Amicus Curiae Brief — Diamond v. Charles

—

No. 84-1379 Supreme Court, U.S.

IN THE |

Supreme Court of the United ER Sicter«

JOSEPH F. SPaNiOL, up

OCTOBER TERM, 1985 ®

>

EUGENE F. DIAMOND, et al.,

Appellants,

—_V—

ALLAN G. CHARLES, et al.,

Appellees.

ON APPEAL FROM THE UNITED STATES COURT

OF APPEALS FOR THE SEVENTH CIRCUIT

BRIEF OF AMICI CURIAE PLANNED PARENTHOOD FEDERATION

OF AMERICA, INC., THE AMERICAN PUBLIC HEALTH ASSOCIA-

TION, THE NATIONAL FAMILY PLANNING AND REPRODUCTIVE

HEALTH ASSOCIATION, INC., THE CENTER FOR POPULATION OP-

TIONS, THE AMERICAN JEWISH COMMITTEE, NATIONAL ASSO-

CIATION OF NURSE PRACTITIONERS IN FAMILY PLANNING, THE

NATIONAL BOARD OF THE YOUNG WOMEN’S CHRISTIAN ASSO-

CIATION OF THE U.S.A., NATIONAL ABORTION FEDERATION, AS-

SOCIATION OF PLANNED PARENTHOOD PROFESSIONALS, INC.,

PHYSICIANS FOR CHOICE, THE AMERICAN JEWISH CONGRESS

AND INDIVIDUAL PROFESSORS, PHYSICIANS AND MEDICAL

SCHOOL DEANS IN SUPPORT OF APPELLEES

(Names of individual amici appear within)

DARA KLASSEL*

BARBARA E. OTTEN

EVE W. PAUL

Planned F.srenthood Federation

of America, Inc.

810 7th Avenue

New York, New York 10019

(212) 541-7800

Attorneys for Amici Curiae

* Counsel of Record

EST AVAILABLE COPY

|

INDIVIDUAL AMICI*

JACK N. BLECHNER, M.D.

Professor and Chairman

Department of Ob/Gyn

University of Connecticut

School of Medicine

Farmington, Connecticut 06032

DANIEL K. BLOOMFIELD, M.D.

Professor of Medicine

University of Illinois

College of Medicine at Urbana-Champaign

Urbana, Illinois 61801

F. J. BONTE, M.D.

Professor of Radiology

The University of Texas

Dallas, Texas 75235

NICHOLAS J. COTSONAS, JR., M.D

Professor of Medicine

University of Illinois at Chicago

Chicago, Illinois 60680

MORTON C. CREDITOR, M.D.

Professor of Clinical Medicine

University of Illinois

Chicago, Illinois 60612

IRVIN M. CUSHNER, M.D., M.P.H.

Professor, Obstetrics and Gynecology

Chief, Division of Women’s Health

Professor, Public Health

University of California, Los Angeles

Los Angeles, California 90024

LEO J. DUNN, M.D.

Professor and Chairman

Department of Obstetrics and Gynecology

Medical College of Virginia

Richmond, Virginia 23298

ROBERT H. EBERT, M.D.

Former Dean

Carolyn Shields Walker Professor Emeritus

Harvard Medical School

Princeton, New Jersey 08540

KENNETH C. EDELIN, M.D.

Professor and Chairman

Department of Ob/Gyn

Boston University Medical Center

Boston, Massachusetts 02118

CLARENCE E. EHRLICH, M.D.

Coleman Professor and Chairman

Department of Obstetrics and Gynecology

Indiana University School of Medicine

Indianapolis, Indiana 46223

TOMMY N. EVANS, M.D.

Professor of Ob/Gyn

Chief of Gynecology

University of Colorado

Denver, Colorado 80262

MYRON GORDON, M.D.

Professor and Chairman

Department of Ob/Gyn

The Albany Medical College of Union University

Chief of Obstetrics and Gynecology

Albany Medical Center Hospital

Albany, New York 12208

DAVID G. HALL, M.D.

Professor and Chairman

Department of Ob/Gyn

University of Missouri

School of Medicine

Columbia, Missouri 6520]

HARRY S. JONAS. M_D.

Dean

University of Missouri

School of Medicine

Kansas City, Missouri

JOHN B. JOSIMOVICH, M.D

Acting Chairman

‘sey Medical School

7103

1\

IRWIN H. KAISER, M.D

Department of Ob/Gyn

Albert Eins i

THEODORE M. KING, M.D., PH.D

Vice Presid Medical Af

Johns Hopkins Hospital

Baltimore, Maryland 21205

SCHUYLER G. KOHL, M.D

Professor of Ob/Gyn

SUNY Downstate Medica! Ce

Brooklyn, New York 11203

KERMIT E. KRANTZ. M._D.. Litt.D

Protessor and Chairman

Department of Gynecology and Obstetrics

s University Medical Center

s City, Kansas 66103

Department of Obs

University of Vermont

College of Medicine

Burlington, Vermont 05405

ics and Gynecology

; Medical Sct

Center for the Health

Los Angeles, Califor

HENRY NADLER, M.D.

Dean

Wayne State University Medic

Detroit, Michigan 48201

FREDERICK NAFTOLIN. M.D... D.PHI

Professor and Chairman

co)

of Obstetrics and Gynecology

Connecticut 06510

SEYMOUR L. ROMNEY.

Professor of Obstet

Albert Einstein College of Me

New York, New York 1046]

LEON E. ROSENBERG, M.D.

