Health Law and Policy Commons^™

Law & Health Care Newsletter, Spring 2019

Law & Health Care Newsletter

No abstract provided.

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Race And Assisted Reproduction: Implications For Population Health, Aziza Ahmed

Faculty Scholarship

This Article emerges from Fordham Law Review's Symposium on the fiftieth anniversary of Loving v. Virginia,¹ the case that found antimiscegenation laws unconstitutional. ² Inspired by the need to interrogate the regulation of race in the context of family, this Article examines the diffuse regulatory environment around assisted reproductive technology (ART) that shapes procreative decisions and the inequalities that these decisions may engender. ³ ART both centers biology and raises questions about how we imagine our racial futures in the context of family, community, and nation. ⁴ Importantly, ART demonstrates how both the state and private actors shape family …

Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso

St. John's Law Review

(Excerpt)

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …

Teaching Bioethics: The Role Of Empathy & Humility In The Teaching And Practice Of Law, Barbara A. Noah

Health Matrix: The Journal of Law-Medicine

The article discusses how bioethics education integrates ideas from ethics, law, science, and public policy with the goal of solving problems associated with the delivery of medical care. Topics discussed include Torts and various health law courses; American legal education's multi-tiered approach to teach students about law; and role of empathy and humility in the teaching and practice of law.

Zika And The Failure To Act Under The Police Power, Jacqueline Fox

Faculty Publications

Zika is a mosquito-borne and sexually transmitted disease that is a dangerous threat to pregnant women, causing catastrophic birth defects in a large percentage of fetuses when their mothers become infected while pregnant. It raises numerous issues related to abortion, birth control, poverty, and women’s control over their procreative choices. While the United States received ample warning from January 2016 onward that it was at risk of local transmission of this virus and public health officials at all levels generally behaved properly, the state and federal legislative responses in the summer of 2016 were entirely inadequate. For example, no state …

Frontiers In Precision Medicine Ii: Cancer, Big Data And The Public, Emily Coonrod, Jorge L. Contreras, Willard Dere, Jeffrey Botkin, Leslie Francis, Jim Tabery

Utah Law Faculty Scholarship

Precision medicine is being developed within a complex landscape of public policy, science, economics, law, and regulation. In these and other policy areas, the goal of developing individually-tailored therapies poses novel challenges for health care research, delivery and policy. In this symposium, a range of experts in genetics, medicine, bioinformatics, intellectual property, health economics and bioethics identified and discussed many of the pressing questions raised by the development and practice of precision medicine. These and other issues will need to be taken into account as precision medicine moves ahead and becomes the standard of medical practice and care in the …

Reproductive Selection Bias, Lauren R. Roth

Scholarly Works

Decades after the advent of assisted reproductive technology (ART) that allows prospective parents to deselect embryos with grave genetic illnesses – a procedure called preimplantation genetic diagnosis (PGD) – it remains a tool largely of upper class whites. In the wake of the Supreme Court’s decision in Whole Woman’s Health v. Hellerstedt, I argue that the time has come to focus on access in this area of reproductive rights. The next logical step is to rebut the presumption that reproductive liberty is only a negative right that prevents government interference with decisions about whether and how to procreate or not …

Don’T Pull The Plug On Bioethics Mediation: The Use Of Mediation In Health Care Settings And End Of Life Situations, Amy Moorkamp

Journal of Dispute Resolution

A hefty decision, such as the life or death of a loved one, requires more than a few minutes of deliberation and a handful of outside consultations. Delicate, emotional, and potentially contentious medical decisions compel a structured, compassionate approach to produce quality and well-informed results. Due to the magnitude of the decision being made, as well as the abundance of other considerations, (emotional, religious, historic, financial, etc.) the case for a creative, problem-solving process of dispute resolution, such as mediation, is ripe.

This Comment will explore the use of mediation in bioethical disputes. In Part II, the Comment will give …

Mid-Atlantic Ethics Committee Newsletter, Spring 2016

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Winter 2016

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Power To The People: Data Citizens In The Age Of Precision Medicine, Barbara J. Evans

Vanderbilt Journal of Entertainment & Technology Law

Twentieth-century bioethics celebrated individual autonomy but framed autonomy largely in terms of an individual's power to make decisions and act alone. The most pressing challenges of big data science in the twenty-first century can only be resolved through collective action and common purpose. This Article surveys some of these challenges and asks how common purpose can ever emerge on the present bioethical and regulatory landscape. The solution may lie in embracing a broader concept of autonomy that empowers individuals to protect their interests by exercising meaningful rights of data citizenship. This Article argues that twentieth-century bioethics was a paternalistic, top-down …

Buyers In The Baby Market: Toward A Transparent Consumerism, Jody L. Madeira, June Carbone

