# Opposition Brief — Bowen v. American Hospital Assn. > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385012_0316%3A03 ## Record - **Collection:** Supreme Court brief - **Document type:** Opposition Brief - **Published:** January 1, 1986 - **Citation:** 476 U.S. 610 ## Text Office sur reme Court, US. rrEL ee No. 84-1529 MAY 25 1985 ~ ALEXANDER L STEVAS, CLERK IN THE Supreme Court of the Wuited States OCTOBER TERM, 1984 MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES, . Petitioner, AMERICAN HOSPITAL ASSOCIATION, et al., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Second Circuit BRIEF OF THE RESPONDENTS AMERICAN MEDICAL ASSOCIATION, ET AL., IN OPPOSITION KIRK B. JOHNSON BENJAMIN W. HEINEMAN, JR. B. J. ANDERSON (Counsel of Record) American Medical Association CARTER G. PHILLIPS 535 North Dearborn Street VINCENT F. PRADA Chicago, Illinois 60610 1722 Eye Street, N.W. (312) 645-4600 Washington, D.C. 20006 ANN E. ALLEN (202) 429-4000 American College of NEWTON N. MINOW Obstetricians & Gynecologists JACK R. BIERIG 600 Maryland Avenue, S.W. One First National Plaza Suite 300-East Chicago, Illinois 60603 Washington, D.C. 20024 (312) 853-7000 (202) 638-5577 SIDLEY & AUSTIN Attorneys for Respondents American Medical Association, et al. [Other Counsel Listed On Inside Front Cover] May 25, 1985 WILSON - EPES PRINTING Co. INC. - 789-0096 - WASHINGTON, D.C. 20001 | JOSEPH A. KEYES, JR. Association of American Medical Colleges One Dupont Circle, N.W. Washington, D.C. 20036 (202) 828-0510 MICHAEL MILLER American Academy of Family Physicians 1740 West 92nd Street Kansas City, Missouri 64114 (816) 333-9700 MARK D. MokRIS Hospital Association of New York State 15 Computer Drive West Albany, New York 12205 (518) 458-7940 STUART M. GERSON Epstein Becker Borsody & Green, P.C. 1140 19th Street, N.W. Washington, D.C. 20036 (202) 861-0900 QUESTION PRESENTED Whether Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794, authorizes: (a) a direct federal role investigating and regulating individual treatment decisions involving severely im- paired newborn infants, which intrudes on the states’ traditional responsibilities for regulating parent-child and physician-patient relationships; and (b) the inevitable creation of a body of “504 malprac- tice law” for determining whether individual treatment decisions in the complex and rapidly evolving area of med- ical care for severely impaired newborns are “reasonable” or “unreasonable” under federal standards. (i) TABLE OF CONTENTS ETE .... ee (1) The State Law Framework .............................. (2) Medical and Ethical Context: The Growth of Infant Care Review Committees (3) The Voided 504 Regulation (4) The Decisions Below ................................. 3 (5) The Child Abuse Amendments of 1984 REASONS FOR DENYING THE PETITION ............. I. II. THE DECISION BELOW WAS CLEARLY CORRECT: SECTION 504 DOES NOT AU- THORIZE DIRECT FEDERAL INVESTIGA- TION AND REGULATION OF INDIVIDUAL TREATMENT DECISIONS INVOLVING IM- PAIRED NEWBORNS S A. Treatment Decisions by Parents on Behalf of Their Impaired Newborn Infants Are Not Within the Scope of Section 50044 B. Decisions by Health Care Providers on Whether or Not to Report Suspected or Known Instances of Parental Medical Neg- lect to State Authorities Are Not Within the Scope of Section 54 C. Providers’ Treatment Decisions In Individual Cases Are Not Within the Scope of Section THERE IS NO SUBSTANTIAL FEDERAL INTEREST IN THE VOIDED REGULA- ,: 7—6„.—! . —— A. The 1984 Child Abuse Amendments, Not the Secretary’s Intrusive Regulatory Ap- proach, Represent the Federal Interest in this Sensitive Area 11 13 14 15 17 iv TABLE OF CONTENTS—Continued B. The Secretary Has Shown No Problem with the Historic State Law Framework that Warrants Direct Federal Investigation and 1 — —— C. Direct Federal Investigation and Regulation in this Sensitive Area Has Caused, and Will if Reinstated Cause, Harm —— ————— — Page 26 V TABLE OF AUTHORITIES CASES Page Alexander v. Choate, 105 S. Ct. 712 (1985)........ 18, 23 American Academy of Pediatrics v. Heckler, 561 F. Supp. 386 (D. D.C. 1968) .................:.-............. 5, 22 Apex Hosiery Co. v. Leader, 310 U.S. 469 (1940).. 23 Barsky v. Board of Regents, 347 U.S. 442 (1954) .. 3 Bennett v. Jeffreys, 40 N.Y.2d 543, 356 N.E.2d r d ee ee ene 15 Consolidated Rail Corp. v. Darrone, 104 S. Ct. D e - e aeereooen 30 Dent v. West Virginia, 129 U.S. 114 (1889 3 FTC v. Bunte Brothers, Inc., 312 U.S. 349 Fer 23 Grove City College v. Bell, 104 S. Ct. 1211 (1984). 18 Heublein, Inc. v. South Carolina Tax Commission, r . 23 Hoyt v. St. Mary's Rehabilitation Center, 711 F. 2d r 23 In re Hudson, 13 Wash. 2d 673, 126 P. 2d 765 r easels 15 In re Infant Doe, No. GU 8204-004A (April 12, 1982), writ of mandamus dismissed sub nom. State ex rel. Infant Doe v. Baker, No. 482 8 140 D, abiveslteisnoces 28 Linder v. United States, 268 U.S. 5 (1925 3 Meyer v. Nebraska, 262 U.S. 390 (1923 15 Parham v. J. R., 442 U.S. 584 (1979) 3 Pennhurst State School & Hospital v. Halderman, , .. inisoeen 23 Pierce v. Society of Sisters, 268 U.S. 510 (1925). 15 Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914) 15 Southeastern Community College v. Davis, 442 Oe aces 22, 23 Sunray Mid-Continent Oil Co. v. FPC, 364 U.S. I ikl, 19 United States v. Bass, 404 U.S. 336 (1971)........ 23 United States v. Cabrini Medical Center, 639 F.2d e 23 23 United States v. Culbert, 435 U.S. 371 (1978) vi TABLE OF AUTHORITIES—Continued Page United States v. University Hospital, 729 F.2d EF fe ee ne passim Wisconsin v. Yoder, 406 U.S. 205 (1972 15 STATUTES AND REGULATIONS Child Abuse Amendments of 1984, Pub. L. No. 98-457, 98 Stat. 1749 (1984) ee... passim Child Abuse Prevention and Treatment Act, 42 ,, 11 Civil Rights Act of 1964, tit. VI, 42 U.S.C. ES Le ee eR 17, 30 Education Amendments of 1972, tit. IX, 20 U.S.C. D r 18 Hill-Burton Act, 42 U.S.C. § 21111 18 Medicaid Act, 42 U.S.C. § 139 18 Medicare Act, 42 U.S.C. § 1399999 18 Rehabilitation Act of 1973, § 504, 29 U.S.C. § 794..passim Cal. Bus. & Prof. Code § 2234 (West 1985 Supp.) .. 4 III. Ann. Stat. ch. 111, § 4433 (Smith-Hurd 1984- BE BENS NT ie a IR CP N.Y. Educ. Law § 6509 (McKinney’s 1984 Supp.).. 1 Airrcecrecebacesntnntecsendantndediecetccsoneneesi ͤĩð ?öWq9«q rw 7 . 7, 8, C. orcicccnsccicinsnnnsnsocctsonenettinientecossesens * 45 C. F. R. § 84.55 (e) 7 . eotcccecectttecntnscncsesncctecnectsivecenececenseree een ae LEGISLATIVE AND REGULATORY MATERIALS H.R. Conf. Rep. No. 1038, 98th Cong., 2nd Sess. // EN ORCS es DU LO YN ibe 12 S. Rep. No. 1135, 92nd Cong., 2d Sess. (1972) 18 130 Cong. Rec. 88017 (daily ed. June 21, 1984).... 10 130 Cong. Rec. H10327 (daily ed. September 26, 1E 12 130 Cong. Rec. H 10329 (daily ed. September 26, —f— = . feen 12 2 SCAND O n o PP vii TABLE OF AUTHORITIES—Continued Page 130 Cong. Rec. H10333 (daily ed. September 26, SE scinrisiniicneiediciinciniegeameninepemaamneimnentee 12 130 Cong. Rec. 812382 (daily ed. September 28, 1777C '] «ͤ äu˙ :¼ʃñ»[.k: D— 12 130 Cong. Rec. $12382-83 (daily ed. September 28 0 12 130 Cong. Rec. 812385 (daily ed. September 28, Nr eee 12 130 Cong. Rec. 812389 (daily ad. September 28, c ee ee 12 130 Cong. Rec. 812392 (daily ed. September 28, . 12 41 Fed. Reg. 29559 (1976)))0ũm0c 2-2 eeeneeeeeee ee 22 41 Fed. Reg. 29567 (1976) 22 48 Fed. Reg. 9630 (1983 10 49 Fed. Reg. 1631 (1984))))))))))))))))):ꝛ 3, 16, 21 49 Fed. Reg. 1632 (1984)))))))) 20 49 Fed. Reg. 1634 (19847) ⸗ꝓ 20 49 Fed. Reg. 1646-1649 (1984hahr;::: 29 49 Fed. Reg. 1649 (1984) 220. 27 49 Fed. Reg. 1653 (1984) 16 50 Fed. Reg. 14878 (April 15, 1985)... 3 50 Fed. Reg. 14879 (April 15, 1985) 13, 24 50 Fed. Reg. 14879-80 (April 15, 19850) 25 50 Fed. Reg. 14880 (April 15, 198857 3. 15, 25 50 Fed. Reg. 14881 (April 15, 19850) 25 50 Fed. Reg. 14883 (April 15, 19850) 24, 26 50 Fed. Reg. 14884 (April 15, 19885) 26 50 Fed. Reg. 14885 (April 15, 1988) 25 50 Fed. Reg. 14886-87 (April 15, 1985) 27 50 Fed. Reg. 14887 (April 15, 1985) 7, 28 MISCELLANEOUS American Academy of Pediatrics, Guidelines for Infant Bioethics Committees (198) 7 American Medical Association, Current Opinions of the Judicial Council (1984)... 4 viii TABLE OF AUTHORITIES—Continued Page American Medical Association, Judicial Council Report, Guidelines for Ethics Committees in Health Care Institutions, 253 J.A.M.A. 2698 RL TAT A IRE A ee EEO 7 Besharov, The Legal Aspects of Reporting Known and Suspected Child Abuse and Neglect, 23 Vill. r 4 Cohen, S., & Sussman, A., Reporting Child Abuse , 4 Holder, A., Medical Malpractice Law (1975) 4 Louisell, D. & Williams, H., Medical Malpractice rr 4 Lyon, J., Playing God in the Nursery (1985) 28 Nelson, W., Textbook of Pediatrics (R. McKay & r,, ̃ ˙a—AA—A—A 5 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Be- havioral Research, Deciding to Forego Life Sustaining Treatment (1983) .......................... 