Dean

Yale University

School of Medicine

New Haven. Connecticut {

KEITH P. RUSSELL, M.D

Clinical Professor of Obstetrics and Gy

University of Southern California

School of Medicine

Los Angeles, California 90004

KENNETH J. RYAN, M.D.

Chairman of the

Harvard Mec

IACK M. SCHN

Clinical Prof

Department

University

Sacramenico.

RICHARD H. Se

Professor and ¢

Department of

SUNY Down

Brooklyn, New

JOSEPH SEITCHIK, M.D

Professor Emeritus

Department of Ob/Gyn

University of Texas

Health Science Center

San Antonio, Texas 78284

WILLIAM N. Spt

Chicago, Ill

DONALD P. SWARTZ

Professor and C|

Former Chairman

Section of General Gy

Department of Obstetrics ¢

Albany Medical Center

Albany, New York 12208

GRAY H. TWOMBLY. M.D

EDWA

Pro

TABLE OF CONTENTS

PAGE(S)

THE “ABORTIFACIENT WARNING” PROVI-

SION OF THE ILLINOIS LAW IS UNCONSTI-

Fer ES 0-b5'5-46:04 0056096 000 0006440064 8o-0 8

A.

B.

[he Statutory Provision Violates The Right To

PRCT CCS CRT ET ORT TT ST TT Cee TOTT Te

|. The Abortifacient Warning is not Informa-

aS Cartas eat teens aie ere Eg EEE ao

2. The Statutory Provision Requires Physi-

cians to Impart Information Which Many

View as Medically Inaccurate ...........

3. The Statutory Provision Forces the Physi-

cian to Act as a Mouthpiece for the State’s

Theory of When Life Begins............

The “Abortifacient Warning” Provision Of

The Illinois Law Violates The Supremacy

PRA FR oe ae oe cuit aues icles ee

|. Federal Law Expressly Preempts the Uli

nois Statutory Provision

>. The Illinois Law Conflicts with Federal

Regulations

CONCLUSION

XI

TABLE OF AUTHORITIES

Cases: PAGE(S)

Charles v. Carey, 627 F.2d 772 (7th Cir. 1980).... 1§

Charles v. Daley, 749 F.2d 452 (7th Cir, 1984)..... 4,5, 18

City of Akron v. Akron Center for Reproductive

Health, 462 U.S. 416 (1983) ................ we yA

14, 15, 16, 18

Colautti v. Franklin, 439 U.S. 379 (1979)...... 3, 4, 5, 13, 14

Commonwealth of Massachusetts v. Hayes, 691 F.2d §7

(ist Cir. 1982) 2]

Doe v. Bolton, 410 U.S. 179 (1973). 4

Griswold v. Connecticut, 381 U.S 479 (1965S) 16

Hines \ Davidowitz. 312 U.S. §2 (1941). 2]

Hoffman Estates v. Flipside, 455 U.S. 489 (1982) 4

Planned Parenthood of Central Missouri \ Danforth.

428 U.S. 52 (1976) 4.5, 6, 13, 14

Rav v. Atlantic Richfield, 435 U.S. 181 (1978) 19, 2

Roe v. Wade, 416 U.S. 113 41973) 12, 13, 14, 18

Speiser v. Randall, 357 U.S. $12 (1988) j

Constitution and Statutes:

Xil

PAGE(S)

tk, 2 SO 0 ee rere 20

43 Fed. Reg. 4223, 4224 (1978) ..........ccceeceaces 19, 22

ey ee ee, Sn MIS 6 6 V4 6-4-0 6 0-600-050-5868 17

43 Fed. Reg. 18663, 18664 (1978)....................-20, 21

Illinois Abortion Law, Ill. Rev. Stat. Ch. 38 4 81-

22(10), 81-26(1), 81-26(4), 81-31(d) (1983).......... passim

Books, Articles and Other Publications:

Binkin ef al., Urea-Prostaglandin Versus Hypertonic

Saline for Instiliation Abortion, 146 Am. J. Obstetrics

and Gynecology 947 (1983) ... 05... cece wees 7, 8,9, 10

Burnhill, /ntrauterine Contraception, in Fertility Con-

trol 271 (Corson, Derman and Tyrer eds. 1985) ..... 17

Dunn & Stirrat, Capable of Being Born Alive?, | Lancet

ee Ga Gh bh os cls 4 Meee See eas ene dese ex 6, 12

Grimes & Cates, Dilatation and Evacuation, in Second

Trimester Abortion, Perspectives After a Decade of

Experience 119 (Berger ef a/. eds. 1981) ............ S

Grimes, Second Trimester Abortion in the United States,

16 Family Planning Perspectives 260 (1984) ....7, 8, 10, 11

Henshaw ef al., Abortion Services in the United States,

1981 and 1982, 16 Family Planning Perspectives 119

SN ee oe ter Rn he a eae ets ee 9)

Henshaw ef al., A Portrait of American Women Who

Obtain Abortions, 17 Family Planning Perspectives 90

SRR a en ee re re ee 7

W. Hern, Abortion Practice 126 (1984).........

Katrissen ef al., Intra-Amniotic Instillation of Hyperos

molar Urea and Prostaglandin F2 alpha v. Dilatation

and Evacuation, 251 J.A.M.A. 916 (1984). ...... 8,9, 10

Xiil

PAGE(S)

Lee & Baggish, Live Birth as a Complication of Second

Trimester Abortion Induced with Intra-Amniotic Pro-

staglandin F2 Alpha, 13 Advances in Planned Parent-

DE ET hee Ce aa daeees auiaee eee ee bund 45 00s te

Magora ef al., Epidural Morphine Analgesia in Second

Trimester Induced Abortion, 138 Am. J. Obstetrics

and Gynecology 260 (1980)............... cee eeees 1]

