I have two excellent guests this week. Dr. Julie Cantor is an adjunct faculty member at the UCLA School of Law. She is a graduate of Stanford University, UC Berkeley School of Law, and the Yale University School of Medicine. Dr Cantor has two decades of public policy and advocacy experience focused on federal healthcare policy. She has published broadly including in the New England Journal, Annals of Internal Medicine, the Indiana Law Review, the ABA Human Rights Journal, the NYT Debate section, and has submitted amicus briefs in several Supreme Court cases. Making a welcome return to the pod is Ross Silverman, Professor of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health at IUPUI, and holds a secondary appointment as Professor of Public Health Law at the Indiana University Robert H. McKinney School of Law. His research interests include legal, ethical and policy issues in public health and medicine, mobile health law and policy, interdisciplinary curriculum development, professional school admissions, medical humanities, human rights, and patient safety. Professor Silverman has published extensively on vaccination issues. Our discussion topic rotates around the recent measles outbreaks and the public health and public health law issues they raise. If you happened to pick up the June 5 issue of the New England Journal of Medicine you will have seen articles by both Julie and Ross (co-authored w/ Douglas Opel and Saad B. Omer) addressing aspects of the current law and policy debates. Other sources noted were this op-ed by Prof. Michael Willrich, Yiddish mistranslation, this New York Times risk-benefit analysis, and Angela Shen’s Measles Madness And Value post.

The Week in Health Law

160. Protecting the Herd. Guests, Julie Cantor & Ross Silverman.

Elizabeth Chamblee Burch holds the Fuller E. Callaway Chair of Law at the University of Georgia. She has a stunning publication record, published in the New York University Law Review, Cornell Law Review, Virginia Law Review, Vanderbilt Law Review, Washington University Law Review, Boston University Law Review and George Washington Law Review, among others. In 2015, Professor Burch was awarded the American Law Institute’s Early Career Scholars Medal in recognition of her work on class actions and multidistrict litigation, and its potential to influence improvements in the law. She teaches and researches civil procedure, class actions and mass torts. Her new book Mass Tort Deals was published last month by Cambridge University Press. The book is an excellent read and illuminates a highly complex area of litigation. Our conversation explored the role of repeat player lead plaintiffs’ and defense attorneys, the functions and control of the MDL judge, and, of course, we discussed the opioid litigation and how the state cases may impact any settlement.

159. Came for the Opioids, Stayed for the Civil Procedure. Guest, Elizabeth Chamblee Burch.

A swift return to the pod by Jennifer Oliva. Jenn is an Associate Professor at West Virginia University in the College of Law and School of Public Health. This Spring she has been a visiting research scholar at The Petrie-Flom Center at Harvard Law School. In the Fall she will be joining the faculty at Seton Hall Law School. Her work has been published by or is forthcoming in the Duke Law Journal, Northwestern University Law Review, Ohio State Law Journal, North Carolina Law Review, and the George Mason Law Review. We continue to explore some of the themes we discussed with Leo Beletsky in the last episode. Here, Jenn and I drill down into some of the issues surrounding the opioid litigation. Issues and questions discussed include the relationship between the federal district court MDL litigation in Cleveland and actions brought by state attorneys-general in their own courts, the implications of the recent Oklahoma settlement, and the chances/challenges of fashioning “public health” remedies that would mitigate the effects of the opioid overdose epidemic.

158. Opioid Litigation Update. Guest, Jennifer Oliva.

I am joined by guests Leo Beletsky & Jennifer Oliva. Leo is a Professor of Law and Health Sciences and the Faculty Director of the Health in Justice Action Lab at Northeastern University School of Law. He holds a joint appointment with the Bouvé College of Health Sciences. He has broad expertise and an enviable research and publication record in the public health impact of laws and their enforcement, with special focus on drug overdose, infectious disease transmission and the role of the criminal justice system as a structural determinant of health. Jennifer is an Associate Professor at West Virginia University in the College of Law and School of Public Health. This Spring she has been a visiting research scholar at The Petrie-Flom Center at Harvard Law School. In the Fall she will be joining the faculty at Seton Hall Law School. Her work has been published by or is forthcoming in the Duke Law Journal, Northwestern University Law Review, Ohio State Law Journal, North Carolina Law Review, and the George Mason Law Review. We discussed the conceptual and practical flaws in Prescription Drug Monitoring Programs (PDMPs), on which see these great articles by Leo and by Jenn, opioidphobic moves such as Michigan’s NonOpioid Advance Directive, the apparent animosity of federal prosecutors towards evidence-based public health initiatives like SEPs or SIFs, some of which is the subject of ongoing litigation. And of course we talked about the role of social determinants on which, again, see Leo or structural determinants on which I have written.