6-7, 26-27 Prosser and Keeton on the Law of Torts (W. a iclisiimennen 15 Rudolph, A., Pediatrics (17th ed. 1983) 5 Shapiro & Rosenberg, The Effect of Federal Reg- ulations Regarding Handicapped Newborns: A Case Report, 252 J.A.M.A. 2031 (19843) 29 Stinson, R., & Stinson, P., The Long Dying of DD iiitieaies 5 Strain, The American Academy of Pediatrics Comments on the “Baby Doe II” Regulations, 309 New Eng. J. Med. 443 (1983) IN THE Supreme Court of the United States OCTOBER TERM, 1984 No. 84-1529 MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES, . Petitioner, AMERICAN HOSPITAL ASSOCIATION, et al., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Second Circuit BRIEF OF THE RESPONDENTS AMERICAN MEDICAL ASSOCIATION, ET AL., IN OPPOSITION The American Medical Association (“AMA”), the American College of Obstetricians and Gynecologists, the Association of American Medical Colleges, the American Academy of Family Physicians, the Hospital Association of New York State, the American Hospital Association and certain individual physicians (“respondents AMA et al.“) oppose the petition for a writ of certiorari filed by Margaret M. Heckler (“the Secretary“), the Secretary of Health and Human Services (“HHS”). The Secretary seeks review of a decision by tlie United States Court of Appeals for the Second Circuit invalidat- ing a regulation issued by the Secretary pursuant to Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. § 794 (“the 504 Regulation”) (Pet. App. 53a-58a), which authorizes direct federal investigation and regulation of individual treatment decisions made by parents on behalf of their severely impaired children in consultation with 2 the physician of their choice. The regulation also places “independent federal dut[ies]” on hospitals and other pro- viders of health services with regard “to the treatment” of severely impaired infants. Pet. 27 n.22 (emphasis sup- plied). Review by this Court is not warranted. First, Section 504 clearly does not authorize direct federal investigation of individual treatment decisions involving impaired new- borns—a federal role that would unnecessarily duplicate and inevitably subvert the states’ traditional responsibili- ties for regulating individual parent-child and doctor- patient relationships. Second, the federal interest with respect to treatment of impaired newborns is reflected not in the 504 Regulation promulgated solely by the Secre- tary but in the 1984 Child Abuse Amendments, Pub. L. No. 98-457, 98 Stat. 1749 (1984), enacted by the Con- gress last fall after the 504 Regulation had been invali- dated. This new legislation uses a state grant program and state agencies to address federal concerns and ex- pressly repudiates a direct federal regulatory role and creation of a federal bureaucracy to enforce the federal “504 malpractice’ standards which are inherent in the Secretary’s voided approach. STATEMENT The Secretary’s statement of the case (Pet. 2-11) is profoundly mislea ling because it fails to describe ade- quately or ignores completely the following crucial dimen- sions of the problem of proper care for impaired new- borns: the historic state law framework which regu- lates parent-child and physician-patient relationships; the complex medical and ethical issues raised by treatment decisions for impaired newborns; the growth of volun- tarily-created, hospital-based infant care review commit- tees which provide a non-governmental response to the difficult issues that arise in this area; the facts of United States v. University Hospital, 729 F.2d 144 (2d Cir. 1984) (Pet. App. 4a-47a), which demonstrate fully how overbearing, intrusive and unnecessary is the federal gov- 3 ernment’s attempt under Section 504 to regulate individ- ual treatment decisions directly; and the Congress’ ex- plicit decision in the 1984 Child Abuse Amendments to reject, on policy grounds, the direct federal investigatory and regulatory role advanced by the Secretary here. (1) The State Law Framework. The public dialogue about appropriate medical treatment of severely impaired newborn infants takes place within an historic state law framework which cedes to parents the ultimate respon- sibility for making decisions about treatment of their seriously ill children. 50 Fed. Reg. 14880 (April 15, 1985). Parental treatment decisions on behalf of their children are controlling, except in the most extreme cases when state courts have determined that a decision not to authorize treatment constitutes “medical neglect” of chil- dren by their parents. Id. All fifty states have child protective service agencies which are generally responsible for investigating reports of child abuse and neglect by parents (including “medical neglect”), counseling families and, where necessary, in- stituting court actions to remove the parent as decision maker for the child. Jd. at 14878. Moreover, most hos- pitals have established procedures for working with the state child protective service agencies and seeking state court orders directing that appropriate medical treatment be given to an infant when the parents are clearly not acting in the best interest of the child. See 49 Fed. Reg. 1631 (1984). State law also has historically governed the relation- ship between patients and physicians.? Unless parents This Court already has recognized the primacy of the parents’ role in making difficult treatment decisions for their children. See Parham v. J.R., 442 U.S. 584, 602 (1979) (historically law has recognized that natural bonds of affection lead parents to act in the best interests of their children). 2 See Barsky v. Board of Regents, 347 U.S. 442 (1954); Linder v. United States, 268 U.S. 5 (1925); Dent v. West Virginia, 129 U.S. 114 (1889). 1 consent to treatment, a physician commits battery if he or she operates on a minor. See note 16, infra. All states have mandatory reporting statutes which require physi- cians (and other health care professionals) to inform the state child protective service agency of known or sus- pected instances of medical neglect by parents.“ More- over, once a physician has been engaged by a patient (or by a parent on behalf of a minor patient) and consent to treatment has been given, then under state statutory or common law the physician has a legal duty to provide appropriate medical care until the doctor-patient rela- tionship is terminated by giving the patient due notice and the opportunity to obtain other medical care. If the physician withdraws before these conditions are satisfied, then he or she is liable for damages under the doctrine of patient abandonment.* The Secretary attempts to mislead this Court by vaguely citing to the “Baby Doe of Indiana” case (“Bloomington Baby Doe“) to illustrate the problem“ with the historic state law framework which, in her view, justifies a direct federal role. Pet. 2-3, 20. But, as dis- cussed infra, pp. 27-28, both private health care providers See generally S. Cohen & A. Sussman, Reporting Child Abuse and Neglect (1975); Besharov, The Legal Aspects of Reporting Known and Suspected Child Abuse and Neglect, 25 Vill. L. Rev. 458 (1977-1978). 4 See 1 D. Louisell & H. Williams, Medical Malpractice . 4.12, 8.08 (Rev. ed. 1984); A. Holder, Medical Malpractice Law 374-393 (1975). Widely accepted principles of medical ethics impose a similar duty on physicians to continue necessary treatment until the physician-patient relationship has been properly terminated in a manner which allows engagement of another physician. AMA, Current Opinions of the Judicial Council § 8.10 (1984). In addition, medical licensing statutes in many states provide for the revocation or suspension of a physician’s license, or other disciplinary action, upon a finding, inter alia, that the physician has abandonea his or her patient by refusing to provide needed treatment. See, e.g., Cal. Bus. & Prof. Code § 2234 (West 1985 Supp.) ; III. Ann. Stat. ch. 111, § 4433 (Smith-Hurd 1984-85 Supp.) ; N.Y. Educ. Law § 6509 (McKinney’s 1984 Supp.). 5 and state executive branch officials sought judicial review of the parental treatment decision in that case. Two dif- ferent state court judges refused to overturn the parents’ treatment choice, and those state judicial decisions are clearly not subject to federal regulation under Section 504. The actions of health care providers and state offi- cials in taking a rare case of questionable parental deci- sionmaking to state court shows that state laws and in- stitutions are working. (2) Medical and Ethical Context: The Growth of In- fant Care Review Committees. The question of what sort of medical treatment, if any, should be given to severely impaired newborn infants is “one of the most difficult and sensitive medical and ethical problems facing our society.” American Academy of Pediatrics v. Heckler, 561 F. Supp. 395, 396 (D.D.C. 1983) (Gesell, J.). The birth of such an infant is often an unexpected and trau- matic event for parents, who are confronted with the necessity of making difficult life or death treatment deci- sions with little advance warning. See R. Stinson & P. Stinson, The Long Dying of Baby Andrew (1983). The difficulties for parents become acute when a particular condition is so serious that severe disability will remain even after treatment of that condition or when an infant has multiple impairments, one that is correctable and one, like anencephaly (entire or substantial absence of a brain), which will have an enormous, adverse impact on the child. In some cases involving impaired newborn infants, physicians can predict with a relative degree of confi- dence that a particular course of treatment is likely to be beneficial or futile.