Solving the Pandemic Vaccine Product Liability Problem

UC Irvine Law Review Volume 12 Issue 1 Article 7 11-2021 Solving the Pandemic Vaccine Product Liability Problem Sam F. Halabi Follow this and additional works at: https://scholarship.law.uci.edu/ucilr Part of the Health Law and Policy Commons, Legal Remedies Commons, and the Torts Commons Recommended Citation Sam F. Halabi, Solving the Pandemic Vaccine Product Liability Problem, 12 U.C. IRVINE L. REV. 111 (2021). Available at: https://scholarship.law.uci.edu/ucilr/vol12/iss1/7 This Article is brought to you for free and open access by UCI Law Scholarly Commons. It has been accepted for inclusion in UC Irvine Law Review by an authorized editor of UCI Law Scholarly Commons. Clean Final Edit_Halabi_V3.docx (Do Not Delete) 11/8/21 8:15 AM Solving the Pandemic Vaccine Product Liability Problem Sam F. Halabi* The global rollout of COVID-19 vaccines is underway, and with it the inevitable occurrence of severe side effects that accompany, rarely, even the safest and most effective vaccines. Governments have invested billions of dollars in supporting research, development, logistics, and supply chains, as well as supporting the creation of networks of healthcare providers to deliver vaccines to recipients all over the world. The European Commission and several international organizations have established the COVAX Facility to pool resources in promising vaccine candidates and to subsidize their procurement by low- and middle-income countries. Yet up-front investment in vaccine development and delivery solves only half the problem with respect to vaccine access. Risks of legal liabilities, particularly product liability for severe side effects, will serve as an important, if not decisive, factor in how vaccine manufacturers participate in the response with Emergency Use Authorized and recently-licensed COVID-19 vaccines. If manufacturers do not receive sufficient assurance against legal liability, especially product liability, they will not ship vaccines. There is limited experience with developing coronavirus vaccines, and severe side effects following immunization are inevitable, as evidenced from Phase III trials and strongly suggested by early administration of Emergency Use Authorized vaccines. Therefore, there is a critical need to balance the risk calculations of manufacturers with justice for immunization recipients who become seriously ill or die in order to contribute to herd immunity in the community. This Article outlines the components of a global no-fault liability, indemnification, and compensation system that includes leveraging current no-fault systems in thirty-nine countries, a World Health Organization insurance mechanism, and a combination of insurance and compensation fund construction based on claims-processing precedents from the Deepwater * Senior Scholar and Visiting Professor, O’Neill Institute for National and Global Health Law, Georgetown University; Professor, Colorado School of Public Health and Senior Associate Vice-President for Health Policy and Ethics, Colorado State University; JD Harvard, MPhil Oxford, BS Kansas State University. This Article was supported by the C. Boyden Gray Center for the Study of the Administrative State at George Mason University. The author thanks organizers of the University of Iowa Faculty Workshop Series and extends special thanks to the following for significant comments on earlier drafts: Ann Laquer Estin, Tom Gallanis, Roger Klein, Erika Lietzan, César Rosado Marzán, Tony Mills, Todd Pettys, Anya Prince, Ana Santos Rutschman, Sean Sullivan, Cristina Tilley, Andrew Torrance, Dan Troy, Adam White, Richard Williams, and Patti Zettler. The author thanks Audrey Honert, Tim Richard, and Shuwen Xu for superb research assistance. 111 Clean Final Edit_Halabi_V3.docx (Do Not Delete) 11/8/21 8:15 AM 112 [Vol. 12:111 UC IRVINE LAW REVIEW Horizon Oil Spill and Boeing 737 Max crashes—both of which had tens of thousands of claims originating from dozens of countries and processed in at least six languages. The proposed system will be essential for vaccine manufacturer response and to address vaccine hesitancy and injury in populations across the globe. Clean Final Edit_Halabi_V3.docx (Do Not Delete) 2021] PANDEMIC VACCINE PRODUCT LIABILITY 11/8/21 8:15 AM 113 Introduction.....................................................................................................................114 I. COVID-19 Vaccines and Product Liability...................................................119 A. The Uniqueness of Vaccines as Regulated Medical Products........... 119 1. Premarket Review ............................................................................. 119 2. Tort Liability as a Regulatory Mechanism ..................................... 121 B. Product Liability and COVID-19 Vaccines ......................................... 123 1. Real and Unknown Risks ................................................................. 123 a. New Vaccine Technologies ......................................................123 b. Side Effects Following Phase III and EUA COVID-19 Vaccines .......................................................................................125 c. H1N1 ...........................................................................................126 d. Dengue .........................................................................................129 2. Perceived and Falsely Attributed Risks ......................................... 132 C. Informed Consent and Product Labeling ............................................ 134 II. Global Pandemic Response Depends on Fairness to Those Suffering Severe Side Effects Following Immunization and Legal Assurance to Manufacturers.....................................................................................................137 A. The Structure of the COVAX Facility.................................................. 138 B. Liability and Compensation for Vaccine Injury Pose Barriers to both Manufacturer and Government Participation in COVAX ...... 145 C. Principles of Fairness and Justice Require Compensation for Those Suffering from Severe Adverse Events Following Immunization with COVID-19 Vaccines ............................................ 146 III. Solving the COVID-19 Vaccine Product Liability Problem ......................148 A. No-Fault Compensation for Vaccine Injury ........................................ 148 1. No-Fault Compensation Systems for Public Health Emergencies ....................................................................................... 148 2. Adapting No-Fault Compensation Systems for Routine Immunizations ................................................................................... 151 a. Funding ........................................................................................151 b. Eligibility ......................................................................................152 c. Administration . (...truncated)