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Recalibrating Vaccination Laws

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RECALIBRATING VACCINATION LAWS EFTHIMIOS PARASIDIS INTRODUCTION ............................................................................................. 2154 I. PLACING THE VACCINE ACT IN HISTORICAL CONTEXT ..................... 2166 A. Manufacturer’s Liability for Vaccine-Related Injuries ............. 2167 1. The Cutter Incident and Vaccine-Induced Polio ................. 2167 2. Cancer and SV40 Contaminated Polio Vaccines ................. 2172 3. Products Liability Claims for Vaccine-Related Injuries ...... 2178 4. Vaccine-Related Injuries and Market Share Liability ......... 2186 B. The 1976 Swine Flu Vaccine: Industry Demands Government Indemnification for Vaccine-Related Injuries ........................... 2192 C. 1980s Public Health Politics: Portraying the FDA as a Bureaucratic Hindrance to Health and Safety .......................... 2200 II. THE VACCINE ACT FRAMEWORK ...................................................... 2208 A. National Vaccine Program: Goals, Funding, and Administration ........................................................................... 2209 B. The National Vaccine Injury Compensation Program .............. 2211 C. The Vaccine Act’s Limits on Tort Claims Against Vaccine Manufacturers ........................................................................... 2219 III. MODERNIZING THE VACCINE ACT ..................................................... 2221 A. Adjusting the Requirements for Adverse Event Reporting and Post-Market Analysis of Vaccine Safety and Efficacy ............... 2222 B. Predicating Limited Liability for Vaccine Manufacturers on Compliance with Post-Market Analysis Requirements .............. 2228 C. Exempting Design Defect Claims from the Preemption Provision of the Vaccine Act in Cases of Negligent Failure to Utilize a Safer Alternative Design ............................................. 2230 D. Restructuring the Burden of Proof for Claims Alleging Off-Table Vaccine-Related Injuries ........................................... 2234 Associate Professor of Law and Public Health, Moritz College of Law and the College of Public Health, The Ohio State University. For valuable comments on this project, I thank Amna Akbar, Micah Berman, Martha Chamallas, Brian Choi, James Curran, Ari Glogower, Peter Jacobson, Margot Kaminski, Aaron Kesselheim, Michelle Mello, Douglas Opel, Magdalen Parasidis, Wendy Parmet, Guy Rub, Marc Spindelman, and Chris Walker. A draft of this work was presented at the American Society of Law, Medicine & Ethics: 40th Annual Health Law Professors Conference, and I am grateful for feedback from attendees. William Donovan and Morgan Shafley provided excellent research assistance; I thank Lee Staley and the editors of the Boston University Law Review for outstanding editorial work. Funding was provided by the Greenwall Foundation Faculty Scholars Program in Bioethics. 2153 2154 BOSTON UNIVERSITY LAW REVIEW [Vol. 97:2153 E. Mandatory Minimum Investment of Trust Fund Proceeds for Vaccine Research and Development ......................................... 2239 CONCLUSION ................................................................................................. 2241 The United States is in the midst of a vaccine crisis. States utilize their police power to establish vaccine mandates, but the federal government—via the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”)—maintains responsibility for incentivizing vaccine innovation, ensuring a stable vaccine market, and affording compensation for vaccine-related injuries. Although the Vaccine Act may have been the cure for the vaccine woes of the 1980s, the law has failed to keep pace with technological advancements and evolving public policy concerns. As was the case during the 1980s, today’s vaccine market is highly consolidated and the public depends on one or two manufacturers for most childhood vaccines. This has led to vaccine shortages and a lack of competition in vaccine design. Rather than incentivizing timely adjustments to vaccine formulas, the Vaccine Act’s broad legal immunities for vaccine manufacturers have created a regulatory vacuum whereby manufacturers are not obligated to incorporate scientific developments into marketed vaccines. Furthermore, the Act’s complex compensation mechanism has failed to resolve vaccine-injury claims fairly and expeditiously. Meanwhile, declining public trust in government and industry fuels vaccine hesitancy and creates population health challenges for public health officials. Recalibrating vaccination laws can help remedy these imbalances. While the Vaccine Act may not be a primary cause of vaccine hesitancy, amendments to the law can be part of the