Amicus Curiae Brief — Gonzales v. Oregon

Iu The

Supreme Court of the Anited States

+

ALBERTO R. GONZALES,

ATTORNEY GENERAL, et al.,

Petitioners,

v.

STATE OF OREGON, et al.,

Respondents.

+

On Writ Of Certiorari To The

United States Court Of

For The Ninth Circuit

+

BRIEF OF THE STATES OF CALIFORNIA,

MISSISSIPPI, MISSOURI, MONTANA, AND THE

DISTRICT OF COLUMBIA AS AMICI CURIAE

IN SUPPORT OF RESPONDENT STATE OF OREGON

-¢@

BrLL LOCKYER

Attorney General of the

State of California

TAYLOR S. CAREY*

Special Assistant Attorney General

1300 I Street

P.O. Box 944255

Sacramento, CA 94244-2550

Telephone: (916) 324-7562

Fax: (916) 322-0206

*Counsel of Record

[Additional Counsel Listed On Inside Cover]

COCKLE LAW BRIEF PRINTING CO. (800) 225-6964

OR CALL COLLECT (402) 342-2831

Jim Hoop

Attorney General

State of Mississippi

Post Office Box 220

Jackson, MS 39205

(601) 359-3820

JEREMIAH W. (JAY) NIXON

Attorney General

State of Missouri

Supreme Court Building

207 West High Street

Jefferson City, MO 65101

(573) 751-3321

MIKE MCGRATH

Attorney General

State of Montana

P.O. Box 201401

Helena, MT 59620-1401

(406) 444-2026

ROBERT J. SPAGNOLETTI

Attorney General

District of Columbia

John A. Wilson Building

1350 Pennsylvania Ave., N.W.

Washington, D.C. 20004

(202) 727-3400

i

TABLE OF CONTENTS

Page

INTEREST OF AMICI CURIAE...o........cccccccccccccccescoeee. 1

SUMMARY OF ARGUMENT .0.0....occccccccccccccecesceseeeee. 2

EE a ne 3

ADMINISTRATIVE INTERFERENCE WITH

STATE AUTHORIZATION OF A MEDICAL

PROCEDURE MUST BE GROUNDED IN CON-

GRESS’ CLEARLY EXPRESSED INTENT TO

SUPERVISE STATE REGULATION OF MEDI-

CAL PRACTICE; NO SUCH EXPRESSION IS

EVIDENT IN THE CSA .....0......cccccccssssscescecceececeees 3

A. Regulation of Medical Practice, Including

End-of-life Issues, Is Traditionally Left to the

Sovereign and Independent Policy J udgment

REIS RELSI LIN ATEN OA Se LD 3

B. Congress Did Not Intend in the Controlled

Substances Act to Delegate to the Attorney

General Authority to Supervise State Regula-

tion of Medical Practice ................ccccccccecssecseocece 11

CONCLUSION ...............000.. statevensensececsesessesenseseesesessneees 16

ii

TABLE OF AUTHORITIES — Continued

Page

CASES

Addington v. Texas, 441 U.S. 418 (1979) ..........-csseeeeeeeereees 3

Alaska Department of Environmental Conservation

v. Environmental Protection Agency, 540 U.S.

461, 124 S.Ct. 983 (2004) ..........ccccesseeeeeeeeeeeensennenenenennnee 12

Anderson v. Dunn, 19 U.S. (6 Wheat.) 204 (1821).............. 8

Barsky v. Board of Regents of the State University

of New York, 347 U.S. 442 (1954) ...........cecceeeeereeeeeeeees 2,4

Buckman Company v. Plaintiffs’ Legal Committee,

B31 UB. B41 (BOOL) ......cccccccccecscccccesescccecscscccsvccosssossseees 14

Canterbury v. Spence, 464 F.2d 772 (C.A.D.C. 1972).......... 9

Christensen v. Thornby, 255 N.W. 620 (Minn. 1934).......... 6

Cruzan v. Director, Missouri Dept. of Health, 497

CEB, BBR CRGIID ccccceccnceccsnsssccsscesscnecssssesssssscssnsssssssssssseses 10

DeBuono v. NYSA-ILA Medical and Clinical Ser-

vices Fund, 520 U.S. 806 (1997)..........cccccccceeeeeeeereneenenes 12

Eastlake v. Forest City Enterprises, Inc., 526 U.S.

EE 3

FE.R.C. v. Mississippi, 456 U.S. 742 (1982)...........see0 9

Franchise Tax Bd. of California v. Hyatt, 538 U.S.

