Amicus Curiae Brief — Gonzales v. Oregon

|_ OFFICE OF THE CLERK

Supreme Courts of th sa Gnited States

ALBERTO R. GONZALES,

ATTORNEY GENERAL, et ai.,

Petitioners,

v.

STATE OF OREGON, et ai.,

Respondents.

7

On Writ Of Certiorari To The

United States Court Of

For The Ninth Circuit

+

BRIEF OF AMERICAN COLLEGE

OF LEGAL MEDICINE, AS AMICUS CURIAE

IN SUPPORT OF RESPONDENTS

*

MILEs J. ZAREMSKI — Counsel of Record

KAMENSKY RUBINSTEIN HOCHMAN

AND DELotTtT, LLP

7250 N. Cicero Avenue, Suite 200

Lincolnwood, Illinois 60712

Telephone: (847) 982-1776

Facsimile: (847) 982-1676

MAXWELL J. MEHLMAN

Arthur E. Petersilge Professor of Law

Director, THE LAW-MEDICINE CENTER

CASE SCHOOL OF LAW

Professor of Bioethics,

CASE SCHOOL OF MEDICINE

11075 East Boulevard

Cleveland, Ohio 44106

Telephone: (216) 368-3983

Atto for Amicus Curiae

American of Legal Medicine .

COCKLE LAW BRIEF PRINTING CO (800) 225-6964

OR CALL COLLECT (402) 342-2831

i

QUESTION PRESENTED

Whether the Attorney General has the unfettered

right under the Controlled Substances Act to decide what

is a legitimate medical purpose or use for determining

parameters for medical intervention by physicians in the

State of Oregon.

li

TABLE OF CONTENTS

Page

QUESTION PRESENTED.........:::::ssssesssssessessessssenssnes i

TABLE OF COOTTEBUTI cccccccsscscscesincssscssenssieensmunnnanan ii

TABLE OF AUTHIORIT ING ..ceccscsccscoscsssoscsscsssssescosssnion iii

INTEREST OF AMICUS CURIAE.........:s:ssssssssesseseseeees 1

SUMMARY OF ARGUMENT .......:::s:sessssssssesssscnsesenenees 2

ARGQUMEIEP oncccccccseccesesssseesoncessianaau 4

I. THE CONTROLLED SUBSTANCES ACT

DOES NOT GIVE THE ATTORNEY GEN-

ERAL THE POWER TO DETERMINE WHAT

IS A LEGITIMATE MEDICAL PURPOSE ....... 4

A. The Attorney General Improperly Invoked

the “Public Interest” Evaluation under 21

U.B.C. § GB Ee) nccccoccccscsccsessssocsasesscsesneusinnnnes 7

B. Court Decisions Uniformly Confirm That

the Attorney General Must Defer to Medi-

cal Experts in Defining Legitimate Medi-

II. THE REGULATION AND DETERMINATION

OF LEGITIMATE MEDICAL PRACTICE IS

RESERVED TO THE STATESG.............-ceeceeeeeees 14

III. PROHIBITING THE USE OF NARCOTICS

UNDER OREGON’S STATUTE WOULD

NULLIFY THIS COURTS DECISION IN

GLUCKSBERG. .......0csecsccoccccosccsescesssessssnossenees 17

IV. ALLOWING POLITICAL PREFERENCE TO

DICTATE LEGITIMATE MEDICAL PRACTICE

WOULD HARM THE MEDICAL PROFESSION

AND THE PRACTICE OF MEDICINE.............. 20

CONCLUSION .........c...cccrccossscsesssssscssessssesoosssesssessoesess 21

-

TABLE OF AUTHORITIES

Page

CASES

Arlen v. State Med. Bd., 399 N.E.2d 1251 (Ohio

EE LLL LLL RS ee 12

Barsky v. Board of Regents, 347 U.S. 442 (1954) ....... 16, 17

Chumbler v. McClure, 505 F.2d 489 (6th Cir. 1974)........ 13

Church v. Bloch, 182 P.2d 241 (Cal. 1947)... 11

Cruzan v. Dir., Mo. Dept. of Health, 497 U.S. 261

EEE EE 14

Davis v. Virginian Railway Co., 361 U.S. 354 (1960)....... 11

Dotson v. Tex. State Bd. of Med. Exam’rs, 612

Ee 12

Downer v. Veilleux, 322 A.2d 82 (Me. 1974) ................000.. 13

Farney v. Anderson, 372 N.E.2d 151 (Ill. 1978)................ 11

Gonzales v. Raich, _ U.S. ___, 125 S.Ct. 2195 (2005) ... 5, 17

In re Williams, 573 N.E.2d 638 (Ohio 1991)..................... 13

Linder v. United States, 268 U.S. 5 (1925)..... 14, 15, 16, 21

Loffredo v. Sobol, 600 N.Y.S.2d 507 (App. Div.

EE 12

McKay v. State Bd. of Med. Exam’rs, 86 P.2d 232

CE 12

Oregon v. Ashcroft, 192 F. Supp. 2d 1077 (D. Or.

