Health Law and Policy Commons^™

Non-Beneficial Pediatric Research And The Best Interest Standard: A Reconciliation, Paul J. Litton

Faculty Publications

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children …

Health Courts?, Philip G. Peters Jr.

Faculty Publications

This article undertakes the first detailed critique of the proposal from Common Good and the Harvard School of Public Health to replace medical malpractice jury trials with adjudication before specialized health courts. Professor Peters concludes that the modest benefits likely to be produced by the current health court proposal are matched by the risks of bias and overreaching that these courts would also present. Missing from the plan is the doctrinal change mostly likely to improve patient safety - hospital enterprise liability. Without enterprise liability, the health court proposal is unlikely to achieve its patient safety goals and, as a …

"Medicover": A Proposal For National Health Insurance, Maxwell J. Mehlman

Faculty Publications

This Article provides a description of the events leading up to the workshop, the discussion that took place, and the proposal that emerged. The proposal is intended to be a discussion document rather than a final product. It needs greater detail, a clearer sense of its costs and financing mechanisms, and input from stakeholders. Nevertheless, the workshop participants believe that Medicover may be a viable option for helping to solve the current health care crisis.

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, …

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 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 …

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 …

The Case Against Smoking Bans, Thom Lambert

Faculty Publications

In recent months, numerous localities and states have banned smoking in public places (i.e., privately owned places to which members of the public are invited). Such sweeping bans are typically justified on grounds that they alleviate externalities, shape individuals' preferences in a desirable manner, and reduce risks. This essay rebuts the externality, preference-shaping, and risk-reduction arguments for smoking bans and contends that such bans are unnecessary and, on the whole, utility-reducing.

A Right To No Meaningful Review Under The Due Process Clause: The Aftermath Of Judicial Deference To The Federal Administrative Agencies, Ruqaiijah Yearby

Faculty Publications

The Due Process Clause of the Fifth Amendment has been perverted in the federal administrative system. For example, federal agencies, such as the U.S. Department of Health and Human Services (HHS), regularly deprive individuals of liberty and property with little to no review. In its regulation of the health care industry through the Medicare program, HHS often turns a blind eye to procedural Due Process protections, such as providing individuals an opportunity to challenge the deprivation of property at a hearing, even though the Constitution, the Administrative Procedure Act, and the Medicare Act grant these protections. The Medicare compliance hearing …

The Ambiguous Meaning Of Human Conception, Philip G. Peters Jr.

Faculty Publications

Nearly all of the state and federal laws that treat embryos as persons contain a fundamental ambiguity. Contrary to common belief, there is no "moment" of conception. Instead, conception is a forty-eight hour process, during which the haploid genomes of the sperm and egg are gradually and precisely transformed into the functioning diploid genome of a new human embryo. During that two-day period, many common clinical and laboratories activities take place, including the culling of unsuitable embryos, the freezing of others, and the testing of embryos for genetic abnormalities. The legal status of these activities will turn on the point …

The Necessity Of Sex Change: A Struggle For Intersex And Transsex Liberties, Noa Ben-Asher

Faculty Publications

(Excerpt)

Transsex individuals often desire the future body that they should have, while intersex individuals often mourn the body they had before an unwanted normalizing surgery interfered with it. Thus, Judith Butler, a dominant feminist-queer theorist who has had a significant role in the shaping of queer theory and politics since the early 1990s, has lately commented that "intersex and transsex sometimes seem to be movements at odds with each other, the first opposing unwanted surgery, the second sometimes calling for elective surgery ...." This proposition serves as a point of departure for this Article, which explores current legal …

Genetic Enhancement: Plan Now To Act Later, Maxwell J. Mehlman

Faculty Publications

No abstract provided.

Is It Too Late For Title Vi Enforcement?: Seeking Redemption Of The Unequal United States‟ Long Term Care System Through International Means, Ruqaiijah Yearby

Faculty Publications

Legal and medical experts have noted continued racism in the health care system that prevents the equal distribution of quality care. Initially most racism was intentional and expressed through de jure segregation, as evidenced by federal funding of the construction of racial segregated health care facilities. Now most racism, expressed through de facto segregation, is subtly incorporated into the daily practices of institutions causing an adverse disparate impact on African-Americans. This institutional racism establishes separate and independent barriers through the neutral denial of opportunities and equal rights to individuals and groups that results from the normal operations of the institutions …

Owning Persons: The Application Of Property Theory To Embryos And Fetuses, Jessica Wilen Berg

Faculty Publications

Embryos are all over the news. According to the New York Times there are currently 400,000 frozen embryos in storage. Headlines proclaim amazing advances in our understanding of embryonic stem cells. And legislation involving cloning and embryos continues to be hotly debated. Despite the media attention, theoretical analysis of embryos' legal status is lacking.

This article advances a number of novel arguments. First, recognition of property interests does not preclude the recognition of personhood interests. Embryos, fetuses and children may be both persons and property. Second, property law is conceptually more suited to resolving debates about embryos than procreative liberty, …

Preserving A Precious Resource: Rationalizing The Use Of Antibiotics, Eric Kades

Faculty Publications

No abstract provided.