157. Misaligned Opioid Policies. Guests, Leo Beletsky & Jennifer Oliva.

I am joined by guest host Claudia Haupt, Associate Professor of Law and Political Science Northeastern University School of Law and guests Ignacio Cofone, Assistant Professor of Law at McGill University, Jessica Roberts, the Director of the Health Law & Policy Institute and an Alumnae College Professor in Law, and Ana Santos Rutschman, Assistant Professor in the Center for Health Law Studies and the Center for International and Comparative Law at Saint Louis University. We were gathered together in Boston for the Promises and Perils of Emerging Health Innovations symposium organized by our friends at Northeastern University School of Law.

156. Promises & Perils. Guest Host, Claudia Haupt; Guests, Ignacio Cofone, Jessica Roberts, & Ana Santos Rutschman.

I am joined by Aaron Kesselheim and Jonathan Darrow, faculty members at Harvard Medical School and members of the Program On Regulation, Therapeutics, And Law (PORTAL) group directed by Dr. Kesselheim. The conversation began with a discussion about drug price narratives, including whether drug prices are still increasing? We also critically discussed at least some of Vox’s 8 ideas for bringing down drug prices, and some better ones! The conversation then shifted to some issues, including pricing and expectations, with gene therapy drugs. We spent a short time on the resignation of Food and Drug Administration Commissioner Scott Gottlieb before ending our discussion with some information about PORTAL’s innovative online course, “The FDA and Prescription Drugs: Current Controversies in Context.”

155. It’s The Prices Stupid! Guests, Aaron Kesselheim and Jonathan Darrow.

For over two decades our school of law In conjunction with the IU School of Medicine has conferred the McDonald-Merrill-Ketcham Memorial Award for Excellence in Law and Medicine. This year’s honoree was Dr. Karen DeSalvo, who is currently Professor of Medicine and Population Health at the University of Texas at Austin Dell Medical School. She served in the Obama Administration as National Coordinator for Health Information Technology and Acting Assistant Secretary for Health and previously was the Health Commissioner for the City of New Orleans. I am very grateful to Dr DeSalvo for making her remarks available on TWIHL. Her talk begins in New Orleans in the aftermath of Katrina, explains zip code health, emphasizes the roles of Social Determinants of Health, demonstrates how social determinants impact particular health outcomes, presents a systematic model for dealing with social determinants, explains Public Health 3.0, and discusses the gap between health and social care spending. Along the way Dr. DeSalvo also discusses the role of technologies such as ride share companies disrupting social services and digital assistants such as Amazon Echo acquiring more health information.

154. Zip Code Health. Guest, Karen De Salvo.

The return of TWIHL’s infamous and extra long “Who’s Been Naughty or Nice?” Holiday show. This year’s festive appreciation of healthcare law and policy features the seasonal vocalizations of Zack Buck, Erin Fuse Brown, and Elizabeth Weeks Leonard. Nominees for both naughty and nice include a wealth of administration moves, plenty of good and bad Medicaid news, drug pricing, and a whole lot more to fill the stockings and require conspicuous amounts of egg nog.

153. Naughty or Nice 2018? Guests, Zack Buck, Erin Fuse Brown, and Elizabeth Weeks Leonard.

Abbe Gluck, Professor of Law and the Faculty Director of the Solomon Center for Health Law and Policy at Yale Law School, and I continue a deep dive into some of the issues raised at the November 2018 Yale roundtable on on “The Law and Policy of AI, Robotics, and Telemedicine in Health Care.” We are joined by our expert friends Nathan Cortez, Professor of Law and Associate Dean for Research at the SMU Dedman School of Law, and Sharona Hoffman, Edgar A. Hahn Professor of Law; Professor of Bioethics and Co-Director of the Law-Medicine Center at Case Western Reserve University School of Law, leading to a deep dive into FDA regulation and data-driven healthcare discrimination. Discussion topics included potential updates to the language of the ADA to deal with discrimination on the basis of AI/Big Data predicted healthcare issues and practical questions about the application and enforcement of the FDA’s functional definition of “medical device.”

