RE-THINKING LIABILITY FOR VACCINE INJURY

Jeffrey A. Van Detta, John Marshall Law School-Atlanta
Joanna B. Apolinsky, John Marshall Law School-Atlanta

Abstract

In April 2009, the first cases of the novel influenza A (H1N1) virus were detected in humans in the United States. To date, there have been 17,855 confirmed or probable cases of H1N1 infection and 45 deaths in the United States alone. More than 70 countries have now confirmed human infection with novel H1N1 flu. On June 11, 2009, the World Health Organization raised the worldwide pandemic alert level to Phase 6. At this time, as H1N1 is a new virus, there is little human immunity to it. Moreover, there is no vaccine to prevent the spread of the virus. Congress has created a variety of statutory systems for adjudicating vaccine injury claims. Most notable of these is the National Childhood Vaccine Injury Act (NCVIA). These kinds of systems undoubtedly are flawed, providing virtual immunity for vaccine manufacturers and arguably modest, if any, compensation to injured vaccine recipients. Yet, they at least provide a potential method for acknowledging and providing some compensation to those injured by vaccines. In the absence of such a statutory system, plaintiffs must rely on state-law tort claims against vaccine manufacturers. Yet state-law tort suits are an expensive, inefficient, and inconsistent means of compensating vaccine injuries or regulating vaccine manufacturers. Moreover, lawyers for pharmaceutical manufacturers have lobbed an assault against the availability of tort recovery by arguing that state-law tort claims are preempted by approval of the drug or device by the Food and Drug Administration. Should an H1N1 vaccine be created, the federal government could attempt to protect manufacturers of the vaccine by statutorily preempting any tort claims which otherwise could be brought by an injured recipient of the vaccine. The time is ripe, therefore, for a re-examination of if, when, and how tort liability should be distributed for vaccine-related injuries. Our rethinking comes at a time when diseases that were supposedly eradicated by 20th century vaccines – such as smallpox and polio – are rearing their heads again, the former as a terroristic weapon and the latter as the product of an anti-vaccine movement in the U.S. and continuing socio-economic problems abroad. Moreover, 21st century society has been confronted with new, continually changing, and potentially devastating strains of pandemic flu virus, threatening not only the public health, but also the very fabric of our economic system and social order. Thus, the legal questions surrounding vaccines and injury compensation have left the realm of academic speculation and been thrust into the spotlight of an imminent, looming crisis. When should there be liability for vaccine-related injuries? What kind of liability should there be? How should liability be allocated for vaccine-related injuries? And might that inquiry be made more meaningful by considering the liability-compensation question within a holistic framework of strategic planning and policy for vaccination as a cornerstone of societal stability and progress, rather than as an isolated pocket of tort or administrative law?