Fe 2,9

G.B. v. Lackner, 145 Cal.Rptr. 555 (Cal. App. 1978) .......... 7

Garcia v. San Antonio Metropolitan Transit Author-

ity, 469 U.S. 528 (1985) ...........cccerseeseenennenennennennnnnsenenens 10

Gonzalez v. Raich, 545 U.S. __, 125 S.Ct. 2195

ee 5, 12, 13

iii

TABLE OF AUTHORITIES - Continued

: Page

Griswold v. Connecticut, O0.T. 1964, No. 496, 4 See 5

Hillsborough County Florida v. Automated Medical

Laboratories, Inc. 471 U.S. 707 (1985)........c..cc0cceeeeceee. 12

Jessin v. Shasta County, 79 Cal.Rptr. 359 (Cal. App.

SPU crnersensesemsenicnnitenstaatensiispianiieapiialiliiiantsciiloeini tania 6

Linder v. United States, 268 U.S. 5 (1924) .........cccccccecees 1,4

Medtronic Inc. v. Lohr, 518 U.S. 470 (1996) ..........cc0000. 4,11

Metropolitan Life Ins. Co. v. Massachusetts, 471

eS Se iiriniceriieciasteyennpticnlisanbiciteiien Rabie taste idee 23) 4

Mistretta v. United States, 488 U.S. 361, 109 S.Ct.

RD Ga rccnnnnentencimnnticgiaiannessinniiiniianiinamiii indi aie lias 13

New State Ice Co. v. Liebmann, 285 U.S. 262 (1932)......3, 8

Planned Parenthood of Southeastern Pennsylvania

v. Casey, 505 U.S. 833 (1992) .........cccccccccscceecceseeeeeees 4,10

Poe v. Ullman, 367 U.S. 497 (1961) .........ccccccccceeseesereeeeeeee 10

Reeves v. Stake, 447 U.S. 429 (1980) .........c..cccccecceecceeceeeee 10

Roe v. Wade, 410 U.S. 113 (1973) ..........cccccccccescceecseeeeeeees 5, 6

Rush v. Johnson, 565 F.Supp. 856 (D.C. Ga. 1983)............ 7

Solid Waste Agency of Northern Cook County v.

United States Corps of Engineers, 531 U.S. 159

Seep ccneseneratinnnscnininancasaniniatiidiametitesie inate aia 2,11, 12

United States v. Moore, 423 U.S. 122 (1975) ..........cccceccee- 13

Washington v. Glucksburg, 521 U.S. 702 (1997)................. 9

iv

TABLE OF AUTHORITIES -— Continued

Page

STATUTES AND REGULATIONS

21 U.S.C. § BO] ef 909. ........00ccsersersereesessereseneescersnsssssossonees 14

21 U.S.C. § 801 ef 909. .........csccceressesrereeseerrsereressssseooers passim

16) 1.9 | 14

QB U.S.C. $ B2BaNA) ........ccccccccccccsescscrssssssererersesssesossssssess 14

, pes Tol T | | : 14

0. |) Ul 11

22A Am. Jur.2d Dead Bodies

BB (1GBB) .2.ccccccccccccececcsecesscocssocssccsoscsoscsesssossossssoosssssossseees 8

Cal. Health & Saf. Code,

§§ 24185, 125300 (2005) ...........-.ccceesceeeeeeeeeeeesneessrsssrnsenees 5

Cal. Pen. Code § 401 (2005) ............cccccccccsseeeeeeeeeeeeeneeennneees 1

Conn. Gen. Stat. Rev. § 53-33 (1958) ...........:seeeeeeeseerees 7

Miss. Code Ann. § 97-3-49 ............ccccccccscseseseeeeeereeeeeeeenseneees 1

Mo. Rev. Stat. § 565.023 (2000)...............ccccceeeeeeeeeeeerenreneeees 1

Mont. Code Ann. § 45-5-105 (2003)............--::cssseeeeeseerreeeees 1

N.J. Stat. Ann.