EES LS ee ae 2,8

Oregon v. Ashcroft, 368 F.3d 1118 (9th Cir. 2004) ....passim

Planned Parenthood of Southeastern Pennsylvania

v. Casey, 505 U.S. 833 (1992)................ccccserscsssssesesseeees 19

Pennsylvania v. Union Gas Co., 491 U.S. 1 (1989)........... 15

iv

TABLE OF AUTHORITIES - Continued

Page

People v. Klvana, 15 Cal. Rptr. 2d 512 (Ct. App.

ee ne 11

Ramirez v. Tex. Bd. of Med. Exam’rs, 995 S.W.2d

BOB Cilame. Rarer, RBBB Da .ccccccccssssesssscsscnsencessscnscssssessssesssssses 21

Rudick v. Prineville Mem'l Hosp., 319 F.2d 764 (9th

ein, TEI crnsrnnnesnetuttniteenmainteiameeiasemnieieiamaaditediemsaineaaaitatis 11

Seminole Tribe v. Florida, 517 U.S. 44 (1996).................. 15

Smith v. Dep’t of Registration, 106 N.E.2d 722 (Ill.

EE eee 12

State v. Warden, 813 P.2d 1146 (Utah 1991).................... 11

Trawick v. Drug Enforcement Admin., 861 F.2d 72

SER, TD cccenncuninmintinsnnmnsinnieebinimmeentiil 8,9

United States v. Bird, No. 95-20792, 1997 U.S. App.

BN Ee 15

United States v. Boettjer, 569 F.2d 1078 (9th Cir.

ae rey ea eee a 11

United States v. Moore, 423 U.S. 122 (1975) .................... 10

United States v. Moore, 505 F.2d 426 (D.C. Cir.

Ee ee eee nen 10, 11

United States v. Morrison, 529 U.S. 598 (2000) ............... 16

United States v. Rosenberg, 515 F.2d 190 (9th Cir.

Ee Ee 10

United States v. Tran Trong Cuong, 18 F.3d 1132

Ne ee 11

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

White v. United States, 399 F.2d 813 (8th Cir. 1968)....... 11

Younger v. Harris, 401 U.S. 37 (1971) ............ccccceseeeeeeeeees 14

8m wees

v

TABLE OF AUTHORITIES - Continued

Page

STATUTES

NN ee 2,4

EE a ee a LIS 6

ET TAT 6

Se ee eee estiretnintinnnsncincinicliittateliniiitatiiatadietatadia i! 4

ae ei etecntnicicnemitnietiniriitletictas emda D ae al 8

LE SS Te 7,9

eT 7,8

ee LS oe ae 7

OTHER AUTHORITIES

66 Fed. Reg. 56,607 (Nov. 9, 2001)...........cccccccceceeseeeeeee 2,10

116 Cong. Rec. 33304 (Sept. 23, 1970) ...........ccccccccecceeeeeeeees 6

Armin Ernst, M.D. and Joseph D. Zibrak, M_D.,

Current : Carbon Monoxide Poisoning,

399 New Eng. J. Med., Nov. 26, 1998 ..0........00ccccccecceee. 18

Brief of Amici Curiae Healthlaw Professors in

Support of Respondents For Affirmance Of The

Court and Opinion Below..................ccccccsccesseesceeeceeseeeeee 13

David E. Joranson, Guiding Principles of Interna-

tional and Federal Laws Pertaining to Medical

Use and Diversion of Controlled Substances, 131

NIDA Research Monograph at 14 (1993), avail-

able at http://www.medsch.wisc.edu/painpolicy/

IND comneperncttinenianniiniieriatinatidabelainineias 5

vi

TABLE OF AUTHORITIES — Continued

Defendants’ Memorandum In Support of Motion to

FDA Approves Botox to Treat Frown Lines, FDA

Talk Paper (U.S. Food and Drug Admin.), April

15, 2002, available at http://www fda.gov/bbs/topics/

ANSWERS/2002/ANS01147. tum .............ccccccceeeeeeeeeees

“‘Historic’ change as opposition to euthanasia ends”

(London) Daily Telegraph (July 5, 2005) (2005

¢ |

Kathy Faber-Langendoen & Jason H.T. Karlawish,

Should Assisted Suicide Be Only Physician As-

sisted?, 132 Annals Internal Med., Mar. 21, 2000.... 18,

Linda Ganzini, M.D., et al., Oregon Physicians’

Attitudes About and Experience With End-of-Life

Care Since Passage of the Oregon Death with

Dignity Act, 285 JAMA 2363, 2365 (May 9, 2001)........

Louis Finkelstein Institute for Religious and Social

Studies, Physician Assisted Suicide Survey

(2005), available at The Jewish Theological

Memorandum from Sheldon Bradshaw and Robert

J. Delahanty, Office of Legal Counsel, Depart-

ment of Justice, to the Attorney General (June

Sats TTI exsnecansinentuadmanenssincineguiieissinbetdininbbepenenpemmauatabiasines

19

- —~ eee ee Ee

vii

TABLE OF AUTHORITIES - Continued

Page

Patricia M. Goode, The Drug Enforcement Admini-

stration and Proposed Model Guidelines for the

Use of Controlled Substances in Pain Manage-

ment, Address Before the Federation of State

ment and State Regulatory Policy (Mar. 17,

1998) (available at http://www. medsch.wisc.edu/

S. Rep. No. 9-455 (1000, rewinesd tn 1906

eae tis Clee iisocircscnsieenenpeidinpesieninbecintbadinausidiaie as 8,9

1

INTEREST OF AMICUS CURIAE

The American College of Legal Medicine (“ACLM”)

respectfully submits this brief as an Amicus Curiae pursu-

ant to Rule 37 of the Rules of the Supreme Court of the

United States. ACLM supports respondents in this case.

ACLM has received the consent of all parties to submit

this brief pursuant to the applicable rules of this Court.’

