMAN BEING

The relevant Oregon law in this case authorizes

physicians, in certain circumstances, to prescribe and

dispense a lethal amount of drugs for the purpose of assisting

in the killing of a human being. Or. Rev. Stat. §§ 127.800 er

seq. (2003). The Oregon law expressly provides that a

physician cannot “be subject to civil or criminal liability or

professional disciplinary action” for engaging in the conduct

authorized by the Oregon law. /d. § 127.885 (1).

* This is why the dispensing of controlled substances is regulated under

the CSA by "“provid{ing] for control . . . through registration of

manufacturers, wholesalers, retailers, and all others [including

physicians] in the legitimate distribution chain....". H.R. Rep. No. 91-

1444, supra, Pt. 1, at 3, 6 (1970), reprinted in 1970 U.S.C.C.A.N. 4566,

4569.

8

The drugs dispensed in the lethal conduct authorized

by the Oregon law are controlled substances regulated under

the Federal CSA. Pet. App. 114a (Memorandum for the

Attorney General, June 27, 2001). Generally, such

substances are among those listed in Schedule II of the CSA.

Id.; see also Pet. App. 65a (opinion of the district court).

The conduct now -authorized as legitimate and

immune from prosecution under Oregon law is a

prosecutable crime carrying serious penalties under the

provisions of the Federal CSA.

Under the CSA, it is a federal crime for a physician

to “dispense” a controlled substance without a legitimate

medical purpose in the usual course of medical treatment.°

See 21 U.S.C. §§ 841(a)(1), 802(21); 829; 21 C.F.R. §

306.04(a) (1973) (re-designated as 21 C.F.R. § 1306.04(a)

(1975): see also United States v. Moore, 423 U.S. 122, 124,

139 (1975) (holding that a physician can be convicted under

the CSA when acting outside professional limits).

When “death . . . results from the use of such

Substance” dispensed, the dispensing physician faces

> Whether the physician acted outside authorized professional limits is

not an element of the offense that the government needs to negate; rather,

it is an affirmative defense available to the practitioner who carries the

burden of going forward with the evidence concerning the exception. 21

U.S.C. § 885(a)(1); Steele, 147 F.3d at 1318-20 (11th Cir. 1998) (en

banc) (and cases cited therein). Congress clearly did not intend an

exception for non-medical use of controlled substances for purposes

harmful to life. There is no expression within the CSA of any such

exception. Permitting states to alter the CSA by injecting such an

exception holds the potential to gut the full intent of the federal law.

Under the appellate court’s decision, for example, California could pass a

law permitting physicians to prescribe and dispense controlled substances

to assist patients to get “high” in order to deal with stress.

9

significant penalties under the CSA. See 21 U.S.C. § 841

(b)(1)(C) (prescribing up to life in prison for dispensing

Schedule II controlled substances in violation of § 841(a)

where death results from the use of the drug); see also

Moore, 423 U.S. at 132 (1975) (recognizing that Congress

geared the CSA’s penalties “to the nature of the violation,

including the character of the drug involved.”) .

It is worth noting that Congress also expressed

disapproval of physician-assisted suicide in its Assisted

Suicide Funding Restriction Act of 1997, Pub. L. No. 105-

12, (1997), 111 Stat. 23 (codified at 42 U.S.C. § 14401 et

seq.). There, Congress expressly stated the principal purpose

of the Act was “to continue current Federal policy by

providing explicitly that Federal funds may not be used to

pay for items and services (including assistance) the purpose

of which is to cause (or assist in causing) the suicide,

euthanasia, or mercy killing of any individual.” 42 U.S.C. §

14401(b). The Assisted Suicide Funding Restriction Act

thus provides further confirmation that Congress, in the

CSA, intended to proscribe the dispensing of controlled

substances by physicians to assist in the killing of human

life. |

Article VI of the United States Constitution states:

This Constitution, and the Laws of the United

States which shall be made in Pursuance

thereof . . . shall be the supreme Law of the

Land; and the Judges in every State shall be

bound thereby, any Thing in the .. . laws of

any State to the Contrary notwithstanding.

U.S. Const. art. VI (emphasis added).