§ 26:2Z-2 (West Supp. 2004)..........-.ccccceereeeessenenenenerennnes 5

Or. Rev. Stat. §§ 127.800-127.995 (2003) ..............cccceeeeeeeees 4

Pub.L. No. 75-717, 52 Stat. 1040 (1938)...............-.eeeeeeees 14

OTHER AUTHORITIES

4 William Blackstone, Commentaries................-.-:-+:+0+++ 6, 8

15 Ops. Cal. Atty. Gem. 100 (1950) ............c-ccereseerreersenneenees 6

v

TABLE OF AUTHORITIES - Continued

Andrews, Legislators as Lobbyists: Proposed State

Regulation of Embryonic Stem Cell Research,

Therapeutic Cloning and Reproductive Cloning,

Appendix E to Monitoring Stem Cell Research,

President’s Council on Bioethics (January 2004)........... 5

Beck & Azari, FDA, Off-Label Use, and Informed

Consent: Debunking Myths and Misconceptions,

53 Food & Drug L.J. 71 (1998) .............ccccccceeceeesceeeesereees 14

Beh & Diamond, An Emerging Ethical and Medical

Dilemma: Should Physicians Perform Sex As-

signment Surgery on Infants With Ambiguous

Genitalia?, 7 Mich. J. Gender & L. 1 (2000)................... 7

Bridy, Confounding Extremities: Surgery at the

Medico-Ethical Limits of Self-Modification, 32

J.L. Med. & Ethics 148 (2004)...............ccccsccccssccsscceseceseee 7

Campbell & Glass, The Legal Status of Clinical and

Ethics Policies, Codes, and Guidelines in Medical

Practice and Research, 46 McGill L. J. 473 (2001)......... i)

Cate, Human Organ Transplantation: The Role of

Law, 20 J. Corp. L. 69 (1995) ..........c.esecccccssssssecssssorcesees 8

Champlin & Winslow, Elective Sterilization, U. Pa.

L. Rev. 415 (1965)

Graber, The Ghost of Abortion Past: Pre-Roe Abor-

tion Law in Action, 1 Va. J. Soc. Pol’y & L. 309

Gee eliectnntenccnssncennestveteiabiiiniiiinaiitiiiiatinepatadiiatiiainatinsineataaditins 5

vi

TABLE OF AUTHORITIES — Continued

Page

Keller, The Bed of Life: a Discussion of Organ

Donation, Its Legal And Scientific History, And a

Recommended “Opt-out” Solution to Organ Scar-

city, 32 Stetson L. Rev. 855 (Summer 2003) ................++ 8

Miller & Dean, Liability of Physicians for Steriliza-

tion Operations, XVI ABA Journal 158 (1930)................ 6

Tribe, American Constitutional Law (3d ed.) ...........:+++++++ 10

Twardy, Medicolegal Aspects of Transsexualism, 26

Medical Trial Technique Q. 249 (Winter 1980)............... 6

1

INTEREST OF AMICI CURIAE

Amici States all regulate the practice of medicine.

They are all concerned about the need to balance respect

for personal liberty and the interests of their broader

societies in addressing sensitive end-of-life issues. Amici

states all prohibit physician assisted suicide.’ Neverthe-

less, amici support the State of Oregon in this matter

because petitioners claim administrative authority to

interfere with Oregon’s regulation of the practice of medi-

cine. Such a claim must be supported by unmistakable

congressional authorization. It is not.

At issue here, is not the question of Congress’ author-

ity to regulate the practice of medicine. Rather, the ques-

tion is whether Congress intended in the Controlled

Substances Act (CSA), 21 U.S.C. § 801 et seg., to regulate

the practice of medicine. That is, did Congress intend to

delegate to the United States Attorney General authority

to supervise state regulation of the practice of medicine by

prosecuting duly licensed physicians and denying them

the ability to practice their trade — for lawfully prescribing

Schedule II drugs in medical procedures that the Attorney

General deems to be “illegitimate.”

Regulation of the practice of medicine has long been

regarded as the responsibility of the individual sovereign

States. 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.”).

Amici, therefore, join Oregon in contending that the

United States Attorney General’s assertion of the preroga-

tive to evaluate a State’s legislative policy concerning

* See, eg., Cal. Pen. Code § 401 (2005); Mo. Rev. Stat. § 565.023

(2000); Mont. Code Ann. § 45-5-105 (2003); Miss. Code Ann. § 97-3-49.

2

medical practice and the physician-patient relationship must

be grounded in “a clear indication that Congress intended

that result.” Solid Waste Agency of Northern Cook County v.

United States Corps of Engineers, 531 U.S. 159, 172 (2001).

Amici further contend that such a sweeping grant of federal

power is not included in the Controlled Substances Act.

