Opposition Brief — Bowen v. American Hospital Assn.

Office sur reme Court, US.

rrEL ee

No. 84-1529

MAY 25 1985

~ ALEXANDER L STEVAS,

CLERK

IN THE

Supreme Court of the Wuited States

OCTOBER TERM, 1984

MARGARET M. HECKLER, SECRETARY OF

HEALTH AND HUMAN SERVICES,

. Petitioner,

AMERICAN HOSPITAL ASSOCIATION, et al.,

Respondents.

On Petition for a Writ of Certiorari to the

United States Court of Appeals for the Second Circuit

BRIEF OF THE RESPONDENTS

AMERICAN MEDICAL ASSOCIATION, ET AL.,

IN OPPOSITION

KIRK B. JOHNSON BENJAMIN W. HEINEMAN, JR.

B. J. ANDERSON (Counsel of Record)

American Medical Association CARTER G. PHILLIPS

535 North Dearborn Street VINCENT F. PRADA

Chicago, Illinois 60610 1722 Eye Street, N.W.

(312) 645-4600 Washington, D.C. 20006

ANN E. ALLEN (202) 429-4000

American College of NEWTON N. MINOW

Obstetricians & Gynecologists JACK R. BIERIG

600 Maryland Avenue, S.W. One First National Plaza

Suite 300-East Chicago, Illinois 60603

Washington, D.C. 20024 (312) 853-7000

(202) 638-5577 SIDLEY & AUSTIN

Attorneys for Respondents

American Medical Association, et al.

[Other Counsel Listed On Inside Front Cover]

May 25, 1985

WILSON - EPES PRINTING Co. INC. - 789-0096 - WASHINGTON, D.C. 20001 |

JOSEPH A. KEYES, JR.

Association of American Medical

Colleges

One Dupont Circle, N.W.

Washington, D.C. 20036

(202) 828-0510

MICHAEL MILLER

American Academy of Family

Physicians

1740 West 92nd Street

Kansas City, Missouri 64114

(816) 333-9700

MARK D. MokRIS

Hospital Association of

New York State

15 Computer Drive West

Albany, New York 12205

(518) 458-7940

STUART M. GERSON

Epstein Becker Borsody

& Green, P.C.

1140 19th Street, N.W.

Washington, D.C. 20036

(202) 861-0900

QUESTION PRESENTED

Whether Section 504 of the Rehabilitation Act of 1973,

29 U.S.C. § 794, authorizes:

(a) a direct federal role investigating and regulating

individual treatment decisions involving severely im-

paired newborn infants, which intrudes on the states’

traditional responsibilities for regulating parent-child

and physician-patient relationships; and

(b) the inevitable creation of a body of “504 malprac-

tice law” for determining whether individual treatment

decisions in the complex and rapidly evolving area of med-

ical care for severely impaired newborns are “reasonable”

or “unreasonable” under federal standards.

(i)

TABLE OF CONTENTS

ETE .... ee

(1) The State Law Framework ..............................

(2) Medical and Ethical Context: The Growth of

Infant Care Review Committees

(3) The Voided 504 Regulation

(4) The Decisions Below ................................. 3

(5) The Child Abuse Amendments of 1984

REASONS FOR DENYING THE PETITION .............

I.

II.

THE DECISION BELOW WAS CLEARLY

CORRECT: SECTION 504 DOES NOT AU-

THORIZE DIRECT FEDERAL INVESTIGA-

TION AND REGULATION OF INDIVIDUAL

TREATMENT DECISIONS INVOLVING IM-

PAIRED NEWBORNS S

A. Treatment Decisions by Parents on Behalf

of Their Impaired Newborn Infants Are Not

Within the Scope of Section 50044

B. Decisions by Health Care Providers on

Whether or Not to Report Suspected or

Known Instances of Parental Medical Neg-

lect to State Authorities Are Not Within the

Scope of Section 54

C. Providers’ Treatment Decisions In Individual

Cases Are Not Within the Scope of Section

THERE IS NO SUBSTANTIAL FEDERAL

INTEREST IN THE VOIDED REGULA-

,: 7—6„.—! . ——

A. The 1984 Child Abuse Amendments, Not

the Secretary’s Intrusive Regulatory Ap-

proach, Represent the Federal Interest in

this Sensitive Area

11

13

14

15

17

iv

TABLE OF CONTENTS—Continued

B. The Secretary Has Shown No Problem with

the Historic State Law Framework that

Warrants Direct Federal Investigation and

1 — ——

C. Direct Federal Investigation and Regulation

in this Sensitive Area Has Caused, and

Will if Reinstated Cause, Harm

—— ————— —

Page

26

V

TABLE OF AUTHORITIES

CASES Page

Alexander v. Choate, 105 S. Ct. 712 (1985)........ 18, 23

American Academy of Pediatrics v. Heckler, 561

F. Supp. 386 (D. D.C. 1968) .................:.-............. 5, 22

Apex Hosiery Co. v. Leader, 310 U.S. 469 (1940).. 23

Barsky v. Board of Regents, 347 U.S. 442 (1954) .. 3

Bennett v. Jeffreys, 40 N.Y.2d 543, 356 N.E.2d

r d ee ee ene 15

Consolidated Rail Corp. v. Darrone, 104 S. Ct.

D e - e aeereooen 30

Dent v. West Virginia, 129 U.S. 114 (1889 3

FTC v. Bunte Brothers, Inc., 312 U.S. 349

Fer 23

Grove City College v. Bell, 104 S. Ct. 1211 (1984). 18

Heublein, Inc. v. South Carolina Tax Commission,

r . 23

Hoyt v. St. Mary's Rehabilitation Center, 711 F. 2d

r 23

In re Hudson, 13 Wash. 2d 673, 126 P. 2d 765

r easels 15

In re Infant Doe, No. GU 8204-004A (April 12,

1982), writ of mandamus dismissed sub nom.

State ex rel. Infant Doe v. Baker, No. 482 8 140

D, abiveslteisnoces 28

Linder v. United States, 268 U.S. 5 (1925 3

Meyer v. Nebraska, 262 U.S. 390 (1923 15

Parham v. J. R., 442 U.S. 584 (1979) 3

Pennhurst State School & Hospital v. Halderman,

, .. inisoeen 23

Pierce v. Society of Sisters, 268 U.S. 510 (1925). 15

Schloendorff v. Society of New York Hospital,

211 N.Y. 125, 105 N.E. 92 (1914) 15

Southeastern Community College v. Davis, 442

Oe aces 22, 23

Sunray Mid-Continent Oil Co. v. FPC, 364 U.S.

I ikl, 19

United States v. Bass, 404 U.S. 336 (1971)........ 23

United States v. Cabrini Medical Center, 639 F.2d

e 23

23

United States v. Culbert, 435 U.S. 371 (1978)

vi

TABLE OF AUTHORITIES—Continued

Page

United States v. University Hospital, 729 F.2d

EF fe ee ne passim

Wisconsin v. Yoder, 406 U.S. 205 (1972 15

STATUTES AND REGULATIONS

Child Abuse Amendments of 1984, Pub. L. No.

98-457, 98 Stat. 1749 (1984) ee... passim

Child Abuse Prevention and Treatment Act, 42

,, 11

Civil Rights Act of 1964, tit. VI, 42 U.S.C.

ES Le ee eR 17, 30

Education Amendments of 1972, tit. IX, 20 U.S.C.

D r 18

Hill-Burton Act, 42 U.S.C. § 21111 18

Medicaid Act, 42 U.S.C. § 139 18

Medicare Act, 42 U.S.C. § 1399999 18

Rehabilitation Act of 1973, § 504, 29 U.S.C. § 794..passim

Cal. Bus. & Prof. Code § 2234 (West 1985 Supp.) .. 4

III. Ann. Stat. ch. 111, § 4433 (Smith-Hurd 1984-

BE BENS NT ie a IR CP

N.Y. Educ. Law § 6509 (McKinney’s 1984 Supp.)..

1 Airrcecrecebacesntnntecsendantndediecetccsoneneesi

ͤĩð ?öWq9«q rw 7

. 7, 8,

C. orcicccnsccicinsnnnsnsocctsonenettinientecossesens *

45 C. F. R. § 84.55 (e) 7

. eotcccecectttecntnscncsesncctecnectsivecenececenseree

een ae

LEGISLATIVE AND REGULATORY MATERIALS

H.R. Conf. Rep. No. 1038, 98th Cong., 2nd Sess.

