UpDate I. LEGISLATIVE REPORT

Transcription

1 UpDate I. LEGISLATIVE REPORT The National Vaccine Injury Compensation Program by Wendy K. Mariner No-fault compensation is a popular solution to controversial problems. It has been proposed as an alternative to litigating medical malpractice, adverse reactions to future acquired immunodeficiency syndrome (AIDS) vaccines, and asbestos injuries. 1 The idea is to reduce the expense and uncertainty of litigation and to ensure more equitable compensation to injured persons. Except for state-level workers compensation and auto accident insurance programs and the Black Lung Benefits Act, the United States has little experience with nofault compensation. 2 For all of these reasons, the National Vaccine Injury Compensation Program is attracting attention. 3 The federal vaccine program provides no-fault compensation to persons injured by vaccines used to prevent seven infectious childhood diseases. Because it awards compensation primarily for specific injuries occurring within a specified time after vaccination, it is the country s simplest program of no-fault compensation. The number of adverse reactions to childhood vaccines is small relative to the number of injuries from other products, medical malpractice, or motor vehicle accidents. 4 Also, the program is designed to operate expeditiously. In spite of its simplicity, the program has encountered surprises. At first, fewer petitions were received than expected, but deciding these few claims was more difficult than anticipated. The statute governing the Wendy Mariner is an associate professor of health law in Boston University s Schools of Public Health and Medicine. program was amended several times, and additional resources were provided to enable it to function as intended. Then, in late 1990 and early 1991, just as one group of claimants right to file claims was about to expire, the program was deluged with almost four thousand petitions. While these events are unique, the program offers an opportunity to study no-fault compensation systems for injuries from specific causes. This report draws on a preliminary evaluation of the program s first-year administrative functioning, conducted for the Administrative Conference of the United States. 5 In June 1991, the conference adopted recommendations to further expedite decision making, as well as to correct several technical problems in the act. 6 The program s experience also raises questions of substantive policy. One is whether a no-fault system that awards compensation only for injuries from a specific cause can avoid contentious disputes over causation. Another is whether a court-based decision-making procedure can operate efficiently. Here, I argue that the answer to both is a qualified yes. The program can achieve its purposes, but it is unlikely to eliminate all disputes or to resolve them inexpensively. Background Congress created the National Vaccine Injury Compensation Program in 1986 as a compromise solution to two decades of controversy over whether and how adverse reactions to vaccines should be compensated. 7 Immunization against the infectious diseases of childhood, such as measles, mumps, poliomyelitis, whooping cough (pertussis), tetanus, and diphtheria, produced major

2 256 HEALTH AFFAIRS Spring 1992 public health benefits by protecting millions of children against death and disability. But the adverse reactions to these vaccines became even more visible against the modem background of reduced disease that immunization produced. It is nearly impossible to predict who might suffer an adverse vaccine reaction, absent a known allergy, imunodeficiency, or previous neurologic deficit. Yet because the risk of disease exceeds the risk of adverse reaction, all states require that children be immunized before they enter school or day care. 8 Parents of children with severe vaccinerelated injuries had few options to cope with random tragedy. Health insurance rarely covered their long-term care needs. Thus, they resorted to the courts, suing the vaccine manufacturer for producing or distributing a defective vaccine or for failing to warn of the risks. The difficulty in predicting adverse reactions made it equally difficult to prove that an injury was caused by the vaccine. Several courts had indicated that some tort causes of action for vaccinerelated injuries were either unavailable to them or unwinnable in practice. 9 The results of lawsuits often appeared as random as the injuries. Vaccine manufacturers found these lawsuits oppressive. The possibility of losing even one expensive lawsuit made manufacturers nervous, given vaccines relatively low profit margins. The number of domestic vaccine producers had been declining since the 1960s. Public health officials worried that if manufacturers abandoned the vaccine market, the country might be left without an adequate vaccine supply. Several national groups studied or recommended a no-fault compensation system to address these problems. 10 Rep. Henry A. Waxman (D-CA) eventually succeeded in getting the National Vaccine Injury Compensation Program passed in The Reagan administration opposed the legislation, fearing a precedent for no-fault systems for other injuries and preferring tort reform to limit the number of lawsuits. 