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THE UNIVERSITY OF VERMONT PH 310 OL1 CRN: 94528 Syllabus COURSE: PH 396 OL3: Public Health Law &

Ethics CREDITS: 3 SEMESTER: Fall, 2012 PREREQUISITES: None FACULTY: Professor William E. Wargo BRIEF COURSE DESCRIPTION: Public health law examines the governments authority, at various jurisdictional levels, to improve the health of the general population within societal limits and norms. INTRODUCTION: Public health law is the study of the legal powers and duties of the state, in collaboration with its partners (e.g., health care, business, the community, the media, and academe), to ensure the conditions for people to be healthy and of the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals. Public health ethics seek to understand and clarify principles and values that guide public health actions, offering a framework for making decisions and a means of justifying them. LEARNING OBJECTIVES: The course has four basic learning objectives: 1. 2. 3. 4. Understand and discuss the operation of the U.S. legal system generally. Understand and define the role of the police power in public health. Understand and describe the role of law in population health. Understand basic public health ethics.

These learning objectives are also intimately related to certain core competencies identified by the Association of Schools of Public Health (ASPH) for the master of public health degree in graduate schools and programs of public health. The primary vision for the ASPH initiative is the graduation of professionals who are more fully prepared for the many challenges and opportunities in public health in the forthcoming decade. See: Calhoun et al., 2008. Development of a core competency model for the Master of Public Health Degree. American Journal of Public Health, 98(9), pp. 1598-1607. See, also: http://www.asph.org/document.cfm?page=851.

DETAILED COURSE DESCRIPTION: The course is divided into four parts consisting of thirteen modules. In the first part (Modules 1 and 2), we will cover the major concepts in the field of public health (e.g., prevention and the population perspective), ethics (e.g., paternalism and the harm principle), socioeconomic disparities, and the regulation of dangerous activities. The second part of the course (Modules 3-7) examines important doctrines and controversies in public health law. We will address the powers and duties of the state in the area of public health and the limitations that our constitutional system place on the exercise of public health powers. We will also focus on three areas that are key to the practice of public health law: administrative law, which delineates when an agency is allowed to directly regulate for the publics health; tort law, which indirectly regulates behavior through civil liability, and transnational law, which facilitates a globalized approach to public health. We will also look at international public health law, world trade law, and human rights. The third part of the course (Modules 8-12) addresses some of the major controversies and trade-offs involved in contemporary public health theory and practice. We will discuss surveillance, public health research, and the right to privacy. We will explore the interplay between speech and behavior by looking at health communications and commercial speech against the backdrop of free expression. We will consider medical countermeasures (immunization, screening, and treatment) and public health strategies (isolation, quarantine, and community containment) for preventing and mitigating the spread of epidemic disease, and the effects of those measures and strategies on bodily integrity and liberty. We will also examine the regulation of businesses and the value of economic liberty. Finally, in the fourth part of the course (Module 13), we will discuss case studies highlighting three of the most complex and important of todays public health challenges: bioterrorism and biosecurity, public health genomics, and obesity. This part of the course also underscores the various course themes public health ethics, the interconnectedness between domestic and global health, and the effects of socioeconomic disparities on public health. COURSE ASSIGNMENTS AND GRADING: The course will be taught online and utilize online discussions guided by questions specific to the issues covered. Some of those questions appear below. Course grading will be based on the following: 30% Discussion. See below for details about Discussion Board postings. 45% Short Written Assignments. There will be five short written papers assigned in the course. Each will require you to write 3-5 pages about a specific topic. I will provide you with additional resources to consider in writing each of your papers. These writing assignments are best submitted to me as e-mail attachments. If some problem develops regarding transmission, please let me know right away. You can contact me at wwargo@uvm.edu or through the Messages section of the upper left hand menu. Again, please do not hesitate to contact me regarding any difficulty. 2