“ But there is a significant area of 5 See generally A. Rudolph, Pediatrics (17th ed. 1983); W. Nel- son, Textbook of Pediatrics (R. McKay & V. Vaughan ed. 1975). ® See Affidavit of Peter A.M. Auld, M.D., professor of Pediatrics and Obstetrics and Perinatal Medicine at Cornell University Medi- cal College, . 2. Plaintiffs-respondents AMA et al. submitted affi- 6 uncertainty in which the results and consequences of a given course of treatment are simply unpredictable and the selection of an appropriate course of treatment be- comes commensurately more difficult. As the President’s Commission for the Study of Ethical Problems in Medi- cine and Biomedical and Behavioral Research stated in its recent report, Deciding to Forego Life-Sustaining Treat- ment 220 (1983) [President's Commission Report“ ]: Much of the difficulty in these [ambiguous] cases arises from factual uncertainty. For the many in- fants born prematurely, and sometimes for those with serious congenital defects, the only certainty is that without intensive care they are unlikely to sur- vive; very little is known about how each individual will fare with treatment. Neonatology is too new a field to allow accurate predictions of which babies will survive and of the complications, handicaps, and potentials that the survivors might have. (Footnote omitted. ) Recent advances in neonatal medicine have also exacer- bated the uncertainty in treatment decisions. As the President’s Commission Report explained (at p. 198): [Mledieine's increased ability to forestall death in seriously ill newborns has magnified the already difficult task of physicians and parents who must attempt to assess which infants will benefit from various medical interventions, and which will not. Not only does this test the limits of medical cer- tainty in diagnosis and prognosis, it also raises pro- found ethical issues. To address the difficult ethical issues which can be raised by the birth of a severely impaired child, the President’s Commission Report (at p. 225-228) repudi- davits and other evidentiary material in support of their motion for summary judgment in this case. In her defense, the Secretary did not submit any testimonial evidence on medical issues. Cita- tions to affidavits in this opposition thus refer to the uncontested testimony submitted to the District Court by the AMA et al. 7 ated an increased federal role like the one advanced by the Secretary in the 504 Regulation and, instead, recom- mended the voluntary formation of infant care review committees. Medical associations have also advocated the formation of such committees.’ These committees deal directly with the fundamental problem in this sensitive area: lack of information and perspective by the parents who must r ke decisions for their severely impaired infant. Presu.ent’s Commission Report at 227. Such com- mittees are comprised of health professionals and, often, of individuals trained in other specialties such as religion, social work, ethics and law. The committees offer parents information, counseling and, where appropriate, review of proposed treatment decisions made in consultation with the attending physician. At present, many hospitals with intensive care units for neonates have some form of spe- cial review process for these difficult cases, and the number of infant care review committees is growing rapidly. 50 Fed. Reg. 14887 (April 15, 1985). (3) The Voided 504 Regulation. Instead of following the recommendation of the President’s Commission Re- port, the Secretary adopted the approach invalidated be- low which injects the federal government directly into individual treatment decisions. The 504 Regulation con- tains four mandatory provisions which were declared un- lawful and enjoined in this case.“ (i) The regulation re- 7 See President's Commission Report at 227-228; AMA, Judicial Council Report, Guidelines for Ethics Committees in Health Care Institutions, 253 J.A.M.A. 2698 (1985); American Academy of Pediatrics, Guidelines for Infant Bioethics Committees (1984). See 45 C. F. R. $§ 84.55(b)-(e). (Pet. App. 54a-58a.) The 504 Regulation also contains several non-mandatory provisions which were not challenged in this case. First, the regulation encourages, but does not require, health care providers to establish infant care review committees and sets forth a model rule for the establish- ment of such committees. 45 C. F. R. §§ 84.55 (a), (f). (Pet. App. 53a-54a, 58a-62a.) Second, an Appendix to the regulation contains “interpretative guidelines” illustrating how the rule might apply to 8 quires recipient hospitals to post a notice, where health care professionals will see it, which states, in part, that discriminatory failure to provide “medically beneficial” treatment to an impaired newborn violates Section 504. The phrase “medically beneficial treatment” is not de- fined in the required notice. The notice must include the telephone number of a 24-hour a day hotline where any person may call federal officials to report suspected viola- tions, even if such reports are based on nothing more than rumor. 45 C.F.R. § 84.55(b). (Pet. App. 54a.) (ii) The 504 Regulation provides that recipient state child protective service agencies must establish and main- tain in written form “methods of administration and procedures to assure that the agency utilizes its full au- thority pursuant to state law to prevent instances of un- lawful medical neglect of handicapped infants.” 45 C.F.R. § 84.55(c) (emphasis supplied). (Pet. App. 56a.) These “methods and procedures” include a federal requirement that physicians and other health care providers must re- port on a timely basis to the state agency “circumstances which they determine to constitute known or suspected instances of unlawful medical neglect of handicapped in- fants.” Id. (emphasis supplied). (iii) The 504 Regulation grants HHS expedited access to pertinent medical records and facilities and authorizes expedited investigations whenever HHS determines that immediate action is necessary to protect the life or health of an infant. 45 C.F.R. § 84.55(d). (Pet. App. 58a.) (iv) The 504 Regulation also authorizes expedited ac- tion by HHS against federal fund recipients to effect compliance with Section 504, including court action. 45 C.F.R. § 84.55(e). (Pet. App. 58a.) particular treatment situations. 45 C.F.R. § 84.55, Appendix C, (a). (Pet. App. 66a-68a.) Finally, the Appendix sets forth in- terpretative guidelines” for the conduct of HHS investigations. 45 C. F. R. § 84.55, Appendix C, f (b). (Pet. App. 68a-72a.) 9 (4) The Decisions Below. The actions of the Secretary in University Hospital—which are conspicuously absent from her description of that case (Pet. 8-9)—perfectly illustrate the intrusive and unnecessary role of the fed- eral government in second-guessing parents and state authorities under Section 504. After Baby Jane Doe was born with multiple birth defects on October 11, 1983, her parents decided not to authorize certain surgery following consultation with “several physicians, nurses, religious advisors, a social worker, and members of their family.” (Pet. App. 6a.) A third party, unrelated to Baby Jane Doe, filed suit in New York State court seeking appoint- ment of a guardian ad litem and an order directing that the surgery be performed. The trial court granted this request, but was immediately overruled by the Ap- pellate Division, which determined that the parents’ deci- sion was in the best interests of the child. (Pet. App. 7a.) The New York Court of Appeals affirmed. (Pet. App. 7a-8a.) While the state court proceedings were still in prog- ress, the federal government, which had received a 504 complaint from an unidentified citizen, referred the mat- ter to the New York State child protective service agency. That agency concluded on November 7, 1983 that there was no cause for state intervention against the parents. (Pet. App. 8a.) Without waiting for the state agency to make its determination, HHS in late October began its own direct Section 504 investigation. University Hos- pital declined to give Baby Jane Doe’s medical records to HHS, based in part on the parents’ refusal to release them. On November 2, 1983, before the state child pro- tective service agency had reached a decision, HHS brought an action under Section 504 in federal court seeking access to the records. The Department then per- sisted in its suit even after the state agency concluded that no state intervention was warranted under New York’s child neglect statute. (Pet. App. 8a-10a.) To protect their interests, Baby Jane Doe’s parents were forced to intervene. 