Rothstein, Mark A.

English

Case Western Reserve University School of Law

Health Matrix: The Journal of Law-MedicineVolume 14 | Issue 12004The Growth of Health Law and BioethicsMark A. RothsteinFollow this and additional works at: https://scholarlycommons.law.case.edu/healthmatrixPart of the Health Law and Policy CommonsThis Symposium is brought to you for free and open access by the Student Journals at Case Western Reserve University School of Law ScholarlyCommons. It has been accepted for inclusion in Health Matrix: The Journal of Law-Medicine by an authorized administrator of Case Western ReserveUniversity School of Law Scholarly Commons.Recommended CitationMark A. Rothstein, The Growth of Health Law and Bioethics, 14 Health Matrix 213 (2004)Available at: https://scholarlycommons.law.case.edu/healthmatrix/vol14/iss1/16THE GROWTH OF HEALTH LAW ANDBIOETHICSMark A. RothsteintLOOKING BACK over the last fifty years, the growth in healthlaw and bioethics has been nothing short of amazing. Although healthlaw barely existed as a discipline fifty years ago, today health issueshave created entire new fields of law, ranging from food and drug lawto fraud and abuse law. Similarly, in the last fifty years, law has be-come an integral (if not universally welcomed) part of medicine. Phy-sician practices are now concerned with privacy notices, informedconsent documents, and advanced directives. At most hospitals, ex-panded in-house legal departments have been joined by related de-partments of risk management, regulatory compliance, and healthinformation privacy and security.Overarching both law and medicine is bioethics, a still-emergingdiscipline that blends philosophy, law, and social science. A majorintellectual source of modem bioethics was the enactment of the Nur-emburg Code after World War II, although the actual term "bioethics"was not used until the latel960s.1 Today, bioethics includes researchethics, 2 clinical ethics, 3 distributional ethics, 4 as well as other con-cers. Bioethics plays an important role at both the individual andsocietal levels. It is the link between private morality, professionalt J.D.; Herbert F. Boehl Chair of Law and Medicine, Director, Institute forBioethics, Health Policy and Law, University of Louisville School of Medicine.1 ALBERT R. JONSEN, THE BIRTH OF BIOETHICS vii (1998). See also VANRENSSELAER POTTER, BIOETHICS: BRIDGE TO THE FUTURE 2 (Carl P. Swanson ed.,1971) ("1 ... propose the term Bioethics in order to emphasize [the important roles ofboth] biological knowledge and human values.").2 E.g., BARUCH A. BRODY, THE ETHICS OF BIOMEDICAL RESEARCH: ANINTERNATIONAL PERSPECTIVE (1998). See also REBECCA DRESSER, WHEN SCIENCEOFFERS SALVATION: PATIENT ADVOCACY AND RESEARCH ETHICS (2001); COMM. ONASSESSING THE SYSTEM FOR PROTECTING HUM. RES. PARTICIPANTS, INST. OF MED.,RESPONSIBLE RESEARCH: A SYSTEMS APPROACH TO PROTECTING RESEARCHPARTICIPANTS (Daniel D. Federman et al. eds., 2003).3 E.g., ALBERT R. JONSEN ET AL., CLINICAL ETHICS: A PRACTICAL APPROACHTO ETHICAL DECISIONS IN CLINICAL MEDICINE (John Dolan & P. McCurdy eds., 4thed. 1998).4 E.g., NORMAN DANIELS, JUST HEALTH CARE (Daniel I. Wikler et al. eds.,1985); MEDICINE AND SOCIAL JUSTICE: ESSAYS ON THE DISTRIBUTION OF HEALTHCARE (Rosamond Rhodes et al. eds., 2002).HEALTH M4 TRIXresponsibility, and public policy. Nevertheless, there are no accred-ited or agreed-upon training programs in the field; there is frequentsuspicion of the competence and motives of the self-appointed "secu-lar priests" who serve as bioethicists; and there is no consensus on theweight to be given to bioethical analyses in individual cases or in pol-icy development.Against this backdrop of explosive growth and poorly definedboundaries in health law and bioethics,5 it is valuable to attempt to putthese developments into perspective. Those who work in health lawand bioethics need to recognize the origins of the fields as well as thesubstantial challenges ahead. I will concentrate my discussion on fiveareas.First, health care is now big business. In the United States, healthcare spending in 2001 was $1.4 trillion, representing approximately14.1 percent of GDP. 6 The practice of medicine is increasingly con-centrated in large conglomerates, including for-profit health care de-livery companies and managed care organizations.7 The biotech,pharmaceutical, and medical device industries are all billion dollarindustries, and their importance to medical care continues to grow.Finally, the health insurance industry, by pre-approving or rejectingmedical interventions, has in many instances blurred the distinctionsbetween those who provide health care and those who provide reim-bursement for health care. Obviously, the practice of medicine todayno longer resembles the time when physicians made house calls andreceived payment in cash.8Second, much of the growth in health care has been driven by newtechnology. We sometimes take for granted the range of medicalmiracles of so recent vintage, including advances in areas such as di-agnostic imaging, laparoscopic- and micro-surgery, renal dialysis,organ transplantation, artificial joints, assisted reproductive technolo-gies, and genetic analysis. With each new advance in medicine comesuch inevitable questions as when is a