Health Law and Policy Commons^™

Health Reform: What's Insurance Got To Do With It? Recognizing Health Insurance As A Separate Species Of Insurance, Wendy K. Mariner

Faculty Scholarship

Health insurance can be, and to a large extent already is, a separate species of insurance. This article describes the different views of insurance that made health reform contentious. It argues that the goals of health reform are incompatible with conventional views of insurance. Nonetheless, reforming health insurance to achieve those goals does not require as dramatic shift as some might think, because health insurance has already become primarily a means of paying for health care, rather than a simple risk spreading device for specified losses.

Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, "integrated" strategy. This would increase reimbursement for the appropriate, …

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail Moncrieff

Faculty Scholarship

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least four important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

Nih Guidelines On Human Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael Ulrich

Faculty Scholarship

Restrictions on federal funding for human embryonic stem cell (hESC) research under President Bush stimulated a number of states and the private sector to fund stem cell research, resulting in a patchwork of varying guidelines throughout the country. The National Institutes of Health’s (NIH) guidelines were expected to change all of this.With President Obama following through on his assurance to remove restrictions, stem cell researchers assumed they would find clarity when the new NIH Guidelines on Human Embryonic Stem Cell Research were promulgated to outline an ethical framework to determine which research was eligible for federal funding. As part of …

Medical Malpractice Liability Crisis Or Patient Compensation Crisis?, Kathryn Zeiler

Faculty Scholarship

Tort reform has been a hot topic among those interested in assessing whether and how well the tort system aids injured plaintiffs in achieving civil justice. The debate has been especially heated when it comes to medical malpractice liability. Until recently, rhetoric about the liability system and its relationship to insurance markets and physician supply dominated tort reform debates. While claims made by both proponents and opponents can seem intuitive, they are often unsubstantiated. In recent years, however, academics and others have acquired or created datasets to perform analyses to enhance our understanding of the relationship between the tort system …

Pregnant Man: A Conversation, Darren Rosenblum, Noa Ben-Asher, Mary Anne Case, Elizabeth Emens, Berta E. Hernandez-Truyol,, Vivian M. Gutierrez, Lisa C. Ikemoto, Angela Onwuachi-Willig, Jacob Willig-Onwuachi, Kimberly Mutcherson, Peter Siegelman, Beth Jones

Faculty Scholarship

I'm a law professor who works on gender, sexuality, and culture in the international and comparative context. That's my head working. In "real" life, my partner, Howard, and I have been engaged in having a baby together for several years, a project that came to fruition with the birth of our daughter Melina. Of course, such a project evokes intensely complex feelings and thoughts. Beyond a simple transposition of the personal onto the political, I feel so fortunate to have engaged in myriad conversations with a variety of friends and colleagues who think much more carefully about the family and …

Price And Pretense In The Baby Market, Kimberly D. Krawiec

Faculty Scholarship

Throughout the world, baby selling is formally prohibited. And throughout the world babies are bought and sold each day. As demonstrated in this Essay, the legal baby trade is a global market in which prospective parents pay, scores of intermediaries profit, and the demand for children is clearly differentiated by age, race, special needs, and other consumer preferences, with prices ranging from zero to over one hundred thousand dollars. Yet legal regimes and policymakers around the world pretend that the baby market does not exist, most notably through prohibitions against “baby selling” – typically defined as a prohibition against the …

Access To Medicine In An Era Of Fractal Inequality, Frank Pasquale

Faculty Scholarship

No abstract provided.

Race And Healthcare In America: Foreword, Barbara A. Noah

Faculty Scholarship

In all four of the articles that form this Symposium, the authors identify troubling disparities and injustices in our healthcare system and suggest strategies to ameliorate these problems. Sadly, the reforms of the Obama administration will probably do little to address these issues directly. The mandated insurance coverage requirement, for example, applies to U.S. citizens and legal residents, but not, unsurprisingly, to undocumented immigrants? Similarly, the legislation expands public programs but does nothing directly to support the burden of EMT ALA's unfunded mandate on hospitals. And, as the evidence has long demonstrated, insurance coverage alone fails to guarantee equal medical …

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Faculty Scholarship

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness. Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories, and provides an early empirical test of these models, using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models, and …