Articles by Maurer Faculty

This Article assesses the forces on the horizon remaking the fertility industry, including greater consolidation in the health care industry, the prospects for expanding (or contracting) insurance coverage, the likely sources of funding for future innovation in the industry, and the impact of globalization and fertility tourism. It concludes that concentration in the American market, in contrast with other medical services, may not necessarily raise prices, and price differentiation may proceed more from fertility tourism than from competition within a single geographic region. The largest challenge may be linking those who would fund innovation, whether innovation that produces new high …

Mid-Atlantic Ethics Committee Newsletter, Fall 2015

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Summer 2015

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Winter 2015

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

The Injustice Of Inclusion And Fair Opportunity: Exploiting Children In Medical Research For The Benefit Of An Unworthy Society, Ruqaiijah Yearby

All Faculty Scholarship

The history of pediatric medical research has been characterized as a history of child abuse. Usually, the debate regarding the use of children in medical research has centered on questions of Autonomy (informed consent) and Beneficence (the best interest of the child based on a benefit risk analysis). The debate has rarely focused on the question of which children should participate in medical research by discussing the legal principle of Justice (prohibits use of vulnerable populations for medical research who are already overly burdened for medical research unrelated to health issues affecting them and requires that populations who participate in …

Mid-Atlantic Ethics Committee Newsletter, Fall 2014

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Spring 2014

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Winter 2014

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Democratic Deliberation And The Ethical Review Of Human Subjects Research, Govind Persad

Sturm College of Law: Faculty Scholarship

In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, and an effort to justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous …

Achieving National Altruistic Self-Sufficiency In Human Eggs For Third-Party Reproduction In Canada, Jocelyn Downie

Articles, Book Chapters, & Popular Press

To avoid the commercialization of reproduction, the Canadian Assisted Human Reproduction Act (AHR Act 2004) prohibits the purchase of human eggs. We endorse this legal prohibition and moreover believe that this facet of the law should not be allowed to have as an unintended consequence an increase in transnational trade in human eggs. In an effort to avoid this consequence, and to be consistent with the AHR Act, we advocate a system of national altruistic self-sufficiency. This article briefly outlines a number of strategies to increase the domestic altruistic supply of third-party eggs and decrease the domestic demand for third-party …

Mid-Atlantic Ethics Committee Newsletter, Fall 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Recommendations For Returning Genomic Incidental Findings? We Need To Talk!, Ellen Wright Clayton, Wylie Burke, Armand H. Matheny Antommaria, Et Al.

Vanderbilt Law School Faculty Publications

The American College of Medical Genetics and Genomics recently issued recommendations for reporting incidental findings from clinical whole-genome sequencing and whole-exome sequencing. The recommendations call for evaluating a specific set of genes as part of all whole-genome sequencing/whole-exome sequencing and reporting all pathogenic variants irrespective of patient age. The genes are associated with highly penetrant disorders for which treatment or prevention is available. The effort to generate a list of genes with actionable findings is commendable, but the recommendations raise several concerns. They constitute a call for opportunistic screening, through intentional effort to identify pathogenic variants in specified genes unrelated …

Mid-Atlantic Ethics Committee Newsletter, Spring 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Winter 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Ovaries, Testicles, And Uteruses, Oh My! Regulating Reproductive Tissue Transplants, Valarie K. Blake

Scholarly Works

This article will explore key regulatory and ethical challenges presented by reproductive tissue transplants (RTTs) as they are currently developing, recognizing that additional issues may reveal themselves as the technologies progress. Part I of this article will begin with a discussion of the current status of the technology, including the results and status of animal and human experiments for all three types of transplants. Part II will explore the demand for RTTs — who might consider such a transplant and why RTTS might be considered by some patients as more favorable than other reproductive options. Part III will explore the …

Death Panels And The Rhetoric Of Rationing, Elizabeth Weeks Leonard

Scholarly Works

This essay offers an explanation for the United States' continued resistance to universal health care as grounded in two taboos: taxation and rationing. Even we were willing to pay more in taxes to directly subsidize the cost of medical care for those in need, rather than our current system of indirect subsidization through private insurance risk-pooling and cost-shifting, we still would face the unavoidable reality of resource limitations. Attempts to limit resource consumption, however, have been strongly opposed, as evidenced by the "death panels" controversy. Governor Palin's grossly erroneous characterization of the Patient Protection and Affordable Care Act (ACA) rendered …

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.

Tuskegee Redux: Evolution Of Legal Mandates For Human Experimentation, Robert S. Levine, Jamila C. Williams, Barbara A. Kilbourne, Paul D. Juarez

Sociology Faculty Research

Human health experiments systematically expose people to conditions beyond the boundaries of medical evidence. Such experiments have included legal-medical collaboration, exemplified in the U.S. by the Public Health Service (PHS) Syphilis Study (Tuskegee). That medical experiment was legal, conforming to segregationist protocols and specific legislative authorization which excluded a selected group of African Americans from any medical protection from syphilis. Subsequent corrective action outlawed unethical medical experiments but did not address other forms of collaboration, including PHS submission to laws which may have placed African American women at increased risk from AIDS and breast cancer. Today, anti-lobbying law makes it …