The Federal CSA expressly preempts state laws to

the extent “there is a positive conflict between [a provision

10

of the CSA] and that state law so that the two cannot

consistently stand together.” 21 U.S.C. § 903. To be sure,

nothing in the CSA prevents a state from enacting its own

stricter drug legislation, or prosecuting drug offenses at the

state level. /d. And, nothing in the Federal CSA preempts a

state from regulating within the field of physician-assisted

suicide (i.e., nothing in the CSA preempts a state law

authorizing physician assisted suicide per se).

Under conventional conflict preemption principles,

however, the Federal CSA clearly preempts Oregon's statute

authorizing the dispensing of controlled substances to assist

suicide. The CSA proscribes the dispensing of controlled

substances by physicians without a legitimate medical

purpose in the usual course of medical treatment—and

provides severe penalties when “death . . . results from the

use of such substance... .” See §§ 841(a)(1), 802(21), 829:

21 C.F.R. § 1306.04(a) (1975); Moore, 423 U.S. at 124

(1975); and 21 U.S.C. § 841 (b)(1)(C). Oregon’s law, on the

other hand, expressly authorizes—and immunizes against

prosecution—the lethal dispensing proscribed and severely

penalized by the CSA. Thus, the two statutes here conflict to

such an extent that they cannot consistently stand together.

Moreover, even if the CSA did not expressly preempt

the Oregon statute, implied preemption exists where

“compliance with both federal and state regulations is a

physical impossibility.” Boggs v. Boggs, 520 U.S. 833, 844

(1997) (internal quotation marks omitted) (citing Gade v.

Nat'l Solid Wastes Mgmt. Ass'n, 505 U.S. 88, 98 (1992)).

The mutually exclusive provisions of the CSA and Oregon

law governing the dispensing of controlled substances make

it impossible for a dispensing physician to comply with both.

In such situations, this Court has deemed the state law

preempted—even where a distinctive state interest is at

stake. See, e.g., Hisquierdo v. Hisquierdo, 439 U.S. §72,

ll

581 (1979) (finding state community property law preempted

by federal military pay law).

Thus, the Ninth Circuit’s analysis, granting Oregon's

request to enjoin the United States from enforcing the

Federal CSA, is incompatible with the Supremacy Clause in

Article VI of the United States Constitution. The CSA and

its implementing regulations plainly proscribe, and therefore

preempt, Oregon's law authorizing the dispensing of drugs to

assist in the death of a human being—even without

considering the Attorney General’s statutorily authorized

reasonable interpretation of the CSA’s implementing

regulation at issue here. As discussed in more detail in

section D of this brief, this interpretive rule confirmed that

dispensing controlled substances to assist suicide violates the

CSA, and verified that assisting suicide is not a “legitimate

medical purpose” within the meaning of 21 C.F.R. 1306.04.

Pet. App. 100a (AG Order no. 2534-2001). When this

reasonable interpretation of the CSA’s implementing

regulation is added into the analysis, the certainty of federal

preemption is irrefutable.

At bottom, the Ninth Circuit’s analysis incorrectly

presumes this case is about Oregon’s right to regulate the

practice of medicine—suggesting that the Attorney

General's ruling alters the usual constitutional balance

between the states and federal government. Pet. App. at lla

(court of appeals opinion). The problem with the appellate

court’s federalism analysis is that it analyzes oranges when

this case is about apples. This case is not about the regulation

of medical practice; it is about the right of the federal

government to regulate controlled substances in a uniform

manner.°

° We also note that the appellate court over-states Oregon's situation,

given that Oregon stands alone among the fifty states in having radically

departed from accepted medical! practice. Physician-assisted suicide bills

12

C. DISPENSING CONTROLLED SUBSTANCES TO ASSIST

SUICIDE IS NOT A TRADITIONAL STATE MEDICAL PRACTICE

PROTECTED FROM FEDERAL REGULATION

The CSA, as interpreted by the Attorney General,

does not interfere with Oregon’s regulation of a traditional

State function. Nothing in the record suggests that dispensing

drugs to assist suicide is a traditional or legitimate medical

practice subject to state regulation. As such, Oregon has no

peculiar local, historical, or traditional interest in its

regulation. It certainly, therefore, has no right to prevent

federal enforcement of the federal drug laws under the CSA.

