Amicus Curiae Brief — Gonzales v. Oregon

(y)

MAY 11

No. 04-623 me eG

In The

Supreme Court of the Gnited States

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ALBERTO GONZALES, ATTORNEY GENERAL,

IN HIS OFFICIAL CAPACITY, ET AL.,

Petitioners,

v.

STATE OF OREGON, ET AL..,

Respondents.

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On Writ Of Certiorari To The

United States Court Of Appeals

For The Ninth Circuit

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BRIEF AMICUS CURIAE OF THE CATHOLIC

MEDICAL ASSOCIATION IN SUPPORT OF

PETITIONERS AND IN SUPPORT OF REVERSAL

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TERESA STANTON COLLETT

Professor of Law

University of St. Thomas

School of Law

MSL 400

1000 LaSalle Avenue

Minneapolis, MN 55403-2015

(651) 962-4973

Fax (651) 962-4996

tscollett@stthomas.edu

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COCKLE LAW BRIEF PRINTING CO (800) 225-6964

OR CALL COLLECT (402) 342-2831

TABLE OF CONTENTS

Page

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SUMMARY OF ARGUMENT. ................ccssecccsssseeeeseees 1

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I. Defining “legitimate medical practice” in

terms of national practice is consistent with

the norms of the medical profession as evi-

denced by professional standards regarding

medical education, licensure, and the liabil-

IN ccstciscsisisichicieenineieanintnnsitintinniiinnininane 4

II. Abuse of prescription drugs and the need for

a uniform definition of “legitimate medical

purpose” for enforcement purposes supports

the interpretation contained in the Ashcroft

a lacnianesbeinsiiveipedinitniniiiemtnstimicuinceiein 6

III. The statutory definition of drugs subject to

prescription would be rendered nonsensical

by including assisting with suicide as a “le-

gitimate medical purpose.”..................:cceeeeees 7

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TABLE OF AUTHORITIES

Page

CASES

Barsky v. Board of Regents, 347 U.S. 442 (1954)................ 7

Minnesota ex rel. Whipple v. Martinson, 256 U.S. 41

) | | En ne! eee 7

Nadler v. West Park Hosp., 254 F.3d 1168 (10th Cir.

BBE) .ccccocrsccssceccevscesecnssssenssnsesnsnnssonsuneininainnnnnnnnnnnnnn 5

O Centro Espirita Beneficiente Uniao Do Vegetal v.

Ashcroft, 389 F.3d 973 (10th Cir. 2004)............ cc ccceeeeeeeeee 7

Oregon v. Ashcroft, 368 F.3d 1118 (9th Cir. 2004)............... 4

People ex rel. Oakland County Prosecuting Atty. v.

