Respondents Brief — Gonzales v. Oregon

FILED

>

Ga) JUL 2 1 2005

OFFICE OF THE CLERK

No. 04-623

In the Supreme Court of the Anited States

Alberto R. Gonzales, Attorney General, et ai.,

Petitioners

v.

State of Oregon et al.,

Respondents

On Writ of Certiorari to the

United States Court of Appeals

for the Ninth Circuit

BRIEF FOR THE RESPONDENTS

filed by Peter A. Rasmussen, M.D.

and David M. Hochhalter

ELI D. STUTSMAN

Counsel of Record

621 SW Morrison

Thirteenth Floor

Portland, OR 97205

(503) 274-4048

QUESTION PRESENTED

Whether the Attorney General has permissibly

construed the Controlled Substances Act, 21 U.S.C. 801 et

seq., and its implementing regulations to prohibit the

distribution of federally controlled substances for the purpose

of facilitating an individual’s suicide, regardless of a state

law purporting to authorize such distribution.

Er

TABLE OF CONTENTS

Page

QUESTION PRESENTED DRAREBSEEGSCCReSescoscee i

STATEMENT OF THE CASE .......cccccccccceces 1

CUED cc ccccccccccccccccces l

TT Ss dc acececcescecccececese 6

The State of Oregon is leading a national

UCC SERE eS GaGedeocccccccccccccce 7

SUMMARY OF ARGUMENT .................055. 8

TT SEPSGSCGGGaSeececccccccccceccccece 11

1. The Attorney General’s enforcement

directive violates the plain language of

the Controlled Substances Act,

»versteps the bounds of the Attorney

Dignity Act establishes Ill. The power to regulate commerce

the “course of between the States does not authorize

professional practice”.......... 14 federal usurpation of medical practice

in the States, or the manner in which

B. Criminal proceedings SND s nedueudenscddccueees 47

Substaw:es Act; drug DEED ok cduncaseudesvesiuedecudesetewais 50

proceedings under the

Controlled Substances

Act; revocations,

denials, and the “public

BE caccccnceceoesetceus 29

The States, not the Attorney General

acting through the Controlled

ill iv

TABLE OF AUTHORITIES

Page

Cases Cited

Alden v. Maine,

$27 U.S. FOG (1DSD) .. wc cccccccccccccces 45, 49

Arthur Andersen, LLP v. United States,

125 S.Ct. 2129 (2005) ....... 02 eee ee eees 21,22

Barsky v. Board of Regents,

347 US. 442 (1953) . 0... ccecccvcceeees 10, 44

Circuit City Stores, Inc. v. Adams,

$32 U.S. 105 (2001)... 2... cence cree ceccees 32

Gibbon v. Ogden,

9 Wheat. 1 (1824) .........ccceeeeceeecees 47

Gonzales v. Raich,

125 S. Ct. 2195 (2005) ........---05-- 12, 15, 49

Gregory v. Ashcroft,

$01 U.S. 452 (1991)... 2... cece ccc eeeccees 45

Estate of Hagedorn ex rel. Hagedorn v. Peterson,

690 N.W.2d 84 (Iowa, 2004) ..........-.-45- 43

Humphreys v. DEA,

96 F.3d 658 (3 Cir. 1996)... ......6--0 ee eee 28

Vv

Jinkins v. Lee,

807 N.E.2d 411 (Ill., 2004) ................, 43

Labor Board v. Jones & Laughlin,

dain tchceeccebbneueeucte 48

LaFramboise v. Thompson,

329 F.Supp.2d 1054 (D.N.D., 2004) .......... 43

Liggett Co. v. Baldridge,

SP cedvecdcetudedetanesecs 44

Linder v. United States,

SE néctdsedeaddntkchdacks 10, 44

Printz v. United States,

i kn vdddsensidtbeddedit 45

Raygor v. Regents of University of Minnesota,

SRE i De renee 46

Rush Prudential HMO, Inc. v. Moran,

FED De FOO GNU occ ccccccccccccccces 10, 44

Semler v. Dental Examiners,

PE evdcdanesnadsddacaeceda 44

Sheeley v. Memorial Hosp.,

Fee Rt UE GRE, BOGE cccccccccccccccces 42

Sturges v. Crowninshield,

4 Wheat. 122 (1819) ........ cece eee eee eee 50

United States v. Aguilar,

SIS U.S. 993 (CIDDS) . wc ccccvcccvccsccccsecs 22

United States v. Brower,

336 F.3d 274 (4" Cir. 2003) ..... 00. cee eee ees 21

United States v. Collier,

478 F.2d 268 (5™ Cir. 1973)... 0.00. ce eee 26, 28

United States v. King,

345 F.3d 149 (2 Cir. 2003) .......0.0 eee ee 21

United States v. Lopez,

514 U.S. 549 (1995) ... 0... cece eee 47, 48, 49

United States v. Moore,

423 U.S. 122 (1975)... 0c cece ee eee eee passim

United States v. Morrison,

529 U.S. 598 (2000)... 0... cece cece eee 47, 50

United States v. Oregon Med. Soc.,

343 U.S. 326 (1951) ......ccccccccccecesens 44

United States v. Rosen,

§82 F.2d 1032 (5" Cir. 1978) ........ 9, 26, 27, 28

Vii

——_

United States v. Rosenberg,

515 F.2d 190 (9 Cir. 1975) ............... 9, 28

U.S. Term Limits, Inc. v. Thornton,

Be es POPE a voccbccccecceceecseccs 50

Washington v. Glucksberg,

IIS bcc cvecencceddeseceades 7

Adjudicated Cases Cited

Wesley G. Harline, M.D.,

65 Fed. Reg. 5665 (2000)................... 29

William J. Roth, M_D.,

60 Fed. Reg. 62262 (1995)..............055. 29

Paul W. Saxton, D.O.,

64 Fed. Reg. 25073 (1999).................. 29

William F. Skinner, M_D.,

60 Fed. Reg. 62887 (1995).................. 29

Federal Statutes

Pee UAE cc cdvcddevccosecccotéents 3

I i ca a a 2

ED ited cide ieeen stead eS passim

Viii

BB CUBE. COGN 2c cccccceccscdcncesccncces 12

BB ERE. CERO) occ ceccscvescvcess 9, 14, 15, 21, 28

TS CE. BE v5 vk sccccescccenccdctssvsics 21

Th BE. BEI ook ccc ccccccevesecnesaccctedss 21

le) erererrrrrrrrr rrr eT Tre 31

38 USE. SERIES cccccccsecens 8, 30, 31, 33, 47, 48, 50

21 U.S.C. § 823(f)(1).43)&(4) . 6. ccc cece eee eee 31

21 UBC. § SABI AS) .. cc ccccccccccccccccss 30, 31

21 UBC. § SARIMAANS) .. cc cccccccccscccccccace 31

25 UBL. OGRE) 2.0 c ccccccccscccccccccccceses 32

TEBE. GOB 5 cc ccccccccccesevcsscsevescves 31

21 UBC. § GAUGE)... ccccccscccccccscvccess 4,31

GE OGD cccccundseveccéevesssguscecseese 23

21 U.S.C. § B29(a) & (B) .. wee cece ec ceeceenees 21

FEUBE. BOG 2. ccccccccvesccvccsecccsovsevece 24

ix

8 I rs Per ere 21

PR icocceccgsectusuusuesauaaad 12

PM cect oecunes dadddsauietenceons 12

Na th Sen 45, 46

Controlled Dangerous Substances Act............... 37

Crime Control Act of 1990 -... 2... ccc ccceecees 48

Dangerous Drug Diversion Control Act

ET codbnunieeedbeuausderaceuss 30, 38, 40

indian Child Welfare Act .........cccccccccccccces 13

National Motor Vehicle Theft Act .................. 13

EIEN ine ouvuseseundéecucvededdduen 13

Security Exchange Act of 1934 .................... 13

Federal Rules

21 CFR § 1306.04 ......... 4, 8, 9, 13, 14, 28, 47, 48, 50

eT EE cceccnnscuciediuniimedsaaios 23

RDS 65g we hie oe li l

State Statutes

Or. Rev. Stat. §§ 127.800 to 127.897 .............. passim

Or. Rev. Stat. § 127.815 ......... cece cece ene 18, 20

Or. Rev. Stat. § 127.815(1)(k) .....----- eee eee eens 16

Or. Rev. Stat. § 127.815(1)(L)(A) ......---- 5+ +e: 16, 18

Or. Rev. Stat. § 127.855(1)-(7) .....-- eee cece eee eee 5

Or. Rev. Stat. § 127.865(3) ........-- 2c eee cece eeees 5

Or. Rev. Stat. § 127.880 ..... 0... 2. ee eee ee ee eee ees 15

Or. Rev. Stat. § 163.125 ......... cece ec eececeee 7,14

Or. Rev. Stat. § 677.095(1) .... 22.2 cece ee ee ee eres 44

Other Authorities

116 Cong. Rec. 973 (1970) ...... 6. cece ee eee eens 34

116 Cong. Rec. 976 (1970) ... 6... cece eee eee eens 34

116 Cong. Rec. 978 (1970) .. 2... cece e ee eee renee 35

116 Cong. Rec. 996 (1970) «2.2... cece eee e eens 35, 36

xi

116 Cong. Rec. 33,315 (1970)

116 Cong. Rec. 33,656 (1970)

seeeeeneeeeeneeeeeeeeeee

116 Cong. Rec. 35,051-52 (1970)

seseeneeeeeneeeneeee#ee¢es.

