- Advanced Regulatory Law and Policy - The Advanced Regulatory Law and Policy seminar provides a unique educational opportunity for anyone interested in contemporary developments in regulatory law and policy across a variety of issue areas. Throughout the term, seminar participants follow regulatory developments in real time as well as encounter some of the most up-to-date research on regulatory issues. The primary work of the seminar centers around the production of RegBlog, a daily online source of writing about regulatory news, analysis, and opinion. The format of weekly seminars varies, ranging from early lectures on the regulatory process to in-depth discussions of contemporary regulatory issues, and from critique of peer writing samples to analysis of current research articles.
Enrollment in the Advanced Regulatory Law and Policy seminar is subject to permission of the instructor. Participants in Advanced Regulatory Law and Policy meet at the same time and location as participants in the Regulatory Law and Policy Seminar. The advanced seminar participants will take a leadership role in producing RegBlog, both preparing their own writing assignments, providing oral presentations about regulatory or writing issues, and conducting a peer editing process overseen by Professor Coglianese. This seminar meets weekly throughout the year, and students in the advanced seminar are expected to enroll in both terms.
Starting in 2013-2014, prior enrollment in one or more terms of the Regulatory Law and Policy seminar will be a prerequisite for enrollment in the advanced seminar.
- Animal Law and Ethics - This seminar course will focus both on fundamental legal and ethical questions, including human duties toward animals and whether conceiving of rights for animals is appropriate, as well as on an understanding of the current legal and administrative rules regulating the relationship between humans and animals. All viewpoints are welcome. We will discuss the varying viewpoints expressed by animal advocates, generally falling into the category of either "animal welfare" or "animal rights" positions. We will discuss the fact that nonhuman animals are considered property under the law and currently have no legal rights, per se, and only limited legal "protections." Discussion of animal rights will necessarily entail an examination of the sources and characteristics of fundamental rights, why animals have historically been denied them, and whether legal rights are appropriately limited to humans. Further, we will discuss whether, if any such rights were recognized, what nonhuman animals should be entitled to them and, if so, to which legal rights they should be entitled. The class will also consider such issues as establishing standing to bring suits on behalf of animals, constitutional issues raised in animal protection cases and an analysis of the law and policy behind the protections afforded (or not afforded) animals under various federal and state laws. We will examine the content and enforcement of state anticruelty laws, the Endangered Species Act, the Federal Animal Welfare Act and accompanying regulations. The seminar will also include environmental issues as they relate to animals including habitat protection, invasive species conflicts and the environmental effects of food animal production. We will have guest speakers for several sessions. In the past, these speakers have included including litigators and legislative advocates from the Humane Society of the United States and public interest law firms, a prosecutor who specializes in animal fighting, and leading legal scholars on animal ethics. Two papers will be submitted in lieu of a final exam. There may also be a group project or presentation to make things more interesting. As this course is intended, in part, as an opportunity to engage in an open dialogue on the potential for developments in this nascent area of law, attendance and participation in class discussion is crucial and laptops are not permitted.
- Cost-Benefit Analysis: Law, Policy and Practice - Federal and state governments, and the U.S. public, are increasingly turning to cost-benefit analysis and risk assessment to guide rulemaking decisions and to set priorities among interventions intended to protect health, safety, environmental quality, homeland security, financial assets, etc. This course prepares students to critically evaluate risk and cost-benefit analyses, in order to help make decisions that are responsive to law, science, economics, and public values. Students will analyze recent and pending decisions by EPA, FDA, OSHA, and other agencies, to explore how analysis has informed or obscured important controversies, and how the courts have shaped both analysis and outcome. We will also discuss the art of crafting cost-effective controls, considering both traditional rulemaking and innovative proposals for new policy instruments. Required readings will include a mix of journal articles about methods of analysis and regulatory policy, along with close analysis of several major court decisions. The course instructor is an environmental health scientist, but the course will not require any particular science or math background. Rather, lectures and class discussion will emphasize insights the instructor gleaned during 10 years as the chief rulemaking official at OSHA and member of numerous EPA advisory committees, including many details of regulatory analyses, court decisions, and enforcement actions that are poorly captured in the public record.