Kevorkian, 534 N.W.2d 172 (Mich. App., 1995) ............ 10

Robinson v. California, 370 U.S. 660 (1962)..................000 7

Shilkret v. Annapolis Emergency Hosp. Assn., 349

PS) 6G, ee ee 5

Swan v. Lamb, 584 P.2d 814 (Utah 1978)................ccccceeeeee 5

United States v. Moore, 423 U.S. 122 (1975) .................00 2

United States v. Oakland Cannabis Buyers’ Coop-

erative, 532 U.S. 483 (2001) seecseevenseceesencnssscovensesoesoesssoeees 3

United States v. Rutherford, 442 U.S. 544 (1979)........ 3, 8, 9

Whalen v. Roe, 429 U.S. 589 (1977) .......cccccceeseseeeeeneeeeeees 7

STATUTES

BA UBC. § GIRARD ..nccccccccccsessosssscicccnsiesitnnesssnennnuananananniann 3

BI UB.G. GB GBB-GOS ..cccccoccccescccccossccssssvenesesssseessnueassnsnenanans 2

TABLE OF AUTHORITIES — Continued

Page

EE 2

a 3,4

OTHER

David B. Brushwood, The Professional Capabilities

and Legal Responsibilities of Pharmacists: Should

“Can” Imply “Ought”?, 44 Drake L. Rev. 439 (1996)......2, 9

Federation of State Medical Boards. Examinations

at http://www.fsmb.org (visited May 5, 2005)................. 4

National Drug Intelligence Center, Pharmaceuti-

cals Drug Threat Assessment (Nov. 2004)..................000 6

National Drug Intelligence Center, Reducing

Prescription Drug Abuse (2004) ............c.cccccccceseeseeeeeeeees 6

OXFORD ENGLISH DICTIONARY (2d ed. 1989)................c000000 9

Pope John Paul II, On Faith and Reason (1998)................ 1

Steven A. Wartman & John H. Littlefield, Changes

in the US Medical Licensure Examination and

Impact on US Medical Schools, 293 JAMA 424

EE LLL 4

S. 5, 74th Cong., Ist Sess. § 201(b), 79 Cong. Rec.

EE 3

1

INTF2EST OF AMICUS’

The Catholic Medical Association is a professional

association of American and Canadian physicians, who seek

to respond to the unique responsibility belonging to all

health-care personnel as guardians and servants of human

life and human dignity. Its members are conscious of the

fact that their patients entrust themselves to the knowledge

As Pope John Paul, IT noted in On Faith and Reason (1998),

“On the one hand, the knowledge acquired through belief

can seem an imperfect form of knowledge, to be perfected

gradually through personal accumulation of evidence; on

the other hand, belief is often humanly richer than mere

evidence, because it involves an interpersonal relationship

and brings into play not only a person’s capacity to know but

also the deeper capacity to entrust oneself to others. . . . ” Jd.

at { 32. This capacity to entrust oneself to others lies at the

heart of the patient-physician relationship, and at the heart

of the patient-physician relationship. The Catholic Medical

Association hopes to assist the Court in properly understand-

ing the impact of this case upon that relationship.

o

SUMMARY OF ARGUMENT

Act was to centralize the enforcement of drug laws to

address the national problem of drug abuse. Congress

rightly understood that an effective response would require

* No counsel for any party authored any portion of this brief. No

persons other than amicus curiae, their members, or their counsel have

made a monetary contribution to the preparation and submission of

this brief. The written consents of the parties will be filed with the

Clerk of the Court pursuant to Supreme Court Rule 37.3.

2

sensitivity to the legitimate role of the medical profession

in fighting disease, restoring health and alleviating

human suffering. It would also require uniform charac-

terization, utilization and availability of drugs to be

determined at the national level. The Attorney General’s

construction of the Act and the implementing regulations

reflect these Congressional concerns and the reality of

contemporary medical practice. In contrast, the position of

the Respondents renders the national design of drug

approval incoherent and federal enforcement subject to the

dictates of state authorities. For these reasons the rulings

of the lower courts must be reversed.

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ARGUMENT

Federal regulation of drugs is based in part on the

reasonable belief that “sick people must be protected from

quacks, charlatans, and those who raise false hopes and

take advantage of human suffering.” The Controlled

Substances Act (“CSA”), 21 U.S.C. §§ 801-904, furthers

society's goal of protecting citizens from both contempo-

rary snake-oil salesmen and drug pushers’ by directing the

Attorney General of the United States to place prescrip-

tion drugs on a statutory schedule after assessing the

drugs for three factors: the drug’s potential for abuse, its

current accepted medical uses, and the possibility that

abuse of the drug will lead to physical or psychological

dependency. 21 U.S.C. § 812.

* David B. py ey very bey rg hd

Responsibilities of Pharmacists: Should “Can” Imply “Ought"?, 44

Drake L. Rev. 439, 450 (1996).

* United States v. Moore, 423 U.S. 122, 143 (1975) (defendant

“acted as a large-scale ‘pusher’ not as a physician.”

3

By including “current accepted medical uses” Con-

gress protected the authentic autonomy of the medical

profession. The history of the Federal Food, Drug, and

Cosmetic Act reveals that the first bill to pass either house

of Congress that was substantially similar to the present

Act included within its definition of “drug” the qualifica-

tion that it did not apply to “the regulation of the legalized

practice of the healing art.” S. 5, 74th Cong., Ist Sess.

