Health Law and Policy Commons^™

Patient Safety Law: From Silos To Systems, Jocelyn Downie, William Lahey Prof., Don Ford, Elaine Gibson, Mary Thomson, Tom Ward, Fiona Mcdonald, Alison Shea

Reports & Public Policy Documents

Patient safety has become a significant and pressing policy issue. Around the world, governments, the health care sector and the public are increasingly cognizant of the need to improve the safety of care delivered by their health systems. Pressure for change has been created by highly publicized incidents in a number of countries involving unsafe acts that were significant both in scale and consequence and a number of empirical studies that revealed the high rates of unsafe acts and their consequences. The costs of unsafe health care – both personal and fiscal – to individuals, their families and their communities …

Medicaid In 2006: A Trip Down The Yellow Brick Road?, Jennifer Ryan

National Health Policy Forum

This issue brief explores the continuing evolution of the Medicaid program on several fronts. It discusses the benefits and cost-sharing flexibility that is included in the Deficit Reduction Act of 2005 (DRA) and examines the implications of these provisions for states, beneficiaries, and providers. The paper also explores recent trends in section 1115 waiver development and considers the use of waivers as a vehicle for restructuring Medicaid financing systems and for testing completely new approaches to health care delivery. The role of section 1115 waivers in the context of the DRA and as a mechanism for continued state innovation is …

Reproductive Cloning Case:How Law And Bioethics Measure A Compelling Governmental Interest, Paulo Farias

ExpressO

Law and Bioethics should be partners in developing public policies to deal with cloning. Law as a Government tool must enforce decisions made in Bioethics Commissions such as the NBAC and the President’s Council, because the Commissions’ discussions offer an array of principles to help legislators and policy makers understand how to find compelling governmental interests. For instance, human dignity is not a vague and obscure legal or bioethical concept. In truth, it is a way of connecting Law and Bioethics to answer questions such as the relationship between the legal protection of procreation and the Report of the President’s …

The Three Faces Of Retainer Care, Frank A. Pasquale

ExpressO

Retainer care arrangements allow patients to pay a fee directly to a physician’s office in order to obtain special access to care. Practices usually convert to retainer status by concentrating their attention on a small panel and dropping the majority of their patients. Proponents call retainer care a triumph of consumer-directed health care; opponents deride it as “boutique medicine.” Both sides are deploying a variety of legal tactics in order to attain their goals.

After surveying these conflicts, this article clarifies what is at stake by analyzing the three key features of retainer care: preventive care, queue-jumping, and amenity-bundling. Most …

Vioxx: How Strong Is The Case Against Merck?, Jason M. Weigand

ExpressO

The thousands of personal injury cases filed after Merck’s voluntary withdrawal of Vioxx appear difficult to prove. A large obstacle for plaintiffs is the admissibility of epidemiologic studies, which are required to prove specific causation. Pharmaceutical companies spend countless hours and resources developing and researching new drugs. Clinical research began to indicate that there may be an increase in adverse cardiovascular (“CV”) side effects associated with Vioxx. The reliability of this data and how it will work in our courts is a great concern.

Fluconomics--Preserving Our Hospital Infrastructure During And After A Pandemic, Vickie Williams

ExpressO

Influenza pandemics occur regularly. The deadly Spanish flu pandemic of 1918 infected more than 25% of the United States population, and killed 2.5% of those infected. Virtually all experts agree that it is not a question of if another influenza pandemic as deadly as the Spanish flu will occur, but a question of when. The Centers for Disease Control and Prevention estimates that the direct and indirect medical costs in the United States associated with a “medium-level” influenza pandemic would range from $71 billion to $167 billion.

Although public health officials are rapidly implementing pandemic preparedness plans on both the …

Racially-Tailored’ Medicine Unraveled, Sharona Hoffman

Faculty Publications

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …

Preplacement Examinations And Job-Relatedness: How To Enhance Privacy And Diminish Discrimination In The Workplace, Sharona Hoffman

Faculty Publications

Medical testing in the workplace is raising growing concern in light of increasingly available genetic tests and what is perceived as a general assault on individual privacy in the United States. Almost seventy percent of major U.S. firms require individuals who receive job offers to undergo medical testing prior to the commencement of employment, and the law does not restrict the scope of these examinations. Thus, employers test job candidates not only for fitness for duty and use of illegal substances, but also for a variety of conditions including susceptibility to workplace hazards, breast and colon cancer, sexually transmitted diseases, …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Responders’ Responsibility: Liability And Immunity In Public Health Emergencies, Sharona Hoffman

Faculty Publications

Many experts predict the advent of a public health emergency resulting from a flu pandemic or bioterrorism attack in the foreseeable future. At the same time, many health care providers express significant concern about liability arising from emergency response activities, because it is unlikely that they would be able to provide optimal care in crisis conditions. They also state that this concern will likely influence their willingness to be involved in response activities. This article addresses issues that have received little attention in the legal literature: liability and immunity in public health emergencies. The article provides a first-of-its-kind comprehensive analysis …

The Children Of Science: Property, People, Or Something In Between?, Star Q. Lopez

ExpressO

How should states classify embryos? The war has often waged between two classifications, people versus property. But what if a state assumed something in between, finding the embryo to be a potential person entitled to special respect? If a state adopted this position, how would the law affect medical research?

