Health Law and Policy Commons^™

Can Clinical Genetics Laboratories Be Sued For Medical Malpractice?, Ellen Wright Clayton, Alexandra L. Foulkes, Jessica L. Roberts, Et Al.

Vanderbilt Law School Faculty Publications

From a legal perspective, is a clinical laboratory a healthcare provider? Physicians are clearly healthcare providers who owe their patients the associated fiduciary duties. It is less clear, however, which-if any-legal duties genetic testing labs owe to the individuals who seek their services.

The question of whether clinical genetics laboratories are healthcare providers for legal purposes may be thornier than it could initially appear. Clinical genetics laboratories perform multiple tasks. Most significantly, they sequence genetic samples and then interpret the results. As "next generation sequencing" has become more accessible,' labs can generate and interpret more sequence data for a growing …

How Planned Parenthood V. Casey (Pretty Much) Settled The Abortion Wars, Neal Devins

Faculty Publications

More than twenty-one years after Robert Bork's failed Supreme Court nomination and seventeen years after Planned Parenthood of Southeastern Pennsylvania v. Casey, the rhetoric of abortion politics remains unchanged. Pro-choice interests, for example, argue that states are poised to outlaw abortion and that Roe v. Wade is vulnerable to overruling. In this Essay, I will debunk those claims. First, I will explain how Casey's approval of limited abortion rights reflected an emerging national consensus in 1992. Second, I will explain why the Supreme Court is unlikely to risk political backlash by formally modifying Casey- either by restoring the trimester test …

Surrogacy And The Politics Of Commodification, Elizabeth S. Scott

Faculty Scholarship

In 2004, the Illinois legislature passed the Gestational Surrogacy Act, which provides that a child conceived through in vitro fertilization (IVF) and born to a surrogate mother automatically becomes the legal child of the intended parents at birth if certain conditions are met. Under the Act, the woman who bears the child has no parental status. The bill generated modest media attention, but little controversy; it passed unanimously in both houses of the legislature and was signed into law by the governor.

This mundane story of the legislative process in action stands in sharp contrast to the political tale of …

Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …

Glass Houses: The Power Of Money In Bioethics Research, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper I explore the power of money in bioethics research and ask whether, while casting stones regarding financial conflicts of interest in health research, bioethics researchers are in fact living in glass houses. I first review the need for money in bioethics research, the sources of money, and key features of the money (specifically, the amount of money involved and the fact that the money often is embedded, encumbered, and required to be matched). Next, I explore a range of possible objectives for the money transfer. I then examine the effects of this transfer and raise some questions …

Human Rights In Health Equity: Cervical Cancer And Hpv Vaccines, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article seeks to demonstrate that health equity, as an empirical and normative concept, is reflected in the human rights to health and equality under international law. The obligations on government that flow from health equity as a human right are then examined. These include the obligation to act in pursuit of health equity as a policy objective, and the obligation to enact measures to ensure health equity as a policy outcome. These obligations are considered in relation to a promising remedial measure for social disparities in cervical cancer: HPV vaccines.

Moral Authority In English And American Abortion Law, Joanna Erdman

Articles, Book Chapters, & Popular Press

In R. (on the application of Axon) v. Secretary of State for Health & Another, the English High Court affirmed that young women are entitled to seek and receive sexual health care, including abortion care, without parental notification. This chapter examines the Court’s use of comparative constitutional authorities in its reasoning, focusing on the rejection of American authorities. Contrast and rejection, it is argued, can be an exercise in self-reflection, revealing how a court understands its own constitutional approach. Aversive constitutionalism presents opportunities to deconstruct claimed similarities and differences in constitutional approaches, to uncover and contest characteristics and assumptions otherwise …

Public Health Protection And Drinking Water Quality On First Nation Reserves: Considering The New Federal Regulatory Proposal, Constance Macintosh

Articles, Book Chapters, & Popular Press

In January 2009, the federal government issued a discussion paper that details its preferred regulatory route for enabling a legislative framework. This route is to referentially incorporate provincial legislation regarding operational standards through a framework statute, and then develop the details of the regime through regulations to be developed in consultation with First Nations over the next few years. Importantly, the opening sentence of the discussion paper's executive summary expressly connects water and public health. It reads: "The provision of safe drinking water and the effective treatment of wastewater are critical in ensuring the health and safety of First Nations …

The Manitoba College Of Physicians And Surgeons Position Statement On Withholding And Withdrawal Of Life-Sustaining Treatment (2008): Three Problems And A Solution, Jocelyn Downie, Karen Mcewen