High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor

Faculty Scholarship

In the fall of 2008, Minnesota public health officials became alarmed by an unusually high number of illnesses and deaths caused by salmonella poisoning. Federal and state regulators and the news media eventually traced the outbreak back to products supplied by the Peanut Corporation of America (PCA). Employees shipped batches that tested positive for salmonella from a plant with a leaking roof, mold growing on ceilings and walls, rodent infestation, filthy processing receptacles, and feathers and feces in the air filtration system. Under an agreement with the Food and Drug Administration (FDA), Georgia state inspectors visited the PCA plant nine …

Nih Guidelines On Human Embryonic Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael R. Ulrich

Faculty Scholarship

No abstract provided.

Penetrating The Silence In Sierra Leone: A Blueprint For The Eradication Of Female Genital Mutilation, Chi Adanna Mgbako, Meghna Saxena, Anna Cave, Nasim Farjad, Helen Shin

Faculty Scholarship

The African grassroots movement to eradicate female genital mutilation (also known as “female genital cutting” and “female circumcision,” hereinafter “FGM”) is widespread. While many African countries and grassroots organizations have made great strides in their efforts to eliminate FGM, Sierra Leone lags behind. In Sierra Leone, FGM is practiced within the bondo secret society, an ancient, all-female commune located in West Africa and also known as the sande. The bondo society’s traditional role was to direct girls’ rites of passage into adulthood. In order to become a member of the bondo, a girl or woman must undergo various rituals, the …

Human Rights And American Bioethics: Resistance Is Futile, George J. Annas

Faculty Scholarship

The Borg are always confident that humans will be assimilated into their collective hive and therefore that, as they say, “resistance is futile.” In Star Trek, of course, the humans always successfully resist. Elizabeth Fenton and John Arras, like the Borg, resist the idea that humans are uniquely special as well as the utility of the human rights framework for global bioethics. I believe their resistance to human rights is futile, and I explain why in this essay. Let me begin with their subtitle, because we do seem to agree that popular culture is a powerful aid to understanding human …

Organophosphates, Friend And Foe: The Promise Of Medical Monitoring For Farm Workers And Their Families, Adriane J. Busby, Gabriel Eckstein

Faculty Scholarship

Millions of farm workers nation-wide who load, mix and/or apply pesticides are exposed to incredible amounts of pesticides on a daily basis. Various inefficiencies and inconsistencies in the regulatory system - including insufficient illness reporting data systems, lack of regulatory compliance and enforcement, and inadequate data and information on the chronic effects of exposure and overexposure to various pesticides - increase the likelihood that these workers will continue to be exposed to dangerous amounts of pesticides.

This Article assesses the existing mechanisms designed to protect farm workers from occupational exposure to pesticides and identifies and analyzes some of the shortcomings …

Pandemic Preparedness: A Return To The Rule Of Law, Wendy K. Mariner, George J. Annas, Wendy E. Parmet

Faculty Scholarship

Current discussions of pandemic influenza and emergency preparedness would do well to heed the lessons of US Airways flight 1549, which landed in the Hudson River in January 2009. This article examines what past emergencies teach us about how to prevent or control epidemics and argues that it is time for a return to the rule of law in pandemic preparedness. The most important resource in emergency preparedness is a healthy, resilient population, which depends importantly on sustainable systems of medical care and public health. Preparedness thus requires more money than law. After September 11, 2001, however, federal emergency preparedness …

Over Under Or Through: Physicians, Law, And Health Care Reform, William M. Sage

Faculty Scholarship

My purpose in this commentary is twofold. First, I want to offer a few thoughts on why the American medical profession sometimes has a hard time accepting law on its own terms. Second, I want to suggest that even “good law” from the perspective of the medical profession—should it overcome its habits of resistance—may still be bad health policy for the United States.