10 Baby Jane Doe’s parents were thus required to defend not only a state court action and a state child protective service agency inquiry but a separate and independent federal lawsuit instituted by the United States. This harassing federal action exposed the parents to continued, unwanted publicity and imposed on them over $75,000 in additional legal fees. See 130 Cong. Rec. $8017 (daily ed. June 21, 1984). The District Court entered summary judgment for University Hospital and the parents. (Pet. App. lla.) On February 23, 1984, the Court of Appeals affirmed, rejecting the Department’s claim of authority to investigate Baby Jane Doe’s parents and University Hos- pital. The Court of Appeals held that Section 504 does not “apply to treatment decisions involving defective newborn infants.” (Pet. App. 40a.) The Secretary did not petition this Court for review of the Court of Ap- peals’ decision in University Hospital. The final 504 Regulation at issue in this proceeding was promulgated by the Secretary on January 12, 1984, while the University Hospital case was pending before the Court of Appeals.“ After publication of this final 504 Regulation and after the Court of Appeals decision in University Hospital, the AMA et al. filed this action on March 12, 1984, in the District Court for the Southern District of New Vork.“ On May 23, 1984, the District Court issued a memorandum and order which held that, The Secretary’s investigation and initiation of court action in University Hospital were undertaken in the fall of 1983 pursuant to her general authority under Section 504 but in the absence of a specific implementing regulation. The final 504 Regulation was not adopted until January 12, 1984, after the University Hospital case had been briefed, argued and submitted to the Court of Appeals for decision. 10 On the same day, the American Hospital Association, the Hos- pital Association of New York State and Strong Memorial Hospital, which had previously filed an action in the same court challenging the validity of the Secretary’s March 7, 1983 interim rule (48 Fed. Reg. 9630 (1983)) amended their complaint to state a claim chal- lenging the lawfulness of the final 504 Regulation. 11 under authority of University Hospital, the 504 Regula- tion was invalid because the Secretary “has no authority under Section 504 to investigate or to otherwise regulate treatment decisions involving impaired newborn infants.” (Pet. App. 51a.) The Court of Appeals, also relying on the controlling effect of University Hospital, affirmed in a two paragraph order. (Pet. App. 2a.) (5) The Child Abuse Amendments of 1984. After holding that neither the express language nor the legisla- tive history of Section 504 authorized the direct federal intrusion into historic state functions contemplated by the Secretary, the Court of Appeals concluded its opinion in University Hospital by noting (Pet. App. 40a-41a) that: it is congress, rather than an executive agency, that must weigh the competing interests at stake in this context in the first instance. Until congress has spoken, it would be an unwarranted exercise of judi- cial power to approve the type of investigation that has precipitated this lawsuit. Following the invalidation of the 504 Regulation in this case, the Congress last year undertook just such an ex- amination. It chose not to revive the direct federal in- vestigatory and regulatory role advanced by the Secre- tary and voided by the courts. Instead, the Congress in the fall of 1984 enacted the Child Abuse Amendments of 1984, Pub. L. No. 98-457, 98 Stat. 1749 (1984), amending the Child Abuse Prevention and Treatment Act, 42 U.S.C. §§ 5101 et seg. In con- trast to Section 504, the Child Abuse Prevention and Treatment Act is a state grant program which seeks to help state child protective service agencies discharge their responsibilities with respect to abused and neglected children in the context of severely impaired newborn in- fants." As a principal sponsor of the 1984 Child Abuse 11 The 1984 Child Abuse Amendments contemplate grants to state child protective service agencies conditioned on incorporation of 12 Amendments stated in a crucial piece of the legislative history: Throughout the statutory language and accompany- ing explanatory material, we refer to authority un- der state law as the mechanism for pursuing legal remedies under our amendment. This legislation does not itself authorize direct federal involvement in individual cases. (Emphasis supplied.) The Congress recognized that in enacting the 1984 Amendments, it was, for the first time, expressly ad- dressing the difficult issues arising out of treatment of impaired newborns. In floor debates on the Conference Report, Representative Bartlett stated that “these Baby Doe provisions are precedent setting. They represent the first time that we have successfully legislated in a very sensitive area.” 130 Cong. Rec. H10329 (daily ed. Sep- tember 26, 1984) (emphasis supplied).’* Moreover, in certain changes in state law and procedure consistent with the provisions of the Amendments. A definition of child neglect in the circumstance of withholding treatment from a severely dis- abled child is set forth; states must adopt certain reporting and other procedures; and the direct federal role is iimited to training and a clearinghouse function for information relating to develop- ments in treatment and support services for impaired newborns. See H.R. Conf. Rep. No. 1038, 98th Cong., 2nd Sess. (1984). See also 130 Cong. Rec. H10327 (daily ed. September 26, 1984); 130 Cong. Rec. $12382 (daily ed. September 28, 1984) (conference report debates on floor of House and Senate). 12 Letter from Senator Hatch to Senator Weicker, 130 Cong. Rec. 812392 (daily ed. September 28, 1984). See also Pet. 27 (no direct federal role in individual cases is authorized). 18 Representative Erlenborn noted that the “disabled infants pro- visions incorporated in the conference report address a myriad of difficult social and ethical issues. The conference agreement is the product of months of painstaking deliberations.” Jd. at H10333. Senators also explained how the Amendments embodied a new ap- preach and an attempt to craft specific provisions to meet difficult problems. See, e.g., 130 Cong. Rec. 812382-83, 812385, 812389 (daily ed. Sept. 28, 1984) (remarks of Senators Hatch, Dodd and Cranston). 13 the preamble to the final regulation implementing the 1984 Child Abuse Amendments (“1984 Child Abuse Reg- ulation”), the Secretary noted the special and explicit Congressional effort to deal with the complex problems in this sensitive area (50 Fed. Reg. 14879 (April i5, 1985) ) : [T)his legislation [the 1984 Child Abuse Amend- ments] was the product of an extraordinary effort on the part of several Senators and Congressmen and representatives of a wide range of medical, right-to- life and disability organizations to forge a substan- tial consensus on an effective and workable program to assure the provision of appropriate medical care to disabled infants... . It is clear that the legislation represented a careful balance between the need to establish effective pro- tection of the rights of disabled infants and the need to avoid unreasonable governmental intervention into the practice of medicine and parental responsibilities. (Emphasis supplied. ) REASONS FOR DENYING THE PETITION In contrast to the 1984 Child Abuse Amendments en- acted by the Congress, the 504 Regulation promulgated solely by the Secretary reflects neither clear congressional authorization nor a careful balancing of the relevant in- terests. Accordingly, this case does not warrant plenary review by this Court. First, the Secretary’s attempt to investigate and regu- late individual treatment decisions involving impaired newborns is clearly not authorized by the language of Section 504. Parents are not recipients of feder: finan- cial assistance” and their treatment decisions on behalf of their infants may not be regulated under Section 504. Similarly, the independent state law duties regarding parental neglect imposed on health care providers are not part of any federally funded “program or activity,” and providers’ decisions whether to report or prosecute par- 14 ents for medical neglect are similarly outside the scope of Section 504. Moreover, the Congress clearly did not intend to subvert the historic state law framework for regulating parent-child and doctor-patient relationships and create a body of “504 malpractice law for determin- ing, according to federal standards, the reasonableness of individual treatment decisions. Second, there is no substantial federal interest in the voided regulations because, inter alia, the Secretary has shown no problem with the historic state law framework that justifies a direct federal role, and the Congress has explicitly and recently adopted an alternative state-based approach in the 1984 Child Abuse Amendments. I. THE DECISION BELOW WAS CLEARLY COR- RECT: SECTION 504 DOES NOT AUTHORIZE DIRECT FEDERAL INVESTIGATION AND REGU- LATION OF INDIVIDUAL TREATMENT DECI- SIONS INVOLVING IMPAIRED NEWBORNS. With respect to “treatment” of impaired newborns, there are three types of decisions which the Secretary’s petition seems to suggest are within the scope of Section 504: the decision by parents whether or not to consent to treatment for their child (Pet. 6); the decision by a health care provider whether or not to, report to state agencies, or seek state court action against, a parent on grounds of medical neglect (id.); and the decision by a physician or hospital whether or not to treat an infant if the parents have consented to treatment (id. at 11-12, 19-20). But, despite the Secretary’s studied vague- ness as to what conduct by whom actually violates Section 504, the Congress clearly intended that none of these types of decisions should be directly regulated by HHS under authority of that provision. 