+

SUMMARY OF ARGUMENT

Physicians have long understood that prescribing

Schedule II narcotics in violation of state law may subject

them to federal prosecution and loss of prescribing privi-

leges under the Controlled Substances Act. But, for the

first time in the 30-year history of that Act, duly licensed

physicians in Oregon face federal prosecution and admin-

istrative penalties because they prescribed a Schedule II

narcotic in full compliance with state law. The sole offense

of these doctors will be participation in a medical proce-

dure that, though sanctioned under Oregon state law, is

not similarly sanctioned by other States or by professional

organizations and is, therefore, deemed to be “illegitimate”

by the Attorney General of the United States.

This is a dramatic alteration of the traditional federal-

state allocation of legislative responsibility. States have

generally enjoyed “broad powers” in matters concerning

the practice of medicine for protection of the health and

welfare of their citizens. Barsky v. Board of Regents of the

State University of New York, 347 U.S. 442, 449 (1954).

And a value consensus among the States regarding medi-

cal matters is not a measure of the validity of any one

State’s legislative policy Cf., Franchise Tax Bd. of Califor-

nia v. Hyatt, 588 U.S. 488 (2003) (Full Faith and Credit

es

—

3

Clause does not compel a State to substitute statutes of

other States for its own statutes dealing with a subject

matter concerning which it is competent to legislate).

Indeed, experimentation by States in the regulation of

social matters has long been regarded as a bedrock of

Federalism. See New State Ice Co. v. Liebmann, 285 U.S.

262, 311 (1932) (Brandeis, J., dissenting) (States as “labo-

ratories” of democracy.) “The essence of federalism is that

states must be free to develop a variety of solutions to

problems and not be forced into a common, uniform mold.”

Addington v. Texas, 441 U.S. 418, 431 (1979).

. An intrusion into the traditional purview of state

legislative control by an administrative agency such as is

effected by the Attorney General’s “directive” here must be

grounded in a clear expression of congressional intent.

However, nothing in the Controlled Substances Act dele-

gates to the Attorney General authority to interfere with

State regulation of the practice of medicine.

+

ARGUMENT

ADMINISTRATIVE INTERFERENCE WITH STATE

AUTHORIZATION OF A MEDICAL PROCEDURE

MUST BE GROUNDED IN CONGRESS’ CLEARLY

EXPRESSED INTENT TO SUPERVISE STATE

REGULATION OF MEDICAL PRACTICE; NO SUCH

EXPRESSION IS EVIDENT IN THE CSA.

A. Regulation of Medical Practice, Including End-

of-life Issues, Is Traditionally Left to the Sov-

ereign and Independent Policy Jud

Each State. He mee

In November 1994, by ballot initiative, a “basic

instrument of democratic government,” Eastlake v. Forest

‘

City Enterprises, Inc., 526 U.S. 668, 679 (1966), Oregon

voters enacted the Death With Dignity Act, Or. Rev. Stat.

§§ 127.800-127.995 (2003). The citizens of Oregon subse-

quently reaffirmed the measure when, in November 1997,

an initiative seeking its repeal was defeated.

Traditionally, States “have had great latitude under

their police powers to legislate as to the protection of the

lives, limbs, health, comfort, and quiet of all persons,”

Medtronic Inc. v. Lohr, 518 U.S. 470, 475 (1996), quoting

Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724,

756 (1985). This Court has characterized as “elemental”

the proposition that States have “broad power” to establish

within their borders standards of conduct relative to

health. Barsky v. Board of Regents of the State University

of New York, 347 U.S. at 449; see also, Linder v. United

States, 268 U.S. at 18.

The scope of the States’ inherent authority over

medical practice cannot be confined to ascertaining

whether accepted medical procedures have been compe-

tently performed. It reasonably must include the authority

to decide what medical procedures are acceptable to

perform in the first instance and, within the Constitution's

limits, to specify the conditions under which medical

procedures may be lawfully performed. Cf, Planned

Parenthood of Southeastern Pennsylvania v. Casey, 505

U.S. 833, 846 (1992) (confirming State’s interest in regu-

lating abortion availability after viability).