The ACLM has been in existence now for 45 years and

is an educational, non-profit organization with nearly 1400

members. It is the only organization within the United

States the majority of whose members possess degrees in

medicine and in law. Its membership also consists of

attorneys, physicians, nurses, persons in health care

administration, in government service and those who hold

full time academic positions in health care and in health

care law. The ACLM is also part of the network of organi-

zations worldwide whose members possess degrees,

background, and interest in the fields of medicine, forensic

science, and law or jurisprudence.

The mission of the ACLM is to educate, train and

advance dialogue and discussion for those who have a

sustained interest in issues at the crossroads of law,

medicine, and health care delivery. This includes promot-

ing the administration of justice and assisting jurists in

deciding issues, such as those presented in this case.

¢

* Petitioners and respondents have consented to the filing of this

brief in letters filed with the clerk. No counsel for a party authored this

brief in whole or in part. No persons or entities other than the amicus

made a monetary contribution to the preparation or submission of this

brief.

2

SUMMARY OF ARGUMENT

The Attorney General, in a November 9, 2001 direc-

tive, declared that the use of controlled substances under

the Oregon Death with Dignity Act was not a “legitimate

medical purpose.” Oregon v. Ashcroft, 192 F. Supp. 2d

1077, 1079 (D. Or. 2002) (quoting 66 Fed. Reg. 56,607

(Nov. 9, 2001)). This interpretation was promulgated in

the Federal Register without prior notice to or comments

by interested parties. Oregon v. Ashcroft, 368 F.3d 1118,

1130 (9th Cir. 2004). The Attorney General’s controversial

interpretation was based on lay opinion and a memoran-

dum from the Justice Department entitled, Whether

Physician-Assisted Suicide Serves a “Legitimate Medical

Purpose” Under The Drug Enforcement Administration’s

Regulations Implementing the Controlled Substances Act

(June 27, 2001) (““OLC Opinion”). The Attorney General’s

statement represented a 180-degree shift in Drug En-

forcement Administration (“DEA”) policy and stood con-

trary to former Attorney General Janet Reno’s position.

Oregon v. Ashcroft, 368 F.3d at 1123. The Ninth Circuit

held that, “the Attorney General has no specialized exper-

tise in the field of medicine and that he imposes a sweep-

ing and unpersuasive interpretation of the CSA...” Id. at

1130. This interpretation was made unilaterally and

without the assistance of the Department of Health and

Human Services (“HHS”), as required by the Controlled

Svbstances Act (“CSA”). 21 U.S.C. §811(b) (2005). The

Ninth Circuit ruled that Attorney General Ashcroft had

overstepped his bounds by making this determination and

upheld the issuance of an injunction against the admini-

stration. Oregon v. Ashcroft, 368 F.3d at 1131.

We respectfully point out that the Attorney General’s

attempt to define “legitimate medical purpose” constitutes

3

a unilateral, uninformed, and politically-motivated action.

The Attorney General does not have the authority, under

the CSA, to make this determination. This determination

is left to the states and the Secretary of HHS, informed by

medical expertise. The Attorney General also failed to

properly evaluate physician-assisted suicide under the

“public interest” standard of the CSA. The Attorney

General further failed to give due deference to input from

the Oregon State Medical Board in assessing the five

factors under the “public interest” standard of the CSA.

Instead of consulting the proper authority, the Attor-

ney General has unilaterally determined what constitutes

a “legitimate medical purpose” under the CSA. The federal

government, however, has limited power under the CSA in

making determinations of medical standards. Tradition-

ally, states have regulated the practice of medicine as part

of the police powers of the state. Allowing the enforcement

of the Attorney General’s view would also violate the Tenth

Amendment, nullify this Court’s opinion in Washington v.

Glucksberg, 521 U.S. 702 (1997), and become a Damoclean

sword unnecessarily held over the practice of medicine.

The Attorney General’s directive serves to invalidate

Oregon’s determination of a valid practice of medicine. If

upheld, the opinion of a single administrative official could

prevent physicians and patients from ensuring a pain-free

and dignified end of life.

4

ARGUMENT

I. THE CONTROLLED SUBSTANCES ACT DOES

NOT GIVE THE ATTORNEY GENERAL THE

POWER TO DETERMINE WHAT IS A LEGITI-

MATE MEDICAL PURPOSE

Under the CSA, controlled substances are scheduled

according to whether they have a “currently accepted

medical use” or “no currently accepted medical use,” with

varying levels of restrictions. 21 U.S.C. § 812(b) (2005).

The Act specifically delineates the manner in which drugs

are scheduled and “accepted medical use” is determined.

Integral to these determinations is the input of the Secre-

tary of HHS. The Secretary’s opinion is not simply advi-

sory with respect to scheduling drugs, but binding. 21

U.S.C. § 811(b). The CSA states:

[T]he recommendations of the Secretary to the

Attorney General shall be binding on the Attor-

ney General as to such scientific and medical

matters, and if the Secretary recommends that a

drug or other substance not be controlled, the At-

torney General shall not control the drug or

other substance.

Id. [emphasis added.]

Thus, the Attorney General can only make a determi-

nation of what is and is not a currently accepted medical

use based on a scientific and medical evaluation from the

Secretary of HHS. The Secretary must also include rec-

ommendations regarding where a substance should be

scheduled. The recommendations of HHS are binding on

the Attorney General as to scientific and medical matters,

including where a drug is scheduled and whether or not a

drug ought to be controlled.

The importance of the Secretary's input was acknowl-

edged by this Court in its recent decision in Gonzales v.

Raich, __ U.S. __, 125 S.Ct. 2195 (2005), where the

Court noted that, under the CSA, the Attorney General

must consult with the Secretary before updating and

modifying the schedules of controlled substances. Id. at

2204. In Gonzales, this Court also noted that even Con-

gres7’ decision to classify marijuana was based, in part, on

the recommendation of the Department of Health and

Human Services (then, the Department of Health, Educa-

tion, and Welfare). Id.

