Law Commons^™

Brave New Eugenics: Regulating Assisted Reproductive Technologies In The Name Of Better Babies, Kerry Macintosh

Kerry L Macintosh

Infertile men and women have been using assisted reproductive technologies (“ART”) to conceive children since the first “test-tube baby” was born in 1978. During the past decade, however, the federal government has begun to clamp down on ART, asserting safety concerns as grounds for banning novel technologies such as cloning, nuclear transfer, and ooplasm transfer. Some scholars and policymakers now want to extend governmental regulation to include conventional ART such as in vitro fertilization (“IVF”) and intracytoplasmic sperm injection (“ICSI”). They claim children conceived through ART face an increased risk of birth defects and other health problems. This Article examines …

Biobanking Newborn Bloodspots For Genetic Research Without Consent, Sandra J. Carnahan

sandra j carnahan

BIOBANKING NEWBORN BLOODSPOTS FOR GENETIC RESEARCH WITHOUT CONSENT

Professor Sandra J. Carnahan

Abstract

State public health programs mandate newborn screening shortly after birth for various genetic disorders that may have serious health consequences if not identified and treated very early in life. Given the individual and public health benefit, most of states conduct newborn screening programs without parental consent. Recently, two high-profile lawsuits have brought to the public's attention that some states are creating research biobanks, storing their newborn bloodspots, and disseminating them to outside entities for genetic research purposes that are unrelated to the original purpose for which the …

The Parentless Child's Right To A Permanent Family, Joseph S. Jackson, Lauren G. Fasig

Joseph S. Jackson

Abstract More than 420,000 children in the United States are in foster care, and more than 110,000 of them are waiting to be adopted. State adoption statutes typically seek to achieve adoption for these children as promptly as possible, but some limit the pool of potential adoptive parents in one way or another. In this Article, we argue that such restrictions violate the State’s constitutional duties to parentless children in its care. Specifically, we contend that children in State custody have a substantive liberty interest in a secure and stable family relationship, because such a relationship is essential in order …

Is The Attorney-Client Privilege A Privilege Of The Rich? Federal Hmis Database Reporting And Homeless Client Confidentiality, Jennifer Hammitt

Jennifer Hammitt

The Homeless Management Information System (HMIS) is a new database reporting system mandated by the Department of Housing and Urban Development to track the usage of HUD services by homeless people. The HMIS requires collecting identifiable personal information about the individuals who use the services and entering that information into a database that enables information sharing and referral services. This comment arose out of an investigation into the HMIS database and confidentiality issues that I did while working at Legal Services of Greater Miami, Inc., as part of the Homeless Legal Assistance Project in the summer of 2009. As this …

Post-Firestone Skirmishes: "Obama Care", Discretionary Clauses And Judicial Review Of Erisa Plan Administrator Decisions, Maria Hylton

Maria Hylton

Ever since the Supreme Court's Firestone decision, ERISA plan administrators have been almost completely insulated from meaningful review in benefit denial cases. The new PPACA (sometimes referred to colloquially as "Obama Care" guarantees independent, external review in benefit denial cases to participants who want to pursue a claim prior to bringing an action in federal court. This paper evaluates the ongoing efforts of states to expand the availability of meaningful external review up until passage of the PPACA and examines the new statute's provisions for ensuring independent evaluation of claims. This article concludes that in spite of the Supreme Court's …

Rhetorical Federalism: The Role Of State Resistance In Health Care Decisionmaking, Elizabeth Leonard

Elizabeth A. Weeks

This Article makes the affirmative case for the widespread trend of state resistance to the recently enacted, comprehensive federal health reform law, the Patient Protection and Affordable Care Act of 2010, or ACA. A significant number of states have engaged in various forms of objection to the new federal laws, including filing lawsuits against the federal government and enacting state laws providing that ACA will not apply to residents of the state. This Article identifies reasons why those actions should not be disregarded simply as Tea Party antics or election-year gamesmanship but instead should be considered valuable to the health …

Will Employers Undermine Health Care Reform By Dumping Sick Employees?, Daniel Benjamin Schwarcz, Amy Monahan

Daniel Benjamin Schwarcz

This Article argues that federal health care reform may induce employers to redesign their health plans to encourage high-risk employees to opt out of employer-provided coverage and instead acquire coverage on the individual market. Although largely overlooked in public policy debates, this prospect of employer dumping of high-risk employees raises serious concerns about the sustainability of health care reform. In particular, it threatens the viability of individual insurance markets and insurance exchanges by raising the prospect of adverse selection caused by the entrance of a disproportionately high-risk segment of the population. This risk, in turn, threatens to indirectly increase the …

Playing God: The Legality Of Plans Denying Scarce Resources To People With Disabilities In Public Health Emergencies, Wendy F. Hensel, Leslie E. Wolf