130 Cong. Rec. 25,846 (1984)

130 Cong. Rec. 25,848 (1984)

130 Cong. Rec. 25,849 (1984)

130 Cong. Rec. 25,851 (1984) ................000..

James O. Pearson, Jr., J.D., Modern Status of

“Locality Rule” in Malpractice Action

Against Physician Who is Not a Specialist, 99

A.L.R.3d 1133 (1980) (updated through 2004) ..

2A N. Singer, Sutherland on Statutes and Statutory

Construction, § 47.17 (1991)

ee fee eeeeeeeeeee

xii

43

STATEMENT OF THE CASE'

One day after the State of Oregon filed suit,

practitioner-respondents Peter A. Rasmussen, M.D., and

David M. Hochhalter, a physician and a pharmacist,

("practitioners") filed a complaint in intervention suing United

States Attorney General John Ashcroft, ef al., to prevent

criminal and civil enforcement proceedings against them for

having prescribed and dispensed schedule II controlled

substances under the Oregon Death With Dignity Act, Or.

Rev. Stat. 127.800 et seq.

The proceedings below

On November 8, 2001, the district court granted all

respondents’ request for a temporary restraining order,

enjoining the Attorney General from enforcing the Controlled

Substances Act (CSA) against Oregon physicians and

pharmacists practicing in accord with the Oregon Death With

Dignity Act.

On November 20, 2001, at the conclusion of the

preliminary injunction hearing, the parties agreed to extend

the temporary restraining order in lieu of a court ruling on

respondents’ motion for a preliminary injunction.

On April 17, 2002, the district court granted summary

judgment in favor of all respondents and permanently

enjoined the Attorney General from enforcing, applying, or

otherwise giving any legal effect to his enforcement directive.

See Pet. App. 97a. The district court reasoned as follows:

' In accord with Supreme Court Rule 24(2), practitioner-

respondents supplement petitioners’ statement.

I conclude that Congress did not intend

the CSA to override a state’s decisions

concerning what constitutes legitimate

medical practice, at least in the absence

of an express federal law prohibiting

that practice. Similarly, I conclude

that Congress never intended, through

*»xe CSA or through any other current

federal law, to grant blanket authority

to the Attorney General or the DEA to

define, as a matter of federal policy,

what constitutes the legitimate practice

of medicine.

plain language of the CSA, contravenes

Congress’ express legislative intent,

and oversteps the bounds of the

Attorney General’s statutory authority.

See 5 U.S.C. § 706(2)(C), (D). * * *.

Pet. App. 2a; see also id. at 9a:

We hold that the Attorney General

lacked Congress’ requisite

authorization. The Ashcroft Directive

violates the "clear statement" rule,

contradicts the plain language of the

CSA, and contravenes the express

Pet. App. 77a-78a. intent of Congress.

On May 26, 2004, the Ninth Circuit Court of Appeals The Ninth Circuit Court of A luded i

affirmed, finding the enforcement directive unenforceable: analysis as follows: Spams cnnatated ts

A doctor, a pharmacist, several

terminally ill patients, and the State of

Oregon challenge an interpretive rule

issued by Attorney General John

Ashcroft which declares that physician

assisted suicide violates the Controlled

Substances Act of 1970 ("CSA"), 21

U.S.C. §§ 801-904. This so-called

"Ashcroft Directive," published at 66

Fed.Reg. 56,607, criminalizes conduct

specifically authorized by Oregon’s

Death With Dignity Act, Or. Rev. Stat.

§ 127.800-127.897. We hold that the

Ashcroft Directive is unlawful and

unenforceable because it violates the

In sum, the CSA was enacted to

combat drug abuse. To the extent that

it authorizes the federal government to

make decisions regarding the practice

of medicine, those decisions are dele-

gated to the Secretary of Health and

Human Services, not to the Attorney

General. The Attorney General’s

unilateral attempt to regulate general

medical practices historically entrusted

to state lawmakers interferes with the

democratic debate about physician

assisted suicide and far exceeds the

scope of his authority under federal

law. We therefore hold that the

Ashcroft Directive is invalid and may

not be enforced.

Id. at 24a.

The Attorney General’s enforcement directive

In a two page enforcement directive (Pet. App. 100a-

105a) released November 6, 2001, the Attorney General

determined the following:

Pet. App. 102a (emphasis added). The Attorney General

directed that his findings be immediately enforced upon

publication:

I hereby direct the DEA, effective

upon publication of this memorandum

in the Federal Register, to enforce and

apply this determination,

notwithstanding anything to the

contrary in the June 5, 1998, Attorney

l. Determination on Use of

Federally Controlled Substances to

Assist Suicide. For the reasons set

forth in the OLC Opinion, J hereby

determine that assisting suicide is not

a "legitimate medical purpose" within

the meaning of 21 CFR § 1306.04

(2001), and that prescribing,

dispensing, or administering federally

controlled substances to assist suicide

violates the CSA. Such 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 under

21 U.S.C. 824(a)(4). This conclusion

applies regardless of whether state law

authorizes or permits such conduct by

practitioners or others and regardless of

the condition of the person whose

suicide is assisted.

General [Janet Reno]’s letter.

Pet. App. 102a-103a (emphasis added). Consequently, but for

the district court’s November 8, 2001 restraining order, the

enforcement directive would have gone into effect upon

publication in the Federal Register on November 9, 2001.

The Attorney General’s enforcement threat was limited

to Oregon practitioners. Jd. at 103a (there is "no change in

the current standards and practices of the DEA in any State

other than Oregon"). The Attorney General further dictated

an enforcement strategy. The Oregon Death With Dignity

Act’ imposes statutory record keeping requirements upon

practitioners’ and public reporting requirements upon the

Oregon Department of Human Services.* The Attorney

? The full text of the Oregon Death With Dignity Act is appended

to the Practitioners’ Brief in Opposition, 1a-20a ("Practitioners’ App.").

> See Practitioners’ App. 9a-10a (Or. Rev. Stat. § 127.855(1)-(7)

(medical record documentation requirements)).

* See Practitioners’ App. 11a (Or. Rev. Stat. § 127.865(3)

(reporting requirements)).

General concluded that those publicly held records should

facilitate enforcement proceedings:

4. Enforcement in Oregon. * **.

Those records should contain the

information necessary to determine

whether those holding DEA

registrations who assist suicides in

accordance with Oregon law are

prescribing federally controlled

substances for that purpose in violation

of the CSA***.

Pet. App. 103a-104a (emphasis added). The Attorney

General determined that the DEA had the authority to obtain

those records, id. at 104a, and concluded his enforcement

directive with a distribution instruction in Oregon:

5. Distribution. Please ensure that

this Memorandum and the OLC

opinion on which it is based are

promptly distributed to appropriate

DEA personnel, especially those with

authority over the enforcement of the

CSA in Oregon.

Id. (emphasis added).

Standing to litigate

Respondents Rasmussen and Hochhalter have standing

to challenge the Attorney General’s enforcement directive

because both have practiced medicine in Oregon and, when

appropriate, have prescribed and dispensed controlled

substances under the CSA and Oregon’s Death With Dignity

Act. See Practitioners’ App. 22a-32a (practitioners’

affidavits). As such, both are among the primary targets of

the Attorney General’s enforcement directive and, but for

injunctive relief, both are subject to administrative and

criminal sanctions pursuant to the Attorney General’s

enforcement directive.

The State of Oregon is leading a national debate

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

this Court declined to recognize a "generalized" constitutional

right to a physician-assisted death.’ Central to that result

was the court’s observation that, "the States are currently

engaged in serious, thoughtful examinations of physician-

assisted suicide and other similar issues." Jd. at 719. "Our

holding permits this debate to continue, as it should in a

democratic society." Jd. at 735. The issue is one that "is

entrusted to the ‘laboratory’ of the States." Jd at 737

(O’Connor, J., concurring, joined by Justices Ginsberg and

Breyer); see also id. at 738 (Stevens, J., concurring) and at

788 (Souter, J., concurring).

Oregon has been at the forefront of this debate. The

Oregon Death With Dignity Act was adopted by the people

of Oregon at the November 8, 1994 election. Three years

later, on November 7, 1997, the people of Oregon decisively

rejected, by a margin of 60 percent to 40 percent, a ballot

. Respondents use the term "assisted death" in recognition that

“assisted suicide” is still a crime in Oregon. See Or. Rev. Stat. §

163.125 (second degree manslaughter), appended, Practitioners’ App.

21a. It is preferable not to use the language of a crime when referring

to non-criminal activity.

measure to repeal the Oregon Death With Dignity Act. Two

years after that, on June 30, 1999, Governor John Kitzhaber,

M.D., signed into law Senate Bill 491, amending the Oregon

Death With Dignity Act. As such, the Oregon Death With

Dignity Act is a-duly enacted state law, twice approved by

Oregon voters, subsequently amended by the state legislature

and signed into law by Oregon’s governor, himself a

physician. It is a rare law that has been so thoroughly tested

and approved by a state’s democratic process.

