Health Law and Policy Commons^™

Genetic Discrimination In The Workplace: Lessons From The Past And Concerns For The Future, Laurie A. Vasichek

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Social Networking In The Age Of Personal Genomics, Sandra Soo-Jin Lee

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Beyond Bidil: The Expanding Embrace Of Race In Biomedical Research And Product Development, Jonathan Kahn

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Will Directed Evolution Destroy Humanity, And If So, What Can We Do About It?, Maxwell J. Mehlman

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Diet Starts Monday: An Analysis Of Current U.S. Dietary Supplement Regulations Through An International Comparison, Greg Lindquist

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Pharmacogenomics And The Genetic Information Nondiscrimination Act Of 2008: Legislation Limitations And Its Impact On Pgx Research And Clinical Opportunity, Amanda Tessmer

Saint Louis University Journal of Health Law & Policy

No abstract provided.

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 …

Thou Good And Faithful Servant, Carl E. Schneider

Articles

Lawmakers are stewards of social resources. A current debate-over screening newborns for genetic disorders-illuminates dilemmas of that stewardship that have particularly plagued bioethics. Recently in the Report, Mary Ann Baily and Thomas Murray told the story of little Ben Haygood. He died from MCADD, a genetic disorder that can make long fasting fatal. Screening at birth would have let doctors alert Ben's parents. "After Ben died," Baily and Murray wrote, "his father became a passionate advocate for expanding Mississippi's newborn screening program to add MCADD and other disorders." Soon, the Ben Haygood Comprehensive Newborn Screening Act increased the number …

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 …

Participation And The Right To Health: Lessons From Indonesia, Sam F. Halabi

Faculty Publications

The right to participation is the “the right of rights” — the basic right of people to have a say in how decisions that affect their lives are made. All legally binding international human rights treaties explicitly recognize the essential role of participation in realizing fundamental human rights. While the substance of the human right to health has been extensively developed, the right to participation as one of its components has remained largely unexplored. Should rights-based health advocacy focus on participation because there is a relationship between an individual’s or a community’s active involvement in health care decision-making and the …

Beyond Bidil: The Expanding Embrace Of Race In Biomedical Research And Product Development, Jonathan Kahn

Faculty Scholarship

In 2005 the FDA approved BiDil, the first drug ever to include a race-specific indication on its label - to treat heart failure in a “black” patient. In the aftermath of this controversial approval and subsequent marketing of the drug, many have wondered whether BiDil was an anomaly or a harbinger of things to come. This article moves beyond BiDil to explore how similar yet distinct models are developing for the continuing exploitation of race in biomedical practice and product development. It will explore the tensions embedded in the persistent use of racial categories even as specific genetic variations linked …

Bottom-Up Or Top-Down? Removing The Privacy Law Obstacles To Healthcare Reform In The National Healthcare Crisis, John W. Hill, Arlen W. Langvardt, Jonathan E. Rinehart

Indiana Law Journal

Issues of healthcare availability and quality are among the most profound facing our nation. If a high-quality, accessible healthcare system of a truly national nature is to be devised, electronic connectivity—including increased use of electronic medical records and similar technological advances—must be a key feature. Yet such connectivity may give rise to patients’ concerns regarding the privacy of their medical information. Because such concerns demand respect, a challenge lies in balancing patients’ privacy interests against the important information-sharing interests underlying a national healthcare network. The Health Insurance Portability & Accountability Act (HIPPAA) is a key federal law that addresses many …

Health Law—Negligent Credentialing And You: What Happens When Hospitals Fail To Monitor Physicians, Whitney Foster

University of Arkansas at Little Rock Law Review

No abstract provided.

The Butterfly Effect Of Politics Over Principle: The Debate Over The Unborn Victims Of Violence Act And The Motherhood Protection Act, Robert E. Steinbuch

Law Faculty Scholarship

No abstract provided.

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

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.

In The Back Alleys Of Health Care: Abortion, Equality And Community In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

The decriminalization of abortion in Canada ensured neither its availability nor accessibility as an integrated and publicly funded health service. While Canadian women are increasingly referred to or seek abortion services from single-purpose clinics, their exclusion from public health insurance often render these services inaccessible. This article considers denied funding for clinic abortion services from the perspective of the Canadian constitutional guarantee of sex equality. The article focuses on the 2004 Court of Queen's Bench's judgment in Jane Doe I v. Manitoba, which framed denied public funding for clinic abortion services as a violation of women's equality rights under the …

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.

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 …

The Regulation Of Nanomedicine: Will The Existing Regulatory Scheme Of The Fda Suffice?, Shanna Harris

Richmond Journal of Law & Technology

Nanotechnology is the science and technology of manipulating molecules and atoms at the molecular level to create devices with new molecular properties, organizations and functions.1 Devices such as new computers that are billions of times more powerful than any currently available2 and boxes the size of sugar cubes that can hold the entire content of the Library of Congress are examples of the power of nanotechnology.

Will The Federal Circuit’S Eli Lilly V. Teva Decision Lead To Efforts To Abuse The Modification Provision Of The Hatch-Waxman Act?, Claire K. Comfort

Richmond Journal of Law & Technology

The Hatch-Waxman Act provides a mandatory thirty-month stay on the Food and Drug Administration’s (FDA) approval of an Abbreviated New Drug Application (ANDA) when a patent infringement suit is filed. The Act includes a provision for a district court to shorten or extend the Act’s thirty-month stay on FDA approval if “either party to the action failed to reasonably cooperate in expediting the action”

Pay For Performance, Quality Of Care And The Revitalization Of The False Claims Act, Devin S. Schindler

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Comments: Privacy At Risk: Patients Use New Web Products To Store And Share Personal Health Records, Juliana Bell

University of Baltimore Law Review

No abstract provided.

Evaluating The Impact Of Remedial Authority: Adjudicative Tribunals In The Health Sector, Lorne Sossin, Steven J. Hoffman

Articles & Book Chapters

Adjudicative tribunals play an important role in the health sector yet their actual influence, as part of the health system remains undetermined, Most of the studies that have evaluated their work have focused on measures of accountability and independence, rather than the indicators of societal impact. As efforts to reform health systems continue internationally, it is crucial that we understand the benefits and costs of adjudicative tribunals for providers and consumers of heath. In this regard, empirically evaluating the impact of adjudicative tribunals will help inform policymaking through the collection of objective data. A strong and accountable health care system …

The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall

Articles

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword. This article evaluates consumerism and the regulatory mechanism …

The Bapcoa's Restriction On Attorney-Client Speech In The Fifth And Eighth Circuits: Worth Saving Or Destroying Comment., Sara Berkeley

St. Mary's Law Journal

Abstract Forthcoming.