Morris & von Wagenen, /nterception: The Use of Pos-

tovulatory Estrogens to Prevent Implantation, 115

Am. J. Obstetrics and Gynecology 101 (1973)....... 18, 21

The National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research, Re-

port and Recommendations, Research on the Fetus

Pe Cee ere ee ea Pee Pee Pe 1]

Obstetric—Gynecologic Terminology (E. Hughes ed.

o_O EEE ET EPC TEST Pee ET Ere Ter eee 17

Phillip et a/., Neonatal Mortality Risk for the Eighties:

The Importance of Birth Weight/Gestational Age

Groups, 68 Pediatrics 122 (1981) ..............005. 12

Planned Parenthood Federation of America, Under-

standing IUDs (revised 1985) ................0055. 17

Pritchard ef a/., Williams Obstetrics (17th ed. 1985) ... 6, 12

Rhoden, 7he New Neonatal Dilemma: Live Births from

Late Abortions, 72 Geo. L.J. 1451 (1984) .. 0.0.0... 12

Rooks & Cates, Emotional Impact of D & E vs. Instilla-

tion, 9 Family Planning Perspectives 276 (1977) ..... Y

U.S. Department of Health and Human Services, Cen-

ters for Disease Control: Abortion Surveillance 1979-

Re Gls COs oe ae te ee seer ee, S

XIN

PAGI (S)

Wellman & Jacobson, /ntra-Amniotic Prostaglandin F2

alpha and Urea for Midtrimester Abortion, 27 Fertil-

oe -& , Bebe, Fi, 5 | ere 1]

Williams ef a/.. Fetal Growth and Perinatal Viability in

California, 59 Obstetrics and Gynecology 624 (1982) . 6

Wilson, Midtrimester Abortion with Urea, Prostaglan-

din F2 alpha, Laminaria, and Oxytocin: A New Regi-

men, 51 Obstetrics and Gynecology 699 (1978) ...... lO, 11

Miscellaneous:

1976 U.S. Code Cong. & Ad. News 1070............. 20

INTEREST OF AMICI*

Planned Parenthood Federation of America, Inc. (PPFA) is

a not-for-profit corporation organized in 1922. PPFA is the

leading national voluntary public health organization in the

field of family planning with 186 affiliates in 44 states and the

District of Columbia operating approximately 761 family plan-

ning clinics. Forty-four affiliates provide abortion services and

most of the affiliates which do not perform abortions offer

pregnancy counseling and referral.

The American Public Health Association (APHA) is:a na-

tional nongovernmental orgaaization. With a membership of

over 50,000, it is the largest public health organization in the

world. At its national conventions, APHA has repeatedly

Stated its support for legalized abortion.

The National Family Planning and Reproductive Health

Association, Inc. (NFPRHA) is a national organization com-

posed of providers and consumers of family planning and

reproductive health care services under the federal Title X

family planning program. It is devoted to the improvement of

family planning throughout the United States.

The Center for Population Options (CPO) is a national

Organization concerned with the prevention of unintended

adolescent pregnancy. CPO believes that the adolescent’s op-

tion as to whether or not to have an abortion must be

maintained.

The American Jewish Committee (AJC), a national organi-

zation dedicated to the protection of civil and religious rights,

supports access to abortion as part of its traditiona! concern

for individual liberty, privacy, and free choice.

National Association of Nurse Practitioners in Family Plan-

ning (NANPFP) is a national non-profit membership organiza-

\ll parties have given their consent to the filing of this brief in letters

tiled with the Clerk of this Court

>

tion of professional nurse practitioners. The aim of the

Organization is to assure accessible quality family planning

services which guarantee reproductive freedom to all.

The National Board of the Young Women’s Christian Asso-

ciation of the U.S.A. (YWCA) represents over two million

women and girls. The YWCA, a non-profit organization, has

had a policy since 1967 of supporting a woman’s right to

choose whether or not to have an abortion, uncoerced by

government.

National Abortion Federation (NAF) is a national, profes-

sional organization composed of abortion providers, individ-

uals, and organizations active in the reproductive health care

field. NAF is committed to making abortion services safe and

accessible for all women.

Association of Planned Parenthood Professionals, Inc.

(APPP) is a New York not-for-profit corporation whose mem-

bers are physicians and health professionals associated with

family planning.

Physicians for Choice, a project of PPFA, is a nationwide,

biparusan organization of 4,000 physicians which supports

family planning issues and believes in preserving the right of

women to decide when or whether to bear a child.

The American Jewish Congress is a national organization of

American Jews. It neither favors nor opposes abortion but

believes that a woman's decision whether to undergo abortion

must be her own, uncoerced by government.

Individual Professors, Physicians and Medical School Deans

practice obstetrics and gynecology as their medical specialty or

are responsible for the education of medical students and

residents, some of whom are in training in the specialty of

obstetrics and gynecology.

Amici submit this brief in order to demonstrate for the

Court the detrimental impact the Illinois law would have on

the health and welfare of women in need of abortions.

alia

SUMMARY OF ARGUMENT

Amici submit this brief in support of Appellees.

Section 6(1) of the Illinois Ab. ortion Law, setting as

of care for aborting a fetus “known to be viable.”

tuttone: fort two reasons. Fil st, it A requires Larsdrmengnety tc

make such judgments on a vublective basis. Colautti

Aireresany: 439 U.S. hs a 9). Second, Mt is void for vaguene

against which the m core: Me is adeod.