25% Research Paper. The research paper should be between 10-15 pages long. I encourage you to choose a research topic that you are excited about. There are many websites that list possible research topics. Here is just one of them: Public Health Law Research Topics Discussion Board Postings Questions will be posted in the Course Modules which you will address on the class discussion board. I will pose sometimes controversial questions that can be argued from pro and con points of view, and I will ask half of the class to argue the pro position, and the other half of the class to argue the con position. The issues covered will include compulsory immunization, imposition of isolation and quarantine, the collection and use of tissue without consent, the legality of cigarette package images, and the constitutionality of the Affordable Care Act, an issue currently before the U.S. Supreme Court. You are required to participate in the online discussion by answering questions posed in the assignments and responding to at least one other student's post for each module (there is no "back of the classroom" in online discussion). All posts to questions are due Wednesday of each week. Responses to others posts occur on Thursday Friday. Here are the ground rules for discussion postings:

Answers to assignment questions should be 200-250 words long Responses to others can be shorter, 1-2 paragraphs All posts must be written in complete, grammatically correct sentences A civil, respectful tone must be maintained in all posts, especially when you disagree

Also, remember to back up anything you post! I STRONGLY recommend you compose your posts as Word or Notepad files, save them, and then cut and paste them into your posts (but do not attach the files to your posts!) because things can be easily lost, and you don't want to spend a long time composing a post and then lose it because of a mistaken key stroke! Your participation in the Discussion Board is graded each time you post an original response and comprises a substantial portion of your final grade. Here are the criteria I will use to grade each original post:

Excellent (A/5): posts answers on time, sometimes exceeding required number; comments are based on detailed and insightful understanding of material; properly refers to specific parts of the texts or other materials to support ideas; suggests other perspectives/directions; posts are clear, organized, and well-written

Good (B/4): posts answers on time; comments show a good understanding of material, may make reference to specific parts of the texts or other materials to support ideas; does not suggest other perspectives/directions; posts are adequately written Fair (C/3): posts answers on time; comments show only a basic understanding of the material; does not refer to specific parts of the texts or other materials to support ideas; posts are understandable but may lose focus and show some consistent mechanical errors Poor (D/2): misses deadline; comments show only a limited understanding of the material with few/no references to texts for support; posts are difficult to understand, frequently wander off-topic, use an inappropriate tone, and/or show significant writing problems Failing (F/1): misses deadline and doesn't participate

The discussion board is a central component of creating an online learning community. It is up to you to foster an online learning community. There are several things you can each do to enhance the learning experiences online: 1. ALWAYS READ THE ASSIGNED READINGS BEFORE POSTING -- If you have not taken an online course before, you will quickly learn that it is much more difficult to come to an online course unprepared than it is to go to a large lecture class unprepared. Don't learn this the hard way! 2. DON'T PROCRASTINATE ... POST EARLY -- Don't wait until the last minute to post your responses to the questions. Having an ongoing dialogue requires students to engage early. Note that I will be monitoring your postings over the course of the semester and keeping track of the time, frequency, and quality of your postings. 3. RESPECT AND CHALLENGE EACH OTHER -- Students are encouraged to challenge each other in a respectful way. I strongly encourage each of you to observe your own silence, anger and defensiveness around the issues we will be addressing in this course, and to try hard to challenge yourself and to engage in the discussions in a respectful manner. Keep in mind that listening is also very important, so when you are responding to your classmates, be sure that you are doing just that rather than re-voicing your own views. 4. STAY FOCUSED! -- It is easy to get off track. Keep in mind that it is fine to bring in personal experiences and observations if you wish, but be sure that you connect them specifically to the course material. Postings need to be anchored in the course concepts and readings. 5. FINALLY-- I can't repeat this enough. Please, when you compose a post, be sure to compose it in a Word or Notepad file, or some equivalent, and then cut and paste it into 4

the online posting screen. So many people have lost lengthy writings because they have not done this - you don't want to be one of them!!