§ 201(b), 79 Cong. Rec. 8351 (1935). While the definition of

“drug” as ultimately enacted did not include this proviso,

see 21 U.S.C. § 321(g) (1976), the legislative history makes

clear that Congress has always sought to protect physi-

cians’ ability to treat their patients, while simultaneously

insuring the efficacy and safety of drugs. In promulgating

21 C.F.R. § 1306.4(a) the Attorney General also recognized

the necessary professional discretion of doctors. “A pre-

scription for a controlled substance to be effective must be

issued for a legitimate medical purpose by an individual

practitioner acting in the usual course of his professional

practice.” Id.

The present case requires this Court to determine

once again whether national or state standards determine

legitimate medical practices for purposes of drug regula-

tions. Cf. United States v. Rutherford, 442 U.S. 544 (1979)

(no exception to FDA approval requirements for Laetrile

administered only to terminally ill patients notwithstand-

ing approval by seventeen states) and United States v.

Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483

(2001) (federal law controls over state law regarding the

distribution of marijuana).

4

I. DEFINING “LEGITIMATE MEDICAL PRAC-

TICE” IN TERMS OF NATIONAL PRACTICE IS

CONSISTENT WITH THE NORMS OF THE

MEDICAL PROFESSION AS EVIDENCED BY

PROFESSIONAL STANDARDS REGARDING

MEDICAL EDUCATION, LICENSURE, AND

THE LIABILITY OF PHYSICIANS.

Defining “legitimate medical practice” by national

norms, rather than the isolated practice of a single state is

a permissible construction of 21 C.F.R. § 1306.4(a), whether

this Court examines the Ashcroft Directive with substantial

deference to the judgment of the Attorney General, or under

a less deferential standard. See Oregon v. Ashcroft, 368 F.3d

1118, 1144 (9th Cir. 2004) (Wallace, J. dissenting). The

medical profession, itself, is increasingly adopting national

standards for self regulation as evidenced by the pervasive

use of a national admissions test for medical school, the

Medical College Admission Test, and the universal re-

quirement that students pass the United States Medical

Licensing Exam in order to obtain a medical license. See

Federation of State Medical Boards, Examinations at

http://www.fsmb. org (visited May 5, 2005). These two tests

alone tend to standardize medical school curriculum, since

medical students who have successfully competed for their

spots in medical school on the basis of a particular test are

more likely to bring similar abilities to their medical

education. Likewise medical schools insure that their

faculty transmits the knowledge and skills that are neces-

sary for students to succeed in passing the United States

Medical Licensing Exam since that is the gateway to

professional licensure. See Steven A. Wartman & John H.

Littlefield, Changes in the US Medical Licensure Examina-

tion and Impact on US Medical Schools, 293 JAMA 424

(2005) (documenting changes in curriculum due to changes

in Medical] Licensure Exam).

5

This trend toward national standards is also evident

in courts’ adoption of a national standard of care for

assessing attorney conduct in medical malpractice cases.

The modern physician bears little resemblance to

his predecessors. As we have indicated at length,

the medical schools of yesterday could not possi-

bly compare with the accredited institutions of

today, many of which are associated with teach-

ing hospitals. But the contrast merely begins at

that point in the medical career: vastly superior

postgraduate training, the dynamic impact of

modern communications and transportation, the

proliferation of medical literature, frequent

seminars and conferences on a variety of profes-

sional subjects, and the growing availability of

modern clinical facilities are but some of the de-

velopments in the medical profession which com-

bine to produce contemporary standards that are

not only much higher than they were just a few

short years ago, but also are national in scope.

Shilkret v. Annapolis Emergency Hosp. Assn., 349 A.2d

245, 252 (Md. 1975). See also Swan v. Lamb, 584 P.2d 814,

817 (Utah 1978).

As the Tenth Circuit has noted, “The growing majority

of jurisdictions employ some variation of the national

standard of care: a physician has a duty to employ the

same reasonable diligence, skill, competence, and pru-

dence as a minimally competent practitioner in the same

general specialty, without regard to whether the care is

delivered in an urban or rural setting.” Nadler v. West

Park Hosp., 254 F.3d 1168, 1176 (10th Cir. 2001).