The Hippocratic Oath, written during the fifth to

fourth centuries B.C., declares, “I will neither give a deadly

drug to anybody if asked for it, nor will I make a suggestion

to this effect.” In keeping with that fundamental principle of

medicine, the AMA and more than 40 other national and

state medical and health care organizations have urged on

this Court that “the ethical prohibition against physician-

assisted suicide is a cornerstone of medical ethics. ...” Brief

of the American Medical Ass’n, American Nurses Ass‘n,

American Psychiatric Ass'n, et al., as Amicus Curiae in

Support of Petitioners at 5, Glucksberg (No. 96-110),

available at 1996 WL 656263.

The AMA has “reexamined and reaffirmed” that

“physician-assisted suicide remains ‘fundamentally

incompatible with the physician’s role as healer, would be

im more than 20 states have failed in the past decade, whereas 16 bills

prohibiting it have been enacted in the past decade and a half. Yale

Kamusar. The Rise and Fall of the “Right” to Assisted Suicide, in Foley

& Hendin, eds.. The Case Against Assisted Suicide, For the Right to End-

of-Life Care 9| (2002) (citations omitted).

13

difficult or impossible to control, and would pose serious

societal risks."” /d. Thus, in reality, the Oregon law

authorizes and protects a non-traditional, deadly practice

using federally controlled substances. Such a practice cannot

be considered medicine (traditionally regulated as a state

function) as Oregon professes it to be. Thus, if suicide is not

medicine, Oregon cannot, in its authorization of the use of

federally controlled substances to assist suicide, claim to be

regulating medicine as a traditional state function. Assisted-

suicide law cannot be regulating medicine as a traditional

state function.

Moreover, relatively few instances even exist in

which Oregon has invoked its state law. These few instances

hardly suggest a significant local impact. Certainly no

widespread impact on the practice of medicine in Oregon

exists from the Attorney General's interpretation of the CSA.

Up until the time when Oregon passed its law, the practice of

medicine in Oregon (and in every other state) did not involve

assisting suicide using federally controlled substances.

Oregon’s federalism argument is, therefore, a canard where

the federal regulation has no direct effect on truly traditional

_ State medical practice.

To be sure, Oregon can regulate whether its

physicians must be licensed. Oregon can also provide that

physicians must keep their patients’ records confidential—

though even that duty is the subject of federal standards. See

Health Insurance Portability and Accountability Act, Pub. L.

No. 104-191, 110 Stat. 1936 (1996). Oregon’s attempt to

legitimize the misuse of federally controlled substances to

take human life (and to provide immunity to physicians

violating federal regulations prohibiting that misuse),

however, cannot stand.

14

D. THE ATTORNEY GENERAL ACTED WITHIN HIS

STATUTORY AUTHORITY

The court of appeals erred when it held that the

interpretive rule promulgated by the Attorney General fell

outside his statutory authority. Pet. App. 9a (court of appeals

opinion).

As previously discussed, the Attorney General's

interpretive rule confirmed that dispensing controlled

substances to assist suicide violates the CSA. It also verified

that helping one to kill oneself is not a “legitimate medical

purpose” within the meaning of 21 C.F.R. 1306.04. Pet.

App. 100a (AG Order no. 2534-2001, 66 Fed. Reg at

56.608). The interpretive rule further concluded that “[s}uch

conduct by a physician registered to dispense controlled

substances may ‘render his registration . . . inconsistent with

the public interest’ and therefore subject to possible

suspension or revocation.” /d (quoting 21 U.S.C. §

824(a)i4)) (emphasis added). For the reasons discussed

below, the Attorney General acted within his statutory

authority when he promulgated this interpretive rule.

Congress, through the CSA, used the concept of

“registration” to identify those physicians who operate

“beyond the bounds of professional practice.” Moore, 423

U.S. at 139 (1975). Physicians and others, who dispense a

controlled substance, must “obtain from the Attorney

General a registration issued in accordance with the rules and

regulations promulgated by him.” 21 U.S.C. § 822 (a)(2).

