Respondents Brief — Bowen v. American Hospital Assn.

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No. 84-1529

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FILED

No 4& 16GG

ANIOL, JR,

IN THE 7

Supreme Court of the United States

OCTOBER TERM, 1985

MARGARET M. HECKLER, SECRETARY OF

HEALTH AND HUMAN SERVICES,

a Petitioner,

AMERICAN HOSPITAL ASSOCIATION, et al.,

Respondents.

On Writ of Certiorari to the United States

Court of Appeals for the Second Circuit

BRIEF FOR THE RESPONDENTS

THE AMERICAN MEDICAL ASSOCIATION,

THE AMERICAN COLLEGE OF OBSTETRICIANS

AND GYNECOLOGISTS,

THE ASSOCIATION OF

AMERICAN MEDICAL COLLEGES, AND

THE AMERICAN ACADEMY OF FAMILY PHYSICIANS,

ET AL.

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 & JACK R. BIERIG

GYNECOLOGISTS One First National Plaza

600 Maryland Avenue, S.W. Chicago, Illinois 60603

Suite 300-East (312) 853-7000

Washington, D.C. 20024 SEW & AUSTIN

(202) 638-5577

Attorneys for Respondents

American Medical Association, et al.

[Other Counsel Listed On Inside Front Cover |

November 4, 1985

SSS

WILSON - Eres PRINTING Co., INC. - 789-0096 - WASHINGTON, D. c. 20001

JOSEPH A. KryYks, JR.

ASSOCIATION OF AMERICAN

MEDICAL COLLEGES

One Dupont Circle, N.W.

Washington, D.C. 20036

(202) 828-0554

R. MICHAEL MILLER

AMERICAN ACADEMY OF

FAMILY PHYSICIANS

1740 West 92nd Street

Kansas City, Missouri 64114

(816) 333-9700

QUESTIONS PRESENTED

When it enacted Section 504 of the Rehabilitation Act

of 1973, 29 U.S.C. § 794, did Congress authorize the Sec-

retary of the Department of Health and Human Services:

(a) to investigate and regulate directly whether par-

ents have made reasonable treatment decisions on behalf

of their impaired newborn children;

(b) to supplant state officials by investigating and de-

termining directly whether physicians have violated their

state law duty under state child abuse and neglect stat-

utes to report to state authorities known or suspected

instances of parental “neglect ;” and

(e) to investigate and regulate directly whether physi-

cians’ treatment decisions involving severely impaired

newborn infants are appropriate under federal “504”

standards of medical care which the Secretary will estab-

lish in individual cases?

(i)

TABLE OF CONTENTS

Page

ee . 1

„ TT—.

(1) The State Law Framework

(2) The Medical and Ethical Context .........................

(3) HHS’s Intrusive Regulatory Regime: Parents

.T.ü%ü T 7

a. HHS's Regulatory Pronouncements 7

I 1——Ü— — 8

ii. Interim Final Rule of 198889. 9

iii. The Final Regulation of 1984 9

b. HHS’s Actual Investigations .......................... 11

(4) The Decisions Below ..................-:....------22-0---2<0-+- 13

a. University Host 13

35 14

SUMMARY OF ARGUMEN“xFf——— 15

DTT ———— ———— 18

I. THE SECRETARY HAS NO AUTHORITY TO

INVESTIGATE AND REGULATE TREAT-

MENT DECISIONS BY PARENTS ON BE-

HALF OF THEIR IMPAIRED NEWBORNS... 19

A. HHS Concedes That Parents’ Decisions Are

Not Within The Scope Of Section 504............. 20

B. HHS’s Efforts Have Nonetheless Been Aimed

Almost Exclusively At Parents’ Treatment

. 20

C. An Affirmance On This Issue Is Necessary 22

(iii)

TABLE OF CONTENTS—Continued

II. THE SECRETARY HAS NO AUTHORITY

III.

TO INVESTIGATE AND DETERMINE, BE-

FORE STATE OFFICIALS HAVE ACTED,

WHETHER PHYSICIANS ARE DISCHARG-

ING THEIR STATE LAW DUTIES TO RE-

PORT MEDICAL NEGLECT BY PARENTS...

A. HHS Has Arrogated To Itself State Law

r canslensiancentagedapeimndenipesocas

B. HHS’s Arrogation Of State Law Functions

To Itself Does Violence To The Language Of

/ ß

1. “Otherwise Qualified“ And “Subjected

. 0. ES Reece

2. “Program Or Activity Receiving Federal

Financial Assistance)

C. HHS’s Arrogation Of State Law Functions

To Itself Is Not Authorized By The Legisla-

tive History Of Section 504

D. HHS’s Arrogation Of State Law Functions

To Itself Violates Basic Canons Of Section

OO CII oan ecsvicsiscececerenennstisensnatsencincnsece

E. HHS’s Arrogation Of State Law Functions

To Itself Violates Sound Principles Of Fed-

THE SECRETARY HAS NO AUTHORITY

TO INVESTIGATE AND REGULATE PHYSI-

CIANS’ TREATMENT DECISIONS IN INDI-

VIDUAL CASES —————

A. Providers' Decisions Not To Treat In Cases

Where Parents Have Withheld Consent To

Page

TABLE OF CONTENTS—Continued

Page

B. Providers’ Decisions Not To Treat In Cases

Where Parents Have Authorized Treatment.. 39

1. The Application Of The Final Regulation

To Such Decisions Is Arbitrary And

ce 39

2. Section 504 Does Not Authorize Direct

Federal Investigation And Regulation

Of Such Provider Treatment Decisions.... 42

ee? 47

TABLE OF AUTHORITIES

Cases

Page

Alexander v. Choate, 105 S. Ct. 712 (1985) ..27, 31, 32, 33,

84, 39, 42, 45, 46

American Academy of Pediatrics v. Heckler, 561

F. Supp. 395 (D. D.C. 1983) ........... 1, 9, 12, 21, 34, 36, 45

Apex Hosiery Co. v. Leader, 310 U.S. 469 (1940).. 37

Black v. Cutter Laboratories, 351 U.S. 292 (1956).. 15

Bowman Transportation, Inc. v. Arkansas-Best

Freight System, Inc., 419 U.S. 281 (1974) ......... 40

Burlington Truck Lines, Inc. v. United States, 371

I I 2 ilies 40, 42

Chevron, U.S. A., Inc. v. National Resources De-

fense Council, Inc., 104 S. Ct. 2778 (1984) 15

Citizens to Preserve Overton Park, Inc. v. Volpe,

r 40

Consolidated Rail Corp. v. Darrone, 104 S. Ct. 1248

„ccc 30

FTC v. Bunte Brothers, Inc., $12 U.S. 349 (1941) 37

General Electric Co. v. Gilbert, 429 U.S. 125

rr ee Ae 36

Grove City College v. Bell, 104 S. Ct. 1211 (1984).. 24, 30

In re Hofbauer, 65 App. Div. 2d 108, 411 N.Y.S.2d

416 (1978), aff'd, 47 N.Y.2d 648, 393 N.E.2d

ö „P 19

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

D, . 43

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

2 — 1 19

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 S 140

r cecittinccnencinciniineiiitiiitietsinnnaineres 8

Meyer v. Nebraska, 262 U.S. 390 (1923).................. 19

Montana-Dakota Utilities Co. v. Northwestern Pub-

lic Service Co., 341 U.S. 246 (19517 38

Motor Vehicle Manufacturers Assoc. of the United

States, Inc. v. State Farm Mutual Automobile

Insurance Co., 463 U.S. 29 (1983) ....... 40

North Haven Board of Education v. Bell, 456 U.S.

. 30

vii

TABLE OF AUTHORITIES—Continued

Page

Oscar Mayer & Co. v. Evans, 441 U.S. 750 (1979). 37

Palmer v. Massachusetts, 308 U.S. 79 (1939) 37

Pennhurst State School & Hospital v. Halderman,

SE TTT NET A ene OR 37

Pierce v. Society of Sisters, 268 U.S. 510 (1925).. 19

Skidmore v. Swift & Co., 323 U.S. 134 (1944) 36

Southeastern Community College v. Davis, 442 U.S.

11 ccc 28, 32, 42

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

r (( 38

T. I. M. E., Inc. v. United States, 359 U.S. 464

AE STE CR 38

United States v. Bass, 404 U.S. 336 (197177 37

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

e . eR 42

United States v. Enmons, 410 U.S. 396 (1973) 37

United States v. University Hospital, 575 F. Supp.

607 (E. D. N. V. 1983), aff' d, 729 F.2d 144 (2d

. eeteeeiettimtitaetite 14

United States v. University Hospital, 729 F. 2d 144

..... p. 3sim

Williams v. United States, 458 U.S. 279 (1982) 37

Wisconsin v. Yoder, 406 U.S. 205 (19727 i9

Statutes and Regulations

Administrative Procedure Act, 5 U.S.C. §§ 551

1 ⅛⁵＋ ˙ͤßK0ö ˙ : w 9, 31, 39, 40

Age Discrimination in Employment Act, 29 U.S.C.

r 37

CAL. Bus. & PROF. Copa § 2234 (West Supp. 1985) 4

CAL. PENAL CODE § 11172 (d) (West Supp. 1985) 25

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

98-457, 98 Stat. 1749 (198a0u¹7 18, 35, 47-48

Civil Rights Act of 1964, tit. VI, 42 U.S.C. §§ 2000d

JI 20, 30, 32, 43

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

D xxx —— 37

viii

TABLE OF AUTHORITIES—Continued

Page

ILL. REv. STAT. ch. 111, § 4433 (Smith-Hurd Supp.

ccc 4-5, 25

Mass. ANN. LAWS ch. 119, §51A (Michie/Law

t,, cccieticidatpaniaelidimnioaianineevies 25

N.Y. Epuc. LAW § 6509 (McKinney Supp. 1984) 5

N.Y. Soc. SERV. LAw § 420 (McKinney 1983) 25

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

r cehatlmpiapones 40

I oe vines ! . 43

gt A ARE 39

,,, d 10, 23

, AE 10, 24, 25, 30

45 C. F. R. § 84.55 (d )) A 10, 23, 26

, creeenumsnieansonenepsenl 10, 24, 26

Legislative and Regulatory Materials

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

% 47

S. Rep. No. 1297, 93rd Cong., 2d Sess. (1974) 42, 43

130 Cong. Rec. 88017 (daily ed. June 21, 1984) 22

130 Cong. Rec. 812392 (daily ed. Sept. 28, 1984) 18

Fe i EC RE 11

J . E 8, 21

r——— 9, 38

e i incinnctnreesenniiiionnnanseniia 21

rr 9

ye 21, 35-36

eee 10, 23

48 Fed. Reg. 30848-30849 (1983))) 26

48 Fed. Reg. 30848-30850 (1983) 20

49 Fed. Reg. 1622 (1984) ...........................-.. 8 6, 9

. , one 21

e ——ñ———————ꝙ 26

49 Fed. Reg. 1625-26 (1984) 8 23

J . TT 26

C . 27

r — 8, 45

49 Fed. Reg. 1631 (1984hy)) e: 10, 20, 26, 30, 36

49 Fed. Reg. 1632 (1984) 12, 26, 35, 44

TABLE OF AUTHORITIES—Continued

Page

r mae LE EE 12

r 12, 44

e 34, 44

rr 4

r 26

CC 36

Z cic ctsess 21

49 Fed. Reg. 1646-1649 (19843) ee 11, 41

a ee I iain oasis, ceccccceceee sce ccc 10, 20

e 12, 35

C I oo coc cece 4

e 48

50 Fed. Reg. 14880 (19880)0ÿʒ.:63;-3 — 3, 19, 47

⁊Cõ⁵˙—L n I I once cccecscnccconss 47

50 Fed. Reg. 14883-14884 (1985)... 47

50 Fed. Reg. 14886-14887 (19880) 35

ZV | a 7

Miscellaneous

American Medical Association, CURRENT OPINIONS

OF THE JUDICIAL COUNCIL (1984) 0.0. 4,6

American Medical Association, Judicial Council

Report, Guidelines for Ethics Committees in

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

nen . 7

American Medical Association & American Hos-

pital Association, Report of the Joint Task Force

on Hospital-Medical Staff Relationships (1985) 4

Besharov, The Legal Aspects of Reporting Known

and Suspected Child Abuse and Neglect, 23 VILL.

1 Fe aes 4

Fost, Baby Doe and Federal Funding: Putting

Hospitals on Notice, 12 HASTINGS CENTER RE-

r ee ee AD 8

Fost, Baby Doe: Problems and Solutions, 1984

, la ie 13

Goldstein, Medical Care for the Child at Risk: On

State Supervention of Parental Autonomy, 86

. 4

TABLE OF AUTHORITIES—Continued

Horowitz, R., & Davids, H., LEGAL RIGHTS OF CHIL-

I —— K

Louisell, D., & Williams, H., MEDICAL MALPRACTICE

Lyon, J., PLAYING GOD IN THE NURSERY (1985) 8,

Nelson, W., Behrman, R., & Vaughan, V., TEXT-

BOOK OF PEDIATRICS (12th ed. 198)

Note, Employment Discrimination Against the

Handicapped and Section 504 of the Rehabilita-

tion Act: An Essay on Legal Evasiveness, 97

Gre... ee

President’s Commission for the Study of Ethical

Problems in Medicine and Biomedical and Be-

havioral Research, DECIDING TO FOREGO LIFE-

SUSTAINING TREATMENT (1983 —

Prosser, W., & Keeton, W., HANDBOOK OF THE LAW

GP TF Ga ie ND esctesiic essence sits...