Seldom have States been of one mind, as a matter of

legislative policy, about the “legitimacy” of every new

medical procedure that develops. Most recently, the Court

5

noted state variation in authorizing the use of Marijuana

in medical treatment. Gonzalez v. Raich, 545 U.S. —_—-

S.Ct. 2195, 2198-99 (2005) (noting that at least ten States

authorize marijuana for medical purposes). And today,

States wrestle with difficult ethical issues surrounding

human stem cell research. Eight States, for example, have

enacted explicit laws to ban reproductive cloning; four of

those also ban therapeutic cloning; and one State only

prohibits the use of state funding in reproductive cloning

Andrews, Legislators as Lobbyists: Proposed State Regula-

tion of Embryonic Stem Cell Research, Therapeutic Clon-

ing and Reproductive Cloning, Appendix E to Monitoring

Stem Cell Research, President’s Council on Bioethics

(January 2004). Some of the States that ban reproductive

cloning actively encourage therapeutic cloning.’

State policy disagreement over some medical proce-

dures has been a reality for much of our history. Birth

control and abortion are obvious examples of medical

procedures that some States came to accept as a matter of

state policy while others did not. At the time of this Court’s

decision in Griswold v. Connecticut, 381 U.S. 479 (1965),

for example, 30 States had laws relating to birth control.

See Brief for Appellee in Griswold v. Connecticut, O.T.

1964, No. 496, p. 7. In 1960, thirteen years before Roe v.

Wade, 410 U.S. 113 (1973), every state criminal code

included provisions forbidding abortion under most cir-

cumstances. Graber, The Ghost of Abortion Past: Pre-Roe

Abortion Law in Action, 1 Va. J. Soc. Pol'y & L. 309, 360

2 . . .

oe Available at: http://www. bioethics.gov/reports/stemcell/appendix_e.

* See, e.g., Cal. Health & Saf. Code, §§ 24185, 125300 (2005

Stat. Ann. § 26:27-2 (West Supp. 2004). ee

6

(1994). But by 1973, some state legislatures had removed

those restrictions,’ while in other States therapeutic

abortion remained a proscribed medical procedure as a

matter of local legislative choice.

Sex-reassignment surgery is another example of a

medical procedure whose “legitimacy” may be questioned

by some but which is nevertheless permitted in States

today. According to one commentator, “[t]he national and

international medical community overwhelmingly en-

dorses sex-reassignment surgery and hormones as the

only known medical treatment for transsexuals.” Hong,

Categorical Exclusions: Exploring Legal Responses to

Health Care Discrimination Against Transsexuals, 11

Colum. J. Gender & L. 88, 91 & n. 18 (2002). But at

common law, castration amounted to felonious mayhem, 4

William Blackstone, Commentaries *206, and consent to

mayhem was no defense, see Twardy, Medicolegal Aspects

of Transsexualism, 26 Medical Trial Technique Q. 249,

297-310 (Winter 1980). Indeed, in the opinion of some, the

common law criminalization of castration precluded even

voluntary vasectomy. See, e.g., 15 Ops. Cal. Atty. Gen. 100,

103 (1950), citing Miller & Dean, Liability of Physicians

for Sterilization Operations, XVI ABA Journal 158, 159

(1930); but see Jessin v. Shasta County, 79 Cal.Rptr. 359

(Cal. App. 1969); Christensen v. Thornby, 255 N.W. 620,

622 (Minn. 1934) (“[A vasectomy] does not render the

patient impotent or unable ‘to fight for the king,’ as was

* Prior to Roe, statutes permitting non-therapeutic abortions had

been enacted in Hawaii (1971), New York (1971), Alaska (1970) and

Washington (1971). Id.

7

the case in mayhem or maiming”).’ Today, no state ex-

pressly prohibits male-female sex-reassignment surgery,

though States are not always in agreement about the

therapeutic value of the medical procedure. Compare, e.g.,

Rush v. Johnson, 565 F.Supp. 856 (D.C. Ga. 1983); (State’s

determinations that “transsexual” surgery was not gener-

ally accepted by the professional medical community as a

proven and effective treatment and that there was no

authority of evidence that the surgery is safe and eifective

were reasonable) and G.B. v. Lackner, 145 Cal.Rptr. 555

(Cal. App. 1978) (proposed surgery to reconstruct genitalia

as treatment for gender identity dysphoria could not be

arbitrarily classified as “cosmetic” and thus claimant was

entitled to Medi-Cal assistance).’

The extremely important medical procedure of organ

transplantation could never have developed were it not for

* Still today, States must wrestle with the | i

whether sex-change operations may be aed pene adh =

intersexed children who are too young to consent. See, e.g., Beh &

Diamond, An Emerging Ethical and Medical Dilemma: Should Physi-

cians Perform Sex Assignment Surgery on Infants With Ambiguous

Genitalia?, 7 Mich. J. Gender & L. 1 (2000). And, as the complexity of

the human condition is slowly being recognized, States will be called

upon to consider the ethical and legal parameters appropriate to

medical disfigurement procedures at what are certainly the “outer

yaad of pop tem See, e.g., Bridy, Confounding Extremities:

thi sind ; :

red + — Limits of Self-Modification, 32 J.L. Med.

the willingness of States to depart from common law

proscriptions in deference to changes in public sentiment.