The CSA does not give the Attorney General the

authority to declare, sua sponte, what is and is not a

currently accepted medical use. Instead, the Attorney

General must defer to the expert medical judgment of

HHS, embodied in a “scientific and medical evaluation.”

The history of the CSA highlights the legislative intent to

preclude the Attorney General from making medical

decisions. In a monograph of the National Institute on

Drug Abuse, David E. Joranson states, “When Congress

adopted the final version of the CSA in October 1970, the

Secretary of Health, Education, and Welfare, and not the

Attorney General, had been given the responsibility for

making medical and scientific decisions concerning drug

control.” David E. Joranson, Guiding Principles of Interna-

tional and Federal Laws Pertaining to Medical Use and

Diversion of Controlled Substances, 131 NIDA Research

Monograph at 14 (1993), available at http://www.medsch.

wisc.edu/painpolicy/publicat/93nida.htm. As Congressman

Paul Rogers of the House Subcommittee on Health and the

Environment stated:

As Members may recall, the scientific and medi-

cal community of this nation were greatly upset

6

over the fact that scientific and medical decisions

in the Senate bill were centered in the Depart-

ment of Justice, with the Attorney General hav-

ing responsibility to make scientific and medical

determinations which were not in the compe-

tency of the Department, and admittedly so. We

have changed that so that the Department of

Health, Education and Welfare will determine

scientific and medical decisions. This is a most

important change in the whole approach as it

came from the Senate.

116 Cong. Rec. 33304 (Sept. 23, 1970).

The Attorney General’s discretion is limited under the

CSA. The Attorney General may determine whether to

schedule a derivative drug in the same schedule or a

higher numerical schedule than its immediate precursor.

21 U.S.C. § 811(e) (2005). And, if there is an imminent

hazard to public safety, the Attorney General may move a

controlled substance to Schedule I (no currently accepted

medical use) for no more than eighteen months. 21 U.S.C.

§ 811th) (2005). Neither of these decisions involves a

determination of what is or is not a legitimate medical use.

The folly of the Attorney General’s presumption that

he can determine what is and is not a legitimate medical

purpose for an approved drug is further illustrated by the

mistaken assertions in his brief. The Attorney General

argues that using controlled substances according to the

Oregon Death with Dignity Act is not a legitimate medical

purpose because it “does not aim to preserve the patient’s

health or to cure, alleviate, prevent, or ‘treat’ the disease

or its symptoms in the patient.” Petitioner’s Brief at 19.

The Attorney General thus confuses “legitimate medical

purpose” with “therapeutic.” Many legitimate medical

interventions are not therapeutic. For example, the FDA

7

has approved the prescription use of botulism injection “to

temporarily improve the appearance of moderate to severe

frown lines between the eyebrows.” FDA Approves Botox to

Treat Frown Lines, FDA Talk Paper (U.S. Food and Drug

Admin.), April 15, 2002, available at http://www.fda.

gov/bbs/topics/ANSWERS/2002/ANS01147.html. This is

a legitimate medical purpose, although its objective is

cosmetic rather than to cure, alleviate, prevent, or treat

disease. Indeed, the Attorney General’s position would

place the entire field of cosmetic surgery outside the

legitimate practice of medicine, thereby making surgeons

who employed controlled substances in the course of their

cosmetic practice felons and at risk of losing their DEA

registrations.

This same confusion is evident in the Attorney Gen-

eral’s reliance on the fact that the Centers for Medicare

and Medicaid Services of the Department of Health and

Human Services has determined that physician-assisted

suicide is not eligible for reimbursement under Medicare

or Medicaid because it is “not reasonable and necessary for

the diagnosis and treatment of disease or injury.” Peti-

tioner’s Brief at 8, 47, n.18. Numerous legitimate medical

interventions are not reimbursed under Medicare or

Medicaid, including outpatient prescription drugs and

routine physical checkups. 42 U.S.C. § 1395y.

A. The Attorney General Improperly Invoked

the “Public Interest” Evaluation Under 21

U.S.C, § 824(2)

In 1984, the United States Congress amended the

CSA by allowing the Attorney General to revoke licenses

when registrants acted in a manner inconsistent with the

“public interest.” 21 U.S.C. § 824(a)4) (2005). The Attorney

General, in this case, has attempted to use this power to

prevent assisted suicide. In his 2001 opinion, the Attorney

General warned that “administering federally controlled

substances to assist suicide may ‘render [a physician’s]

registration ... inconsistent with the public interest and

therefore subject to possible suspension or revocation

under 21 U.S.C. § 824(a)(4).’” Oregon v. Ashcroft, 192

F. Supp. 2d at 1079. As noted by the Ninth Circuit, the

Attorney General impermissibly applied the “public

interest” revocation standard by failing to properly evalu-

ate the registrant’s actions. Oregon v. Ashcroft, 368 F.3d at

1130.

The determination that a registrant’s actions are

“against the public interest” requires an assessment of five

factors outlined in 21 U.S.C. § 823(f). Trawick v. Drug

Enforcement Admin., 861 F.2d 72, 75 (4th Cir. 1988).

Paramount among these factors is the recommendation of

the presiding state medical board. Oregon v. Ashcroft, 368

F.3d at 1129. The legislative history of this amendment

stressed this fact, stating that “the Attorney General must

‘continue to give deference to the opinions of the State

licensing authorities,’ as their recommendations are the

‘first of the factors to be considered.’” Jd. (quoting S. Rep.