14 Section 504 provides, in pertinent part: “No otherwise quali- fied handicapped individual in the United States . . shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial Assistance... .” 29 U.S.C. § 794. K 15 A. Treatment Decisions by Parents on Behalf of Their Impaired Newborn Infants Are Not Within the Scope of Section 504. Although the Secretary withholds this fact from the Court, she has conceded elsewhere that, absent state court action, parents are the sole decisionmakers for their infant children and that parental treatment decisions on behalf of impaired newborns are not within the scope of Section 504 because parents are not recipients of “federal financial assistance.” As noted, parents have the ultimate responsibility for making decisions about the treatment of seriously ill new- borns.““ As the Secretary recently stated in the preamble to the Child Abuse Regulation, The decision to provide or withhold medically indi- cated treatment is, except in highly unusual circum- stances, made by the parents or legal guardian. Par- ents are the decision makers concerning treatment for their disabled infant, based on the advice and reasonable medical judgment of their physician (or physicians). (Emphasis supplied.) 50 Fed. Reg. 14880 (April 15, 1985). Indeed, physicians, nurses and hospitals have no authority to perform treat- ment on newborn infants to which parents have not con- sented on behalf of their child.“ 15 State law has always recognized the parents’ inherent right to make medical decisions on behalf of their minor children. See, e. g., Bennett v. Jeffreys, 40 N.Y.2d 548, 356 N.E.2d 277 (1976); In re Hudson, 13 Wash. 2d 673, 126 P.2d 765 (Wash. 1942). Parental autonomy to make decisions for their children is also protected under the Constitution. See, e.g., Wisconsin v. Yoder, 406 U.S. 205 (1972) ; Meyer v. Nebraska, 262 U.S. 390 (1928) ; Pierce v. Society of Sisters, 268 U.S. 510 (1925). 16 A physician or hospital is guilty of assault and battery if surgery is performed on an infant without parental consent. See Prosser and Keeton on the Law of Torts § 18, at 116 (W. Keeton ed. 1984). See also Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). 16 After conceding that, absent a court order, only par- ents can make treatment decisions for their infant chil- dren, the Secretary then makes the further, devastating concession that parental decisionmaking is outside the scope of Section 504 because parents are not recipients of “federal financial assistance.” In the preamble to the 504 Regulation voided below, the Secretary stated: Section 504 applies only to programs or activities receiving federal financial assistance; it does not apply to decisions made by parents. 49 Fed. Reg. 1631 (1984) (emphasis supplied.) Simi- larly, in the interpretative guidelines to the 504 Regula- tion, the Secretary stated unequivocally: Section 504 and the provisions of this part are not applicable to parents (who are not recipients of Fed- eral financial assistance). Id. at 1653 (emphasis supplied.) (Pet. App. 67a.) Accordingly, the Secretary’s argument (Pet. 12-18) that the terms of Section 504 clearly authorize direct federal investigation and regulation of treatment deci- sions involving impaired newborns is fatally flawed by her own explicit concessions that (a) parents, not health care providers, make treatment decisions on behalf of newborn infants, and (b) parents are not federal fund recipients and, thus, not within the scope of Section 504. Indeed, these concessions, made after briefing and argu- ment in University Hospital, completely invalidate her own actions in that case, because there HHS was attempt- ing to investigate and regulate directly decisions by Baby Jane Doe’s parents.“ See pp. 9-10, supra.“ 17 Given the decision of the state child protective service agency not to proceed against Baby Jane Doe's parents (Pet. App. 8a), the Secretary could hardly have been arguing in University Hos- pital that she needed to investigate whether the physicians or hospital had failed to report alleged parental neglect to state authorities. 18In light of the Secretary’s own explicit concessions about the inapplicability of a federal law triggered by receipt of federal 17 B. Decisions by Health Care Providers on Whether or Not to Report Suspected or Known Instances of Parental Medical Neglect to State Authorities Are Not Within the Scope of Section 504. Given her fatal recognition in the 504 Regulation that the federal government has no authority under Section 504 to regulate parental treatment decisions, the Secre- tary attempts in the Regulation to do indirectly what she has conceded she cannot do directly. Section 84.55(c) of the Regulation (Pet. App. 57a) requires that health care providers report on a timely basis to the state agency circumstances which they deter- mine to constitute known or suspected instances of unlawful medical neglect [by parents] of handi- capped infants. (Emphasis supplied.) Similarly, the interpretative guidelines to the 504 Regula- tion state (Pet. App. 67a) : Whenever parents make a decision to withhold con- sent for a medically beneficial treatment or nourish- ment, . . providers [who receive federal financial assistance] may not, solely on the basis of the in- fant’s present or anticipated future mental or physi- cal impairments, fail to follow applicable [state] pro- cedures on reporting such incidents to the state child protective services agency or to seek judicial review [in state court]. See also Pet. 24-25. In other words, under putative authority of Section 504, the Secretary intends to investi- gate in individual cases whether health care providers funds to parental treatment decisions, Judge Winter's statement in his University Hospital dissent—that “denial of medical treat- ment to an infant because the infant is black is not legitimated by parental consent“ —is clearly in error. (Pet. App. 44a.) Regard- less of the race, color or creed of an infant, health care providers have no authority to operate on a child without parental consent or without a court order removing the parent as decision maker for the child, and neither Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., nor Section 504 alters this fundamental rule. 18 are discharging their mandatory statutory duties under state child neglect laws to report parents to state agencies or sue parents in state courts. See p. 8, supra. But this contorted position, invalidated below, does not war- rant review by this Court. First, health care providers’ decisions whether to report or prosecute parents under state child negiect laws are clearly outside the express terms of Section 504 because those decisions are not part of a “program or activity” receiving “federal financial assistance.” The Secretary makes no showing either in her petition (see p. 15 n. 12) or in the preamble to the 504 Regulation that health care providers’ independent, mandatory duties under state child neglect statutes are part of Medicaid, 42 U.S.C. § 1395 et seqg., Medicare, 42 U.S.C. § 1396 et seq., Hill- Burton, 42 U.S.C. § 291 et seqg., or any other federally funded “program or activity.” And she can make no such showing. Independent state law duties of health care providers are simply not part of a federal “program or activity” and therefore may not be regulated by the Secretary under Section 504. Cf. Grove City College v. Bell, 104 S. Ct. 1211 (1984) (construing narrowly pro- gram or activity” language of Title IX of the Education Amendments of 1972, 20 U.S.C. § 1681 (a)). Second, nothing in the legislative history of Section 504 suggests that it was intended to make independent