11 But the program was linked to a bill expanding export of pharmaceuticals that the administration favored, and Reagan signed the program into law in November The legislation included the National Vaccine Program to encourage research to improve the safety of vaccines, require reporting of adverse events, and improve information on vaccines. However, the compensation program itself focused on the goals of fair and efficient compensation that would attract potential litigants away from the burdens and unpredictability of tort litigation. This, it was hoped, would also stabilize the supply and the price of vaccines. Eligibility For Compensation Eligibility for compensation depends upon (1) receiving one of the seven listed childhood vaccines, alone or in combination, or contracting polio from someone who was vaccinated with the oral polio vaccine; (2) receiving the vaccine in the United States or while a U.S. government employee or dependent overseas, or receiving a U.S. company s vaccine within six months before returning to the United States; (3) suffering an injury listed in the Vaccine Injury Table or caused by a covered vaccine; (4) the injury s lasting more than six months and resulting in more than $1,000 in unreimbursable expenses or death; and (5) having never collected an award or settlement for the injury. 12 Persons seeking compensation must file a petition with the U.S. Claitns Court and demonstrate that they meet all five requirements. While these eligibility requirements apply to everyone, there will be two classes of petitioners for the first several years of the program s operation: prospective cases, brought by those who received a covered vaccine on or after 1 October 1988 (the program s effective date); and retrospective cases, brought by those who were vaccinated at any time before 1 October 1988 and limited in the amount of compensation payable. All retrospective cases were to have been filed by 31 January Because the program is an alternative source of compensation, petitioners retain the option of bringing a lawsuit. However, petitioners in prospective cases may not commence a lawsuit until they have filed a

3 U PD ATE claim with the program, received a final judgment, and rejected it in favor of litigation. 14 Petitioners in retrospective cases may choose between civil litigation and the program. Like prospective petitioners, they may institute a lawsuit (or resume a voluntarily dismissed action) if they reject the program s final judgment. In practice, however, opportunities for a new civil action are restricted by statutes of limitation. The act also limits the tort causes of action available for vaccine-related injuries for vaccines administered after 1 October Thus, the program is a required first resort but not the only source of possible compensation for prospective injuries. For retrospective cases, it is an alternative and often a last resort. Retrospective and prospective cases also differ in amount and source of compensation. Prospective cases are paid out of a Vaccine Injury Compensation Trust funded by a surtax on sales of covered vaccines. Congress authorized funding ($80 million per year) for retrospective awards out of general revenues but limited the number. If more than 3,500 retrospective cases are found to be compensable, the program will cease to function for the excess cases; those petitioners will be relegated to tort litigation as their sole remedy. Eligible petitioners are entitled to compensation for (1) actual and estimated medical expenses, including rehabilitation and home care, to the extent not covered by private or public insurance (except Medicaid); (2) actual and estimated future lost earnings, calculated on the basis of average, private nonfarm wages for children over age eighteen; (3) actual pain and suffering and emotional distress up to $250,000; and (4) reasonable attorneys fees and costs for petitions brought in good faith, regardless of the final judgment. 16 In the case of death, a lump sum of $250,000 is payable. The compensation available in retrospective cases is limited: First, medical expenses are limited to those incurred after the judgment; past expenses are not reimbursed. Second, the total amount payable for lost earnings, pain and suffering, and attorneys fees and costs together may not exceed $30, Determination Of Claims In addition to compensating retrospective cases, the act included two programmatic innovations. The first was lodging the program in the U.S. Claims Court, instead of in a federal agency. The second, discussed later, was creating the Vaccine Injury Table to list presumptively compensable injuries in the statute. The U.S. Claims Court makes all determinations of eligibility for and amounts of compensation. 18 U.S. Claims Court special masters receive petitions and issue decisions. Unlike special masters in other courts, who handle various types of cases, these devote themselves entirely to vaccine compensation program petitions and can make final binding determinations. Claims court judges act as an appellate court in such cases, with final review vested in the Federal Circuit Court of Appeals. The decision to house the program in a court arose out of opposition by parents of children with vaccine-related injuries to granting decision making to the executive branch. Parents groups, notably Dissatisfied Parents Together (DPT), which joined with the American Academy of Pediatrics to draft the original legislation, believed that agencies within the U.S. Department of Health and Human Services (HHS) were unsympathetic to compensating vaccine-related injuries. This belief was partly based on the fact that agencies such as the Centers for Disease Control were committed to universal immunizations for children. They had more faith in the impartiality of the court system. The act had originally placed decision-making authority for the program in the several U.S. District Courts. The single U.S. Claims Court was more attractive because of its national jurisdiction and its familiarity with judging monetary claims against the federal govemment. 19 The decision-making process outlined in the act is relatively straightforward. Petitioners must file a petition demonstrating eligibility with the claims court. A randomly assigned special master reviews the petition and ordinarily holds a hearing to decide whether the petitioner is eligible for