// EN ORCS es DU LO YN ibe 12

S. Rep. No. 1135, 92nd Cong., 2d Sess. (1972) 18

130 Cong. Rec. 88017 (daily ed. June 21, 1984).... 10

130 Cong. Rec. H10327 (daily ed. September 26,

1E 12

130 Cong. Rec. H 10329 (daily ed. September 26,

—f— = . feen 12

2

SCAND O n o PP

vii

TABLE OF AUTHORITIES—Continued

Page

130 Cong. Rec. H10333 (daily ed. September 26,

SE scinrisiniicneiediciinciniegeameninepemaamneimnentee 12

130 Cong. Rec. 812382 (daily ed. September 28,

1777C '] «ͤ äu˙ :¼ʃñ»[.k: D— 12

130 Cong. Rec. $12382-83 (daily ed. September 28

0 12

130 Cong. Rec. 812385 (daily ed. September 28,

Nr eee 12

130 Cong. Rec. 812389 (daily ad. September 28,

c ee ee 12

130 Cong. Rec. 812392 (daily ed. September 28,

. 12

41 Fed. Reg. 29559 (1976)))0ũm0c 2-2 eeeneeeeeee ee 22

41 Fed. Reg. 29567 (1976) 22

48 Fed. Reg. 9630 (1983 10

49 Fed. Reg. 1631 (1984))))))))))))))))):ꝛ 3, 16, 21

49 Fed. Reg. 1632 (1984)))))))) 20

49 Fed. Reg. 1634 (19847) ⸗ꝓ 20

49 Fed. Reg. 1646-1649 (1984hahr;::: 29

49 Fed. Reg. 1649 (1984) 220. 27

49 Fed. Reg. 1653 (1984) 16

50 Fed. Reg. 14878 (April 15, 1985)... 3

50 Fed. Reg. 14879 (April 15, 1985) 13, 24

50 Fed. Reg. 14879-80 (April 15, 19850) 25

50 Fed. Reg. 14880 (April 15, 198857 3. 15, 25

50 Fed. Reg. 14881 (April 15, 19850) 25

50 Fed. Reg. 14883 (April 15, 19850) 24, 26

50 Fed. Reg. 14884 (April 15, 19885) 26

50 Fed. Reg. 14885 (April 15, 1988) 25

50 Fed. Reg. 14886-87 (April 15, 1985) 27

50 Fed. Reg. 14887 (April 15, 1985) 7, 28

MISCELLANEOUS

American Academy of Pediatrics, Guidelines for

Infant Bioethics Committees (198) 7

American Medical Association, Current Opinions

of the Judicial Council (1984)... 4

viii

TABLE OF AUTHORITIES—Continued

Page

American Medical Association, Judicial Council

Report, Guidelines for Ethics Committees in

Health Care Institutions, 253 J.A.M.A. 2698

RL TAT A IRE A ee EEO 7

Besharov, The Legal Aspects of Reporting Known

and Suspected Child Abuse and Neglect, 23 Vill.

r 4

Cohen, S., & Sussman, A., Reporting Child Abuse

, 4

Holder, A., Medical Malpractice Law (1975) 4

Louisell, D. & Williams, H., Medical Malpractice

rr 4

Lyon, J., Playing God in the Nursery (1985) 28

Nelson, W., Textbook of Pediatrics (R. McKay &

r,, ̃ ˙a—AA—A—A 5

President's Commission for the Study of Ethical

Problems in Medicine and Biomedical and Be-

havioral Research, Deciding to Forego Life

Sustaining Treatment (1983) .......................... 6-7, 26-27

Prosser and Keeton on the Law of Torts (W.

a iclisiimennen 15

Rudolph, A., Pediatrics (17th ed. 1983) 5

Shapiro & Rosenberg, The Effect of Federal Reg-

ulations Regarding Handicapped Newborns: A

Case Report, 252 J.A.M.A. 2031 (19843) 29

Stinson, R., & Stinson, P., The Long Dying of

DD iiitieaies 5

Strain, The American Academy of Pediatrics

Comments on the “Baby Doe II” Regulations,

309 New Eng. J. Med. 443 (1983)

IN THE

Supreme Court of the United States

OCTOBER TERM, 1984

No. 84-1529

MARGARET M. HECKLER, SECRETARY OF

HEALTH AND HUMAN SERVICES,

. Petitioner,

AMERICAN HOSPITAL ASSOCIATION, et al.,

Respondents.

On Petition for a Writ of Certiorari to the

United States Court of Appeals for the Second Circuit

BRIEF OF THE RESPONDENTS

AMERICAN MEDICAL ASSOCIATION, ET AL.,

IN OPPOSITION

The American Medical Association (“AMA”), the

American College of Obstetricians and Gynecologists, the

Association of American Medical Colleges, the American

Academy of Family Physicians, the Hospital Association

of New York State, the American Hospital Association

and certain individual physicians (“respondents AMA et

al.“) oppose the petition for a writ of certiorari filed by

Margaret M. Heckler (“the Secretary“), the Secretary of

Health and Human Services (“HHS”).

The Secretary seeks review of a decision by tlie United

States Court of Appeals for the Second Circuit invalidat-

ing a regulation issued by the Secretary pursuant to

Section 504 of the Rehabilitation Act of 1973, 29 U.S.C.

§ 794 (“the 504 Regulation”) (Pet. App. 53a-58a), which

authorizes direct federal investigation and regulation of

individual treatment decisions made by parents on behalf

of their severely impaired children in consultation with

2

the physician of their choice. The regulation also places

“independent federal dut[ies]” on hospitals and other pro-

viders of health services with regard “to the treatment”

of severely impaired infants. Pet. 27 n.22 (emphasis sup-

plied).

Review by this Court is not warranted. First, Section

504 clearly does not authorize direct federal investigation

of individual treatment decisions involving impaired new-

borns—a federal role that would unnecessarily duplicate

and inevitably subvert the states’ traditional responsibili-

ties for regulating individual parent-child and doctor-

patient relationships. Second, the federal interest with

respect to treatment of impaired newborns is reflected not

in the 504 Regulation promulgated solely by the Secre-

tary but in the 1984 Child Abuse Amendments, Pub. L.

No. 98-457, 98 Stat. 1749 (1984), enacted by the Con-

gress last fall after the 504 Regulation had been invali-

dated. This new legislation uses a state grant program

and state agencies to address federal concerns and ex-

pressly repudiates a direct federal regulatory role and

creation of a federal bureaucracy to enforce the federal

“504 malpractice’ standards which are inherent in the

Secretary’s voided approach.

STATEMENT

The Secretary’s statement of the case (Pet. 2-11) is

profoundly mislea ling because it fails to describe ade-

quately or ignores completely the following crucial dimen-

sions of the problem of proper care for impaired new-

borns: the historic state law framework which regu-

lates parent-child and physician-patient relationships; the

complex medical and ethical issues raised by treatment

decisions for impaired newborns; the growth of volun-

tarily-created, hospital-based infant care review commit-

tees which provide a non-governmental response to the

difficult issues that arise in this area; the facts of United

States v. University Hospital, 729 F.2d 144 (2d Cir.

1984) (Pet. App. 4a-47a), which demonstrate fully how

overbearing, intrusive and unnecessary is the federal gov-

3

ernment’s attempt under Section 504 to regulate individ-

ual treatment decisions directly; and the Congress’ ex-

plicit decision in the 1984 Child Abuse Amendments to

reject, on policy grounds, the direct federal investigatory

and regulatory role advanced by the Secretary here.

(1) The State Law Framework. The public dialogue

about appropriate medical treatment of severely impaired

newborn infants takes place within an historic state law

framework which cedes to parents the ultimate respon-

sibility for making decisions about treatment of their

seriously ill children. 50 Fed. Reg. 14880 (April 15,

1985). Parental treatment decisions on behalf of their

children are controlling, except in the most extreme cases

when state courts have determined that a decision not to

authorize treatment constitutes “medical neglect” of chil-

dren by their parents. Id.

All fifty states have child protective service agencies

which are generally responsible for investigating reports

of child abuse and neglect by parents (including “medical

neglect”), counseling families and, where necessary, in-

stituting court actions to remove the parent as decision

maker for the child. Jd. at 14878. Moreover, most hos-

pitals have established procedures for working with the

state child protective service agencies and seeking state

court orders directing that appropriate medical treatment

be given to an infant when the parents are clearly not

acting in the best interest of the child. See 49 Fed. Reg.

1631 (1984).

State law also has historically governed the relation-

ship between patients and physicians.? Unless parents

This Court already has recognized the primacy of the parents’

role in making difficult treatment decisions for their children. See

Parham v. J.R., 442 U.S. 584, 602 (1979) (historically law has

recognized that natural bonds of affection lead parents to act in

the best interests of their children).