SUMMARY OF ARGUMENT

Schedule I banned substances are not used under the

Oregon Death With Dignity Act, and the Attorney General

does not allege that Oregon practitioners are diverting lawful

Schedule II substances out of the "closed" system of

regulation, from legitimate to illicit channels, or that Oregon

practitioners are unlicensed, unregistered, or otherwise

unqualified to possess, prescribe, or dispense controlled

substances. | Consequently, this case has nothing to do with

illicit drug use, drug trafficking, or drug diversion.

The Attorney General’s interpretative ruling is simply

an enforcement directive giving effect to national medical

policy, regulating the practice of medicine, and specifically

targeting the State of Oregon and DEA registrants practicing

under the Oregon Death With Dignity Act. To accomplish

his purpose, the Attorney General relies upon a 1984

amendment to the CSA (21 U.S.C. § 823(f)--"public interest")

and an agency rule (21 C.F.R. § 1306.04--"legitimate medical

purpose"), neither of which empower the Attorney General to

regulate the practice of medicine or to impose his preferred

medical policies upon the State of Oregon.

el

The Attorney General substitutes the language of the

rule, 21 C.F.R. § 1306.04 ("legitimate medical purpose") for

the language of the statute, 21 U.S.C. § 802(21) ("course of

professional practice"), and then infuses the word "legitimate"

with a subjective, value-laden meaning unsupported by the

legislative record. Congress, however, never intended that the

Attorney General would pass judgment on the "legitimacy" of

medical policy in the States in the absence of illicit drug use,

drug trafficking and drug diversion.

The Attorney General also removes his authorities

from their proper context. Unlike the drug-dealing physicians

in the Rosenberg, Moore, and Rosen cases, for example, there

is no allegation by the DOJ or the DEA that physicians

practicing under the Oregon Death With Dignity Act are

diverting drugs from legitimate to illicit channels. Rather,

both the DOJ and the DEA concede that Oregon practitioners

are practicing in accordance with Oregon law, and that the

drugs are used for their intended purpose within the closed

system of regulation. Consequently, there is no illicit drug

use, no drug trafficking, and no drug diversion. No law is

broken. No crime is committed. Not even the community

standard of care is violated.

The express language of the CSA, the case law

interpreting the CSA, and the legislative record in support of

the CSA, all make clear that the Attorney General’s proper

role is to regulate the manufacture, dispensing and distribution

of controlled substances to prevent illicit drug use, trafficking,

and diversion. Aside from encouraging drug education,

research, and rehabilitation, the CSA serves a law-

enforcement purpose and no other purpose. Nothing

contained in the CSA gives the Attorney General direct

control over the practice of medicine in the States, nor could

it. See, e.g., Linder v. United States, 268 U.S. 5, 18 (1924)

("Obviously, direct control of medical practice in the States

is beyond the power of the Federal Government"); Barsky v.

Board of Regents, 347 U.S. 442, 449 (1953) ("It is elemental

that a state has broad power to establish and enforce standards

of conduct within its borders relative to the health of

everyone there. It is a vital part of a state’s police power");

Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 387

(2002) (determination of medical necessity and standards of

reasonable care are "quintessentially state-law"

determinations).

Not only must the Attorney General persuade this

Court that his interpretation of the CSA is correct, he must

further demonstrate that it was the intent of Congress to alter

the state/federal framework--in this case, by permitting federal

encroachment into the practice of medicine, an area of

traditional State concern. He fails on beth counts.

The Attorney General’s bias was exposed in the Ninth

Circuit Court of Appeals below when he framed the issue as

"healing, not killing." Appellants’ Brief, 11. Once the

Attorney General’s argument is exposed for what it is--a

policy disagreement with the State of Oregon over the

practice of medicine, and not a disagreement over the

enforcement of the CSA to prevent illicit drug use, drug

trafficking, or drug diversion--the inquiry should be over.

Finally, the power to regulate commerce between the

States does not permit federal control over the manner in

which Oregonians die, the choices they possess when facing

death, the scope of state criminal laws prohibiting assisted

suicide, or state health-care laws permitting a physician-

assisted death.

10

ARGUMENT

I. The Attorney General’s enforcement directive

violates the plain language of the Controlled

Substances Act, oversteps the bounds of the

Attorney General’s statutory authority, and

contravenes Congress’ express legislative intent.

The Controlled Substances Act, 21 U.S.C. §§ 801-950,

controls certain delineated substances by first classifying them

and then setting restrictions on each class of substance. These

restrictions apply to the manufacture, distribution, sale,

possession, and use of such substances. The classifications

range from schedule I substances, which have no recognized

medical use and are therefore banned except in very limited

research contexts, to schedule II, III, IV and V substances,

which have recognized uses and can be manufactured,

distributed, possessed and used, subject to the restrictions of

the CSA. As this Court recently explained:

the CSA, repealed most of the earlier

antidrug laws in favor of a

comprehensive regime to combat the

international and interstate traffic in

illicit drugs. The main objectives of

the CSA were to conquer drug abuse

and to control the legitimate and

illegitimate traffic in controlled

substances. * * * Congress was

particularly concerned with the need to

prevent the diversion of drugs from

legitimate to illicit channels. * * * .

11

To effectuate these goals,

Congress devised a closed regulatory

system making it unlawful to

manufacture, distribute, dispense, or

possess any controlled substance except

in a manner authorized by the CSA.

21 U.S.C. §§ 841(a)(1), 844(a).

Gonzales v. Raich, 125 S.Ct. 2195, 2203 (2005) (emphasis

added, footnotes omitted); citing 21 U.S.C. §§ 801(1)-(6)

(Congressional findings); United States v. Moore, 423 U.S.

122, 135 (1975); H.R. Rep. No. 91-1444, pt. 2, p. 22 (1970).

In Gonzales v. Raich, this Court very recently upheld

the power of Congress to classify marijuana as a schedule I

banned substance. Unlike in Raich, however, there is no

allegation in the instant case that a schedule I banned

substance is being used under the Oregon Death With Dignity

Act. Nor does the Attorney General allege that Oregon

practitioners are diverting lawful Schedule II substances out

of the "closed" system of regulation, from legitimate to illicit

channels, or that Oregon practitioners are unlicensed,

unregistered, or otherwise unqualified to possess, presc: be,

or dispense controlled substances.

The Attorney General instead argues that althouga

"schedule II substances have other generally accepted medical

© The Attorney General readily concedes that schedule II

substances are used under Oregon’s unique law. See Pet. App. 132a,

n.25: see also Pet. Br. 29, n.11 ("the three drugs that have been

dispensed pursuant to the DWDA are secobarbital, pentobarbital, and

amobarbital, all of which are schedule II depressants").

12

uses in treatment, deliberately assisting a person to commit

suicide is not one of them." Pet. Br. 30 (italics in original,

underscore added). In support of his position, the Attorney

General invokes what he describes as a "broad consensus"

evidenced by "centuries of almost uniform Opposition" and

"the law of 49 of the 50 States." Pet. Br. 18.

The Attorney General locates in the CSA each use of

the words "legitimate" and "treatment" and concludes that he

is empowered under the CSA to judge whether a specific

medical practice is legitimate, Pet. Br. 18-24, even in the

absence of illicit channels of distribution, drug trafficking, or

drug diversion, and regardless of state law and the medical

standard of care.

The Attorney General cites four authorities (Pet. Br.

25-26) in support of his "national standards" argument (Pet.

Br. 26-37) that when Congress enacted the CSA, it "believed

[that] medical judgments could and should be made on the

national level." Pet. Br. 27 (emphasis added). The Attorney

General relies upon cases that interpret "maturity," as used in

the Security Exchange Act of 1934; "stolen," as used in the

National Motor Vehicle Theft Act; "future interests," as used

in the Revenue Act of 1932; and "domicile," as used in the

Indian Child Welfare Act. Pet. Br. 25. In none of these

cases, however, did a federal agency seek through application

of an agency rule (21 C.F.R. § 1306.04--"legitimate medical

purpose") to so drastically alter the meaning of a statute, or

to expand a federal agency’s power to regulate medicine, an

area of t-aditional state concern.

Although Congress provided immunity from criminal

prosecution to physicians and pharmacists who prescribe,

possess, and dispense controlled substances "in the course of

13

professional practice" (21 U.S.C. § 802(21)), the Attorney

General instead relies upon a fragment of an agency rule, i.e.,

that pursuant to 21 C.F.R. § 1306.04, a prescription for a

controlled substance must be issued for a "/egitimate medical

purpose."’ See Pet. App. 102a (enforcement directive). The

Attorney General places a particularly strong emphasis on the

word "legitimate" and, by the time he is through with his

interpretation of the rule, any deference to the practice of

medicine under the "course of professional practice” standard,

or to the States to regulate medicine, is subsumed by the

Attorney General’s inquiry into the legitimacy of Oregon’s

medical policy. Although he fails to allege drug trafficking,

drug diversion, or the use of schedule I banned substances,

the Attorney General has nonetheless construed an agency

rule so as to empower the DEA to investigate, prosecute and

convict both respondents for what amounts to a violation of

the national medical policy he espouses in his enforcement

directive.

A. Medical practice under the Oregon Death

With Dignity Act establishes the "course of

professional practice."

When the State of Oregon adopted its Death With

Dignity Act in 1994, it created a narrow exception to its penal

code prohibiting assisted suicide* and also codified a new

721 CER. § 1306.04 provides in relevant part, "[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 professiona! practice * * * ."