4 258 HEALTH AFFAIRS Spring 1992 compensation. If so, the special master also determines the amount of compensation and how it is to be paid, usually after a hearing on the petitioner s expenses. Decisions must be made within 240 days, although extensions are permitted. 20 No vaccine manufacturer, physician, or health facility may be designated a defendant in the proceeding, and there is no determination of legal fault or responsibility for injury. In theory, petitions could be decided ex parte, that is, without any opposing party. However, the act specifies that the HHS secretary is to be respondent in the proceeding. This appears to have resulted from the need to create a case or controversy to enable the U.S. District Courts to take jurisdiction of the petitions under Article III of the U.S. Constitution. However, when decision making was shifted to the claims court, created under Article II of the Constitution, the HHS secretary s designation as respondent was not deleted. The secretary has delegated responsibility to a new Division of Vaccine Injury Compensation in the Health Resources and Services Administration, Bureau of Health Professions. Physicians engaged by the division review petitions to determine whether the injury is listed in the Vaccine Injury Table or was otherwise caused by a covered vaccine and submit a report to the special master. The act does not require the secretary to defend against the claim. It does provide, however, that compensation may not be awarded if the special master finds that a death or injury resulted from factors unrelated to the administration of the vaccine. 21 Thus, where the division finds an injury to be ineligible, it often presents alternative theories of causation to the special master to rebut a petitioner s claim. In such cases, the review process takes on the appearance of an adversarial proceeding. Division physicians would prefer to act as independent experts, yet their role as respondent makes it impossible for them to be seen as impartial advisers. Department of Justice (DOJ) attorneys represent the division before the court. Until recently, petitioners were represented by private attorneys in virtually all cases. This adversarial posture nearly brought the program to a halt. In April 1989, DOJ and HHS requested a ninety-day moratorium on deciding cases because they were unable to process petitions in a timely manner with the few attorneys and physicians assigned to the program. They also complained that the court s insistence on compliance with traditional litigation rules complicated and lengthened proceedings intended to be quick. The court refused to grant any suspension, concluding that the problem lay in the government s failure to allocate the resources required to carry out the statute. 22 After the decision, DOJ withdrew its participation in most of the cases being decid ed. In December 1989, Congress amended the statute to authorize funding for more program staff and to simplify court procedures. 23 The Conference Report explaining the amendment admonished all involved with the program to rededicate themselves to the creation of an expeditious, less adversarial, and fair system. 24 The amendments provided the funds to enable the program to function, but they did not change its basic structure. Decision making remained in the claims court, within the culture of the courthouse. The HHS secretary remained the respondent, in the position of a defendant in a court action for money damages. The Vaccine Injury Table The program s second notable innovation is including a list of compensable injuries-the Vaccine Injury Table-in the statute itself (Exhibit 1). 25 The table specifies, by vaccine, the injuries or medical conditions and the time period after vaccination within which they must materialize for a claimant to qualify for compensation. Petitioners who demonstrate, on the basis of medical records and other evidence, that a listed injury occurred within the applicable time period are presumed to have a compensable injury. There is no need to prove causation. Petitioners can also be eligible for compensation if their injury is not listed in the table or occurred outside the applicable time period, but they must prove that their

5 U PD ATE Exhibit 1 Vaccine Injury Table, National Vaccine Injury Compensation Program Diphtheria-tetanus-pertussis (DTP); pertussis; DTP/ polio combination; or any other vaccine containing whole cell pertussis bacteria, extracted or partial cell bacteria, or specific pertussis antigen(s) Anaphylaxis or anaphylactic shock, within 24 hours Encephalopathy (or encephalitis), within 3 days Shock-collapse or hypotonic-hyporesponsive collapse, within 3 days Residual seizure disorder in accordance with subsection (b)(2), within 3 days Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed Measles, mumps, rubella, or any vaccine containing the foregoing as a component; DT; Td; or tetanus toxoid Anaphylaxis or anaphylactic shock, within 24 hours Encephalopathy (or encephalitis), within 15 days for mumps, rubella, measles, or any vaccine containing any of the foregoing as a component, within 3 days for DT, Td, or tetanus toxoid Residual seizure disorder in accordance with subsection (b)(2), within 15 days for mumps, rubella, measles, or any vaccine containing any of the foregoing as a component, within 3 days for DT, Td, or tetanus toxoid Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed Polio vaccines (other than inactivated polio vaccine) Paralytic polio: in a nonimmunodeficient recipient, within 30 days; in an immunodeficient recipient, within 6 months; in a vaccine-associated community case, no time limit Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed Inactivated polio vaccine Anaphylaxis or anaphylactic shock, within 24 hours Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed Note: Illness, disability, injury, or condition covered and time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration, by vaccine. 