Ethics and Law for Neurosciences Clinicians: Foundations and Evolving Challenges

By James E. Szalados

The brain represents the final frontier in medical sciences. Clinical neurosciences include the subspecialties of neurology, neurosurgery, neuro-imaging, cerebrovascular interventional specialties, neurocritical care, and the allied specialties in pharmacy and nursing. The first lens through which we see our patients is the clinical perspective; however, the complexity of neurosciences and the rapidity of the advances in these subspecialties require that clinicians not lose sight of the personhood of the patients, the professionalism required in the care of these complex patients, or the regulatory environment in which we practice. Science and technology are advancing more rapidly than regulations or the law can interpret and integrate them into a supportive or regulatory framework.  Thus, morality, ethics, and the law comprise the final lens through which we approach complex patient management issues, frame our communications with patients and families, and evaluate the risks and potential benefits of new technology. Ethics and Law for Neurosciences Clinicians is written for all clinicians in the neurosciences specialties to examine and re-examine the ethical and legal implications of advances in clinical neurosciences. 

• Language: English
• Publisher: Rutgers University Press
• Release date: Feb 4, 2019
• ISBN: 9780813595993

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ETHICS AND LAW FOR NEUROSCIENCES CLINICIANS

ETHICS AND LAW FOR NEUROSCIENCES CLINICIANS

Foundations and Evolving Challenges

JAMES E. SZALADOS

RUTGERS UNIVERSITY PRESS

New Brunswick, Camden, and Newark, New Jersey, and London

Library of Congress Cataloging-in-Publication Data

Names: Szalados, James E., author.

Title: Ethics and law for neurosciences clinicians : foundations and evolving challenges / by James E. Szalados.

Description: New Brunswick : Rutgers University Press, [2019] | Includes bibliographical references and index.

Identifiers: LCCN 2018006047 | ISBN 9780813593883 (pbk.) | ISBN 9780813595993 (epub) | ISBN 9780813593906 (Web PDF)

Subjects: | MESH: Neurosciences—ethics | Neurosciences—legislation & jurisprudence | Clinical Medicine | Ethics, Clinical

Classification: LCC QP360 | NLM WL 21 | DDC 174.2/968—dc23

LC record available at https://lccn.loc.gov/2018006047

A British Cataloging-in-Publication record for this book is available from the British Library.

Copyright © 2019 by James E. Szalados

All rights reserved

No part of this book may be reproduced or utilized in any form or by any means, electronic or mechanical, or by any information storage and retrieval system, without written permission from the publisher. Please contact Rutgers University Press, 106 Somerset Street, New Brunswick, NJ 08901. The only exception to this prohibition is fair use as defined by U.S. copyright law.

The paper used in this publication meets the requirements of the American National Standard for Information Sciences—Permanence of Paper for Printed Library Materials, ANSI Z39.48-1992.

www.rutgersuniversitypress.org

Manufactured in the United States of America

This could not have been possible without my lovely supportive family. For my dad, who taught me that personal fortitude and a gentle spirit can co-exist and prevail; for my mom, who taught me to win by never quitting and never giving up; for my sister Liz, who taught me that there is magic in this world and that we just need to keep believing; and, finally but not lastly, for my love, my wife, and my life companion, Doris, who shares the credit for all I have accomplished because she has been with me every moment and on every step of our journey and she has never stopped encouraging and supporting my dreams.