Guidelines for All Other Written Assignments (Short Written Assignments and Research Paper) A Level 1. Introduction is comprehensive, gives reader good direction, sets the scene, and is followed throughout paper. 2. Summary/conclusion is thoughtful and relevant. 3. Fundamental issues addressed in depth with original arguments and critical judgements, demonstrating insight and creativity. 4. Current and classic primary literature sources are utilized. 5. Writing style shows evidence of individuality, unity and fluency. 6. Overall presentation of the paper is professional with no errors in syntax, spelling, etc. (i.e. Proper English language usage), and follows APA format. B Level 1. Introduction gives reader direction and is addressed throughout the paper. 2. Summary/conclusion is clear and concise. 3. Fundamental issues addressed with evidence of some original arguments and critical judgments. 4. Current literature sources utilized (primary and secondary) 5. Writing style is fluent with evidence of individuality and clarity. 6. Overall presentation of paper is neat and well organized with few minor errors in syntax, spelling, etc. (i.e. Proper English language usage), and follows APA format. C Level 1. Introduction gives reader direction. 2. Summary/conclusion is clear and concise. 3. Fundamental issues described but limited originality of arguments and few critical judgments. 4. Limited literature sources are utilized (current and/or classic). 5. Writing style is fluent and some evidence of individuality and clarity. 6. Overall presentation of paper is neat and minor errors in syntax, spelling, etc. (i.e. proper English language usage), and follows APA format. READING: The main text for the course is Public Health Law & Ethics: A Reader (2nd edition, 2010) edited by Lawrence O. Gostin (hereinafter Gostin). I will occasionally share other readings with you, including news items related to the topics we will be covering. COURSE CALENDAR AND READING Module 1. The Publics Health Gostin, Chapter 1 (23-58). 5

SOURCES: Ali H. Mokdad et al., Actual Causes of Death in the United States, / Geoffrey Rose, Sick Individuals and Sick Populations / Dan Beauchamp, Community: The Neglected Tradition of Public Health / Norman Daniels, Bruce Kennedy, and Ichiro Kawachi, Justice Is Good for Our Health / Lawrence O. Gostin and Madison Powers, What Does Social Justice Require for the Publics Health? Public Health Ethics and Policy Imperatives / Lawrence O. Gostin, Jo Ivey Boufford, and Rose Marie Martinez, The Future of the Publics Health: Vision, Values, and Strategies. Some Online Discussion Questions: What is public health? What are the core values of public health? How have perspectives on the public health system changed? Why? What is social justice and what does it require for the public health? What are some of the court-imposed limits on government in protecting the health and safety of the public? Can there be good reasons for public health paternalism in a democracy? Are health and safety individual interests, or are they also common and shared ends?

The above Online Discussion Questions, and those posed in other modules below, should be considered in responding to the discussion issues that I present in the modules respective forums. Module 2. Public Health Ethics Gostin, Chapter 2 (59-98). SOURCES: The National Commission for the Protection of Human Subjects of Biomedical and Behavior Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research / Ronald Bayer and Amy L. Fairchild, The Genesis of Public Health Ethics / James F. Childress et al., Public Health Ethics: Mapping the Terrain / Daniel Callahan and Bruce Jennings, Ethics and Public Health: Forging a Strong Relationship / Supreme Court of Vermont, Benning v. State / Marian Moser Jones and Ronald Bayer, Paternalism and Its Discontents: Motorcycle Helmet Laws, Libertarian Values, and Public Health / Stephen Breyer, Breaking the Vicious Circle: Toward Effective Risk Regulation / Richard Wilson and E.A. C. Crouch, Risk Assessment and Comparisons: An Introduction. Some Online Discussion Questions: What are the appropriate limits on the states power when its exercise to safeguard the publics health and safety interferes with individual interests? What are the features that distinguish public health ethics from conventional medical ethics or bioethics? 6

Are ethical principles and values, or the methods of ethical analysis, materially different when applied to populations rather than to individuals? What are the ethical implications of the courtsapplication of a scientific understanding of risk assessment?