- Disability Law - This course surveys the significant laws that protect the civil rights of people with disabilities, with a primary focus on the Americans With Disabilities Act of 1990, the Rehabilitation Act of 1973 and the cases that interpret them. The Individuals With Disabilities in Education Act and the Fair Housing Act Amendments of 1988 will also be addressed in lesser detail.
In addition to discussing the doctrine that governs disability discrimination in the United States, the course will also explore the reasons why the disability laws have diverged from traditional Title VII doctrine and the benefits and limitations of the model of discrimination that is encompassed in the disability discrimination laws. Individual class sessions will also address some of the specific obstacles to full equality that exist in the disability context, including our country’s limited social welfare framework and sovereign immunity concerns.
- Doctors, Death Panels & Democracy - This seminar will explore the manner in which decisions about medical treatment are, and ought be, made within a complex twentieth-century health care system. With the passage of the recent federal health reform in the spring of 2010, Americans are more closely interconnected in the public and private health insurance systems than ever before. Yet actual decision-making in medicine remains highly devolved to individual doctors and their patients. This provokes serious concerns about optimal quality and cost control, as decisions made for one patient increasingly reverberate throughout the system. Many other countries have more explicitly investigated techniques by which public or aggregative judgment is brought to bear on individual medical decisions. In the American context even the hint of such centralized control provokes heated backlash, as evidenced by the rhetorical success of the “death panels” claim and the government’s repudiation of its own panel’s mammography testing recommendations last fall.
This course will explore such debates in the context of the way in which medical decisions have been made in the United States, are being made in other industrialized countries, and will be made in the future. Among topics of interest will be historical patterns of physician and patient authority, the rise of standardized “best practices” in medicine, efforts by private and public payors to control medical utilization, and policy experiments such as the Oregon Medicaid reform and the United Kingdom’s National Institute of Clinical Excellence, which applies cost-effectiveness criteria to all new medical therapies.
This will be a discussion seminar highly dependent on active and thoughtful engagement by students. Evaluation will be based on participation in weekly discussions as well as written work product. My present intention is to require that students complete short topical memos in response to weekly readings at a few points during the semester, although I may alternatively allow a longer independent research paper option, and will clarify that by the end of this summer.
- Drug Product Liability Litigation - More product liability lawsuits are filed against prescription drug manufacturers than against all other industries combined. As one legal scholar put it, the pharmaceutical industry is now “in tobacco-land in terms of how much people hate it,” and drug product liability litigation is now a “growth industry.” This course will consider the theory and practice of such lawsuits before, and now after, the Supreme Court’s landmark decision in Wyeth v. Levine (2009). At the outset, we will focus on the similarities and differences between such litigation and other product liability cases, using the “Phen-Fen” cases tried by the instructor as a model, and on the special context of FDA regulation. We will then consider the legal principles governing such lawsuits, such as inadequate warning; the learned intermediary doctrine; and medical causation. As part of each class, we will review the manner in which the controlling issues were presented to a jury using the edited record of a recent pharma products trial. The course will also consider the practical application of these doctrines, including the problems when doctors are witnesses; discovery strategies; and techniques to present complex information to juries. For the final class, each student will prepare one portion of opposing opening statements, based on the edited trial record they have been reviewing, which will then be combined and presented to a “jury” recruited from Philadelphia residents. No Prerequisite. Course Requirements: A “bench memo” due Week 8; a 5-6 page section of the final jury presentation due Week 12; class participation. No exam.
