Will I get in trouble?

Transcription

1 Will I get in trouble? Sadath A. Sayeed, J.D., M.D. Division of Medical Ethics, Harvard Medical School Division of Newborn Medicine, Children s s Hospital Boston

2 The answer: it depends

3 The relationship between law and ethics Fear of the law frustrates ethically justifiable clinical choices at the bedside Hospital counsel s perspective may be different from yours

4 What do we mean by law? In ordinary speech, we think of law as an either-or word What What you propose would be a little unjust What What you propose would be a little illegal The term law in common usage disguises a much deeper complexity Criminal, civil, regulatory actions Different kinds of penalties for different kinds of violations

5 A theme for today Clinical ethical dilemmas interact with law and the legal system at one end of a very complex jurisprudential story Law is constructed Law is enforced Law is interpreted

6 Some of law s s peculiarities THERE HAS TO BE A CASE OR CONTROVERSY It s s only illegal if you get caught Better questions: What s s the risk of liability? How How willing are to expose yourself to risk?

7 Law s s peculiarities Law in its various forms can be responsive to evolving societal norms BUT it is meant to guide today s s and future action Time frame for reevaluation and reformulation are not coincidental with actual occurrence of clinical ethical dilemmas (there is a lag time) Judges must respect the structure of legal institutions as a whole

8 Practical advice: law and ethics The law as it relates to medical ethics is rarely black and white Difficult cases provide reasonable grounds for differences of opinion This indeterminacy spills over into judicial interpretation and makes authoritative declarations less likely

9 Grand legal theme in thinking about parents, children and medical care A basic moral tension: The law s s concept of the family rests on a presumption that parents possess what a child lacks in maturity, experience, and capacity for judgment required for making life s s difficult decisions. More importantly, historically, it has recognized that the natural bonds of affection lead parents to act in the best interests of the their child. As with so many legal presumptions, experience and reality may rebut what the law accepts as a starting point. Chief Justice Burger, Parham vs. J.R. 442 US 584, 1979

10 What are the best interests of Role play newborns in legal terms? You are a very good lawyer Called frantically at 2 am by a 40 yr old partner in your firm who is pregnant at 22 weeks and is labor that cannot be stopped She is sobbing after hearing that the docs are not willing to attempt a resuscitation Naturally, it is an IVF pregnancy, her one chance after many failures.

11 Your task help her Sources of law Federal level US US Constitution Supreme, Appellate, District court opinions US US Code (federal statutory law) US US administrative law (DHHS regulations) State level State State Codes State State case law

12 Federal law Child Abuse Prevention and Treatment Act (CAPTA) Amended in 1984 by Congress partly in response to Indiana Baby Doe case So-called Baby Doe amendments drafted with input from AAP and other interested parties

13 CAPTA 1984 Grants to States for child abuse and neglect prevention and treatment programs: (B) an assurance that the State has in place procedures for responding to the reporting of medical neglect (including instances of withholding of medically indicated treatment from disabled infants with life-threatening conditions)

14 Text of Baby Doe Regulations All such disabled infants must under all circumstances receive appropriate nutrition, hydration and medication. All such disabled infants must be given medically indicated treatment. Three circumstances in which treatment is not considered medically indicated.

15 Three exceptions If the infant is chronically and irreversibly comatose If the provision of such treatment would merely prolong dying, not be effective in ameliorating or correcting all of the infant s life-threatening conditions, or otherwise be futile in terms of the survival of the infant. If the provision of such treatment would be virtually futile in terms of the survival of the infant and the treatment itself under such circumstances would be inhumane.

16 Baby Doe regulations The physician s reasonable medical judgment concerning the medically indicated treatment must be one that would be made by a reasonably prudent physician, knowledgeable about the case and the treatment possibilities with respect to the medical conditions involved. It is not to be based on subjective quality of life or other abstract concepts.

17 CAPTA Despite strong language CAPTA is toothless from an enforcement perspective CAPTA DOES NOT create private rights of action or criminal penalties It ties federal funding for state child protective services to the local implementation of rules and regulations that mirror the federal standards Individual state CPS agencies left to police (and most do not)

18 Another source of federal law The Born Alive Infant Protections Act of 2002 (BAIPA) Amends Title 1 of US Code as follows: (a) In determining the meaning of any Act of Congress, or any ruling, regulation, or interpretation of the various administrative bureaus and agencies of the United States, the words person, human being, child, and individual, shall include every infant member of the species homo sapiens who is born alive at any stage of development.

19 BAIPA Amends Title 1 of US Code as follows: Amends Title 1 of US Code as follows: (b) As used in this section, the term born alive, means the complete expulsion or extraction from his or her mother of that member, at any stage of development, who after such expulsion or extraction breathes or has a beating heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, regardless of whether the umbilical cord has been cut, and regardless of whether the expulsion or extraction occurs as a result of natural or induced labor, cesarean section, or induced abortion.