42 U.S.C. 300aa-14(1)(a). condition was caused by a covered vaccine. The table is intended to streamline the decision-making process by eliminating the need for proof of causation, one of the most difficult, costly, and time-consuming elements of a tort action for personal injury. The listed injuries were derived from epidemiologic and other studies of adverse reactions to covered vaccines and represent a best approximation of injuries actually resulting from vaccines. At the same time, Congress recognized that the table would not always equate with actual causation. Nevertheless, savings in time and expense from applying the table (instead of contesting actual causation) were expected to more than compensate for the few false positives and negatives. 26 The Vaccine Injury Table was a political solution to a political problem. It was created to avoid disputes about whether a vaccine caused adverse reactions at all. Congress was aware of the scientific controversy over whether some vaccines could cause serious injuries. The table was designed to sidestep the problem of relitigation in each case and compensate on the basis of medical condition alone (where the other eligibility criteria were met). If and when more concrete scientific data made possible more precise relationships between vaccines and injuries, the table could be revised. 27

6 260 HEALTH AFFAIRS Spring 1992 Despite, or perhaps because of, the table s simplicity, disputes over causation have been common. By the end of March 1990, the HHS Division of Vaccine Injury Compensation had recommended against compensating 73.7 percent of fifty-seven petitions on the grounds that the injuries did not fit the table or were caused by something other than a covered vaccine. 28 Thirty-eight petitions were in cases noting injuries related to pertussis vaccine, alone or in combination with diphtheria and tetanus (DTP). Final decisions by the claims court in these cases were equally dramatic. The court awarded compensation in 89.5 percent (fifty-one) of these cases, rejecting the division s recommendation in all but a handful. Some of these decisions were in cases in which the division s position was not considered because of the DOJ s withdrawal from participation. The results are striking nonetheless. These problems demonstrate the practical difficulties of creating and applying a list of compensable injuries. Often there is disagreement over the appropriateness of including a particular condition in the table at all. Early on, division medical reviewers conceded some discomfort with the table. 29 Some found it difficult to assimilate the difference between actual causation of injury and the legal causation established by the table. Petitioners were equally convinced that their injuries resulted from vaccination. Their attorneys easily accepted the table s concept of legal causation, and several viewed the search for alternative causation as an unnecessarily adversarial tactic. Disputes over DTP vaccine and its pertussis component, which were the subject of 81.6 percent of petitions filed and decided by 28 February 1990, grew increasingly bitter because of renewed inquiry into adverse reactions to pertussis vaccine. 30 The original act required the secretary of HHS to review the relevant literature on possible adverse consequences of pertussis and rubella vaccines. 31 The results of the review were to serve as the basis for amending the Vaccine Injury Table. 32 HHS asked the Institute of Medicine (IOM) to conduct the study, and in July 1991, the IOMS Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines issued its findings.) 33 The IOM committee did not conduct new research; it reviewed existing epidemiologic studies and case reports. The committee found evidence indicating a causal relation between rubella vaccine and acute arthritis, which is not listed in the table. Regarding the DTP vaccine, the committee found evidence consistent with or indicating a causal relation between the vaccine and three conditions listed in the Vaccine Injury Table: anaphylaxis, acute encephalopathy, and shock collapse. However, it found insufficient evidence to indicate a causal relation between the vaccine and permanent neurological damage. Since long-term damage is required to qualify for compensation under the program, the report undermines the Vaccine Injury Table s inclusion of encephalopathy and certain seizures as a basis for eligibility. The committee found that the evidence indicates a causal relation between DTP vaccine and febrile seizures, but not afebrile seizures or infantile spasms, whereas the Vaccine Injury Table covers afebrile but not febrile seizures as a manifestation of residual seizure disorder. The committee also found that the evidence does not indicate a causal relation between DTP vaccine and sudden infant death syndrome (SIDS). Although the committee explained its reasons for reaching each conclusion, there is room for some difference of opinion. For example, a conclusion that there is insufficient evidence to indicate a causal relationship does not necessarily mean that the vaccine does not cause an adverse reaction. It could be argued, as the committee noted, that there is as yet not enough evidence to detect or confirm a causal relationship, especially for such rare events. As of the end of November 1991, the HHS secretary was preparing recommendations to amend the Vaccine Injury Table. Although the act certainly contemplated such amendments, they are likely to generate more controversy. Since most program cases involve percussis vaccine, the exclusion of neurological injuries following pertussis vaccination could either significantly reduce the size of the