At common law, no one had power to convey his body parts

after death, because the common law recognized no prop-

erty right in one’s body See 22A Am. Jur. 2d Dead Bodies,

§ 3 (1988). And anatomical dissection at common law was

so reprehensible a notion as to have been reserved as an

additional post-mortem punishment to exact against the

corpse of an executed murderer. See 4 William Blackstone,

Commentaries *202; Keller, The Bed of Life: a Discussion

of Organ Donation, Its Legal And Scientific History, And a

Recommended “Opt-out” Solution to Organ Scarcity, 32

Stetson L. Rev. 855, 863-64 (Summer 2003). States ini-

tially differed on their treatment of body and organ dona-

tion, but in the 1960s, the National Conference of

Commissioners on Uniform State Laws began the process

of formulating a modei organ donation act. By 1972, some

version of the Uniform Anatomical Gift Act had been

adopted in every State and the District of Columbia. See

Cate, Human Organ Transplantation: The Role of Law, 20

J. Corp. L. 69, 71 & n. 24 (1995).

Advances in medicine and advances in understanding

of the human physical and psychological condition increas-

ingly present issues of great sensitivity and controversy.

But, “[tJhe science of government ... is the science of

experiment,” Anderson v. Dunn, 19 U.S. (6 Wheat.) 204,

226 (1821), and the Court has often acknowledged the

States’ important role as “laboratories” of democracy. New

State Ice Co. v. Liebmann 285 U.S. 262, 311 (1932)

(Brandeis, J., dissenting) (“It is one of the happy incidents

of the federal system that a single courageous state may, if

its citizens choose, serve as a laboratory; and try novel

social and economic experiments without risk to the rest of

the country.”) The Constitution does not compel policy

consensus among the States. Cf. Franchise Tax Bd. of

California v. Hyatt, 538 U.S. 488 (2003) (Full Faith and

Credit Clause does not compel a State to substitute statutes

of other States for its own statutes dealing with a subject

matter concerning which it is competent to legislate).’

State experimentation in social policy has been the

source of many important innovations, such as the right of

women to vote, the advent of unemployment insurance

and minimum-wage laws, and environmental protection.

See FE.R.C. v. Mississippi, 456 U.S. 742, 788-89 (1982)

(O’Connor, J., dissenting). The Court recognized nearly a

decade ago that the States were “engaged in serious,

thoughtful examinations of physician-assisted suicide and

other similar issues.” Washington v. Glucksburg, 521 U.S.

702, 719 (1997). Indeed, the Court was concerned that, by

extending constitutional protection to an asserted right to

end one’s life, it would, “to a great extent, place the matter

Pye the arena of public debate and legislative action.”

at 720.

" Nor have the States surrendered their policy-making responsibil-

ity to professional associations. At best, the views and opinions of

professional associations amount to a kind of “soft law,” Campbell &

Guidelines in Medical Practice and Research, 46 McGill L. J. 473

10

Federalism’s wisdom of deferring to the States’ inven-

tiveness for solving pressing issues of public health and

welfare has no less force because one State’s experiment

challenges conventional norms. Reflection on the tradi-

tions from which States break is as important as reflection

on the traditions to which they adhere in discerning an

appropriate constitutional balance between respect for

individual rights and the demands of organized society.

See Poe v. Ullman, 367 U.S. 497, 542 (1961) (Harlan, J.,

dissenting from dismissal on jurisdictional grounds),

quoted in Planned Parenthood of Southeastern Pennsyl-

vania v. Casey, 505 U.S. 833, 849 (1992); ef., Garcia v. San

Antonio Metropolitan Transit Authority, 469 U.S. 528, 545-

46 (1985) (The “essence of our federal system is that

within the realm of authority left open to them under the

Constitution, the States must be equally free to engage in

any activity that their citizens choose for the common

weal, no matter how unorthodox or unnecessary anyone

else ... deems state involvement to be.”). If “federalism’s

capacity for institutional innovation,” Tribe, American

Constitutional Law (3d ed.) 910, justifies deference to state

experimentation with remedies for chronic cement short-

ages, see Reeves v. Stake, 447 U.S. 429, 441 (1980), it

surely justifies deference to state experimentation in

resolution of “the difficult, indeed agonizing, questions

that are presented by the constantly increasing power of

science to keep the human body alive for longer than any

reasonable person would want to inhabit it.” Cruzan v.