2 See Barsky v. Board of Regents, 347 U.S. 442 (1954); Linder

v. United States, 268 U.S. 5 (1925); Dent v. West Virginia, 129

U.S. 114 (1889).

1

consent to treatment, a physician commits battery if he

or she operates on a minor. See note 16, infra. All states

have mandatory reporting statutes which require physi-

cians (and other health care professionals) to inform the

state child protective service agency of known or sus-

pected instances of medical neglect by parents.“ More-

over, once a physician has been engaged by a patient (or

by a parent on behalf of a minor patient) and consent to

treatment has been given, then under state statutory or

common law the physician has a legal duty to provide

appropriate medical care until the doctor-patient rela-

tionship is terminated by giving the patient due notice

and the opportunity to obtain other medical care. If the

physician withdraws before these conditions are satisfied,

then he or she is liable for damages under the doctrine

of patient abandonment.*

The Secretary attempts to mislead this Court by

vaguely citing to the “Baby Doe of Indiana” case

(“Bloomington Baby Doe“) to illustrate the problem“

with the historic state law framework which, in her view,

justifies a direct federal role. Pet. 2-3, 20. But, as dis-

cussed infra, pp. 27-28, both private health care providers

See generally S. Cohen & A. Sussman, Reporting Child Abuse

and Neglect (1975); Besharov, The Legal Aspects of Reporting

Known and Suspected Child Abuse and Neglect, 25 Vill. L. Rev.

458 (1977-1978).

4 See 1 D. Louisell & H. Williams, Medical Malpractice . 4.12,

8.08 (Rev. ed. 1984); A. Holder, Medical Malpractice Law 374-393

(1975). Widely accepted principles of medical ethics impose a

similar duty on physicians to continue necessary treatment until

the physician-patient relationship has been properly terminated in

a manner which allows engagement of another physician. AMA,

Current Opinions of the Judicial Council § 8.10 (1984).

In addition, medical licensing statutes in many states provide

for the revocation or suspension of a physician’s license, or other

disciplinary action, upon a finding, inter alia, that the physician

has abandonea his or her patient by refusing to provide needed

treatment. See, e.g., Cal. Bus. & Prof. Code § 2234 (West 1985

Supp.) ; III. Ann. Stat. ch. 111, § 4433 (Smith-Hurd 1984-85 Supp.) ;

N.Y. Educ. Law § 6509 (McKinney’s 1984 Supp.).

5

and state executive branch officials sought judicial review

of the parental treatment decision in that case. Two dif-

ferent state court judges refused to overturn the parents’

treatment choice, and those state judicial decisions are

clearly not subject to federal regulation under Section

504. The actions of health care providers and state offi-

cials in taking a rare case of questionable parental deci-

sionmaking to state court shows that state laws and in-

stitutions are working.

(2) Medical and Ethical Context: The Growth of In-

fant Care Review Committees. The question of what sort

of medical treatment, if any, should be given to severely

impaired newborn infants is “one of the most difficult

and sensitive medical and ethical problems facing our

society.” American Academy of Pediatrics v. Heckler,

561 F. Supp. 395, 396 (D.D.C. 1983) (Gesell, J.). The

birth of such an infant is often an unexpected and trau-

matic event for parents, who are confronted with the

necessity of making difficult life or death treatment deci-

sions with little advance warning. See R. Stinson & P.

Stinson, The Long Dying of Baby Andrew (1983). The

difficulties for parents become acute when a particular

condition is so serious that severe disability will remain

even after treatment of that condition or when an infant

has multiple impairments, one that is correctable and

one, like anencephaly (entire or substantial absence of a

brain), which will have an enormous, adverse impact on

the child.

In some cases involving impaired newborn infants,

physicians can predict with a relative degree of confi-

dence that a particular course of treatment is likely to be

beneficial or futile.“ But there is a significant area of

5 See generally A. Rudolph, Pediatrics (17th ed. 1983); W. Nel-

son, Textbook of Pediatrics (R. McKay & V. Vaughan ed. 1975).

® See Affidavit of Peter A.M. Auld, M.D., professor of Pediatrics

and Obstetrics and Perinatal Medicine at Cornell University Medi-

cal College, . 2. Plaintiffs-respondents AMA et al. submitted affi-

6

uncertainty in which the results and consequences of a

given course of treatment are simply unpredictable and

the selection of an appropriate course of treatment be-

comes commensurately more difficult. As the President’s

Commission for the Study of Ethical Problems in Medi-

cine and Biomedical and Behavioral Research stated in its

recent report, Deciding to Forego Life-Sustaining Treat-

ment 220 (1983) [President's Commission Report“ ]:

Much of the difficulty in these [ambiguous] cases

arises from factual uncertainty. For the many in-

fants born prematurely, and sometimes for those

with serious congenital defects, the only certainty is

that without intensive care they are unlikely to sur-

vive; very little is known about how each individual

will fare with treatment. Neonatology is too new a

field to allow accurate predictions of which babies

will survive and of the complications, handicaps, and

potentials that the survivors might have. (Footnote

omitted. )

Recent advances in neonatal medicine have also exacer-

bated the uncertainty in treatment decisions. As the

President’s Commission Report explained (at p. 198):

[Mledieine's increased ability to forestall death in

seriously ill newborns has magnified the already

difficult task of physicians and parents who must

attempt to assess which infants will benefit from

various medical interventions, and which will not.

Not only does this test the limits of medical cer-

tainty in diagnosis and prognosis, it also raises pro-

found ethical issues.

To address the difficult ethical issues which can be

raised by the birth of a severely impaired child, the

President’s Commission Report (at p. 225-228) repudi-

davits and other evidentiary material in support of their motion

for summary judgment in this case. In her defense, the Secretary

did not submit any testimonial evidence on medical issues. Cita-

tions to affidavits in this opposition thus refer to the uncontested

testimony submitted to the District Court by the AMA et al.

7

ated an increased federal role like the one advanced by

the Secretary in the 504 Regulation and, instead, recom-

mended the voluntary formation of infant care review

committees. Medical associations have also advocated the

formation of such committees.’ These committees deal

directly with the fundamental problem in this sensitive

area: lack of information and perspective by the parents

who must r ke decisions for their severely impaired

infant. Presu.ent’s Commission Report at 227. Such com-

mittees are comprised of health professionals and, often,

of individuals trained in other specialties such as religion,

social work, ethics and law. The committees offer parents

information, counseling and, where appropriate, review

of proposed treatment decisions made in consultation with

the attending physician. At present, many hospitals with

intensive care units for neonates have some form of spe-

cial review process for these difficult cases, and the

number of infant care review committees is growing

rapidly. 50 Fed. Reg. 14887 (April 15, 1985).

(3) The Voided 504 Regulation. Instead of following

the recommendation of the President’s Commission Re-

port, the Secretary adopted the approach invalidated be-

low which injects the federal government directly into

individual treatment decisions. The 504 Regulation con-

tains four mandatory provisions which were declared un-

lawful and enjoined in this case.“ (i) The regulation re-

7 See President's Commission Report at 227-228; AMA, Judicial

Council Report, Guidelines for Ethics Committees in Health Care

Institutions, 253 J.A.M.A. 2698 (1985); American Academy of

Pediatrics, Guidelines for Infant Bioethics Committees (1984).

See 45 C. F. R. $§ 84.55(b)-(e). (Pet. App. 54a-58a.) The 504

Regulation also contains several non-mandatory provisions which

were not challenged in this case. First, the regulation encourages,

but does not require, health care providers to establish infant care

review committees and sets forth a model rule for the establish-

ment of such committees. 45 C. F. R. §§ 84.55 (a), (f). (Pet. App.

53a-54a, 58a-62a.) Second, an Appendix to the regulation contains

“interpretative guidelines” illustrating how the rule might apply to

8

quires recipient hospitals to post a notice, where health

care professionals will see it, which states, in part, that

discriminatory failure to provide “medically beneficial”

treatment to an impaired newborn violates Section 504.

The phrase “medically beneficial treatment” is not de-

fined in the required notice. The notice must include the

telephone number of a 24-hour a day hotline where any

person may call federal officials to report suspected viola-

tions, even if such reports are based on nothing more

than rumor. 45 C.F.R. § 84.55(b). (Pet. App. 54a.)

(ii) The 504 Regulation provides that recipient state

child protective service agencies must establish and main-

tain in written form “methods of administration and

procedures to assure that the agency utilizes its full au-

thority pursuant to state law to prevent instances of un-

lawful medical neglect of handicapped infants.” 45 C.F.R.