No. 98-225, at 267 (1983), reprinted in 1984 U.S.C.C.A.N.

3182, 3449.) However, “[i]t is undisputed that the Attorney

General made uo effort to solicit input from the State of

Oregon before issuing his directive.” Id. Accordingly, the

Attorney General cannot assert that assisting suicide with

controlled substances is against the public interest in

Oregon because he has failed to perform the proper five-

factor analysis necessary for making this conclusion.

In addition to ignoring the proper interpretation of the

“public interest”, the Attorney General’s directive attempts

improperly to expand the scope of the CSA and the 1984

amendment. The CSA was enacted specifically to deal with

“problems associated with drug abuse and addiction.” Jd.

at 1128. The Attorney General’s attempt to bar physician-

assisted suicide is outside the scope of the act as “assisted

suicide is not a form of drug abuse that Congress intended

the CSA to cover.” Jd. at 1125.

The 1984 amendment similarly targets criminal

diversion and abuse of drugs. The Attorney General’s use

of the amendment to bar assisted euicide is, again, beyond

the scope of the act. The Fourth Circuit has held that 21

U.S.C. § 824(a) and the “public interest” standard were

promulgated specifically to thwart criminal diversion of

drugs. Trawick, 861 F.2d at 75. The Fourth Circuit also

noted that “[tJhe ‘public interest’ standard was added in

1984 in recognition of the specific weaknesses of the felony

conviction criterion that made it difficult to reach the

‘many violations involving controlled substances which are

prescription drugs [but] are not punishable as felonies

under state law.’” Id. (quoting S. Rep. No. 98-225 (1983)),

reprinted in 1984 U.S.C.C.A.N. 3182, 3448-49). Allowing

the Attorney General to utilize 21 U.S.C. § 824(a) to bar

assisted suicide would improperly expand the CSA and its

1984 amendment beyond the intended criminal scope.

B. Court Decisions Uniformly Confirm That

the Attorney General Must Defer to Medical

Experts in Defining Legitimate Medical Use

The CSA does not provide a definition of “legitimate

medical purpose” in its extensive definitions. Court deci-

sions, however, uniformly confirm that the Attorney

General must defer to expert medical judgment in deter-

mining what is and is not a legitimate medical use. The

10

Attorney General relies on two cases in his brief, United

States v. Rosenberg, 515 F.2d 190 (9th Cir. 1975) and

United States v. Moore, 423 U.S. 122 (1975) for the propo-

sition that the CSA prohibits physicians from prescribing

drugs except for legitimate medical purposes. Both cases

demonstrate that expert medical judgment is required in

order to determine what is and is not a legitimate medical

purpose. In Rosenberg, the Ninth Circuit held that Dr.

Rosenberg violated the CSA by prescribing Schedule II, III

and IV controlled substances to patients he had not

examined. Rosenberg, 515 F.2d at 192. These actions were

violations of the CSA because expert medical testimony

showed that they were outside the “usual course of his

professional practice.” Jd. at 199.

Moore was relied on by the Attorney General, 66 Fed.

Reg. 56,607, and by the OLC Opinion. Memorandum from

Sheldon Bradshaw and Robert J. Delahanty, Office of

Legal Counsel, Department of Justice, to the Attorney

General 5-6 (June 27, 2001). In Moore, a physician pre-

scribed methadone, a Schedule II controlled substance, in

large quantities, charging by the pill, to patients not in

detoxification or maintenance programs. United States v.

Moore, 505 F.2d 426, 447 (D.C. Cir. 1974). What is note-

worthy is that expert medical opinion was necessary to

prove that this was not a legitimate medical practice

and, therefore, violated the CSA. 505 F.2d at 447-48

(MacKinnon, J., dissenting). Reversing the Court of

Appeals, this Court held that the physician could be liable

for failing to use controlled substances if prescribed

outside the boundaries of “professional practice”. Moore,

423 U.S. at 142. The Court’s statement here affirmed the

lower court’s finding that expert testimony was required to

demonstrate that the defendant’s use of a drug [under the

— -

11

CSA] was not“... consistent with any method ... that is

accepted by the medical profession in this country [citation

omitted].” 505 F.2d at 447. Thus, requiring expert medical

testimony in a case predicated on violations of the CSA

equates to determining legitimate medical use or purpose.

Other cases as well support the position that expert

medical knowledge is required in all jurisdictions to

determine legitimate medical use for purposes of proving

that a physician has violated the CSA in the course of

professional practice. “The general rule is that the propri-

ety or impropriety of particular medical treatment can be

established only by expert medical testimony.” Church v.

Bloch, 182 P.2d 241, 245 (Cal. 1947). See also United

States v. Boettjer, 569 F.2d 1078, 1079 (9th Cir. 1978);

Farney v. Anderson, 372 N.E.2d 151, 154 (IL 1978),

United States v. Tran Trong Cuong, 18 F.3d 1132, 1137-38

(4th Cir. 1994); and White v. United States, 399 F2d 813,

820 (8th Cir. 1968). Additionally, this required deference is

consistent with the manner in which the law establishes

what is and is not a legitimate medical use in contexts

outside of the CSA. This Court, in Davis v. Virginic:;