Presuming embryos constitute potential persons, the debate would continue with how to define “special respect.” The status of a potential person runs along a spectrum between property and personhood. How one defines “special respect” determines where the potential person falls along this spectrum. Special respect would create a spectrum of …

Fair Housing Is Good Medicine: Applying The Fair Housing Act's No-Inquiry Regulation When Housing And Health Care Are Provided Together, Eric M. Carlson

ExpressO

The Fair Housing Act (FHA) protects individuals with disabilities from discrimination in the housing or rental markets. The FHA’s no-inquiry regulation prohibits a landlord from inquiring into an applicant’s health condition.

Although the FHA routinely has been applied to long-term care facilities – usually to protect a group home or similar facility from unfair zoning practices – the no-inquiry regulation has not been utilized to challenge the admissions practices of assisted living facilities, nursing facilities, and other long-term care facilities. Indeed, at first glance, a no-inquiry rule seems a poor fit for a facility that provides health care along with …

The Expressive Impact Of Patents, Timothy R. Holbrook

ExpressO

Patents represent a quid pro quo between the public and the inventor: in exchange for disclosing the invention, the inventor receives the right to exclude others from practicing her invention. They therefore serve as a source technical information. Patents also communicate information to markets and companies that serve to reduce various transaction costs, allowing more efficient transactions and investment. Patents consequently communicate various types of information beyond the technical.

There is no reason, however, that such messages must be limited to the technical or the pecuniary. This Article explores whether patents, like other governmental acts such as legislation, can create …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

The Legalization Of Fat: Law, Science, And The Construction Of A Moral Panic, Paul Campos

ExpressO

Over the past decade, American public health authorities have made increasingly alarming claims regarding how obesity is becoming the nation’s leading public health problem. These warnings have inspired a flurry of legislative, administrative, and judicial responses, and calls for further legal intervention are issuing constantly from obesity researchers and public health officials. This article surveys and critiques the sudden wave of attempts to use the American legal system to shrink the nation’s waistline The article demonstrates that the health risks associated with the populace’s fairly modest increasing average weight have been greatly exaggerated; that the causal links, if any, between …

Rebalancing Long-Term Care: The Role Of The Medicaid Hcbs Waiver Program, Cynthia Shirk

National Health Policy Forum

This paper reviews the history and background of the Medicaid home and community-based services (HCBS) waiver program. It describes the eligibility, benefits, and financing structure, as well as the trends in program expenditures over time. The paper considers the contribution of the HCBS waiver program toward improving access to community-based care for Medicaid beneficiaries who are elderly and disabled and discusses the barriers that remain. This paper also summarizes the provisions included in the recently enacted Deficit Reduction Act of 2005 that may further expand Medicaid HCBS and considers how it may continue the process of redefining the concept of …

Guarding Against The High Risk Of High-Deductible Health Plans: A Proposal For Regulatory Protections, Michele Melden

ExpressO

High deductible health plans are a cornerstone of "consumer-driven health care." This article explores a number of myths promoted by proponents of such plans and challenges these myths to discuss the various ways such plans pose risks to consumers both individually and generally. While most articles on this topic explore the arguments for and against such plans, this article, unlike others, proposes specific regulatory protections with model language. In fact, this article already has been used as the basis for testimony before the California State Assembly which, for the first time, has introduced legislation aimed at regulating such plans and …

Getting It Right By Getting It Wrong: How The Supreme Court Helped Healthcare Reform By Incorrectly Applying The Standard Of Review In Pharmaceutical Research And Manufacturers Of America V. Walsh, Brian Y. Furuya

Brigham Young University Journal of Public Law

No abstract provided.

The Scarlet Gene: Behavioral Genetics, Criminal Law, And Racial And Ethnic Stigma, Karen H. Rothenberg, Alice Wang

Faculty Scholarship

Imagine that a scientist from the state university asks you and your family to participate in a study on a particular gene variant associated with alcoholism. The project focuses on your ethnic group, the Tracy Islanders, who have a higher incidence of alcoholism, as well as a higher incidence of the gene variant, than the general population. You will not be informed whether you have the gene variant, but your participation in the study might help scientists develop drugs to help individuals control their addiction to alcohol. You have a family history of alcoholism, and you are concerned that your …

Constitutional Arguments In Favor Of Modifying The Hcqia To Allow The Dissemination Of Physician Information To Healthcare Consumers, Laura A. Chernitsky

Washington and Lee Law Review

No abstract provided.

Minor Discrepancies: Forging A Common Understanding Of Adolescent Competence In Healthcare Decision-Making And Criminal Responsibility, Kimberly M. Mutcherson

Nevada Law Journal

No abstract provided.

