Law Commons^™

King V. Burwell - The Supreme Court Upholds Federal Subsidies For State And Federal Health Insurance Exchanges, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

Regulatory Updates To Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan

Mary Ann Chirba

No abstract provided.

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …

Legal Methodologies For Maximizing Freedom Of Scientific Research, Charles Baron

Charles H. Baron

No abstract provided.

Review Of Future Issues In Health Care: Social Policy And The Rationing Of Medical Services, By David Mechanic, Charles Baron

Charles H. Baron

No abstract provided.

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Harmonizing The Affordable Care Act (Obama Care) With The Three Main National Systems For Healthcare Quality Improvement: The Tort, Licensure And Hospital Peer Review Systems, K Van Tassel

Katharine A. Van Tassel

According to an estimate by the Institute of Medicine made over a decade ago, treatment errors in hospitals alone caused 98,000 deaths yearly. This IOM report is proving to be very conservative. A recent Consumer Reports investigation came to the conclusion that “[m]ore than 2.25 million Americans will probably die from medical harm this decade…. That’s like wiping out the entire populations of North Dakota, Rhode Island, and Vermont. It’s a manmade disaster.”

One of the reasons for this astonishing mortality rate is the normative practice of custom-based medicine in the United States. A large and rapidly growing group of …

Stigma And The Emerging Law Of Obesity Control, Lindsay F. Wiley

Lindsay Wiley

Scholars have proposed a wide range of legal tools for fighting the obesity epidemic by altering the obesigenic environment: zoning regulations to create more physically active communities; taxes, bans and subsidies to create a healthier food marketplace; and disclosure requirements and advertising restrictions to alter the information environment. As policymakers take up the war on obesity, however, these promising environmental interventions are losing out to cheaper and more politically palatable interventions that target obese individuals in an effort to convince them to lose weight. For example, recent reforms have encouraged employers and insurance companies to penalize obese people through higher …

Agencies In Crisis?: An Examination Of State And Federal Agency Emergency Powers, Babette Boliek

Babette Boliek

That state and federal agencies have emergency powers, is well known. Much less is known about the process and circumstances under which these powers are exercised—subjects that divide scholars into two theoretical camps. Scholars on one side assert that ample agency discretion in time of need is not only desirable, but it is laudable in the pursuit of efficiency and “deossification” of regulatory action. Scholars on the other side contend that emergency powers are so broadly granted, and representative procedure is so easily abandoned, that the inevitable result is agency unaccountability and aggrandizement. In response, this article presents new empirical …

Patient Protection And Decision Aid Quality: Regulatory And Tort Law Approaches, Nadia N. Sawicki

Nadia N. Sawicki

One of the most enduring debates at the intersection of administrative and tort law focuses on the challenge of identifying the most effective means of ensuring consumer safety. In some circumstances, standard-setting administrative regulations may be sufficient to protect consumers from harm while at the same supporting the growth of valuable industries. In other circumstances, regulation may need to be supplemented by a complementary tort regime that fills the compensation gap when consumers suffer injury. The discussion among policymakers and legal scholars about which system to favor is continually playing out in a variety of arenas, most notably in the …

Opening Doors: Preventing Youth Homelessness Through Housing And Education Collaboration, Courtney L. Anderson

Courtney L Anderson

This article will contribute to the general literature on homelessness by recommending that permanent supportive housing units for homeless children, youth and families provide education services in order to prevent and end homelessness among families, youth and children. I will explain how the legal framework for such housing requires a broad interpretation of the McKinney-Vento Homeless Assistance Act, and assert that federal programs provide a foundation for the creation of such housing. Identifying and educating homeless youth is particularly challenging as the majority of homeless youth live on the streets or in the homes of others, suffer from serious mental …

"A Necessary Cost Of Freedom"? The Incoherence Of Sorrell V. Ims, Tamara R. Piety

Tamara R. Piety

On June 23, 2011 the Supreme Court announced its decision in a closely watched case, Sorrell v. IMS, striking down Vermont’s law prohibiting pharmacies from selling physicians’ prescription records without their permission for use in marketing brand name drugs. The Court’s majority struck down Vermont’s statute as unconstitutional on the grounds that the law was not “content neutral” because it singled out marketing for disparate treatment. It in effect applied a strict scrutiny test to a category of speech that has technically if not in practice been subject to intermediate scrutiny. This ruling effectively does away with the commercial speech …

Erisa Preemption Of Provider Reimbursement Litigation Post-Ppaca:Some Things (Unfortunately) Never Change, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

No abstract provided.

