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

• Publication year: 2018

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

Mary S. Holland

LIABILITY FOR VACCINE INJURY: THE UNITED STATES, THE EUROPEAN UNION, AND THE DEVELOPING WORLD

Mary S. Holland^*

Introduction..............................................................................................416

I. The 1986 U.S. National Childhood Vaccine Injury Act..........417

A. Stakeholders .............................................................................. 420
B. The Legislative Compromise ..................................................... 423
C. Preemption of Design Defect Claims ........................................ 424
D. The National Vaccine Injury Compensation Program .............. 425
E. The Vaccine Injury Table .......................................................... 427
F. Limitation of Compensation and Damages ............................... 429
G. Opt-Out Procedure .................................................................... 430
H. Liability Protection for "Unavoidably Unsafe" Products ........ 431
I. The Problems of the Vaccine Act ............................................... 432
J. HHS Administrative Changes in the 1990s ............................... 433
K. Compensating Victims ............................................................... 435
L. Bruesewitz v. Wyeth ................................................................. 436
M. The Supreme Court's Decision.................................................. 438
N. The Dissent ................................................................................ 443
O. The Impact of the Vaccine Act and the Bruesewitz Decision .... 444
P. Empirical Research on Vaccine Injury Before and After the Vaccine Act ................................................................................ 445
Q. Liability Protection in Emergencies: The PREP Act................. 447

II. The European Union's Different Approach..............................451

A. N.W. v. Sanofi Pasteur MSD SNC............................................ 452
B. Commentary on the ECJ Decision ............................................. 457

III. The Coalition for Epidemic Preparedness Innovations..........460

Conclusion..................................................................................................462

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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.

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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.⁴ Many infectious diseases, including smallpox, polio, diphtheria, and rubella are extremely uncommon today, at least in part because of widespread uptake of vaccines.⁵ Death rates from infectious disease

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in the United States are low.⁶ Many consider vaccination one of the most significant advances in public health.⁷

Science suggests that vaccine efficacy is based on herd immunity. This theory postulates that as the level of immunity within a community rises, chains of infectious disease transmission are interrupted, eventually resulting in elimination of those infections and their risk of harm to the public altogether.⁸ The precise level of vaccination coverage necessary to achieve herd immunity depends on the disease and is difficult to determine empirically,⁹ but the imprecise theory of herd immunity guides national immunization programs.¹⁰

The U.S. national immunization program builds on state laws that mandate children's vaccination prior to enrollment in daycare and preschool to prevent the transmission of infectious diseases among children at school.¹¹ In 1964, the Secretary of Health, Education, and Welfare¹² chartered the Advisory Committee on Immunization Practices (ACIP) pursuant to the Public Health Service Act¹³ to support state efforts to prevent and control communicable diseases.¹⁴ ACIP advises the states on public health and funds state vaccination programs.¹⁵ ACIP's charter requires it to recommend when and for whom vaccines should be used to prevent disease.¹⁶ It also requires that ACIP decide

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which vaccines the federal government will subsidize for indigent children.¹⁷ By 1981, all states made vaccination a prerequisite for school attendance unless applicable exemptions applied.¹⁸ Today, ACIP's recommendations guide most state public health agencies in determining which vaccines to mandate for school entry.¹⁹

The success of the national vaccine program has come at a cost. Some children are permanently disabled or die from their vaccine exposures.²⁰ A broad spectrum of suspected and confirmed adverse vaccine events has grown in the decades from the beginning of mass vaccination.²¹ Although the percentage of those who experience adverse reactions to vaccines is believed to be small,²² thousands have been compensated for injury, and vaccine adverse events are almost certainly underreported.²³ In total, over 600,000 people in the

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United States have filed vaccine adverse event reports since 1990.²⁴ Furthermore, people receive little warning of the risks of vaccination because of minimal information requirements under the Vaccine Act.²⁵

Between 1980 and 1986, people who claimed vaccine injury brought over three billion dollars of damages claims to U.S. civil courts against vaccine manufacturers.²⁶ Although some vaccine-injured plaintiffs' claims were successful, most went uncompensated because of the difficulty of proving causation in the tort system.²⁷ Many potential plaintiffs could not afford representation to bring their claims. Because legal costs were high and vaccine manufacturers argued they were unable to obtain cost-effective liability insurance, manufacturers began to leave what they asserted was an unprofitable market.²⁸ For example, Wyeth Laboratories temporarily halted production of the diphtheria, pertussis, and tetanus (DPT) vaccine in 1984 "because of extreme liability exposure, cost of litigation and the difficulty of continuing to obtain adequate insurance."²⁹ By 1985, four manufacturers produced the primary vaccines used in state vaccination programs.³⁰ Congress recognized a supply crisis.³¹

A. Stakeholders

The parents of...