CONTENTS

Preface

Author’s Note

1 Morality, Ethics, and the Law: An Overview of the Foundations of Contemporary Clinical Ethical Analysis

2 Case Studies: Ethical and Legal Challenges in the Care of the Neurologically Injured Critically Ill Patient

3 Civil Law and Liability: The Law of Medical Malpractice

4 Legal Reasoning, Legal Process, Legal Proof, and Why It Is Confusing to Clinician Scientists

5 Regulatory Law and the Clinical Practice of the Neurosciences

6 Digital Medicine and the Data Revolution: Managing Digital Distraction and Electronic Medical Record Liability While Leveraging Opportunities in Teleneurology and Telecritical Care

7 Developing and Leading a Sustainable High-Reliability, High-Performing Unit: Theories of Quality, Teamwork, Medical Error, and Patient Safety

8 Neurolaw and the Integration of Neuroscience, Ethics, and the Law: The New Frontiers

9 Afterword

Acknowledgments

Notes

Index

PREFACE

The practices of medicine and its allied professions are among the most highly regulated of public services and economic activities. There is little doubt that health care providers, by and large, chose health care as a profession to help their fellow human beings through illness and personal medical catastrophes. Thus, almost uniformly, health care providers are persons with strong internal moral and ethical compasses, driven to their respective fields because of a sense of caring, work ethic, diligence, and intellectual need. My fellow health care workers are truly special. In contrast to almost all other professions, health care entails enormous commitment and personal sacrifice and also is not devoid of personal risks. In their day-to-day and moment-to-moment hectic worlds, health care practitioners tend to be so focused on the care of each individual patient, tending to each successive urgency and emergency, and completing paperwork requirements, that they seldom stand back to look at the legal and regulatory complexity of the health care system; that is, until they find themselves, their work, or practices under scrutiny.

The purposes of this book are both to provide a concise practical review of the ethical, legal, and regulatory foundations that affect our complex practices, and to explore new and evolving areas of neuroscience practice, in which many will find new opportunities and challenges, as well as legal and ethical risks and conundrums.

Neurosciences represent what is arguably the final frontier of medicine. Research, diagnostic tools, therapeutic interventions, and delivery of care models in neuroscience are evolving rapidly, largely because of digital imaging and processing technologies that allow us to see what we have never seen before. Throughout this revolution in medical sciences, we must ensure that technology does not distract us from our ethics and morality.

Technology is rarely created by legislation, regulations, or laws; instead, technological innovation forces the development of laws and regulations to harmonize technological innovation with existing public policy. However, health care providers are typically scientists, whereas regulators and politicians are instead typically social scientists with disparate but not necessarily irreconcilable views. Thus, it is imperative that providers participate fully in organizations that represent patient and provider interests to help those who formulate public policy, rules, regulations, and even standards understand the intricacies of clinical care.

To the extent possible, we must take steps to understand and shape the environments in which we practice, and we can only accomplish that goal through active involvement and engagement. I hope this book helps us all start that dialogue by presenting an overview of the most critical ethical, legal, and regulatory issues facing us now and into the future.

—JES

AUTHOR’S NOTE

The material presented here is intended to provide readers with an academic overview of legal and ethical principles for educational purposes only and to convey general information.

The material and perspective herein deal primarily with the laws and the legal system in the United States and may not represent a worldwide subject view.

The material herein in not intended and must not be construed in any way to provide legal advice in any form. This book in no way implies the existence of an attorney-client relationship. The information presented herein may not reflect new and evolving legal developments. No actions should be taken in reliance on the information contained here, and the author disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this material to the fullest extent permitted by law.

Please consult with a qualified attorney regarding specific legal advice on your specific legal issues.

The opinions expressed are the opinions of the individual author and may not reflect the opinions of any institutions or firms with which the author previously has been or is currently affiliated with.