Wendy F. Hensel

The threat of an international pandemic captivated much of the news media in 2009. The spread of H1N1 in the United States ultimately prompted President Obama to declare a state of national emergency. It was predicted that hospitals would be overburdened and shortages would occur, necessitating difficult decisions about who should get access to scarce medical resources, such as ventilators and critical care beds. Few questions are more ethically or legally loaded than determining who will receive scarce medical resources in the event of a wide-spread public health emergency. The answer will often mean the difference between life and death …

Fueling The Coal War--The Courts, The Feds, And The Epa: Who Is In A Better Position To Curb Coal-Related Pollution?, Corwyn Davis

Corwyn M Davis

ABSTRACT: With the United States’ continued and growing dependence on the use of coal for energy production, it is vital that the country examines ways to eliminate coal wastes more efficiently. The courts have varying opinions on who should ultimately bear responsibility for environmental torts connected with carbon pollution. With greenhouse gases and global warming stealing the environmental spotlight, the equally hazardous nature of coal combustion waste disposal has taken a back door to national policy reform. This paper introduces the problems associated with the disposal of this hazardous by-product. By analyzing the status quo of environmental regulation, it becomes …

No Role For Apology: Remedial Work And The Problem Of Medical Injury, Steven Raper

Steven E Raper MD

The past decade has produced ample evidence that patients are injured by medical care. A landmark document “To Err is Human” articulated a way to protect patients based on analysis of health care organizations according to complex systems and principles of human performance rather than “blame and shame”. To understand how to prevent injury, full – but protected – disclosure is required as well as institutional will to change. The literature is full of success stories all of which are based on frank and honest reporting of adverse events. Central to such reporting and analysis is the ability to discuss …

Antidote: Strategies For Containing America's Runaway Health Care Costs, Leslie Meltzer Henry, M. Gregg Bloche

Leslie Meltzer Henry

Soaring healthcare costs have put medical spending at the top of the national agenda and in the spotlight of the 2008 elections. Both the public and private spheres are struggling with this urgent problem. Medicare and Medicaid spending are straining federal and state budgets, private employers are abandoning coverage or shifting costs to workers and their families, and firms that provide generous coverage are risking their competitiveness in the global economy. Meanwhile, nearly 50 million uninsured Americans remain hostage to uncontrolled health costs, while the combustible combination of third-party payments and technological advances continues to fuel spending. Quality and value …

Putting The Gene Back In The Bottle: Why California Needs Stronger Protection Of Genetic Privacy In The Wake Of Affordable Dna Testing, Farid Zakaria

Farid Zakaria

In recent years, many “direct-to-consumer” genetic testing companies have started offering a DNA analysis service to the public. Based on the analysis of the DNA contained in saliva, these companies are able to inform the customer about his or her likelihood of having certain traits and of developing a number of diseases. Given the sensitive nature of this kind of information, this paper considers whether it is sufficiently protected under the current legal and regulatory framework. Specifically, the paper studies whether current federal, state, and common law that protects medical and private information also guarantees the privacy of genetic information. …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Medicine That Works: The Road Not Taken In Healthcare Reform, Julie C. Suk

Julie C Suk

Although the immediate future of healthcare reform remains uncertain, it is clear that significant long-term improvements to American healthcare will require effective methods of controlling healthcare costs that go beyond those currently being proposed. The United States lags behind many European countries in health, spending much more of its GDP on healthcare while posting worse health outcomes, largely due to the increased prevalence of preventable chronic conditions. This article exposes an important but often ignored component of European preventive healthcare: the law of workplace health and safety, which imposes on employers the positive duty to identify and prevent harms to …

Neuroimaging And Competency To Be Executed After Panetti, Michael L. Perlin

Michael L Perlin

Scholars have begun to consider the impact of neuroimaging evidence on capital punishment trials, questioning whether reliance on such testimony can actually make “sentencing more rational and humane.” They have also considered the impact of this evidence on criminal sentencing, expressing concern that such evidence will be improperly used “as predictive factors to increase sentences,” and counseling policymakers to “avoid misuse of new techniques.” In an earlier article on neuroimaging and criminal procedure, I considered the questions of a criminal defendant’s competency to submit to neuroimaging testing, and the impact of antipsychotic medications on the results of such testing.

What …

Improving The Fda Approval Process, Anup Malani

Anup Malani

The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients to respond differently to a drug. Therefore, the average-patient standard can reject a drug that benefits certain patient subgroups (false negative) and even approval a drug that harms other patient subgroups (false positives). These errors increase the cost of drug development – and thus health care – by wasting research on unproductive or unapproved drugs. The reason why the FDA sticks with an average patient standard is …

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith

George P Smith

Abstract

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions are central to managing pain which induces suffering. At the end-stage of life, an inextricable component of an ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as efficacious palliative treatment and as a reasonable medical procedure in order to safeguard a “right” to …

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …

Erisa Preemption Of State 'Play Or Pay' Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Avoiding The Avoidable: Why State Laws Need To Protect Kids From Airbags, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.