Rudolph, A., PEDIATRICS (17th ed. 1982)

Shapiro & Rosenberg, The Effects of Federal Reg-

ulations Regarding Handicapped Newborns: A

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

Stinson, R., and Stinson, P., THE LONG DYING OF

gf RBS A SLSISER ESE owes

Strain, The American Academy of Pediatrics Com-

ments on the “Baby Doe II” Regulations, 309

New ENG. J. MED. 443 (1983)))))))ʒ

Wald, State Intervention on Behalf of “Neglected”

Children: A Search for Realistic Standards, 27

STAN. L. REV. 985 (1975) .

Page

12, 13

5, 6, 7

12, 34

IN THE

Supreme Cuurt of the United States

OCTOBER TERM, 1985

No. 84-1529

MARGARET M. HECKLER, SECRETARY OF

HEALTH AND HUMAN SERVICES,

Petitioner,

AMERICAN HOSPITAL ASSOCIATION, et al.,

Respondents.

On Writ of Certiorari to the United States

Court of Appeals for the Second Circuit

BRIEF FOR THE RESPONDENTS

AMERICAN MEDICAL ASSOCIATION, ET AL.

INTRODUCTION

This case presents the question of whether Section 504

of the Rehabilitation Act of 1973, 29 U.S.C. § 794, au-

thorizes direct federal investigation and regulation of in-

dividual treatment decisions made by parents and health

care providers relating to severely impaired newborn in-

fants. The question of what sort of medical treatment,

if any, should be given to severely impaired newborns is

“one of the most difficult and sensitive medical and ethical

problems facing our society” and federal “intervention

into the difficult medical and human decisions that must

be made in the delivery rooms and newborn intensive care

units of our hospitals involves a profound change in the

manner in which these decisions . . are made.“

American Academy of Pediatrics v. Heckler, 561 F. Supp. 395,

396, 403 (D.D.C. 1983) (Gesell, J.) (emphasis supplied).

Neither the 1973 statute nor its legislative history men-

tions, much less authorizes, a direct federal role in these

sensitive decisions in which the infant’s interests have

historically been protected within the state law frame-

work governing parent-child and physician-patient rela-

tionships. Nonetheless, until enjoined by the courts below,

petitioner, the Secretary of the Department of Health and

Human Services (“HHS”), had undertaken direct, intru-

sive and overbearing federal investigations—including 17

on-site inquiries by federal “Baby Doe” squads—in the

days, even hours, immediately following the birth of a

child, during a period of maximum stress for families.

The focus of these HHS investigations has not been on

discrimination between handicapped and non-handicapped

but rather on alleged “medical neglect” of an impaired

infant when its parents refuse to authorize treatment—

a subject historically regulated exclusively under state

child abuse and neglect laws. In not one of those 49 harm-

ful federal investigations reported in HHS’s Final Regu-

lation on this subject (J.A. 11) did HHS find any viola-

tion of Section 504. (J.A. 96-106).

Respondents American Medical Association (“AMA”)

et al.“ seek affirmance of the judgment below which en-

joined HHS (a) from implementing the Final Regulation

with respect to individual treatment decisions by parents

and health care providers and (b) from investigating

such decisions in the absence of a specific regulation on

the subject, as HHS had done in all 49 of its reported in-

quiries. When parents do not consent to treatment for

their seriously ill infant, HHS may not convert state law

issues of possible child neglect into federal issues of dis-

crimination against the handicapped in order to put pres-

sure on parents through direct federal investigations, as

2 This case, American Medical Association, et al. v. Heckler, was

brought separately and then consolidated in the District Court with

American Hospital Association, et al. v. Heckier after the Court

of Appeals decision in United States v. University Hospital, 729

F.2d 144 (2d Cir. 1984) (Pet. App. 4a). Respondents in each case

are briefing and arguing separately in this Court.

— —

it has tried to do in the regulatory regime invalidated be-

low. As the Court of Appeals held, HHS has no authority

to investigate and regulate directly either parental treat-

ment decisions or physicians’ duties under state law to

report possible parental neglect to state authorities.

When parents do consent to treatment for their severely

ill infant, physicians provide it. HHS has not cited, and

cannot cite, even a single example when physicians have

failed to provide treatment to impaired newborns after

parental consent. HHS may not use this wholly implausi-

ble and highly misleading hypothetical example—which

has not been the focus of its regulatory efforts, but which

it emphasizes in this Court—to retain its power to con-

duct intrusive investigations in neonatal intensive care

units.

STATEMENT

The Secretary’s statement of the case (HHS Br. 2-11)

is either inaccurate or incomplete in virtually every im-

portant respect. It largely ignores the medical, ethical

and state law framework which is crucial to understand-

ing this action. It also gives a completely distorted view of

HHS’s efforts to date by omitting any discussion of HHS’s

numerous investigations of parental decisionmaking, in-

cluding its oppressive actions in the controlling Univer-

sity Hospital case.

(1) The State Law Framework. State law provides

protection to impaired newborns when parents do not con-

sent to treatment on their behalf. Under the law of all

50 states, parents, as the individuals best suited to protect

their child, have the ultimate responsibility for making

decisions about treatment for seriously ill newborns.

Their decision is final except in the most extreme case

when a state court has determined that a decision by the

parents not to authorize treatment constitutes “medical

neglect” of a child. 50 Fed. Reg. 14880 (1985). All 50

states also have child protective service agencies which

are responsible for investigating reports of child abuse

and neglect by parents—including “medical neglect”—and

addressing the sensitive issue of when government should

institute court actions to remove the parents as decision-

makers for the child. Id. at 14878.“ In addition, all 50

states have mandatory statutory provisions requiring phys-

icians to report known or suspected instances of medical

neglect by parents to state authorities. Civil sanctions,

criminal penalties or both may be imposed on physicians

for failing to discharge these state reporting duties.“

State law also protects minor patients in their relation-

ship with physicians when parents do consent to treat-

ment. Of course, without parental consent, a physician

may not treat a minor patient because treatment without

such consent is a battery. See note 23, infra. But, it is

a fundamental rule of state law and medical ethics that,

once parental consent to treatment has been given, then

physicians have a legal duty to provide appropriate medi-

cal care until the physician-patient relationship is termi-

nated by giving the parents due notice and an oppor-

tunity to obtain other care. Under the state law doc-

trine of patient abandonment, if physicians withdraw

before these conditions are satisfied, then they are liable

for damages and subject to state disciplinary action.“

8 See generally Goldstein, Medical Care foi the Child at Risk: On

State Supervention of Parental Autonomy, 86 YALE L.J. 645 (1977) ;

Wald, State Intervention on Behalf of “Neglected” Children: A

Search for Realistic Standards, 27 STAN. L. REv. 985 (1975).

+ See generally Besharov, The Legal Aspects of Reporting Known

and Suspected Child Abuse and Neglect, 23 VILL. L. REv. 458 (1977-

1978). Only physicians, not hospitals, are authorized under state

law to provide medical treatment. See AMA & AHA, Report of the

Joint Task Force on Hospital-Medical Staff Relationships (1985).

For purposes of discussion, however, we will assume that, under the

Final Regulation, the duties of physicians and hospitals (which are

customarily the recipients of federal health care funds) are synony-

mous. See 49 Fed. Reg. 1637 (1984) (J.A. 65).

5 See 1 D. Louisell & H. Williams, MEDICAL MALPRACTICE U 4.12,

8.08 (rev. ed. 1984). See also AMA, CURRENT OPINIONS OF THE

JUDICIAL COUNCIL § 8.10 (1984) (similar duty under canons of

medical ethics). Medical licensing statutes also provide sanc-

tions, including revocation or suspension of a license, for patient

abandonment. See, e.g., CAL. Bus. & PRor. CoDE § 2234 (West Supp.

1985) ; D.C. Copg ANN. § 2-1326 (1981); ILL. Rev. Start. ch. 111,

(2) The Medical and Ethical Context. As a 1983

Presidential commission reported, the birth of an infant

with severe mental or physical impairments is often an

unexpected and traumatic event for parents, who are con-

fronted with the necessity of making difficult life or death

treatment decisions with little ur no advance warning. In

such circumstances, treatment iiself may cause the infant

great pain and suffering.“ These trying cases may test

the limits of medical science and present physicians with

highly complex and often uncertain choices about what

treatment, if any, is appropriate to recommend. Although

physicians can in some cases predict with a relative de-

gree of confidence that a particular course of treatment

is likely to be beneficial or futile, there is a significant

area of uncertainty (exacerbated by rapid and continuing

advances in medical techniques) in which the results and

consequences of a given course of treatment are simply

unpredictable and may, in fact, change as the condition

of the severely impaired newborn changes. President’s

Commission Report at 198, 217. Three types of medical

conditions have been the subject of the most widespread

medical and ethical discussion about areas of certainty

and uncertainty: spina bifida, Down’s Syndrome, and

low birth-weight or premature infants.’ As the Presi-

dent’s Commission Report noted (at p. 220) :

§ 4433 (Smith-Hurd Supp. 1984-85); N.Y. Epuc. Law § 6509

(McKinney Supp. 1984).

See President's Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral Research, DECIDING TO

FOREGO LIFE-SUSTAINING TREATMENT 215-216 (1983) (President's

Commission Report”) ; R. Stinson and P. Stinson, THE LONG DYING

OF BABY ANDREW (1983).

Spina bifida with meningomyelocele is a congenital disorder

characterized by an open spinal column and exposure of neural

tissue and, in most cases, hydrocephalus (an abnormally large fluid

collection in the brain), which can cause varying (and unpredict-

able) degrees of impairments, including mental retardation and

paralysis. Down’s Syndrome is a rare chromosomal disorder in-

volving varying degrees of mental retardation and an increased

incidence of sometimes correctable congenital defects. Premature

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).

Nonetheless, despite this uncertainty in some cases, physi-

cians are required by basic principles of medical ethics

to provide all available medical treatment which is ex-

pected to benefit these severely impaired infants and to

which parents consent.“

To address the difficult medical and ethical issues

which can be raised by the birth of a severely impaired

child, the President's Commission Report (at pp. 225-

227; J.A. 189-192), repudiated a direct federal role like

the one advanced by the Secretary and, instead, recom-

mended the voluntary formation of infant care review

committees to deal directly with the fundamental prob-

lem in this sensitive area: parental lack of information

or low birth-weight infants, by far the largest category of cases

involving difficult decisions about treatment of newborns, often

suffer from a host of different but related disorders, many of

them life-threatening. See A. Rudolph, Pediatrics 140-148, 243-

245, 1594-1596 (17th ed. 1982); W. Nelson, R. Behrman & V.

Vaughan, Textbook of Pediatrics 134-136, 342-353, 1561-1562 (12th

ed. 1983).

8 The AMA and other medical organizations have made clear

that medical treatment which is expected to benefit the infant

should always be provided and that, in determining what treatment

will benefit the infant, the anticipated burdens of an impaired child

on the family and on society should not be the basis for decision.

See, e.g., AMA, CURRENT OPINIONS OF THE JUDICIAL COUNCIL § 2.14

(1984) ; 49 Fed. Reg. 1622 (1984) (J.A. 12-13) (quoting Principles

of Treatment of Disabled Infants adopted by several major medical

and disability groups).

and perspective. Id. at 227.“ Despite the trying cir-

cumstances in which choices must be made, parents have

been able to make appropriate treatment decisions that

are in the best interests of their child. Id. at 209 & n.51

(“rare” for parents not to act appropriately).

(3) HHS’s Intrusive Regulatory Regime: Parents As

Targets. HHS’s brief mischaracterizes its regulatory pro-

nouncements, ignores its intrusive investigative efforts

and fails to describe any “problem” involving individ-

ual treatment decisions for impaired newborns which

justifies a direct, intrusive federal role.

a. HHS’s Regulatory Pronouncements. The regula-

tory approach reflected in the Final Regulation is the

product of several rounds of official notices and interim

or proposed rules published by HHS since 1982. These

pronouncements reveal inconsistent and contradictory in-

terpretations of Section 504 with respect to the three

types of decisions by parents or health care providers

which are at issue in this case. This regulatory history

shows that the central focus of the Secretary’s regula-

tory activities, despite contrary assertions to this Court,

has been the decision of parents not to authorize cer-

tain treatment for their impaired newborns. The Sec-

retary’s attempt to investigate the state law duties of

health care providers to report known or suspected in-

stances of parental neglect was only conceived after the

Secretary was forced to acknowledge that parental deci-

sions not authorizing treatment could not be regulated

under Section 504. Until its brief to this Court, “non-

treatment” decisions by health care providers themselves,

® See President's Commission Report at 227-228 (J. A. 191-192).