® See Or. Rev. Stat. § 163.125 (second degree manslaughter),

appended, Practitioners’ App. 21a.

14

standard of care regarding medical treatment near the end of

life,” two areas of traditional State concern.

. The question for the Attorney General under the CSA

is whether Oregon practitioners are practicing in the "course

of professional practice” (21 U.S.C. § 802(21)), or for a

“medical purpose." United States v. Moore, supra, 423 U.S.

at 137, n.13. This Court’s review of generally accepted

medical practices in Moore was limited to effectuating the

"course of professional practice" standard, a screening device

to detect drug diversion. Unlike in Moore, however, the

Attorney General does not allege a single incident of drug

diversion. And unlike in Raich, which involved the medical

use of marijuana, the Attorney General does not allege a

single use of a schedule I banned substance.

The Oregon Death With Dignity Act is a “prescribing

law" only. Only Schedule II and lower drugs are prescribed.

Oregon’s novel law expressly prohibits "lethal injection

mercy killing [and] active euthanasia"'® and requires that

practitioners be licensed by the state Board of Medical

9

See Or. Rev. Stat. 127.800 et seg. (Oregon Death With Dignity

Act), appended, Practitioners’ App. la-20a.

'° Or. Rev. Stat. § 127.880 provides as follows:

Construction of Act. Nothing in ORS 127.800 to

127.897 shall be construed to authorize a physician or

any other person to end a patient’s life by lethal

injection, mercy killing or active euthanasia. Actions

taken in accordance with ORS 127.800 to 127.897

shall not, for any purpose, constitute suicide, assisted

suicide, mercy killing or homicide, under the law.

[1995 c.3 §3.14]

15

Examiners and registered with the DEA. See Or. Rev. Stat.

§ 127.815(1)(L)(A), appended, Practitioners’ App. 7a. The

role of an attending physician is limited to caring for the

patient and ensuring that all medical and legal criteria are

satisfied before prescribing or dispensing controlled

substances for use by the patient. Subsection 815(1)(k)

provides, for example, that:

(1) The attending physician shall: * *

* (k) Ensure that all appropriate steps

are carried out in accordance with ORS

127.800 to 127.897 prior to writing a

prescription for medication to enable a

qualified patient to end his or her life

in a humane and dignified manner * *

7

Or. Rev. Stat. § 127.815(1)(k).

Dr. Rasmussen has demonstrated on this record that he

and others like him practicing under the Oregon Death With

Dignity Act are acting in their professional capacities in

conformity with state law and the medical standard of care.

In support of his request for permanent relief, Dr. Rasmussen

averred that:

9. Prior to [the district]

court’s issuance of a _ temporary

restraining order, my ability to meet

the community standard of care as

established under Oregon law and

practice was severely restricted. As

the direct result of th{e district] court’s

preliminary injunctive relief, my ability

16

to meet the community standard of

care as established under Oregon law

and practice has been restored.

Practitioners’ App. 24a, 9 (Rasmussen affidavit, emphasis

added). Similarly, Dr. Rasmussen averred:

16. ***. Due to Attorney

General John Ashcroft’s directive to

enforce the Controlled Substances Act

against physicians like myself

practicing in accord with Oregon law

and the community standard of care,

and in the absence of a permanent

injunction, I will no longer be able to

meet the community standard of care

as established under Oregon law and

practice. I cannot risk DEA

registration revocation proceedings or

other sanctions, criminal and financial.

I cannot risk my ability to practice as

a medical oncologist, which has

provided my livelihood for 21 years.

Nor can I risk my family’s security, or

my ability to provide for my family.

See Practitioners’ App. 26a, § 16 (Rasmussen affidavit,

emphasis added).

Only controlled substances are suitable for use under

the Oregon Death With Dignity Act:

17. In the absence of a

permanent injunction, the Oregon

17

Death With Dignity Act will be

rendered useless. Only controlled

substances are suitable for use under

the Oregon Death With Dignity Act;

they are used for what Oregon has

determined to be a legitimate medical

purpose in the normal course of

medical practice in Oregon. These

controlled substances are prescribed by

physicians and dispensed by

pharmacies for other purposes as well.

Prescriptions for controlled substances

under the Oregon Death With Dignity

Act are written by state-licensed

physicians and filled by state-licensed

pharmacists, in full compliance with

the closed system of procedures

established by the CSA and enforced

by the DEA. These drugs are not

otherwise available.

See Practitioners’ App. 26a-27a, § 17 (Rasmussen affidavit,

emphasis added). :

As expressly required under the Oregon Death With

Dignity Act, see Or. Rev. Stat. § 127.815(1)(L)(A), Dr.

Rasmussen is registered with the state Board of Medical

Examiners and the DEA. See Practitioners’ App. 22a 4] 1-2

(Rasmussen affidavit).

The standard of care for the attending physician

practicing under the Oregon Death With Dignity Act is set

out at Or. Rev. Stat. § 127.815 (attending physician

responsibilities), appended, Practitioners’ App. 5a-7a.

18

Consistent with those numerous statutory requirements, Dr.

Rasmussen makes an initial determination of whether his

patient has a terminal disease, is capable, and has made the

request voluntarily. Dr. Rasmussen ensures that his patient is

making an informed decision by informing the patient of the

patient’s medical diagnosis, prognosis, the potential risk and

probable result associated with taking the medication to be

prescribed, and the feasible alternatives, including, but not

limited to, comfort care, hospice care and pain control. Dr.

Rasmussen further refers his patients to a consulting physician

for medical confirmation of his diagnosis and for a second

opinion that the patient is capable and acting voluntarily.

When appropriate, Dr. Rasmussen also refers his patients for

counseling. He recommends that the patient notify next of

kin and counsels the patient about the importance of having

another person present when the patient takes the medication

prescribed under Oregon law. See Practitioners’ App. 24a-

25a, YJ 10-11 (Rasmussen affidavit).

As further required by Oregon’s statutory standard of

care, Dr. Rasmussen dispenses the medications directly,

including ancillary medications intended to facilitate the

desired effect and minimize the patient’s discomfort or, in the

alternative, Dr. Rasmussen contacts a pharmacist and informs

the pharmacist of the prescription, and he then delivers the

written prescription personally or by mail to the pharmacist,

who will dispense the medications to either the patient, the

attending physician, or the patient’s chosen agent. See

Practitioners’ App. 25a | 12 (Rasmussen affidavit).

Dr. Rasmussen further satisfies all of the statutory

medical documentation requirements and provides a copy of

his dispensing record to the Department of Human Services.

In sum, Dr. Rasmussen ensures that all appropriate steps are

19

carried out in accordance with Or. Rev. Stat. § 127.800 to

127.897 (see Practitioners’ App. 25a, 9 13), as is required of

him under state statutory and regulatory law, and the

community standard of care. See, e.g., Or. Rev. Stat. §

127.815. Dr. Rasmussen is at all times practicing medicine,

acting for a medical purpose:

13. ***. I comply with

all the provisions of the Oregon Death

With Dignity Act. I never engage in

drug trafficking or diversion. As a

physician practicing under the Oregon

Death With Dignity Act, I am

practicing legitimate medicine in the

course of my professional practice.

See Practitioners’ App. 25a, § 13 (Rasmussen affidavit,

emphasis added).

B. Criminal proceedings under the Controlled

Substances Act; drug trafficking, drug

diversion, and the “course of professional

practice."

The CSA establishes both criminal and administrative

recourse against those who violate its provisions. In a

criminal prosecution to convict a DEA registered practitioner

of unlawful distribution, the government must prove beyond

a reasonable doubt that the practitioner:

(1) knowingly or intentionally;

(2) prescribed or dispensed a controlled substance;

(3) outside the course of professional practice.

20

These three elements of the crime are derived from the

circular structure of the CSA.'' The crime of unlawful

distribution is a specific intent crime--the practitioner must

have specifically intended ("knowingly or intentionally") to

commit a criminal act.'? This mens rea requirement applies

to the second element (distribution) and to the third element

(outside the course of professional practice).'? It is not

'" It is a crime to (1) knowingly or intentionally (2) distribute or

dispense a controlled substance unless "authorized" by the Act. See 21

U.S.C. § 841(a). Authorization is obtained by “registering” with the

Attorney General. See 21 U.S.C. § 822(a)(2). Persons registered with

the Attorney General are authorized to possess, manufacture, distribute,

or dispense controlled substances to the extent authorized by their

registration. See 21 U.S.C. § 822 (b). Physicians and pharmacists

licensed by a state and registered with the Attorney General are

“practitioners,” and, as such, they are authorized to dispense controlled

substances (see 21 U.S.C. § 829(a)&(b)) in "the course of [their]

professional practice." See 21 U.S.C. § 802(21); see also United States

v. Moore, 423 U.S. 122, 140 (1975).

= See, e.g., 21 U.S.C. § 841(a); see also United States v. Brower,

336 F.3d 274, 276 (4th Cir. 2003) ("The Government’s mens rea

burden is defined under § 841(a), which makes ii an offense to

‘knowingly or intentionally’ distribute a controlled substance"); United

States v. King, 345 F.3d 149, 153 (2nd Cir. 2003) (" * * * § 841(a)

contains a mens rea requirement: The trier of fact must determine that

the defendant ’knowingly or intentionally’ manufactured, distributed,

dispensed, or possessed with intent to distribute a schedule I or II

controlled substance").