Module 3. Public Health Duties and Powers Gostin, Chapter 3 (99-134). SOURCES: Supreme Court of the United States, DeShaney v. Winnebago County Department of Social Services / Supreme Court of the United States, Castle Rock v. Gonzales / William J. Novak, Governance, Police, and American Liberal Mythology / Supreme Court of the United States, South Dakota v. Dole / Supreme Court of the United States, United States v. Lopez / Supreme Court of the United States, Gonzales v. Raich / Supreme Court of the United States, New York v. United States. Some Online Discussion Questions: Does government have a duty to protect the publics health? What power does government have to regulate in the name of public health? What limits exist in the exercise of public health powers? What are the competing claims of the national and state governments in matters of public health? When should federal government jurisdiction reign over state jurisdiction?

Module 4. Public Health and the Protection of Individual Rights Gostin, Chapter 4 (135-166) SOURCES: Supreme Court of the United States, Jacobson v. Massachusetts / Circuit Court, Northern District of California, Jew Ho v. Williamson / Supreme Court of the United States, City of Cleburne v. Cleburne Living Center / Bureau of National Affairs, Second Amendment Shields Individual Rights, Is Violated by D.C.s Prohibition of Handguns / Supreme Court of Appeals of West Virginia, Greene v. Edwards. Some Online Discussion Questions: What are some restraints on government power that protect individual interests in autonomy, privacy, liberty, and property? How have such restraints changed since 9-11? 7

How do the U.S. Supreme Court decisions regarding sex between men illustrate different judicial perspectives? How do the courts seek to ensure that we reach a fair balance between the common goods of public health regulation and individual rights or freedoms?

Module 5. Public Health Governance: Direct Regulation for the Publics Health and Safety Gostin, Chapter 5 (167-194) SOURCES: Supreme Court of the United States, Gonzales v. Oregon / Supreme Court of the United States, Food and Drug Administration v. Brown & Williamson Tobacco Corp. / New York Court of Appeals, Boreali v. Axelrod / Supreme Court of the United States, Massachusetts v. EPA / Lawrence O. Gostin, The Deregulatory State . Some Online Discussion Questions: How are governmental public health powers exercised to achieve communal health and safety? What role does administrative law play in regulation and how is this role carried out to assure fairness? What are the limits of administrative power? How can self-regulation assure that the public health is protected? What are the limits of such self-regulation?

Module 6. Tort Law and the Publics Health: Indirect Regulation Gostin, Chapter 6 (195-222). SOURCES: Stephen P. Teret, Litigating for the Public Health / Wendy E. Parmet and Richard A. Daynard, The New Public Health Litigation / Tom Christoffel and Stephen P. Teret, Epidemiology and the Law: Courts and Confidence Intervals / Supreme Court of the United States, Daubert v. Merrell Dow Pharmaceuticals, Inc. / Peter W. Huber, Galileos Revenge: Junk Science in the Courtroom / Jon S. Vernick, Lainie Rutkow, and Stephen P. Teret, Public Health Benefits of Recent Litigation against the Tobacco Industry / Court of Appeals for the Second Circuit, Pelman v. McDonalds Corp. / Lawrence O. Gostin, The Deregulatory Effects of Preempting Tort Litigation. Some Online Discussion Questions: What is tort law? 8

How can attorneys general and private citizens carry out indirect regulation through the tort system? What are some of the major theories of tort litigation? What are toxic torts? How can such litigation protect the public? How do the courts deal with the admissibility of scientific evidence? What are the public health benefits of litigation against the tobacco industry? How can litigation affect obesity? What are the limitations of tort law in terms of economic and social costs?

Module 7. Global Health Law: Health in a Global Community Gostin, Chapter 7 (233-284). SOURCES: Lawrence O. Gostin, Why Rich Countries Should Care about the Worlds Least Healthy People / Laurie Garrett, The Challenge of Global Health / David P. Fidler and Lawrence O. Gostin, The New International Health Regulations: An Historic Development for International Law and Public Health / Allyn L. Taylor and Douglas W. Bettcher, WHO Framework Convention on Tobacco Control: A Global Good for Public Health / Jonathan M. Mann et al., Health and Human Rights / United Nations Committee on Economic, Social, and Cultural Rights, The Right to the Highest Attainable Standard of Health / M. Gregg Bloche and Elizabeth R. Jungman, Health Policy and the WTO / Lawrence O. Gostin, Meeting the Survival Needs of the Worlds Least Healthy People: A Proposed Model for Global Health Governance. Some Online Discussion Questions: What is global health law? What is its mission? Why should rich countries care about the worlds least healthy people? What are International Health Regulations? What challenges do they pose? What is the relationship between global health law and human rights?