Medical groups have made similar proposals. See e.g., AMA, Judicial

Council Report, Guidelines for Ethics Committees in Health Care

Institutions, 253 J.A.M.A. 2698 (1985). These committees may be

comprised of physicians, nurses, ethicists, clergy, social workers,

lawyers and representatives of disability groups. At present, many

hospitals with intensive care units for neonates have special review

processes, including infant care review committees, for these diffi-

cult cases. 50 Fed. Reg. 14887 (1985).

when parents have given consent, have not been of any

concern to HHS because such decisions never occur:

HHS has never cited an instance when parents have

consented to medically indicated treatment and physicians

have not then provided it.

i. The 1982 Notice. On May 18, 1982, the Secretary

issued a “notice” to health care providers stating that

Section 504 applied to treatment decisions involving se-

verely impaired newborns. 47 Fed. Reg. 26027 (1982)

(J.A. 127). The Notice was clearly aimed at parents’

decisions not to authorize treatment because it was ex-

plicitly addressed to the widely publicized “Baby Doe of

Indiana” case, where parents had withheld consent to

life-sustaining surgery and the hospital had promptly

referred the matter to the appropriate state agency and

courts for decision under the state’s child neglect laws.“

In this 1982 Notice, the Secretary further stated that, in

cases where parents refused to authorize medically indi-

cated treatment for their impaired newborn child, Sec-

tion 504 required hospitals to discharge the infant from

the hospital so as not to acquiesce in the parents’ “dis-

criminatory” decision. The Notice made no mention of a

provider’s duty under state law to report instances of

parental neglect to state authorities nor was there any

10 See HHS Br. 2 & n.1. In that case, the parents of a newborn

with Down’s Syndrome refused to authorize surgery to repair

a blocked esophagus. The case was nonetheless referred to the hos-

pital, which sought immediate judicial review. The state court

decided that the parents had made a reasonable decision among

treatment options. See 49 Fed. Reg. 1630 (1984) (J.A. 39) (com-

ments of state court judge who decided case). The county prosecutor

then brought à second action and a second state court judge also

refused to find parental neglect. The infant then died. See 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

(Ind. May 27, 1982); J. Lyon, PLAYING GOD IN THE NURSERY 21-39

(1985).

11 This position was roundly criticized. See, e.g., Fost, Baby Doe

and Federal Funding: Putting Hospitals on Notice, 12 HASTINGS

CENTER RETORT 5, 7 (1982) (implementation of such a practice

would be “gruesome”’).

hint that it was addressed to the situation in which physi-

cians or hospitals refuse to provide treatment to which

the parents had consented.

ii. Interim Final Rule of 1983. Less than one year

later, HHS issued an “interim final rule“ which was

again aimed at parents’ decisions not to consent to treat-

ment on behalf of their newborn children. 48 Fed. Reg.

9630 (1983). The Interim Rule did not suggest that

providers are required under Section 504 to refer cases

of alleged parental medical neglect to state authorities.

Instead, the Interim Rule, in complete disregard of con-

trolling law in all states, required physicians and hos-

pitals to provide needed medical treatment to impaired

newborns regardless of the parents’ treatment decision.

Id.“ On April 14, 1983, a district court declared the

Interim Rule invalid under the Administrative Proce-

dure Act (5 U.S.C. §§ 551 et seg.) because it had been

issued without proper notice and comment procedures,

and because HHS had arbitrarily and capriciously failed

to consider “many highly relevant factors.” “

iii. The Final Regulation of 1984. Following the in-

validation of the Intcrim Rule, the Secretary on July 5,

1983, proposed a new rule, 48 Fed. Reg. 30846 (1983),

which she adopted in final form with minor changes on

January 12, 1984, 49 Fed. Reg. 1622 (1984) (J.A. 11)

(the “Final Regulation”). The Final Regulation con-

12 See American Academy of Pediatrics, supra, 561 F. Supp. at

401 (statements of HHS counsel at oral argument) (quoted at

Pet. App. 23a). There was also no suggestion that hospitals or

physicians were not providing medically indicated treatment to

impaired infants after parents had consented to such treatment.

18 American Academy of Pediatrics, supra, 561 F. Supp. at 399.

Among the many critical factors ignored or inadequately considered

by HHS were: the disruptive effects on ongoing treatment of

newborns caused by “the sudden descent of [federal] ‘Baby Doe’

squads on the scene”; the problems of ignoring parental choices

about a child’s “best interests”; and the fact that the administra-

tive record failed to disclose “a widespread denial of proper newborn

care such as would justify the type of regulation selected.” 561

F. Supp. at 399-400.

tains four mandatory provisions: (i) each recipient hos-

pital must post a notice with a 24-hour, toll-free “hot-

line“ number for callers to use in reporting to HHS sus-

pected violations of Section 504 relating to newborns;

(ii) expedited HHS access to medical records is author-

ized; and (iii) expedited compliance actions, including

referral of cases to the Justice Department, is author-

ized. 45 C.F.R. §§ 84.55 (b), (d), (e) (J. A. 112-116).

The last mandatory provision (iv) authorizes HHS to

investigate directly whether hospitals and physicians are

discharging their state law duty to report instances of

parental neglect to state authorities. See 45 C. F. R.

§ 84.55(c) (J.A. 114-115) and pp. 25-27, infra.

When issuing the Final Regulation, HHS made a ma-

jor, explicit concession and announced an entirely new

theory of the applicability of Section 504 to treatment of

impaired newborns. Contrary to the position espoused

only months before in the Interim Rule, HHS in the

preambles to both the proposed and Final Regulation at

last explicitly conceded that, absent a state court order,

only parents are authorized to make the ultimate treat-

ment decisions on behalf of impaired newborns and that

these parental decisions not to consent to treatment, no

matter how “discriminatory,” are outside the scope of

Section 504. 48 Fed. Reg. 30848 (1983); 49 Fed. Reg.

1631 (1984) (J.A. 43-44). Nonetheless, despite this

fundamental concession, the Final Regulation was still by

its terms aimed at parents. See pp. 23-24, infra.

The Secretary also articulated a new Section 504 theory

that, when parents withhold consent to treatment, HHS

may investigate whether health care providers have dis-

charged their duties to report cases of parental neglect to

the appropriate state authorities, as required by state law.

48 Fed. Reg. 30848 (1983); 49 Fed. Reg. 1631, 1653

(1984) (J.A. 44, 122). The Secretary formally aban-

doned her previous Section 504 theory that, when parents

did consent, providers had to treat the infant over the

parents’ objection or to discharge the infant from the

hospital. The hypothetical issue which the Secretary em-

phasizes almost exclusively in this Court whether Sec-

tion 504 applies to non- treatment“ decisions by health

care providers after parents have consented to such treat-

ment—was not addressed in the Final Regulation nor in

the supporting HHS statements.

b. HHS’s Actual Investigations. In the preamble to

the Final Regulation, the Secretary described the results

of 49 separate cases in which, without authorization by a

specific regulation relating to impaired infants, she in-

vestigated reports of suspected violations of Section 504

in the treatment of impaired newborns. 49 Fed. Reg.

1646-1649 (1984) (J.A. 96-106).“ Not one of ‘hese

cases has resulted in a finding of discrimiz.tory with-

holding of medical care. Virtually all of these direct fed-

eral investigations—which were conducted within days,

even hours, of the birth of the child—were aimed at de-

cisionmaking by parents. In not one of these reported

investigations did HHS investigate, much less find, that

physicians had failed to refer cases of suspected medical

neglect to state authorities. Nor was there even a hint

that a physician or hospital had refused to provide a

newborn infant treatment to which the parents had con-

sented.

The futility of the Secretary’s intrusive investigations,

however, was not for want of trying. Of the 49 cases,

fully 17 involved on-site investigations. Moreover, in

over three quarters of these on-site investigations, HHS

apparently made no use of qualified medical consultants,

and so HHS employees, as opposed to medical experts,

purported to judge the reasonableness of the complex

treatment decisions at issue. Significantly, in mly four

14 Because the Interim Rule of March 1983 had been struck down

almost immediately and the proposed rule of July 1983 had no

operative effect, virtually all these investigations were undertaken

pursuant to the Secretary’s claimed inherent authority under Sec-

tion 504 and the general Section 504 regulation of 1977, 42 Fed.

Reg. 22676 (1977), and not pursuant to a specific regulation relat-

ing to severely impaired infants. See HHS Br. 3, 44 (HHS claims

inherent authority under Section 504 and general 1977 regulation to

act in absence of specific regulation on impaired infants).

of the cases is there even any mention of coordination

with the relevant state child protective service agency,

which the Secretary has claimed she will work with

closely. HHS Br. 7.“

HHS’s own record of investigatory and enforcement

activity also reveals, on its face, the significant harms

that its regulatory approach has caused parents, impaired

newborn infants and health care providers. See 49 Fed.

Reg. 1632 (1984) (J.A. 47-48) (HHS’s description of as-

serted harms of investigations and failure to show those

harms do not occur). Often prompted by nothing more

than anonymous telephone tips,“ HHS “Baby Doe

squads” descended on hospitals at all hours of the day

and night, demanding to see confidential patient records,

interrogating nurses, physicians and other hospital staff

and, in some cases, asserting the right to examine the

physical condition of the involved newborn infant.“ As

the facts of University Hospital illustrate graphically,

see pp. 21-22, infra, the Secretary’s investigatory actions

had a devastating impact on the parents of the child being

investigated, by subjecting them to harassing challenges

to their fitness to act as decisionmakers for their child,

chreatening them with potential criminal liability, and

embroiling them in unwanted and damaging publicity, all

at a time of great emotional anguish and pressure.

Moreover, as a direct result of these investigutions,

critical ongoing treatment of impaired newborn infants

was significantly delayed or disrupted as HHS investiga-

15 The preamble and interpretative guidelines to the Final Regu-

lation provide general HHS policy on the conduct of investigations.

See 49 Fed. Reg. 1633 (J.A. 48) (any doubts to be resolved in favor

of on-site HHS investigation) ; id. 1634 (J.A. 52) (no commitment

to have medical consultants present in such investigations); id.

1654 (J.A. 124) (HHS must itself investigate all complaints within

24 hours).

16 See, e.g., J. Lyon, PLAYING GOD IN THE NURSERY 42-44 (1985) ;

American Academy of Pediatrics, supra, 561 F. Supp. at 399-400;

Strain, The American Academy of Pediatrics Comments on the

“Baby Doe II” Regulations, 309 NEw ENG. J. MED. 443 (1983).

tors monopolized patient charts and records and diverted

the medical staff from its important health care func-

tions.“ This drain on hospital resources impaired the

delivery of care to all patients and aroused unnecessary

confusion, anxiety and fear among other parents and

their families.“

(4) The Decisions Below. a. University Hospital. In

November, 1983, after the state courts of New York had

refused to intervene and after the state child protective

service agency had determined there was no medical

neglect by the parents, HHS and the Department of

Justice nonetheless prosecuted a suit against University

Hospital asserting, under Section 504, the right to ex-

amine the medical records of an impaired newborn infant

(known only as Baby Jane Doe), whose parents had with-

held consent to certain surgery and then refused to give

HHS access to the infant’s medical records. The District

Court, on November 17, 1983, granted summary judg-

ment against the government, holding that the hospital’s

failure to provide surgical treatment was the result of

the parents’ decision and not discrimination within the

meaning of Section 504 and that, in any event, the par-

7 See, e.g., J. Lyon, PLAYING GOD IN THE NURSERY 42-44 (1985) ;

Affidavit of Richard L. Epstein §9 (J.A. 164-165); Affidavit of

Peter A.M. Auld, M.D. {18 (J. A. 170-171); Affidavit of Rita G.

Harper, M.D. § 15 (J.A. 176). The AMA et al. submitted uncon-

tested affidavits in support of their motion for summary judgment

in this case. In her defense, the Secretary did not submit any testi-

monial evidence on medical issues. See also Affidavit of Paul M.

Rosenberg (J.A. 178); Affidavit of Norman B. Urmy (J.A. 183)

(harmful effects of inquiries in Rochester, N.Y. and Nashville,

Tenn.).

18 See, e.g., Affidavit of Peter A.M. Auld, M.D. 912, 17 (J.A.

169-170); Affidavit of Rita G. Harper, M.D. {15 (J. A. 176). In

addition, there is a significant risk that the arrival of federal Baby

Doe squads will lead to painful and futile overtreatment which could

injure not just the particular child being investigated but also other

seriously ill children by depriving them of scarce places in hospital

neonatal intensive care units. See, e.g., Fost, Baby Doe: Problems

and Solutions, 1984 Ariz. St. L.J. 637, 639; Affidavit of Peter A.M.

Auld, M.D. § 18 (J. A. 169).

ents’ treatment decision had in all respects been reason-

able. United States v. University Hospital, 575 F. Supp.

607 (E.D.N.Y. 1983). On February 23, 1984, the Court

of Appeals affirmed on broader grounds, 729 F.2d 144

(Pet. App. 4a), holding that Section 504 does not “apply

to treatment decisions involving defective newborn in-

fants.” (Pet. App. 40a). The Secretary declined to pe-

tition this Court for review of the Court of Appeals’ de-

cision in University Hospital.

b. The Instant Case. The Final Regulation was pro-

mulgated by the Secretary on January 12, 1984, while

the University Hospital case was pending before the

Court of Appeals. On March 12, 1984, the AMA et al.

filed the instant action in the United States District Court

for the Southern District of New York. (J.A. 129). On

June 11, 1984, the District Court, under authority of

University Hospital, issued a final judgment which (a)

enjoined HHS from implementing the Final Regulation

with respect to treatment decisions by parents and pro-

viders in individual cases involving impaired newborns

and (b) enjoined HHS from otherwise investigating and

regulating such decisions in the absence of a specific reg-

ulation on the subject, as HHS had done in its 49 in-

vestigations reported before publication of the Final Reg-

ulation. (Pet. App. 50a-52a). The Court of Appeals, also

relying on the controlling effect of University Hospital,

summarily affirmed the judgment in a two paragraph

order. (Pet. App. 3a).