'? In Arthur Andersen, LLP v. United States, 125 S.Ct. 2129, 2135

(2005), this Court recently explained:

We have recognized with regard to similar statutory

language that the mens rea at least applies to the acts

(continued...)

21

enough to prove beyond a reasonable doubt that a practitioner

knowingly or intentionally distributed a controlled substance,

for all practitioners who prescribe or dispense controlled

substances intend that much. Rather, it must be proven

beyond a reasonable doubt that the practitioner intentionally

departed the course of professional practice--i.e., that the

physician was no longer practicing medicine--but instead

dealing drugs.“

In sharp contrast, the phrase "legitimate medical

purpose" is not the value-laden phrase the Attorney General

portrays it to be,'* and the Attorney General misconstrues

this Court’s decision in United States v. Moore, when he

argues as follows:

(continued)

that immediately follow, if not to other elements

down the statutory chain.

'4 In Arthur Andersen, supra, this Court stressed the importance

of, "limiting criminality * * * to reach only those with the level of

‘culpability * * * we usually require in order to impose criminal

liability.” 125 S.Ct. at 2136; quoting United States v. Aguilar, 515

U.S. 593, 602 (1995).

'S See, e.g., Pet. Br. 10-11 (that "physician-assisted suicide is not a

legitimate medical purpose is well supported by an ’overwhelming

historical, legal, and medical consensus’); 23 ("In light of the

historical unanimity of opinion on this issue, and the fact that the CSA

predated Oregon’s DWDA by several decades, it is inconceivable that

Congress, in enacting the CSA, regarded assisted suicide as a legitimate

‘medical’ practice in the ‘treatment’ of disease"); 23 ("Numerous health

care experts have likewise agreed that physician-assisted suicide is not a

legitimate medical treatment"); 24 ("In other federal laws and programs

as well, physician-assisted suicide is not regarded as a legitimate

medical practice").

22

As this Court noted in Moore, the

requirement that a controlled substance

be prescribed for a legitimate medical

purpose may be implicit in various

provisions of the CSA, such as 21

U.S.C. 829, but is, in any event, made

explicit by virtue of the implementing

regulation, 21 C.F.R. 1306.04(a). See

Moore, 423 U.S. at 137-139 & n.13.

Pet. Br. 5 (emphasis added). Correctly stated, however, this

Court in Moore said:

The medical purpose requirement

explicit in subsection (c) could be

implicit in subsections (a) and (b).

Regulation § 306.04 makes it explicit.

Moore, 423 U.S. at 137, n.13 (emphasis added). The

Attorney General has thus transformed "medical purpose," a

phrase not inconsistent with the statutory phrase "course of

professional practice," into the value laden term that he

prefers, "legitimate medical purpose." This Court in Moore

never went so far, and a simple word search indicates that the

phrase "legitimate medical purpose" was used only one time,

in footnote 12, when this Court quoted the text of 21 CFR §

1306.04(a) (formerly, § 306.04). See Moore, 423 U.S. at

136-137, n.12.

. The Attorney General repeatedly removes Moore from

its proper context. In Moore, this Court held that a physician

who acts as a "’pusher’--not as a physician," violates the

23

CSA. Id. at 143.'° Moore involved a physician who was

convicted for drug diversion in violation of 21 U.S.C. § 841.

The court of appeals overturned the conviction, holding that,

"a physician registered under the Act is per se exempted from

prosecution under § 841 because of his status as a registrant."

Id. at 131. This Court reversed, holding that, "only the

lawful acts of registrants are exempted." Jd. The legislative

history of the CSA, explained the Court, "indicates that

Congress was concerned with the nature of the drug

transaction, rather than with the status of the defendant." /d.

at 134 (emphasis added). Citing the House Report, the Court

concluded that a violation of the CSA, “was intended to turn

on whether the ’transaction’ falls within or without legitimate

channels." Id. at 135 (emphasis added). This Court

explained that "[t]he evidence presented at trial was sufficient

for the jury to find that [Dr. Moore’s] conduct exceeded the

bounds of professional practice.’" /d. at 142. That evidence,

explained the Court, was sufficient to convince the jury that

Dr. Moore "acted as a large-scale ‘*pusher’--not as a

physician." Jd. at 143. Thus, the Court equated acting

'© This Court summarized Dr. Moore’s conduct as follows:

[Dr. Moore] gave inadequate physical examinations or none at

all. He ignored the results of the tests he did make. He did

not give methadone at the clinic and took no precautions

against its misuse and diversion. He did not regulate the

dosage at all, prescribing as much and as frequently as the

patient demanded. He did not charge for medical services

rendered, but graduated his fee according to the number of

tablets desired. In practical effect, he acted as a large-scale

“pusher"-not as a physician.

United States v. Moore, 423 U.S. 122, 142-143 (1975).

24

outside "the bounds of professional practice" with acting as a

"pusher," diverting drugs outside of legitimate channels.

In Moore, this Court also described the "closed

system" of regulation established by the CSA, i.e., "Congress

was particularly concerned with the diversion of drugs from

legitimate channels to illegitimate channels." Id. at 135

(citing the House Report, emphasis added). Under the

scheme fashioned by Congress, "[{i]nstead of expressly

removing from the protection of the Act those physicians who

operate beyond the bounds of professional practice, the CSA

uses the concept of ’registration.’"" Jd. at 140. The federal

registration "contemplates that [the physician] is authorized by

the State to practice medicine and to dispense drugs in

connection with his professional practice." /d. at 141

(emphasis added). The federal registration, explained the

Court, "extends no further. It authorizes transactions within

‘the legitimate distribution chain’ and makes all others

illegal." Jd. (emphasis added). Implicit in a physician’s

registration, "is the understanding that he is authorized only

to act ‘as a physician." Jd. This understanding reflects

Congressional recognition that "registrants, who have the

greatest access to controlled substances and therefore the

greatest opportunity for diversion, were responsible for a large

part of the illegal drug traffic." Jd. at 135 (emphasis added).

Thus the question, whether a physician is prescribing

in the course of his or her professional practice, simply asks

whether the controlled drugs remain within the "closed

system,” or within "legitimate channels" or with a "legitimate

distribution chain." A review of the case law interpreting the

phrase, "course of professional practice," including Moore,

supra, further reveals that until recently DEA enforcement

activity has focused exclusively upon drug abuse or diversion

25

flowing from egregious departures from the course of

professional practice.

In United States v. Collier, 478 F.2d 268 (Sth Cir.

1973), the court equated "the course of professional practice"

to “within the bounds of professional practice," or the

opposite of the physician as drug pusher:

Manifestly the language "in the course

of professional practice" is intended to

limit the immunity of a licensed

practitioner. It is apparent that a

licensed practitioner is not immune

from the act solely due to his status *

* * but rather because he is expected

to prescribe or dispense drugs within

the bounds of his professional practice

of medicine. * * * . However, under

the guise of treatment a physician

cannot sell drugs to a dealer nor

distribute drugs intended to cater to

cravings of an addict. * * * Congress

did not intend for doctors to become

drug "pushers."

Collier, 478 F.2d at 271-72 (emphasis added). In United

States v. Rosen, 582 F.2d 1032 (Sth Cir. 1978), the court

acknowledged the difficulty of direct application of the -

Collier interpretation in close-call cases, prompting the court

to describe its dilemma this way:

Our facile quotation of general

principle does not diminish the

difficulty in its application. A majority

26

of cases have dealt with facts which

were so blatant that a statement of

clear cut criteria in a form useful in

other cases would have been

superfluous to the decision. We are,

however, able to glean from reported

cases certain recurring concomitance of

condemned behavior, examples of

which include the following [nine

factors. }

Rosen, 582 F.2d at 1035-36. The Rosen court then listed nine

behaviors from the case law that may be present when a

physician is diverting drugs, i.e., practicing medicine outside

the "course of professional practice," as follows:

l.

2.

3.

An inordinately large quantity of controlled

substances was prescribed;

Large numbers of prescriptions were issued;

No physical examination was given;

The physician warned the patient to fill

prescriptions at different drug stores;

The physician issued prescriptions to a patient

known to be delivering the drugs to others;

The physician prescribed controlled drugs at

intervals inconsistent with legitimate medical

treatment;

The physician involved used street slang rather

than medical terminology for the drugs

prescribed;

There was no logical relationship between the

drugs prescribed and treatment of the condition

allegedly existing; and

27

G. The physician wrote more than one prescrip-

tion on occasions in order to spread them out.

Rosen, 582 F.2d at 1036.

Both Collier and Rosen demonstrate that even in cases

involving "close call" medical judgment, the only relevant

issue under the CSA is whether legitimate drugs are being

diverted into illicit channels. When the courts compare the

practitioner’s conduct against professional practice standards,

the only purpose is to screen for diversion of controlled

substances; the "course of professional practice” standard, 21

U.S.C. § 802(21), is simply a screening device intended to

preserve the closed system of regulation. See also Humphreys

v. DEA, 96 F.3d 658, 666 (3 Cir. 1996) (reversing DEA’s

decision to revoke a physician’s registration because the

evidence proffered by DEA showed that the potential for

diversion “is so unlikely as to be unsustainable"); United

States v. Rosenberg, 515 F.2d 190, 197, 199 (9" Cir. 1975)

(affirming conviction based on the jury’s finding, "that Dr.

