Digital Commons Network^™

Researchers Without Borders?: Limiting Obligations Of Ancillary Care Through The Rescue Model, Michael Ulrich

Faculty Scholarship

With the expansion of clinical research in developing countries, there is a need to explain obligations that researchers have to their subjects beyond those required by the study protocol. This paper outlines a model founded on the duty to rescue that provides ethical clarification of the obligations of ancillary care.

Germ Shed Management In The United States, Kevin Outterson

Faculty Scholarship

The U.S. Medicare program reimburses only for discrete treatments of individuals with infections, but fails to pay for infection control or antibiotic stewardship more generally. By focusing solely on discrete hospitals and patients, Medicare ignores the larger epidemiological reality - that hospitals, nursing homes and other institutions operate within a germ shed. Under current Medicare rules, institutions that invest in infection control or antibiotic stewardship, may actually lose money and benefit rival firms in the market. In effect, current Medicare rules subsidize MRSA pollution. Worse yet, Medicare rules block potentially efficient Coasian contracts to promote private coordination within germ sheds.

The Freedom Of Health, Abigail Moncrieff

Faculty Scholarship

What would have happened if the Patient Protection and Affordable Care Act (PPACA) really had authorized government “death panels” that would decide whether an elderly patient could get treatment? Leaving aside commerce clause and other constraints particular to Congress, would that kind of direct healthcare rationing be a constitutional exercise of governmental power in the United States? I think not. I argue here that an emergent substantive due process constraint would invalidate such an exercise; direct rationing of that kind would violate a constitutional “freedom of health” that is nascent in Supreme Court jurisprudence. Based on that logic, I argue …

Should The Patient Conquer?, William M. Sage

Faculty Scholarship

In 1596, Robert Bainbridge carved “The patient shall conquer” into the wall of his cell in the Tower of London. It is highly unlikely that Bainbridge was an early advocate for recipients of medical care, imprisoned perhaps by a cruel sheriff denied his payroll taxes or by a domineering barber refused his fee. But its unintended meaning would immediately provoke sympathy from many health care reformers. As we confront the critical challenges of implementing national health-care reform, however, whether the patient should conquer is a legitimate topic for debate. Does the patient’s conquest risk the collapse of the health-care system …

Human Coronaviruses Are Uncommon In Patients With Gastrointestinal Illness, Frank Esper, Zhen Ou, Yung T. Huang

Faculty Scholarship

BACKGROUND: Coronaviruses infect numerous animal species causing a variety of illnesses including respiratory, neurologic and enteric disease. Human coronaviruses (HCoV) are mainly associated with respiratory tract disease but have been implicated in enteric disease. OBJECTIVES: To investigate the frequency of coronaviruses in stool samples from children and adults with gastrointestinal illness by RT-PCR. STUDY DESIGN: Clinical samples submitted for infectious diarrhea testing were collected from December 2007 through March 2008. RNA extraction and RT-PCR was performed for stools negative for Clostridium difficile using primer sets against HCoV-229E, HCoV-OC43, HCoV-NL63, and HCoV-HKU1. Clinical data from samples positive for coronaviruses were reviewed …

Respecting Working Mothers With Infant Children: The Need For Increased Federal Intervention To Develop, Protect, And Support A Breastfeeding Culture In The United States, Heather M. Kolinsky

Faculty Scholarship

The author argues that the benefits of breastfeeding are overwhelming and that more needs to be done to ensure that all women have a viable option to continue breastfeeding upon returning to work, particularly the working poor and minorities. Those least likely to breastfeed are more likely to be part of an at risk population in terms of health. Most significantly, the lack of a cohesive policy in the workplace has had a disparate impact on the most vulnerable populations of breastfeeding mothers and their children. The lack of federal protection and a patchwork of protection in the states have …

Multihospital Outbreak Of Clostridium Difficile Infection, Cleveland, Ohio, Usa, Robin L.P. Jump, Ajay K. Sethi, Curtis J. Donskey

Faculty Scholarship

To determine whether a multihospital Clostridium difficile outbreak was associated with epidemic strains and whether use of particular fl uoroquinolones was associated with increased infection rates, we cultured feces from C. difficile-infected patients. Use of fl uoroquionolones with enhanced antianaerobic activity was not associated with increased infection rates.