19 Although she had lost in the District Court, the Secretary

moved in the Court of Appeals for summary affirmance of the judg-

ment striking down her regulatory regime, claiming that the earlier

decision in University Hospital (which involved an HHS investiga-

tion of a single family) made plenary appellate review unnecessary.

Although stating they were ultimately entitled to affirmance, the

AMA et al. opposed summary disposition on the ground that, be-

cause HHS was clearly going to seek review in this Court, a fuller

treatment of the issues relating to the Secretary’s regulatory efforts

would aid Supreme Court consideration. See J.A. 9 (docket entry).

Accordingly, the AMA et al. will argue for affirmance on grounds

similar to, but, in certain respects, distinct from, the reasoning of

SUMMARY OF ARGUMENT

Neither the express language of Section 504 nor its

legislative history nor the general Section 504 regulation

promulgated by HHS in 1977 mentions, let alone author-

izes, direct federal involvement in the sensitive and com-

plex issue of providing appropriate treatment in individ-

ual cases to severely impaired newborns. Nonetheless,

since 1982, the Secretary has taken two types of actions

asserting her authority to intrude directly in this most

sensitive area of parent-child and physician-patient rela-

tions historically governed within a state law framework.

She has issued notices and regulations, and she has in-

vestigated individual cases directly.

(A) Both HHS’s regulatory pronouncements and its

investigations have been aimed at instances where parents

do not consent to treatment for their severely impaired

infant. They have thus been aimed at a problem, not of

discrimination between handicapped and non-handicapped,

but at possible “medical neglect” in individual cases when

parents do not authorize treatment for severely impaired

newborns. The vexing question of when government

should interfere with parents’ choices for their infants in

these complex, often tragic situations has historically been

left to state authority under child abuse and neglect stat-

utes. The related and equally vexing question of when

physicians or hospitals should come between parents and

their infant children and report parents for known or

suspected neglect to state authorities has also been gov-

erned by these state statutes. In both its regulatory pro-

nouncements and its actual investigations, HHS has un-

lawfully tried to turn these state law issues surrounding

possible parental neglect into federal issues of discrimina-

tion against the handicapped in order to put direct fed-

eral pressure on parents through intrusive investigations.

The judgment below declared this effort unlawful and

the Court of Appeals in University Hospital. See, e.g., Chevron

U.S.A., Inc. v. NRDC, 104 S. Ct. 2778, 2781 (1984); Black v. Cutter

Laboratories, 351 U.S. 292, 297 (1956).

enjoined HHS from investigating and regulating individ-

ual treatment decisions by parents or providers either

under the Final Regulation or under HHS’s inherent Sec-

tion 504 authority. In support of that judgment, respond-

ents AMA et al. seek two related holdings barring HHS

from intruding directly into state law issues of parental

neglect.

First, the Secretary is not authorized by Section 504 to

investigate and regulate parents’ treatment decisions on

behalf of their severely impaired newborns. The Secre-

tary has changed her initial position and has now ex-

plicitly conceded that she has no authority under Section

504 to regulate parents directly. She has, thus, implicitly

conceded that the judgment of the Court of Appeals in

University Hospital, barring her from investigating par-

ents who do not authorize treatment, was correct. None-

theless, a holding of this Court is necessary, because even

after stating in July 1983 that she had no authority to

investigate non-treatment decisions of parents directly,

the Secretary in November 1983 launched the oppressive

pursuit of Baby Jane Doe’s parents that resulted in the

University Hospital decision. See Part I, infra.

Second, the Secretary has no authority under Section

504 to investigate and determine directly, before state

executive and judicial officials have acted, whether health

care providers have violated their state law duties to re-

port known or suspected parental neglect to state au-

thorities. The Secretary’s theory here is so far beyond

the scope of Section 504 that she barely attempts to de-

fend it in her brief—and for good reason because it has

not a shred of support in either the language or legisla-

tive history of Section 504. Moreover, this contorted in-

terpretation violates basic rules of construction: it au-

thorizes intrusive federal investigations which totally

duplicate state responsibilities and thus constitute a for-

bidden “fundamental modification” of how health pro-

viders operate; it is not based on HHS’s finding of a

“particularly significant problem”; and it is not the prod-

uct of the clear statement of congressional intent which

is necessary when the federal government attempts to reg-

ulate concurrently in an area historically left to the states.

In sum, it simply cannot be that a health care provider

could be held by HHS to have violated Section 504 for

failing to discharge a state law reporting duty when there

has been no final state determination by responsible state

officials that state law has been violated. See Part II,

infra.

(B) HHS’s regulatory pronouncements and actual in-

vestigations have never been concerned with the wholly

hypothetical case where parents do consent to treatment

for their severely impaired infant but physicians refuse

to provide it. In her brief to this Court, however, the

Secretary has systematically distorted her regulatory

statements, studiously ignored her actual investigations

and misleadingly attempted to defend her actions on the

basis of just such a hypothetical case—a case which bears

no relationship to the regulatory regime invalidated below

or to the world of medical practice. But HHS’s attempt

to retain intrusive investigative power in this area based

on a hypothetical case is demonstrably unlawful.

Respondents AMA et al. thus also respectfully request

this Court to hold that decisions by physicians in individ-

ual cases not to treat severely impaired infants are out-

side the scope of Section 504. There is no factual or

rational basis under the Administrative Procedure Act

for HHS regulation in this area. If parents consent to

treatment for their impaired infants, physicians provide

it. Despite HHS’s development of a voluminous adminis-

trative record from 1982-1984, the Secretary has never

found or cited a single case in which a physician has

refused to provide treatment to a severely handicapped

infant after the infant’s parents have consented to such

treatment. Moreover, neither the language nor legisla-

tive history of Section 504 evidences any Congressional

intent to authorize direct HHS regulation of the “rea-

sonableness” of physician decisions according to federal

“504” standards of medical care established by the Sec-

retary or to authorize an HHS investigation, before state

authorities have acted, of whether patient “abandon-

ment,” an area of medical practice traditionally regu-

lated by the states, has occurred. See Part III, infra.

invalidating HHS’s actions against parents and health

care providers in this most sensitive and complex area,

this Court would not, of course, impair in any way Con-

gress’ authority in the future to amend Section 504 if it

felt that the problem of appropriate treatment for severely

impaired newborn infants warranted direct federal in-

vestigation and regulation of parental and provider de-

cisions in individual cases. At issue is nothing more than

the discretionary action of a single executive department,

not a law of Congress. In this regard, it should be

stressed that in the fall of 1984—the only time Congress

addressed the question of what federal response to this

complex issue is appropriate—Congress refused to au-

thorize HHS’s direct federal investigation and regulatory

role in individual cases which had been invalidated earlier

that year in this case. Instead, Congress used a state

grant program and the existing state child protective serv-

ice agencies to address the issue. In so doing, the sponsors

of the law explicitly stated that HHS was prohibited un-

der the Amendments from investigating treatment deci-

sions in individual cases or from establishing federal

treatment standards.” See pp. 47-48, infra.

ARGUMENT

The interests of severely impaired newborn infants are

protected by their parents, by their physicians, by hos-

pitals, by infant care review committees, by state child

protective service agencies and by state courts. The ques-

tion presented by this case is whether the Congress in-

tended to authorize an additicnal level of federal involve-

ment immediately after the birth of a severely impaired

child and thus meant to empower the Secretary of HHS

2° See Child Abuse Amendments of 1984, Pub. L. No. 98-457, 98

Stat. 1749 (1984); 130 Cong. Rec. 812392 (daily ed. Sept. 28, 1984)

(letter from Sen. Hatch to Sen. Weicker) ; HHS Br. 45 (no direct

federal duties for providers created by 1984 Amendments).

to investigate and regulate directly the three decisions at

issue in this case—decisions by parents not to consent to

treatment, decisions by physicians when parents do not

consent, and decisions by physicians when parents do con-

sent. The answer mandated by the language of Section

504, its legislative history, sound principles of statutory

construction and the Secretary’s own concessions is clearly

„no.“ 21

I. THE SECRETARY HAS NO AUTHORITY TO IN-

VESTIGATE AND REGULATE TREATMENT DE-

CISIONS BY PARENTS ON BEHALF OF THEIR

IMPAIRED NEWBORNS.

The historic right of parents in consultation with health

care professionals to make treatment decisions for their

minor children is bottomed on state common law and on

the federal constitutional right of privacy. As the Sec-

retary recently stated:

The decision to provide or withhold medically indi-

cated treatment is, except in highly unusual circum-

stances, made by the parents or legal guardian.

Parents are the decision makers concerning treat-

ment of their disabled infant, based on the advice

and reusonable medical judgment of their physician.

50 Fed. Reg. 14880 (1985) (emphasis supplied). Thus,

absent a state court finding of medical neglect, final legal

responsibility for making decisions about appropriate

treatment of seriously ill newborns is vested exclusively

in parents.”

21 The relationship between the three requested holdings and the

judgment of the Court of Appeals is discussed at n.60, infra.

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

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

Hofbauer, 65 App. Div. 2d 108, 411 N.Y.S.2d 416 (1978), aff'd, 47

N.Y.2d 648, 393 N.E.2d 1009 (1979) ; In re Hudson, 13 Wash. 2d 673,

126 P.2d 765 (1942). Parental autonomy to make decisions for their

children is also protected under the Constitution. See, e.g., Wiscon-

sin V. Yoder, 406 U.S. 205 (1972); Pierce v. Society of Sisters,

268 U.S. 510 (1925) ; Meyer v. Nebraska, 262 U.S. 390 (1923).

%8 See pp. 3-4, supra. A physician or hospital is guilty of battery if

surgery is performed on an infant without parental consent. See,

A. HHS Concedes That Parents’ Decisions Are Not

Within The Scope Of Section 504.

In both the July 1983 proposed regulation and the

January 1984 Final Regulation, the Secretary conceded

that parental decisionmaking is outside the scope of Sec-

tion 504. In the preamble to the Final Regulation, 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) (J.A. 43) (emphasis supplied). Similarly,

in the interpretative guidelines to the Final Regulation,

the Secretary stated unequivocally: “Section 504 and the

provisions of this part are not applicable to parents (who

are not recipients of Federal financial assistance).” Id.

at 1653 (J.A. 122) (emphasis supplied).** See also 48

Fed. Reg. 30848-30850 (1983) ; HHS Br. 5.

B. HHS’s Efforts Have Nonetheless Been Aimed Al-

most Exclusively At Parents’ Treatment Decisions.

Despite HHS’s concession in July 1983 and January

1984, its regulatory regime has unmistakably been aimed

at parents’ decisions involving treatment for their severely

impaired newborns. Indeed, the “Baby Doe of Indiana”

case, which gave rise to the 1982 Notice and al! subse-

quent regulations in this area, involved a decision by par-

ents not to authorize treatment for their child, as the

Secretary now explicitly acknowledges for the first time.

HHS Br. 2.” The 1982 Notice, the 1983 Interim Rule,

e.g., W. Prosser & W. Keeton, HANDBOOK OF THE LAW OF TORTS

§18, at 116 (5th ed. 1984).

24 In light of HHS’s concessions, the argument by analogy in the

University Hospital dissent—that “denial of medical treatment to

an infant because the infant is black is not legitimated by parental

consent“ —is clearly in error. (Pet. App. 44a). Regardless of the

race, color, creed or impairment 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 decisionmaker for the

child. Neither Title VI of the Civil Rights Act of 1964, 42 U.S.C.

SS 2000d et seg., nor Section 504 alters this fundamental rule.

25 See note 10, supra. In each of her regulatory pronouncements

in this area, as well as in her petition (Pet. 2-3, 17, 20, 22), the

the 1983 proposed rule and the 1984 Final Regulation

have all in significant respects been aimed directly at

parents’ decisions. See American Academy of Pediatrics,

supra, 561 F. Supp. at 400 (“primary purpose” of in-

terim rule “to prevent parents” from making decisions) ,

401 (same). Most importantly, virtually all of the 49 in-

vestigations reported by HHS in the preamble to the Final

Regulation have been aimed directly at parental decisions.

See pp. 11-13, supra.

In fact, the oppressive actions of the Secretary in Uni-

versity Hospital—which have been conspicuously absent

from her description of that case in this Court (Pet. 8-9;

HHS Br. 9-11)—conclusively demonstrate that the pur-

pose of the Secretary’s regulatory approach is to interfere

with parental decisions not to authorize treatment. After

Baby Jane Doe was born with multiple birth defects on

October 11, 1983, her parents decided not to consent to

certain surgery following consultation with “several phy-

sicians, nurses, religious advisors, a social worker, and

members of their family.” (Pet. App. 6a). The state

courts of New York rejected the claim of a third party,

unrelated to Baby Jane Doe, seeking appointment of a

guardian ad litem and an order directing that surgery be

performed.“

While the state court proceedings were still in progress,

HHS, which had received a Section 504 complaint from

an unidentified person, referred the matter to the New

York state child protective service agency. (Pet. App. 8a).