- FDA Law and Policy - This course will explore a variety of topics related to the Food and Drug Administration and its oversight of prescription drugs, medical devices and food safety. The FDA is a crucial federal regulatory agency, with authority over more than a quarter of the consumer products sold in the United States. We will discuss the history and basic approval authority of the FDA over food safety and therapeutic products, along with specific focus on a number of emerging developments. The class dynamic will be a mixture of Socratic teaching and more interactive legal and policy discussion, and I expect all students in the course to take an active role in our critique and analysis of various FDA policies and issues throughout the semester.
My intention is to offer students a choice of evaluation methods, either a self-scheduled “take away” final exam or a 20-25 page research paper on an FDA topic of your choosing. I may revisit the paper option if class enrollment is larger than expected, and will announce any changes to the paper option during the add/drop period. A small fraction of the grade will be based on class participation throughout the semester. This is a 1L elective course and 1Ls will receive priority in enrollment.
- Freedom & Responsibility Seminar - The seminar will read two important new books that address problems of responsibility. Attendance, preparation and consistent participation are required. A paper limited to 15 pages on any related topic the student chooses is required. A longer paper can also satisfy the senior writing requirement.
- Health Law - This course will examine the regulatory environment that surrounds the United States health care delivery and financing systems. It will explore how statutes, regulations, common law, and market forces help or hinder three major goals of policy makers: increasing access, reducing cost, and improving quality. Specific topics will include the history of professional self-regulation and common law rules surrounding the doctor-patient relationship, the regulation of health care quality through medical malpractice torts and statutes, the extensive statutory regulation of both private and public health insurance, and modern health care reform. Casebook readings will be supplemented by government publications, academic articles, and policy materials. Towards the end of the semester, we will cover extensive additional readings on the Patient Protection and Affordable Care Act (aka Obamacare). Evaluation will be based on exam and class participation.
- Health Law and Policy - This seminar will discuss and apply methods from health economics to analyze the relationship between laws, health behaviors, and health outcomes. We will examine scholarly works from the legal, economic, and medical fields. Topics will likely include the social determinants of health, health disparities, the obesity epidemic, malpractice liability reform, regulation of risky behaviors, and healthcare costs. No prior knowledge of economics or statistics is assumed. Weekly discussions, an oral presentation, and a final research paper are required.
- Health Law, Economics and Policy - This class will briefly discuss the basics of health economics and the use of empirical methods to isolate the causal effects of laws on individual behavior and health outcomes. We will then analyze a host of current issues in health policy, including the effect of insurance coverage on health, the determinants and the effects of the rise in obesity in the developed world, and what drives the explosion of healthcare costs in the U.S. No prior training in economics or statistics is required. Students will be evaluated on the basis of a written paper.
- Intellectual Property & National Econ Value Creation - This course will explore the legal structure of intellectual property laws in the United States and select foreign countries and the effect of these laws on the countries national economic development. In this process, we will explore the nature of the correlation between different types of intellectual property laws and national economic development. We will also discuss the quantification of the economic value of different types of intellectual property laws. Lastly, we will engage in a discussion as to whether intellectual property laws can be effective tools for social engineering.
- Mental Health Law - This course will cover the theoretical, doctrinal and practical issues in mental health law, with special reference to the criminal context. It will also be of interest to students interested in bioethics, health law, family law, and torts.
- Patent Law - In our modern technologically-based economy, the creation and enforcement of patent rights can make or break a business. With record numbers of patents being issued every year, the stakes for inventors (and, indeed, their lawyers) continue to increase, even as the patent law and its administration faces growing criticism. This course seeks to equip students with a detailed overview of the law and policy of the United States patent system. We'll organize our inquiry into four components. The first considers the justifications for (e.g., economic, moral, political) and creation of patent rights as well as the relationship between patent law and other "intellectual property" concepts. The second will delve into the details of the statutory requirements for patentability, with a focus on both the "black letter" law and the underlying policies. Third, we'll consider the scope and enforcement of patent rights, again considering how the policies expressed in the legal doctrine relate to the justifications for patent rights we discussed in section one. And finally, we'll conclude with a look at the subject matter of patents -- considering specifically the cases of biotechnology, computer software, and internet business models -- drawing together the ideas introduced throughout the course. Class exercises and simulations will be used throughout to highlight important concepts. Last year's syllabus and additional information can be found at http://patents.pennlaw.net/.