§ 84.55(c) (emphasis supplied). (Pet. App. 56a.) These

“methods and procedures” include a federal requirement

that physicians and other health care providers must re-

port on a timely basis to the state agency “circumstances

which they determine to constitute known or suspected

instances of unlawful medical neglect of handicapped in-

fants.” Id. (emphasis supplied).

(iii) The 504 Regulation grants HHS expedited access

to pertinent medical records and facilities and authorizes

expedited investigations whenever HHS determines that

immediate action is necessary to protect the life or health

of an infant. 45 C.F.R. § 84.55(d). (Pet. App. 58a.)

(iv) The 504 Regulation also authorizes expedited ac-

tion by HHS against federal fund recipients to effect

compliance with Section 504, including court action. 45

C.F.R. § 84.55(e). (Pet. App. 58a.)

particular treatment situations. 45 C.F.R. § 84.55, Appendix C,

(a). (Pet. App. 66a-68a.) Finally, the Appendix sets forth in-

terpretative guidelines” for the conduct of HHS investigations.

45 C. F. R. § 84.55, Appendix C, f (b). (Pet. App. 68a-72a.)

9

(4) The Decisions Below. The actions of the Secretary

in University Hospital—which are conspicuously absent

from her description of that case (Pet. 8-9)—perfectly

illustrate the intrusive and unnecessary role of the fed-

eral government in second-guessing parents and state

authorities under Section 504. After Baby Jane Doe was

born with multiple birth defects on October 11, 1983, her

parents decided not to authorize certain surgery following

consultation with “several physicians, nurses, religious

advisors, a social worker, and members of their family.”

(Pet. App. 6a.) A third party, unrelated to Baby Jane

Doe, filed suit in New York State court seeking appoint-

ment of a guardian ad litem and an order directing

that the surgery be performed. The trial court granted

this request, but was immediately overruled by the Ap-

pellate Division, which determined that the parents’ deci-

sion was in the best interests of the child. (Pet. App.

7a.) The New York Court of Appeals affirmed. (Pet.

App. 7a-8a.)

While the state court proceedings were still in prog-

ress, the federal government, which had received a 504

complaint from an unidentified citizen, referred the mat-

ter to the New York State child protective service agency.

That agency concluded on November 7, 1983 that there

was no cause for state intervention against the parents.

(Pet. App. 8a.) Without waiting for the state agency to

make its determination, HHS in late October began its

own direct Section 504 investigation. University Hos-

pital declined to give Baby Jane Doe’s medical records to

HHS, based in part on the parents’ refusal to release

them. On November 2, 1983, before the state child pro-

tective service agency had reached a decision, HHS

brought an action under Section 504 in federal court

seeking access to the records. The Department then per-

sisted in its suit even after the state agency concluded

that no state intervention was warranted under New

York’s child neglect statute. (Pet. App. 8a-10a.) To

protect their interests, Baby Jane Doe’s parents were

forced to intervene.

10

Baby Jane Doe’s parents were thus required to defend

not only a state court action and a state child protective

service agency inquiry but a separate and independent

federal lawsuit instituted by the United States. This

harassing federal action exposed the parents to continued,

unwanted publicity and imposed on them over $75,000 in

additional legal fees. See 130 Cong. Rec. $8017 (daily ed.

June 21, 1984). The District Court entered summary

judgment for University Hospital and the parents. (Pet.

App. lla.) On February 23, 1984, the Court of Appeals

affirmed, rejecting the Department’s claim of authority to

investigate Baby Jane Doe’s parents and University Hos-

pital. The Court of Appeals held that Section 504 does

not “apply to treatment decisions involving defective

newborn infants.” (Pet. App. 40a.) The Secretary did

not petition this Court for review of the Court of Ap-

peals’ decision in University Hospital.

The final 504 Regulation at issue in this proceeding

was promulgated by the Secretary on January 12, 1984,

while the University Hospital case was pending before

the Court of Appeals.“ After publication of this final 504

Regulation and after the Court of Appeals decision in

University Hospital, the AMA et al. filed this action on

March 12, 1984, in the District Court for the Southern

District of New Vork.“ On May 23, 1984, the District

Court issued a memorandum and order which held that,

The Secretary’s investigation and initiation of court action in

University Hospital were undertaken in the fall of 1983 pursuant

to her general authority under Section 504 but in the absence of a

specific implementing regulation. The final 504 Regulation was not

adopted until January 12, 1984, after the University Hospital case

had been briefed, argued and submitted to the Court of Appeals

for decision.

10 On the same day, the American Hospital Association, the Hos-

pital Association of New York State and Strong Memorial Hospital,

which had previously filed an action in the same court challenging

the validity of the Secretary’s March 7, 1983 interim rule (48 Fed.

Reg. 9630 (1983)) amended their complaint to state a claim chal-

lenging the lawfulness of the final 504 Regulation.

11

under authority of University Hospital, the 504 Regula-

tion was invalid because the Secretary “has no authority

under Section 504 to investigate or to otherwise regulate

treatment decisions involving impaired newborn infants.”

(Pet. App. 51a.) The Court of Appeals, also relying on

the controlling effect of University Hospital, affirmed in

a two paragraph order. (Pet. App. 2a.)

(5) The Child Abuse Amendments of 1984. After

holding that neither the express language nor the legisla-

tive history of Section 504 authorized the direct federal

intrusion into historic state functions contemplated by

the Secretary, the Court of Appeals concluded its opinion

in University Hospital by noting (Pet. App. 40a-41a)

that:

it is congress, rather than an executive agency, that

must weigh the competing interests at stake in this

context in the first instance. Until congress has

spoken, it would be an unwarranted exercise of judi-

cial power to approve the type of investigation that

has precipitated this lawsuit.

Following the invalidation of the 504 Regulation in this

case, the Congress last year undertook just such an ex-

amination. It chose not to revive the direct federal in-

vestigatory and regulatory role advanced by the Secre-

tary and voided by the courts.

Instead, the Congress in the fall of 1984 enacted the

Child Abuse Amendments of 1984, Pub. L. No. 98-457, 98

Stat. 1749 (1984), amending the Child Abuse Prevention

and Treatment Act, 42 U.S.C. §§ 5101 et seg. In con-

trast to Section 504, the Child Abuse Prevention and

Treatment Act is a state grant program which seeks to

help state child protective service agencies discharge their

responsibilities with respect to abused and neglected

children in the context of severely impaired newborn in-

fants." As a principal sponsor of the 1984 Child Abuse

11 The 1984 Child Abuse Amendments contemplate grants to state

child protective service agencies conditioned on incorporation of

12

Amendments stated in a crucial piece of the legislative

history:

Throughout the statutory language and accompany-

ing explanatory material, we refer to authority un-

der state law as the mechanism for pursuing legal

remedies under our amendment. This legislation

does not itself authorize direct federal involvement in

individual cases. (Emphasis supplied.)

The Congress recognized that in enacting the 1984

Amendments, it was, for the first time, expressly ad-

dressing the difficult issues arising out of treatment of

impaired newborns. In floor debates on the Conference

Report, Representative Bartlett stated that “these Baby

Doe provisions are precedent setting. They represent the

first time that we have successfully legislated in a very

sensitive area.” 130 Cong. Rec. H10329 (daily ed. Sep-

tember 26, 1984) (emphasis supplied).’* Moreover, in

certain changes in state law and procedure consistent with the

provisions of the Amendments. A definition of child neglect in

the circumstance of withholding treatment from a severely dis-

abled child is set forth; states must adopt certain reporting and

other procedures; and the direct federal role is iimited to training

and a clearinghouse function for information relating to develop-

ments in treatment and support services for impaired newborns.

See H.R. Conf. Rep. No. 1038, 98th Cong., 2nd Sess. (1984). See

also 130 Cong. Rec. H10327 (daily ed. September 26, 1984); 130

Cong. Rec. $12382 (daily ed. September 28, 1984) (conference

report debates on floor of House and Senate).

12 Letter from Senator Hatch to Senator Weicker, 130 Cong. Rec.

812392 (daily ed. September 28, 1984). See also Pet. 27 (no direct

federal role in individual cases is authorized).

18 Representative Erlenborn noted that the “disabled infants pro-

visions incorporated in the conference report address a myriad of

difficult social and ethical issues. The conference agreement is the

product of months of painstaking deliberations.” Jd. at H10333.

Senators also explained how the Amendments embodied a new ap-

preach and an attempt to craft specific provisions to meet difficult

problems. See, e.g., 130 Cong. Rec. 812382-83, 812385, 812389

(daily ed. Sept. 28, 1984) (remarks of Senators Hatch, Dodd and

Cranston).