Combating Antimicrobial Resistance: Regulatory Strategies And Institutional Capacity, William M. Sage, David A. Hyman

Faculty Scholarship

Amnesia is a common, important, but rarely noted side effect of antibiotics. Apart from medical historians, few recall the severe morbidity and mortality once associated with acute bacterial infection. However, decades of antibiotic overuse and misuse have compromised the long-term availability and efficacy of these life-saving therapies. If designed and implemented appropriately, regulation can reduce the risk of bacterial infection, reserve antibiotics for circumstances where they are necessary, and rationalize the use of the most powerful agents. Regulation of antibiotic resistance can be justified, and should be guided, by both efficiency and fairness. A range of regulatory options are available--some …

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 …

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 …

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, …

Changing The Topography Of Sentencing, Kate Bloch

Faculty Scholarship

No abstract provided.

Prisoners As Human Subjects: A Closer Look At The Institute Of Medicine's Recommendations To Loosen Current Restrictions On Using Prisoners In Scientific Research, Osagie K. Obasogie

Faculty Scholarship

No abstract provided.

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 …

Water Scarcity, Conflict, And Security In A Climate Change World: Challenges And Opportunities For International Law And Policy, Gabriel Eckstein

Faculty Scholarship

Although climate change is expected to have major consequences that affect the global environment in its broadest sense, one of the earliest and most direct impacts will be on Earth’s fresh water systems. While some regions will experience increased precipitation, others will suffer serious scarcity. Among others, consequences are likely to include severe flooding, extreme droughts, and meandering border-rivers. This, in turn, will affect human migration patterns, population growths, agricultural activities, economic development, and the environment. This article explores the impact that climate change will have on regional and global freshwater resources and the resulting legal and policy implications that …

Happiness And Punishment, John Bronsteen, Christopher Buccafusco, Jonathan Masur

Faculty Scholarship

This Article continues our project of applying new findings in the behavioral psychology of human happiness to some of the most deeply analyzed questions in law. When a state decides how to punish criminal offenders, at least one important consideration is the amount of harm any given punishment is likely to inflict. It would be undesirable, for example, to impose greater harm on those who commit less serious crimes or to impose harm that rises to the level of cruelty. Our penal system fits punishments to crimes primarily by adjusting the size of monetary fines and the length of prison …

Theorizing And Generalizing About Risk Assessment And Regulation Through Comparative Nested Analysis Of Representative Cases, Jonathan B. Wiener, Brendon Swedlow, Denise Kall, Zheng Zhou, James K. Hammitt

Faculty Scholarship

This article provides a framework and offers strategies for theorizing and generalizing about risk assessment and regulation developed in the context of an on-going comparative study of regulatory behavior. Construction of a universe of nearly 3,000 risks and study of a random sample of 100 of these risks allowed us to estimate relative U.S. and European regulatory precaution over a thirty-five-year period. Comparative nested analysis of cases selected from this universe of ecological, health, safety, and other risks or its eighteen categories or ninety-two subcategories of risk sources or causes will allow theory-testing and -building and many further descriptive and …

Using Decision Analysis To Improve Malaria Control Policy Making, Jonathan B. Wiener, Randall A. Kramer, Katherine L. Dickinson, Richard M. Anderson, Vance G. Fowler, Marie Lynn Miranda, Clifford M. Mutero, Kathryn A. Saterson

Faculty Scholarship

Malaria and other vector-borne diseases represent a significant and growing burden in many tropical countries. Successfully addressing these threats will require policies that expand access to and use of existing control methods, such as insecticide-treated bed nets (ITNs) and artemesinin combination therapies (ACTs) for malaria, while weighing the costs and benefits of alternative approaches over time. This paper argues that decision analysis provides a valuable framework for formulating such policies and combating the emergence and re-emergence of malaria and other diseases. We outline five challenges that policy makers and practitioners face in the struggle against malaria, and demonstrate how decision …

Defining Health Law Or The Edgewood Syndrome, Paula Lobato De Faria, Wendy K. Mariner, George J. Annas

Faculty Scholarship

The authors' main purpose is to present ideas on defining Health Law by highlighting the particularities of the field of Health Law as well as of the teaching of this legal branch, hoping to contribute to the maturity and academic recognition of Health Law, not only as a very rich legal field but also as a powerful social instrument in the fulfillment of fundamental human rights. The authors defend that Health Law has several characteristics that distinguish it from traditional branches of law such as its complexity and multidisciplinary nature. The study of Health Law normally covers issues such as …

Toward An Architecture Of Health Law, Wendy K. Mariner

Faculty Scholarship

This article examines 3 questions: What is an academic field of law? Is health law such a field? If it is, how can or should it be described? The first question may have no answer; scholars and practicing lawyers have fashioned their owns spheres of expertise. Describing health law faces particular challenges, including the breadth of applicable doctrines and the decline of unique medically-oriented adaptations of general principles. The article offers a blueprint based on the health and human rights framework as a functional description of the eclectic and translegal field of health law. This approach can identify the principles …