new device, medication, or5 E.g., Mark A. Hall. Law, Medicine and Trust, 55 STAN. L. REV. 463, 464-65 (2002) ("[U]nlike other areas of law, no unifying principle or animating concernhas yet been identified for the law of health care delivery.").6 CENTERS FOR MEDICARE AND MEDICAID SERVICES, REPORT DETAILSNATIONAL HEALTH CARE SPENDING INCREASES IN 2001, athttp://cms.hhs.gov/media/press/release.asp?Counter-693 (Jan. 8, 2003).7 E.g., MARY R. ANDERLIK, THE ETHICS OF MANAGED CARE: A PRAGMATICAPPROACH 179 (2001) ("Corporations have long been a part of health care. What isunprecedented is the consolidation among corporations and the extension of the cor-porate domain to include physicians.").8 PAUL STARR, THE SOCIAL TRANSFORMATION OF AMERICAN MEDICINE 66-71(1982).214 [Vol. 14:213THE GROWTH OF HEALTH LAW AND BIOETHICSprocedure ready to move from research to the clinic; who should haveaccess to it; who will pay for it; and how will it be regulated.9 Theability to attempt more complex medical procedures, along with thediffuse responsibility for care, means an increased risk of adverseoutcomes. Efforts to reduce medical errors and to compensate victimsof error continue to be sources of great controversy.' 0Third, numerous specialty areas of health law practice and studyhave been created by the enactment of federal and state regulatorystatutes. Medicare, Medicaid, and other government-sponsored healthfinance programs, originally opposed in the mid-1960s by organizedmedicine," dominate today's health care reimbursement system, andrequire a detailed knowledge of specific laws and regulations. Subse-quent legislation included the Employee Retirement Income SecurityAct (ERISA),' 2 Emergency Medical Treatment and Active Labor Act(EMTALA), 13 Americans with Disabilities Act (ADA), 14 Health In-surance Portability and Accountability Act (HIPAA), 15 and other lawsregulating such issues as health finance, health services, disabilitydiscrimination, and privacy. While rejecting comprehensive reforms,the U.S. health care "system" has mutated incrementally into anamorphous mass of laws and regulations, each enacted with good in-tentions but, cumulatively, achieving unsatisfactory results by nearlyany measure of population health. Increasingly, policy makers willneed to focus on substantially improving measures of populationhealth, such as infant mortality rates, childhood immunization rates,and life expectancy.Fourth, patients have changed over the last fifty years, and sohave their relationships with health care providers. The physician-patient relationship fifty years ago was characterized by paternalism,in which largely white, male, generalist physicians provided care ontheir own terms. It was common for doctors to withhold diagnostic9 See ETHICAL DIMENSIONS OF HEALTH POLICY (Marion Danis et al. eds.,2002) (exploring questions of regulatory authority, resource distribution, and theirinfluence on each other).10 See generally COMvM. ON QUALITY OF HEALTH CARE IN AMERICA, INST. OFMED., To ERR is HUMAN: BUILDING A SAFER HEALTH SYSTEM (Linda T. Kohn et al.eds., 2001). See also E. HAAVI MORREIM, HOLDING HEALTH CARE ACCOUNTABLE:LAW AND THE NEW MEDICAL MARKETPLACE (2001); MARGIN OF ERROR: THE ETHICSOF MISTAKES IN THE PRACTICE OF MEDICINE (Susan B. Rubin & Laurie Zoloth, eds.,2000).1 STARR, supra note 8, at 367-78.12 29 U.S.C. §§ 1003-1191 (2000).'3 42 U.S.C. § 1395dd (2000).14 42 U.S.C. §§ 12101-12213 (2000).1" Pub. L. No. 104-191, 110 Stat. 1936 (1996) (codified as amended in scat-tered sections of 42 U.S.C.).20041HEALTH MATRIXand prognostic information from their patients on the grounds thatthey wouldn't understand the information or were better off not know-ing.' 6 Physicians are more diverse today in terms of ethnicity andgender, and patients are usually more informed about and interested intheir own health. Diagnosis and treatment are based on principles ofinformed consent, patient autonomy, and shared decision making afterdisclosure of all relevant information.' 7 Growth in telemedicine ande-health, the expanding scope of practice by allied professionals, andcomplementary and alternative medicine will further complicate phy-sician-patient relations.Fifth, the Human Genome Project, which formally began in 1990,has committed three to five percent of its annual scientific researchbudget to the study of the ethical, legal, and social implications ofgenome research.' 8 This Ethical, Legal, and Social Implications(ELSI) program has channeled millions of dollars into bioethics andhealth law research. Both the amount of money and the timing of theELSI research (concurrent with the scientific research) are unprece-dented.' 9 The ELSI program has been subject to various criticisms,including that it is an attempt to buy off potential critics.20 Neverthe-less, ELSI grantees have generated a substantial number of excellentstudies and publications, many with applications well beyond genom-ics, which have served to promote an awareness of key issues. 