- Public Health Law & Policy - This seminar will examine a number of urgent issues at the intersection of law and public health, particularly those that involve a conflict between the rights of individuals and the well-being of the community. Rather than being wedded to a particular field of legal doctrine, we will use a case study approach to analyze US and international conflicts over (and regulation of) tobacco, junk food, pandemics/vaccines, natural and nuclear disasters, and HIV/AIDS, among others. Several distinguished guests will be invited to speak to the class, and students will have the opportunity to research, write, and present original research.
- Regulation of Health Insurance Markets - This seminar will examine the regulation of the U.S. health insurance market as the Affordable Care Act is implemented. Weekly topics may vary depending on student interest, but will include the economics of health insurance, legal and policy limits on administrative discretion in the specification of benefit design requirements, the creation and structure of the new health exchanges, the Massachusetts experience, insurance market rules, legal and ethical issues related to wellness incentives, and the implications of the new health insurance marketplace for hospitals and other medical service providers. Requirements include active participation in weekly team-based reaction papers, a team-based presentation about a current topic (with powerpoint and handouts), regular attendance, and completion of an individual research and policy analysis project culminating in a 10-12 page paper. Students from the Medical School and other schools outside the law school are strongly encouraged to enroll; there will be seats reserved for non-law students. The team-based nature of the assignments means that no legal background is required. Law student members of the teams will supply the necessary legal expertise.
- Regulatory Law and Policy - This seminar provides a unique educational opportunity for anyone interested in contemporary developments in regulatory law and policy across a variety of issue areas. Throughout the term, seminar participants follow regulatory developments in real time as well as encounter some of the most up-to-date research on regulatory issues. The primary work of the seminar centers around the production of RegBlog, a daily on-line source of writing about regulatory news, analysis, and opinion. The format of weekly seminars varies, ranging from early lectures on the regulatory process to in-depth discussions of contemporary regulatory issues, and from critique of peer writing samples to analysis of current research articles. Seminar participants complete short weekly writing assignments which may be selected for posting on RegBlog through a peer editing process overseen by Professor Coglianese. Participants have the opportunity to focus their work on the regulatory law and policy issues that interest them the most. This seminar meets weekly throughout the year, and students may enroll for the Fall Term, Spring Term, or both terms. The seminar is open to students from outside the law school by permission.
Starting in 2013-2014, prior enrollment in one or more terms of the Regulatory Law and Policy seminar will be considered a prerequisite for enrollment in the Advanced Regulatory Law and Policy seminar.
- Risk Regulation - Society faces a range of risks, from both natural sources and economic activities. A core challenge for society’s major institutions – governments, businesses, non-profits – is to understand these risks and learn to manage them effectively and efficiently. This seminar will focus on how society deals with risks, ranging from, on the one end of the spectrum, voluntary action by business to, on the other end, strict rules imposed by government on the private sector – with many variants in between. These risk management responses also include the design of institutions to identify, monitor, and provide information about risks. Understanding what makes for effective institutional responses to risk is especially challenging, for it calls for not just an understanding of institutions themselves -- e.g., law and business -- but also an understanding of how these institutions interact with and affect the risks they are supposed to reduce or mitigate. This seminar will meet on alternating Tuesday afternoons throughout the entire 2010-2011 academic year. One seminar meeting each month will feature a guest speaker presenting new scholarship or policy analysis related to risk regulation. The other sessions will provide general background on risk regulation, further consideration of the specific topics covered by the guest speakers, and discussion of research papers seminar participants will be expected to complete by the end of the spring term.