Compensation Programs for Vaccine-Related Injury Abroad: A Comparative Analysis

Adverse physical reactions to immunizations, 1 although comparatively rare, raise fundamental questions about the relationship between the state and the individual. In the United States, responsibility for vaccine-related injuries has been judicially and administratively debated for nearly two decades, beginning with the seminal decision of Davis v. Wyeth Laboratories. The primary issue is whether a person who suffers an unpredictable adverse reaction to a vaccination is entitled to receive compensation for his or her injuries, and if so, whether compensation should be provided by the manufacturer of the vaccine as part of its responsibility for the effects of its products, by the government as part of its responsibility to protect the health and welfare of the population, or by some other source like private health insurance. Vaccines cause injuries in several ways. Contamination, adulteration, improper configuration or other errors in the manufacturing process, inadequate testing,4 or improper labeling5 can result in defective vaccines. Even if the vaccine is not defective, injury may occur if the vaccine is administered improperly or in an improper dosage, or is contraindicated because of allergy, illness, immunosuppression, or age.\u27 Whether such problems are intentional or unintentional, their fault lies with a third party in the sense that the manufacturer or the administering health practitioner failed to ensure that the vaccine or the vaccination was what it should have been. Moreover, nondefective vaccines that are properly administered can produce unforeseeable adverse reactions in individual cases.\u27 Although such reactions are not necessarily anyone\u27s fault, any resulting injury is obviously a serious matter to the injured person. In the United States, compensation for adverse reactions to vaccinations is mediated under the principles of tort law. Entitlement to compensation depends upon whether a manufacturer or some other person, such as the administering physician, is legally liable for causing the injury. Physicians are sometimes held liable for improper administration of vaccines under principles of negligence or medical malpractice.8 Manufacturers have been held liable, under principles of product liability law, for producing vaccines with impurities or other defects.9 Additionally, manufacturers can be held liable for failure to provide the physician or vaccine recipient with an adequate warning of the inherent risks of a vaccine. 10 Entitlement to compensation for adverse reactions to vaccines, therefore, is defined in terms of the failure of manufacturers, and, to a lesser extent, physicians, to perform legal duties. In the absence of conduct amounting to fault, there is no basis for imposing liability, and consequently, no entitlement to compensation. Much of the controversy in the United States over liability for vaccine-related injuries reflects a belief that the class of injuries deserving compensation is broader than the class of injuries for which manufacturers of vaccines should be held responsible. The utility of existing tort law as a mechanism for allocating liability and compensation is thus drawn into question. Altering the principles of tort liability does not appear to be a universally acceptable solution, since reforms are unidirectional. 13 A comprehensive expansion of the class of compensable injuries would expand the liability of manufacturers to the point that the affected manufacturers would be reluctant to produce vaccines. Conversely, restricting the class of compensable injuries would leave a significant group of persons without recourse. If the goals of compensation and liability are addressed separately, however, it may be possible to construct mechanisms to achieve each one independently. Compensation for vaccine-related injuries can be achieved by administrative compensation programs as well as by tort law. A critical question for United States vaccine policy is discerning the compensation systems that best suit this country. To lay the groundwork for answering that question, this Article describes and compares the compensation and benefit systems14 of California, Denmark, the Federal Republic of Germany, France, Japan, Switzerland, and the United Kingdom. This Article describes and compares these seven compensation systems in several ways. 16 Part II contains a summary of the seven programs as background for cross-national comparison of their individual features. Part III describes program elements found to be common to most systems: source of authority, purpose, nonexclusivity of remedy, eligibility criteria, types of benefits, coordination with other benefits, and claims experience. Part IV compares the legislation authorizing the programs in terms of statutory structure, types of benefits offered, purposes and specificity of the legislation, decisionmaking authority, degree of administrative agency discretion, and source of funding. Part V summarizes conclusions concerning the relationship between the text of the statutes and operation of the programs, whether the objectives of the programs are being met, and the statutory and programmatic characteristics that appear to be either essential or optional in operating a vaccine injury compensation program. In essence, the Article describes the purposes and operation of the seven programs in question. It sets forth the specific guidelines of each program, how the programs are administered, and how they are used. What emerges from the comparison of the programs is a remarkable convergence of goals and basic operating principles set forth in different configurations to suit the respective legal and administrative structures of diverse social assistance programs