Section 6(4) of the law. setting a standard of care for

aborting “possibly viable” fetuses, is sonstitutional because

it burdens the right to abortion pric lability by making

. less accessible and i. .e painful and emo

tionally | traumatic. It is also unconstitutionally vague because it

fails to specify to which period in pregnancy it applies.

Sections } HN(d) and } LES of i the law, W ~~ requ re Payee clans

cleats, | are unconstitutional bec cause

of non-informative, medically d

tion. These provisions are al

eww he

Clause because they are preempt

by federal law

the labeling of contraceptives.

ARGUMENT

I. SECTION 6(1) OF THE ILLINOIS LAW UNCONSTI-

TUTIONALLY RESTRICTS A WOMAN'S RIGHT TO

ABORTION

Section 6(1) of the Illinois Abortion Law criminalizes the

failure to use the same care in aborting a fetus which is

“known to be viable” that the physician or his assistant would

use in bringing a fetus to live birth. Ill. Rev. Stat. ch. 38,

€ 81-26(1) (1983). Amici support the court of appeals holding

that § 6(1) is unconstitutionally vague, encroaches on the

exercise of the attending physician's medical judgment, and

adversely impacts upon the woman's right to obtain an abor-

tion. Charles v. Daley, 749 F.2d 452, 459-60 (7th Cir. 1984).

As this Court has observed, the viability determination itself

is uncertain because of the number and imprecision of varia-

bles that must be considered. Moreover, different physicians

equate viability with different probabilities of survival and

some refuse to equate viability with any numerical probability

at all. Colautti, 439 U.S. at 395-96. While physicians will

necessarily disagree as to whether a particular fetus has

reached viability, this Court has held repeatedly that “the

determination of whether a particular fetus is viable is, and

must be a matter for the judgment of the responsible attending

physician.” Planned Parenthood of Central Missouri v. Dan-

forth, 428 U.S. 52, 64 (1976); Colaurti, 439 U.S. at 496-97. See

also Doe v. Bolton, 410 U.S. 179, 192 (1973). The Ilinois law

fails to give deference to the individual judgment of the

attending physician as required by these cases.

physician must look to in order to determine viability. Does

“known to be viable” refer to some general medical standard?

refer? Because the statute does not specify whose medical

judgment is determinative, it is unconstitutionally vague. Co/-

autti, 439 U.S. at 393-94. This is especially true where, as here,

‘Al

“the uncertainty induced by the statute threatens to

exercise Of constitutionally protected rights.” /d. ;

There is no doubt that the Illinois statute has a ch

on the exercise of constitutional rights. Physicians unw

risk criminal sanctions will be reluctant to perform

City of Akron v. Akron Center for Reproductive

462 U.S. 416, 427 (1983); Charles v. Daley, 749 F.2d at

Hl. SECTION 6(4) OF THE ILLINOIS LAW SIGNIFI-

CANTLY INTERFERES WITH A WOMAN'S RIGHT

TO ABORTION AND IS NOT JUSTIFIED BY A

COMPELLING STATE INTEREST

- es that a physi

a “possibly” viable fetus

manner as h

ve birth. Hl

tly inte

would attempt to bring suc

ch. 38, © 81-26(4) (1983)

woman's right to abortion

it forces a woman to e preenaney

h are costlier, lengthier, more painful and ps)

those she might otherwise choose ji

attending physician. Second, it vi

> woman s physician on the basis of

ain as to chill physicians in their wi

rdens solely

to viability

6

A. The Illinois Law Interferes With the Right To Abortion

By Requiring Abortions Which Are Costlier, Lengthier,

More Painful and Psychologically Traumatic

Appellants claim that because the Illinois law does not

“medical risk,” it imposes no legally significant burden on the

right to abortion. Brief for Appellants at 40. This argument

ignores the precedents of this Court which have viewed as

burdens on the right to abortion factors other than increased

medical risk, such as cost, delay, and decreased accessibility of

abortion services. For example, in Akron, the Court ruled that

a requirement of hospitalization for a second trimester abor-

tion placed a “significant obstacle in the path of women

seeking an abortion” because it would have increased the cost

of the procedure and made it less accessible. 462 U.S. at

434-35. The same case struck down the entorced delay caused

by a 24 hour waiting period for abortion. /d. at 449-51. See

also Danforth, 428 U.S. at 75-79 (striking down ban on saline

amniocentesis because it made post-first trimester abortions

more difficult to obtain). The Illinois law imposes all these

burdens and more.

1. The Choice of Method

€ Slatute apphes to a period

i 24th weeks of gestation, the

t trom the mother becomes

t reported surviving infants

hav

Born

and Per

(19RD). Ver. z

gestational

ams ef ai.. Fe

and ¢

ants as 5

.

age and ¢ al rtality

100%.” Pruchard ef ai 749 (17th

discussed in Part B, aire. hoy

wo Vaguc a. lo De unconstitutional

known as dilatation and evacuation (D &

woman's cervix and remove the products

ym and instrut

)

There is no possi

Is used ) «& t

vhen this tec

yf abort

oo

uterus." This method may result in live birth but is the most

dangerous to the woman. It is, therefore, rarely used.''