Articles, Book Chapters, & Popular Press

The College of Physicians and Surgeons of Manitoba (CPSM) recently issued a Statement on Withholding and Withdrawl of Life-Sustaining Treatment (2008). The College should be given enormous credit for trying to provide guidance with respect to physicians' obligations in an area of great confusion and controversy. Unfortunately, however, there are some very serious flaws in the Statement. In this paper, we describe three major problems with it that we believe make the case for the claim that the Statement must be revised. We then provide a revised statement that, if adopted, could represent significant progress as it would provide: greater …

Safety First: Recognizing And Managing The Risks To Child Participants In Magnetic Resonance Imaging Research, Matthias Schmidt, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Specialized and up-to-date knowledge is required to identify and manage the risks associated with advanced biomedical research. Additional complexities need to be considered when the research involves infants or young children. In this article, we focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps. With an eye to assisting institutional review boards and researchers, we consider strategies for the management of these risks and formulate key questions aimed at exposing hidden hazards. Institutional review boards should ask these questions, and researchers should bear them in mind as they develop research protocols.

Medical Hope, Legal Pitfalls: Potential Legal Issues In The Emerging Field Of Oncofertility, Gregory Dolin, Dorothy E. Roberts, Lina M. Rodriguez, Teresa K. Woodruff

All Faculty Scholarship

The article will begin its discussion by identifying the values at stake in the field of oncofertility. These values include the constitutional protection of the rights of women and minors to bear children and to use reproduction-assisting technologies, as well as the feminist critique of gendered expectations that may pressure women to use these technologies.

Part III will focus on the medical options of oncofertility. It will also discuss some conditions that may lead otherwise fertile and young patients to lose their ability to bear children as a side-effect of necessary medical treatment. The article will then proceed to discuss …

A Kernel For Open Source Drug Discovery In Tropical Diseases, Leticia Ortı, Rodrigo J. Carbajo, Ursula Pieper, Narayanan Eswar, Stephen M. Maurer, Arti K. Rai, Ginger Taylor, Matthew H. Todd, Antonio Pineda-Lucena, Andrej Sali, Marc A. Marti-Renom

Faculty Scholarship

Open source drug discovery, a promising alternative avenue to conventional patent-based drug development, has so far remained elusive with few exceptions. A major stumbling block has been the absence of a critical mass of preexisting work that volunteers can improve through a series of granular contributions. This paper introduces the results from a newly assembled computational pipeline for identifying protein targets for drug discovery in ten organisms that cause tropical diseases. We have also experimentally tested two promising targets for their binding to commercially available drugs, validating one and invalidating the other. The resulting kernel provides a base of drug …

Social Factoring The Numbers With Assisted Reproduction, Bridget J. Crawford, Lolita Buckner Inniss

Publications

In early 2009 the airwaves came alive with sensational stories about Nadya Suleman, the California mother who gave birth to octuplets conceived via assisted reproductive technology. Nadya Suleman and her octuplets are vehicles through which Americans express their anxiety about race, class and gender. Expressions of concern for the health of children, the mother's well-being, the future of reproductive medicine or the financial drain on taxpayers barely conceal deep impulses towards racism, sexism and classism. It is true that the public has had a longstanding fascination with multiple births and with large families. This is evidenced by a long history …

Why We Should Ignore The “Octomom”, Kimberly D. Krawiec

Faculty Scholarship

No abstract provided.

Theorizing And Generalizing About Risk Assessment And Regulation Through Comparative Nested Analysis Of Representative Cases, Jonathan B. Wiener, Brendon Swedlow, Denise Kall, Zheng Zhou, James K. Hammitt

Faculty Scholarship

This article provides a framework and offers strategies for theorizing and generalizing about risk assessment and regulation developed in the context of an on-going comparative study of regulatory behavior. Construction of a universe of nearly 3,000 risks and study of a random sample of 100 of these risks allowed us to estimate relative U.S. and European regulatory precaution over a thirty-five-year period. Comparative nested analysis of cases selected from this universe of ecological, health, safety, and other risks or its eighteen categories or ninety-two subcategories of risk sources or causes will allow theory-testing and -building and many further descriptive and …

Teaching Sicko, Elizabeth Weeks

Scholarly Works

This article provides insights in how to make up cancelled law classes to ensure compliance with American Bar Association accreditation instructional hours requirements. How to cover the missed course content. How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students. Faced with the prospect of having to make up two hours each of my Health Care Financing and Regulation course and my Public Health Law seminar, I turned to the teacher's little helper: the DVD player

Towards Achieving Lasting Healthcare Reform: Rethinking The American Social Contract, Fazal Khan