Topical Application Of Entry Inhibitors As "Virustats" To Prevent Sexual Transmission Of Hiv Infection, Michael M. Lederman, Robin L.P. Jump, Heather A. Pilch-Cooper, Scott F. Sieg

Faculty Scholarship

With the continuing march of the AIDS epidemic and little hope for an effective vaccine in the near future, work to develop a topical strategy to prevent HIV infection is increasingly important. This stated, the track record of large scale "microbicide" trials has been disappointing with nonspecific inhibitors either failing to protect women from infection or even increasing HIV acquisition. Newer strategies that target directly the elements needed for viral entry into cells have shown promise in non-human primate models of HIV transmission and as these agents have not yet been broadly introduced in regions of highest HIV prevalence, they …

Science, Intersubjective Validity, And Judicial Legitimacy, Richard B. Katskee

Faculty Scholarship

No abstract provided.

Civil War In The U.S. Foreign Relations Law: A Dress Rehearsal For Modern Transformations, The The Use And Misuse Of History In U.S. Foreign Relations Law, Thomas H. Lee

Faculty Scholarship

The first of the four U.S. foreign relations law insights of the Prize Cases that this Article will discuss is the notion that international law provides a basis for the President's exercise of military force in a manner neither specifically enumerated in the Constitution nor preauthorized by congressional enactments. The specific military action was the proclamation of a naval blockade that applied not only to active Confederate belligerents but also to loyal U.S. citizens residing in seceding or soon-to-secede states and to foreign neutral citizens. The second insight is the notion that federal constitutional law protections for U.S. citizens, such …

Market-Based Licensing For Hpv Vaccines In Developing Countries, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Human papillomavirus (HPV) vaccines hold great promise for preventing cervical cancer, but 93 percent of mortality worldwide occurs in low- and middle-income countries, where high vaccine costs can restrict dissemination. Current models for promoting international access to health care innovations include differential pricing, advance market commitments, and voluntary and compulsory licensing. Some of these mechanisms have been effective, but much room for improvement remains. We discuss the usefulness of a new type of license that uses market forces to lower prices through generic competition in low- and middle-income countries while ensuring that pharmaceutical companies are appropriately reimbursed for their research …

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

Faculty Scholarship

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, …

The International Enclosure Movement, Peter K. Yu

Faculty Scholarship

Most of the recent intellectual property literature concerns the enclosure of the public domain or the one-way ratchet of intellectual property protection. While these concerns are significant and rightly placed, a different, and perhaps more important, enclosure movement is currently taking place at the international level. Instead of the public domain, this concurrent movement encloses the policy space of individual countries and requires them to adopt one-size-fits-all legal standards that ignore their local needs, national interests, technological capabilities, institutional capacities, and public health conditions. As a result of this enclosure, countries are forced to adopt inappropriate intellectual property systems, and …

The Check Isn't In The Mail: The Inadequacy Of State Prompt Pay Statutes, Michael Flynn

Faculty Scholarship

No abstract provided.

Mission Creep: Public Health Surveillance And Medical Privacy, Wendy K. Mariner

Faculty Scholarship

The National Security Agency's domestic surveillance program has parallels in the growth of disease surveillance for public health purposes. This article explores whether laws requiring health providers to report to government names and identifiable information about patients with infectious or chronic diseases may be vulnerable to challenge as an invasion of privacy. A shift in the use of disease surveillance data from investigating disease outbreaks to data mining and analysis for research, budgeting, and policy planning, as well as bioterrorism, tests the boundaries of liberty and privacy. The Supreme Court has not reviewed a disease reporting law. Its few related …

Introduction To The Tenth Anniversary Issue Of The Journal Of Health Care Law & Policy , Karen H. Rothenberg, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.

Social Contagion Of Violence, Jeffrey A. Fagan, Deanna L. Wilkinson, Garth Davies

Faculty Scholarship

In this chapter, we assess whether the roller-coaster pattern of homicides in New York City beginning in 1985 fits a contagion model and identify mechanisms of social contagion that predict its spread across social and physical space. This framework for interpreting the homicide trends as an epidemic includes two perspectives. First, the sharp rise and fall are indicative of a nonlinear pattern in which the phenomenon spreads at a rate far beyond what would be predicted by exposure to some external factor and declines in a similar pattern in which the reduction from year to year exceeds what might be …