Law Commons^™

Everything Old Is New Again: The Re-Emerging Public Health Right, Elizabeth A. Weeks

Elizabeth A. Weeks

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. …

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Vicki W Girard

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Comments On Liebman And Zeckhauser, Simple Humans, Complex Insurance, Subtle Subsidies, Edward J. Mccaffery

Edward J McCaffery

These are brief comments on an excellent paper by Jeffrey Liebman and Richard Zeckhauser, prepared for a conference sponsored by the Urban Institute and Brookings on tax and health care policy. Liebman and Zeckhauser summarize the complexities involved in making optimal health insurance decisions, and offer generally cautionary notes about conflating these with tax law (a theme of the conference). Most importantly, Liebman and Zeckhauser suggest a positive role for employers in health care and insurance decisions, as better setters or framers of choice sets—witness 401(k) plans. In this Commentary, I applaud Leibman and Zeckhauser’s general work and particular observation, …

An Analysis Of Medical Peer Review Immunity In Texas:, Lamar Odom, John A. Daniels

lamar odom

ABSTRACT The physician and hospital share a symbiotic relationship. Most physicians need to have access to the medical equipment, staff and facilities provided by hospitals. Hospitals rely on physicians admitting patients as a primary source of revenue. Notwithstanding this fact, the physician’s ability to utilize the services of the hospital is contingent upon her obtaining medical staff membership and privileges. Prior to being granted privileges, the physician must submit to a process known as medical peer review. Peer review is a mandatory process that promotes quality of care, facilitates accreditation and is a necessary compliance requirement for hospitals to receive …

When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law, Mark A. Hall

Mark A Hall

Our principal task in this essay is to show how the three principle parts of health law -- malpractice, bioethics, and health care finance -- are colliding in ways that will require adjustments in legal doctrine. These parts are like neighboring tectonic plates, either with their own central purposes and basic assumptions. For years each part developed quite independently. Recently, however, public policy increasingly has moved the plates into tension, producing seismic potential that has been largely unnoticed. We demonstrate this through a case study of one tectonic encounter -- a patient who says no to standard-of-care treatment because of …

Voluntary Disclosure Of Hiv/Aids Status By A Public Health Official To Law Enforcement Agents: The Shortcomings Of South Dakota's Law Section 34-22-12.1(6) And Traditional Public Health Measures, Daniel C. Moon

Daniel C Moon

Section 34-22-12.1(6) of South Dakota’s Codified Laws grants the Secretary of the Health Department to disclose private medical information regarding an individual’s HIV/AIDS status if he or she thinks that that individual is engaged in intentionally infecting another person with HIV/AIDS. This law is problematic because it does not (1) adequately protect an individual’s privacy, and (2) achieve its public health goals. From the privacy aspect, it provides less protection to information regarding an individual’s HIV/AIDS status from three aspects: (1) less protection than the same information possessed by covered entities under the Health Insurance Portability and Accountability Act (“HIPAA”), …

Hipaa And Its Privacy Regulations: Is There Too Much Privacy Regulation On Health Care Information?, Yuhong Wu

Yuhong Wu

In 1996, Congress passed HIPAA, and later on August 14, 2003 Department of Health and Human Services finalized HIPAA privacy regulations. HIPAA privacy regulation creates privacy right of personal healthcare information by giving individuals absolute control over their health information, setting boundaries on the use and disclosure of health information, and mandating covered entities to establish safeguards for healthcare information. In fact, HIPAA defines the privacy right in its finest granular form: the privacy right is enforced not only at individual level, but also for every chunk of personal healthcare information that is needed in any possible usage. This article …

The Medium Of Exchange Paradigm: A Fresh Look At Compensated Live-Organ Donation, Dean Lhospital

Dean Lhospital

For over twenty years, human live-organ sales have been banned in the United States and most of the rest of the world. Observations and data arising from black market transactions and the few legal markets for organs suggest that permitting and regulating organ sales leads to more humane conditions than outlawing sales. Despite the data, opponents of organ sales still argue that selling human organs devalues human life. This article examines the panoply of organ markets – white, grey, and black – and identifies the source of this cognitive dissonance. Recognizing that there is a fundamental paradox in ethical objections, …

Dna Inside, Lori B. Andrews

Lori B. Andrews

Theoretical Perspectives On Public Law, Administration And Public Health History, Lydia C. Stewart Ferreira

Lydia C. Stewart Ferreira

The struggle between authority and liberty, the tyranny of the majority, the prevention of harm, unlimited state control, the necessary rights belonging to citizens, and the establishment of contritutional checks by a consenting community - is the theory and practice of public health. This paper seeks to explore the interaction of epidemics on public and administrative legal theory. It is proposed that the legal theories of Locke in the 1600s and Mills in the 1800s regarding state and individual legal rights were shaped by public health disease epidemics of their day.