Emerging Federal And International Guidelines For Stem Cell Research: Increased Funding Increases The Need For Consensus, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

The [Sur]Reality Of Mental Health Parity For Adolescent Psychiatric Disorders And Developmental Disabilities, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.

The Vaccine Efficacy Standard: Ethical And Policy Concerns In Light Of Emerging Vaccines, Vincent Y. Ling

Vincent Y. Ling

An efficacy showing is one prerequisite for market approval of vaccines in the United States. The Food and Drug Administration’s current standard for efficacy, however, is low and vague, which allows partially effective vaccines on the market. The use of partially effective vaccines poses an ethical dilemma, especially when more effective vaccines are, or will be, available. Non-regulatory forces contribute to a higher efficacy showing in practice, but more instructive efficacy regulation will be necessary as partially effective vaccines become a viable health care option. A growing emphasis on comparative effectiveness research under the Patient-Centered Outcomes Research Institute (“PCORI”), established …

Addressing Access To Medicine: The Influence Of Competing Patent Perspectives, Cynthia M. Ho

Cynthia M Ho

Promoting access to affordable medicine for poor countries is considered important by a wide range of actors, including not only rich and poor countries, but also public health advocates, patent owners, and scholars. However, promoting access has been elusive. Public health advocates argue that access to medicine is increasingly difficult due to changes in domestic and international laws that limit access to unpatented and low-cost generic drugs by expanding the scope of patent rights. Patent owners and some countries deny these claims while simultaneously advocating for more expansive patent rights as necessary to promote innovation and development. This article addresses …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, K Van Tassel, R Goldman

Katharine A. Van Tassel

Consumers in the United States are being exposed to steadily increasing levels of novel and untested engineered nanoparticles as a result of their contact with everyday consumer products. Nanoparticles are very small particles that are engineered using innovative technologies to be 1 to 100 nanometers in size. Just how small is small? In comparison, a human hair is 80,000 nanometers wide. Nanoscale materials are increasingly being used in a wide variety of areas, including electronic, magnetic, medical imaging, drug delivery, catalytic, materials applications, and cosmetic products. According to the National Institute of Occupational Health, new nanotechnology consumer products are coming …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, K Van Tassel, R Goldman

Katharine A. Van Tassel

Consumers in the United States are being exposed to steadily increasing levels of novel and untested substances as a result of their contact with consumer products containing nanoparticles. Hundreds of consumer products are being marketed for human consumption, including food, dietary supplements, cosmetics and sunscreens. This expanding market ignores the growing scientific understanding that nanoparticles can create unintended human health and environmental risks. This Article discusses the public health, regulatory, legal and ethical issues raised by the developing appreciation of the health risks associated with nanotech products and is arranged as follows. After this Introduction, this Article describes the present …

The Hollow Promise Of Freedom Of Conscience, Nadia N. Sawicki

Nadia N. Sawicki

Two hundred years ago, Thomas Jefferson asserted that no law “ought to be dearer to man than that which protects the rights of conscience against the enterprises of the civil authority." Since then, freedom of conscience has continued to be heralded as a fundamental principle of American society. Indeed, many current policy debates – most notably in the medical and military contexts – are predicated on the theory that claims of conscience are worthy of legal respect. This Article challenges established assumptions, concluding that claims about the importance of conscience in American society have been highly exaggerated.

This Article first …

The Abortion Informed Consent Debate: More Light, Less Heat, Nadia N. Sawicki

Nadia N. Sawicki

State abortion informed consent laws – including those requiring physicians to disclose that abortion terminates the life of a “whole, separate, unique, living human being” or display ultrasound images to patients seeking abortions – are being adopted at a rapid pace. Health law scholars who oppose these laws uniformly criticize them as being fundamentally inconsistent with the doctrine of informed consent. This Article directly challenges this conventional approach. It argues that the doctrine of informed consent does not impose nearly as significant a barrier to abortion disclosure laws as many critics claim. Rather, the ethical and legal principles of informed …

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

Jennifer Hammitt

No abstract provided.

Due Process In Civil Commitments, Alexander Tsesis

Alexander Tsesis

In one of its most controversial decisions to date, United States v. Comstock, the Roberts Court upheld a federal civil commitment statute requiring only an intermediate burden of proof. The statute provided for the postsentencing confinement of anyone proven by “clear and convincing evidence” to be mentally ill and dangerous. The law relied on a judicial standard established more than thirty years before. The majority in Comstock missed the opportunity to reassess the precedent in light of recent psychiatric studies indicating that the ambiguity of available diagnostic tools can lead to erroneous insanity assessments and mistaken evaluations about patients’ likelihood …

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 …

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. …

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.

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 …