Secretary has relied on the “Baby Doe of Indiana” case as justifi-

cation for her regulatory approach, although it involved a decision

by parents not to authorize treatment, which the Secretary now con-

cedes is outside the scope of Section 504. See 47 Fed. Reg. 26027

(1982) (J. A. 127); 48 Fed. Reg. 9631 (1983); 48 Fed. Reg. 30847

(1983) ; 49 Fed. Reg. 1623 (1984) (J.A. 14). See also 49 Fed. Reg.

1646 (1984) (J.A. 96) (summarizing HHS’s formal investigation of

case).

26 The trial court granted this request, but was immediately over-

ruled by the Appellate Division, which determined that the parents’

decision was in the best interests of the child. (Pet. App. 7a). The

New York Court of Appeals affirmed on October 28, 1983. (Pet.

App. 7a-8a).

Without waiting for the state agency to make its deter-

mination, HHS in late October began its own direct Sec-

tion 504 investigation, repeatedly requesting the patient’s

records. (Pet. App. 8a). University Hospital declined to

give Baby Jane Doe’s medical records to HHS, based in

part on the parents’ refusal to release them. On Novem-

ber 2, 1983, before the state child protective service agency

had reached a decision, HHS and the Department of Jus-

tice brought a federal court action under Section 504

seeking access to the records to determine if the parents

were making a reasonable medical decision. The govern-

ment then persisted in its suit even after the state courts

had refused to override the parents’ choice and after the

state agency concluded on November 7, 1983 that no state

intervention was warranted under New York’s child neg-

lect statute. (Pet. App. 8a-l1la).

To protect their interests, Baby Jane Doe's parents

were forced to intervene in the federal suit, after defend-

ing a state court action and answering a state child pro-

tective service agency inquiry. This harassing federal

lawsuit, which ignored state administrative and judicial

decisions, exposed the parents to continued, unwanted pub-

licity and imposed on them over $75,000 in additional

legal fees. See 130 Cong. Rec. S8017 (daily ed. June 21,

1984). Given her explicit concession that she has no au-

thority under Section 504 to investigate parents, the Sec-

retary has implicitly conceded that the result in Univer-

sity Hospital—barring her investigation of Baby Jane

Doe’s parents—was correct and her harassing lawsuit was

completely unjustified.?’

C. An Affirmance On This Issue Is Necessary.

Notwithstanding HHS’s concession of July. 1983 and

January 1984 that it is forbidden, under Section 504,

27 HHS can hardly argue with any credibility that it was seeking

to investigate whether physicians or hospitals were discharging

their duties under state law to report parental neglect since the suit

was brought while the state agency was considering the issue of

parental neglect and continued after the agency determined there

was no such neglect.

to investigate or regulate individual treatment decisions

of parents, a holding of this Court on this issue is nec-

essary for two related reasons. First, such a holding

is required to ensure that the Secretary does not unlaw-

fully continue to investigate parents and thereby to en-

sure that University Hospital will never be repeated.

Despite the July 1983 concession in the proposed regula-

tion, 48 Fed. Reg. 30848 (1983), the Secretary nonethe-

less commenced, in October and November of 1983, the

Baby Jane Doe investigation and lawsuit that led to the

decision in University Hospital. Indeed, following her

concession in July 1983, the Secretary launched at least

12 investigations which appear to have been directed solely

at parents’ decisions not to authorize treatment and which

were stopped only when the injunction was entered in

this case. (J. A. 103-105; cases No. 38-No. 49).

Second, three of the four mandatory provisions of the

Final Regulation are aimed directly at parental decision-

making. The notice which hospitals must post under the

Final Regulation is unquestionably aimed at parents be-

cause it recites that any withholding of medically bene-

ficial care from an impaired newborn violates Section

504, with no suggestion, much less clarification, that Sec-

tion 504 is wholly inapplicable if such decisions are made,

as they must be, by parents. 45 C.F.R. § 84.55(b) (J.A.

112-114).* Similarly, the mandatory provisions authoriz-

ing expedited HHS access to infant medical records and

expedited compliance actions do not clearly exclude treat-

ment decisions by parents from HHS’s reach; they

broadly establish HHS’s authority both to investigate the

parents’ decisions concerning the course of treatment for

their impaired infant child and to institute a federal

court action to override the parents’ decision, as HHS’s

own investigations demonstrate. 45 C.F.R. § 84.55(d),

28 See 49 Fed. Reg. 1625-1626 (1984) (J.A. 23-27) (refusal of

HHS to make non-applicability to parents clear in notice, despite

concession that Section 504 does not apply to parental decisions).

§84.55(e) (J.A. 115-116) Thus, a holding by this

Court that Section 504 does not apply to parents’ treat-

ment decisions is also necessary to invalidate three of

the four mandatory provisions of the Final Resolution.“

Il. THE SECRETARY HAS NO AUTHORITY TO IN-

VESTIGATE AND DETERMINE, BEFORE STATE

OFFICIALS HAVE ACTED, WHETHER PHYSI-

CIANS ARE DISCHARGING THEIR STATE LAW

DUTIES TO REPORT MEDICAL NEGLECT BY

PARENTS.

Having been forced to admit that she cannot investi-

gate and regulate parents’ decisions not to consent to

treatment for their infant, the Secretary in the Final

Regulation impermissibly asserts her authority to do in-

directly what she concedes she cannot do directly—to

pressure parents by investigating and determining, before

state authorities have acted, whether health care provid-

ers are discharging their duties under state law to re-

port parental “medical neglect” to state authorities. This

contorted view of Section 504 violates the statute because

HHS is investigating neglect of a single child, not dis-

crimination between the handicapped and non-handicapped

—an investigation which will necessarily and impermissi-

bly require HHS to determine, before state authorities

have acted, whether the level of care requested by parents

is adequate under varying state standards of medical care

in these complex cases. This application of Section 504 is,

to use Justice Powell’s phrase, not only an illegal but also

an “unedifying example of over-zealousness on the part of

the Federal government.” Grove City College v. Bell,

104 S. Ct. 1211, 1223 (1984).

20 The expedited access to medical records is designed to enable

HHS investigators to review and monitor the treatment of infants,

which is the prerogative of parents.

* The other mandatory provision of the Final Regulation, 45

C. F. R. § 84.55(c) (J.A. 114-115), relates solely, for purposes of tnis

case, to HHS’s authority directly to investigate and regulate health

care providers, not parents. See pp. 25-27.

A. HHS Has Arrogated To Itself State Law Functions.

As noted, under the statutes of all 50 states, health care

providers have a duty to report to state authorities known

or suspected instances of medical neglec: by parents.

Similarly, allegations that health care providers them-

selves have not discharged their statutory reporting duty

are investigated by the state’s child protective service

agencies or prosecutors. Thus, any health care provider’s

failure to discharge the state law duty to report known

or suspected instances of medica] neglect must be ad-

judicated ultimately in state court—and a violation of

that duty can lead to a criminal pri secution and crim-

inal sanctions."

With respect to cases where parents do not consent to

treatment, the Secretary in the Final Regulation shifted

position and claimed that she may investigate directly

and immediately after the birth of a severely impaired

child the issue of whether health care providers are dis-

charging their state law duties to report parental medicai

neglect. Section 84.55 (e) of the Final Regulation (J.A.

114; emphasis supplied) requires, under “authority pur-

suant to State law” that “health care providers report on

a timely basis to the state agency circumstances which

they determine to constitute known or suspected instances

of unlawful medical neglect [by parents] of handicapped

%1 The child abuse and neglect statutes in all 50 states impose

upon physicians, and other health care professionals, a manda-

tory reporting duty which arises whenever the provider either

knows of or suspects, or has reasonable cause to know of or

suspect, the occurrence of child abuse and/or neglect. Each stat-

ute designates a state welfare and/or law enforcement agency

as having responsibility for receiving reports, conducting investi-

gations and initiating appropriate judicial proceedings. The failure

of a physician or other health care official to report a suspected

instance of abuse or neglect to the requisite agency is punishable in

every state by criminal or civil penalties or both. See R. Horowitz &

H. David., LEGAL RIGHTS OF CHILDREN § 7.12 (1984). See also e. .,

CAL. PENAL CobE §11172(d) (West Supp. 1985); ILL. Rey. Star.

ch. 111, § 4433 (Smith-Hurd Supp. 1984-1985); Mass. ANN. Laws

ch. 119, §51A (Michie/Law. Co-op. Supp. 1985); N.Y. Soc. Serv.

Law § 420 (McKinney 1983).

infants.” Similarly, the interpretative guidelines to the

Final Regulation state (J.A. 122; emphasis supplied):

Section 504... [is] not applicable to parents. How-

ever, each recipient health care provider must in all

aspects of its health care programs receiving Fed-

eral financial assistance provide health care and re-

lated services in a manner consistent with the re-

quirements of Section 504 . . . . Such aspects in-

cludes [sic] decisions on whether to report, as re-

quired by State law ... , to the appropriate child

protective services agency a suspected instance of

medical neglect of a child [by its parents.

As the preamble states (49 Fed. Reg. 1631; J.A. 44; em-

phasis supplied) :

[Tihe proper analysis of the applicability of section

504 in cases where the failure to provide medically

indicated treatment is due to a lack of parental con-

sent is that a recipient hospital is not required to

seek to unilaterally overrule the parents, but it must

adhere to the standard practice, as required by state

law, to make a report to the state agency... .”

Although the Secretary uses violations of state report-

ing duties as the predicate for a finding of discrimina-

tion, she does not leave the determination of whether

physicians have discharged their reporting duties under

state law to the duly constituted state executive and judi-

cial authorities. Rather, the Secretary asserts her au-

thority, under Section 504, to make an independent in-

vestigation and determination even before state authori-

ties have acted. Implicit in this determination is the

issue of whether the child is receiving medicaliy indi-

* The proposition that the physicians’ reporting duty is based on

state law is repeated throughout the preamble to the Final Regula-

tion. 49 Fed. Reg. 1624, 1627, 1631, 1644 (J.A. 19, 27-28, 44, 90).

See also 48 Fed. Reg. 30848-30849 (1983): Pet. 6; HHS Br. 7, 27.

49 Fed. Reg. 1632 (1984) (J.A. 47-48). Section 84.55(d), as

noted, provides for “expedited access” to records, including access

at any hour of the day or night. (J.A. 115). Section 84.55(e) pro-

vides for “expedited action to effect compliance,” and HHS claims

authority to do this without providing notice to the hospital or

physician. (J.A. 115-116).

cated treatment under state law standards. Only if a

child’s parents do not appear to be authorizing adequate

care is there a basis for a physician to report the par-

ents to state authorities for possible neglect. Incredibly,

the Secretary thus claims the power in a federal admin-

istrative proceeding to make a determination of the ade-

quacy of treatment under state law standards of medical

care in these complex cases (standards which may vary

from state to state) in order to see if physicians’ reporting

duties have been violated. Thus, the Secretary claims that

HHS, a federal agency with no power to enforce any

state’s law, can immediately determine when there has

been a “failure [by a provider] to comply” with varying

state law reporting requirements in each of the 50 states

and can seek a temporary restraining order to stop such

state law violations. 49 Fed. Reg. 1628 (1984) (J.A. 33).

B. HHS’s Arrogation Of State Law Functions To Itseli

Does Violence To The Language Of Section 504.

The Secretary’s claimed ability to substitute her “Baby

Doe squads” for state child protective agencies, state

prosecutors and even state courts in determining whether

health care providers have violated state law reporting

duties is demonstrably not authorized by the language of

Section 504. The Secretary’s brief makes virtually no

attempt to show that her claimed authority is supported

by the words of the statute—and no such showing is

possible. HHS Br. 27.

1. “Otherwise Qualified” And “Subjected To Discrimi-

nation.” In Alexander v. Choate, 105 S. Ct. 712, 720 n.19

(1985), this Court stated that the “question of who is

‘otherwise qualified’ and what actions constitute ‘discrimi-

nation’ under” Section 504 “would seem to be two sides

of a single coin.” When parents of a severely impaired

child do not consent to medical treatment in a federally

funded health program, the child is not “otherwise quali-

fied” for such treatment within the terms of Section 504.

In such circumstances, recipients of federal health care

funds do not fail to provide treatment in a federally

funded health program solely on the basis of the child’s

handicap, but rather solely on the basis of the child’s in-

fancy.* The Secretary does not—and cannot—dispute

this unassailable conclusion which removes federally

funded hospitals from the reach of Section 504 when par-

ents do not consent to treatment on behalf of their child.

HHS Br. 21-26.

Instead, in an improper attempt to bring federally

funded hospitals within the reach of Section 504 in a

situation involving potential parental neglect of a single

child—not discrimination between an impaired child and

a non-impaired child regarding access to a federally

funded health program—the Secretary simply asserts

without citation that, under the “subjected to discrimina-

tion” language of Section 504, health care providers may

not fail to discharge their state law duties to report the

parents of severely impaired children to state law au-

thorities. HHS Br. 27. But only when there has been

such a final state law determination of a physician’s re-

porting violation, which would involve complex medical

and legal considerations in individual cases under the

varying laws of each state, could HHS even conceivably

begin to determine whether the violation constituted “dis-

crimination” against the severely impaired child within

the meaning of Section 504.