Rosenberg was not acting in the course of his professional

practice” after the jury was instructed that the CSA was

violated if Dr. Rosenberg, "was not acting in good faith as a

doctor, but simply pushing pills"). Remarkably, in the instant

case, the Attorney General fails to allege a single violation of

the closed system of regulation, and instead invokes 21

C.F.R. § 1306.04 as authority to pass judgment on the

"legitimacy" of medical policy in the States. The rule and the

statute, however, mean the same thing, Moore, 423 U.S. at

137, n.13. In other words, a prescription is written for a

"medical purpose" if it is written in the "course of

professional practice." Jd. If there is any disagreement

between the rule and the statute, the rule must give way to

the statute.

28

C. Administrative proceedings under the

Controlled Substances Act; revocations,

denials, and the "public interest."

A violation of the "course of professional practice"

standard is also actionable in administrative proceedings."”

Although, in an administrative proceeding, the burden of

proof is lower and the sanctions less severe, the meaning of

the phrase "course of professional practice" remains the same,

rendering further analysis of this phrase unnecessary.

In an administrative context, however, the Attorney

General goes one step further and concludes as a matter of

law that medical practice under the Oregon Death With

Dignity Act is not in the “public interest," thereby

empowering the DEA to revoke existing registrations and

deny new applications.

The impact upon medicine in the State of Oregon is

undeniable. The Oregon Death With Dignity Act requires

that practitioners possess a DEA registration and, as this

record makes clear, schedule II drugs are not only used under

the Oregon Death With Dignity Act, they are also necessary,

and there are no substitutes. See discussion supra, 12, n.6 &

17-18. Consequently, the power to revoke or deny the DEA

registrations of those who practice under the Oregon Death

With Dignity Act is the power to regulate medicine in

Oregon.

” See, e.g., William J. Roth, M.D., 60 Fed. Reg. 62262 (1995);

William F. Skinner, M.D., 60 Fed. Reg. 62887 (1995); Paul W. Saxton,

D.O., 64 Fed. Reg. 25073 (1999); Wesley G. Harline, M.D., 65 Fed.

Reg. 5665 (2000).

29

The Attorney General’s role in construing the "public

interest" flows from a 1984 amendment to the CSA. It is not,

however, the expansive grant of power that the Attorney

General portrays it to be. Congress, once again concerned

about the diversion of controlled substances from legitimate

to illicit channels by physicians and pharmacists who had

easy access via their DEA registrations, sought to give the

Attorney General more leeway when issuing and revoking

DEA registrations. Congress was motivated by the fact that

the States were often slow to take action. The solution, aptly

named, was the Dangerous Drug Diversion Control Act of

1984, the relevant section of which is now codified at 21

U.S.C. § 823(f)(1)-(5), under which section the Attorney

General is empowered to deny, "an application for * * *

registration if he determines that the issuance of such

registration would be inconsistent with the public interest." 21

U.S.C. § 823(f) (emphasis added). The Attorney General’s

power to construe the public interest is narrowly

circumscribed, however. Congress mandated that when

"determining the public interest," the Attorney General "shall"

consider the following five factors:

(1) The recommendation of the

appropriate State licensing board or

professional disciplinary authority.

(2) The applicant’s experience in

dispensing, or conducting research with

respect to controlled substances.

(3) The applicant’s conviction record

under Federal or State laws relating to

the manufacture, distribution, or

dispensing of controlled substances.

30

—————— meg =

(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(f)(emphasis added).'"* As such, the

Attorney General’s discretion to determine the "public

interest” has clear limits. Although the phrase "public

interest" is itself broad and abstract, Congress dictated five

criteria that "shall" be considered when determining the public

interest under the CSA. /d. Three of those criteria direct the

Attorney General to consult state law. 21 U.S.C. §

823(f)(1),(3)&(4). The remaining two subsections, although

not expressly referencing state law, certainly include state

law. 21 U.S.C. § 823(f)(2)&(5). Inasmuch as the 1984

amendment was partially in response to the perceived slow

action of the States, the five factors set out in 21 U.S.C. §

823(f)(1)-(5) are best viewed as placing the Attorney General

"in the shoes" of the State, to empower the Attorney General

to make a determination similar to a State’s determination,

had the State acted first. In no event does § 823(f)(1)-(5)

| Sa corresponding amendment was made to 21 U.S.C. § 824(a),

which applies to the revocations of § 823 registrations, listing five

“grounds” for revocation. The criteria for revocation differ from the

criteria applicable when granting an initial registration, except that §

824(a)(4) incorporates by reference the § 823(f) "public interest"

requirement. Consequently, the public interest is relevant to both initial

registrations and subsequent revocations.

31

empower the Attorney General to ignore or reject state law,

as he has in the instant case."

The Attorney General’s desire to reject state law is

further remarkable in view of the fact that during the first 14

years of the CSA, the only thing that mattered was the

practitioner’s compliance with state law:

Practitioners shall be registered

to dispense * * * controlled substances

in schedule II, III, IV, or V if they are

authorized to dispense or conduct

research under the law of the State in

which they practice. * * * .

Pharmacies (as distinguished

from pharmacists) when engaged in

commercial activities, shall be

registered to dispense controlled

substances in schedule II, III, IV, or V

if they are authorized to dispense under

'? Limiting the "public interest" clause, as well as the catchall

provision found in subsection (f)(5) (“such other conduct") to the

consideration of federal, state and local law is consistent with the

maxim, ejusdem generis:

the statutory canon that "where general words follow specific

words in a statutory enumeration, the general words are

construed to embrace only objects similar in nature to those

objects enumerated by the preceding specific words."

Circuit City Stores, Inc. v. Adams, 532 U.S 105, 114-115 (2001);

quoting, 2A N. Singer, Sutherland on Statutes and Statutory

Construction § 47.17 (1991).

32

the law of the State in which they

regularly conduct business.

Former 21 U.S.C § 823(f) (emphasis and paragraphing

added); see also, Moore, 423 U.S. at 140-141 ("Registration

of physicians and other practitioners * * * is mandatory if the

applicant is authorized to dispense drugs or conduct research

under the law of the State in which he practices"). The

Moore decision relied upon the House Report explanation that

DEA registration is "a matter of right" where the practitioner

~ using the controlled substances in compliance with state

aw:

The House Report described the

rationale behind § 823(f) as follows:

"Practitioners * * * engaged in the

distribution chain would be required to

be registered, but registration would be

as a matter of right where the

individual or firm is engaged in

activities involving these drugs which

are authorized or permitted under State

law*** "

Id. at 141, n.19 (emphasis added). Prior to the 1984

amendment, then, the Attorney General’s role was clerical,

limited to issuing DEA registrations so long as the applicant

was authorized under state law. Consequently, it is an

amazing contention by the Attorney General today that, as a

result of a 1984 amendment, he is newly empowered to reject

state law and exert de facto control over the practice of

medicine in the States when, prior to 1984, he had no choice

but to follow state law.

33

~

D. The Congressional record establishes that dispensing of controlled drugs to

the Controlled Substances Act is an anti- furnish us with better law enforcem

ent

drug law-enforcement statute, not a medical tools so that the rampant drug abuse

practices act problem can finally be curbed

one . effectively.

The legislative record demonstrates that the CSA is a

law-enforcement statute and that Congress never intended that Quoting Senator Dodd, 116 Cong. Rec. 978 phasi

it would be used to regulate medicine or to alter the added). —— — ;

state/federal framework. The following excerpts from the But it cannot be overemphasiz-

1970 Senate floor debate reveal that the CSA was at first ed that the bill before the Senate today

focused solely upon preventing drug trafficking and diversion; is entirely concerned with enforcement.

it served a law-enforcement purpose and no other purpose: It contains no medical or rehabilitative

| | provisions.

This measure--in concept, in

spirit, and in detail--is a It is designed to crack down

law-enforcement measure. It only hard on the narcotics pusher and the

approaches one side of the problem of illegal diverters of pep pills and goof

drug abuse. balls. ***.

Quoting Senator Hughes, 116 Cong. Rec. 973 (1970) Quoting Senator Dodd, 116 Cong. Rec. 978 (19 phasi

(emphasis added). added). petits sali '

| 7 . * * * this title reaffirms the Federal

That is my position on this Government’s role in drug control

problem. The legislation before us is Basically this role is to regulate the

a law enforcement bill. * * * we legitimate drug trade fo prevent

concluded it would be better to keep diversion of medically useful dangerous

this particular piece of legislation a law drugs into illegitimate channels and to

enforcement measure. help reduce the criminal traffic in all

narcotic and dan

Quoting Senator Dodd, 116 Cong. Rec. 976 (1970) (emphasis local, national porated le

added), ) |

The proposed legislation Quoting Senator 116 Co :

provides a regulatory schedule for the added). — ela oii

lawful manufacture, distribution, and

34 35

All of these provisions are

designed to reduce the diversion of

drugs from the legitimate course of

commerce and use into _ illegal

channels. This is important in the face

of evidence that about half of the

annual production of amphetamine and

barbiturate drugs, or between 8 and 9

billion pills, have been diverted to

nonmedical use.

Quoting Senator Dodd, 116 Cong. Rec. 996 (1970) (emphasis

added).

The debate changed little as it moved to the House.