state- law duties a part of a fund recipient’s federally financed “program or activity.” The essence of Section 504 is to prevent recipients of federal funds—in this case federal health care funds—from denying otherwise qualified handicapped individuals “access” to the programs in which the recipient receives such funds. Alexander v. Choate, 105 S. Ct. 712, 721 (1985). See also S. Rep. No. 1135, 92nd Cong., 2d Sess. 49 (1972). Here, by contrast, the Secretary is trying to force health care providers to provide severely impaired infants “access” to state ad- ministrative or judicial processes so that these infants may have their parents’ fitness determined by state agen- 19 cies or state courts under state “medical neglect” stand- ards. Nothing in Section 504, or its legislative history, suggests the provision was intended to provide such access to state administrative or judicial processes for determi- nations under state law standards. Indeed, the Secretary does not—and cannot—cite a single shred of legislative history or a single judicial precedent contemplating or authorizing such a contorted use of Section 504, a federal civil rights statute, to enforce independent state law duties of federal fund recipients. See Pet. 18-21 (discus- sion of legislative history). Third, while conceding that she cannot directly investi- gate or regulate parental treatment decisions, the Secre- tary—by trying to oversee the state law duties of health care providers to refer parental neglect to state agencies or courts—is indirectly using federal power to force others to review and possibly supplant the exercise of parental authority. This she simply may not do under the well-established principle that federal departments and agencies may not do indirectly what they are forbid- den by statute from doing directly. See, e.g., Sunray Mid-Continent Oil Co. v. FPC, 364 U.S. 137, 151-152 (1960). The Secretary cannot regulate parental decisions under Section 504, and she cannot force health care pro- viders to do it for her. Fourth, as discussed in the next section, Congress did not intend when it enacted Section 504 to authorize the creation of a body of “504 malprac- tice law“ for determining whether a health care provid- er’s decision not to report parents to state child neglect authorities in individual cases was a “reasonable medical judgment” or “unreasonable discrimination” under Sec- tion 504.“ 10 The decision whether or not to report parents for alleged medical negiect is much more complicated and much more inter- twined with medical practice in cases involving impaired newborns than in cases involving denial of treatment by parents on religious grounds. See Pet. 20, 25. In the latter case, the effects of medical treatment are crystal clear and the only bar is the religious convictions of the parents. In cases involving impaired newborns, parental decisions not to treat and providers’ decisions not to re- 20 C. Providers’ Treatment Decisions In Individual Cases Are Not Within the Scope of Section 504. The Secretary also maintains that “not every decision by a hospital that happens to relate to the furnishing of medical treatment is perforce a bona fide medical judg- ment. Pet. 19. In other words, the Secretary asserts her power, under Section 504, to use officials in HHS's Office for Civil Rights, who may not even have the advice of medical consultants, to investigate and deter- mine whether a provider’s decision not to treat in an individual case, if parental consent is given, constitutes a “reasonable medical judgment.” See 49 Fed. Reg. 1632, 1634 (1984) (504 to be applied in this context on “case- by-case” basis but no commitment to use medical consult- ants). But, this position is not worthy of review by this Court for several related reasons. First, the fundamental problem with the Secretary’s position is that it is based on a situation that has not occurred and will not occur—in real life. As we already have explained, parents, not physicians and other pro- viders, have sole legal authority to decide whether or not a child receives medical treatment. For the Secretary’s hypothetical to occur, parents, in consultation with their child’s physician, would have to authorize treatment for the impaired infant and the physician or hospital would then have to refuse to provide it to an “otherwise quali- fied” child on the basis of the child’s handicap alone. Such a sequence of events is implausible on its face. Not surprisingly, the Secretary cites no case where this has occurred.” In fact, nothing in its regulatory history port such parents are based on much more complicated medical determinations about the prognosis for the child even after treat- ment. See pp. 5-6, supra. 20 As the Court of Appeals noted in University Hospital, “Baby Jane Doe has been treated in an evenharded manner at least to the extent that the hospital has always been and remains willing to perform the dual, corrective surgeries if her parents would consent.” (Pet. App. 39a.) See also pp. 27-28, infra (“Baby Doe of 21 suggests that the purpose of the voided 504 Regulation was intended to deal with this type of situation. See Pet. App. 66a-77a. Instead, the interpretative guidelines to the 504 Regulation make clear that it is aimed at par- ental “neglect” and the duty of health care providers to report such alleged “neglect.” See also Pet. 24 (Secre- tary’s efforts aimed at parental withholding of consent) ; 49 Fed. Reg. 1631 (1984) (same). Thus, the Secretary does not need the extensive regulatory regime she has created through this Regulation, which is designed to deal with known or suspected cases of parental “neglect,” in order to respond instead to the nonexistent problem of physicians who refuse to treat handicapped infants after parental consent is given. Second, when it enacted Section 504, the Congress clearly did not authorize creation of a body of “504 fed- eral malpractice” law. But that is precisely what will occur under the Secretary’s approach if HHS civil rights officials attempt to determine whether a provider’s deci- sion constituted a “reasonable medical judgment” or “ynreasonable discrimination” under Section 504. The Secretary’s glib statements that this distinction is easy to draw (Pet. 14-15, 20) and that Congress intended such line drawing are simply wrong. As the Court of Appeals stated concisely (Pet. App. 30a-31a) : ... in arguing that Baby Jane may have been sub- jected to discrimination” the government has taken an oversimplified view of the medical decision-making process. Where the handicapping condition is re- lated to the condition(s) to be treated, it will rarely, if ever, be possible to say with certainty that a par- ticular decision was “discriminatory”. It is at this point that the analogy to race, relied on so heavily by the dissent, breaks down. Beyond the fact that no two cases are likely to be the same, it would in- variably require lengthy litigation primarily involv- ing conflicting expert testimony to determine whether Indiana” case relied upon by Secretary did not involve physician refusal to treat). 22 a decision [by a physician] to treat, or not to treat, . . . was based on a “bona fide medical judgment“, however that phrase might be defined. Before ruling that congress intended to spawn this type of litiga- tion under section 504, we would want more proof than is apparent from the face of the statute. (Em- phasis supplied.) The Court of Appeals’ succinct discussion of the legisla- tive history of Section 504 indicates clearly that Congress did not intend HHS to determine when a physician’s refusal to treat was reasonable or unreasonable—a ques- tion closely akin to the one asked in medical malpractice cases brought under state law. (Pet. App. 31a-35a.) Indeed, the Secretary does not cite a single passage from the legislative history indicating that Congress con- templated such an inquiry in individual medical cases by HHS officials. And, although numerous decided cases have interpreted Section 504 in the context of “health care“ programs or activities, not one,“ however, author- 21 See American Academy of Pediatrics v. Heckler, 561 F. Supp. 395, 401 (D.D.C. 1983) (“no congressional committee or member of the House or Senate ever even suggested that section 504 would be used to monitor medical treatment of defective newborn infants or establish standards for preserving a particular quality of life“). 22 The regulatory history of Section 504, as the Court of Appeals in University Hospital recognized (Pet. App. 18a-20a), also refutes the Secretary’s position. The original 504 regulations clearly re- jected any individualized, federal right to treatment. 41 Fed. Reg. 29559 (1976). The references in the general Section 504 regulations to “health services,” see Pet. 22, reflect a concern with access to federally funded programs and not authorization of a detailed HHS inquiry into the reasonableness or unreasonableness of a medical decision in the context of a multiply handicapped child. 