Module 8. Surveillance and Public Health Research: Privacy and the Right to Know Gostin, Chapter 8 (285-322). SOURCES: Ronald Bayer and Amy L. Fairchild, Public Health: Surveillance and Privacy / Amy L. Fairchild, Ronald Bayer, and James Colgrove, Panoptic Visions and Stubborn Realities in a New Era of Privacy / Sandra Roush et al., Mandatory Reporting of Diseases and Conditions by Health Care Providers and Laboratories / Ronald Bayer and Kathleen E. Toomey, HIV Prevention and the Two Faces of Partner Notification / James G. Hodge Jr., An 9

Enhanced Approach to Distinguishing Public Health Practice from Human Subjects Research / David R. Buchanan and Franklin G. Miller, Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: The Ethics of Public Health Research on Less Expensive, Less Effective Interventions / Supreme Court of the United States, Whalen v. Roe / Centers for Disease Control and Prevention and Department of Health and Human Services, HIPAA Privacy Rule and Public Health: Guidance from CDC and the U.S. Department for Health and Human Services / Lawrence O. Gostin, James G. Hodge Jr., and Ronald O. Valdiserri, Informational Privacy and the Publics Health: The Model State Public Health Privacy Act. Some Online Discussion Questions: How has public health surveillance grown and changed? What are the legal and ethical aspects of public health practices such as reporting of injuries and diseases and partner notification? What are the distinctions between public health research and practice? How can the collective benefits of surveillance be reconciled with individual interests in privacy? What role does federal legislation such as the HIPAA privacy rule play in assuring protection of the public health?

Module 9. Health, Communication, and Behavior Gostin, Chapter 9 (323-364). SOURCES: Sonya Grier and Carol A. Bryant, Social Marketing in Public Health / Ruth R. Faden, Ethical Issues in Government-Sponsored Public Health Campaigns / Supreme Court of the United States, 44 Liquormart, Inc. v. Rhode Island / Supreme Court of the United States, Lorillard Tobacco Co. v. Reilly / Court of Appeals for the Second Circuit, International Dairy Foods Association v. Amestoy / United States District Court for the Southern District of New York, New York State Restaurant Association v. New York City Board of Health. Some Online Discussion Questions: What ethical issues are raised by health communication and the provision of health information by the government? What is and should be the governments role as provider of health information? How can the government compel entities to speak, such as through mandatory health and safety disclosures? To what effect? What is the commercial speech doctrine and how has it affected the public health? What legal standard guides the governments power to compel truthful speech?

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Module 10. Medical Countermeasures for Epidemic disease: Bodily Integrity Gostin, Chapter 10 (365-410). SOURCES: Garrett Hardin, The Tragedy of the Commons / Supreme Court of the United States, Zucht v. King / Supreme Court of Mississippi, Brown v. Stone / United States District Court for the Eastern District of Arkansas, Boone v. Boozman / James Colgrove, Expansion and Backlash: Vaccination at the Turn of the Twenty-first Century / Ruth R. Faden, Nancy Kass, and Madison Powers, Warrants for Screening Programs: Public Health, Legal and Ethical Frameworks / Supreme Court of the United States, Ferguson v. City of Charleston / Ronald Bayer and David Wilkinson, Directly Observed Therapy for Tuberculosis: History of an Idea / Supreme Court of Wisconsin, In re Washington / James Hodge et al., Expedited Partner Therapy for Sexually Transmitted Diseases: Assessing the Legal Environment. Some Online Discussion Questions: What are the biological approaches to prevent, detail, and intervene in epidemics? What are their limitations? What are the arguments for and against compulsory vaccination? What are the arguments for exemptions to compulsory vaccinations and how are they responded to? What are the benefits and detriments of mandatory treatment in dealing with epidemics such as tuberculosis and HIV/AIDS?

