Health Law and Policy Commons^™

Protecting Women's Human Rights: A Case Study In The Philippines, Tamar Ezer

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No abstract provided.

The Hydra, Carl E. Schneider

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Almost nobody favors long consent forms for prospective research subjects. Almost everybody thinks they interfere with informed consent's purpose-good decisions. Nevertheless, almost everybody believes consent forms have long been getting longer. Years ago, Paul Appelbaum lamented the "tendency to cram ever more information into consent forms." Weeks ago, Ilene Albala and her colleagues (one of them Appelbaum) reported in IRE: Ethics & Human Research that the length of one institutional review board's forms "increased roughly linearly by an average of 1.5 pages per decade. In the 1970s, the average consent form was less than one page long and often only …

What Scribner Wrought: How The Invention Of Modern Dialysis Shaped Health Law And Policy, Sallie Thieme Sanford [email protected]

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In March 1960, Clyde Shields, a machinist dying from incurable kidney disease, was connected to an "artificial kidney" by means of a U-shaped Teflon tube that came to be known as the Scribner shunt. By facilitating long-term dialysis, Dr. Belding Scriber’s invention changed chronic kidney failure from a fatal illness to a treatable condition. This medical advance has, in turn, had a profound impact on key areas of health law and policy. This paper focuses on the historical roots and current context of three interrelated areas: ethical allocation of scarce medical resources; public financing of expensive health care; and decisions …

Reducing Disparities Through Health Care Reform: Disability And Accessible Medical Equipment, Elizabeth Pendo

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People with disabilities face multiple barriers to adequate health care and report poorer health status than people without disabilities. Although health care institutions, offices, and programs are required to be accessible, people with disabilities are still receiving unequal and in many cases inadequate care. The 2009 report by the National Council on Disability, The Current State of Health Care for People with Disabilities, reaffirmed some of these findings, concluding that people with disabilities experience significant health disparities and barriers to health care; encounter a lack of coverage for necessary services, medications, equipment, and technologies; and are not included in the …

Promoting Public Health Through Clinical Legal Education: Initiatives In South Africa, Thailand, And Ukraine, Tamar Ezer

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No abstract provided.

Constitutional Flaw?, Carl E. Schneider

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Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …

The Paternalistic Ideology Of Erisa And Unforgiving Courts: Restoring Balance Through A Grand Bargain, Edward A. Zelinsky

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No abstract provided.

When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider

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The ultimate aim of health care public policy is good care at good prices. Managed care stalled at achieving this goal by trying to influence providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy are now pressuring patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's watchword. This Article evaluates this ideal type …

Candor After Kadlec: Why, Despite The Fifth Circuit's Decision, Hospitals Should Anticipate An Expanded Obligation To Disclose Risky Physician Behavior, Sallie Thieme Sanford [email protected]

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An anesthesiologist admitted to having been drug-impaired during a tubal ligation that left the patient with massive, incapacitating brain damage. In granting the anesthesiologist privileges, one of the items Kadlec Medical Center had relied upon was a short credentialing letter from Lakeview Regional Medical Center. That letter stated simply that the doctor had held anesthesia privileges there for several years; it did not disclose concerns about on-duty drug use, or that he could not exercise his privileges after having been terminated from his practice group for "put[ting] our patients at significant risk" by "report[ing] to work in an impaired physical, …

A Black Robe And Healing Words: Constants In A Changing World, Sallie Thieme Sanford [email protected]

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This narrative article describes a bedside hospital hearing to compel surgery, notes the applicable legal standards, and considers the potential impact of the judge in this type of proceeding. The patient, whose back was badly burned, adamantly and vocally refused skin graft surgery. Her physicians believed she lacked decisional capacity; that belief was borne out during the hearing at which the judge did enter an order for surgery. The judge’s handling of the hearing was central to the patient’s expressed agreement with the decision and subsequent successful treatment.