41 Fed. Reg. 29567 (1976) (health services should be “accessible” and available“). See also Southeastern Community College v. Davis, 442 U.S. 397, 411 (1979) (Secretary’s interpretation of Sec- tion 504 entitled to deference only if it “honors” the language, purpose and history of the statute). 23 Indeed, the Eighth Circuit recently dismissed a Section 504 claim alleging in part that a nursing home had discriminated 23 izes the kind of “504 federal malpractice” determination in individual cases contemplated by the Secretary here. Third, sound principles of statutory construction require rejection of the Secretary’s attempt to regulate health provider decisions in this area. This Court in a long line of decisions has held that “unless the Congress conveys its purpose clearly, it will not be deemed to have significantly changed the federal-state balance” in areas where the states have historically regulated. United States v. Bass, 404 U.S. 336, 349 (1971).% Cf. Penn- hurst State School & Hospital v. Halderman, 451 U.S. 1, 17 (1981). See also Alexander v. Choate, 105 S. Ct. 712, 720 (1985) (importance of interpreting § 504 so as to keep it “within manageable bounds’). As noted above, state licensure, child neglect and other laws require that health care providers report instances of parents’ medical neglect and not refuse to treat their patients unless notice is given and other treatment is available. See p. 4, supra. The Secretary’s attempt to regulate, under Section 504, providers’ decisions whether to treat after parental con- sent demonstrably intrudes on this area of historic state concern without the requisite clear expression of intent against a resident by failing to provide adequate medical care, concluding that “[i]n substance, this is a medical malpractice case” not cognizable under Section 504. Hoyt v. St. Mary’s Re- habilitation Center, 711 F.2d 864, 867 (8th Cir. 1983). The cases that have considered Section 504 claims in the health care field have dealt with such issues as employment, e.g., United States v. Cabrini Medical Center, 639 F.2d 908 (2d Cir. 1981), admission to medical schools and other medical training programs, e. g., Southeastern Community College v. Davis, 442 U.S. 897 (1979), and reduction in medicaid assistance or other federally-supported medical insurance and benefits, e.g., Alexander v. Choate, 105 S. Ct. 712 (1985). 24 See, e.g., Apex Hosiery Co. v. Leader, 310 U.S. 469, 513 (1940) ; FTC v. Bunte Brothers, Inc., 312 U.S. 349, 354-355 (1941). See also United States v. Culbert, 485 U.S. 871, 378 (1978); Heublein, Inc. v. South Carolina Tax Commission, 409 U.S. 275, 281-283 (1972). 24 by the Congress to alter the historic federal-state balance. This regulation is thus outside the scope of her authority. * * * * In sum, Section 504 clearly does not authorize the Sec- retary’s attempt to investigate and regulate directly par- ental decisions concerning treatment of their severely impaired infants, providers’ decisions about whether to refer parents to state authorities for parental neglect determinations or providers’ decisions whether or not to treat if parental consent is given. Because the Court of Appeals reasonably concluded that the Secretary’s regulatory approach is so demonstrably beyond the scope of her authority under Section 504, further review by this Court is not warranted. II. THERE IS NO SUBSTANTIAL FEDERAL INTER- EST IN THE VOIDED REGULATION. The petition should also be denied because there is no substantial federal interest in the voided regulation. A. The 1984 Child Abuse Amendments, Not the Secre- tary’s Intrusive Regulatory Approach, Represent The Federal Interest In This Sensitive Area. In contrast to the challenged regulatory approach adopted solely by the Secretary, the 1984 Child Abuse Amendments, as the Secretary concedes, represented an “extraordinary effort” to develop a consensus on the part of the Congress and constituted a “careful balance“ be- tween protecting severely impaired newborns and avoid- ing “unreasonable governmental intervention” into the practice of medicine and parental responsibilities. 50 Fed. Reg. 14879 (April 15, 1985). In contrast to the Secretary’s intrusive federal regulatory approach, the 1984 Child Abuse Amendments augment existing state child protective services, rather than subverting them with a duplicative and inconsistent federal role. Id. at 14883 (clear intent of Congress that states use existing child protective system to carry out amendments). This con- sidered, balanced and explicit Congressional enactment 25 reflects a clear Congressional intent, on policy grounds, not to follow the Secretary’s regulatory approach in a number of important ways. Unlike the Secretary’s intrusive regulatory approach, the Congress clearly did not want a direct federal role in investigating and regulating individual cases, as the Sec- retary concedes in the 1984 Child Abuse Regulation, id. at 14885: The major difference between the section 504-based approach and that of the Child Abuse Amendments of 1984 is that the former is implemented and en- forced directly by the Federal government, whereas the latter, within the framework of the Child Abuse Prevention and Treatment Act, relies on State im- plementation and enforcement regarding individual instances of child abuse and neglect. ... (Emphasis supplied. ) As the Secretary further concedes, the legislative history of the 1984 Child Abuse Amendments clearly indicates that the Congress did not want a “new system and a new bureaucracy” created at the federal level to deal directly with the issue of treatment for impaired newborns. /d. at 14881. Unlike the Secretary’s intrusive regulatory approach, the Congress also did not want the creation of “federally- prescribed medical standards for approved treatment for specific cases.” Id. at 14880 (emphasis supplied). Such federally prescribed standards are the inevitable result of direct federal inquiry under Section 504 into the rea- sonableness of parental or physician decisions regarding treatment of impaired newborns. Finally, unlike the Secretary’s regulatory approach, which utilizes direct federal hotlines for the reporting of 25 As the Senate sponsors of the 1984 Child Abuse Amendments stated in a letter to the Secretary dated March 13, 1985, the “in- dividuality of each case and the complexities of the medical situa- tions associated with each case make it unwise, we believe, to establish any ‘standard’ form of treatment for a particular type of case.” See 50 Fed. Reg. 14879-80 (April 15, 1985). 26 cases to HHS officials, the Congress in the 1984 Child Abuse Amendments did not want such federal hotlines or any regulation of the internal affairs of hospitals. As the Secretary concedes in the 1984 Child Abuse Regulation, id. at 14883, “matters relating to the internal affairs of hospitals are beyond the scope of this regulation.” See also id. at 14884. In sum, the Congress in the fall of 1984—after Uni- versity Hospital was finally decided and after the 504 Regulation was voided—clearly addressed the question of what federal response was appropriate with respect to the tragic question of providing appropriate treatment to severely impaired newborns. It explicitly adopted a state- based approach that, in all its particulars, rejected on policy grounds the direct federal role adopted solely by the Secretary in her 504 Regulation. Given this recent and clear legislative statement by the Congress of the federal interest in this sensitive area, further review of the validity of the Secretary’s intrusive administrative approach is not warranted.” B. The Secretary Has Shown No Problem With the Historic State Law Framework That Warrants Direct Federal Investigation and Regulation. After extensive hearings, the taking of written testi- mony and extensive deliberations, the President’s Com- 26 Although the Secretary asserts (Pet. 27 n.22) that the “new amendments do not, either practically-or legally, obviate the need for review in this case,” this claim is clearly wrong. Congress did include a provision in the Amendments indicating that they did not affect any rights under Section 504. Section 127(a), 98 Stat. 1754. But if Congress had concluded that a direct federal involvement in this area—in addition to the role of parents, doctors, nurses, hospitals, and state authorities—was appropriate, it surely would have ratified the Secretary’s interpretation rather than enacting new state-based legislation and creating legislative history which explicitly rejects, on policy grounds, the Secretary’s direct federal approach. As a “practical” matter, the 1984 Child Abuse Amend- ments should take effect; if a direct federal role is necessary under Section 504, Congress can in the future provide the explicit authori- zation for such a role that is so clearly absent here. 27 mission Report (p. 209 & n.51) concluded