7 U PD ATE program or create a substantial backlog of nontable cases. Efforts to prove that injuries deleted from the table were actually caused by pertussis vaccine probably would entail costly and protracted litigation-like proceedings. If parents of injured children abandon the program to litigate claims against vaccine manufacturers, the hope of reducing litigation, assuring continued vaccine production, and stabilizing the vaccine would be threatened. Even if manufacturers succeed in defending most lawsuits, they might have to litigate many more cases. The result could be a return to the very circumstances that gave rise to the program. The acceptability of amendments to the table to the general public and to Congress may depend upon whether the IOM committee was correct in its conclusions, or at least whether such conclusions are an acceptable basis for public policy. If parents are not convinced that their children s injuries were not the result of vaccination, it will be difficult to settle vaccine policy. If the Vaccine Injury Table is amended, should the amendments apply to anyone who has already filed a petition? Applying a revised table to petitions that have been filed but not heard or decided, for example, could raise constitutional questions of taking a property interest without just compensation or due process of law. Strictly prospective use of the amended table would allow the several thousand cases now before the claims court to be decided under the current table. This seems the more prudent course, since it is likely to take a year or two to approach consensus on the acceptability of any amendments. However, the existence of amendments affecting future cases with similar facts could invite additional disputes over eligibility in current cases. A second type of dispute concerning the Vaccine Injury Table will not necessarily be resolved by amending the table. This is the practical problem of applying the table in individual cases. For example, what counts as acceptable evidence that a particular injury actually occurred? Must the petitioner produce contemporary medical records, or is it sufficient for the parent to describe the condition and have a physician testify that the condition is listed in the table? The statute appears to permit the latter in somewhat ambiguous language. A more common difficulty is interpreting the medical evidence to determine whether the child s condition qualifies as an injury described in the table. Often equally difficult is the question of whether death or permanent injury resulted from the initial injury. The act contains Qualifications and Aids to Interpretation to help decide whether a condition qualifies under the table s definition of a compensable injury, but these are somewhat vague, and reasonable people disagree about the meaning of symptoms in individual cases. In principle, clarifying them should help to describe the nature and symptoms of conditions listed in the table and how they can be identified and diagnosed. A complete description of how to diagnose each of the table injuries, however, might require an extensive technical analysis inappropriate for inclusion in the statute itself. A shorter summary, while certainly feasible, may still be subject to interpretation by those who know a condition when they see it. Moreover, it should be recognized that almost any clarification is likely to alter the existing definition of a listed injury, sometimes to the disadvantage of those who would have qualified for compensation before the amendment. Claims Experience The program has gone through several stages of development in rapid succession. Although it became effective 1 October 1988, special masters did not join it until the beginning of By the end of February 1990, about one year after the program became fully operational at the claims court, only 236 petitions had been filed. This fell far short of the Congressional Budget Office s 1986 estimate of 1,500 claims. 34 Of these, seventy cases had been finally decided, and seventeen had been voluntarily withdrawn. Compensation totaling $32.5 million (exclusive of attorneys fees and costs) was awarded in sixty-three (90 percent) of the seventy cases. An award of $250,000 was made in each of forty-one

8 262 HEALTH AFFAIRS Spring 1992 cases of death. The average award in twenty-two cases of permanent injury was slightly more than $1 million. In 1991, this picture changed dramatically. As of 31 January 1991, the extended deadline for filing petitions in retrospective cases, the program had received about 4,100 petitions in retrospective cases and 98 petitions in prospective cases. About 733 of a cumulative total of 4,225 cases had been finally decided by 1 September 1991; 226 awards totaling $143.8 million had been paid. A thousand retrospective cases and ninety-two prospective cases were pending, and 2,400 retrospective cases were awaiting assignment to a special master. A smaller percentage of cases were awarded compensation in 1991 than in 1989 or 1990, but an increasing proportion of cases involved permanent injury to younger children. The cost of caring for these children now averages $1 2 million, so that the dollar amount of total awards granted is rising