It must be emphasized that, in making such a deter-

mination, HHS would necessarily and impermissibly have

In Southeastern Community College v. Davis, 442 U.S. 397, 406

(1979), this Court stated that the plain meaning of “otherwise quali-

fied handicapped individual” is one who is able to meet all of a pro-

gram’s requirements in spite of his handicap.” When parents do not

provide consent to treatment for a severely impaired child, one of

the requirements of a health care program—consent to treatment—

is not present and thus the severely impaired child is not “other-

wise qualified” for treatment in that program.

Nor does HHS even attempt to show that an impaired newborn

is “otherwise qualified” to have a recipient of federal funds in a

health care program provide access, not to that federally funded

health care program, but instead to state administrative and

judicial processes for determination under state law standards

of the parents’ fitness to make medical decisions on the infants’

behalf when its parents have not consented to treatment.

to determine the adequacy of the care a child was

receiving under the varying standards of medical care in

the 50 states because only if the care requested by par-

ents is, or appears to be, inadequate are physicians re-

quired under state law to report parents for possible

neglect. See note 31, supra. In its brief, HHS never

addresses this obvious and fatal implication of its regula-

tory approach—which is built on the distinction between

bona fide and discriminatory care in individual cases

(HHS Br. 16)—and thus never attempts to respond to the

basic holding of the Court of Appeals in University Hos-

pital that determinations by HHS of the standard of

medical care in individual cases is simply not authorized

hy Section 504. HHS Br. 26-38.“ Thus, the express lan-

guage of Section 504 demonstrably does not authorize the

Secretary to make an independent federal investigation

and determination of whether recipients of federal health

care funds have violated state child abuse and neglect

laws—including the necessary determination of whether

a child has received appropriate medical care under state

law standards—before a final state court judgment to

that effect.“ See pp. 25-27, supra."

Neither the language, nor the legislative history, see pp. 42-45,

infra, of Section 504 authorizes such an unprecedented expansion of

federal power, as the Court of Appeals correctly held. See Pet.

App. 30a-3la (“subjected to discrimination” language of Section

504 does not authorize HHS to establish standard of medical care

for distinguishing bona fide medical judgments from discriminatory

ones).

Respondents AMA et al. do not maintain, by this discussion, that

a violation of a state reporting duty, as determined by a final state

court judgment, would give rise to a Section 504 violation. That

issue is not before this Court. Our position is only that no Section

504 action is even conceivabie without such a final judgment.

The issue of whether, and to what extent, the Secretary can

investigate and regulate the enforcement practices of state child

protective service agencies which receive federal child abuse funds—

as opposed to the state law reporting duties of health care providers

who receive federal health care funds—is not presented in this case.

* There are occasional HHS statements that “discriminatory”

applications of hospitals’ “policies” and “practices” of either report-

2. “Program Or Activity Receiving Federal Financial

Assistance”. This Court has made clear that simply be-

cause an entity, including a hospital, receives federal

money does not mean that every action taken by that

entity is subject to the federal antidiscrimination ban un-

der Title VI, Title IX or Section 504. Instead, the phrase

“program or activity” is a limiting concept and the duties

created by those statutes are program-specific in their

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

1248, 1255-1256 (1984) ; Grove City College v. Bell, 104

S. Ct. 1211, 1220-1222 (1984); North Haven Board of

Education v. Bell, 456 U.S. 512, 538 (1982).

In support of her claimed authority to regulate physi-

cians’ state law reporting duties, the Secretary simply

asserts in a single sentence, without citation, that the

physicians’ duty, established under state statute, to re-

port parental medical neglect to state authorities is part

of a federally funded “program or activity.” HHS Br.

27. But this assertion is certainly not supported by the

plain meaning of Section 504. It is, to the contrary, a

very contorted use of the term “program,” in the context

of the provision of health care, to apply it to a physician’s

decision required solely by state law to ieport parents of

infant children to state authorities for enforcement of the

state’s neglect statute. Indeed, in its brief, HHS concedes

that the Final Regulation has made no showing that these

state law reporting duties are part of a federally funded

program or activity. HHS Br. 21 n.9. As a matter of

ing parental neglect or seeking court orders displacing parents as

decisionmakers may violate Section 504. 49 Fed. Reg. 1631 (J.A.

43); HHS Br. 27. The short answer to that erroneous contention is

that the Final Regulation itself is clearly restricted to enforcing the

state law duties of hospitals and physicians. See 45 C.F.R. § 84.55(c)

(J. A. 114-115) and pp. 25-27, supra. Moreover, since such practices“

in fact involve nothing more than the hospital’s efforts to comply

with state law (in the case of reporting neglect“) or to make state

law judgments (in the case of taking “neglectful” parents to court),

HHS’s investigations of such “practices” would necessarily, and

improperly, require HHS to make state law judgments based in part

on its own view of te standards of medical care in individual

cases.

law, at least a minimal showing by HHS that the activity

being regulated is part of a federally funded “program

or activity” should be required before such intrusive

regulations are allowed.*

C. HHS’s Arrogation Of State Law Functions To Itself

Is Not Authorized By The Legislative History Of

Section 504.

The legislative history of Section 504 also does not

authorize the Secretary to make an independent investiga-

tion and determination whether a health care provider

who is the recipient of federal health care funds is vio-

lating reporting duties established by state child neglect

statutes before state executive and judicial officials have

acted. HHS’s 15-page discussion in its brief (pp. 29-44)

of the legislative history of Section 504 adduces no au-

thority from the congressional deliberations to support its

contorted position that it has authority to make state law

judgments before state authorities do.“

The legal requirement that a regulation must have a factual

basis to justify the burdens it imposes is derived from both the

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq., and Section

504. The APA requires every agency rule to be supported, at a mini-

mum, by a reasonable basis in fact. See page 40, infra. In addition,

it would be fundamentally inconsistent with the limitations in the

scope of Section 504, recognized by this Court in Alexander v.

Choate, 105 S. Ct. 712 (1985) (page 32, infra), to allow an agency

to delve into a new area of enforcement, never contemplated by

Congress, without making at least a minimal showing that the

decisions being regulated are related to some federally funded

activity. But as noted above, the Secretary has conceded that

she has made no such showing with respect to physicians’ state

reporting duties. HHS Br. 21 n.9.

During the course of its discussion of the legislative history,

HHS also discusses the general Section 504 regulation which was

promulgated in 1977 to implement the legislation and which was

subsequently cited in the 1978 amendments to Section 504. HHS

Br. 39-44. Again, HHS cites nothing in that general regulation

which authorizes HHS to investigate and determine violations of

state law reporting duties before state officials have acted. See also

pp. 42-45, infra (legislative history of Section 504 provides no au-

thority for HHS 5% apply state standards of adequate medical

care to individual cases or to establish federal standards of medical

care for evaluating such cases).

D. HHS’s Arrogation Of State Law Functions To Itseif

Violates Basic Canons Of Section 504 Construction.

Although the Secretary’s attempt to make state law

judgments before state officials have acted is clearly not

authorized by the language and legislative history of Sec-

tion 504, any ambiguity on the reach of the statutory

language clearly must be resolved against the Secretary.

This Court has held that the determination of the scope

of Section 504 must be responsive to two powerful but

countervailing considerations—the need to give effect to

the statutory objectives of protecting the beneficiaries of

the Act and the desire to keep Section 504 within man-

ageable bounds. Alexander, supra, 105 S. Ct. at 720. This

Court in Alexander thus restated the fundamental rule of

Section 504 construction set forth in Southeastern Com-

munity College v. Davis, supra (105 S. Ct. at 720; em-

phasis supplied) :

Davis thus struck a balance between the statutory

rights of the handicapped to be integrated into so-

ciety and the legitimate interests of federal gran-

tees in preserving the integrity of their programs:

while a grantee need not be required to make “fun-

damental” or “substantial” modifications to accom-

modate the handicapped, it may be required to make

“reasonable” ones.

Thus, in contrast to other civil rights statutes, such as

Title VI, Section 504 requires the judiciary to make an

independent inquiry into the reasonableness of HHS ac-

tion when it is not clearly authorized by the Congress.“

% Unlike race, which never is a bona fide consideration under-

lying any particular decision unless used to remedy the effects of

past discrimination, handicap may be a relevant factor in deciding

whether someone is qualified for access to federally funded pro-

grams. For this reason Section 504 cannot be and has not been

interpreted by this Court in the same way as a statute such as Title

VI, even though Section 504 was in broad outline patterned after

Title VI. See Alexander v. Choate; Note, Employment Discrimina-

tion Against The Handicapped and Section 504 of the Rehabilitation

Act: An Essay On Legal Evasiveness, 97 Harv. L. Rev. 997, 1006-

1007 (1984). Instead, in a case such as this, the Court must decide

whether the accommodation HHS has required health care providers

1. But HHS cannot satisfy the basic rule of construc-

tion established in Alexander. Its efforts to investigate

and regulate directly physicians’ state law reporting du-

ties constitute a forbidden “substantial modification” of

the providers’ ealth program (even assuming, as we do

not, that a fe ally funded hospital’s state law reporting

duties are part of any federally funded “program or

activity,” see pp. 30-31, supra). Before HHS’s regula-

tory efforts in this area, hospitals and physicians had to

respond to investigations by state agents of state law re-

porting duties and defend court actions brought for fail-

ure to discharge such duties. Now, however, the Secre-

tary claims that health care providers also must submit

to independent, duplicative and wholly improper state-

law-based investigations by HHS in the hours and days

after the birth of a severely impaired newborn. Before

state authorities have acted, physicians must also defend

themselves in an HHS fund withdrawal proceeding which

must be bottomed, implausibly, on HHS’s determination of

whether state law reporting duties have been violated—a

determination which necessarily requires HHS in a fed-

eral forum to show that state standards of reasonable

medical care have not been followed and which would nec-

essarily force hospitals and physicians to rebut that show-

ing in these unprecedented “504 malpractice” cases. This

is demonstrably a “substantial” modification in the prac-

tices of hospitals and physicians because it involves the

imposition of a “wholly unwieldy administrative and ad-

judicative burden” forbidden by Alexander. 105 S. Ct. at

719.

Moreover, HHS requires interviews by federal “Baby

Doe” squads with physicians, nurses and other profes-

sionals; it requires making records available to federal

investigators. It thereby has the potential for duplicating

any investigation by the state authorities who are duly

constituted under state statute to determine whether state

reporting laws are being followed. It is hard to imagine

to make to protect handicapped infants is a reasonable one. Alez-

ander, supra, 105 S. Ct. at 720.

a more “substantial” or “fundamental” modification in a

program of health care for newborns—a modification

which is not necessary because HHS simply cannot make

state law judgments before state authorities do. More-

over, not only is this a substantial modification, but it is

also one which actually causes harm as the uncontradicted

record below demonstrates. American Academy of Pedia-

trics, supra, 561 F. Supp. at 396, 399-400 (HHS approach

causes “profound change” in way care provided)“

2. In Alexander v. Choate, this Court also stated that

the Secretary will have “substantial leeway to explore

areas in which discrimination against the handicapped

posed particularly significant problems and to devise reg-

ulations to prohibit such discrimination.” 105 S. Ct. at

722 n.24 (emphasis supplied). But despite her attempt

to find in that sentence a roving commission to take any

action she deems appropriate, HHS Br. 29, 36, it, in fact,

offers another reason, if one is needed, to strike down the

Secretary’s efforts in this area. In Alexander, the Court

was referring to “particularly significant problems” which

had been identified in the general Section 504 regulation

promulgated in 1977 by HEW (the predecessor depart-

ment for these purposes to HHS) and recognized by the

Congress in 1978 amendments to Section 504. 105 S. Ct.

at 724 n.27. But, there was simply no discussion in those

regulations of what HHS itself has conceded are the

unique and complex issues surrounding treatment for se-

verely impaired newborns,” let alone any mention of the

41 See p. 12, supra. Indeed, even HHS’s cursory description

of its own reported investigations makes clear that they have re-

sulted in invasions of family privacy, medical records and confi-

dential medical decisionmaking, and have disrupted hospital opera-

tions and delayed ongoing treatment for impaired newborns and

other patients. (J.A. 95-106). See also Shapiro & Rosenberg, The

Effects of Federal Regulations Regarding Handicapped 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. Mep. 443 (1983); J. A. 162-186 (unrebutted

affidavits submitted in this case).

42 See 49 Fed. Reg. 1636 (1984) (J.A. 61) (noting that application

of Section 504 in this area is “much more subtle and difficult” than

need for HHS independently to make state law judgments

regarding reporting duties of providers under state child

abuse and neglect laws before state officials have acted.

Moreover, the Department has itself failed in the ad-

ministrative record to demonstrate that there is any prob-

lem—let alone a particularly significant one—with pro-

viders’ failure to discharge such reporting duties and with

state agencies’ failure to enforce those duties. In the

1984 Child Abuse Amendments—the only instance in

which the Congress has addressed the question of appro-

priate care for impaired infants—the Congress sought to

strengthen the authority of state agencies, not supplement

or supplant it with a duplicative federal role as proposed

by the Secretary. See pp. 47-48, infra; HHS Br. 28, 45.

Moreover, in the regulations implementing the 1984 Child

Abuse Amendments, the Secretary noted 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 [parental]

medical neglect” under state law. 50 Fed. Reg. 14886-

14887 (1985). In fact, the Secretary further conceded in

the 1984 Child Abuse Regulation that use of infant care

review committees should reduce the already minuscule

need for formal state legal proceedings against parents

involving impaired newborns to a “[v]ery few cases.” Id.