Module 11. Public Health Strategies for Epidemic Disease: Association, Travel, and Liberty Gostin, Chapter 11 (411-448). SOURCES: J. M. Eager, The Early History of Quarantine: Origin of Sanitary Measures Directed against Yellow Fever / Supreme Court of South Carolina, Kirk v. Wyman / Supreme Court of Ohio, Ex parte Company / Supreme Court, Queens County, City of New York v. Antoinette R. / Lawrence O. Gostin, Ronald Bayer, and Amy L. Fairchild, Ethical and Legal Challenges Posed by Severe Acute Respiratory Syndrome: Implications for the Control of Severe Infectious Disease Threats / Howard Markel, Lawrence O. Gostin, and David P. Fidler, Extensively Drug-Resistant Tuberculosis: An Isolation Order, Public Health Powers, and a Global Crisis / Ezekiel J. Emanuel and Alan Wertheimer, Who Should Get Influenza Vaccine When Not All Can? / Lawrence O. Gostin, Public Health Law in an Age of Terrorism: Rethinking Individual Rights and Common Goods / George J. Annas, Bioterrorism, Public Health, and Human Rights. 11

Some Online Discussion Questions: What is the difference between quarantine and isolation? What are the legal advantages and limitations of isolation and quarantine in dealing with infectious diseases? How can public health law deal with bioterrorism while respecting individual rights and common goals?

Module 12. Economic Liberty and the Pursuit of Public Health Gostin, Chapter 12 (449-480). SOURCES: Supreme Court of the United States, Dent v. West Virginia / Supreme Court of the United States, Camara v. Municipal Court of the City and County of San Francisco / United States District Court for the Southern District of New York, Players, Inc. v. City of New York / Supreme Court of New York, New York v. New St. Marks Baths / Supreme Court of the United States, Lochner v. New York / Supreme Court of the United States, Lucas v. South Carolina Coastal Council / Supreme Court of the United States, Kelo v. City of New London. Some Online Discussion Questions: Can there be effective free market solutions to social problems? What are the positives and negatives of such an approach? How can a system of licenses and permits best assure that the public health is protected? In what ways can administrative searches and inspections protect public health? When would such actions be deemed too intrusive? What is public nuisance law and what are its boundaries in protecting public health? How important is unbridled freedom in property cases, financial relationships, and the pursuit of occupations? Should we strive for a well-regulated society that deters harmful commercial activities?

Module 13. Concluding Reflections on the Field: Case Studies in Biosecurity, Genomics, and Obesity Gostin, Chapter 13 (481-519). SOURCES: Donald A. Henderson, The Looming Threat of Bioterrorism / David L. Heymann, The Evolving Infectious Disease Threat: Implications for National and Global Security / Halla Thorsteinsdttir et al., GenomicsA Global Public Good? / Wendy C. Perdue, Obesity, Poverty, and the Built Environment: Challenges and Opportunity. 12

Some Online Discussion Questions: What are the practical effects of actions taken to deal with the threat of bioterrorism? How can genetic knowledge be used in ways that alleviate ongoing health inequities? What privacy problems are presented by genetic science? What actions can be effectively taken to deal with the obesity pandemic?

Some Useful Public Health Law and Ethics Websites http://www.publichealthlaw.net/reader/ This is a companion website to the first edition of our text, with full-text versions of the cases excerpted in the first Gostin Reader along with additional material and links related to public health law. Note that www.publichealthlaw.net is a useful resource (separate from the text companion site). www.oyez.org United States Supreme Court multimedia archive featuring audio of oral arguments and much other useful information. http://www2.cdc.gov/phlp/index.asp CDCs Public Health Law Program and the Public Health Law News are excellent resources: http://www.phaionline.org/ The Public Health Advocacy Institute.

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