Under the CSA, physicians and others registered by the

Attorney General to dispense controlled substances are

authorized to dispense such substances only “to the extent

authorized by their registration and in conformity with the

[provisions of the CSA].” 21 U.S.C. § 822 (b). Thus, only

15

“the lawful acts of registrants are exempted” from

prosecution. Moore, 423 U.S. at 130 (1975).

Congress expressly granted the Attorney General the

authority “to promulgate rules and regulations . . . relating to

the registration and control of the . . . dispensing of

controlled substances and to the registration and control of

regulated persons and regulated transactions.” 21 U.S.C. §

821.

Under 21 U.S.C. § 823(f), Congress gave the

Attorney General the express authority to deny an

application for registration “if he determines the issuance of

such registration is inconsistent with the public interest.”

Moreover, Congress also expressly gave the Attorney

General the authority to suspend or revoke a registration

authorized pursuant to section 823 if the Attorney General

finds that the registrant committed an act that would “render

his registration under section 823 [of the CSA] inconsistent

with the public interest as determined under such section.”

21 U.S.C. § 824.

In denying, revoking, or suspending an application,

the Attorney General must consider the following factors in

determining the public interest:

(1) The recommendation of the appropriate

State licensing board or professional

disciplinary authority.

” Congress expressly further granted the Attorney General the authority

to “promulgate and enforce any rules, regulations, and procedures”

deemed “necessary and appropriate for the efficient execution of his

functions under this subchapter.” 21 U.S.C. § 871(b).

16

(2) The applicant’s experience dispensing . . .

controlled substances.

(3) The applicant’s conviction record under

Federal or State laws relating to the

manufacture, distribution, or dispensing of

controlled substances.

(4) Compliance with applicable State,

Federal, or local laws relating to controlled

substances.

(5) Such other conduct which may threaten

the public health and safety.

21 U.S.C. § 823.

Most of the drugs dispensed in the lethal conduct

authorized by the Oregon law likely fall within Schedule II

of the CSA, the “most strictly regulated category of

substances available for non-research purposes.” Pet. App.

114a (Memorandum for the Attorney General, June 27,

2001). See also Pet. App. 65a (opinion of the district court).

In 21 U.S.C. § 829, Congress mandated the following

in connection with the dispensing of Schedule II controlled

substances:

Except when dispensed directly by a practitioner,

other than a pharmacist, to an ultimate user, no

controlled substance in schedule I] . . . may be

dispensed without the written prescription of a

practitioner, [with emergency exceptions not relevant

to the discussion at bar].”*

* The word “dispense” means “to deliver a controlled substance to an

ultimate user... by. or pursuant to the lawful order of, a practitioner,

17

Pursuant to the above discussed rulemaking authority |

vested in the Attorney General by Congress, the Attorney

General, in the early 1970’s, enacted regulations pursuant to

Section 829:

A prescription for a controlled substance to be

effective must be issued for a legitimate medical

purpose by an individual practitioner acting in the

usual course of his professional practice . .. An order

purporting to be a prescription issued not in the usual

course of professional treatment . . . is not a

prescription within the meaning of this Act and the

person knowingly filling such a purported

prescription, as well as the person issuing it, shall be

subject to the penalties provide for violations of the

provisions of law relating to controlled substances.

21 CFR § 306.04(a) (1973) (redesignated as 21 C.F.R. §

1306.04(a) (1975).”

If the Attorney General in the early 1970's

promulgated the above rule pursuant to statutory authority,

including the prescribing and administering of a controlled substance . . .

.” 21 U.S.C. § 802(10). “‘Ultimate user’ means a person who has

lawfully obtained ... a controlled substance for his own use ve Tt

U.S.C. § 802 (27). The term “practitioner” includes a “physician .. .

licensed, registered, or otherwise permitted, by the United States or the

jurisdiction in which he practices . . . [to] dispense . . . a controlled

substance in the course of professional practice... .” 21 U.S.C. § 802

(21) (emphasis added).