13

the preamble to the final regulation implementing the

1984 Child Abuse Amendments (“1984 Child Abuse Reg-

ulation”), the Secretary noted the special and explicit

Congressional effort to deal with the complex problems in

this sensitive area (50 Fed. Reg. 14879 (April i5,

1985) ) :

[T)his legislation [the 1984 Child Abuse Amend-

ments] was the product of an extraordinary effort

on the part of several Senators and Congressmen and

representatives of a wide range of medical, right-to-

life and disability organizations to forge a substan-

tial consensus on an effective and workable program

to assure the provision of appropriate medical care

to disabled infants... .

It is clear that the legislation represented a careful

balance between the need to establish effective pro-

tection of the rights of disabled infants and the need

to avoid unreasonable governmental intervention into

the practice of medicine and parental responsibilities.

(Emphasis supplied. )

REASONS FOR DENYING THE PETITION

In contrast to the 1984 Child Abuse Amendments en-

acted by the Congress, the 504 Regulation promulgated

solely by the Secretary reflects neither clear congressional

authorization nor a careful balancing of the relevant in-

terests. Accordingly, this case does not warrant plenary

review by this Court.

First, the Secretary’s attempt to investigate and regu-

late individual treatment decisions involving impaired

newborns is clearly not authorized by the language of

Section 504. Parents are not recipients of feder: finan-

cial assistance” and their treatment decisions on behalf

of their infants may not be regulated under Section 504.

Similarly, the independent state law duties regarding

parental neglect imposed on health care providers are not

part of any federally funded “program or activity,” and

providers’ decisions whether to report or prosecute par-

14

ents for medical neglect are similarly outside the scope

of Section 504. Moreover, the Congress clearly did not

intend to subvert the historic state law framework for

regulating parent-child and doctor-patient relationships

and create a body of “504 malpractice law for determin-

ing, according to federal standards, the reasonableness of

individual treatment decisions.

Second, there is no substantial federal interest in the

voided regulations because, inter alia, the Secretary has

shown no problem with the historic state law framework

that justifies a direct federal role, and the Congress has

explicitly and recently adopted an alternative state-based

approach in the 1984 Child Abuse Amendments.

I. THE DECISION BELOW WAS CLEARLY COR-

RECT: SECTION 504 DOES NOT AUTHORIZE

DIRECT FEDERAL INVESTIGATION AND REGU-

LATION OF INDIVIDUAL TREATMENT DECI-

SIONS INVOLVING IMPAIRED NEWBORNS.

With respect to “treatment” of impaired newborns,

there are three types of decisions which the Secretary’s

petition seems to suggest are within the scope of Section

504: the decision by parents whether or not to consent

to treatment for their child (Pet. 6); the decision by a

health care provider whether or not to, report to state

agencies, or seek state court action against, a parent on

grounds of medical neglect (id.); and the decision by a

physician or hospital whether or not to treat an infant

if the parents have consented to treatment (id. at

11-12, 19-20). But, despite the Secretary’s studied vague-

ness as to what conduct by whom actually violates Section

504, the Congress clearly intended that none of these

types of decisions should be directly regulated by HHS

under authority of that provision.

14 Section 504 provides, in pertinent part: “No otherwise quali-

fied handicapped individual in the United States . . shall, solely

by reason of his handicap, be excluded from participation in, be

denied the benefits of, or be subjected to discrimination under any

program or activity receiving Federal financial Assistance... .”

29 U.S.C. § 794.

K

15

A. Treatment Decisions by Parents on Behalf of Their

Impaired Newborn Infants Are Not Within the

Scope of Section 504.

Although the Secretary withholds this fact from the

Court, she has conceded elsewhere that, absent state court

action, parents are the sole decisionmakers for their

infant children and that parental treatment decisions on

behalf of impaired newborns are not within the scope of

Section 504 because parents are not recipients of “federal

financial assistance.”

As noted, parents have the ultimate responsibility for

making decisions about the treatment of seriously ill new-

borns.““ As the Secretary recently stated in the preamble

to the Child Abuse Regulation,

The decision to provide or withhold medically indi-

cated treatment is, except in highly unusual circum-

stances, made by the parents or legal guardian. Par-

ents are the decision makers concerning treatment

for their disabled infant, based on the advice and

reasonable medical judgment of their physician (or

physicians). (Emphasis supplied.)

50 Fed. Reg. 14880 (April 15, 1985). Indeed, physicians,

nurses and hospitals have no authority to perform treat-

ment on newborn infants to which parents have not con-

sented on behalf of their child.“

15 State law has always recognized the parents’ inherent right to

make medical decisions on behalf of their minor children. See, e. g.,

Bennett v. Jeffreys, 40 N.Y.2d 548, 356 N.E.2d 277 (1976); In re

Hudson, 13 Wash. 2d 673, 126 P.2d 765 (Wash. 1942). Parental

autonomy to make decisions for their children is also protected

under the Constitution. See, e.g., Wisconsin v. Yoder, 406 U.S. 205

(1972) ; Meyer v. Nebraska, 262 U.S. 390 (1928) ; Pierce v. Society

of Sisters, 268 U.S. 510 (1925).

16 A physician or hospital is guilty of assault and battery if

surgery is performed on an infant without parental consent. See

Prosser and Keeton on the Law of Torts § 18, at 116 (W. Keeton

ed. 1984). See also Schloendorff v. Society of New York Hospital,

211 N.Y. 125, 105 N.E. 92 (1914).

16

After conceding that, absent a court order, only par-

ents can make treatment decisions for their infant chil-

dren, the Secretary then makes the further, devastating

concession that parental decisionmaking is outside the

scope of Section 504 because parents are not recipients of

“federal financial assistance.” In the preamble to the 504

Regulation voided below, the Secretary stated:

Section 504 applies only to programs or activities

receiving federal financial assistance; it does not

apply to decisions made by parents.

49 Fed. Reg. 1631 (1984) (emphasis supplied.) Simi-

larly, in the interpretative guidelines to the 504 Regula-

tion, the Secretary stated unequivocally:

Section 504 and the provisions of this part are not

applicable to parents (who are not recipients of Fed-

eral financial assistance).

Id. at 1653 (emphasis supplied.) (Pet. App. 67a.)

Accordingly, the Secretary’s argument (Pet. 12-18)

that the terms of Section 504 clearly authorize direct

federal investigation and regulation of treatment deci-

sions involving impaired newborns is fatally flawed by

her own explicit concessions that (a) parents, not health

care providers, make treatment decisions on behalf of

newborn infants, and (b) parents are not federal fund

recipients and, thus, not within the scope of Section 504.

Indeed, these concessions, made after briefing and argu-

ment in University Hospital, completely invalidate her

own actions in that case, because there HHS was attempt-

ing to investigate and regulate directly decisions by Baby

Jane Doe’s parents.“ See pp. 9-10, supra.“

17 Given the decision of the state child protective service agency

not to proceed against Baby Jane Doe's parents (Pet. App. 8a),

the Secretary could hardly have been arguing in University Hos-

pital that she needed to investigate whether the physicians or

hospital had failed to report alleged parental neglect to state

authorities.

18In light of the Secretary’s own explicit concessions about the

inapplicability of a federal law triggered by receipt of federal

17

B. Decisions by Health Care Providers on Whether or

Not to Report Suspected or Known Instances of

Parental Medical Neglect to State Authorities Are

Not Within the Scope of Section 504.

Given her fatal recognition in the 504 Regulation that

the federal government has no authority under Section

504 to regulate parental treatment decisions, the Secre-

tary attempts in the Regulation to do indirectly what she

has conceded she cannot do directly. Section 84.55(c) of

the Regulation (Pet. App. 57a) requires

that health care providers report on a timely basis

to the state agency circumstances which they deter-

mine to constitute known or suspected instances of

unlawful medical neglect [by parents] of handi-

capped infants. (Emphasis supplied.)

Similarly, the interpretative guidelines to the 504 Regula-

tion state (Pet. App. 67a) :

Whenever parents make a decision to withhold con-

sent for a medically beneficial treatment or nourish-

ment, . . providers [who receive federal financial

assistance] may not, solely on the basis of the in-

fant’s present or anticipated future mental or physi-

cal impairments, fail to follow applicable [state] pro-

cedures on reporting such incidents to the state child

protective services agency or to seek judicial review

[in state court].

See also Pet. 24-25. In other words, under putative

authority of Section 504, the Secretary intends to investi-

gate in individual cases whether health care providers

funds to parental treatment decisions, Judge Winter's statement

in his University Hospital dissent—that “denial of medical treat-

ment to an infant because the infant is black is not legitimated

by parental consent“ —is clearly in error. (Pet. App. 44a.) Regard-

less of the race, color or creed of an infant, health care providers

have no authority to operate on a child without parental consent

or without a court order removing the parent as decision maker

for the child, and neither Title VI of the Civil Rights Act of 1964,

42 U.S.C. §§ 2000d et seq., nor Section 504 alters this fundamental

rule.