Thou Good And Faithful Servant, Carl E. Schneider

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Lawmakers are stewards of social resources. A current debate-over screening newborns for genetic disorders-illuminates dilemmas of that stewardship that have particularly plagued bioethics. Recently in the Report, Mary Ann Baily and Thomas Murray told the story of little Ben Haygood. He died from MCADD, a genetic disorder that can make long fasting fatal. Screening at birth would have let doctors alert Ben's parents. "After Ben died," Baily and Murray wrote, "his father became a passionate advocate for expanding Mississippi's newborn screening program to add MCADD and other disorders." Soon, the Ben Haygood Comprehensive Newborn Screening Act increased the number …

The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall

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The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword. This article evaluates consumerism and the regulatory mechanism …

The Professional Ethics Of Billing And Collections, Mark A. Hall, Carl E. Schneider

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Medicine is a Profession on which physicians rely for their livelihood and patients for their lives. If physicians do not charge for services, they cannot survive. If patients cannot afford those services, they cannot survive. No wonder many physicians have long agreed that fees are “one of the most difficult problems . . . between patient and physician.” For years comprehensive insurance subdued this problem, but currently widespread underinsurance and consumer-directed health care are reviving it. Even as the ranks of the uninsured continue to increase,the latest hope for controlling medical costs requires insured patients to pay for much more …

The Use Of Litigation Screenings In Mass Torts: A Formula For Fraud?, Lester Brickman

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The article critically examines the pervasive abuse of litigation screenings in mass tort cases, revealing a system driven by financial exploitation where medical evaluations are manipulated to generate lawsuits. These screenings, often designed to produce false positives, undermine the integrity of the legal system by creating a flood of specious claims. The analysis highlights how lawyers, doctors, and screening companies exploit legal loopholes and financial incentives, leading to billions of dollars in settlements and eroding public trust in the civil justice system.

Health Privacy In A Techno-Social World: A Cyber-Patient's Bill Of Rights, Patricia S. Abril, Anita Cava

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No abstract provided.

(Debate) Medicare: Did The Devil Make Us Do It?, D. A. Hyman, Jill R. Horwitz

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In this lively and creative debate, Professors David Hyman and Jill Horwitz argue about the virtues and vices of the federal Medicare program. As some predict a bleak future for the American’s government’s ability (or inability) to continue paying for Medicare as the population ages, this debate shows that there is genuine disagreement about the severity of the problem. In his Opening Statement, Professor Hyman offers a satirical letter to the Devil from one of his demonic servants, describes the Medicare program through the lens of the seven deadly sins. Arguing that Medicare’s faults are represented in each sin, the …

Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk

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We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the …

Disability, Equipment Barriers And Women’S Health: Using The Ada To Provide Meaningful Access, Elizabeth Pendo

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It is well-known that people with disabilities face multiple barriers to adequate health care, including lower average incomes, disproportionate poverty, and issues with insurance coverage. This article focuses on a more fundamental barrier-one that has not been discussed in the legal literature-inaccessible medical equipment and its effect on the delivery of women's health care to millions of women with disabilities .

How Not To Do Medical Malpractice Reform: A Florida Case Study, Mary I. Coombs

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No abstract provided.

The New Massachusetts Health Law: Preemption And Experimentation, Edward A. Zelinsky

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The Employee Retirement Income Security Act of 1974 (ERISA) preempts major features of the new Massachusetts health law. Although regrettable, this conclusion is mandated by ERISA's statutory terminology and the controlling case law. Other states, in fashioning their health care policies, are looking at elements of the new Massachusetts law. Just as ERISA preempts the individual and business contribution mandates of the Massachusetts statute, ERISA will preempt any similar provisions adopted by other states.

