Health Law and Policy Commons^™

Adopting A New Approach To Medical Information For Adoptees, Jessica Marie Yoke

Richmond Journal of Law and the Public Interest

Some estimates indicate that at least six million adoptees lived in the United States in 1997. "After factoring in birth parents and adoptive parents for each adoptee, the number of persons directly affected by the adoption process grows to over [twenty-four million] persons." States conducted many of these adoptions privately, particularly those that did not occur recently, so the parties remain anonymous to one another. Thus, an enormous number of Americans are now struggling in a system built on antiquated law that is not very useful, and in fact might be harmful. This Comment proposes a solution to this overlooked …

Candor After Kadlec: Why, Despite The Fifth Circuit's Decision, Hospitals Should Anticipate An Expanded Obligation To Disclose Risky Physician Behavior, Sallie Thieme Sanford [email protected]

Articles

An anesthesiologist admitted to having been drug-impaired during a tubal ligation that left the patient with massive, incapacitating brain damage. In granting the anesthesiologist privileges, one of the items Kadlec Medical Center had relied upon was a short credentialing letter from Lakeview Regional Medical Center. That letter stated simply that the doctor had held anesthesia privileges there for several years; it did not disclose concerns about on-duty drug use, or that he could not exercise his privileges after having been terminated from his practice group for "put[ting] our patients at significant risk" by "report[ing] to work in an impaired physical, …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

Empirical Health Law Scholarship: The State Of The Field, Michelle M. Mello, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

The last three decades have seen the blossoming of the fields of health law and empirical legal studies and their intersection--empirical scholarship in health law and policy. Researchers in legal academia and other settings have conducted hundreds of studies using data to estimate the effects of health law on accident rates, health outcomes, health care utilization, and costs, as well as other outcome variables. Yet the emerging field of empirical health law faces significant challenges--practical, methodological, and political.

The purpose of this Article is to survey the current state of the field by describing commonly used methods, analyzing enabling and …

Assessing Laws And Legal Authorities For Obesity Prevention And Control, Lawrence O. Gostin, Jennifer L. Pomeranz, Peter D. Jacobson, Richard N. Gottfried

Georgetown Law Faculty Publications and Other Works

This is the first paper in a two part series on the laws and legal authorities for obesity prevention and control, which resulted from the National Summit on Legal Preparedness for Obesity Prevention and Control in 2008. In this paper, the authors apply the “laws and legal authorities” component of the Centers for Disease Control and Prevention (CDC) legal framework on public health legal preparedness to demonstrate the essential role that law can play in the fight against obesity. Their analysis identified numerous laws and policies in the three vital domains of healthy lifestyles, healthy places, and healthy societies. For …

Reshaping The Common Good In Times Of Public Health Emergencies: Validating Medical Triage, George P. Smith Ii

Scholarly Articles

Public health ethics require individuals who are inherently at risk for transmitting communicable disease to be subjected, oftentimes, to isolation, quarantine, or compulsory vaccination - all undertaken, as such, to protect the common good and thereby secure the public-at-law for exposure to the spread of an infectious disease.

This article tests the extent to which public health emergencies necessitate a reinterpretation or reshaping of the common good and proceeds to analyze the extent to which the medical principle of triage is a relevant construct for allocating scarce medical resources during contemporary public health emergencies. The article proceeds to test the …

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 …

After The Revolution: Global Health Politics In A Time Of Economic Crisis And Threatening Future Trends, David P. Fidler

Articles by Maurer Faculty

In 2008, global health’s political revolution, which unfolded over the preceding 10-15 years, ended when four global crises damaged global health and altered the political, diplomatic, and governance contexts in which global health activities operate. The climate change, energy, food, and economic crises revealed limitations in global health’s ability to shape large-scale political, economic, and environmental problems that adversely affect health or harm underlying determinants of health. In addition, projected trends in world affairs potentially threaten health and the ability of countries to craft effective collective action responses to global problems damaging health directly and indirectly. In the post-revolution period, …

Andy Nuñez: His Life, Career, & Contributions, Bridgette Burbank, Jerold Widdison

Water Matters!

For years and years, reaching back well before his time in the Legislature, Rep. Nuñez has been a strong advocate not only for the state’s people but for its land and water resources.

