Liability for Vaccine Injury: The United States, the European Union, and the Developing World

By Holland, Mary S. | Emory Law Journal, January 1, 2018 | Go to article overview

Liability for Vaccine Injury: The United States, the European Union, and the Developing World


Holland, Mary S., Emory Law Journal


INTRODUCTION

The 2017 Thrower Symposium focused on how law addresses serious global public health challenges. One critical way the world community addresses disease is through vaccination. The World Health Organization (WHO) and other national health bodies strongly recommend vaccines in many circumstances.1 Yet there is a scientific consensus that vaccines can and do cause harm and death in certain individuals, even when vaccines are properly manufactured and appropriately administered. So, who should bear this risk? Of course, the individual bears all the physical risk, both of protection from disease and potential adverse side effects. But what of the financial risk of potential vaccine harms? Who should pay-the manufacturer, the individual, the government, or some combination thereof?

This Article looks at current models for vaccine injury liability in the United States and the European Union, and also focuses on possibilities for the developing world in the future. In the United States, vaccine manufacturers have attained an extremely high level of liability protection through legislation and judicial interpretation. The 1986 National Childhood Vaccine Injury Act (the Vaccine Act); the 2005 Public Readiness and Emergency Preparedness Act (the PREP Act); and Bruesewitz v. Wyeth LLC, the U.S. Supreme Court's decision interpreting the Vaccine Act, together afford vaccine manufacturers almost blanket liability protection from damages for vaccine harms.2

In June 2017, the Court of Justice of the European Union (ECJ) provided guidance in a vaccine injury case that strikes a remarkably different balance. In E.U. countries, an injured person has the right to seek compensation in civil court and to allege that a vaccine is unreasonably dangerous or defective. The ECJ held that an injured party may bring "serious, specific and consistent evidence," and can prevail if this evidence shows that the vaccine is "the most plausible explanation for the occurrence of the damage."3 The plaintiff can assert this claim even if a scientific consensus that a vaccine can cause the alleged injury does not yet exist.

While some contend that this ECJ decision opens the floodgates to litigation, scholarly commentary disfavors this view. Empirical work indicates that leaving courthouse doors open elevates vaccine safety. While access to courts for vaccine injury in the United States is essentially closed, it is more open in Europe; accordingly, the ways in which developing countries proceed is at stake.

The U.S.-based Bill and Melinda Gates Foundation and other major intergovernmental, governmental, and private-sector actors have joined together recently to create a vaccine fund to respond to potential epidemic disease threats on a global basis. The new fund, the Coalition for Epidemic Preparedness Innovations (CEPI), has stated that it seeks to create liability protection and compensation mechanisms based on the U.S. model for vaccine liability. CEPI's intent to export the U.S. model warrants serious consideration and caution.

This Article seeks to explore these different liability regimes. Part I explores the liability protection mechanisms in the United States, including a review of the National Vaccine Injury Compensation Program (NVICP), the Supreme Court's Bruesewitz v. Wyeth LLC decision, and the PREP Act's compensation program. Part II discusses the June 2017 ECJ judgment of liability for vaccine injury and its implications in the European Union. Part III explores the liability standards that the new global CEPI is reviewing. This Article concludes that the E.U. model better balances the concerns of public health and individual rights, and thus is an important model for CEPI to consider.

I. THE 1986 U.S. NATIONAL CHILDHOOD VACCINE INJURY ACT

Advancements in vaccine science and the concomitant development of vaccination policy dramatically changed public health in the United States during the twentieth century. …

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