” See also, 21 U.S.C. § 830 (b\(3)ii) Regulation of Llisted Chemicals -|

Mail Order Reporting - “The term ‘valid prescription’ means a

prescription which is issued for a legitimate medical purpose by an

individual practitioner licensed by law to . . . prescribe the drugs

concerned and acting in the usual course of the practitioner's professional

18

then the Attorney General in 2001 certainly had the authority

to interpret what it means. Indeed, as noted above, Congress,

in 21 U.S.C. § 821, expressly granted the Attorney General

authority “to promulgate rules and regulations . . . relating to

the registrations and control of the . . . dispensing of

controlled substances and to the registration and control of

regulated persons and regulated transactions.” The Attorney

General's interpretive ruling directly promotes the CSA’s

purposes, by restricting use of controlied substances to

legitimate medical purposes. It promotes the medical use of

drugs, furthering the public interest in a manner perfectly

consistent with the broad intent of Congress. Thus, when the

Attorney General published the interpretive rule, confirming

that dispensing controlled substances to assist suicide

violates the CSA, and verified that assisting suicide is not a

“legitimate medical purpose” within the meaning of 21

C.F.R. 1306.04, he acted well within his cor ressionally

authorized authority. Pet. App. 100a (AG Order no. 2534-

2001. 66 Fed. Reg. at 56,608).

Moreover, it was reasonable for the Attorney General

to subsequently conclude in the interpretive rule that “[s}uch

conduct by a physician registered to dispense controlled

substances may ‘render his registration . . . inconsistent with

the public interest’ and therefore subject to possible

Suspension or revocation.” Pet. App. 100a (AG Order no.

2534-2001, 66 Fed. Reg. at 56,608 (quoting 21 U.S.C. §

824(a)(4))) (emphasis added).

The court of appeal’s holding that the Attorney

General’s action exceeded statutory authority because it

“evaluates public interest under 21 U.S.C. § 823 without

considering all five factors required by that subsection” is

misplaced. Pet. App. 17a (court of appeals opinion).

19

This part of the Attorney General's interpretive rule

is merely public notice of a logical consequence that may

come to one from ignoring the previously established

premise that dispensing drugs to assist one to kill oneself is

not a legitimate medical practice and violates the CSA. In

this regard, although the Attorney General certainly

evaluated the public’s interest in promulgating the

interpretive rule, nothing in the law requires him to consider

all five factors delineated in 21 U.S.C. § 823(f). Under the

CSA, the Attorney General is required to consider these five

factors only when denying, revoking, or suspending an

application for a registration. 21 U.S.C. §§ 823(f), 824.

Nothing in the record indicates that the Attorney General has

even contemplated taking such action against the named

plaintiffs. Thus, the court of appeals erred since no statutory

authority required the Attorney General to consider the five

factors when promulgating the interpretive rule.

E. ENJOINING THE UNITED STATES FROM PROTECTING THE

CITIZENRY AGAINST DISPENSING DRUGS TO KILL A PERSON,

CREATES A CULTURE OF DEATH WITH SERIOUS IMPLICATIONS

The court of appeals mandated that the United States

must not enforce the nation’s drug laws against physicians

who dispense controlled substances to assist in the killing of

a human being. Amici believe that human beings are made

in the image of God and that, therefore, every life is sacred.

Genesis 1:26. Underlying the court of appeals decision is a

rejection of this inviolable standard present in the natural

law, divine law, and positive law, in favor of a morally-

relative standard where each individual chooses when and

whether a human life has value.

Ultimately, allowing the dispensing of federally

controlled drugs to assist suicide flows directly from the

20

fundamentally erroneous premise that human life in certain

conditions has no positive value. That premise has

incalculably serious implications for all of us. Here, an

appellate court has ruled that individuals have the right to

take life in certain situations, and that the United States

cannot enforce the federal drug laws in ways that protect life.

When we abandon moral absolutes today, it becomes easy

tomorrow to choose death in other ways, for other people, in

other situations, since the positive value of life has become

an immorally-relative individual choice.

The prominent ethicist Sissela Bok concluded, “No

society has yet worked out the hardest questions of how to

help those patients who desire to die, without endangering

others who do not.” Sissella Bok, Physician-Assisted

Suicide, in Euthanasia and Physician-Assisted Suicide 139

(Gerald Dworkin, et al., eds., (1998)).