Scholarly Works

The famous preamble to the United States Declaration of Independence reflects a concise and eloquent understanding of the Lockean social contract theory that underpinned the foundation of the original American government: that free people will naturally find it in their self-interest to leave the state of nature (and the tyranny of foreign rule) and join a society where a legitimate sovereign power and the rule of law protect the citizens' fundamental rights. As of the writing of this essay, a new decade approaches and both the U.S. Senate and House have passed historic healthcare reform bills. The two legislative bodies, …

The Public’S Right To Health: When Patient Rights Threaten The Commons, Elizabeth Weeks Leonard

Scholarly Works

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a "public health right" that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. …

The Burden Of Knowledge, Christian Turner

Scholarly Works

Sometimes we are better off not knowing things. While we often hear that "ignorance is bliss," there has not been a comprehensive consideration in the legal academy of the virtues of ignorance and its regulation. Though the distribution of knowledge, like the distribution of other goods, is affected both directly and indirectly by law, several characteristics of knowledge distinguish it from other kinds of property. Much has been written about the impact of the nonrival and nonexclusive nature of knowledge on its production and distribution. This Article centers around two other attributes of knowledge that combine to create a special …

How Medicare Could Get Better Prices On Prescription Drugs, Kevin Outterson

Faculty Scholarship

Congress may reform drug pricing policies under Medicare Part D as part of a larger health reform effort. Currently, the "noninterference" provision prevents the government from negotiating drug prices on behalf of Medicare Part D prescription drug plans. Commonly considered reform proposals borrow ideas from Medicaid, either through returning dual eligibles to Medicaid drug pricing or by imposing mandatory rebates across the Part D population. We examine a menu of other options, including value-based pricing; expansion of generic and therapeutically equivalent substitution; increased formulary diversity; importation; and limited antitrust waivers. These latter options may reduce federal spending without direct government …

Federalization Snowballs: The Need For National Action In Medical Malpractice Reform, Abigail Moncrieff

Faculty Scholarship

Because tort law generally and healthcare regulation specifically are traditional state functions and because medical, legal, and insurance practices are highly localized, legal scholars have long believed that medical malpractice falls within the states' exclusive jurisdiction and sovereignty. Indeed, this view is so widely held that modern legal scholarship takes it for granted. Articles on general federalism issues use medical malpractice as an easy example of a policy in which federal intervention lacks functional justification, and articles that focus on federalization of other tort reforms use medical malpractice as an easy foil, pointing out that the uniformity interest that justifies …

Defining Health Law Or The Edgewood Syndrome, Paula Lobato De Faria, Wendy K. Mariner, George J. Annas

Faculty Scholarship

The authors' main purpose is to present ideas on defining Health Law by highlighting the particularities of the field of Health Law as well as of the teaching of this legal branch, hoping to contribute to the maturity and academic recognition of Health Law, not only as a very rich legal field but also as a powerful social instrument in the fulfillment of fundamental human rights. The authors defend that Health Law has several characteristics that distinguish it from traditional branches of law such as its complexity and multidisciplinary nature. The study of Health Law normally covers issues such as …

Protecting Hiv Positive Women’S Human’S Rights: Recommendations For The Obama Administration, Aziza Ahmed, Catherine Hanssens, Brook Kelly

Faculty Scholarship

To bring the United States in line with prevailing human rights standards, its National HIV/AIDS Strategy will need to explicitly commit to a human rights framework when developing programmes and policies that serve the unaddressed needs of women. This paper focuses on two aspects of the institutionalized mistreatment of people with HIV: 1) the criminalization of their consensual sexual conduct; and 2) the elimination of informed and documented consensual participation in their diagnosis through reliance on mandatory and opt-out testing policies. More than half of US states have HIV-specific laws criminalizing the consensual sexual activity of people with HIV, regardless …

Answering The Millennium Call For The Right To Maternal Health: The Need To Eliminate User Fees, Margaux J. Hall, Aziza Ahmed, Stephanie E. Swanson

Faculty Scholarship

Complications during childbirth and pregnancy are a main source of death and disability among women of reproductive age. Approximately 536,000 women die from pregnancy-related complications each year. Developing countries suffer most profoundly, accounting for 99% of deaths. The world's nations, by endorsing U.N. Millennium Development Goals, recognized that most deaths are preventable; they have pledged to reduce maternal mortality by 75% by 2015. This Article assesses the barriers presented by user fees - formal charges for health services still charged by many countries - to the attainment of MDGs. It shows that user fees hamper healthcare access, particularly in emergency …