18

are discharging their mandatory statutory duties under

state child neglect laws to report parents to state agencies

or sue parents in state courts. See p. 8, supra. But

this contorted position, invalidated below, does not war-

rant review by this Court.

First, health care providers’ decisions whether to report

or prosecute parents under state child negiect laws are

clearly outside the express terms of Section 504 because

those decisions are not part of a “program or activity”

receiving “federal financial assistance.” The Secretary

makes no showing either in her petition (see p. 15 n. 12)

or in the preamble to the 504 Regulation that health care

providers’ independent, mandatory duties under state

child neglect statutes are part of Medicaid, 42 U.S.C.

§ 1395 et seqg., Medicare, 42 U.S.C. § 1396 et seq., Hill-

Burton, 42 U.S.C. § 291 et seqg., or any other federally

funded “program or activity.” And she can make no

such showing. Independent state law duties of health

care providers are simply not part of a federal “program

or activity” and therefore may not be regulated by the

Secretary under Section 504. Cf. Grove City College v.

Bell, 104 S. Ct. 1211 (1984) (construing narrowly pro-

gram or activity” language of Title IX of the Education

Amendments of 1972, 20 U.S.C. § 1681 (a)).

Second, nothing in the legislative history of Section 504

suggests that it was intended to make independent state-

law duties a part of a fund recipient’s federally financed

“program or activity.” The essence of Section 504 is to

prevent recipients of federal funds—in this case federal

health care funds—from denying otherwise qualified

handicapped individuals “access” to the programs in

which the recipient receives such funds. Alexander v.

Choate, 105 S. Ct. 712, 721 (1985). See also S. Rep. No.

1135, 92nd Cong., 2d Sess. 49 (1972). Here, by contrast,

the Secretary is trying to force health care providers to

provide severely impaired infants “access” to state ad-

ministrative or judicial processes so that these infants

may have their parents’ fitness determined by state agen-

19

cies or state courts under state “medical neglect” stand-

ards. Nothing in Section 504, or its legislative history,

suggests the provision was intended to provide such access

to state administrative or judicial processes for determi-

nations under state law standards. Indeed, the Secretary

does not—and cannot—cite a single shred of legislative

history or a single judicial precedent contemplating or

authorizing such a contorted use of Section 504, a federal

civil rights statute, to enforce independent state law

duties of federal fund recipients. See Pet. 18-21 (discus-

sion of legislative history).

Third, while conceding that she cannot directly investi-

gate or regulate parental treatment decisions, the Secre-

tary—by trying to oversee the state law duties of health

care providers to refer parental neglect to state agencies

or courts—is indirectly using federal power to force

others to review and possibly supplant the exercise of

parental authority. This she simply may not do under

the well-established principle that federal departments

and agencies may not do indirectly what they are forbid-

den by statute from doing directly. See, e.g., Sunray

Mid-Continent Oil Co. v. FPC, 364 U.S. 137, 151-152

(1960). The Secretary cannot regulate parental decisions

under Section 504, and she cannot force health care pro-

viders to do it for her. Fourth, as discussed in the next

section, Congress did not intend when it enacted Section

504 to authorize the creation of a body of “504 malprac-

tice law“ for determining whether a health care provid-

er’s decision not to report parents to state child neglect

authorities in individual cases was a “reasonable medical

judgment” or “unreasonable discrimination” under Sec-

tion 504.“

10 The decision whether or not to report parents for alleged

medical negiect is much more complicated and much more inter-

twined with medical practice in cases involving impaired newborns

than in cases involving denial of treatment by parents on religious

grounds. See Pet. 20, 25. In the latter case, the effects of medical

treatment are crystal clear and the only bar is the religious

convictions of the parents. In cases involving impaired newborns,

parental decisions not to treat and providers’ decisions not to re-

20

C. Providers’ Treatment Decisions In Individual Cases

Are Not Within the Scope of Section 504.

The Secretary also maintains that “not every decision

by a hospital that happens to relate to the furnishing of

medical treatment is perforce a bona fide medical judg-

ment. Pet. 19. In other words, the Secretary

asserts her power, under Section 504, to use officials in

HHS's Office for Civil Rights, who may not even have the

advice of medical consultants, to investigate and deter-

mine whether a provider’s decision not to treat in an

individual case, if parental consent is given, constitutes a

“reasonable medical judgment.” See 49 Fed. Reg. 1632,

1634 (1984) (504 to be applied in this context on “case-

by-case” basis but no commitment to use medical consult-

ants). But, this position is not worthy of review by this

Court for several related reasons.

First, the fundamental problem with the Secretary’s

position is that it is based on a situation that has not

occurred and will not occur—in real life. As we already

have explained, parents, not physicians and other pro-

viders, have sole legal authority to decide whether or not

a child receives medical treatment. For the Secretary’s

hypothetical to occur, parents, in consultation with their

child’s physician, would have to authorize treatment for

the impaired infant and the physician or hospital would

then have to refuse to provide it to an “otherwise quali-

fied” child on the basis of the child’s handicap alone.

Such a sequence of events is implausible on its face.

Not surprisingly, the Secretary cites no case where this

has occurred.” In fact, nothing in its regulatory history

port such parents are based on much more complicated medical

determinations about the prognosis for the child even after treat-

ment. See pp. 5-6, supra.

20 As the Court of Appeals noted in University Hospital, “Baby

Jane Doe has been treated in an evenharded manner at least to

the extent that the hospital has always been and remains willing

to perform the dual, corrective surgeries if her parents would

consent.” (Pet. App. 39a.) See also pp. 27-28, infra (“Baby Doe of

21

suggests that the purpose of the voided 504 Regulation

was intended to deal with this type of situation. See Pet.

App. 66a-77a. Instead, the interpretative guidelines to

the 504 Regulation make clear that it is aimed at par-

ental “neglect” and the duty of health care providers to

report such alleged “neglect.” See also Pet. 24 (Secre-

tary’s efforts aimed at parental withholding of consent) ;

49 Fed. Reg. 1631 (1984) (same). Thus, the Secretary

does not need the extensive regulatory regime she has

created through this Regulation, which is designed to deal

with known or suspected cases of parental “neglect,” in

order to respond instead to the nonexistent problem of

physicians who refuse to treat handicapped infants after

parental consent is given.

Second, when it enacted Section 504, the Congress

clearly did not authorize creation of a body of “504 fed-

eral malpractice” law. But that is precisely what will

occur under the Secretary’s approach if HHS civil rights

officials attempt to determine whether a provider’s deci-

sion constituted a “reasonable medical judgment” or

“ynreasonable discrimination” under Section 504. The

Secretary’s glib statements that this distinction is easy

to draw (Pet. 14-15, 20) and that Congress intended

such line drawing are simply wrong. As the Court of

Appeals stated concisely (Pet. App. 30a-31a) :

... in arguing that Baby Jane may have been sub-

jected to discrimination” the government has taken

an oversimplified view of the medical decision-making

process. Where the handicapping condition is re-

lated to the condition(s) to be treated, it will rarely,

if ever, be possible to say with certainty that a par-

ticular decision was “discriminatory”. It is at this

point that the analogy to race, relied on so heavily

by the dissent, breaks down. Beyond the fact that

no two cases are likely to be the same, it would in-

variably require lengthy litigation primarily involv-

ing conflicting expert testimony to determine whether

Indiana” case relied upon by Secretary did not involve physician

refusal to treat).

22

a decision [by a physician] to treat, or not to treat,

. . . was based on a “bona fide medical judgment“,

however that phrase might be defined. Before ruling

that congress intended to spawn this type of litiga-

tion under section 504, we would want more proof

than is apparent from the face of the statute. (Em-

phasis supplied.)

The Court of Appeals’ succinct discussion of the legisla-

tive history of Section 504 indicates clearly that Congress

did not intend HHS to determine when a physician’s

refusal to treat was reasonable or unreasonable—a ques-

tion closely akin to the one asked in medical malpractice

cases brought under state law. (Pet. App. 31a-35a.)

Indeed, the Secretary does not cite a single passage

from the legislative history indicating that Congress con-

templated such an inquiry in individual medical cases by

HHS officials. And, although numerous decided cases

have interpreted Section 504 in the context of “health

care“ programs or activities, not one,“ however, author-

21 See American Academy of Pediatrics v. Heckler, 561 F. Supp.

395, 401 (D.D.C. 1983) (“no congressional committee or member

of the House or Senate ever even suggested that section 504 would

be used to monitor medical treatment of defective newborn infants

or establish standards for preserving a particular quality of life“).

