Health Law and Policy Commons^™

Liability For Life, Carl E. Schneider

Articles

Marshall Klavan headed the Obstetrics and Gynecology Department of the Crozer-Chester Medical Center. He deeply feared strokes, perhaps because his father had been savaged by one. In 1993, Dr. Klavan wrote an advance directive which said that (as a court later put it) "he 'absolutely did not want any extraordinary care measures utilized by health care providers.'" On April29, 1997, Dr. Klavan tried to kill himsel£ He left suicide notes and a note refusing resuscitation. The next morning, medical center employees found him unconscious and took him to the emergency room, where he was resuscitated. By May 2, Dr. Klavan …

Making Lawyers Compete, Lester Brickman

Articles

The article argues that the market for contingent-fee-financed tort litigation is not price competitive, primarily due to uniform contingency fees charged by lawyers regardless of case-specific factors such as risk or effort required. This lack of competition leads to excessive costs for claimants and contributes to the expansion of tort liability. The author contends that the legal profession maintains this system through various barriers, including ethical rules and entry restrictions, which prevent competitive market forces from functioning effectively.

Enough: The Failure Of The Living Will, Angela Fagerlin, Carl E. Schneider

Articles

Enough. The living will has failed, and it is time to say so. We should have known it would fail: A notable but neglected psychological literature always provided arresting reasons to expect the policy of living wills to misfire. Given their alluring potential, perhaps they were worth trying. But a crescendoing empirical literature and persistent clinical disappointments reveal that the rewards of the campaign to promote living wills do not justify its costs. Nor can any degree of tinkering ever make the living will an effective instrument of social policy. As the evidence of failure has mounted, living wills have …

Vanishing Vaccinations: Why Are So Many Americans Opting Out Of Vaccinating Their Children?, Steve P. Calandrillo

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Part I of this Article details the historical development and medical achievements made possible by vaccines. From Edward Jenner to Jonas Salk to Albert Sabin, immense strides have been made in eradicating or substantially eliminating some of the worst diseases in human history. Smallpox, polio, measles, mumps, rubella, diphtheria, pertussis, tetanus, influenza, hepatitis A and B, and even the chicken pox are all now largely preventable.

Literally hundreds of millions of deaths have been avoided and many more lives markedly improved, to say nothing of the financial ramifications for the American healthcare system. All fifty states have therefore enacted compulsory …

Images Of Health Insurance In Popular Film: The Dissolving Critique, Elizabeth Pendo

Articles

Several recent films have villainized the health insurance industry as central elements of their plots. This Article examines three of those films: Critical Care, The Rainmaker, and John Q. It analyzes these films through the context of the consumer backlash against managed care that began in the 1990s and shows how these films reflect the consumer sentiment regarding health insurance companies and the cost controlling strategies they employ. In addition, the Article identifies three key premises about health insurance in the films that, although exaggerated and incomplete, have significant factual support. Ultimately, the author argues that, despite their passionately critical …

Cash For Kidneys? Utilizing Incentives To End America's Organ Shortage, Steve P. Calandrillo

Articles

This article addresses the growing organ shortage in America, analyzes current donation and procurement law, and explores both monetary and nonmonetary incentives aimed at eliminating the worsening crisis.

Part I details the law governing human organ donation. Under both the Uniform Anatomical Gift Act (“UAGA”) and the National Organ Transplant Act (“NOTA”), no donor of a human organ may receive “valuable consideration” for providing it. Congress’ intention was simply that the organ recipient be given the “gift” of life—not one which she had to purchase on the market. In reality, the consequences of the Act bear little resemblance to its …

Benumbed, Carl E. Schneider

Articles

I originally intended to write a column on tort liability and research ethics, and I still plan to do so. But this column is a cri de coeur as I finish another semester teaching law and bioethics. This year, I asked with growing frequency, urgency, and exasperation, "Must law's reverence for autonomy squeeze out the impulse to kindness? Where is the beneficence in bioethics?" These questions assail me every term. Why? Consider Steele v. Hamilton County Community Mental Health Board. Mr. Steele was involuntarily "hospitalized after his family reported that he was 'seeing things and trying to fight imaginary …

Where Is The "There" In Health Law? Can It Become A Coherent Field?, Mark A. Hall, Carl E. Schneider

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Gerturde Stein complained of Oakland, "There is no there there." Churchill complained of his pudding that "it has no theme." And everybody complains of health law that it lacks an organizing principle. Health law scholars bemoan the "pathologies" of health law and its contradictory and competing "paradigms'. which form a "chaotic, dysfunctional patchwork." But it should not surprise us that any field which grows by accretion lacks a unifying idea or animating concern. And health law certainly grew by accretion. It began in the 1960s, when the Law-Medicine Center was established, concerned with medical proof in litigation, physicians' malpractice, and …

Border Patrol, Carl E. Schneider

Articles

Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …

Against A Federal Patients' Bill Of Rights, Edward A. Zelinsky

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The failure of the 107th Congress to pass a "Patients' Bill of Rights" (PBR) is widely considered a major disappointment, to be remedied in the 108th Congress by the adoption of such legislation. Indeed, federal PBR proposals have achieved the proverbial motherhood-and-apple-pie status; it is virtually impossible to find anyone actively opposing a federal PBR. Many members of the 108th Congress likely feel pressure to pass PBR legislation before returning to the electorate in 2004.