ETHICS AND LAW FOR NEUROSCIENCES CLINICIANS

1 • MORALITY, ETHICS, AND THE LAW

An Overview of the Foundations of Contemporary Clinical Ethical Analysis

THE DELICATE INTERPLAY BETWEEN MORALITY AND THE LAW

The laws of a nation are inextricably linked to the culture of the people who govern. Therefore, laws vary greatly between nations because of shared cultural values, which, in turn, are reflected in governmental structures and the method of governance of any particular nation. Discussions of fracture and morality presuppose a shared cultural definition of socially acceptable and socially unacceptable behaviors. Cultural definitions of behavioral norms are largely rooted within tradition and religion. Culture creates a shared ethical system. Although any one person may reflect and discover his or her internal sense of what is good, right, and meaningful, the course of human history is punctuated by diverse groups and cultures unifying around unique sets of values, purposes, and principles. Laws evolve from the ethical system when the culture forms a government. Each society in some fashion defines its own government, and, in doing so, entitles the government with the authorities of oversight, compulsion, and control over its people. Laws are created and put into practice through societal processes. Therefore, notions of legal versus illegal activities are defined in the context of shared cultural values, delegated authority, and social context. People of common morality traditionally have joined together in forming communities. A society cannot survive without limits of toleration and standards for conformity, and each society has the right to preserve its own existence and therefore to sanction and punish. Morality refers to a set of deeply held, widely shared, and relatively stable values within a given society. Society imposes moral standards by enforcing conformity because a society cannot survive without such laws.¹ Laws that are written but do not conform to the values shared by the majority within a society will likely be resisted unless the people governed are powerless to effect change.

In general, there are two types of freedoms: the first is the freedom to pursue one’s own individuality and personal goals and interests; the second type of freedom is from the encroachment upon one’s rights by others. Just laws must be carefully crafted in such a way as to delicately balance personal freedoms against societal interests. Laws exist to reconcile principles of conformity and individual initiative, group living and private freedom of choice, social regulation and personal autonomy.² Thus, to individuality should belong the part of life in which it is chiefly the individual that is interested; to society, the part which chiefly interests society … everyone who receives the protection of society owes a return for the benefit, and the fact of living in society renders it indispensable that each should to observe a certain conduct towards the rest.³ To a large extent then, laws are arguably utilitarian in the sense that the standard for morality is determined by the laws’ usefulness to a specific society, or, as Mill would argue, the greatest good for the greatest number.

The concept of justice is therefore not uniformly normative but instead defined as conformity with existing laws. Legal order implies that decisions will be made not arbitrarily but rather in accordance with rules, which are neither good nor bad in themselves but rather designed to accomplish a specific purpose.⁴ Thus, laws are teleological in that they are designed to achieve a specific end or goal, that of societal harmony. Justice presupposes that laws are enforced uniformly and that people can expect equal and impartial treatment in the eyes of the law. In the United States, the Constitution represents the foundational legal principles from which laws are derived. The Preamble to the Constitution articulates its guiding principles to be unity, domestic tranquility, and general welfare.

We the People of the United States, in Order to form a more perfect Union, establish Justice, insure domestic Tranquility, provide for the common defence, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity, do ordain and establish this Constitution for the United States of America.⁵

THE RELATIONSHIP OF ETHICS TO LAW

Although morality strongly informs the basis of laws, that morality represents shared societal values that demand enforcement to promote societal harmony, ethics more properly addresses a person’s internal and more personal moral compass. Thus, as violations of moral norms are likely to carry a punishment enforced through a system of justice, ethical violations are less likely to be enforceable. Traditionally, ethical violations were considered unenforceable; however, some ethical norms, such as the failure to obtain informed consent prior to treatment, have become enforceable and punishable by both legal and regulatory bodies. Regulations and laws often incorporate ethical principles to which the majority within a society subscribes. The Greek philosopher Plato is credited with the statement that "ethics belongs to the body polis," referring to the political body and the community; what a society decides to be ethical or unethical is ultimately determined through the courts and through legislation.