The primary difference was that the House expanded the

legislation to include drug research, education and treatment,

in addition to the Senate’s narrower focus upon the

prevention of drug trafficking and diversion. The entire

debate remained, however, in the context of the drug

problem:

There are a limited number of

approaches to attack this problem—

preventive steps, aimed at stopping

experimentation before it starts;

control, to regulate the supply and

availability of drugs; rehabilitation to

lead individuals away from drug

dependence and addiction. It is my .

conviction that the Federal Government

must make a concentrated effort in all

of these areas.

36

Quoting Representative Boland, 116 Cong. Rec. 33,315

(1970).

The word "control" in the title,

of course, simply means enforcement

by the Justice Department in problems

related to drug abuse, by any person or

corporation whether a manufacturer,

wholesaler, or retailer. These controls

cover all the hard narcotics and opiates,

marihuana, and hallucinogens such as

LSD, amphetamines, barbiturates, and

even any tranquilizers subject to abuse.

Quoting Representative Randall, 116 Cong. Rec. 33,656

(1970) (emphasis added).

Here again, nothing from the 1970 House floor debate

remotely suggests that Congress intended the Attorney

General to determine the "legitimacy" of medicine, or to

establish medical policy in the States. To better control the

rampant drug problem, the House expanded the reach of the

CSA to include drug research, education, treatment, and

rehabilitation, but included not a word about regulating

medical practice. The relevant language in the proposed

legislation did not significantly change when it returned to the

Senate later that same year:

I am particularly grateful that

the basic Controlled Dangerous

Substances Act was passed in almost

its entirety by the House. There were

a number of minor disagreements; but

more than 90 percent of the law which

was reported by the Senate

37

Subcomittee [sic] on Juvenile

Delinquency will soon become the law

of the land.

This is no mean achievement.

The Senate legislation passed the very

close scrutiny of the House{,] which

investigated the bill for many months.

No significant changes were made, a

procedure which does not often occur

in bills sent over from the Senate.

Quoting Senator Dodd, 116 Cong. Rec. 35,051-52 (1970).

Fourteen years later, the 1984 amendments reveal that

once again Congress was concerned about a rampant drug

abuse problem, the diversion of otherwise lawful drugs to

illicit or recreational uses. The bill was aptly named the

Dangerous Drug Diversion Control Act of 1984 and it was

described as follows:

Mr. Speaker, I move to suspend

the rules and pass the bill (H.R. 5656)

to amend the Controlled Substances

Act to strengthen the authority to

prevent diversion of controlled

substances, and for other purposes, as

amended.

Quoting Representative Hughes, 130 Cong. Rec. 25,846

(1984) (emphasis added).

This bill addresses one of the

most critical areas of drug abuse, the

38

abuse of prescription drugs.

Prescription drugs are responsible for

close to 70 percent of the deaths and

injuries due to drug abuse. But I am

sorry to say this aspect of drug abuse,

the diversion problem, has often failed

to get the societal or the enforcement

attention that it deserves.

Quoting Representative Hughes, 130 Cong. Rec. 25,848

(1984) (emphasis added). The Attorney General would likely

take the "deaths and injuries" phrase above out of context,

just as he does in his petition and brief (see Pet. Cert. 23; Pet.

Br. 45: "misuse of a drug in suicides and attempted

suicides"), but the Congress was only concerned with illicit

use flowing from "diversion":

Diversion is the connotation for

the various means by which legitimate

medical controlled substances are

diverted from proper use to improper

use. Invalid prescriptions and

pharmacy robberies are two types of

retail level diversion. While much of

the drug enforcement focus has been

placed on the interdiction of

improperly imported substances, the

problem of domestic diversion has

quietly grown to _ staggering

proportions.

* * * _ Abuse of prescription drugs

through diversion at the manufacturing

and distribution levels [is] severely

39

curtailed under current law by DEA.

The vast majority of diversions occur

at the retail level. * * *.

**x** *

* * * This bill provides the Drug

Enforcement Agency with the necessary

tools to join State agencies in reducing

diversion.

Quoting Representative Sawyer, 130 Cong. Rec. 25,849

(1984) (emphasis added).

Mr. Speaker, I rise in strong

support of H.R. 5656, the Dangerous

Drug Diversion Control Act of 1984.

The bill amends the Controlled

Substances Act to attempt fo prevent

the diversion of controlled substances

from legitimate channels of medical

distribution and administration to

illegitimate channels for purposes of

abuse. Evidence suggests that

prescription drugs diverted by

legitimate medical distributors to the

illicit drug market accounts for about

three-fourths of deaths and injuries due

to drug abuse.

Quoting Representative Gilman, 130 Cong. Rec. 25,851

(1984) (emphasis added).

In sum, whether reviewing the 1970 or the 1984

legislative history, it is clear that the CSA was intended as a

solution to the problems of illicit drug use, drug trafficking,

40

and drug diversion. Congress never intended through the

CSA to empower the Attorney General to rule upon the

legitimacy of medical practice in the States.

Il. The States, not the Attorney General acting

through the Controlled Substances Act,

regulate medicine.

The Attorney General’s current interpretation of

"legitimate medical purpose" and the "public interest" results

in the direct regulation of medicine in the States and indeed

the Attorney General argues for a national standard of care,

e.g., that "the ‘standard of medical practice generally

recognized and accepted’ for purposes of the CSA, * * * is

: oy one." Pet. Br. 35, quoting Moore, supra, 423 U.S.

, 139.

The Attorney General further argues that there is a

trend away from the "locality rule" applicable in medical

malpractice actions, Pet. Br. 36, and complains that if the

CSA "incorporates the views of each of the 50 States * * *,

[then] the prosecution of physicians would become much

more difficult." Pet. Br. 35 (emphasis added).

The Attorney General commits several errors. First,

with respect to prosecuting physicians, fifty different state

malpractice standards should be of no consequence to the

Attorney General because malpractice--or ordinary medical

negligence--even when it involves controlled substances, is

not a criminal act. See nn. 11-14, supra.

Second, the "locality rule" presents an intrastate issue

only. In those states that have dispensed with the locality

rule, they have merely decided that the standard of care shall

41

be uniform throughout the state, in both rural and urban

settings, meaning that the rural practitioner is no longer held

to a lesser standard of care than is his or her big-city

counterpart. Thus, to the extent that a state dispenses with

the locality rule, it is a state-level decision only, it impacts

civil malpractice actions only, and it has no impact on federal

drug diversion prosecutions where the issue is whether a

DEA-registered practitioner is diverting controlled substances

out of the closed system, from legitimate to illicit channels.

Third, although some highly urban states have adopted

a standard of care that speaks in "national" terms,” these

2° Rhode Island provides a good example of the rationale behind

the adoption of a national standard of care:

In sum, the traditional locality rules no longer fit the

present-day medical malpractice case. * * *

* * * the Legislature failed to employ any reference

to the "similar locality" rule. We conclude that this

omission was deliberate and constitutes a recognition

of the national approach to the delivery of medical

services, especially in the urban centers of this

country, of which Rhode Island is certainly one.

Accordingly we join the growing number of

jurisdictions that have repudiated the “same or

similar” communities test in favor of a national

standard and hold that a physician is under a duty to

use the degree of care and skill that is expected of a

reasonably competent practitioner in the same class to

which he or she belongs, acting in the same or similar

circumstances.

Sheeley v. Memorial Hosp., 710 A.2d 161, 166-167 (R.1., 1998)

(emphasis added).

42

States are in the minority.”' More importantly, a state’s

decision to adopt a so-called national standard of care remains

a state-level decision, requiring the exercise of state power; it

does not mean that a state has surrendered its traditional role

to regulate medicine, or to legislate exceptions to its

"national" standard of care.

. Fourth, and perhaps most importantly, Oregon has

decided. When Oregon enacted, amended, and implemented

its Death With Dignity Act, it established the standard of care

regarding medical treatment near the end of life. Oregon also

continues its tradition of a community standard of care,

complete with a locality rule:

Duty of care; * * * (1) A

physician * * * licensed to practice

medicine * * * by the Board of

Medical Examiners for the State of

Oregon has the duty to use that degree

of care, skill and diligence that is used

by ordinarily careful physicians * * *

in the same or similar circumstances in

2! Contrary to the Attorney General’s argument that a national

standard of care predominates (Pet. Br. 36), more modern authority

than that cited by the Attorney General reveals that more than 30 years

later, less than half the states joined the trend that started in the 1970s.

See, e.g. Estate of Hagedorn ex rel. Hagedorn v. Peterson, 690 N.W.2d

84, 89 (lowa, 2004) (modified locality rule); Jinkins v. Lee, 807 N.E.2d

411, 421 (Ill, 2004) (locality rule); LaFramboise v. Thompson 329

F.Supp.2d 1054, 1056 (D.N.D., 2004) (locality rule); see, also, James

O. Pearson, Jr., J.D., Modern Status of “Locality Rule” in Malpractice

Action Against Physician Who is Not a Specialist, 99 A.L.R.3d 1133

(1980) (updated through 2004).

43

the community of the physician * * *

or a similar community.

Or. Rev. Stat. § 677.095 (emphasis added).