Director, Missouri Dept. of Health, 497 U.S. 261, 292

(1990) (Scalia, J., concurring).

11

B. Congress iid Not Intend in the Controlled

added dante

Medical Practice.

This case does not present the question whether

Congress could, under the Commerce Clause, preempt the

States in regulating physician treatment of end-of-life

matters, though the presumption would certainly be

against such preemption. Medtronic, Inc., 518 U.S. at 485.

Cony eae, pean Case do aah eqnantly exgue Gat

ngress intended in CSA to preem regulati

of end-of-life medical decisions. sess we

Rather, petitioners rely on the phrase “legitimate

medical purpose,” which appears in an administrative

regulation implementing the CSA, 21 C.FR. 1306.04.

Certainly, that phrase gives the Attorney General power to

evaluate the veracity of a physician’s asserted justification

for prescribing a Schedule II drug. But petitioners argue

that the phrase must also be understood to authorize the

meery oy to evaluate the merits of a State's

we peliey in eutherial aed :

state law in the first instance. "8 -

Inasmuch as petitioners claim delegation of the power

to preemptively interfere with Oregon’s choice to authorize

Oregon physicians to perform a medical procedure exclu-

sively within that State, petitioners “invoke the outer limits

of Congress’ power” and must, therefore, demonstrate “a

clear indication that Congress intended that result.” Solid

Waste Agency of Northern Cook County v. United States

Corps of Engineers, 531 U.S. 159, 172 (2001); see also

Gregory v. Ashcroft, 501 U.S. 452, 460 (1991) (“[I}f Congress

intends to alter the usual constitutional balance between

the States and the Federal Government, it must make its

12

intention to do so unmistakably clear in the language of

the statute”); Alaska Department of Environmental Con-

servation v. Environmental Protection Agency, 540 U.S.

461, 513 (2004) (Kennedy, J., concurring) (“liJf, by some

course of reasoning, state(s] ... must live with the insult

that their judgments can be revised by a federal agency,

the Court should at least insist upon a clear instruction

from Congress.”)* Whether Congress has the power to

impose on a State its view of the “legitimacy” of a medical

procedure is not presented here.” Rather, the question here

* Petitioners dismiss Solid Waste Agency as irrelevant. Br. for Pet.

at 41 n. 16. But petitioners would have the Court read Solid Waste

Agency at such a high level of abstraction as to render it meaningless to

limit exercise of administrative authority. In this case, the United

States Atvorney General does not merely invoke congressional power to

regulate the jistribution of controlled substances as a matter of

interstate commerce. Rather, the Attorney General invokes an asserted

congressional power to determine — for the States - the “legitimacy” as a

medical procedure of a use to which a Schedule II drug may lawfully be

put under state law. Such a power, touching as it does on an area of

traditional state governance, is indeed at the “outer limits” of congres-

sional authority. Cf., Hillsborough County Florida v. Automated

Medical Laboratories, Inc., 471 U.S. 707, 715 (1985) (presumption

against an intent by Congress in the FDA to preempt local regulation

for the protection of blood plasma donors); see also, DeBuono v. NYSA-

ILA Medical and Clinical Services Fund, 520 U.S. 806, 807 (1997) (no

ERISA preemption of state health facility assessment because the

assessment “clearly operates in a field that has been traditionally

occupied by the States: the regulation of health and safety matters.”).

* This Court has not yet squarely addressed the question of

Congress’ power to preempt a State's legislative determination that

marijuana has a legitimate medical purpose. See Gonzalez v. Raich, 125

S.Ct. at 2204-05 (2005) (“[Rlespondents’ challenge is actually quite

limited; they argue that the CSA’s categorical prohibition of the

manufacture and possession of marijuana as applied to the intrastate

manufacture and possession of marijuana for medical purposes

Raich held only that, given Congress’ determination that marijuana has

(Continued on following page)

13

is whether in the CSA can be found a delegation

to the

Attorney General of authority preemptively to interfere

with a State’s administration of its medical practice laws

based on an evaluation of the authorized practice's “le-

gitimacy” ~ especially when “legitimacy” is not measured

against a constitutional standard, but by the approbation

of other States and professional medical organizations

The “main objectives of the CSA were to

conquer drug

abuse and to control the legitimate and illegitimate traffic

in controlled substances.” Gonzalez v. Raich, 545 U.S.