22 The regulatory history of Section 504, as the Court of Appeals

in University Hospital recognized (Pet. App. 18a-20a), also refutes

the Secretary’s position. The original 504 regulations clearly re-

jected any individualized, federal right to treatment. 41 Fed. Reg.

29559 (1976). The references in the general Section 504 regulations

to “health services,” see Pet. 22, reflect a concern with access to

federally funded programs and not authorization of a detailed

HHS inquiry into the reasonableness or unreasonableness of a

medical decision in the context of a multiply handicapped child.

41 Fed. Reg. 29567 (1976) (health services should be “accessible”

and available“). See also Southeastern Community College v.

Davis, 442 U.S. 397, 411 (1979) (Secretary’s interpretation of Sec-

tion 504 entitled to deference only if it “honors” the language,

purpose and history of the statute).

23 Indeed, the Eighth Circuit recently dismissed a Section 504

claim alleging in part that a nursing home had discriminated

23

izes the kind of “504 federal malpractice” determination

in individual cases contemplated by the Secretary here.

Third, sound principles of statutory construction

require rejection of the Secretary’s attempt to regulate

health provider decisions in this area. This Court in a

long line of decisions has held that “unless the Congress

conveys its purpose clearly, it will not be deemed to have

significantly changed the federal-state balance” in areas

where the states have historically regulated. United

States v. Bass, 404 U.S. 336, 349 (1971).% Cf. Penn-

hurst State School & Hospital v. Halderman, 451 U.S. 1,

17 (1981). See also Alexander v. Choate, 105 S. Ct. 712,

720 (1985) (importance of interpreting § 504 so as to

keep it “within manageable bounds’). As noted above,

state licensure, child neglect and other laws require that

health care providers report instances of parents’ medical

neglect and not refuse to treat their patients unless notice

is given and other treatment is available. See p. 4, supra.

The Secretary’s attempt to regulate, under Section 504,

providers’ decisions whether to treat after parental con-

sent demonstrably intrudes on this area of historic state

concern without the requisite clear expression of intent

against a resident by failing to provide adequate medical care,

concluding that “[i]n substance, this is a medical malpractice

case” not cognizable under Section 504. Hoyt v. St. Mary’s Re-

habilitation Center, 711 F.2d 864, 867 (8th Cir. 1983). The cases

that have considered Section 504 claims in the health care field

have dealt with such issues as employment, e.g., United States v.

Cabrini Medical Center, 639 F.2d 908 (2d Cir. 1981), admission

to medical schools and other medical training programs, e. g.,

Southeastern Community College v. Davis, 442 U.S. 897 (1979),

and reduction in medicaid assistance or other federally-supported

medical insurance and benefits, e.g., Alexander v. Choate, 105 S. Ct.

712 (1985).

24 See, e.g., Apex Hosiery Co. v. Leader, 310 U.S. 469, 513

(1940) ; FTC v. Bunte Brothers, Inc., 312 U.S. 349, 354-355 (1941).

See also United States v. Culbert, 485 U.S. 871, 378 (1978);

Heublein, Inc. v. South Carolina Tax Commission, 409 U.S. 275,

281-283 (1972).

24

by the Congress to alter the historic federal-state balance.

This regulation is thus outside the scope of her authority.

* * * *

In sum, Section 504 clearly does not authorize the Sec-

retary’s attempt to investigate and regulate directly par-

ental decisions concerning treatment of their severely

impaired infants, providers’ decisions about whether to

refer parents to state authorities for parental neglect

determinations or providers’ decisions whether or not to

treat if parental consent is given. Because the Court

of Appeals reasonably concluded that the Secretary’s

regulatory approach is so demonstrably beyond the scope

of her authority under Section 504, further review by

this Court is not warranted.

II. THERE IS NO SUBSTANTIAL FEDERAL INTER-

EST IN THE VOIDED REGULATION.

The petition should also be denied because there is no

substantial federal interest in the voided regulation.

A. The 1984 Child Abuse Amendments, Not the Secre-

tary’s Intrusive Regulatory Approach, Represent

The Federal Interest In This Sensitive Area.

In contrast to the challenged regulatory approach

adopted solely by the Secretary, the 1984 Child Abuse

Amendments, as the Secretary concedes, represented an

“extraordinary effort” to develop a consensus on the part

of the Congress and constituted a “careful balance“ be-

tween protecting severely impaired newborns and avoid-

ing “unreasonable governmental intervention” into the

practice of medicine and parental responsibilities. 50

Fed. Reg. 14879 (April 15, 1985). In contrast to the

Secretary’s intrusive federal regulatory approach, the

1984 Child Abuse Amendments augment existing state

child protective services, rather than subverting them with

a duplicative and inconsistent federal role. Id. at 14883

(clear intent of Congress that states use existing child

protective system to carry out amendments). This con-

sidered, balanced and explicit Congressional enactment

25

reflects a clear Congressional intent, on policy grounds,

not to follow the Secretary’s regulatory approach in a

number of important ways.

Unlike the Secretary’s intrusive regulatory approach,

the Congress clearly did not want a direct federal role in

investigating and regulating individual cases, as the Sec-

retary concedes in the 1984 Child Abuse Regulation, id.

at 14885:

The major difference between the section 504-based

approach and that of the Child Abuse Amendments

of 1984 is that the former is implemented and en-

forced directly by the Federal government, whereas

the latter, within the framework of the Child Abuse

Prevention and Treatment Act, relies on State im-

plementation and enforcement regarding individual

instances of child abuse and neglect. ... (Emphasis

supplied. )

As the Secretary further concedes, the legislative history

of the 1984 Child Abuse Amendments clearly indicates

that the Congress did not want a “new system and a new

bureaucracy” created at the federal level to deal directly

with the issue of treatment for impaired newborns. /d.

at 14881.

Unlike the Secretary’s intrusive regulatory approach,

the Congress also did not want the creation of “federally-

prescribed medical standards for approved treatment for

specific cases.” Id. at 14880 (emphasis supplied). Such

federally prescribed standards are the inevitable result

of direct federal inquiry under Section 504 into the rea-

sonableness of parental or physician decisions regarding

treatment of impaired newborns.

Finally, unlike the Secretary’s regulatory approach,

which utilizes direct federal hotlines for the reporting of

25 As the Senate sponsors of the 1984 Child Abuse Amendments

stated in a letter to the Secretary dated March 13, 1985, the “in-

dividuality of each case and the complexities of the medical situa-

tions associated with each case make it unwise, we believe, to

establish any ‘standard’ form of treatment for a particular type of

case.” See 50 Fed. Reg. 14879-80 (April 15, 1985).

26

cases to HHS officials, the Congress in the 1984 Child

Abuse Amendments did not want such federal hotlines or

any regulation of the internal affairs of hospitals. As the

Secretary concedes in the 1984 Child Abuse Regulation,

id. at 14883, “matters relating to the internal affairs of

hospitals are beyond the scope of this regulation.” See

also id. at 14884.

In sum, the Congress in the fall of 1984—after Uni-

versity Hospital was finally decided and after the 504

Regulation was voided—clearly addressed the question of

what federal response was appropriate with respect to

the tragic question of providing appropriate treatment to

severely impaired newborns. It explicitly adopted a state-

based approach that, in all its particulars, rejected on

policy grounds the direct federal role adopted solely by

the Secretary in her 504 Regulation. Given this recent

and clear legislative statement by the Congress of the

federal interest in this sensitive area, further review of

the validity of the Secretary’s intrusive administrative

approach is not warranted.”

B. The Secretary Has Shown No Problem With the

Historic State Law Framework That Warrants

Direct Federal Investigation and Regulation.

After extensive hearings, the taking of written testi-

mony and extensive deliberations, the President’s Com-

26 Although the Secretary asserts (Pet. 27 n.22) that the “new

amendments do not, either practically-or legally, obviate the need

for review in this case,” this claim is clearly wrong. Congress did

include a provision in the Amendments indicating that they did not

affect any rights under Section 504. Section 127(a), 98 Stat. 1754.

But if Congress had concluded that a direct federal involvement

in this area—in addition to the role of parents, doctors, nurses,

hospitals, and state authorities—was appropriate, it surely would

have ratified the Secretary’s interpretation rather than enacting

new state-based legislation and creating legislative history which

explicitly rejects, on policy grounds, the Secretary’s direct federal

approach. As a “practical” matter, the 1984 Child Abuse Amend-

ments should take effect; if a direct federal role is necessary under

Section 504, Congress can in the future provide the explicit authori-

zation for such a role that is so clearly absent here.