fast. The large influx of retrospective cases has created a new challenge for the program. Funds specified for retrospective cases are likely to be insufficient to pay the compensation specified by the act. If only half of the petitions filed are eligible for compensation, the amount payable could reach $2 billion-five times the $400 million authorized by Congress. The act provides that the program will cease to be in effect for retrospective cases if there are insufficient funds to pay awards for 180 days. 35 Lessons Congress acted boldly in creating the program. The program s hybrid structure represents an innovation in federal benefit systems. It contains elements of Social Security disability type determinations and administrative tribunal proceedings. Although intended to be nonadversarial, the program s very structure encourages, if not dictates, fact-finding and decision-making processes that resemble litigation. The initial designation of the HHS secretary as respondent to meet constitutional requirements for judicial determination of claims created a mechanism for parties to argue opposing positions. The hybrid structure does not preclude efficiency. After all, there is an adversarial element in most claims against the government, even when they are made to an administrative agency. The program can operate quite well in this posture. The use of special masters who have no allegiance to any position on adverse reactions to vaccines, for example, furthers the goal of objective decision making. Efficiency is served because they handle only program cases and become familiar with the law and the issues. On the other hand, it risks encouraging shortcuts that lead to errors. In addition, the program has developed expedited, informal ways to review and test evidence of eligibility and losses. Staff attorneys in the Office of Special Masters screen incoming petitions for completeness and do an initial assessment of eligibility. Hearings by conference call enable petitioners, attorneys, and experts from different parts of the country to meet conveniently with the special master to debate contested issues, at a considerable savings of time and expense. Specially created Rule 5 conferences give the parties an opportunity to present their cases informally and receive a nonbinding reaction from the master. These can narrow differences, encourage settlement, and expedite final decisions. The requirement that petitioners submit all of their evidence when the petition is first filed, known as front-end loading, helps reduce discovery or additional fact-finding time by the parties and allows a decision to be reached quickly. Such techniques, while foreign to many attorneys, have been assimilated remarkably easily, so that a new relaxed form of dispute resolution is emerging. The program s experience demonstrates that it is possible to streamline traditional litigation procedures. There are, of course, limits to the simplicity possible in a program that restricts eligibility to injuries from a particular cause. Disputes are bound to arise over whether an individual s condition fits the defined injury. Moreover, disputes over the kind and amount of compensation frequently require lengthy proceedings to resolve. About half of the time is devoted to determining eligi-

9 U PD ATE bility and half to compensation. The most troublesome surprise to the program is the bunching of retrospective claims in numbers that, while contemplated in the statute, are larger than Congress may have expected. It could take two or three extra years to process these petitions unless additional special masters and DOJ and HHS staff become available. Since the program was premised on a speedy determination in less than a year such delays could compromise its effectiveness. Still, petitioners seem willing to give the program extra time, if its remaining features stay intact, and a 1991 amendment permits extending the time for deciding petitions by 540 days. After all, the bunching is limited to retrospective cases, which had to be filed within twenty-eight months after the program became effective. New prospective cases must be filed within two to four years after injury, thereby spreading fewer claims over many more years. The retrospective cases are an expensive if temporary problem. In this time of fiscal austerity, Congress may be reluctant to authorize, much less appropriate, the revenues to pay the awards in retrospective cases. The awards could not be reduced to less than actual losses without amending the statute and threatening the delicate political balance. But if there are insufficient funds to pay awards, the program could cease to exist. In June 1991, the Administrative Conference of the United States recommended that the Advisory Commission on Childhood Vaccines consider developing guidelines for calculating elements of compensation, such as the costs of long term care for particular disabilities. 