(2005). The CSA was “designed to deal in comprehensive

fashion with the growing menace of drug abuse in the

ony States|[.]” United States v. Moore, 423 U.S. 122, 141

This is not to suggest, of course, that the

General lacks rule making sadhestie entie teat en

the Attorney General’s use of his rule making authority in

this instance expands the role of his office into a sort of

‘Junior-varsity Congress,” Mistretta v. United States 488

US. 361, 472, 109 S.Ct. 647, 683 (1989) (Scalia, J., dis-

senting), substituting a federal agency's notions of medical

propriety for the informal legislative policy of the States.

no accepted medical use in treatment - a proposition with which

Stateo wave grestmaiiy in agpeement of Ge Gan of exudes

Congress may lawfully proscribe even wholly intrastate cultivation and

use of marijuana, notwithstanding cultiva

lawful under state law. —— tien and use may be

a

14

Certainly, the legislative history of the CSA suggests a

congressional intent to regulate the abuse of prescription

privileges to furnish Schedule II drugs in a manner incon-

sistent with accepted medical practice in a State. See 28

U.S.C. §§ 823(f) & 823(a)(4). But nothing in the legislative

history of the Act suggests Congress’ intention to correct

State authorization of permissible uses of Schedule II

narcotics.

This “hands-off” policy in respect to regulation of the

practice of medicine is consistent with the historic under-

standing of Congress’ intent under the Food, Drug and

Cosmetic Act, Pub.L. No. 75-717, 52 Stat. 1040 (1938),

codified as amended 21 U.S.C. § 301 et seg. (1994). Under

long-standing practice, physicians may use legally mar-

keted drugs in any way that they believe, in their profes-

sional judgment, will best serve their patients - a

prerogative that is repeatedly recognized by the courts and

the FDA itself. See Beck & Azari, FDA, Off-Label Use, and

Informed Consent: Debunking Myths and Misconceptions,

53 Food & Drug L.J. 71, 76-77 (1998), cited in Buckman

Company v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350

(2001). Moreover, several state statutes recognize off-label

uses in varying contexts. Beck & Azari, supra, at 76 n. 56.

Nothing in the CSA suggests Congress’ intent to change

this paradigm of deferring to state regulation of profes-

sional prescription practices. Indeed, Congress expressly

stated its intention not to preempt state laws that are

otherwise within the authority of a State to enact. 21

U.S.C. § 903.

It is evident that former Attorney General Janet Reno

saw nothing in the Act or its legislative history to per-

suade her in 1998 of Congress’ intent to enter this area. To

the contrary, she noted in a letter to the Chairman of the

15

House Judiciary Committee that the CSA was not “in-

tended to displace the states as the primary regulators of

the medical profession or to override a state’s determina-

tion as to what constitutes legitimate medical practice.”

See Pet. App. 7a. The CSA has not been amended since

1998 to suggest that Attorney General Reno was wrong.”

Certainly, Congress can state legislative policies

under its Commerce Clause powers. And Congress has

nullified state legislative choices in furtherance of its

powers under the Fourteenth and Fifteenth Amendments.

But Amici are unaware of any context wherein it was

shown that Congress intended to delegate to an adminis-

trative agency the power to nullify a state legislative

policy, in an area of traditional state regulation, applying a

standard of “legitimacy” — measured, not by the Constitu-

tion or by reference to conflicting federal enactment, but

rather by the policy's acceptance by other States and

professional organizations. Merely to state the proposition

is to demonstrate its anomaly.

Even if it be assumed that Congress would have the

power to make such a delegation of supervisory authority,

the delegation must necessarily be unmistakable. And no

grant of such authority is evident in the CSA.

SJ

” In 1998 and 1999, Congress refused passage of a measure to

amend the CSA to authorize the United States Attorney General to

revoke the registration of practitioners who “intentionally dispensed or

distributed a controlled substance with a purpose of causing, or

assisting in causing, the suicide or euthanasia of any individual.” H.R.

4006, 105th Cong. (1998) (“Lethal Drug Abuse Prevention Act of 1998”).

16

CONCLUSION

The judgment of the Court of Appeals should be

affirmed.

Respectfully submitted,

BILL LOCKYER

Attorney General

of the State of California

TAYLOR S. CAREY

Special Assistant Attorney General

Counsel for Amici States