Influenza Genetic Sequence Patents: Where Intellectual Property Clashes With Public Health Needs, Lori B. Andrews, Laura A. Shackelton

Lori B. Andrews

Entrenched Inequity: Health Care In The United States Of America, Jean Connolly Carmalt, Sarah Zaidi, Alicia Ely Yamin

Jean Connolly Carmalt

This article analyzes the U.S. system for delivering health services in terms of the international human rights standards that apply to the human right to health. To that end, the article evaluates whether the health care system provides available, accessible, acceptable, and quality health goods and services. It finds that the United States fails to provide available care because services are insufficient in quantity and not located in reasonable proximity to all communities; that it fails to provide accessible care because of financial barriers to access and overly complicated requirements for access; that it fails to provide acceptable care because …

King Solomon’S Solution To The Disposition Of Embryos: Recognizing A Property Interest And Using Equitable Division, Kansas R. Gooden

Kansas R Gooden

In your family law class, your professors have probably not lectured on the area of embryo disposition in divorce proceedings. Were you aware that courts across the country have ruled that the right not to procreate trumps the right to procreate in these situations? When divorce and IVF combine, it results in a complex legal battle. When a couple that used IVF divorces, who should get the remaining embryos? This article asserts that embryos should be considered property. The elements of ownership, possession, use, and exclusion, otherwise known as the bundle of sticks, are present. American law has taken an …

Open Source, Open Access, Open Transfer: Market Approaches To Research Bottlenecks, Robin C. Feldman

Robin C Feldman

One of the most hotly contested issues in the field of intellectual property law concerns the existence, or non-existence, of patent thickets and the extent to which any such bottlenecks may be interfering with research. For decades, scholars warned that problems related to the over proliferation of patent rights would interfere with innovation. In contrast, a growing body of commentary argues that patent thickets are not a problem in modern industries. Either patent thickets do not exist, or if they do, patent thickets do not interfere with the progress of research.

The rhetoric is particularly heated these days because of …

The Ghost In Our Genes: Legal And Ethical Implications Of Epigenetics, Gary E. Marchant, Mark A. Rothstein, Yu Cai

Gary E. Marchant

Epigenetics is one of the most scientifically important, and legally and ethically significant, cutting-edge subjects of scientific discovery. Epigenetics link environmental and genetic influences on the traits and characteristics of an individual, and new discoveries reveal that a large range of environmental, dietary, behavioral, and medical experiences can significantly affect the future development and health of an individual and their offspring. This article describes and analyzes the ethical and legal implications of these new scientific findings.

A Crisis Waiting To Happen: What’S Wrong With Pennsylvania Public Health Law., John A. Bozza

John A Bozza

There are few areas of government enterprise where the need to “get it right” is so critical, as formulating and executing laws affecting the public health. When the government sets out to exercise its police power to control the spread of disease its goal is to accomplish an immensely important practical task. This article is intended to identify those aspects of Pennsylvania's public health law that may be impediments to the government's ability to effectively respond to a public health crisis. It is suggested that by revising and clarifying certain key provisions of statutes and regulations clear decision making at …

The "Fetal Protection" Wars: Why America Has Made The Wrong Choice In Addressing Maternal Substance Abuse - A Comparative Legal Analysis, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

No abstract provided.

Provena Covenant Medical Center And Its Unresolved Tax-Exempt Status - It's Time For The Illinois Supreme Court To Revise The Methodist Old People's Home Test, Joseph J. Hylak-Reinholtz

Joseph J. Hylak-Reinholtz

Not-for-profit hospitals tax exemptions have been challenged by government officials for providing insufficient charity care to needy patients. In Illinois, not-for-profit tax exemptions are analyzed under a test developed by the state Supreme Court in Methodist Old Peoples Home v. Korzen. This comment argues, in light of the Provena litigation and subsequent appeal, that the court must revise its outdated test to reflect the realities of providing health care today in a not-for-profit system.

Hungry For Victory: Why High School Wrestling Coaches Should Not Be Held Liable For Injuries Resulting From Weight Loss, Alexander J. Pal

Alex J Pal

The purpose of this Note is to advocate for the universal application of primary assumption of the risk as a defense to a negligence cause of action involving interscholastic wrestling. Primary assumption of the risk is a defense which infers that a participant in a particular activity knew or should have known of a risk inherent in that activity. If a court deems a plaintiff to have assumed such a risk, they will be barred from recovering in a lawsuit. Jurisdictions are not in agreement in applying this doctrine in a sports setting.