36 Guidelines are attractive because they promote consistency and could expedite determinations of awards. Yet they do not offer substantial promise of reducing awards or raising additional funds. One alternative might be to make successful petitioners eligible for institutional or home care under Medicare or Medicaid. This has the advantages of ensuring that disabled children receive the services they need, spreading out the cost of such care, and avoiding the need to immediately estimate and pay the present value of future costs. This would require a new category of eligibility under Medicare or Medicaid. Although Medicare is primarily intended to cover acute care hospital services, as a federal program, it could provide uniform benefits to the petitioners under the vaccine compensation. program. For Medicaid, a federal authority, such as a benefits determination committee, would probably be required to assure uniform coverage across states. These options may be unattractive to those who are sensitive to the increasing cost of health care today. But they merely point out the gaps in health and disability insurance coverage that gave rise to the program in the first place. The fact that it is expensive to care for seriously disabled children has nothing to do with the effectiveness of the program. Conclusion The National Vaccine Injury Compensation Program was created to respond to a possible threat to the price and supply of childhood vaccines and the need to compensate those injured as a result of immunizations required by law. It was not intended to provide a model for resolving all personal injury problems. Nevertheless, its decisionmaking processes may be adaptable to other circumstances, especially in cases in which causation is controversial, such as occupational diseases in workers compensation, medical malpractice, and injuries related to drugs and devices, toxic substances, and environmental hazards. A table of compensable injuries has limited applicability because it depends upon a sufficient body of acceptable scientific evidence identifying particular injuries caused by specific sources. Such a table could be developed for products, including drugs and vaccines, that have been studied and in use for a long time, and perhaps for a few injuries clearly resulting from medical malpractice. 37 It may also offer a solution to disputes over causation in a few controversial cases, such as some occupational diseases. The enactment of the Radiation Exposure Compensation Act, modeled in part on the vaccine

10 264 HEALTH AFFAIRS Spring 1992 program, suggests that it may be possible to bypass uncertainty in causation in some circumstances. 38 A table of injuries is not likely to be feasible for new products, devices, pharmaceuticals, or biologics, such as future vaccines to prevent human immunodeficiency virus (HIV) infection, or for injuries for which causation is difficult to determine, such as most cases of medical malpractice. The program s problems have to do with the requirement that only specified vaccinerelated injuries be compensated, the high cost of care for such injuries, and limited funds. Preliminary experience suggests that no matter how simply an ostensibly no-fault system is constructed, if it is limited to injuries from a particular cause, it will be forced to identify causation. This is often difficult to resolve, no matter what the forum. But the program had an additional handicap. The determination of what injuries are compensable was primarily a political decision, and enacting the program did not put to rest the controversy over whether some injuries should be included in the Vaccine Injury Table. Amending the table is not likely to settle the controversy, either. The optimal way to compensate injuries would be by means of a universal compensation system, including disability insurance and long-term care coverage, for all personal injuries, regardless of cause. This would eliminate the inherent unfairness of compensating some individuals whose injuries happened to be caused by one source and leaving others whose injuries were genetic, accidental, or an act of God to fend for themselves. Until a universal system gains political acceptance, however, there is a role for the National Vaccine Injury Compensation Program. If new sources of funding can be found, the program should be able to dispose of the retrospective cases satisfactorily. It will then be free to operate as originally conceived in its treatment of prospective cases. NOTES 1. The Harvard Medical Practice Study, Patients, Doctors. and Lawyers: Medical Iniury. Malpractice Litigation, and Patient Compensation in New York (Boston, Mass.: Harvard Medical Practice Study. 1990). 8-82; and Keystone AIDS Vaccine Liability Project, Final Report (Keystone, Colo.: The Keystone Center, 1990) U.S.C Stat. 3756, codified as Title XXI, Subtitle 2 of the Public Health Service Act at 42 U.S.C. 300aa- 1 to Institute of Medicine, Vaccine Supply and Innovation (Washington, D.C.: National Academy Press, 1985). 5. W.K. Mariner, Innovation and Challenge: The First Year of the National Vaccine Injury Compensation Program, Report to the Administrative Conference of the United States (Washington, D.C., 1991). 6. Administrative Conference of the United States, Recommendations of the Administrative Conference regarding Administrative Practice and Procedure. Federal Register 56 (24 July 1991): codified at 1 CF.R After this UpDate was written, several of these recommendations were adopted in the Vaccine Injury Compensation Technical Amendments of 1991, P.L , 105 Stat. 1102, 26 November Mariner, Innovation and Challenge; J.K. Iglehart, Compensating Children with Vaccine-related Injuries, The New England Journal of Medicine 3 16 (1987): ; and E.W.Kitch. TheVaccine Dillemma, Issues in Science and Technology 2 (1986): Immunization is not required where it is medically contraindicated, as for children with impaired immune systems. At least nine states do not require immunization against whooping cough, and several exempt children from immunization on religious or personal philosophy grounds. 