Good Enough To Use For Research, But Not Good Enough To Benefit From The Results Of That Research: Are The Clinical Hiv Vaccine Trials In Africa Unjust?, Ruqaiijah Yearby

Faculty Publications

The epidemic of the Human Immunodeficiency Virus (HIV) infection in Sub-Saharan Africa, the region most affected by the HIV pandemic and where HIV is the leading cause of death, is reaching insurmountable proportions. In fact, out of the 36.1 million HIV infections worldwide, 25.3 million, seventy percent, are in Sub-Saharan Africa. Additionally, of the more than 15,000 people who are infected with HIV every day, ninety-five percent of the cases are in populations that live in developing countries such as those located in Sub-Saharan Africa. Due to the significant number of Africans infected with HIV, many researchers and ethicists have …

Symposium: Issues In Bioterrorism -Introduction, Jessica Wilen Berg

Faculty Publications

This issue of Health Matrix focuses on the legal issues involving bioterrorism.

Regulating Clinical Research: Informed Consent, Privacy, And Irbs, Sharona Hoffman

Faculty Publications

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task.

Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical …

Genetic Health And Eugenics Precedents: A Voice Of Caution, Larry I. Palmer

Faculty Publications

No abstract provided.

Unwarranted Variations In The Quality Of Health Care: Can The Law Help Medicine Provide A Remedy/Remedies?, Philip G. Peters Jr., John E. Wennberg M.D.

Faculty Publications

This article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed …

Income Tax Planning For Long-Term Care, David M. English

Faculty Publications

Planning for long-term involves more than the preparation of powers of attorney and counseling on possible asset transfers to qualify for Medicaid reimbursement. Steps should also be taken to make certain that the person receiving care continues to file an income tax return and does so at a minimum possible income tax cost. Practitioners should be familiar with the procedure for filing a return on behalf of an incapacitated individual. The medical expense deduction, while of little importance for most taxpayers, is critical for many elderly, particularly for those receiving long-term care. Long-term care insurance and life insurance may be …

The Role Of Jury In Modern Malpractice Law, Philip G. Peters Jr.

Faculty Publications

This article explores the policy issues raised by the choice between a custom-based standard of care and a jury-determined reasonability standard. The author examines not only traditional legal arguments but also the recent findings of cognitive psychology, jury performance studies, and health industry research. Not surprisingly, this analysis reveals that both options are imperfect. However, the author cautiously recommends the reasonable physician standard. The revolutionary transformation of the health care industry in last quarter of a century has transferred considerable power from physicians to the health insurance industry, an industry that has not yet earned the privilege of self-regulation. Unlike …

Aids Caps, Contraceptive Coverage, And The Law: An Analysis Of The Federal Anti-Discrimination Statutes’ Applicability To Health Insurance, Sharona Hoffman

Faculty Publications

Traditionally, health insurers have enjoyed the freedom to determine their own terms of coverage, to decide to what extent, if any, patients should be reimbursed for different kinds of treatment, and to establish premium prices. Health insurers typically deny coverage for speech therapy, eye glasses, hearing aids, most foot care, and treatment for infertility. Many insurance providers also exclude or severely limit coverage for mental health, dental care, AIDS, diabetes mellitus, morbid obesity, epilepsy, and alcoholism or drug abuse. Therefore, while some Americans enjoy full coverage for all their health needs, others who have insurance and suffer from serious or …

Disease Management And Liability In The Human Genome Era, Larry I. Palmer

Faculty Publications

No abstract provided.

The Uniform Health-Care Decisions Act And Its Progress In The States, David M. English

Faculty Publications

Over the past decade, planning for health care decision making through the making of an advance directive has become a routine part of personal counseling. Public interest in the subject has been fueled by well-publicized cases such as Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990). In response to this interest, most states authorize their citizens to make at least one form of advance directive: all states statutorily authorize powers of attorney for health care, and all but Massachusetts, Michigan and New York authorize living wills. State legislation has been a mixed blessing. Although intended to facilitate …

The Use Of Placebos In Clinical Trials: Responsible Research Or Unethical Practice?, Sharona Hoffman

Faculty Publications

Developments in medical research have been occurring at a rapidly increasing rate during the past two decades. Expanding budgets, augmented computer capabilities, and new research tools have all dramatically enhanced research technology. Accompanying the proliferation of medical research are increasing concerns about research risks. This article focuses on placebo-controlled clinical trials. The use of placebos enables clinical investigators to compare results from subjects taking an experimental intervention to results from a group that is receiving an inactive substance, such as a sugar pill, in order to determine the efficacy of the new medication. In recent years, some surgeons have also …

The Integrity Of Death: Resolving Dilemmas In Medicine, Larry I. Palmer

Faculty Publications

No abstract provided.

Nursing Home Residents And The New California Health Care Decisions Law, David M. English, Rebecca C. Morgan

Faculty Publications

This article explores issues involving advance directives made by nursing home residents, both prior to and during their stay in a facility, including the frequency of making directives, the reasons why residents fail to make directives, and the reasons why facilities often fail to honor them. Specifically, this article examines these issues in light of the 1999 California Health Care Decisions Law, effective July 1, 2000, and focuses on how this new statute can be used to empower nursing home residents, and adults more generally, to take control of decisions regarding their own health care.