It follows, a fortiori, that the problem of health care pro-

viders failing to report parental neglect is even smaller,

and the problem of state agencies failing to deal with

such cases is virtually non-existent. See also HHS Br.

2-11, 28 (no mention of any problem) .“ Accordingly, no

other areas) ; id. 1632 (J.A. 45-46) (few “definitive statements” on

application of Section 504 in this area possible) ; id. 1654 (J.A. 123)

(“special circumstances” of each case) .

* HHS Br. 6 (federal “enforcement” is “unnecessary” given infant

care review committees). Nothing in the Final Regulation demon-

strates any reporting problem of federal dimensions. The single case

noted by HHS did not, by HHS’s own account, involve determi-

nation of a state law or Section 504 violation, but only the voluntary

resolution of a complaint when a hospital stated it would do what it

was obligated to do anyway: follow state law HHS Br. 44; 48 Fed.

deference is due to the Secretary’s attempt to regulate a

non-existent problem and, therefore, her construction of

Section 504 in this regard should be rejected. See also

Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944);

General Electric Co. v. Gilbert, 429 U.S. 125, 143 (1976)

(inconsistent agency interpretation owed no deference) .**

E. HHS’s Arrogation Of State Law Functions To Itself

Violates Sound Principles Of Federalism.

The Secretary’s assertion of authority to disregard tra-

ditional state processes for responding to suspected medi-

cal neglect and to investigate and regulate directly health

care providers’ conduct before the state acts evidences a

striking lack of respect for the states and violates another

fundamental rule of construction which requires a clear

statement of congressional intent. The Secretary makes no

effort in either the administrative record or her brief to

explain why, given her reliance on state law as the basis

for judging physicians’ conduct, she is completely unwill-

ing to defer to the states to make state law judgments.

This disrespect for the states stands in stark contrast to

how the Congress itself ordinarily treats concurrent fed-

eral and state enforcement efforts. For instance, in both

Reg. 30847 (1983). The other cases and studies cited in the Final

Regulation do not even address the only relevant question of whether

there is some problem with the state child protective service agencies

which justifies HHS investigations, not of those agencies themselves,

but of the health care professionais regulated by those agencies

before those agencies have acted. See 49 Fed. Reg. 1645 (1984)

(J.A. 90-93).

With respect to situations where parents refuse to consent to

treatment, HHS has shifted position dramatically in a short period

of time. First, it said physicians should discharge patients from

hospitals; then it indicated in its Interim Rule and argued to Judge

Gesell that physicians should simply provide treatment against the

parents’ wishes; and, only when it finally realized that parents have

ultimate legal responsibility for their children absent a neglect

finding, did it focus on physicians’ state law reporting duties. See

pp. 7-11, supra; 49 Fed. Reg. 1631 (1984) (J.A. 43-44). See also

American Academy of Pediatrics, supra, 561 F. Supp. at 400

(Interim Rule product of “haste and inexperience”’) .

Title VII, 42 U.S.C. § 2000e-5(d), and the Age Discrimi-

nation in Employment Act, 29 U.S.C. § 633 (b), Congress

expressly required federal agencies to refer all discrimi-

nation claims in the first instance to a state agency if the

state has a parallel anti-discrimination statute. See Oscar

Mayer & Co. v. Evans, 441 U.S. 750, 756 (1979). It is

completely incongruous to think that the same Congress

intended to authorize HHS in the guise of a federal civil

rights statute for the handicapped to enforce physicians’

state law reporting duties within hours and days after

birth without any deference to the investigations and de-

terminations of state agencies and courts.

Indeed, the Secretary’s proposed effort to modify the

“federal-state balance” by intruding into the states’ tra-

ditional regulation of medical neglect cases could only be

justified by a clear statement of congressional intent to

permit this regulation. See FTC v. Bunte Brothers, Inc.,

312 U.S. 349, 354-355 (1941); Apex Hosiery Co. v.

Leader, 310 U.S. 469, 513 (1940) ; United States v. Bass,

404 U.S. 336 (1971). Cf., Pennhurst State School &

Hospital v. Halderman, 451 U.S. 1, 17 (1981). This

Court, in reviewing federal attempts to regulate behavior

condurrently with the states, has held that, absent a “clear

statement” of congressional intent, the federal action was

prohibited. That rule applies with special force in this

case. Here the Secretary is acting in an area historically

ceded to the states: the regulation of sensitive parent-

child and physician-patient relationships, under the states’

parens patriae and police powers. See pp. 3-4, supra.

Thus, this case is even more extreme than other “con-

current regulation” cases requiring a clear statement of

Congressional intent because the duties of the health care

providers to report parental neglect which the Secretary

seeks to regulate arise solely under state law. Absent a

clear statement from the Congress, the Secretary simply

may not precede, duplicate and/or supplant state execu-

See, e.g., Williams v. United States, 458 U.S. 279, 290 (1982);

United States v. Enmons, 410 U.S. 396, 411 (1973); Palmer v.

Massachusetts, 308 U.S. 79, 83-85 (1939).

tive and judicial authorities who investigate and deter-

mine whether state law reporting duties have been vio-

lated by health care professionals.“

Ill. THE SECRETARY HAS NO AUTHORITY TO

INVESTIGATE AND REGULATE PHYSICIANS’

TREATMENT DECISIONS IN INDIVIDUAL CASES.

In addition to her unlawful application of Section 504

to providers’ duties under state law to report for neglect

parents who do not authorize treatment, the Secretary has

also claimed authority to apply the statute to decisions

by providers not to treat impaired newborns. HHS Br.

13. Such provider decisions not to treat can arise in only

two circumstances: when parents have not consented to

treatment for their child and when they have. In neither

circumstance is action by the Secretary lawful.

A. Providers’ Decisions Not To Treat In Cases Where

Parents Have Withheld Consent To Treatment.

In the preamble to the Final Regulation, HHS finally

conceded that health care providers have no authority to

treat an infant over parents’ objections and that, as a re-

sult, providers’ treatment decisions in these circumstances

are wholly beyond the purview of Section 504. See, e.g.,

J. A. 43-44; HHS Br. 27-28. Nevertheless, because HHS

has in previous statements—most notably in the Interim

Rule, 48 Fed. Reg. 9630 (1983)—asserted authority un-

der Section 504 to require providers to treat infants over

their parents’ objections, and has ignored other concessions

in prosecuting University Hospital, it is appropriate that

this Court formally hold that Section 504 does not apply

to providers’ treatment decisions when the parents have

withheld consent to treatment.

% HHS’s efforts to enforce parental neglect reporting duties are

also invalid under the fundamental rule of construction that a gov-

ernment agency or department cannot do indirectly what it is pro-

hibited from doing directly (i.e., regulate parents’ decisions). See

TIM. E., Inc. v. United States, 359 U.S. 464 (1959). See also

Montana-Dakota Utilities Co. v. Northwestern Public Service Co.,

341 U.S. 246 (1951); Sunray Mid-Continent Oil Co. v. FPC, 364

U.S. 187, 152 (1960).

B. Providers’ Decisions Not To Treat In Cases Where

Parents Have Authorized Treatment.

In this Court, HHS devotes virtually all of its brief to

the argument that it is authorized under Section 504 to

investigate and regulate directly providers’ decisions not

to provide treatment when parents have given their con-

sent. But this Court need not even reach this issue of

construction because the application of Section 504 to

such decisions is clearly unlawful under the Administra-

tive Procedure Act (“APA”). 5 U.S.C. § 551 et seg.“

In any event, this application of the Regulation is also

not authorized by Section 504.

1. The Application Of The Final Regulation To

Such Decisions Is Arbitrary And Capricious.

Because the application of Section 504 to provider

decisions not to treat in individual cases invades an area

traditionally governed by state law processes, the Secre-

tary may regulate them, if at all, only on the basis of a

valid, specific regulation. Under Alexander v. Choate,

she cannot rely solely on any inherent Section 504 author-

ity under the statute or the general implementing regula-

tions.“ But, the Final Regulation cannot provide her

such specific authority because applicaiion of that regu-

* See J. A. 146-147 (respondents AMA et al. alleged APA count

in their complaint) and note 19, supra (this Court may affirm

judgment on alternate ground).

In Alexander, this Court held that the Secretary could not,

simply on the authority of the “generally-worded” Section 504 regu-

lations promulgated in 1977, intrude on the states’ traditional dis-

cretion in administering Medicaid, a federal/state program, if such

action was not explicitly authorized by the statute, its ler'slative

history or the general regulation. 105 S. Ct. at 724 & n.32. The

need for a specific implementing regulation before the Secretary

may act is even stronger with respect to physicians’ treatment deci-

sions where the application of Section 504 is wholly unprecedented,

intrudes on existing state law standards governing the reasonable-

ness of medical practice in individual cases, and is not explicitly

authorized. Cf., 42 U.S.C. § 1395 (disavowing federal supervision

or control over the practice of medicine) .

lation to these provider treatment decisions violates ele-

mentary principles of administrative law.

Under the APA, courts must invalidate regulations

that are “arbitrary, capricious, [or] an abuse of discre-

tion.“ 5 U.S.C. § 706 (2) (A). This Court has consistently

interpreted this provision to require, at a minimum, that

administrative rules have a reasonable basis in fact and

that the agency or department articulate a satisfactory

explanation for its action, including a “rational connec-

tion between the facts found and the choice made.” See

Motor Vehicle Manufacturers Assoc. of the United States,

Inc. v. State Farm Mutual Automobile Insurance Co.,

463 U.S. 29, 43 (1983). The Secretary’s claim in her

brief that, under the Final Regulation, she may investi-

gate and regulate directly providers’ decisions not to treat

after parents consent fails to withstand scrutiny under

both of these basic requirements.

First, and most importantly, the Secretary’s argument

is totally unsupported by any factual evidence that such

alleged decisions are ever made by health care providers

in the context of care for impaired newborns. Indeed,

this “case” involves a wholly hypothetical situation that

is on its face implausible: a health care provider would

first have to communicate the treatment options to the

infant’s parents and then, after the parents selected a

course of treatment, fail to provide it solely because of

the infant’s handicap. Such a failure to treat could sub-

ject the physician to tort liability and state disciplinary

action under the licensing laws of all 50 states. See pp.

4-5, supra. Of course, HHS has not been able to cite

even a single instance in which a provider has refused

to provide a newborn infant medically indicated treat-

ment which its parents have authorized—not in the

preamble to the Final Regulation, not in any of her

49 This fundamental rule has often been emphasized by the Court.

See, e.g., Bowman Transportation, Inc. v. Arkansas-Best Freight

System, Inc., 419 US. 281, 285-86 (1974); Citizens to Preserve

Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971); Burlington

Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962).

lengthy regulatory pronouncements in this area, and not

in her brief to this Court, which remarkably contains not

one citation to any authority suggesting even the ex-

istence of such a case.“

Second, given its failure to cite a single case of what

it purports to be regulating, HHS has a fortiori not been

able in the preamble to the Final Regulatiun to establish

any connection, much less a “rational connection,“ between

the administrative record and its claimed authority to in-

vestigate providers’ decisions in these circumstances. In-

deed, there does not appear to be a single word in the

Final Regulation, in its preamble, or in any of HHS’s

regulatory pronouncements even remotely suggesting that

the purpose of HHS’s presence in the delivery rooms

and newborn nurseries was to review alleged provider de-

cisions not to treat when parents of impaired newborns

have authorized treatment.“ In short, one looks in vain

in the Secretary’s regulatory pronouncements for any

mention of, or justification for, the application of the

Final Regulation to the hypothetical provider “non-treat-

ment” decisions which are virtually the sole focus of her

brief in this Court. The application of the Final Regula-

tion to such decisions is demonstrably arbitrary and

capricious and, therefore, unlawful, and this Court should

so hold to prevent HHS from using it as a pretext to con-

duct intrusive, harmful investigations.“

See HHS Br. 15, 26 (HHS’s paradigm example of refusal to

treat is hypothetical only; no citation to specific case). See also

49 Fed. Reg. 1646-1649 (1984) (J. A. 95-106) (none of 49 cases

reported by HHS involved this situation). In University Hospital,

for example, the Court of Appeals noted that the hospital remained

willing to perform corrective surgery on Baby Jane Doe if her par-

ents would consent. (Pet. App. 39a). In the Baby Doe of Indiana

case, parents refused to authorize treatment. HHS Br. 2.

51 Moreover, nowhere in the administrative record did the Secre-

tary ever discuss the state law duties of health care providers under

state licensing statutes not to “abandon” patients; and nowhere

did she explain why existing state law processes need to be short-

circuited by her own direct involvement in the first instance.

52 Moreover, the Secretary cannot, in her reply brief to this Court,

make up for these obvious deficiencies. Administrative action may

2. Section 504 Does Not Authorize Direct Federal

Investigation And Regulation Of Such Provider

Treatment Decisions.