Because state experimentation with health care is particularly desirable today, Congress should, at a minimum, amend ERISA to validate the new Massachusetts health law. More comprehensively, …

The Cash Nexus, Carl E. Schneider

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Courts and legislatures have labored for decades to protect patients' choice of medical treatments, even though patients seize that gift less eagerly than lawmakers expect. Yet while courts have rushed to build the whited sepulchre of informed consent, they have fled from a related problem that patients actually yearn to solve and that actually can be ameliorated the plight of patients who perforce agree to a treatment before they know its costs and who receive a bill both unrelated to the treatment's value and several times what an insured patient would pay. Increasingly, patients must be consumers in the medical …

The Health Care Choice Act: The Individual Insurance Market And The Politics Of "Choice", Elizabeth Pendo

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The Health Care Choice Act of 2005 (HCCA) aims to reform perceived problems in the individual market, and is touted as part of the solution to the problem of the uninsured. It purports to allow individuals who are not eligible for or cannot afford group coverage to purchase an individual policy in and from any state. If passed, the HCCA would allow health insurers to offer individual policies of insurance from any state without being required to comply with the laws of the insured's own state. Its proponents claim that it would lower the cost of individual health insurance by …

Does Nonprofit Ownership Matter?, Jill R. Horwitz

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In recent years, policymakers have increasingly questioned whether nonprofit institutions, particularly hospitals, merit tax exemption. They argue that nonprofit hospitals differ little from their for-profit counterparts in the provision of charity care and, therefore, should either lose their tax-exempt status or adhere to new, strict, and specific requirements to provide free services for the poor. In this Article, I present evidence that hospital ownership-whether it is for-profit, nonprofit, or government owned-has a significant effect on the mix of medical services it offers. Despite notoriously weak enforcement mechanisms, nonprofit hospitals act in the public interest by providing services that are unlikely …

Void For Vagueness, Carl E. Schneider

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When law regulates a profession, where does it get its standards? Largely from the profession. Members of professions acquire esoteric and abstract knowledge through formal education and the experience of practice. They use professional judgment in applying this knowledge to each case. Because legislatures and courts lack this expertise, they adopt the standards of the experts. Thus in a malpractice suit, juries are instructed to determine whether the doctor met medicine's standard of care. Furthermore, physicians must be called as expert witnesses to guide juries in that work. Even when lawmakers contemplated intensifying their regulation of medicine by creating the …

Global Health And Human Rights Imperative, Patricia C. Kuszler

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Open any magazine, click on a television news channel, or surf the net and you are likely to find global health highlighted as one of the foremost challenges of new millennium. First, this article will consider the meaning and measures of global health and detail the path to improved health and development prescribed by the United Nations Millennium Development Goals. Second, it will trace the development of international human rights law as it relates to health. Third, it demonstrate how human rights and health, long traversing parallel routes, are in fact converging in the 21st Century quest for global health–a …

The Social Security Administration's New Disability Adjudication Rules: A Significant And Promising Reform, Frank S. Bloch, Jeffrey S. Lubbers, Paul R. Verkuil

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The article evaluates the Social Security Administration's (SSA) new Disability Service Improvement (DSI) process, introduced in 2006, which aims to address inefficiencies and inconsistencies in disability adjudication. The reforms include key innovations such as Quick Disability Determinations (QDDs), the Medical and Vocational Expert System (MVES), and the replacement of the Appeals Council with the Decision Review Board (DRB). While the reforms represent a significant and promising step toward improving the disability determination process, the article identifies remaining concerns, particularly regarding the role of the Federal Reviewing Official (FRO) and rules for submitting evidence at administrative hearings.

Drugged, Carl E. Schneider

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The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

After Autonomy, Carl E. Schneider

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Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …

Liability, Regulation And Policy In Surgical Innovation: The Cutting Edge Of Research And Therapy, Anna C. Mastroianni

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This article examines the implications of the foregoing competing claims from a U.S. legal perspective, focusing particularly on how the legal system addresses patient safety concerns and autonomous decision-making of surgeons in the context of surgical innovation. The lack of oversight and the risks borne by patients during surgeons' development and subsequent refinement of a novel procedure must be balanced with the need to encourage medical progress through the development of improved techniques designed to benefit the health of current and future patients. This article argues that current reliance on the medical malpractice system and the federal regulatory system of …

The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar

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Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.