The Attorney General is no more empowered to reject

the standard of care set out in the Oregon Death With Dignity

Act than he is to reject Oregon’s community standard of care,

or its locality rule. These are state-level decisions, and it is

the States, not the Federal Government, that regulate

medicine. See, e.g., Linder v. United States, 268 U.S. 5, 18

(1924) ("Obviously, direct control of medical practice in the

States is beyond the power of the Federal Government");

Liggett Co. v. Baldridge, 278 U.S. 105, 112 (1928) (the

States have authority to regulate drug prescriptions and

pharmacists); Semler v. Dental Examiners, 294 U.S. 608, 611

(1934) (Oregon has authority to regulate the practice of

dentistry within its borders); United States v. Oregon Med.

Soc., 343 U.S. 326, 338 (1951) (practice of medicine within

Oregon is not interstate commerce); Barsky v. Board of

Regents, 347 U.S. 442, 449 (1953) ("It is elemental that a

state has broad power to establish and enforce standards of

conduct within its borders relative to the health of everyone

there. It is a vital part of a state’s police power"); Rush

Prudential HMO, Inc. v. Moran, 536 U.S. 355, 387 (2002)

(determination of medical necessity and standards of

reasonable care are "quintessentially state-law"

determinations). Although the Attorney General criticizes

Linder, supra, as an outdated Lochner-era opinion (Pet. Br.

37, 40), similar propositions are found in Barsky and Rush

Prudential HMO, supra.

This is no small point of dispute. The framers of the

Constitution "split the atom of sovereignty" two ways:

44

horizontally among the three branches of government and

vertically between the federal and state governments. See

Alden v. Maine, 527 U.S. 706, 714-15, 751 (1999); Printz vy.

United States, 521 U.S. 898, 921-22 (1997). As this Court

recently explained:

This separation of the two spheres is

one of the Constitution’s structural

protections of liberty. "Just as the

separation and independence of the

coordinate branches of the Federal

Government serve to prevent the

accumulation of excessive power in

any one branch, a healthy balance of

power between the States and the

Federal Government will reduce the

risk of tyranny and abuse from either

front."

Printz, 521 U.S. at 921 (emphasis added); quoting Gregory v.

Ashcroft, 501 U.S. 452, 458 (1991).

The Congress, when legislating and later amending the

CSA, was certainly aware of the traditional and constitutional

allocation of power that resides at the core of our federal

form of government, and it expressly provided that, "absent

a positive conflict," the CSA dves not prohibit the states from

legislating on, “subject matter which would otherwise be

within the authority of the State." See 21 U.S.C. § 903.”

*? Section 903 (Application of State law) provides:

(continued...)

45

Thus, the Attorney General may enforce the "uniform

national policy” intended by Congress to prevent illicit drug

use, drug trafficking, and drug diversion and, at the same

time, Oregon practitioners acting in accord with state law,

authorized by the Board of Medical Examiners and registered

with the DEA, may possess, prescribe, and/or dispense

schedule II substances within "the course of their professional

practice,” and in the “public interest." These two policies are

not mutually exclusive, and there is no positive conflict

between state and federal law such that the two "cannot

consistently stand together." 21 U.S.C. § 903. In view of the

plain language of the CSA, decades of jurisprudence, and the

demonstrated intent of Congress, all discussed above, the

Attorney General’s contrary interpretation of the CSA and its

implementing regulations seeks to accomplish too much. See

Raygor v. Regents of University of Minnesota, 534 U.S. 533,

543 (2002) ("When Congress intends to alter the usual

constitutional balance between the States and the Federal

Government, it must make its intention to do so unmistakably

clear in the language of the statute")(internal quotation marks

omitted).

2 continued)

No provision of this subchapter shall be construed as

indicating an intent on the part of the Congress fo occupy the

field in which that provision operates, including cnminal

penalties, to the exclusion of any State law on the same subject

matter which would otherwise be within the authority of the

State, unless there is a positive conflict between that provision

of this subchapter and that State law so that the two cannot

consistently stand together.

21 U.S.C. § 903 (emphasis added).

46

Ill. The power to regulate commerce between the

States does not authorize federal usurpation of

medical practice in the States, or the manner in

which Oregonians die.

For the purposes of this discussion, the power of

Congress to schedule or ban drugs, or to create a closed

system or regulation, is not challenged. However, the

Attorney General’s expansive reinterpretation of 21 C.F.R. §

1306.04 (legitimate medical purpose) and 21 U.S.C. § 823(f)

(public interest), does nothing to further those ends.

Congress, unlike the States, does not possess a general

police power. United States v. Lopez, 514 U.S. 549, 566-67

(1995). Rather, "[e}very law enacted by Congress must be

based on one or more of its powers enumerated in the

Constitution." United States v. Morrison, 529 U.S. 598, 607

(2000). The commerce power is the power, "to prescribe the

rule by which commerce is to be governed." Lopez, 514 U.S.

at 553; quoting, Gibbon v. Ogden, 9 Wheat. 1, 196 (1824).

Congress may not, “use a relatively trivial impact on

commerce as an excuse for broad general regulation of state

or private activities." Lopez, 514 U.S. at 558. Although

Statutes come to the courts bearing a presumption of

constitutionality, Morrison, 529 U.S. at 607, any enactment

that purports to be premised upon the commerce clause must

in fact bear a substantial relationship to the regulation of

interstate commerce. See, e.g., id at 613-19 (Congress

lacked authority to establish tort remedy for violence based

on gender); Lopez, 514 U.S. at 561-67 (Congress lacked

authority to prohibit carrying a gun within 1000 feet of a

school; impact upon interstate commerce was too attenuated).

47

Congressional enactments premised upon the power to

regulate commerce are more carefully scrutinized when they

invade areas of “traditional state concern." See, e.g., Lopez,

514 U.S. at 564-68. Regulating the practice of medicine has

long been regarded as a traditional state concern. See

discussion and authorities, supra, 41-45. To uphold the

Attorney General’s enforcement directive is to go from

regulating drug trafficking and diversion into regulating the

practice of medicine within the states, a line that may not be

crossed:

The authority of the federal

government may not be pushed to such

an extreme as to destroy the

distinction, which the commerce clause

itself establishes, between commerce

“among the several States" and the

internal concerns of a State. That

distinction * * * is vital to the

maintenance of our federal system.

Labor Board v. Jones & Laughlin, 301 U.S. 1, 30 (1937).

Each Congressional enactment and subsequent

interpretation must stand or fall on its own merits. The

provision at issue in Lopez was section 1,702 of the Crime

Control Act of 1990. This Court did not ask whether sections

1 through 1,701 were valid, or pertained to interstate

commerce, but focused exclusively upon section 1,702. Here,

the similarly narrow question is whether the Attorney

General’s expansive reinterpretation of a 1984 amendment

(see 21 U.S.C. § 823(f)--"public interest") and an agency rule

(see 21 C.F.R. § 1306.04--"legitimate medical purpose”),

exceeds the Commerce Clause power.

48

The prescriptions in question are issued by state-

licensed physicians, and filled by state-licensed pharmacists,

in full compliance with the closed system of control

established by the CSA. The prescriptions are to be used for

what the State of Oregon has determined is within the course

of professional practice. The medications are types

commonly prescribed by physicians, and there are no

allegations that these prescriptions have or will enter into the

stream of illicit commerce. The Federal Government’s

legitimate interest in regulating interstate commerce has been

fulfilled.

The concerns that led to this Court’s decision in Raich

do not apply here. Prescribing controlled substances to dying

Oregonians for use as authorized by the State would not

"leave a gaping hole" in the closed system of regulation, and

prohibiting such use is not "necessary and proper" to prevent

drug trafficking or drug diversion, which is the core purpose

of the CSA, especially those provisions upon which the

Attorney General relies. Indeed, the Attorney General does

not, and cannot, point to a hole in the closed system that his

new interpretation fills, nor can he explain how the purpose

of the CSA would be undercut if this activity is not regulated.

Although the Constitution grants certain powers to

Congress, the States have a constitutionally-protected role in

the federal scheme as, "residuary sovereigns and joint

participants in the governance of the Nation." Alden, supra,

527 U.S. at 748. The rights of the States are not confined to

those expressly enumerated in the text of the Constitution, but

also include other rights recognized at the time the

Constitution was ratified or implicit in its design. Id. at 713-

15, 728-32. “[{I}t was neither necessary nor proper to define

the powers retained by the States" because they retain all

49

powers they had before enactment of the Constitution, "except

so far as they may be abridged by that instrument." U_S.

Term Limits, Inc. v. Thornton, 514 U.S. 779, 801 (1995);

quoting Sturges v. Crowninshield, 4 Wheat. 122, 193 (1819).

Just as judicial enforcement of "separation of powers"

prevents one branch from usurping functions reserved for

another branch, the courts similarly enforce the vertical

separation of powers, to keep the Federal Government from

usurping the powers and role reserved for the States.

Morrison, 529 U.S. at 616-17, n.7. Here, the Attorney

General’s enforcement directive, specifically his expansive

reinterpretation of 21 C.F.R. § 1306.04 (legitimate medical

purpose) and 21 U.S.C. § 823(f) (public interest), is a direct

attempt to regulate medical practice in the States, and it

therefore exceeds not only the scope of the CSA, but also the

limits of the Congressional power to regulate commerce.

CONCLUSION

FOR THE FOREGOING REASONS, this Court is

urged to affirm the Ninth Circuit Court of Appeals.

Respectfully submitted,

ELI D. STUTSMAN

Counsel of Record

621 SW Morrison

Thirteenth Floor

Portland, OR 97205

July 21, 2005 (503) 274-4048