that erroneous parental decisions about the treatment of newborns ap- pears to be “very rare.” The Report described no in- stances where health care providers failed to report pa- rental neglect or refused to provide treatment to which parents had consented. Most importantly, the Secretary herself, in the preamble to the 504 Regulation, described the status of 49 cases in which HHS had investigated reports of possible “discrimination” under Section 504 with respect to impaired newborns. Although investiga- tions had not been completed in all the cases, the Secre- tary concluded that “no case has resulted in a finding of discriminatory withholding of medical care.” 49 Fed. Reg. 1649 (1984). Moreover, in her petition, the Secretary does not remotely make the case that there is any problem with parental decisions or decisions by health care providers which warrants direct federal intrusion. See Pet. 2-3, 26.77 Instead, the Secretary tries to mislead this Court by vaguely (and almost exclusively) citing to the “Baby Doe of Indiana” case (“Bloomington Baby Doe“), as if this case represented the kind of Section 504 “discrimi- nation” which would be remedied by a direct HHS role. But in that situation, where a newborn with Down’s Syndrome died after parents refused to authorize surgery to repair a blocked esophagus, the child’s doctors initially followed the parents’ decision yet the case was neverthe- less referred to the hospital for further discussion. The hospital then sought judicial review of that parental non- 27 For example, the Secretary’s citation to the preamble to the final 504 Regulation, 49 Fed. Reg. 1649 (1984), simply references the 49 cases investigated by HHS which yielded no finding of “dis- crimination” under Section 504. Pet. 26. Moreover, the Secretary’s claim in the petition that a problem exists requiring a direct federal role is directly contradicted by her statement in the 1984 Child Abuse Regulation that “only a very small fraction of births involve any serious question of survival” and only “a fraction” of this tiny fraction would “involve even a potential allegation of medical neglect” under state law. 50 Fed. Reg. 14886-87 (April 15, 1985). 28 treatment decision. The state court decided that the par- ents had made a reasonable decision between treatment options. The county department of public welfare re- viewed the case and decided not to challenge the judge’s order further. The county prosecutor then brought a sec- ond action. And a second state court judge refused to find parental neglect.** In short, hospital and state authorities actively sought review of the parents’ decision and two separate state court decisions supporting the parents were rendered. Accordingly, this case shows active provider and state involvement in a case of ques- tionable parental decisionmaking—and does not remotely support the Secretary’s claim that an additional level of direct federal intrusion is necessary. Finally, not only are formal state laws and procedures functioning as intended, but the development of volun- tary, hospital-based infant care review committees, see p. 7, supra, underscores that a direct federal investi- gatory and regulatory role is unnecessary. Indeed, as the Secretary conceded in the 1984 Child Abuse Regulation, use of these committees should reduce the need for formal state legal proceedings involving impaired newborns to a “[vlery few cases.” 50 Fed. Reg. 14887 (April 15, 1985). It follows a fortiori from this concession that there is no need for an intrusive, duplicative HHS 504 bureaucracy to investigate directly possible Section 504 violations in this sensitive area. C. Direct Federal Investigation and Regulation In This Sensitive Area Has Caused, And Will If Reinstated Cause, Harm. The Secretary’s actions in University Hospital and her other 48 direct federal investigations under Section 504 perfectly illustrate the harm that is caused by a direct federal role that, in effect, duplicates and attempts to 28 See In re Infant Doe, No. GU 8204-004A (April 12, 1982), writ of mandemus dismissed sub nom. State ex rel. Infant Doe v. Baker, No. 482 S 140 (Ind. May 27, 1982). See also J. Lyon, Play- ing God in the Nursery 21-39 (1985). 29 second-guess decisions made by parents, providers and state authorities. In University Hospital, the federal gov- ernment pressed its own duplicative, harassing effort even after relevant state agencies and state courts determined that there were no grounds for state intervention. Most of the Secretary’s other investigations have been equally intrusive, although none has resulted in a finding of dis- crimination under Section 504. 49 Fed. Reg. 1646-1649 (1984) .?® Moreover, by imposing on health care providers vague and confusing federal obligations—which are dif- ferent than, Pet. 27 n.22, and may conflict with their duties under state law—the Secretary’s regulatory ap- proach has distorted medical decisionmaking. The un- certain and conflicting nature of these independent fed- eral duties may lead to overtreatment which will only prolong the suffering of an impaired infant and which will preclude use of scarce infant intensive care units for newborns who could genuinely benefit from treat- ment.“ CONCLUSION The interests of severely impaired newborns are pro- tected by their parents, by infant care review commit- tees, by the duties of health care providers under state law, by state child protective service agencies and by 20 Even HHS’ cursory description of these investigations, id., makes clear that they have resulted in invasions of family privacy, medical records and confidential medical decisionmaking, and have disrupted hospital operations and delayed ongoing treatment for impaired newborns and other patients. See also Affidavit of Ervin E. Nichols, M.D., Director of Practice Activities of the American College of Obstetricians and Gynecologists, 111; Affidavit of Rita G. Harper, M.D., Chief of Perinatal Medicine, North Shore Uni- versity Hospital, ſ 15; Auld Affidavit, note 6, supra, { 18; Shapiro & Rosenberg, The Effect of Federal Regulations Regarding Handi- capped Newborns: A Case Report, 252 J.A.M.A. 2031 (1984); Strain, The American Academy of Pediatrics Comments on the “Baby Doe II” Regulations, 309 New Eng. J. Med. 443 (1983). 0 Auld Affidavit, note 6, supra, 9, 21; Affidavit of Hubert &. Ritter, M.D., clinical professor of obstetrics and gynecology, St. Louis University School of Medic.ne, 10-11. 30 state courts. Neither Section 504, nor any substantial federal interest, justifies the direct and intrusive federal investigation and regulation of treatment decisions in- volving impaired newborns advocated by the Secretary.“ Accordingly, for the reasons stated above, respondents AMA et al. respectfully request that the Secretary’s peti- tion for a writ of certiorari be denied. Respectfully submitted, KIRK B. JOHNSON B. J. ANDERSON BENJAMIN W. HEINEMAN, JR. (Counsel of Record) American Medical Association CARTER G. PHILLIPS 535 North Dearborn Street VINCENT F. PRADA Chicago, Illinois 60610 1722 Eye Street, N.W. (312) 645-4600 Washington, D.C. 20006 ANN E. ALLEN (202) 429-4000 American College of NEWTON N. MINOW Obstetricians & Gynecologists JACK R. BIERIG 600 Maryland Avenue, S. W. One First National Plaza Suite 300-East Chicago, Illinois 60603 Washington, D.C. 20024 (312) 853-7000 (202) 688-5577 SIDLEY & AUSTIN 31 Contrary to the Secretary’s claims, Pet. 12, 27-28, the holding of the Court of Appeals in University Hospital and this case— which is by its terms confined to treatment decisions involving severely impaired newborns—does not control the application of Section 504 to other decisions involving impaired newborns, other treatment decisions involving non-infants, or general policies or procedures regarding federally funded health care or other pro- grams. Nor a fortiori does it control any interpretation of Title VI of the Civil Rights Act of 1964. See Consolidated Rail Corp. v. Darrone, 104 S. Ct. 1248, 1254 n. 13 (1984) (recognizing distinc- tions between Title VI and § 504). Moreover, other than the deci- sions in this case, no reported decisions of any court have relied upon the holding of University Hospital, decided more than a year ago, in any of the other contexts cited by the Secretary. 31 JOSEPH A. KEYES, JR. Association of American Medical Colleges One Dupont Circle, N.W. Washington, D.C. 20036 (202) 828-0510 MICHAEL MILLER American Academy of Family Physicians 1740 West 92nd Street Kansas City, Missouri 64114 (816) 333-9700 MARK D. MokRIS Hospital Association of New York State 15 Computer Drive West Albany, New York 12205 (518) 458-7940 STUART M. GERSON Epstein Becker Borsody & Green, P. C. 1140 19th Street, N. W. Washington, D.C. 20036 (202) 861-0900 Attorneys for Respondents American Medical Association, et al. May 25, 1985 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385012_0316%3A03. Public record. Not legal advice.