27

mission Report (p. 209 & n.51) concluded that erroneous

parental decisions about the treatment of newborns ap-

pears to be “very rare.” The Report described no in-

stances where health care providers failed to report pa-

rental neglect or refused to provide treatment to which

parents had consented. Most importantly, the Secretary

herself, in the preamble to the 504 Regulation, described

the status of 49 cases in which HHS had investigated

reports of possible “discrimination” under Section 504

with respect to impaired newborns. Although investiga-

tions had not been completed in all the cases, the Secre-

tary concluded that “no case has resulted in a finding of

discriminatory withholding of medical care.” 49 Fed.

Reg. 1649 (1984).

Moreover, in her petition, the Secretary does not

remotely make the case that there is any problem with

parental decisions or decisions by health care providers

which warrants direct federal intrusion. See Pet. 2-3,

26.77 Instead, the Secretary tries to mislead this Court

by vaguely (and almost exclusively) citing to the “Baby

Doe of Indiana” case (“Bloomington Baby Doe“), as if

this case represented the kind of Section 504 “discrimi-

nation” which would be remedied by a direct HHS role.

But in that situation, where a newborn with Down’s

Syndrome died after parents refused to authorize surgery

to repair a blocked esophagus, the child’s doctors initially

followed the parents’ decision yet the case was neverthe-

less referred to the hospital for further discussion. The

hospital then sought judicial review of that parental non-

27 For example, the Secretary’s citation to the preamble to the

final 504 Regulation, 49 Fed. Reg. 1649 (1984), simply references

the 49 cases investigated by HHS which yielded no finding of “dis-

crimination” under Section 504. Pet. 26. Moreover, the Secretary’s

claim in the petition that a problem exists requiring a direct federal

role is directly contradicted by her statement in the 1984 Child

Abuse Regulation that “only a very small fraction of births involve

any serious question of survival” and only “a fraction” of this tiny

fraction would “involve even a potential allegation of medical

neglect” under state law. 50 Fed. Reg. 14886-87 (April 15, 1985).

28

treatment decision. The state court decided that the par-

ents had made a reasonable decision between treatment

options. The county department of public welfare re-

viewed the case and decided not to challenge the judge’s

order further. The county prosecutor then brought a sec-

ond action. And a second state court judge refused to

find parental neglect.** In short, hospital and state

authorities actively sought review of the parents’ decision

and two separate state court decisions supporting the

parents were rendered. Accordingly, this case shows

active provider and state involvement in a case of ques-

tionable parental decisionmaking—and does not remotely

support the Secretary’s claim that an additional level of

direct federal intrusion is necessary.

Finally, not only are formal state laws and procedures

functioning as intended, but the development of volun-

tary, hospital-based infant care review committees, see

p. 7, supra, underscores that a direct federal investi-

gatory and regulatory role is unnecessary. Indeed, as the

Secretary conceded in the 1984 Child Abuse Regulation,

use of these committees should reduce the need for formal

state legal proceedings involving impaired newborns to

a “[vlery few cases.” 50 Fed. Reg. 14887 (April 15,

1985). It follows a fortiori from this concession that

there is no need for an intrusive, duplicative HHS 504

bureaucracy to investigate directly possible Section 504

violations in this sensitive area.

C. Direct Federal Investigation and Regulation In This

Sensitive Area Has Caused, And Will If Reinstated

Cause, Harm.

The Secretary’s actions in University Hospital and her

other 48 direct federal investigations under Section 504

perfectly illustrate the harm that is caused by a direct

federal role that, in effect, duplicates and attempts to

28 See In re Infant Doe, No. GU 8204-004A (April 12, 1982),

writ of mandemus dismissed sub nom. State ex rel. Infant Doe v.

Baker, No. 482 S 140 (Ind. May 27, 1982). See also J. Lyon, Play-

ing God in the Nursery 21-39 (1985).

29

second-guess decisions made by parents, providers and

state authorities. In University Hospital, the federal gov-

ernment pressed its own duplicative, harassing effort even

after relevant state agencies and state courts determined

that there were no grounds for state intervention. Most

of the Secretary’s other investigations have been equally

intrusive, although none has resulted in a finding of dis-

crimination under Section 504. 49 Fed. Reg. 1646-1649

(1984) .?® Moreover, by imposing on health care providers

vague and confusing federal obligations—which are dif-

ferent than, Pet. 27 n.22, and may conflict with their

duties under state law—the Secretary’s regulatory ap-

proach has distorted medical decisionmaking. The un-

certain and conflicting nature of these independent fed-

eral duties may lead to overtreatment which will only

prolong the suffering of an impaired infant and which

will preclude use of scarce infant intensive care units

for newborns who could genuinely benefit from treat-

ment.“

CONCLUSION

The interests of severely impaired newborns are pro-

tected by their parents, by infant care review commit-

tees, by the duties of health care providers under state

law, by state child protective service agencies and by

20 Even HHS’ cursory description of these investigations, id.,

makes clear that they have resulted in invasions of family privacy,

medical records and confidential medical decisionmaking, and have

disrupted hospital operations and delayed ongoing treatment for

impaired newborns and other patients. See also Affidavit of Ervin

E. Nichols, M.D., Director of Practice Activities of the American

College of Obstetricians and Gynecologists, 111; Affidavit of Rita

G. Harper, M.D., Chief of Perinatal Medicine, North Shore Uni-

versity Hospital, ſ 15; Auld Affidavit, note 6, supra, { 18; Shapiro

& Rosenberg, The Effect of Federal Regulations Regarding Handi-

capped Newborns: A Case Report, 252 J.A.M.A. 2031 (1984);

Strain, The American Academy of Pediatrics Comments on the

“Baby Doe II” Regulations, 309 New Eng. J. Med. 443 (1983).

0 Auld Affidavit, note 6, supra, 9, 21; Affidavit of Hubert &.

Ritter, M.D., clinical professor of obstetrics and gynecology, St.

Louis University School of Medic.ne, 10-11.

30

state courts. Neither Section 504, nor any substantial

federal interest, justifies the direct and intrusive federal

investigation and regulation of treatment decisions in-

volving impaired newborns advocated by the Secretary.“

Accordingly, for the reasons stated above, respondents

AMA et al. respectfully request that the Secretary’s peti-

tion for a writ of certiorari be denied.

Respectfully submitted,

KIRK B. JOHNSON

B. J. ANDERSON

BENJAMIN W. HEINEMAN, JR.

(Counsel of Record)

American Medical Association CARTER G. PHILLIPS

535 North Dearborn Street VINCENT F. PRADA

Chicago, Illinois 60610 1722 Eye Street, N.W.

(312) 645-4600 Washington, D.C. 20006

ANN E. ALLEN (202) 429-4000

American College of NEWTON N. MINOW

Obstetricians & Gynecologists JACK R. BIERIG

600 Maryland Avenue, S. W. One First National Plaza

Suite 300-East Chicago, Illinois 60603

Washington, D.C. 20024 (312) 853-7000

(202) 688-5577 SIDLEY & AUSTIN

31 Contrary to the Secretary’s claims, Pet. 12, 27-28, the holding

of the Court of Appeals in University Hospital and this case—

which is by its terms confined to treatment decisions involving

severely impaired newborns—does not control the application of

Section 504 to other decisions involving impaired newborns, other

treatment decisions involving non-infants, or general policies or

procedures regarding federally funded health care or other pro-

grams. Nor a fortiori does it control any interpretation of Title VI

of the Civil Rights Act of 1964. See Consolidated Rail Corp. v.

Darrone, 104 S. Ct. 1248, 1254 n. 13 (1984) (recognizing distinc-

tions between Title VI and § 504). Moreover, other than the deci-

sions in this case, no reported decisions of any court have relied

upon the holding of University Hospital, decided more than a year

ago, in any of the other contexts cited by the Secretary.

31

JOSEPH A. KEYES, JR.

Association of American Medical

Colleges

One Dupont Circle, N.W.

Washington, D.C. 20036

(202) 828-0510

MICHAEL MILLER

American Academy of Family

Physicians

1740 West 92nd Street

Kansas City, Missouri 64114

(816) 333-9700

MARK D. MokRIS

Hospital Association of

New York State

15 Computer Drive West

Albany, New York 12205

(518) 458-7940

STUART M. GERSON

Epstein Becker Borsody

& Green, P. C.

1140 19th Street, N. W.

Washington, D.C. 20036

(202) 861-0900

Attorneys for Respondents

American Medical Association, et al.

May 25, 1985