Section 6(4)’s fetal protection mandate requires that a physi-

cian faced with this array of options favor a hysterotomy or

prostaglandin-induced abortion over those methods which use

agents toxic to the fetus such as saline or urea and to favor

each of these methods over the D & E abortion,

While the “medical risk” provision of § 6(5) may allow the

physician to rule out hysterotomy as clearly increasing medical

risk to the woman, the choice among the other methods from a

health viewpoint is less clear. In the second half of pregnancy,

differences in maternal mortality among the methods are

small.'- There are differences in morbidity, but comparisons

are complex, each method involving different types of rare

serious ep prone ’ Also, the safety of D & E abortions at

penalties which anand ¢ an error, the statute will clearly ened

the physician to favor a labor-inducing abortion over D & E as

the method least ayers to the fetus. There are a number of

ways, however, in which selection of this method burdens a

*s night to ‘hanten.

1/3 See Katrissen ef a/..

trea and Prostaglandin }

1 AANLA. 916, 918 (1984): Bi

LO

tions because they require less staff and institutional time.

The Illinois law allows none of these significant factors to be

weighed in the woman’s abortion decision.

3 Labor Induction Meth Compared

The preferred method of labor induction abortion is the

intrauterine instillation of a solution of hyperosmolar urea and

prosiaglandins.~' This method is the most toxic to the fetus of

the induction methods but is also believed to be the safest for

the woman.~ Yet, apart from safety, there are other factors

which lead physicians to favor this method over the saline

abortion or the abortion using prostaglandins alone. Chief

among these reasons is that it entails the shortest interval

between instillation of the abortifacient agents and expulsion

of the products of conception.~’ This shortened interval alles

ates some of the psychological trauma and physical pain fo

the woman and lowers the cost of the procedure.~ Yet, the

Illinois law allows none of these factors to be taken into

account in choosing an abortion method.

Another advantage of the urea-prostaglandin abortion 1s

that because of the synergistic effect of the two chemicals, the

level of prostaglandin can be lowered from what would be

required in an abortion using only prostaglandins. This reduces

2 Kafrissen, supra note 13, at 919

21 Cirimes, supra note 3, at 265

22 Binkin ef a/., supra note 6, at 950

23 \ large scale study showed that urea-prostaglandin abortions aver

aged 14.2 hours from instillation to expulsion of the fetus, while saline

averaged 25.6 hours. Binkin er a/., supra note 6, at 948 Table Il. Another

study showed that 12 hours after the instillation of abortifacients, 21.4% of

the patients receiving only urea, 47.8% of those receiving only prostaglan

dins and 77% of those receiving prostaglandins in combination with urea had

aborted. Wilson, Midtrimester Abortion with Urea, Prostaglandin F , alpha,

Laminaria, and Oxytocin: A New Regimen, 51 Obstetrics and Gynecology

499. 700-01 (1978)

24 Binkin, ef a/., supra note 6, at 952

tt

1]

some of the unpleasant side effects of prostaglandins, includ-

ing nausea, dizziness and diarrhea.~* Although some physicians

may associate these minor side effects with increased medical

isk, others may consider the association too tenuous to risk

the criminal penalties of the statute.

The Illinois law also constrains the types of drugs that can be

given to alleviate the pain the woman must undergo in a labor

induction abortion. Physicians feel they can administer ex-

tremely effective analgesic drugs such as morphine to a woman

experiencing an abortion, drugs which might be ruled out in

alleviating the pain of childbirth because of adverse effects on

the fetus.*° The Illinois law would compel physicians to con-

sider the health of the fetus in choosing pain medication, a

consideration which would lead to increased rain for the

woman.

The I!linois law adds to the cost of abortions in yet another

way. Physicians who feel compelled to perform abortions by

the method least toxic to the fetus, namely induction of labor

by prostaglandin agents alone, may also feel compelled by

professional ethics and fear of criminal prosecution to arrange

for resuscitation and neonatal intensive care for aborted fe-

tuses who may exhibit any sign of life.~’ In abortions utilizing

prostaglandins alone, this rate can be as high as 7%.** Yet, live

birth and viability are not equivalent” and the chance of such

25 Wellman & Jacobson, /ntra-Amniotic Prostaglandin F, alpha and

Urea for Midtrimester Abortion, 27 Fertility and Sterility 1274, 1378 (1976);

Wilson, supra note 23, at 701.

26 Magora et al., Epidural Morphine Analgesia in Second Trimester

Induced Abortion, 138 Am. J. Obstetrics and Gynecology 260 (1980).

27 See, e.g., Lee & Baggish, supra note 7, at 8.

28 See Grimes, supra note 3, at 264.

29 The National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research, Report and Recommendations, Re-

search on the Fetus 55-56 (1975).

4

Section 6(4) introduces a new element of vagueness and

removes this discretion. It puts physicians in the position of

guessing what degree of probability separates the merely “pos-

sible” from the “reasonably likely”. Inevitably, the result will

be that in order to avoid the severe criminal penalties imposed

by the statute, physicians will err on the side of caution, giving

the statute its widest possible berth. They will feel constrained,

therefore. to abandon the individual judgments envisioned in

Colautti in favor of rigid formulas based on the latest medical

miracle. A report of an isolated instance of survival of an

extremely premature infant will cause many physicians to

apply the restrictive provision of § 6(4) te all pregnancies of

similar gestation, or even to refuse to perform abortions past

that stage of pregnancy.

Thus, the vagueness of section 6(4) stiaitjackets physicians

in their professional judgments, thereby impeding their pa-

tients’ ability to obtain abortions. This is exactly the chilling

effect on constitutional rights that this Court has sought to

eliminate in the abortion cases.** See Danforth, 428 U.S. at 67

n.8: Akron, 462 U.S. at 427; Colautti, 439 U.S. 379.