Railway Co., 361 U.S. 354 (1960), articulated the standard

of proof for malpractice as requiring two elements of

evidence, “ ... evidence as to the recognized standard of

care of the medical community in the particular kind of

case, and a showing that the physician in question negli-

gently departed from this standard in his treatment of the

plaintiff.” Id. at 357. Expert medical testimony is necessary

to prove both elements. See State v. Warden, 813 P-2d 1146,

1151 (Utah 1991); People v. Klvana, 15 Cal. Rptr. 2d 512,

536 (Ct. App. 1992); and Rudick v. Prineville Mem'l Hosp.,

319 F.2d 764 (9th Cir. 1963). Expert medical knowledge,

whether from outside experts or based on the expertise of

12

the physician members of the state medical boards, is also

necessary to determine what is and is not a legitimate

medical use in disciplinary hearings before state medical

boards. See Dotson v. Tex. State Bd. of Med. Exam’rs, 612

S.W.2d 921, 923 (Tex. 1981); Loffredo v. Sobol, 600

N.Y.S.2d 507, 509-10 (App. Div. 1993); McKay v. State Bd.

of Med. Exam’rs, 86 P.2d 232, 236 (Colo. 1938); Smith v.

Dep't of Registration, 106 N.E.2d 722, 730-31 (Ill. 1952);

and Arlen v. State Med. Bd., 399 N.E.2d 1251, 1254 (Ohio

1980). The Texas Supreme Court in Dotson reversed a

medical board’s decision to suspend a doctor’s license

because there was no expert testimony to support the

Board’s factual conclusions. Dotson, 612 S.W.2d at 923.

Both the Attorney General and the DEA also appear

to recognize the appropriateness of deferring to expert

medical judgment. The DEA has recognized the need for

experts to dictate and define “legitimate medical purpose.”

Patricia M. Goode, Chief of the Liaison and Policy Section

of the DEA, told the Federation of State Medical Boards in

a 1998 speech that, “[t]he CSA by design does not define

“legitimate medical purpose” nor does it set forth stan-

dards of medical practice. These issues can only be defined

by the medical community and its internal review proc-

ess.” Patricia M. Goode, The Drug Enforcement Admini-

stration and Proposed Model Guidelines for the Use of

Controlled Substances in Pain Management, Address

Before the Federation of State Medical Boards Symposium

on Pain Management and State Regulatory Policy (Mar.

17, 1998) (available at http?/www.medsch.wisc.edu/painpolicy/

domestic/dea98.htm) (last visited April 17, 2005). The

Attorney General referred to the American Medical Asso-

ciation’s (AMA’s) and the American Nurses Association’s

(ANA’s) opinions opposing the Oregon Death with Dignity

Act. Defendants’ Memorandum In Support of Motion to

13

Dismiss at 34. However, it is important to note that the

AMA's and ANA’s views, themselves, do not settle the

question of what is a legitimate medical use. The law

recognizes that the practice of medicine is complex and

that reasonable physicians may differ on what is legiti-

mate and appropriate. There is room for disagreement

among reasonable practitioners, as is reflected in the

“respectable minority doctrine,” which recognizes medical

practices that are not the norm but are, nonetheless,

legitimate in that they are acceptable and supported by a

school of expert medical thought. In re Williams, 573

on eee (Ohio 1991); Chumbler v. McClure, 505 F.2d

» 492 (6th Cir. 1974); and Downer v. Veille

82, 87 (Me. 1974). wacueass

Life Care Since Passage of the Oregon Death with Dignity

14

A national survey also established that 57% of US.

physicians support physician-assisted suicide. Louis

Finkelstein Institute for Religious and Social Studies,

Physician Assisted Suicide Survey (2005), available at The

Jewish Theological Seminary, http://www.jtsa.edu/research/

finkelstein/surveys/pas.shtml. Even professional medical

views recently adopted outside this country support not

advocating against assisted suicide. “‘Historic’ change as

opposition to euthanasia ends” (London) Daily Telegraph

(July 5, 2005) (2005 WLNR 10348879). (Long-standing

opposition among doctors to euthanasia dropped by the

British Medical Association. ).

Il. THE REGULATION AND DETERMINATION OF

LEGITIMATE MEDICAL PRACTICE IS RE-

SERVED TO THE STATES

In Justice O’Connor’s concurring opinion in Glucks-

berg, this Court recognized that the legality of physician-

assisted suicide was an issue reserved to the “‘laboratory’

of the States in the first instance” and that states were

undertaking extensive and serious evaluation of such

issues. Glucksberg, 521 U.S. at 737 (quoting Cruzan v.

Dir., Mo. Dept. of Health, 497 U.S. 261, 292 (1990)). The

Court noted as well, “Throughout the Nation, Americans

are engaged in an earnest and profound debate about the

morality, legality, and practicality of physician-assisted

suicide. Our holding permits this debate to continue, as it

should in a democratic society.” Jd. at 735. Further, in past

cases this Court has noted that the regulation and licens-

ing of medical practices is generally reserved to the states

under the United States Constitution. See Linder v. United

States, 268 U.S. 5, 18 (1925); and Younger v. Harris, 401 U.S.

37, 44-45 (1971). In Linder, this Court reversed a physician’s

conviction under the Harrison Anti-Narcotic Law as outside

the scope of the purpose of revenue collection. Linder, 268

15

U.S. at 22. This Court held that, “direct control of medical

practice in the States is beyond the power of the federal

government.” Jd. ai 18. Allowing the Attorney General to

dictate and define “legitimate medical purpose” would

permit the federal government impermissibly to expand

the scope of the CSA and exercise direct control over the

practice of medicine in Oregon.

. Although the CSA regulates the dispensing of medica-

tions under the Interstate Commerce Clause (U.S. Const.

art. I, §8, cl. 3), the Tenth Amendment (U.S. Const.

amend. X), in addition to the stated purpose of the CSA,

limits its power. As noted in the legislative history of the

CSA, the State must be given deference to determine

medical standards and licensing under its police power.