I advance a contrary perspective: A federal PBR is an idea whose time is past or, to be precise, is an idea whose rationales are …

Going To Pot, Carl E. Schneider

Articles

In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.

Why We Need The Independent Sector: The Behavior, Law, And Ethics Of Not-For-Profit Hospitals, Jill R. Horwitz

Articles

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made, …

The Physician As A Conscientious Objector, J. David Bleich

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No abstract provided.

All My Rights, Carl E. Schneider

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Diane Pretty was an Englishwoman in her early 40s who had been married nearly a quarter of a century. In November 1999, she learned she had amyotrophic lateral sclerosis-in Britain, motor neurone disease. Her condition deteriorated rapidly, and soon she was "essentially paralysed from the neck downwards." She had "virtually no decipherable speech" and was fed by a tube. She was expected to live only a few months or even weeks. AB a court later explained, however, "her intellect and capacity to make decisions are unimpaired. The final stages of the disease are exceedingly distressing and undignified. AB she is …

How Underlying Patient Beliefs Can Affect Physician-Patient Communicaion About Prostate-Specific Antigen Testing, Michael H. Farrell, Margaret Ann Murphy, Carl E. Schneider

Articles

Routine cancer screening with prostate-specific antigen (PSA) is controversial, and practice guidelines recommend that men be counseled about its risks and benefits. OBJECTIVE. To evaluate the process of decision making as men react to and use information after PSA counseling. DESIGN. Written surveys and semistructured qualitative interviews before and after a neutral PSA counseling intervention. PARTICIPANTS. Men 40 to 65 years of age in southeastern Michigan were recruited until thematic saturation—that is, the point at which no new themes emerged in interviews (n = 40). RESULTS. In a paper survey, 37 of 40 participants (93%) said that they interpreted the …

The Bill For Rights, Carl E. Schneider

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Where today is legislative ingenuity lavished more bountiully than on the titles of statutes? And where has that ingenuity been better exercised than in the name "patients' bill of rights"? Do not our dearest liberties flow from the Bill of Rights? And who more deserves similar protection than patients in the hands of an angry Managed Care Organization? And behold, both Democrats and Republicans, both President Clinton and President Bush, have summoned us to arms. The patients' bill of rights is an idea whose time has seemed to have come for several years, and only conflicts among the numerous proposals …

Curing Conflicts Of Interest In Clinical Research: Impossible Dreams And Harsh Realities, Patricia C. Kuszler

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This article will explore conflicts of interest in the context of clinical research, focusing on the incentives and practices that foster such conflicts. Part I will briefly define and categorize the revenue streams at play in clinical research—both contemporaneous with the clinical trial, and the downstream, long-term gains available to the researcher and research university. Part II will discuss how these entangled revenue streams result in financial and non-financial conflicts of interest that affect the nature and balance of the research enterprise and potentially endanger patients and human subjects. Part III will summarize current conflicts of interest regulations and policies, …

Gang Aft Agley, Carl E. Schneider

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In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …

Responsible Regulation: A Sensible Cost-Benefit, Risk Versus Risk Approach To Federal Health And Safety Regulation, Steve Calandrillo

Articles

Federal health and safety regulations have saved or improved the lives of thousands of Americans, but protecting our citizens from risk entails significant costs. In a world of limited resources, we must spend our regulatory dollars responsibly in order to do the most we can with the money we have. Given the infeasibility of creating a risk-free society, this paper argues that a sensible cost-benefit, risk versus risk approach be taken in the design of U.S. regulatory oversight policy. The goal should always be to further the best interests of the nation, rather than to satisfy the narrow agenda of …

The Best-Laid Plans, Carl E. Schneider

Articles

It is natural to suppose law is like the centurion and can do as it will: "I say to this man, Go, and he goeth; and to another, Come, and he cometh; and to my servant, Do this, and he doeth it." But a thousand years ago, King Canute tried to disillusion his courtiers about his efficacy by commanding the waves to stop beating. And fifty years ago, Harry Truman predicted of Dwight Eisenhower, "He'll sit here, and he'll say, 'Do this! Do that!' And nothing will happen. Poor Ike-it won't be a bit like the Army. He'll find it …

Financing Clinical Research And Experimental Therapies: Payment Due, But From Whom?, Patricia C. Kuszler

Articles

This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit.