Application of the doctrine in the sport …

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

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

Mark A Hall

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 …

Regulation With Placebo Effects, Anup Malani

Anup Malani

There is a growing body of empirical evidence supporting the existence of placebo effects in medical contexts and is suggestive of nontrivial placebo effects in non-medical contexts. This paper reviews the literature on placebo effects, examines the implications for four fields of law (drug approval, informed consent law, consumer protection law, and torts) and suggests future areas for research on placebo effects. Specifically, it make the case for altering the drug approval process to account for, if not credit, placebo effects. It suggests allowing evidence of placebo effects as a defense in cases alleging violations of informed consent or false …

Law's Misguided Love Affair With Science, Robin Feldman

Robin C Feldman

The allure of science has always captivated members of the legal profession. Its siren’s song has followed us throughout much of American legal history. We look to science to rescue us from the experience of uncertainty and the discomfort of difficult legal decisions, and we are constantly disappointed.

The notion of what constitutes science and what it would take to make law more scientific varies across time. What does not vary is our constant return to the well. We are constantly seduced into believing that some new science will provide answers to law’s dilemmas, and we are constantly disappointed.

This …

Competition And Relevant Markets In The Pharmaceutical Industry: The Case Of Pah Drugs, Kevin C. Green

Kevin C Green

The nature and extent of competition between different therapies for a given medical condition often is a critical and controversial issue in both antitrust cases and in general strategic analysis in the pharmaceutical industry. The market for pulmonary arterial hypertension (“PAH”) therapies provides an interesting case study for analyzing these issues. An event study analyzing how the stock prices of PAH therapy providers respond to competitive developments sheds light on the nature of competition among different types of therapies. The results support the view that not all drugs for a given medical condition should necessarily be included in the same …

The Duty Of States To Assist Other States In Need: Ethics, Human Rights, And International Law, Lawrence O. Gostin, Robert Archer

O'Neill Institute Papers

This article deals with a foreign policy question of extraordinary importance: What responsibilities do States have to provide economic and technical assistance to other states that have high levels of need affecting the health and life of their citizens? The question is important for a variety of reasons. There exist massive inequalities in health globally, with the result that poorer countries shoulder a disproportionate burden of disease and premature death. While poor countries have by far the greatest ongoing health needs, they also have the least capacity to meet those needs. In addition to the pervasive and debilitating effects of …

Readability Studies: How Technocentrism Can Compromise Research And Legal Determinations, Louis J. Sirico Jr.

Working Paper Series

One way to determine whether consumers understand a document is to use a readability formula to assign it a score. These formulas calculate readability by counting such variables as the number of words and syllables in a passage or document. The idea of readability formulas has been defined as “an equation which combines those text features that best predict text difficulty. The equation is usually developed by studying the relationship between text features (e.g., words, sentences) and text difficulty (e.g., reading comprehension, reading rate, and expert judgment of difficulty).” Even though readability formulas are mechanical and imperfect, they are easy …

Pharmacy Compounding Of Bioidentical Hormone Replacement Therapy (Bhrt): A Proposed New Approach To Justify Fda Regulation Of These Prescription Drugs, Bruce Patsner

Bruce Patsner M.D., J.D.

No abstract provided.

Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Is Today The Day We Free Electroconvulsive Therapy?, Mike Jorgensen

Mike Jorgensen

ABSTRACT IS TODAY THE DAY WE FREE ELECTROCONVULSIVE THERAPY? By Mike E Jorgensen Electroconvulsive Therapy, or “ECT,” has become increasingly more popular to treat certain mental illnesses, especially severe depression and pseudo dementia. The stigma it suffered due to prior barbaric type applications in the past are largely historic, and most medical professionals will agree that ECT is safe today, has very minimal side effects, not inherently abusive, and no long- term detriments. Yet, with the increase in popularity and the safe applications, ECT is still treated archaically under the law and the legislative restraints are causing an indigent, elderly …

Restricting Access To Infertility Services: What Is A Justified Limitation On Reproductive Freedom, Crystal K. Liu

Crystal K Liu

The realm of reproductive freedoms has been one that has been heavily restricted in the history of our country. For purposes of this particular article, reproductive freedom refers not only to the ability to procreate but to the ability to be a parent as well. Throughout the history of the United States, these limitations have been epitomized in a variety of forms. These include state sponsored sterilization during the eugenics movement, child protection laws, as well as adoption laws. By exploring limitations that have been enacted, some of which have been repealed and others that continue to be in place, …