With the medical profession increasingly relying upon

national assessments for those who are entering the

profession, and with doctors being held accountable under

national standards of care, the Attorney General’s use of

6

national norms to define “legitimate medical practice” is

clearly a permissible construction of the regulations

regarding the prescribing privileges of physicians.

II. ABUSE OF PRESCRIPTION DRUGS AND THE

NEED FOR A UNIFORM DEFINITION OF “LE-

GITIMATE MEDICAL PURPOSE” FOR EN-

FORCEMENT PURPOSES SUPPORTS THE

INTERPRETATION CONTAINED IN THE

ASHCROFT DIRECTIVE.

Nationwide, the rate of abuse for pharmaceuti-

culs [prescription drugs] is relatively high com-

pared with rates of abuse for other drug types.

National Survey on Drug Use and Health

(NSDUH) data indicate that 6.3 percent of per-

sons aged 12 or older reported nonmedical use of

any prescription-type pain reliever, tranquilizer,

stimulant (including both illicit and prescription

methamphetamine), or sedative (not including

over-the-counter drugs) in 2003, second only to

marijuana (10.6%) and much higher than cocaine

(2.5%) and heroin (0.1%).

National Drug Intelligence Center, Pharmaceuticals Drug

Threat Assessment 2 (Nov. 2004). Nearly fourteen percent

of young people between the ages of 12 and 17 report

having used prescription drugs for non-medical purposes at

some point in their lives. National Drug Intelligence Center,

Reducing Prescription Drug Abuse 1 (2004) at http://www.

whitehousedrugpolicy.gov/news/press04/prescrip_fs.pdf (last

visited at May 5, 2005). In the past ten years emergency

room visits associated with narcotic pain relievers have

increased 163%. Id. Illegal prescribing by physicians is a

significant source of this problem. Pharmaceuticals Drug

Threat Assessment at 6.

7

To require the Attorney General to accommodate a

state’s deviation from common medical practices as de-

manded by the Respondents in this case risks compound-

ing the existing problem of prescription drug abuse by

multiplying the applicable legal standards to be applied by

law enforcement in evaluating the conduct of the prescrib-

ing physician. This lack of uniformity in drug control laws

is one of the very ills that the CSA was intended to elimi-

nate. O Centro Espirita Beneficiente Uniao Do Vegetal v.

Ashcroft, 389 F.3d 973, 984 (10th Cir. 2004) (Murphy J.

concurring in part and dissenting in part) (congressional

findings in CSA speak to a need for uniformity in admini-

stration given the serious problem of drug abuse in the

United States). The Attorney General’s use of a uniform

standard of “legitimate medical practice” for physicians

prescribing controlled substances in all states is clearly a

permissible construction of the regulations under the CCA.

lil, THE STATUTORY DEFINITION OF DRUGS

SUBJECT TO PRESCRIPTION WOULD BE

RENDERED NONSENSICAL BY INCLUDING

ASSISTING WITH SUICIDE AS A “LEGITI-

MATE MEDICAL PURPOSE.”

In Whalen v. Roe, the Court stated, “It is, of course,

well settled that the State has broad police powers in

regulating the administration of drugs by the health

professions.” 429 U.S. 589, 603 n.30 (1977), citing Robin-

son v. California, 370 U.S. 660, 664-665 (1962); Minnesota

ex rel. Whipple v. Martinson, 256 U.S. 41, 45 (1921); and

Barsky v. Board of Regents, 347 U.S. 442, 449 (1954).

“Although the State no doubt could prohibit entirely the

use of particular Schedule II drugs, it has not done so.” Id.

at 603. Schedule II drugs “have accepted uses in the

amelioration of pain and in the treatment of [various

diseases]” (id. at 593 n.8); they are safe and effective, but

8

are also liable to abuse. If a state may prohibit entirely the

use of such drugs, then surely the government may re-

strict the circumstances of their use.