Also known as moral philosophy, normative ethics is a branch of philosophy that has its foundations in philosophy and focuses on the generally accepted standards of values regarding right and wrong and the consequent assignment of quasi-legal rights and obligations. Actions are ethically justified on the basis of such shared values. Internalized values, ethical principles, and a sense of purpose define our sense of goodness—of right and wrong—and they give meaning to our lives while defining our choices and actions. Classically, western ethics are derived from Judaic-Christian principles and the subsequent teachings of Aristotle (virtue ethics), Kant (duty-based ethics), and Bentham and Mill (utilitarian and consequentialist ethics). Eastern ethical principles are derived from diverse sources including those that are Buddhist, Taoist, Confucian, Hindu, and the Islamic Hadith. Arguably, western ethics are more concerned with the exploration of universal truths, whereas eastern ethical principles are more concerned with protocol and respect; however, it is evident that there are in fact recognizable and indistinct universally shared ethical principles.⁶

Ethical duties frequently have legal ramifications. Laws delineate concrete duties that are thus necessary to maintain equality and social order and to provide a predictable and uniformly applied framework for preventing and resolving disputes.

OF OATHS AND CODES

In a manner similar to societies at large, which share common values, professions represent a culturally heterogeneous group of individuals who share a common training and who are bound together by values specific to their profession, even as these professionals practice within a larger society with potentially conflicting values. Nonetheless, codes of conduct are one hallmark of professionals that address the fiduciary nature of the relationship between the professional and the client. Professional codes hold members to a higher standard than the law imposes, and some societies have enforceable codes that predicate membership upon ethical behaviors. Values derived from statements of normative ethics act as behavioral guidelines for professionals within segments of the professional medical fraternity.

The general guiding ethical principles for the medical profession are contained within oaths, sworn to ritualistically by medical graduates, which embody the ethics of good medicine. Oaths outline the ethical elements of patient and physician relationships but have their greatest meaning when they are taken in a free and heartfelt fashion. Oaths represent promises, aspirational statements, of idealized ethics. Many traditional oaths are criticized for their potential lack of applicability in a modern world; however, such criticisms likely lose sight of the importance of aspirational statements in codes of ethics. It has been argued that oaths are characterized by greater moral weight compared with promises because of their public character, their validation by transcendent appeal, the involvement of the personhood of the swearer, the prescription of consequences for failure to uphold their contents, the generality of the scope of their contents, the prolonged time frame of the commitment, the fact that their moral force remains binding in spite of failures on the part of those to whom the swearer makes the commitment, and the fact that interpersonal fidelity is the moral hallmark of the commitment of the swearer.⁷ The most well-known is the Hippocratic Oath, in either its classical version⁸ or its modern version,⁹,¹⁰ written in 1964 by Louis Lasagna, the Academic Dean of the School of Medicine at Tufts University at that time. The modern version¹¹ states:

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug.

I will not be ashamed to say I know not, nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.

I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.

Other less widely known oaths of medical conduct include the Oath of Maimonides attributed to Maimonides (circa 1145–1204), a Jewish theologian and physician born in Cordova, Spain, and the Physician’s Oath developed by the World Medical Association in Geneva, Switzerland in 1948 and subsequently amended, most recently in 1983. Similar to the Nuremberg Code, which addresses research on human subjects, the Physician’s Oath was written in response to atrocities committed in Nazi Germany during World War II and reads:

I solemnly pledge myself to consecrate my life to the service of humanity;

I will give my teachers the respect and gratitude which is their due;

I will practice my profession with conscience and dignity;

The health of my patient will be my first consideration;

I will respect the secrets which are confided in me, even after the patient has died;

I will maintain by all the means in my power, the honor and the noble traditions of the medical profession;

My colleagues will be my brothers;

I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient;

I will maintain the utmost respect for human life from its beginning even under threat and I will not use my medical knowledge contrary to the laws of humanity;