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.

Of Lies And Disclaimers - Contracting Around Fraud Under Texas Law., Robert K. Wise, Andrew J. Szygenda, Thomas F. Lillard

St. Mary's Law Journal

The Texas Supreme Court has failed to provide a bright-line test in determining whether reliance disclaimers are enforceable. A reliance disclaimer is a provision in a contract that disclaims all extra-contractual representations and provides that the contracting parties are not relying on any such representations. By including a reliance disclaimer, a contracting party may be attempting to immunize itself from liability for false statements made during negotiations. Even if a contracting party’s misrepresentations or non-disclosures were made with fraudulent intent, Texas law gives contracting parties broad freedom to contract around misrepresentation claims. In Forest Oil Corp. v. McAllen, the Texas …

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 …

Decisional Dignity: Teenage Abortion, Bypass Hearings, And The Misuse Of Law, Carol Sanger

Faculty Scholarship

How might we think about reforming abortion regulation in a world in which the basic legality of abortion may, as a matter of constitutional law, at last be relatively secure? I have in mind the era just upon us in which the overturn of Roe v. Wadeno longer looms so threateningly over the reproductive rights community in the United States and is no longer necessarily its central concern. There is now a general and seemingly well-founded optimism that under the Obama administration, those who support and rely on reproductive rights will not have to pray nightly for the health …

A Black Robe And Healing Words: Constants In A Changing World, Sallie Thieme Sanford [email protected]

Articles

This narrative article describes a bedside hospital hearing to compel surgery, notes the applicable legal standards, and considers the potential impact of the judge in this type of proceeding. The patient, whose back was badly burned, adamantly and vocally refused skin graft surgery. Her physicians believed she lacked decisional capacity; that belief was borne out during the hearing at which the judge did enter an order for surgery. The judge’s handling of the hearing was central to the patient’s expressed agreement with the decision and subsequent successful treatment.

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”

Public Bioethics And The Bush Presidency, O. Carter Snead

Journal Articles

Public bioethics figured prominently during the tenure of President George W. Bush. This Article explores the Bush legacy in this domain. It begins by articulating and examining the grounding norms of President Bush’s approach to public bioethics. Next, it analyzes how these norms were applied to concrete areas of concern. Building on this analysis, the next section reflects on what the President’s actions illustrate about the capacity of the Executive Branch to shape public bioethics. The Article concludes with a brief discussion of the possible metrics by which the Bush Administration’s efforts might be judged, and then offers several assessments …

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.

Patient-Tailored Medicine, Part Two: Personalized Medicine And The Legal Landscape, Corrine Parver

Scholarly Articles in Law Reviews & Journals

In Part One, the authors addressed the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States.* Part Two examines current and proposed federal and state laws and regulations intended to protect individuals from the misuse of genetic information, including uses that discriminate based on genetic predispositions. This Part next explores the potential for litigation against both manufacturers and providers, as well as potential defenses. The authors also discuss legal issues relating to research that relies on the use of genetic information.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

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.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

Advertising Obesity: Can The U.S. Follow The Lead Of The Uk In Limiting Television Marketing Of Unhealthy Foods To Children?, David Darwin

Vanderbilt Journal of Transnational Law

Childhood obesity has tripled in the U.S. since the 1970s, and television advertisement of unhealthy foods has been linked to the unhealthy eating habits of children. The United Kingdom, facing a similar problem, promulgated regulations in 2007 banning the advertisement of foods high in fat, sodium, and sugar during programming directed at children below age 16.