2' Itremains to be seen whether other biomedical research undertakings16 See, e.g., DAVID J. ROTHMAN, STRANGERS AT THE BEDSIDE: A HISTORY OFHOW LAW AND BIOETHICS TRANSFORMED MEDICAL DECISION MAKING 1-2 (1991)("Well into the post-World War 11 period, decisions at the bedside were the almostexclusive concern of the individual physician, even when they raised fundamentalethical and social issues.").17 E.g., A HISTORY AND THEORY OF INFORMED CONSENT 274-82 (Ruth R.Faden et al eds., 1986) (explaining the role of the patient or research subject in au-thorizing treatment or experimentation rather than merely assenting or acquiescing).But see CARL E. SCHNEIDER, THE PRACTICE OF AUTONOMY: PATIENTS, DOCTORS, ANDMEDICAL DECISIONS (1998) (discussing research that shows that many patients do notwant autonomy, the reasons why, and what decisions they should be required tomake).18 ROBERT M. COOK-DEEGAN, THE GENE WARS: SCIENCE, POLITICS AND THEHUMAN GENOME 255 (1994)." See id. at 245-55 (1994) (describing the ELSI program as "an attempt toarticulate the values that should govern the research, and to anticipate adverse socialconsequences of science in time to avert them." Id. at 248.).20 Eric T. Juengst, Self-Critical Federal Science? The Ethics ExperimentWithin the U.S. Human Genome Project, 13 SOC. PHIL. & POL'Y 63, 67 (1996)(evaluating various criticisms of the ELS1 program).21 For a list of ELSI publications, refer to their website,http://www.genome.gov/10001798.[Vol. 14:213THE GROWTH OF HEALTH LA WAND BIOETHICSwill similarly commit to studying the ethical, legal, and social impli-cations of their research.One thing is clear from this brief review: health law and bioethicsare here to stay. In a culture dominated by law, health law establishesthe standards for individual, professional, and institutional conductand relations. In a pluralistic and diverse society, bioethics serves toframe the secular moral discourse on issues ranging from cloning tophysician-assisted suicide. Yet, health law and bioethics must movebeyond a boutique area of law practice and an abstract academic pur-suit. Professional education and health policy development presentimportant challenges for health law and bioethics.A major limitation on incorporating health law and bioethics intothe legal and health professions is that legal and medical educatorshave yet to determine whether or how to integrate health law and bio-ethics into professional and continuing education. Although the pro-liferation of health law courses at some law schools suggests a grow-ing recognition of the importance of the subject; at even those lawschools with an emphasis on health law, curricular coherence andintegration are often lacking. At most law schools, health law isbarely a part of the curriculum. Furthermore, very few law schoolsoffer any instruction in public health law, now an important part ofnational security planning and infection control at all levels of gov-ernment.The ethics education situation is even worse at schools of medi-cine, dentistry, nursing, and public health. For example, medical eth-ics instruction typically has involved a series of lectures by non-clinician faculty members. Because the material is usually neither onmedical school examinations nor national boards and the subject is nottaught by "real doctors," medical ethics instruction usually has beenreceived with little enthusiasm by medical students. There is an ur-gent need to modernize medical ethics instruction, to integrate it overthe four years of medical school, to relate it more closely to the studyand practice of medicine, and to include essential legal principles. Inmid-2004, the United States Medical Licensing Examination (Step 2)will begin including a clinical skills examination.22 If, in the future, aclinical ethics component were added to the national clinical skillsexamination it would quickly lead to a greater emphasis on ethicsinstruction in medical schools and an integration of ethics into clinicalinstruction.22 United States Medical Licensing Examination, Step 2 Clinical Skills Ex-anination: Frequently Asked Questions, athttp://www.usmle.org/news/cse/step2csfaqs1 103.htm (last updated Nov. 5, 2003).2004]HEALTH MA TRIXHealth law and bioethics also need to play a more important rolein the political process. The occasional national commissions andtask forces charged with bioethics analysis have been too haphazard,politicized, and ad hoc to develop any continuity or stature in influ-encing the political process. Bioethics must both inform and be in-formed by public attitudes; it must apply rigid analytical tools andmethods; 23 and it must promote our unique national mores while rec-ognizing the increasing importance of international perspectives.Those of us who work in the field of health law and bioethics need tobecome more involved in the political process. We need to movebeyond sound bites and clever quotes in the media to help delineatethe values, interests, and legal foundations on which the health policyof the future will be based.23 See generally METHODS IN MEDICAL ETHICS (Jeremy Sugarman & DanielP. Sulmasy eds., 2001) (explaining that empirical evidence is necessary to avoidpremature value judgments and moral inferences).[Vol. 14:213

The Growth of Health Law and Bioethics

bepress Legal Repository

https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=1271&amp;context=healthmatrix

The Growth of Health Law and Bioethics

Abstract

Similar works

Full text

Available Versions

Case Western Reserve University School of Law

bepress Legal Repository