Oregon v. Ashcroft, 368 F.3d at 1128. The dissenting judge

in the Ninth Circuit did note that activities restricting

prescription of controlled substances under the CSA are

borne of Constitutional authority under the Interstate

Commerce Clause. Jd. at 1142. Such authority, however,

does not always trump antecedent Amendments. Seminole

Tribe v. Florida, 517 U.S. 44, 65 (1996). This Court, inter-

preting constitutional construction, stated that it could not

accept “limitation of the principle embodied in the Elev-

enth Amendment through appeal to antecedent provisions

of the Constitution.” Jd. (quoting Pennsylvania v. Union

Gas Co., 491 U.S. 1, 42 (1989) (Scalia, J., dissenting)).

Similarly, the Tenth Amendment cannot be

limited by the antecedent provisions of the Commerce

Clause. Jd. Though the scope of the Commerce Clause has

been extensive and often used to interfere with intrastate

police power, this power is not limitless. United States v.

Bird, No. 95-20792, 1997 U.S. App. LEXIS 33988, at *23

n.10 (5th Cir. 1997). In Bird, The Fifth Circuit warned

that, though “[t]he Tenth Amendment contains no sub-

stantive restriction on the legitimate exercise of Congress’s

16

Commerce Clause authority ... the Tenth Amendment

plainly does confirm that the commerce power is not

limitless, that hence such boundaries do exist, and that

they must not be transgressed.” Jd. Our federal system

precludes the Commerce Clause from becoming an excuse

for the federal government to infringe upon state sover-

eignty and traditional state power. The Commerce Clause

should not be utilized by one federal official to justify such

a violation.

Allowing the Attorney General to define “legitimate

medical purpose” and, in so doing, bar physician-assisted

suicide, would be an unconstitutional invasion of the State

of Oregun’s police power. As Linder held, direct control of

medical practice is outside the province of the federal

government. Linder, 268 U.S. at 18. This Court took the

same view when striking down a federal statute prohibit-

ing gender-motivated crimes of violence. United States v.

Morrison, 529 U.S. 598, 617-18 (2000). The majority in

Morrison held that the Commerce Clause should not be

utilized to usurp the proper police power of the states. Id.

This Court stated, “[w]e accordingly reject the argument

that Congress may regulate noneconomic, violent criminal

conduct based solely on that conduct’s aggregate effect on

interstate commerce. The Constitution requires a distinc-

tion between what is truly national and what is truly

local.” Id. Oregon’s Death with Dignity Act is both sub-

stantively and geographically a truly local law because its

impact and operation do not survive outside Oregon's

borders.

Regulation of the practice of medicine, like the sup-

pression of violent crime, is part of the police power of the

state. As noted by this Court in Barsky v. Board of Re-

gents, 347 U.S. 442 (1954), “[iJt is elemental that a state

ee

17

has broad power to establish and enforce standards of

conduct within its borders relative to the health of every-

one there. It is a vital part of a state’s police power.” Jd. at

449. The Attorney General’s directive is an attempt to

infringe this police power and thwart the state of Oregon’s

right to regulate health care as it sees fit. This Court

should not allow the federal government to interfere with

this state law.

Finally, this court’s recent decision in Gonzales v.

Raich, at 5, is consistent with our position. In that case,

this court correctly determined that a California law could

not avoid the CSA's classification of marijuana as a Sched-

ule I substance. The Court stated that the CSA extended

to regulation of drugs “ ... produced and consumed lo-

cally.” Gonzales, ___ U.S. __, 125 S.Ct. at 2201. In con-

trast, the current matter does not address whether a

locally produced medication is governed by the CSA.

Rather, it concerns whether the Attorney General may use

his position to dictate how a drug regulated by the CSA

can be used in medical practice by Oregon physicians.

Such determinations are beyond the scope of the Attorney

General’s statutory power.

Il. PROHIBITING THE USE OF NARCOTICS UN.

DER OREGON’S STATUTE WOULD NULLIFY

THIS COURT'S DECISION IN GLUCKSBERG

Allowing the Attorney General to disregard states’

rights here would invalidate this Court’s decision in

Glucksberg. If the Attorney General could prohibit the

dispensing of narcotics for use in assisted suicide, he

alone, would essentially nullify this Court’s determination

4 aaa could permit these practices. Glucksberg, 521

S. a .

18

In the present case, the dissent in the court below

argued that the effect of the Attorney General's directive is

minimized by the mere availability of other methods of

assisting suicide. Oregon v. Ashcroft, 368 F.3d at 1135

(Wallace, J., dissenting). This reasoning gives short shrift

to the issue and ignores the true effects of the Attorney

General’s rule. Utilization of controlled narcotics in has-

tening death may represent the most humane manner of

effectuating a patient’s directive of death by physician

assistance. Kathy Faber-Langendoen & Jason H.T. Kar-

lawish, Should Assisted Suicide Be Only Physician As-

sisted?, 132 Annals Internal Med., Mar. 21, 2000, at 482-

87. Judge Wallace points to a law review article that

suggests carbon monoxide poisoning as an alternative

method of suicide. Oregon v. Ashcroft, 368 F.3d at 1135.