Prior to the enactment of the Federal CSA.’°

euthanasia societies grew during the late 19" and early 20"

century eugenics movements in the United States and

Europe. Kathleen Foley and Herbert Hendin, /ntroduction.

in The Case Against Assisted Suicide, For the Right to End-

of-Life Care 6-7 (Foley & Hendin eds., 2002). Thirty states

passed sterilization laws embraced by both Presidents

Theodore Roosevelt and Woodrow Wilson. /d.

The Nazis legalized voluntary euthanasia, and then

involuntarily euthanized hundreds of thousands of the

mentally ill: they then extended euthanasia’s reach to Jews,

gypsies, and other “undesirables.” /d. at 7.

The Ninth Circuit erred in relying on former Attorney General

Reno's January 5. 1998 letter suggesting that the CSA did not prohibit

prescription-assisted suicide. See Pet. App. 7a. The Reno letter

assumed, ahistorically, that the CSA was written before there was any

consideration of assisted suicide.

21

As late as the 1940s, this country’s leading

euthanasia proponent, Dr. Foster Kennedy, continued to

advocate compulsory euthanasia for retarded children on

eugenics grounds. By the 1970s, the euthanasia movement's

focus shifted to easing the “burden” of caring for the elderly,

and then to easing suffering, id. at 8,—though notably, no

suffering requirement exists in the Oregon law, which

purports instead to be based on personal choice. The Oregon

law requires the physician to advise the patient of palliative

care and hospice, but does not require that the physician have

any training in either and requires no palliative care

consultation.

While utterly failing to protect the family of the

patient, the Oregon law grants “good faith” immunity to the

physician and fails to provide an enforcement mechanism for

physician non-compliance. Moreover, inadequate data

collection requirements limit any possible study of the

Oregon experiment. For example, the form used by Oregon

to effectuate the killing requires no disclosure of the reason

for the patient’s request. /d.

The Dutch experiment in physician-assisted suicide

failed frighteningly. Dutch legal requirements were

consistently violated and could not be enforced. /d. at 10.

Sixty percent of Dutch assisted suicide cases go unreported.

Id. Most non-reporting involves cases in which physicians

failed to follow established guidelines for voluntariness or

consultation.

Worse, in several thousand cases each year

physicians ended their patient’s life without the patient's

consent. /d. Twenty-five percent of physicians terminated

one or more patient’s life without request. /d. In the 1995

study year, 40 percent of the more than 6,000 cases in which

22

physicians actively intervened to cause death involved no

explicit request from the patient. Herbert Hendin, Zhe Dutch

Experience, in Foley & Hendin, supra, at 105; see also

Zbigniew Zylicz, M.D., Palliative Care and Euthanasia in

the Netherlands: Observations of a Dutch Physician, in

Foley & Hendin, supra, at 123.

Each major Dutch measure enacted to control and

regulate physician-assisted suicide (including informed

consent, consultation, and reporting) largely failed, was

modified, or was violated. Foley & Hendin, supra, at 103

(citing C. Gomez. Regulating Death: Euthanasia and the

Case of the Netherlands (1991)). This Court in Washington

v. Glucksberg, 521 U.S. 702, 733 (1997), recognized that

“what is couched as a limited right to ‘physician-assisted

suicide’ is likely, in effect. a much broader license, which

could prove extremely difficult to solve and contain.”

Indeed, what we sow today, we will reap tomorrow.

As the fundamental units of society, families must be

protected and promoted by the law and by legal institutions,

if order and liberty are to flourish. Yet clinical research

shows that suicides in general and physician-assisted

suicides more particularly, devastate families. M.D. Reed

and J.Y. Greenwald, Survivor Victim Status, Attachment and

Sudden Death Bereavement, 21 J. of Suicide and Life-

Threatening Behavior 385-401 (1991); N.L. Farberow, D.E.

Gallagher-Thompson, N.J. Gilewski, and L.W. Thompson,

Changes in Grief and Mental Health of Bereaved Spouses of

Older Suicides, 47 J. Gerontology 357-66 (1992), both cited

in Kathleen Foley and Herbert Hendin, 7he Oregon

Experiment, in The Case Against Assisted Suicide, For the

Right to End-of-Life Care 158 (Foley & Hendin, ed. 2002)

(noting the “devastating grief and guilt that we see in

survivors of suicide”).