In the U.S., industry representatives, public policy advocates, and government officials are debating whether to rely on self-regulation efforts or to implement government-established guidelines. Industry representatives argue that government guidelines would do little to solve the childhood obesity problem and that the UK regulations …

You Get What You Pay For?: Rethinking U.S. Organ Procurement Policy In Light Of Foreign Models, J. Andrew Hughes

Vanderbilt Journal of Transnational Law

The U.S. organ transplant system is in crisis due to the paucity of transplantable organs. Such a shortage exists because otherwise viable organs are too often buried along with the bodies in which they reside. Organs are wasted because the existing U.S. organ transplant system sets up barriers to organ donation--chiefly the legal presumption of unwillingness to donate ("voluntary donation') and the National Organ Transplant Act's ban on the transfer of organs for valuable consideration. This Note surveys the qualified successes of Austria, Belgium, Brazil, and France with their various "presumed consent" models of organ procurement. It also considers other …

Working Sick: Lessons Of Chronic Illness For Health Care Reform, Elizabeth Pendo

All Faculty Scholarship

Although chronic illness is generally associated with the elderly or disabled, chronic conditions are widespread among working-age adults and pose significant challenges for employer-based health care plans. Indeed, a recent study found that the number of working-age adults with a major chronic condition has grown by 25 percent over the past 10 years, to a total of nearly 58 million in 2006. Chronic illness imposes significant costs on workers, employers, and the overall economy. This population accounts for three-quarters of all personal medical spending in the United States, and a Milken Institute study recently estimated that lost workdays and lower …

Healthy Planet, Healthy People: Integrating Global Health Into The International Response To Climate Change, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

The potentially groundbreaking negotiations currently underway on the international response to climate change and national implementation of commitments under the United Nations Framework Convention on Climate Change (UNFCCC) include a number of hotly contested issues: (1) what degree of climate change is acceptable as a basis for emissions targets, (2) to what extent and in what ways climate change mitigation should incorporate emissions reductions or increased sinks for developing countries, (3) whether the legal regime governing mitigation can take advantage of the huge mitigation potential of changed practices in the land use and agricultural sectors, (4) how adaptation should be …

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

Kairos And Safe Havens: The Timing And Calamity Of Unwanted Birth, Susan Ayres

Faculty Scholarship

It is impossible to know the number of infants killed or illegally abandoned at birth. No official reporting requirements exist, but conservative estimates claim that in the United States, 150-300 infants are killed within twenty-four hours of life and that over 100 infants are illegally abandoned. Beginning in 1999, in an effort to stem the problem of neonaticide and illegal abandonment, states began enacting laws to legalize abandonment. By 2008, all fifty states had enacted safe haven laws, which allow parents to anonymously abandon newborns by delivering them to designated providers, such as hospitals. This article provides a practical and …

Estimating The Effect Of Damages Caps In Medical Malpractice Cases: Evidence From Texas, David A. Hyman, Bernard Black, Charles Silver, William M. Sage

Faculty Scholarship

Using claim-level data, we estimate the effect of Texas's 2003 cap on non-economic damages on jury verdicts, post-verdict payouts, and settlements in medical malpractice cases closed during 1988–2004. For pro-plaintiff jury verdicts, the cap affects 47-percent of verdicts and reduces mean allowed non-economic damages, mean allowed verdict, and mean total payout by 73-percent, 38-percent, and 27-percent, respectively. In total, the non-econ cap reduces adjusted verdicts by $156M, but predicted payouts by only $60M. The impact on payouts is smaller because a substantial portion of the above-cap damage awards were not being paid to begin with. In cases settled without trial, …

Improving Laws And Legal Authorities For Obesity Prevention And Control, Lawrence O. Gostin, Jennifer L. Pomeranz

Georgetown Law Faculty Publications and Other Works

This is the second paper in a two part series on the laws and legal authorities for obesity prevention and control. In this paper, the authors present the applicable laws and legal authorities that public health professionals and lawyers can consider implementing to close the legal gaps identified in the first paper (“Assessing Laws and Legal Authorities for Obesity Prevention and Control”). This set of legal action items encompass the federal, tribal, state, local, and community levels and should be considered when developing, implementing, and evaluating obesity prevention and control strategies and interventions.

The paper organizes the action items within …

Ten Fingers, Ten Toes: Newborn Screening For Untreatable Disorders, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

This movie makes two important points despite its admitted unreality. The first, which the screen writer probably did not fully appreciate at the time, is that genetic testing cannot now and probably will never be able to predict with complete certainty the occurrence and course of complex diseases. It is not true that "Genes-R-Us." Rather, we are the products of complex interactions of our genes, the genomes of other organisms (many of which we live in relation with), and the environment, broadly understood to include the air we breathe, the water we drink, the food we eat, the drugs we …