I make these promises solemnly, freely and upon my honor.¹²

Professional associations, boards, and organizations have also authored codes of ethics. Standards of conduct in any profession reflect the shared values of that profession and define behaviors by its members that are considered either mandatory or proscribed. Violations can lead to revocations of licenses, suspensions of rights to practice, censures, or other sanctions or penalties.¹³ Thomas Percival, an English physician and philosopher, in 1803 published a version of the Code of Medical Ethics generally outlining professional duties and ideal behaviors for providers and hospitals.¹⁴ Percival’s Code is credited with forming the basis for the American Medical Association’s (AMA) Code of Ethics, enacted at the initial meeting of the AMA in Philadelphia, PA in 1847. The AMA Code of Ethics adopted at that meeting drew heavily on Percival’s Medical Ethics. The AMA Principles of Medical Ethics and the Opinions of the AMA Council on Ethical & Judicial Affairs compose the AMA Code of Medical Ethics.¹⁵ The AMA’s Council on Ethical and Judicial Affairs (CEJA) publishes an annual report chronicling each year’s adjudications of the complaints presented before it.¹⁶

The Neurocritical Care Society has published a code of professional conduct¹⁷ developed by the society’s ethics committee and ratified by the society’s board of directors, the preamble of which states that [t]he medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. As a member of this profession, neurocritical care personnel must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self. The following Principles adopted by the Neurocritical Care Society are not laws, but standards of conduct which define the essentials of honorable behavior for our members. As members, all are expected to exhibit the highest standards of honesty and integrity.¹⁸ Similarly, the American Academy of Neurology codified its own code of professional conduct¹⁹ and the American Association of Neurological Surgeons (AANS) published a code of ethics²⁰ that is a statement of ideals, commitments, and responsibilities of neurological surgeons to patients, other health professionals, society and themselves. In contrast to the AMA’s CEJA, which rarely, if ever, imposes sanctions on its members for ethics violations, the AANS has received considerable attention and publicity, and it has even been the target of litigation because it has chosen to enforce its code of ethics with respect to member neurosurgeons’ reports and testimonies²¹ that were provided in professional liability litigation.²² Over the years of 2004 to 2009, the AANS investigated twenty-two complaints of alleged improper expert witness testimony of its members.²³

It is notable that such codes of conduct or codes of ethics are not unique to the medical profession; for example, the American Bar Association has a similar code,²⁴ which is very much enforced among practicing attorneys, and violations of which can result in harsh disciplinary action. The legal profession places great weight on ethics as part of law school education and as a fact of day-to-day law practice. In fact, an ethics examination represents a separate component of the multistate bar examination process and yearly continuing legal educations in ethics in mandatory for state bar membership and licensure.

BIOMEDICAL ETHICS

Applied ethics develop the practical framework by which professionals approach problems that arise in the daily practice of a profession such as medicine or law. Biomedical ethics, or bioethics, are concerned with health policy, biomedical sciences and research, and medical practice. Beauchamp and Childress articulated four guiding principles that have come to be accepted as the core values of modern bioethical theory: (1) the principle of respect for autonomy; (2) the principle of nonmaleficence; (3) the principle of beneficence; and, (4) the principle of justice.²⁵

Hospital ethics committees are advisory groups, usually composed of a variety of members such as providers, nurses, social workers, bioethicists, lay persons, and attorneys who review, on request, ethical or moral questions that may arise during inpatient care. Although ethics committees had been informally established since at least the 1960s,²⁶ it was the New Jersey Supreme Court which, in its opinion, suggested that ethics committees might play an advisory role in such cases as an alternative to the courts.²⁷

Hurst and colleagues identified the main reasons for ethics consultations:

To obtain needed help in deciding what to do

To identify a practical way of doing what had already been decided should be done

To implement a practical solution

To obtain reassurance that the correct decision was being made

To better to face people who might otherwise think that the decision was inappropriate

To seek consensus.²⁸

THE PRINCIPLE OF RESPECT FOR AUTONOMY: CONSENT AND RIGHT TO DIE

The principle of respect for autonomy addresses personal autonomy and assumes that rational persons have the right to make uncoerced, informed, and voluntary decisions regarding their personhood and their bodies. The antithesis of autonomy is that of paternalism whereby individual choice is subjugated to the