The contours of this case are deceptively narrow. The

claim urged at present is only in support of a judgment that

prohibits the federal government from interfering with

access by Oregon physicians assisting terminally ill pa-

tients in accordance with that state’s law. But the logic of

the claim goes touch further. If, as the lower courts held,

state law determines the right of access to any drug, then it

is difficult to see how the CSA can be enforced with respect

to any drug if a state chooses to legislate to the contrary.

This Court confronted a similar issue in United States

v. Rutherford, 442 U.S. 544 (1979) when reviewing a lower

court decision that exempted the drug Laetrile from FDA

approval when used by terminally ill cancer patients.

Seventeen states had legalized the use of Laetrile for

cancer treatment, notwithstanding the fact that the drug

had not been approved by the FDA. Jd. at 554, n. 10. The

lower court had ruled that the FDA requirements of safety

and effectiveness had no reasonable application to termi-

nally ill patients, and thus doctors were free to prescribe it

for cancer patients who were dying. Jd. at 551.

In reversing the court of appeals, this Court observed,

“To accept the proposition that the safety and efficacy stan-

dards of the Act have no relevance for terminal patients is to

deny the Commissioner’s authority over all drugs, however

toxic or ineffectual, for such individuals.” Similarly, to accept

Respondents’ characterization of assisting suicide as a

“legitimate medical purpose” is to render virtually meaning-

less the safety and efficacy analysis engaged in by the FDA

9

when evaluating drugs.‘ The Oxford English Dictionary

defines safety as “exemption from hurt or injury.” OxFORD

ENGLISH DICTIONARY (2d ed. 1989). If inducing death is a

legitimate use of the drug under consideration, how is the

safety of that drug to be assessed? Does death become

merely a possible adverse side effect for some uses, or is it

simply another indicated use?

As this Court so presciently noted in the Rutherford

case:

If history is any guide, this new market would

not be long overlooked. Since the turn of the cen-

tury, resourceful entrepreneurs have advertised a

wide variety of purportedly simple and painless

cures for cancer, including liniments of turpen-

tine, mustard, oil, eggs, and ammonia; peat

moss; arrangements of colored floodlamps; pastes

made from glycerin and limburger cheese; min-

eral tablets; and “Fountain of Youth” mixtures of

spices, oil, and suet. In citing these examples, we

do not, of course, intend to deprecate the sincer-

ity of Laetrile’s current proponents, or to imply

any opinion on whether that drug may ulti-

mately prove safe and effective for cancer treat-

ment. But this historical experience does suggest

why Congress could reasonably have determined

to protect the terminally ill, no less than other

patients, from the vast range of self-styled pana-

ceas that inventive minds can devise.

442 US. at 558.

Similarly, if Respondents prevail in this case, lethal

substances suddenly become candidates for a new category

* Cf. David B. Brushwood, The Professional Capabilities and Legal

Responsibilities of Pharmacists: Should “Can” Imply “Ought”?, 44

Drake L. Rev. 439, 448-52 (1996).

10

of controlled substances to be marketed to physicians and

patients for suicides. Just as Dr. Kevorkian found patients

for his suicide machine before he was enjoined from using

it, other enterprising purveyors of death will no doubt seek

to capitalize on the suffering of the terminally ill. See People

ex rel. Oakland County Prosecuting Atty. v. Kevorkian, 534

N.W.2d 172 (Mich. App., 1995).

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CONCLUSION

The Attorney General’s construction of the CSA and

its implementing regulations is consistent with the medi-

cal profession’s increasing reliance on national norms for

self-regulation, is an integral part of the enforcement of

the laws prohibiting abuse of prescription drugs, and is a

necessary construction to retain any coherent regulatory

authority over the safety of prescription drugs. For all the

foregoing reasons, Amicus respectfully urges this Court to

reverse the judgment of the courts below.

Respectfully submitted,

TERESA S. COLLETT

Professor of Law

University of St. Thomas School of Law*

MSL 400

1000 LaSalle Avenue

Minneapolis, MN 55403-2015

(651) 962-4973

(651) 962-4996 FAX

tscollett@stthomas.edu

Counsel for Amicus Curiae

The Catholic Medical Association

*affiliation listed for informational

purposes only