Regulating Doctors, Carl E. Schneider

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Alawyer today can hardly speak to a doctor--or even be treated by one-without being assailed by lawyer jokes. These jokes go well beyond good-humored badinage and pass the line into venom and gall. They reflect, I think, the sense many doctors today have that they are embattled and endangered, cruelly subject to pervasive and perverse controls. This is puzzling, almost to the point of mystery. Doctors have long been the American profession with the greatest social prestige, the greatest wealth, and the greatest control over its work. Indeed, what other profession has been as all-conquering? One may need to go …

Telemedicine And Integrated Health Care Delivery: Compounding Malpractice Liability, Patricia C. Kuszler

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This Article considers how theories of medical negligence might be applied in the context of telemedicine and integrated delivery health plans. Part Two summarizes the history of telemedicine, its increasing breadth of application and opportunity and promise for the future. Part Three reviews traditional negligence principles and precedents and demonstrates how they might be applied when a telemedicine interaction results in negligence and harm to the patient. Part Four discusses evolving theories of shared liability applicable to health plans and managed care entities. Finally, Part Five demonstrates how shared liability theories will be applied to situations involving telemedicine technologies.

Corralling Kevorkian: Regulating Physician-Assisted Suicide In America, Steve Calandrillo

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This article examines the evolution and history of the development of the right-to-die in America, the ethical considerations surrounding physician-assisted suicide (P.A.S.), and the dangers posed by the rise of managed care. I then explore and analyze efforts to legalize and regulate assisted suicide (Netherlands, Oregon, The Model State Act), and suggest the criteria I believe are essential to include in any P.A.S. regulatory scheme.

Justification By Faith, Carl E. Schneider

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In June 1997 a sixteen-year-old girl named Shannon Nixon began to feel ill. Her parents belonged to the Faith Tabernacle Church, one of a number of American sects which believe that illness should be treated spiritually rather than medically. Accordingly, the Nixons prayed for Shannon and took her to be anointed at their church. Shannon reported that she felt better and that the spiritual treatment had gained her her victory-her recovery. Before long, however, Shannon again felt ill. She became weaker and weaker and then fell into a coma. A few hours later she died. An autopsy revealed that she …

Testing Testing, Carl E. Schneider

Articles

Last year, Congress passed the Ryan White Care Act Amendments of 1996. The amendments authorize ten million dollars for each fiscal year from 1996 through 2000 for counseling pregnant women on HIV disease, for "outreach efforts to pregnant women at high risk of HN who are not currently receiving prenatal care," and for voluntary testing for pregnant women. The amendments compromise a central question: whether prenatal and neonatal AIDS testing should be compelled. The compromise is complex. The director of the Centers for Disease Control and Prevention is instructed to establish a system for states to use to discover and …

Making Sausage: The Ninth Circuit's Opinion, Carl E. Schneider

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As I write, the Supreme Court has just agreed to hear Compassion in Dying v. Washington and Quill v. Vacco, the two cases in which United States circuit courts of appeals held that a state may not constitutionally prohibit physicians from helping a terminally ill person who wishes to commit suicide to do so. These cases have already received lavish comment and criticism, and no doubt the Supreme Court's opinion will garner even more. Reasonably enough, most of this analysis addresses the merits of physician-assisted suicide as social policy. I, here, want to talk about how setting bioethical policy …

Is There A Right To Physician-Assisted Suicide, J. David Bleich

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No abstract provided.

Balancing The Barriers: Exploiting And Creating Incentives To Promote Development Of New Tuberculosis Treatments, Patricia C. Kuszler

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This Article considers the many barriers that health-care providers and public health authorities face in stemming the modem TB epidemic. Part II reviews historical public health measures, their results, and their adaptability to resurgent and MDR-TB. Part III considers the fundamental barriers to a successful global effort using these public health strategies, concluding that these barriers are insurmountable given the current arsenal of anti-tuberculosis therapies. Part IV examines the reasons why research and development of new anti-tuberculosis drugs and vaccines have stagnated over the last quarter century. Finally, part V explores incentives that might revive research and development of such …

From Consumer Choice To Consumer Welfare, Carl E. Schneider

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In trying to understand the I SUPPORT study, it may be useful to think of contemporary bioethics reform in terms of the principles of consumer protection. The central tendency of that reform (particularly in my own field-the law) has been to employ the model of consumer choice. That model sets as its purpose to allow consumers to choose the kinds of products they prefer. It seeks to accomplish that purpose primarily by supplying consumers the information they need to make choices and by insisting that they are given what they chose. Thus, for example, merchants may be required to reveal …