C. No Compelling State Interest Justifies Section 6(4)

Section 6(4) restricts abortion rights prior to viability. As

such, it may be justified only if it promotes the state’s interest

in maternal health. Roe v. Wade, 410 U.S. at 164. Clearly, no

maternal health interest is implicated here. The statute is

*herefore invalid.

Appellants ask this Court to recognize an important interest

in fetal life prior to viability sufficient to justify § 6(4)’s direct

restrictions on the abortion right. Brief for Appellants at 43.

Such an approach was clearly rejected by this Court in Co-

lautti, where it stated that “viability is the critical point” when

the state’s compelling interest in fetal life or health arises and

34 The idea that vague statutes lead persons to “steer far wider of the

unlawful zone” and avoid conduct which would otherwise be constitutionally

protected has long been recognized by this Court. Hoffman Estates v.

Flipside, 455 U.S. 489, 494 n.6 (1982) (quoting Speiser v. Randall, 357 U.S.

§13, 526 (1958)).

15

“we have recognized no attempt to stretch the point of viability

one way or the other.” 439 U.S. at 389. By carving out a new,

vaguely defined gray area prior to this critical point, appellants

advocate just such a “stretching” of the state’s power over a

woman’s abortion decision. Amici urge this Court to reject this

approach and adhere to the clear precedent of its abortion

decisions to date.

il. THE “ABORTIFACIENT WARNING” PROVISION OF

THE ILLINOIS LAW IS UNCONSTITUTIONAL

A. The Statutory Provision Violates The Right To Privacy

The Illinois Abortion Law (§§ 11(d), 2(10)) requires physi-

cians to describe methods of birth control that act after

fertilization as “abortifacients”. Ill. Rev. Stat. ch. 38, €€ 81-

31(d). 81-22(10) (1983).°° This requirement is unconstitutional

under ‘he standards for informed consent laws set forth by this

Court in Akron, 462 U.S. 416.

In Akron, this Court struck down a requirement that a

physician recite an inflexible set of statements to every patient

requesting an abortion. The Court held that th: purpose of the

“informed consent” script was not to inform, but to persuade

the woman to withold her consent altogether because the

physician was required to make misleading statements regard-

ing the dangers of abortion and to articulate the state’s theory

of when life begins. Jd. at 444-45.*° The Illinois law suffers the

35 Although the appellants claim that the statute does not require the

physician to use any particular language, see Brief for Appellants at 12, the

plain language of the statute indicates otherwise. Moreover, the State of

Illinois is not before this Court to present its view on how the statute should

be read. The court of appeals stated that, at the least, the statute requires the

physician to tell the woman that certain birth control methods cause fetal

death, a requirement which is no less objectionable. Charles v. Daley, 749

F.2d at 462.

36 The Akron law required the physician to tell the woman that “the

unborn child is a human life from the moment of conception” and that

abortion is a major surgical procedure with numerous possible complica-

tions, characterized by the Court as a “ ‘parade of horribles’ intended to

suggest that abortion is a particularly dangerous procedure.” 462 U.S. at 445.

16

same defects. It articulates a medically dubious viewpoint, is

essentially uninformative, and attempts to make the physician

the mouthpiece for the state’s theory of life. As such, it is pure

propaganda, designed not to inform but to dissuade women

from choosing certain birth control methods. It must be struck

down as violative both of the standards of Akron and of a

woman’s right of access to contraceptives. Griswold v. Con-

necticut, 381 U.S. 479 (1965).

l. The Abortifacient Warning is not Informative.

Appellants contend that telling women that drugs and

devices which cause the demise of the fertilized egg are “aborti-

facients” serves to give them relevant information which is

otherwise withheld by physicians. Brief for Appellants at 14.

This is not true.

Millions of women in this country use methods of birth

control which are believed to prevent pregnancy at least in part

by interfering with the implantation of the fertilized ovum in

the lining of the uterus. Chief among these are the intrauterine

device (IUD) and the progestogen-only or “mini-pill”. Con-

trary to appellants’ insinuations, there is no medical conspiracy

afoot to confuse or mislead women as to the way these

methods work. Every woman requesting an IUD receives a

brochure containing the following federally prescribed state-

ment: “How the IUD prevents pregnancy is not completely

understood. Several theories have been suggested. I.U.D.’s

seem to interfere in some manner with the implantation of the

fertilized egg in the lining of the uterine cavity. The IUD

does not prevent ovulation.” 21 C.F.R. §§ 310.502(b)(2),

801.427(b)(2) (1985) (Patient Information).’ Similarly, every

37 Amicus PPFA’s patient brochure on IUDs states:

There’s no doubt that IUDs work, and work very well. Although we

do not know all the ways in which an IUD works, one theory is that

IUDs create a change (inflammation) in the lining of the uterus. This

chronic inflammation keeps a fertilized egg from attaching itself to the

lining of the uterus and starting a pregnancy. Also, the copper in a

copper IUD can inactivate sperm.

(footnote continued)

17

package of oral contraceptives contains a pamphlet with the

following statement: “the ‘mini pill’ contains only a progesto-

gen. It works in part by preventing release of an egg from the

ovary but also by keeping sperm from reaching the egg and by

making the uterus (womb) less receptive to any fertilized egg

that reaches it.” 43 Fed. Reg. 4231 (1978).

The Illinois requirement, therefore, adds nothing to a wo-

man’s fund of knowledge about birth control. It merely adds

the state’s ideological gloss—that the mode of action of these

contraceptives, in interfering with implantation, constitutes

abortion—to the information she already receives in accord-

ance with federal regulations. Clearly, the only purpose for this

statement is to dissuade women from choosing these highly

effective and widely used birth control methods.

