manufacturers were confronted by claims for disabilities believed to be caused by immunization. Some feared damage awards of several million dollar cases, as there were no reliable guidelines for predicting the limits and the magnitude of liability litigation. Some companies saw the threat of huge settlements as an unreasonable risk, particularly given the development costs and relatively low profit margin associated with vaccines. A fair number of companies simply dropped out of the vaccine manufacturing business altogether, many citing liability (U.S. Congress, House, 1986). Those companies that remained in the market began to raise their prices significantly, in part to cover anticipated liability expenses (Institute of Medicine, 1985).
In the early to mid-1980s, several committees, including the Institute of Medicine Committee on Vaccine Supply and Innovation (Institute of Medicine, 1985), endorsed the creation of a no-fault compensation system. In 1984, the American Academy of Pediatrics took the initiative in seeking federal legislation to create a national compensation program. Several bills were introduced by members of Congress and were debated in congressional hearings, and in 1986, the National Vaccine Injury Compensation Program was enacted under the sponsorship of Representative Henry Waxman and Senator Orrin Hatch.
In the first step in the claims process, the petitioner files a petition with the U.S. Claims Court to demonstrate eligibility. A randomly assigned special master then reviews the petition, elicits a recommendation from the NVICP Office in the Department of Health and Human Services, and makes a determination regarding eligibility (all special masters are lawyers, almost always with no prior experience in vaccines). The Secretary of the Department of Health and Human Services is the respondent in the proceedings and may contest the petitioner's claim. If the petitioner is eligible for the program, the special master then decides the amount of compensation. Neither vaccine manufacturers nor healthcare providers are part of this process, and there are no determinations of legal fault. Once accepted into the program, petitioners are prohibited from bringing civil action for damages until after a decision is made.
There are two types of claimants: retrospective and prospective. Retrospective petitioners are those injured before October 1, 1988, who were required to file by January 31, 1991. Congress appropriated $80 million per year for the first 4 years of the program to pay retrospective claims. Prospective petitioners are those who were injured on or after October 1, 1988. They are required to file within 2 to 4 years of the date of