solution. Grounded in a comprehensive analysis of the historical context preceding the enactment of the Vaccine Act, this Article details how statutory levers can address modern-day concerns in vaccine policy and provides draft legislation that furthers the Vaccine Act’s public health, compensation, and market stabilization goals. Using law as a means of furthering the public health and building public trust in vaccines, the proposals focus on increasing safety and efficacy research, adjusting preemption provisions, and expanding the safety net for vaccine-related injuries. INTRODUCTION Just as the health benefits of vaccines cannot be questioned seriously, neither can the shortcomings of the legal framework governing immunizations be ignored. The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”)— the federal regime governing vaccine innovation, the vaccine market, and compensation for vaccine-related injuries—was established over three decades ago, at a time when there were fewer vaccine doses and vaccine-preventable diseases,1 electronic health records and health information technology were in 1 For children eighteen and younger, in 1986 there were seven vaccine-preventable diseases and eleven total doses, while in 2017 there are sixteen vaccine-preventable diseases and fifty-two total doses. Compare U.S. CTRS. FOR DISEASE CONTROL & PREVENTION, 2017] RECALIBRATING VACCINATION LAWS 2155 their infancy,2 and lawmakers heavily favored corporate welfare and deregulation over consumer protection.3 Although the statute nurtured a pro- business environment that contributed to the development of new vaccines,4 the Vaccine Act lacks the necessary incentives to ensure that manufacturers keep pace with vaccine science. Manufacturers enjoy robust immunity from tort claims for vaccine-related injuries.5 However, once a vaccine is approved and made available to the public, a manufacturer does not have a statutory obligation to actively collect and analyze safety and efficacy data, nor are manufacturers obligated to update vaccine formulas in light of new scientific advancements.6 RECOMMENDED SCHEDULE FOR ACTIVE IMMUNIZATION OF NORMAL INFANTS AND CHILDREN 1 (1983) [hereinafter 1983 CDC VACCINE SCHEDULE], with U.S. CTRS. FOR DISEASE CONTROL & PREVENTION, RECOMMENDED IMMUNIZATION SCHEDULE FOR CHILDREN AND ADOLESCENTS AGED 18 YEARS OR YOUNGER 2 (2017) [hereinafter 2017 CDC VACCINE SCHEDULE]. The 1983 schedule, which was in effect in 1986, included: (1) four doses of the oral attenuated polio virus vaccine; (2) five doses of the diphtheria, tetanus, and pertussis vaccine (“DTP”), with a tetanus-diphtheria booster at age sixteen and every ten years thereafter; and (3) one dose of the measles, mumps, and rubella (“MMR”) vaccine. 1983 CDC VACCINE SCHEDULE, supra, at 4. The 2017 schedule includes: (1) three doses of the hepatitis B vaccine; (2) three doses of the haemophilus influenzae type b (“hib”) vaccine; (3) four doses of the pneumococcal conjugate vaccine; (4) five doses of the diphtheria, tetanus, and acellular pertussis (“DTaP”) vaccine, with a booster at age eleven; (5) three doses of the rotovirus vaccine; (6) four doses of the inactivated poliovirus vaccine; (7) two doses of the hepatitis A vaccine; (8) two doses of the MMR vaccine; (9) two doses of the varicella vaccine; (10) three doses of the human papillomavirus (“HPV”) vaccine; (11) two doses of the meningococcal vaccine; and (12) eighteen doses of the seasonal flu vaccine. 2017 CDC VACCINE SCHEDULE, supra, at 2. 2 See, e.g., A.L. Rector et al., Foundations for an Electronic Medical Record, 30 METHODS INFO. MED. 179 (1991) (detailing efforts during 1970s and 1980s to develop standards for electronic medical records); Huibert J. Tange et al., Medical Narratives in Electronic Medical Records, 46 INT’L J. MED. INFORMATICS 7 (1997) (describing development of health information systems since their inception in late 1970s). 3 See generally JOHN EHRMAN, THE EIGHTIES: AMERICA IN THE AGE OF REAGAN (2005) (discussing political, economic, and societal changes that took place in America during Reagan Administration). 4 Geoffrey Evans, Update on Vaccine Liability in the United States: Presentation at the National Vaccine Program Office Workshop on Strengthening the Supply of Routinely Recommended Vaccines in the United States, 42 CLINICAL INFECTIOUS DISEASES S130, S134 (2006) (crediting Vaccine Act with stabilizing vaccine market and incentivizing development of new vaccines). 5 42 U.S.C. §§ 300aa-21, -23 (2012); Bruesewitz v. Wyeth LLC, 562 U.S. 223, 243 (2011) (holding that “[Vaccine Act] pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by a vaccine’s side effects”). 6 See Bruesewitz, 562 U.S. at 250 (Sotomayor, J., dissenting) (pointing out that Court’s decision
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