9. See, for example, Johnson v. American Cyanamid Co., 239 Kan. 279, 718P.2d 1318 (1986). In Brown v. Superior Court of San Francisco, 44 Cal. 3d 1049, 245 Cal. Rpt. 412, 751 P.2d 470 (1988). the Calfornia Supreme Court found that public interest in the development, availability, and reasonable price of drugs required protecting pharmaceutical manufacturers from liability for a drug-diethylstilbestrol (DES)-challenged as defectively designed. It disagreed with a lower-court opinion permitting the cause of action in a case involving oral polio vaccine, Kearl v. Lederle Laboratories, 172 Cal. App. 3d 827, 218 Cal. Rptr. 453 (1985). In Toner v. Lederle Laboratories; 732 P.2d 297 (Idaho 1987), 828 F.2d 510 (9th Cir. 1987), cert. denied, Lederle Laboratory Division v. Toner, 108 S.Ct (1988), the Supreme Court of Idaho accepted the cause of action in a case involving pertussis vaccine but intimated that it would be difficult for a plaintiff to prove at trial. 10. U.S. Department of Health, Education, and Welfare, Liability Arising out of Immunization Problems: Final Report to Congress (Washington, D.C.: DHEW. 1978): U.S. Congress. Office of Technology Assessment, Compensation for Vaccine-related Injuries (Washington, D.C.: OTA, 1980); American Academy of Pediatrics, Need for Legislation to

11 U PD ATE Establish a Federal Compensation Program for Vaccine-related Injuries in Childhood Immunization Progams (Washington, DC.: AAP, 1983); American Medical Association, Final Report of the Ad Hoc Commission on Vaccine Injury Compensation (Chicago: AMA, 1984); American College of Physicians, Compensation for Vaccine-related Injuries (Washington, D.C.: ACP, 1984); American College of Physicians and American Academy of Pediatrics, Joint Resolution on Compensation for Vaccine-related Injuries (Washington, DC., 1985); and IOM, Vaccine Supply and Innovation. 11. Statement of Sen. Dan Quayle (R-IN), Congressional Record 132. S daily ed.. 18 October 1986; statements of the Department of Justice, hearings on S. 827 before the Senate Committee on Labor and Human Resources, 99th Cong., 1st sess. 228, 1985; and testimony of the Assistant Secretary for Health, Department of Health and Human Services. on H.R before the House Energy and Commerce Subcommittee on Health and the Environment, 10 September U.S.C. 300aa-11(c). The Act originally set 1 October 1990 as the last day for filing all retrospective petitions. The extension was provided in a November 1990 amendment to the statute. Prospective claims for injury must be filed within thirty-six months after manifestation of the injury. Prospective claims for death must be filed within twenty-four months after the date of death, but no later than forty-eight months after manifestation of the injury that resulted in death. 42 U.S.C. 300aa-16(a)(2),(3). 15. Product Liability for unavoidable vaccine side effects is generally precluded under 42 USC. 300aa- 22(b). Liability for a manufacturer s failure to provide direct warnings to a vaccine recipient (or the recipient s parent or guardian) of risks associated with a vaccine is precluded under 42 U.S.C. 300aa-22(c). These are the primary tort causes of action that have been brought against manufacturers of childhood vaccines. W.K. Mariner and R.C. Gallo, Getting to Market: The Scientific and Legal Climate for Developing an AIDS Vaccine, Law, Medicine, and Health Care 15 (1987): 17-26: Kitch The Vaccine Dilemma; and V. Schwartz, Unavoidably Unsafe Products: Clarifying the Meaning and Policy behind Comment k, Washington and Lee Law Review 42 (1985): U.S.C. 300aa-15(a) U.S.C. 300aa-15(b),(e) U.S.C. 300aa U.S.C (1982) U.S.C. 300aa-12(d)(3) U.S.C. 300aa-13(a)(l)(B). 22. Gregson v. Secretary, 17 Cl. Ct. 19, 23 (1989). 23. Vaccine Injury Compensation Technicals, Omnibus Budget Reconciliation Act of 1989, P.L , sec. 6601, 19 December 1989, effective 1 January Conference Report no , to accompany H.R. 3299, Omnibus Budget Reconciliation Act of : , 101st Cong., 1st sess., 509, U.S.C. 300aa-14(a). H.R , Ibid., Mariner, Innovation and Challenge, Ibid., 22, 63. See, for example, Ad Hoc Committee for the Child Neurology Society Consensus Statement on Pertussis Immunization and the Central Nervous System, Pertussis Immunization and rhc Central Nervous System, Annals of Neurology 29 (1991): ; M.R. Griffin et al., Risk of Seizures and Encephalopathy after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine, Journal of the American Medical Association 263 (1990): ; J.D. Cherry, Pertussis Vaccine Encephalopathy : It Is Time to Recognize It as the Myth that It Is, Journal of the American Medical Association 263 (1990): 1679; A.H. Griffith, Permanent Brain Damage and Pertussis Vaccination: Is the End of the Saga in Sight? Vaccine 7 (1990): 199; and C. Bowie; Lessons from the Pertussis Vaccine Court Trial. The Lancet 335 (1990): National Childhood Vaccine Injury Act of 1986, sec. 312, 100 Stat The act grants the HHS secretary authority to amend the table, after giving the Advisory Commission on Childhood Vaccines ninety days to make recommendations and comments, and after notice and a public hearing providing for 180 days of public comment. 33. CP. Howson, C.J. Howe, and H.V. Fineberg, cds., Adverse Effects of Pertussis and Rubella Vaccines: A Report of the Committee to Review the Adverse Consequences of Pertussis ad Rubella Vaccines (Washington, DC.: National Academy Press, 1991). 34. Congressional Budget Office Estimate, H.R , accompanying H.R. 5546, U.S. Code and Congressional and Admininstrative News (25 September 1986) 6378, Stat. 3784, section 323(b). 36. Administrative Conference of the United States. Recommendations; and Mariner, innovation and Challenge, R.R. Bovbjerg, L.R. Tancredi, and D.S. Gaylin, Obstetrics and Malpractice: Evidence on the Performance of a Selective No-Fault System, Journal of the American Medical Association 265 (1991): The Radiation Exposure Compensation Act, P.L , 104 Stat. 920 (15 October 1990), pays $50,000 or $100,000 to persons exposed to radiation in uranium mines or above-ground nuclear tests in the federal nuclear weapons program of the 1950s.