Fitness, Knowledge, Progress: Assessing Physician Qualification, Lisa Sprague

National Health Policy Forum

The informed and empowered consumer is an ideal invoked by many would-be health care reformers. An actual consumer wishing to don the mantle of power may be hindered by the scarcity of information available, particularly with respect to choosing among physicians. How is one to know who is best qualified? This issue brief looks at the basics of physician qualification and the processes by which physicians are licensed, credentialed, and board-certified. It examines how the evolution of these processes (for example, the move from lifetime certification to ongoing maintenance of certification) affects clinicians and their patients. The rise of quality …

The Constitutional Right To Make Medical Treatment Decisions: A Tale Of Two Doctrines, B. Jessie Hill

Faculty Publications

The Supreme Court has taken very different approaches to the question whether individuals have a right to make autonomous medical treatment choices, depending on the context. For example, in cases concerning the right to choose ¿partial-birth¿ abortion and the right to use medical marijuana, the Supreme Court reached radically different results, based on radically different reasoning.

More recent developments, including last Term's decision in Gonzales v. Carhart, have only highlighted the doctrinal confusion and the need for a resolution. In light of this pressing need, the goal of this Article is to view all of the constitutional cases touching on …

“It’S The [Tort System], Stupid:” Consumer Deductibles; How To More Equitably Distribute The Risks Of Medical Malpractice And Adequately Compensate Victims Without Statutory Damage Caps., Bradford Luke Ledbetter

ExpressO

No abstract provided.

Ethics And E-Medicine, Jessica Wilen Berg

Faculty Publications

The computer revolution has had enormous effect on all aspects of the practice of medicine from scheduling and billing, to treatments, to research and beyond. This article focuses on the impact of new internet technologies on relationships between physicians and patients. These forms e-medicine may be utilized outside the confines of a pre-existing relationship, and thus have the potential to replace rather than merely augment traditional medical care. They change the setting and nature of the physician-patient relationship and thereby alter how medicine is practiced.

Initial discussions of this issue implied that e-medicine was problematic because it failed to create …

Constructing Competence: Formulating Standards Of Legal Competence To Make Medical Decisions, Jessica Wilen Berg

Faculty Publications

A young woman twenty-six weeks pregnant and dying from cancer lies heavily sedated and attached to a respirator. Is she competent to determine what life-prolonging measures should be taken, or to consent to an emergency cesarean section that may save her fetus but will probably shorten her life? A quadriplegic young man wishes to end his life and requests a court order granting immunity for the medical staff who will unhook his respirator and administer sedatives. Is he competent to choose to die? A person's competence will have implications for whether he or she is allowed to decide what type …

Health Benefits In Retirement: Set For Extinction?, Mark Merlis

National Health Policy Forum

Nearly 18 million people rely on employer-provided retiree health benefits to fill gaps in Medicare’s coverage or to provide basic insurance until they reach Medicare age. Rising costs have led many employers to limit benefits, require participants to pay a larger share of the costs, or stop offering coverage at all for workers who have not yet retired. This background paper describes recent developments in retiree health benefits, possible future trends, and policy options for slowing the erosion of coverage or providing alternative ways for retirees to meet their expected medical expenses.

Autonomy Suspended: Using Female Patients To Teach Intimate Exams Without Their Consent, Robin Fretwell Wilson

Faculty Scholarship

Recent reports of medical students performing pelvic exams for training purposes on anesthetized women without their consent have produced a firestorm of controversy. Peter Ubel and colleagues found that 90% of medical students performed such exams during their obstetrics/gynecology rotations. A series of 2003 reports focused a white-hot spotlight on this teaching practice and resulted in Federal Trade Commission and Department of Justice hearings and action by the American Association of Medical Colleges and the American College of Obstetrics and Gynecology. In this article, Professor Wilson examines the merits of the defenses and justifications for using female patients for pelvic …

Genetic Databases And Biobanks: Who Controls Our Genetic Privacy?, Yael Bregman-Eschet

ExpressO

In the past several years a growing number of private biotech companies have been collecting and storing our genetic information and bodily tissues and linking it to life-long medical histories. Many of these commercial companies have close relationships with the public sector: they rely on public institutions to get access to certain medical data and tissue samples, while the public sector relies on those companies for commercial exploitation of the research. Despite the unique nature of the information collected and the sensitivity of genetic databases, these private bio-libraries are largely unregulated in the United States. This article examines who has …

Aids Prevention And The Right To Health Under International Law: Burma As The Hard Case, Rhianna M. Fronapfel

Washington International Law Journal

Many commentators suggest that states have a human rights obligation to prevent the spread of HIV/AIDS within their borders. Specifically, state HIV/AIDS prevention obligations are often premised on the “right to health” contained within many international human rights documents. Other approaches encourage states to implement AIDS prevention measures by emphasizing the detrimental effects of AIDS on economies and national and international security instead. Many commentators who adhere to the health-and-human-rights model, however, reject such other approaches as overly concerned with the interests of developed countries and lacking the ethical focus that underlies health and human rights. Implicit in such arguments …