However, this suggestion ignores the fact that this toxin is

not used by any physicians for any legitimate medical

purpose. Armin Ernst, M.D. and Joseph D. Zibrak, M.D.,

Current Concepts: Carbon Monoxide Poisoning, 399 New

Eng. J. Med., Nov. 26, 1998, at 1603-1608. Carbon monox-

ide is not an FDA-approved medication and has no current

bona fide use in the medical field. Physician inexperience

with carbon monoxide administration may result in failed

suicide attempts. Faber-Langendoen & Karlawish, supra,

at 482-87. Additionally, carbon monoxide poisonings, in

contrast to narcotic overdoses, may result in significant

pain and suffering during a patient’s death. Ernst &

Zibrak, supra, at 1603-1608. (noting significant acute

symptoms from carbon monoxide poisoning including

headache, nausea, shortness of breath, chest pain and

abdominal pain). Failed attempts at poisoning may also

result in significant neurological deficits. Up to 30% of

surviving carbon monoxide poisoning victims experience a

neuropsychiatric syndrome up to 240 days after poisoning.

19

Id. Symptoms may include psychosis, dementia, personal-

ity change, incontinence and parkinsonism. Jd. As a result,

and despite Judge Wallace’s suggestions to the contrary,

this form of assisted suicide is not an effective substitute

for assisted suicide with controlled substances. It would be

reckless for this Court to approve all manners of terminat-

ing life as the practice of medicine. Allowing all methods of

poisoning to achieve such a result within the ambit of

medical practice would also set a broad and dangerous

precedent that may damage the medical profession.

Narcotics remain integral to providing sedation and

pain control in current forms of physician-assisted suicide.

Faber-Langendoen & Karlawish, supra, at 482-87. En-

forcement of the Attorney General’s directive may com-

pletely prohibit the administration of these controlled

substances, causing a painful and angst-ridden demise.

This prohibition directly infringes on liberty interests

implied in the Glucksberg ruling. As Justice Stevens

pointed out in his concurring opinion, “[a]voiding intoler-

able pain and the indignity of living one’s final days

incapacitated and in agony is certainly ‘at the heart of

[the] liberty . . . to define one’s own concept of existence, of

meaning, of the universe, and of the mystery of human

life.’” Glucksberg, 521 U.S. at 745. (Stevens, J., concur-

ring) (quoting Planned Parenthood of Southeastern Penn-

sylvania v. Casey, 505 U.S. 833, 851 (1992)). As a result,

the Attorney General’s restricting the states’ ability to

allow a dignified and pain-free death unconstitutionally

violates the liberty interests of an entire class of Orego-

nians.

20

IV. ALLOWING POLITICAL PREFERENCE TO

DICTATE LEGITIMATE MEDICAL PRACTICE

WOULD HARM THE MEDICAL PROFESSION

AND THE PRACTICE OF MEDICINE

Allowing politically-appointed administrators to dictate

proper medical practices would harm the integrity and

stability of the medical field. As noted in Glucksberg, the

integrity of the practice of medicine is important and, “the

state also has an interest in protecting the integrity and

ethics of the medical profession.” Jd. at 731. Allowing the

standard of care to be subject to mercurial political whim

could have devastating consequences on this profession.

As noted in the Ninth Circuit’s opinion, Attorney

General Janet Reno refused to declare assisted suicide as

a violation of the CSA. Oregon v. Ashcroft, 368 F.3d at

1123. Instead, Attorney General Reno made it clear that,

“the CSA was not ‘intended to displace the states as the

primary regulators of the medical profession, or to over-

ride a state’s determination as to what constitutes legiti-

mate medical practice.’” Jd. A subsequent political regime

change reversed this position. If this Court were to uphold

such a reversal, the determination of “legitimate medical

practice” would face continuous revision depending on the

prevailing politics in the executive branch. This uncer-

tainty was noted by the dissent in the Ninth Circuit who

stated, “[a] change in presidential administrations or a

shift in the current President or Attorney General’s per-

spective might precipitate the Ashcroft Directive’s rescis-

sion.” Id. at 1148. This uncertainty in the standards of

practice cannot be allowed.

Medical practice must be determined by objective

standards of care and clinically-based studies. Judicially,

21

“[w]hat constitutes bona fide medical practice must be

determined upon consideration of evidence and attending

circumstances.” Linder, 268 U.S. at 18. Scientific journ Js,

specialty boards, and peer review must dictate standards

of practice, not partisan politicians. It is in recognition of

the need for this expertise that every state’s legislature

has ceded part of its police power to expert medical boards

and those with requisite medical expertise. Additionally,

recognition of this expertise has prompted state courts to

afford great discretion to board decisions. Ramirez v. Tex.

Bd. of Med. Exam’rs, 995 S.W.2d 915, 919 (Tex. App. 1999).

Allowing the will of politically-motivated officials to

circumvent proper oversight and regulation by health care

and medical professionals would serve to undermine the

medical profession.

+

CONCLUSION

In conclusion, the plain language of the CSA, its

accompanying legislative history, and the cases interpret-

ing its provisions make it clear that determining a legiti-

mate medical purpose is a matter of expert medical

judgment, not a political decision by the Attorney General.

The statutory scheme requires the Attorney General to

defer to the Secretary of Health and Human Services,

informed by appropriate and sound medical expertise, and

to not act with a Draconian hand as he has chosen to do by

issuing the directive at issue in this case. Moreover, as

Justice O’Connor wisely observed in this Court’s Gluck:-

berg decision, the states are the proper laboratories {o

experiment with adjusting the scope of acceptable medical

practice. The State of Oregon has done so with its Death

22

With Dignity Act. Its decision should be followed and

respected by this Court.

For the foregoing reasons, the judgment of the Ninth

Circuit should be affirmed.

Respectfully submitted,

MILES J. ZAREMSKI — Counsel of Record

KAMENSKY RUBINSTEIN HOCHMAN

AND DELOTT, LLP

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