20 An aside: How does a ridiculous law like this get passed? Ushered through Congress as a symbolic anti-abortion abortion law Congressional sponsors insisted it would not change existing law nor affect neonatal treatment decision-making Only a few physicians publicly voiced concern over law s s potential implications

21 BAIPA More important question: should practitioners be concerned? The stated purpose of Act is as follows: to repudiate the flawed notion that a child s entitlement to the protections of the law is dependent upon whether that child s mother or others want him or her

22 Our lawyerly question When a newborn at 22 weeks is delivered, separated from her mother, and has a beating heart, is she a citizen of the US, entitled to all of the protections of the law as an individual? Does her imminent death in a hospital setting require evaluation and treatment?

23 One possible answer In 2005, U.S. Department of Health and Human Services (DHHS) Secretary Mike Leavitt announced: As a matter of law and policy, we will investigate all circumstances where individuals and entities are reported to be withholding medical care from an infant born alive in potential violation of federal statutes for which we are responsible.

24 BAIPA and EMTALA DHHS responsible for enforcing the Emergency Medical Treatment and Labor Act (EMTALA) EMTALA obligates providers to medically stabilize or transfer of any person or individual presenting to a hospital with an emergency medical condition EMTALA creates both regulatory and private rights of action It IS an enforcement statute that contemplates civil penalties

25 BAIPA and EMTALA Under BAIPA individuals clearly include all born-alive infants and therefore, EMTALA potentially applies DHHS s Center for Medicare and Medicaid Services (CMS) memo Guidance on the Interaction of the Born-Alive Infants Protection Act and EMTALA

26 DHHS Memo an infant born alive and a prudent layperson observer concluded, based on the infant s s appearance or behavior, that the infant were suffering from an emergency medical condition the the hospital and its staff would be required to perform a medical screening examination.. If determined [that EMC existed], an obligation to admit the infant, or to comply with [stabilization or transfer requirement]

27 Vexing questions Query: Who is a prudent layperson observer? What is an emergency medical condition at the margins of viability? What infant appearance or behavior is relevant? What constitutes a sufficient (legally adequate) medical screening exam in the DR?

28 More sources of law: state decisions From Wisconsin Burks v. St. Josephs 1999 Plaintiff Plaintiff alleged EMTALA violation when hospital failed to resuscitate roughly 200 gram, ~22 week newborn Physician filed affidavit stating resuscitation was medically inappropriate Court Court reversed lower decision dismissing EMTALA claim without reaching merits

29 From Wisconsin State law Preston v. Meriter 2005 Plaintiff Plaintiff alleged physician and hospital failed, refused, and neglected to provide any care to newborn weighing over 600 grams at 23 and 2/7ths weeks gestation Court Court did not reach merits of case, but reversed lower court case dismissing EMTALA claim, stating: When a baby is born in a hospital birthing center, the newborn has come to the emergency department for purposes of the EMTALA duty to provide a medical screening examination.

30 More State law Miller v. HCA (Texas 2003) Controversial decision granting PHYSICIANS the unilateral right to resuscitate marginally viable newborns regardless of parental preference under common law doctrine of emergent circumstances [I]t is impossible for the courts to calculate the relative benefits of an impaired life versus no life at all.

31 More State law Montalvo v. Borkovec (Wisconsin 2002) What the doctors did was save this child s life, and I understand the legal position of the parents is that was a decision they should make, but.protection of children is something that the community has an interest.we simply can t say that the possibility that this child could be disabled or even the probability if it is that strong is sufficient to withhold life-saving measures and decide this child does not deserve to live. Trial court judge

32 More state law This determination could vary greatly based on the parents beliefs. One set of parents may view a particular disability as worse than death, while another set of parents would not. Such a process, not unreasonably, has kaleidoscopic, unending implications. - State appellate court Montalvo opinion

33 More state law Montalvo v. Borkovec [T]here is a presumption that continued life is in the best interests of a patient. In the absence of proof of a persistent vegetative state, our courts have never decided it is in the best interests of a patient to withhold or withdraw life-sustaining medical care.

34 What does the law suggest? Remember we re trying to make the case! I haven t t shared with you case law that might support the other side Hardly any judicial interpretations specifically on point at the appellate level to make robust claims about what the law requires Federal law is remarkably passive - both BAIPA and CAPTA depend on voluntary reporting to generate potential investigation and sanction

35 Practical Analysis You may only get into trouble if appropriately invested parties contest an issue that has legal teeth In any situation, the key ingredient necessary to raise legal worry is CONFLICT between provider, parent, or other staff Unclear what an emergency medical condition is and what a medical screening exam should consist of

36 The legal reality are are you anxious? A sub-legal practice Below Below the regulatory radar No No internal incentive to reveal decisions Scrupulous efforts to avoid conflict, which for some of us perhaps sometimes means DIRECTIVE counseling? Rarely Rarely a legal problem if attention there is good communication with parents

37 Our current ethic A sub legal practice that is informed by A A humble recognition of our limited therapeutic capabilities A A honest assessment of the limited resources available to parents forced to provide long-term care for severely disabled children A A tremendous worry about the impossibility of parents making truly informed decisions in these crisis moments Yes, this may be paternalistic, and yes, this may be justifiable!

38 Thank you