23

Imagine the shock of an adult child making the

weekly visit to a parent’s nursing home, only to discover that

a physician proscribed and dispensed a federally controlled

substance to help the parent commit suicide the day before.

(Oregon’s law requires no pre-suicide notification to

families.)

The toll on family life is incalculable. Allowing

physicians to dispense drugs to assist in killing has an

insidious effect on families who support seniors, burdening

both the family and the dying. The number of patients in

Oregon reporting a concern about being a burden on the

family increased from 1? percent in 1998 to 63 percent in

2000, subsequent to the passage of Oregon’s physician-

assisted suicide law. Jd. at 162. Physician-assisted suicide

creates in practice a frightening “duty to die”—frightening

because the practice of physician-assisted suicide has been

shown to be so imperfect a means of death that in one Dutch

study fully 20 percent of patients given what was considered

to be a lethal dose lived for more than three hours, in some

cases requiring the physician to intervene with a lethal

injection which would be illegal under the Oregon law. /d.

at 166 (citing JH. Groenewould, A. van der Heide, B.D.

Onwuteaka-Philipsen, D.L. Willems, P.J. van der Maas, and

G. van der Wal, Clinical Problems with the Performance of

Euthanasia and Physician-Assisted Suicide in _ the

Netherlands, 342 New England J. Med. 551-56 (2000).

Families are occasionally called on to intervene with pillows

or plastic bags. Foley & Hendin, supra at 164 (citations

omitted).

The court of appeals decision rejects the inviolable

standard serving as the foundation for the Hippocratic Oath,

as well as the AMA’s view that physician-assisted suicide is

fundamentally incompatible with the physician’s role as

healer. Underlying its decision instead is a morally-relative

24

foundation, where each individual chooses when and

whether a human life has positive value. The serious

implications for our nation that accompany such a choice are

clear. Proper historical foundations do matter. Because they

do. amici urge this Court to reverse the decision of the court

of appeals.

This case implicates important federalism concerns

vital to proper constitutional governance under the rule of

law. Mutually exclusive provisions of the Federal CSA and

Oregon law make it impossible for a dispensing physician to

comply with both laws. Thus, the Federal CSA preempts the

Oregon law. The appellate court’s analysis, granting

Oregon’s request to enjoin the United States from enforcing

the Federal CSA, is incompatible with the Supremacy Clause

in Article VI of the United States Constitution.

The Attorney General's interpretive rule confirmed

that dispensing controlled substances to assist suicide

violates the CSA, and verified that assisting suicide is not a

“legitimate medical purpose.” The Attorney General, in

promulgating this rule, acted well within a plethora of

statutory authority expressly allowing him to do so.

Amici ask that this Court restore the right of the

federal government to enforce our nation’s drug laws under

the CSA. Undeniably, we stand at a statutory construction

site. If, in the name of an individual’s morally relative

choice, we enjoin the federal government from proscribing

the dispensing of drugs to kill a human being, we merely

create an illusion of a nation willing to protect fundamental

freedoms. Such a course inevitably erodes the fundamental

foundations of our country. As structural institutions of free

25

government stand for a time, the essence for which they

stand ceases to exist. Who we are morally, as a nation,

matters. Those who came before us built a constitutional,

democratic republic upon fundamental foundations of

decency. It is now our watch. It is well for us to recall,

therefore, the ancient truth that “nghteousness exalts a

nation.” Proverbs 14:34.

For the reasons discussed, amici urge this Court to

reverse the United States Court of Appeals for the Ninth

Circuit.

Respectfully submitted,

WILLIAM WAGNER

NELSON P. MILLER

Counsel of Record

STEPHEN W. REED

35 N. Lake Ave.

Pasadena, CA 91101 COOLEY LAW SCHOOL

(626)449-4521 300 South Capitol

Lansing, MI 48933

PATRICK A. TRUEMAN (517) 371-5140

801 G. Street NW

Washington D.C. 2001

(202)393-2100

April 2, 2005