2. The Statutory Provision Requires Physicians to Impart

information Which Many View as Medically Inaccurate.

The view that prevention of implantation of the fertilized

egg constitutes an abortion is also contrary to accepted medical

standards. The American College of Obstetricians and Gyne-

cologists’ glossary of terms for the field of obstetrics and

gynecology defines “induced abortion” as the “deliberate inter-

ruption of pregnancy.” “Pregnancy” is defined as the “state

of a female after conception and until termination of the

gestation.” “Conception” is defined as “the implantation of

the blastocyst. It is not synonymous with fertilization.”*’ Using

Planned Parenthood Federation of America, Understanding IUDs (revised

1985). PPFA’s affiliates provide a contraceptive method to nearly 1.5 million

patients each year.

See also Burnhill, /ntrauterine Contraception, in Fertility Control 271, 280

(Corson, Derman and Tyrer eds. 1985) (physicians prescribing IUD’s should

verbally inform patients “that the [UD works primarily by preventing a

fertilized egg from implanting”).

38 Obstetric-Gynecologic Terminology 414 (E. Hughes ed. 1972)

39 Id. at 327.

40 Id. at 299.

18

these definitions, agents which work to prevent implantation

or conception are contraceptives, not abortifacients.*! The

Illinois law, therefore, requires physicians to contravene the

accepted views of their profession on this issue.

3. The Statutory Provision Forces the Physician to Act as a

Mouthpiece for the State’s Theory of When Life Begins.

The view that birth control methods which cause demise of

the fertilized egg before implantation are “abortifacients” is

based on the state’s theory that human life and human preg-

nancy begin at the moment when sperm and egg unite and that,

accordingly, any agent which interferes with the development

of the fertilized ovum causes an abortion. As previously

shown, this view is not based on medical principles; rather it is

a philosophical or religious theory of when life begins. Roe v.

Wade, 410 U.S. at 159-162. The state may not utilize such

theories as the basis for intervention in the physician-patient

consultation. Akron, 462 U.S. at 444; Charles v. Carey, 627

F.2d 772, 789 (7th Cir. 1980).

The Illinois law serves no purpose other than to convey to

the woman the state’s moral disapproval of her choice of birth

control method and thus persuade her to forgo her choice.

Such indoctrination of state values with no concomitant infor-

mative purpose is unconstitutional.

4] See also the federally required patient package insert for diethyl-

stilbestrol (DES), a drug which may be prescribed as a post-coital contracep-

tive in emergency situations such as rape. Although DES acts after

fertilization to prevent implantation, see Morris & von Wagenen, /ntercep-

tion: The Use of Postovulatory Estrogens to Prevent Implantation, 115 Am.

J. Obstetrics and Gynecology 101 (1973), the brochure states that “this

treatment is usually effective in preventing pregnancy if used as described

above. However, this drug will not cause an abortion if you are already

pregnant.” 21 C.F.R. § 310.501(b)(1). Thus, the federal Food and Drug

Administration (FDA) subscribes to the prevailing medical view that the

demise of the fertilized egg before it implants in the uterus is not an abortion.

”

19

B. The Abortifacient Warning Provision Of The Ilinois Law

Violates The Supremacy Clause.

Federal laws regulating the labeling of contraceptive drugs

and devices preempt §§ 11(d) and 2(10) of the Illinois Abortion

Law under the Supremacy Clause of the United States Consti-

tution. Art. VI, § 2. Regulations of the IUD.” progestogen-

only contraceptive pills*’ and diethylstilbestrol (DES).*4

promulgated under the Federal Food, Drug and Cosmetic Act

(FDCA), 21 U.S.C. § 301 et seg. (amended 1984), meet the

criteria for determining federal preemption.* First, the Medi-

cal Device Amendments of the FDCA, id. §§ 360c-360k. are an

unambiguous declaration by Congress that it occupies the field

of regulating contraceptive devices. The amendments expressly

preempt state regulations of medical devices, iacluding IUDs,

which are “different from, or in addition to” Food and Drug

Administration (FDA) requirements. /d. § 360k(a). Second.

the information in the federally mandated patient package

inserts for contraceptive drugs and devices directly conflicts

with the requirements of the Illinois law. Compliance with

both the federal and state regulations is impossible; in addi-

tion, the Illinois law frustrates the purpose of the federal laws

to promote safe and effective contraceptive use through ac-

curate labeling.

42 21 C.F.R. §§ 310.502, 801 ef seg. (1985).

43 43 Fed. Reg. 4224 (1978).

44 21 C.F.R. § 310.501(b).

45 See Ray v. Atlantic Richfield, 435 U.S. 151, 157-59 (1978) (to

determine preemption, look to (1) clear federal intent to preclude state

regulation; (2) actual conflict; (3) state law as obstacle to federal purpose; (4)

pervasiveness of federal regulation; or (5) dominance of federal regulation)

(citations omitted).

20

1. The Federal Law Expressly Preempts the Illinois Statu-

tory Provisions.

Congress expressly maintains exclusive contro! over the regu-

lation of contraceptive devices. In 1976, Congress passed the

comprehensive Medical Device Amendments of the FDCA

(“Amendments”), id. §§ 360c-360k, in response to a Senate

Health Subcommittee hearing on the Dalkon Shield IUD. The

Senate had concluded that federal uniform standards for the

IUD could have averted the Dalkon Shield’s significant health

hazard to women. See 1976 U.S. Code Cong. & Ad. News

1070, 1071. As a ‘2sult, the FDA promulgated national stan-

dards for labeling all new medical devices, including the IUD.