152. Regulate Now or Regulate Later? Guests, Nathan Cortez, Sharona Hoffman, and Abbe Gluck.

I am joined by Abbe Gluck, Professor of Law and the Faculty Director of the Solomon Center for Health Law and Policy at Yale Law School. In November 2018 her team pulled together an excellent roundtable on “The Law and Policy of AI, Robotics, and Telemedicine in Health Care.” This episode of TWIH is the first of two taking a deeper dive into just a few of the issues that were so well presented at the roundtable. Here we were joined by Michael Froomkin, the Laurie Silvers and Mitchell Rubenstein Distinguished Professor of Law at the University of Miami School of Law and by Nicholson Price, Assistant Professor of Law at The University of Michigan Law School. Topics ranged from consent in the next generation of healthcare research to data protection, and appropriate regulatory models.

151. Automating Drudgery. Guests, Michael Froomkin, Abbe Gluck, and Nicholson Price.

A long overdue return from health care privacy and security guru Kirk Nahra. Kirk is a partner at Wiley Rein LLP in DC and teaches privacy courses at American University. We have a broad-ranging discussion touching on European General Data Protection Regulation (particularly its territorial scope), the new California Consumer Privacy Act of 2018 (particularly its attempted HIPAA carve-out), the (un)likelihood of federal privacy regulation, and some recent HIPAA cases and settlements.

150. A Two-in-Ten Chance. Guest, Kirk Nahra.

What do you get when you put some super-smart lawyers from a top law firm and the Federation of State Medical Boards in a room and raise the topic of AI regulation? Answer: Some pretty smart ideas about future implementation, reimbursement, liability and regulation. Joining me for the discussion are Terry Dee, Jiayan Chen, Kate McDonald, and Dale Van Demark, all partners in various offices of McDermott Will & Emery and Eric Fish, Senior Vice President for Legal Services at The Federation of State Medical Boards. The discussion involves some predictable issues such as data protection and FDA regulation but also raises additional questions about business models, liability constructs, and the role of reimbursement.

149. AI & the Practice of Medicine. Guests, MWE-FSMB All-Stars.

I am joined by Professor Wendy Mariner, Professor of Health Law at Boston University School of Public Health and Professor of Law at Boston University School of Law. It’s three days after the midterm elections and we thought it would be a good idea to reflect on some of the health law and policy stories. For more see http://blog.petrieflom.law.harvard.edu/ 2018/11/08/10-health-law-and-policy-takeaways-from-the-midterm-election/#more-26940

148. Midterm Takeaways Director’s Cut. Guest, Wendy Mariner.

If you listened to the last episode of TWIHL you may recall that it was recorded early on October 26th 2018 just before I kicked off our conference on the intersection of health care and immigration policy. Thereafter, it was my distinct pleasure to welcome Wendy Parmet as our keynote speaker. Professor Parmet is the Matthews Distinguished University Professor of Law and Director, Center for Health Policy and Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs. With Patricia Illingworth she authored The Health of Newcomers, Immigration, Health Policy, and the Case for Global Solidarity, published last year by NYU Press. Wendy was most generous in letting me share her talk on TWIHL.

147. Because We Are Human. Guest, Wendy Parmet.

This week I welcome to the pod YY Brandon Chen, Brietta Clark, and Medha Makhlouf. We have a broad discussion about the intersection of health care and immigration policy. We look at federal initiatives such as the proposed public charge rule and existing federal restrictions on providing healthcare to “newcomers.” Our guests explain attributes of the Canadian and Californian systems that, rather than being exceptional and progressive example, themselves in their detail illustrate some of the broader discussions we are (or should be) having.

146. Health Law Profs on Immigration Getting Coffee. Guests, YY Brandon Chen, Brietta Clark, and Medha Makhlouf.

Frank Pasquale, Nicolas Terry and their Guests discuss the significant health law and policy issues of the week

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The Week in Health Law

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