Application of the Final Regulation to physicians’ de-

cisions not to treat when parents have consented is also

unlawful because it is plainly outside the scope of the

Secretary’s authority under Section 504.

a. The vast bulk of the Secretary’s brief is spent de-

riving two propositions from the language and legislative

history of Section 504. But neither proposition supports

the Secretary’s authority to investigate and determine

the “reasonableness” of physicians’ decisions in individ-

ual cases. First, HHS maintains that Section 504 ap-

plies generally to health services and mandates non-

discriminatory access to federally funded health services

for otherwise qualified handicapped individuals. This

proposition, of course, is nothing more than a restatement

of the general rule of Section 504 itself, and there have

been a number of cases decided by the lower federal courts

involving Section 504 and health services—none of which

remotely supports the extreme construction of the statute

urged here by the Secretary.™

be upheld by a reviewing court, if at all, only on the same grounds

articulated by the agency itself, and “appellate counsel’s post hoc

rationalizations for agency action” are impermissible. Burlington

Truck Lines, supra, 371 U.S. at 168-169.

88 The Secretary places principal reliance on the Senate report

accompanying the 1974 amendment to Section 504 which listed

“health services” along with employment, housing, transportation

and education as areas to which Section 504 would apply. HHS Br.

35; S. Rep. No. 1297, 98rd Cong., 2d Sess. 39 (1974). But cf.,

Alexander, supra, 105 S. Ct. at 724 (the principal focus of Section

504 was not on health services but rather on employment, education

and the elimination of physical barriers).

6 See, e.g., United States v. Cabrini Medical Center, 639 F.2d

908 (2d Cir. 1981) (employment); Southeastern Community Col-

lege v. Davis, 442 U.S. 397 (1979) (admission to nursing school);

Alexander v. Choate, 105 S. Ct. 712 (1985) (reduction in health

assistance). No case has approved the application of Section 504

to individual medical treatment decisions. Indeed, the Eighth

Second, HHS maintains that Section 504 specifically

applies to “treatment” decisions involving otherwise quali-

fied handicapped individuals. Although its brief is filled

with enumerable references to bills, amendments and re-

ports, HHS derives this proposition not from the legisla-

tive history of Section 504 but only from several examples

—involving denial of medical treatment due to race, deaf-

ness, alcoholism and drug addiction—contained in the

legislative histories of other statutes or in the preamble

of the general Section 504 regulation promulgated in

1977. But these exaiaples, on their face, do not involve

a federal determination first of an appropriate standard

of medical care in an individual case and then a deter-

mination that the health care provider did not act in a

“reasonable” or “bona fide” medical fashion. Instead,

these examples all involve discriminatory general policies

declaring ineligible for treatment broad types of indi-

viduals in which the minority status or handicapping

condition—blacks denied surgery, deaf persons denied

burn treatment and alcoholics denied cancer therapy-—

is on its face wholly unrelated to the condition requiring

treatment.

Circuit recently dismissed a Section 504 claim alleging, in part,

that a nursing home had discriminated against a resident by

failing to provide adequate medical care, concluding that [iln

substance, this is a medical malpractice case” not cognizable under

Section 504. Hoyt v. St. Mary’s Rehabilitation Center, 711 F.2d

864, 867 (8th Cir. 1983).

55 See HHS Br. 11, 35-36 (example, drawn from Title VI, of black

person denied medical treatment); id. 40 (example, drawn from

1977 general Section 504 regulations, of deaf person denied care by

a burn treatment center); id. 37-39, 41-42 (example, drawn from

42 U.S.C. § 290dd-2(a), of alcoholic or drug addict denied care for

unrelated medical condition). The only “health services” example

drawn from the legislative history of Section 504 itself has nothing

to do with treatment in individual cases after admission to a pro-

gram. The Senate Report cites as the onli, example of the application

of Section 504 to health services the denial of admission to a feder-

ally assisted nursing home solely on the basis of handicap. S. Rep.

No. 1297, supra, at 38-39.

These examples are in sharp contrast to the Secretary’s

claim in this Court regarding her authority to investigate

physicians’ decisions involving impaired infants. The

Secretary concedes that application of Section 504 to

medical treatment decisions involving severely ill infants

is “much more subtle and difficult” than more conven-

tional applications, 49 Fed. Reg. 1636 (1984) (J.A. 61),

and that, because of the inherent difficulty and complexity

of determining appropriate medical care for impaired

newborns, she is simply unable to develop even the most

general standards for applying Section 504 in this

swiftly changing area of medical practice, 49 Fed. Reg.

1632 (1984) (J.A. 46). Thus, the Secretary has an-

nounced that she can and will proceed only on a “case-by-

case basis” to assess the standard of reasonable care with

respect to the complex cases and then to determine

whether providers in individual cases have made “reason-

able” or bona fide medical treatment decisions as opposed

to discriminatory decisions based solely on the handicap

of an otherwise qualified infant. 49 Fed. Reg. 1632

(1984) (J. A. 46). But cf., id. 1634 (J.A. 52) (HHS re-

fusal to commit to use medical consultants in all on-site

investigations) .

At the very least, as the Court of Appeals in University

Hospital noted, the determination of whether a provider

has “discriminated” in this sense against his infant pa-

tient would necessarily involve federally established

“504 malpractice” standards, lengthy litigation, extraor-

dinarily burdensome administrative costs, and no sure

conclusion, especially in the highly complex and swiftly

changing field of neonatology. (Pet. App. 30a-31la). As

the only courts to address this issue have concluded, there

is simply no support anywhere in the legislative history

for this kind of direct establishment by HHS of a fed-

eral standard of care in individual cases and then a fur-

ther determination whether providers have deviated from

that standard of care in a way that is “discriminatory”

under Section 504.“ Congress simply did not intend that

HHS would determine in individual cases whether or not

medical treatment [was] contraindicated.” HHS Br. 24.

b. The total lack of support in the “subjected to dis-

crimination” language of Section 504 and in the legisla-

tive history of the Act for the Secretary’s attempt to

investigate and regulate directly the “reasonableness” of

a physician’s decision not to treat in an individual case

after parental consent has been given should end the

inquiry. But, even if there is some ambiguity on this

point in the legislative history, the Secretary is barred

from such an application of Section 504 because it would

require a “substantial modification” in the provider’s

program prohibited under the rule of Alexander v. Choate.

If parents have consented to treatment, HHS can in-

vestigate only two types of situations. In the first, the

physician does not himself treat but responds to the in-

fant’s condition by helping to obtain an alternative physi-

cian satisfactory to the parents.“ In that situation the

infant receives treatment, but HHS could nevertheless

make a federal “504 malpractice” investigation and de-

% See University Hospital, supra, 729 F.2d at 157-160 (Pet. App.

31a-38a) ; American Academy of Pediatrics, supra, 561 F. Supp. at

400 (“there is no customary standard of care” of impaired infants),

401 (“no congressional committee or member of the House or Sen-

ate ever even suggested that Section 504 would be used to monitor

medical treatment of defective newborn infants ...”). As noted,

in its brief, HHS never addresses this fundamental holding in the

Court of Appeals opinion. HHS Br. 26-28. See 49 Fed. Reg. 1630

(1984) (J.A. 38-39) (HHS recognition that individual cases will

turn on experience and judgment). The hypothetical case cited re-

peatedly by HHS—a Down’s Syndrome infant who is denied surgery

to correct a blocked esophagus (HHS Br. 12-13, 15, 23, 26)—is, as

HHS's own emphasis on case-by-case determinations indicates, a sim-

plified example which is not likely to reflect medical realities. See

pp. 5-7, supra; Brief for Amici Curiae American Academy of

Pediatrics, et al. See also HHS Br. 5 n.2 (recognition of complicat-

ing factors).

7 This could happen if the physician were faced with two emer-

gencies simultaneously and could only treat one.

termination, even though no unlawful “abandonment”

under state law has occurred. See p. 4, supra. The

new federe} substantive standard of medical care im-

posed upon health care providers in such a circumstance

would involve an even more “fundamental modification”

of a hospital’s treatment program than the Secretary’s

attempt to enforce existing state reporting duties because

federal standards of medical care are being established

and enforced. Any HHS efforts to devise and enforce fed-

eral medical standards of care in this type of situation,

where there has been no patient abandonment under state

law, plainly violates the rule in Alexander v. Choate.

In the second situation, which is wholly implausible,

the physician, after receiving parental consent, both re-

fuses to treat a child who is severely impaired and de-

clines in clear violation of state law to help parents

secure a second physician to treat the infant. Obviously,

this would be scandalous, but even in this hypothetical

circumstance all of the rules of construction discussed

in Part II undercut HHS’s attempt to regulate before

state authorities have acted. The federal intrusion laid

on top of existing state enforcement mechanisms to deal

with patient “abandonment” will significantly modify

the hospital’s program. No problem has been identified

by the Secretary that warrants a federal role and there-

fore no deference is due to her extreme construction of

the Act. Finally, the state would surely prosecute such

a case and its prerogatives should not be interfered with

solely on the basis of a tortured reading of Section 504

and without a clear statement from Congress that it

wanted HHS involved in this fundamental issue of state

regulation of medical praetice.“ Under applicable rules

58 There is little danger that, if such a scandalous case ever

occurred, state authorities would not proceed promptly against the

physician and any federal interest could be vindicated, as appropri-

ate, after a final state law determination. There is danger, however,

that if HHS is allowed to investigate this “type” of case before

final state action it will, as it has in the past, direct its attention to

cases where parents have not consented to treatment.

of construction, HHS simply cannot bootstrap itself into

intensive care nurseries with broad Section 504 investi-

gative powers based on so flimsy a hypothetical.

CONCLUSION

In University Hospital, the Court of Appeals concluded

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. . . the type of investigation that has

precipitated this lawsuit [is unlawful].

Following invalidation of HHS’s Section 504 regulatory

regime in this case, Congress weighed those interests and

chose not to revive that regime. Instead, in the Child Abuse

Amendments of 1984, note 20, supra, the Congress

strengthened a state grant program and sought to help

state child protective service agencies discharge their re-

sponsibilities in the context of severely impaired new-

borns.* A principal sponsor emphasized that: “This

legislation does not itself authorize direct federal in-

volvement in individual cases.” See note 20, supra (let-

ter of Sen. Hatch). In regulations implementing the

new law, HHS has admitted that, in contrast to its

Section 504 regulatory regime, Congress in the 1984

Child Abuse Amendments did not want a “new bureauc-

racy” created at the federal level to deal with treatment

for impaired newborns; did not want creation of “fed-

erally prescribed medical standards for approved treat-

ment of specific cases;” and did not want direct federal

hotlines or other regulation of a hospital’s internal af-

fairs. 50 Fed. Reg. 14880, 14881, 14883-14884 (1985).

HHS noted that the 1984 Amendments were “the product

of an extraordinary effort“ by Congres and medical,

5° See H.R. Conf. Rep. No. 1038, 98th Cong., 2d Sess. (1984)

(federal grants to state child protective service agencies conditioned

on incorporation of certain changes in state law and procedure).

“right-to-life” and disability groups “to forge a substan-

tial consensus on an effective and workable program to

assure” appropriate medical care for impaired newborns,

concluding:

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 responsibili-

ties. 50 Fed. Reg. 14879 (1985).

By contrast, HHS’s 504 regulatory regime does not

represent a careful balance by the Congress of the need

to protect disabled infants and the need to avoid un-

reasonable governmental intervention into parental re-

sponsibilities and the practice of medicine. Indeed, the

regulatory regime is far beyond anything remotely con-

templated by the Congress and is cleariy not authorized

by Section 504. Accordingly, the judgment of the Court of

Appeals should be affirmed.”

% The judgment below (Pet. App. 50a-52a) enjoined HHS from

(a) implementing the Final Regulation with respect to individual

treatment decisions involving impaired newborns and (b) from

otherwise investigating or regulating such decisions absent a spe-

cific regulation on the subject. Such decisions for impaired infants

in individual cases are made only by parents and physicians. When

parents do not consent to treatment for their child, Parts I and II,

supra, have demonstrated that HHS has no authority to regulate

parents’ non-treatment decisions or physicians’ duties under state

law to report parental neglect. When parents do consent, Part III

has demonstrated that HHS has no authority to regulate physicians’

decisions. Accordingly, the judgment below should be affirmed and

HHS should be enjoined from implementing the Final Regulation

or otherwise regulating individual treatment decisions by parents

or providers. As noted, the applicability of Section 504 to the en-

forcement practices of child protective service agencies is not pre-

sented by this case. See note 36, supra.

KIRK B. JOHNSON

B. J. ANDERSON

AMERICAN MEDICAL ASSOCIATION

535 North Dearborn Street

Chicago, Illinois 60610

(312) 645-4600

600 Maryland Avenue, S.W.

Suite 300-East

Washington, D.C. 20024

(202) 638-5577

JOSEPH A. KEyEs, Jr.

ASSOCIATION OF AMERICAN

MEDICAL COLLEGES

One Dupont Circle, N.W.

Washington, D.C. 20036

(202) 828-0554

R. MICHAEL MILLER

AMERICAN ACADEMY OF

FAMILY PHYSICIANS

1740 West 92nd Street

Kansas City, Missouri 64114

(816) 333-9700

Respectfully submitted,

BENJAMIN W. HEINEMAN, JR.

(Counsel of Record)

CARTER G. PHILLIPs

VINCENT F. PRADA

1722 Eye Street, N.W.

Washington, D.C. 20006

(202) 429-4000

NEWTON N. MInow

JACK R. BRRG

One First National Plaza

Chicago, IIlinois 60603

(312) 853-7000

SIDLEY & AUSTIN

Attorneys for Respondents

American Medical Association, et al.

November 4, 1985

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.