41 Fed. Reg. 6896 (1976) (codified at 21 C.F.R. § 801 ef seq.).

In addition, the Amendments expressly provide for the pre-

emption of any state regulation which “relates to” the federal

law and is “different from” that law. 21 U.S.C. § 360k(a).

Requiring a doctor to call an IUD an “abortifacient” “rela-

tes to” the federal regulation governing the labeling for IUDs.

Both the federal and Illinois laws set forth prescribed informa-

tion which must be given to each woman seeking an IUD. In

particular, the federal law requires that the IUD’s “mode of

action” be included in both the physician and patient package

insert. Similarly, the Illinois law requires that the physician use

the word “abortifacient,” a term describing the way certain

devices allegedly work in the woman’s body.

The state statute also meets the second prong of the preemp-

tion test for medical devices: the Illinois law is substantially

different from the federal law governing IUDs. The FDA

defines the term “different” as different in an essential way so

as to interfere with the FDA requirement. 43 Fed. Reg. 18663

(1978). Under 21 C.F.R. § 801.427(b)(1), each patient label

must state that the [UD interferes somehow with the implanta-

tion of the fertilized egg to prevent pregnancy.” By contrast,

under Illinois law, the doctor must describe the IUD’s mode of

action as abortifacient, not as preventing pregnancy. This

46 See supra text accompanying note 3°.

21

essential difference between the state and federal regulations

clearly interferes with the FDA requirement. Describing an

IUD as “abortifacient” does not promote the effective use of

the device. It merely confuses women who read one explana-

tion and hear atiother from their doctor.”

2. The Illinois Law Conflicts with Federal Regulations

As shown above, the federal regulations governing the label-

ing of contraceptive devices explicitly preempt the Illinois law.

The Illinois law is also implicitly preempted by federal regula-

tions of contraceptive drugs and devices because the Illinois

law conflicts with the federal regulations. This Court has held

that a conflict results in preemption if compliance with both

the state and federal regulation is impossible or if the state

regulation “stands as an obstacle to the accomplishments and

execution of the full purposes and objectives of Congress.”

Hines v. Davidowitz, 312 U.S. 52, 67-68 (1941); see Ray y.

Atlantic Richfield, 435 U.S. 151, 158 (1978). The Illinois law

and the regulations promulgated under the FDCA conflict in

both respects.

The clearest example of a direct conflict comes from the

information contained in the federally mandated patient pack-

age insert for DES. The federal pamphlet expressly states

that the drug will not cause an abortion. 21 C.ER.

47 The Illinois law would not be exempted from preemption under

§ 360k(b) of the Amendments to the FDCA. The Commissioner may grant

an exemption only if the state requirement is more “stringent” than the

federal law or if it is required by local conditions. The Illinois law is not more

Stringent in that it does not reduce or eliminate health risks. See Common-

wealth of Massachusetts. v. Hayes, 691 F.2d 57, 63 (1st Cir. 1982). Rather, it

simpiy adds the state’s ideological gloss to the federal requirements. See

supra p. 17.

Moreover, requiring doctors to say “abortifacient” would not serve any

public health interes:, especially since the package insert already explains

how the IUD works. Thus, the Illinois law is not exempt from preemption.

See 43 Fed. Reg. 18664 (1978) (codified at 21 ©.F.R. § 898.20(c)(7)).

22

§ 310.501(b)(4).** By contrast, the Illinois law requires the

doctor to describe DES, a drug which takes effect after

fertilization, as an abortifacient. Similarly, the federal insert

for IUDs states that an IUD works after fertilization to prevent

pregnancy, id. § 310.502, while the Illinois law requires that it

be described as an agent which aborts a fetus.*” Compliance

with both the federal and state regulations would be impossi-

ble.

Moreover, the Illinois law frustrates the FDA’s stated pur-

pose of creating a uniform system of accurate labeling of

contraceptive drugs and devices. The FDA’s objective in re-

quiring oral contraceptive labeling is stated as follows: “[t]he

FDA is charged with assuring that drugs are safe and effective

for their intended use and that their labeling provides adequate

information for such use and is not false or misleading.” 43

Fed. Reg. 4223 (1978). The FDA states a similar objective for

its IUD package inserts: “in the interest of safe and effective

use, and prevention of misleading labeling, there is a need to

establish uniform physician and patient labeling for such

devices.” 21 C.F.R. §§ 310.502(b), 801.427(b). Requiring doc-

tors to call IUDs, DES and progestogen-only pills abortifa-

cients is just the sort of misleading and inaccurate information

which the federal inserts were designed to avoid.

In sum, federal laws governing the dissemination of contra-

ceptive information explicitly and implicitly preempt the Illi-

nois Abortion Law. Thus, §§ 11(d) and 2(10) of the Illinois

Abortion L#w are unconstitutional under the Supremacy

Clause of the United Siates Constitution.

48 See supra note 41.

49 See also 21 C.F.R. § 884.5360 (“A contraceptive intrauterine device

(IUD) is a device used to prevent pregnancy.”).

nN

Ww

CONCLUSION

For all the foregoing reasons, the decision of the court of

appeals should be affirmed.

Respectfully submitted,

Dara Klassel*

Barbara E. Otten

Eve W. Paul

Planned Parenthood Federation

of America, Inc.

810 Seventh Avenue

New York, NY 10019

(212) 541-7800

Attorneys for Amici Curiae

* Counse! of Record

August, 1985

Amici wish to acknowledge the assistance of Jean Simons, a

student at New York University School of Law, in the prepara-

tion of this brief.