Creating A Paternalistic Market For Legal Rules Affecting The Benefit Promise, Brendan S. Maher

Faculty Scholarship

Notwithstanding the fact that ERISA was enacted to protect employee benefits, courts have narrowly construed the relief available when benefits are denied, out of concern that a stronger remedy would be too costly for the system to bear. Judges, I argue, are ill-equipped to make this policy judgment. Instead, a regulated, subsidized, paternalistic market should be created to permit the benefit players themselves to choose and price the strength of the remedy they desire. This is a superior means to reach the right level of remedial strength for the most players. To protect against undesirably weak remedial options being selected, …

Solidarity: Unfashionable, But Still American, William M. Sage

Faculty Scholarship

Illness, we are often told, is a private matter. Accordingly, none must interfere in the medical decisions that emerge from the confidential relationship be- tween physician and patient. Yet evidence of interdependence is ubiquitous in health care. One person’s malady can harm families, workplaces, clubs, churches, and sometimes entire communities. Similarly, a suffering pa- tient must rely on many individuals, associational groups, corporate entities, and government agencies for support and assistance. It is, therefore, unsurprising that various social units claim an interest and a voice in maintaining health and treating disease.

However, explicit solidarity has long been out of vogue …

Enhancing The Fighting Force: Medical Research On American Soldiers, Catherine L. Annas, George J. Annas

Faculty Scholarship

During President Barack Obama's first primetime press conference, reporters asked primarily about the state of the economy and terrorism. Wedged between questions on these two vital issues was a query from the Washington Post's Michael Fletcher:

Question: What is your reaction to Alex Rodriguez's admission that he used steroids as a member of the Texas Rangers?

Obama: You know, I think it's depressing news.... And if you're a fan of Major League Baseball, I think it - it tarnishes an entire era, to some degree. And it's unfortunate, because I think there are a lot of ballplayers who played it …

Out Of The Box: The Future Of Retail Medical Clinics, William M. Sage

Faculty Scholarship

The 2000s was mostly a lost decade for reform of the health care delivery system. Among the few significant innovations was the retail medical clinic, where individuals could receive basic health care at posted prices without appointments, typically from nurse practitioners or physician assistants. Most retail clinics were associated with chain drugstores, supermarkets, or other "big box" retailers. This short article describes the implications of the retail clinic model for US health policy and health care reform. It is no longer available from the online journal in which it originally appeared.

Pick Your Poison: Responses To The Marketing And Sale Of Flavored Tobacco Products, Kathleen Hoke Dachille

Faculty Scholarship

This law synopsis explores legal approaches for addressing the marketing and sale of flavored tobacco products to youth.

Prosecuting Doctors For Trusting Patients, Deborah Hellman

Faculty Scholarship

In an escalating phase of our country’s war on drugs, doctors treating patients in pain are being prosecuted for drug trafficking under the Controlled Substances Act. While doctors surely can be guilty of drug trafficking when they sell drugs for money, lately some doctors have been prosecuted for violations of a statute that requires knowingly distributing or dispensing controlled substances in an unauthorized manner for simply being willfully blind to the fact that their patients were reselling the drugs. While willful blindness may be an apt substitute for knowledge in the traditional drug courier scenario, doctors in these cases are …

Physicians Who Break The Law, Diane E. Hoffmann

Faculty Scholarship

This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …

A Circumspect Look At Problem-Solving Courts, Richard C. Boldt

Faculty Scholarship

No abstract provided.

Violence On The Brain: A Critique Of Neuroscience In Criminal Law, Amanda C. Pustilnik

Faculty Scholarship

Is there such a thing as a criminally "violent brain"? Does it make sense to speak of "the neurobiology of violence" or the "psychopathology of crime"? Is it possible to answer on a physiological level what makes one person engage in criminal violence and another not, under similar circumstances?

This Article first demonstrates parallels between certain current claims about the neurobiology of criminal violence and past movements that were concerned with the law and neuroscience of violence: phrenology, Lombrosian biological criminology, and lobotomy. It then engages in a substantive review and critique of several current claims about the neurological bases …

The Costs Of Multiple Gestation Pregnancies In Assisted Reproduction, Urska Velikonja

Faculty Scholarship

The United States, unlike most developed countries, does not regulate its fertility industry. Rather, it vests control over the industry to professional organizations and to market forces. While lack of regulation has produced a vibrant market for fertility services, it has also produced an undesirable consequence: a high rate of multiple gestation pregnancies, including twin pregnancies. This Article summarizes the data on the medical, psychological, and financial costs associated with multiple pregnancies to the parents, the children, and American society. It suggests that the current U.S. regulatory regime has not only failed to address these costs as they surfaced but …

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 …

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 …

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 …