Elizabeth Weeks Leonard

Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the studys outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDAs auspices.

Rhetorical Federalism: The Role of State Resistance in Health Care Decision‐Making

This paper identifies potential values deriving from the seemingly destructive, distracting health reform nullification movement. Both before and after passage of the Patient Protection and Affordable Care Act of 2010, states engaged in various forms of resistance to the new law. The debate highlights the increased role of government in health care delivery and generates active deliberation of core values and public policy concerns.

Stigmatizing the Unhealthy

Stigma can lead to poor health outcomes. At the same time, people who are perceived as unhealthy may experience stigma as the result of that perception. As part of a larger project examining discrimination on the basis of health status or “healthism,” we explore the role of stigma in producing disadvantage based on health status. Specifically, we look to the principles of health equality and health justice. An intervention violates health equality when it is driven by animus, which can be the result of stigma. Additionally, laws and policies offend health justice when they worsen health outcomes or they create or deepen health disparities. An intervention that produces stigma — whether intentionally or unintentionally — may offend health justice by making people worse off, in absolute or in comparative terms. Stigma-related health laws and policies can therefore be healthist in at least two ways. We therefore conclude that stigma should neither be the basis, nor the product, of efforts to improve health.

Teaching Health Law

Elizabeth Weeks Leonard Necessity Is the Mother of Invention In long Midwestern winters, two things are certain: snow and basketball. But two things that you cannot count on are snow day school closures and a home-team collegiate basketball championship. In Kansas last winter, we had both. Winter precipitation was much above average, resulting in a rare invocation of the University’s inclement weather policy to cancel classes in early February. And the Kansas Jayhawks basketball team brought home the National Collegiate Athletic Association championship trophy for the first time in two decades. The Chancellor commemorated the achievement with a campuswide celebration, including all-day class cancellation. This is all well and good. I am all for respecting Mother Nature’s forces and celebrating remarkable athletic accomplishments. But the combination of events does leave law professors nearing the end of the semester in a bit of a quandary. How to make up the cancelled classes to ensure compliance with American Bar Association accreditation instructional hours requirements? How to cover the missed course content? How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students? Faced with the prospect of having to make up two hours each of my Health Care Financing and Regulation course and my Public Health Law seminar, I turned to the teacher’s little helper: the DVD player. By way of full disclosure, I must admit that I am doggedly old-school in many of my teaching philosophies and methods. I mostly stick to some “soft” version of the traditional Socratic, case-method even in my upper-level courses. I do not use Power Point in class. I am not entirely sure how to turn on the “smart classroom” “sympodia” that clutter the fronts of our classrooms and require me to stash several remote control devices before placing my casebook and printed out, manila-filed notes on the dais. For better or worse, I understand my mission primarily to teach students to “think like lawyers,”1 not to entertain them. Accordingly, the idea of using a feature-length, major Hollywood studio release in class seemed scandalous. I recognize that our students are products of the media generation, suffer from hyper-stimulated, short attention spans, and are immersed in visual and electronic stimuli. But I resist playing into their “weaknesses.” Rather, I believe in teaching them patience and the slow, deliberate, and sometimes dry process of legal reasoning.2 Accordingly, I felt guilty, like a busy parent buying the kids McDonald’s for dinner and sticking them in front of the television when what they really need and deserve is a good helping of vegetables and some fresh outdoor air. But I rationalized that if I added a sufficiently meaty assignment along with the movieviewing, maybe they would get some sustenance out of it. And after all, my students had worked hard all semester; maybe they deserved a break that day.3 I required students in both classes, either during an in-class make-up session on a Friday afternoon or on their own, to watch and comment on Michael Moore’s 2007 documentary exposé of the U.S. health care system, Sicko.4 I required the seminar students to write short, two-to-threepage “reaction papers” to satisfy