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6 Liability for the Production and Sale of Vaccines Potential liability for vaccine-related injuries has received much attention as a deterrent to vaccine manufacturing. A variety of approaches to the issue have been suggested, but there have been few attempts to determine the magnitude of the problem or to analyze basic trends in the interpretation of laws in this area. This chapter provides such an analysis and examines the ways in which the state of the law influences decisions that ultimately affect vaccine availability and innovation. STATE OF THE LAW Liability for injury resulting from vaccination is a matter of state law. Thus, there are potentially 51 different sets of rules on this subject in the United States. No vaccine-related product liability litigation resulting in a publicly available opinion has occurred in . . . . . . . . . . . . . . . . most ~urlsulctlons, and In many there nas Been no llanlllty litigation related to drugs. Although it is possible by extrapolation from other product liability cases to predict how these states would handle vaccine cases, any such extrapolation might prove inaccurate. The subject of product liability has become increasingly controver- sial over the past few years. Manufacturers have complained about the costs, the unpredictability of the law, and the unavailability and cost of insurance. A majority of states have enacted statutes relating to some aspect of product liability actions.1 Legislation at the feder- al level has been considered extensively, but has not been passed.2 A manufacturer who produces and sells a defective vaccine that creates a risk of significant injury to the recipient is liable to any person injured by that defect under the principles stated in section 402A of the Restatement of Torts 2d.3 This is thought to be the law in every American jurisdiction. ~ ~ ~ ~ states: The key portion of section 40ZA One who sells any product in a defective condition unreason- ably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer. . . . [The rule applies although] 85

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86 the seller has exercised all possible care in the preparation and sale of his product. Cases holding manufacturers or others liable for allegedly defective vaccines administered to humans are very rare.4 The reported cases are: Griffin v. United States, in which the U.S. government was held liable because the Division of Biologics Standards of the National Institutes of Health released a batch of Sabin polio vaccine that did not conform to its own regulatory standards (the manufacturer settled), 351 F. Supp. 10 (E.D. Pa. 1972), aff'd in part, rev'd in part and remanded, 500 F.2d 1059 (ad Cir. 1974~; Grinnell v. Charles Pfizer & Co., in which the manufacturer was held liable for virulent particles in Salk killed-virus vaccine, 274 Cal. App. 2d 24, 79 Cal. Rep. 369 (Diet. Ct. App. 1969~; Four cases in which the manufacturers of quadrivalent vaccine (diphtheria, tetanus, pertussis, and poliomyelitis) were held liable because new preservative activated the pertussis component, Tinnerholm v. Parke-Davis & Co., 285 F. Supp. 432 (S.D.N.Y. 1968), aff 'd, 411 F.2d 48 (2d Cir. 1969), Stromsodt v. Parke-Davis & Co., 257 F. Supp. 991 (D.N.D. 1966). aff 'd. 411 F.2d 1390 (8th Cir. 1969). Vincent v. Thompson, 79 Misc. 2d 1029 (N.Y. 1974), and Ezagui v. Dow Chemical Corn. 598 F.2d 727 (2d Cir. 1979); Gottsdanker v. Cutter Laboratories, in which live particles were found in Salk killed-virus vaccine, 182 Cal. App. 2d 602, 6 Cal Rptr. 320 (Diet. Ct. App. 1960); and Sandel v. State, in which pus was found in typhoid vaccine, 115 S.C. 168, 104 S.E. 567 (1920). . A manufacturer is not liable for harm caused by a nondefective product due to its inherent or unavoidable dangerousness. Thus, if a properly manufactured vaccine will cause harmful side effects in some portion of the recipient population, the manufacturer of the vaccine is not liable for those side effects. This principle is the subject of comment k to section 402A. k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences -~hen it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidably high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines,-and the like, many of which for this very-reason cannot legally be __1 ~& , _ _ the like, sold except

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87 to physicians or under the prescription The seller of such products, again with of a physician. . . . the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. The qualification "proper warning is given is critically important and a manufacturer will be liable if he markets a drug or vaccine with known risks and fails to warn of them, and it can be shown that the recipient would not have taken the drug or vaccine had he known of the risks. An example of this situation involving polio vaccine is Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968~. In that case, Sabin polio vaccine had been administered to the plaintiff, a 39-year-old male, in a mass immunization campaign conducted with the assistance of a sales representative of the defendant. The plaintiff had developed polio. The Surgeon General had recommended that mass programs using Sabin Type III be limited to children because of the risk of transmission of the disease to adult recipients. The mass immunization campaign involved in the case, however, included adults. The defendant's promotional materials failed to warn of the risk to adults, although the package insert did. The pharmacist who dispensed the oral vaccine did not read the package insert and did not warn the plaintiff of the risk. The duty to warn arises from the notion that the failure to inform consumers of dangerous aspects of a product may render the product unreasonably dangerous. For instance, if an electric device operated in a certain way will blow up and cause harm to bystanders, a failure to warn the consumer of this risk so that he can avoid the harm will make the manufacturer liable for the harm. Or in the Davis case, if the plaintiff had been warned of the risk, he could have chosen not to take the vaccine, as was then recommended in the case of adults. If a product is not sold directly to the public, but is distributed through intermediaries who can be expected to know about the product and its risks and to be responsible for informing the ultimate consumer on its proper use, then the manufacturer does not have a duty to warn the public (although it does have a duty to warn the intermediaries of risks not known to them). Prior to Davis, this exception to the duty to warn was thought to be applicable to drugs and vaccines distributed through health professionals (as contrasted with over-the-counter drugs, for which the manufacturer does have a duty to warn the user). In Davis the defendant manufacturer argued that its duty to warn had been satisfied by the fact that it had informed the county medical society sponsoring the mass immunization program of the risk that a vaccines might develop polio. The court rejected this argument in the context of the mass immunization program: Here . . . although the drug was denominated a prescription drug it was not dispensed as such. It was dispensed to all

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88 comers at mass clinics without an individualized balancing by a physician of the risks involved. In such cases (as in the case of over-the-counter sales of nonprescription drugs) warning by the manufacturer to its immediate purchaser will not suffice. . . . In such cases, then, it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or by obligating the purchaser to give warning. Here . . . [the manufacturer; knew that warnings were not reaching the consumer. Appellee had taken an active part in setting up the mass immunization clinic program for the society and well knew that the program did not make any such provision, either in advertising prior to the clinics or at the clinics themselves. On the contrary, it attempted to assure all members of the community that they should take the vaccine. 399 F.2d 131. The Missouri Supreme Court reached the same result in Stahlheber v. American Cyanamid Co., 451 S.W. 2d 48 (Mo. 1970), involving another mass administration of oral polio vaccine. Recipients included a 41-year-old adult who contracted polio. The manufacturer had not warned that the vaccine should not be administered to adults other than those facing special risks of contracting the disease. The law summarized here appears to lead to the conclusion that a vaccine manufacturer need not fear liability from injuries resulting from the administration of the vaccine if (1) the vaccine is correctly manufactured in accordance with regulatory standards and prudent manufacturing practices and (2) the manufacturer has taken reasonable steps to ensure that the recipient of the vaccine will be warned of possible side effects. Merrill's comprehensive 1973 survey of the law of liability for all drugs concludes: "If a manufacturer adequately warns physicians [or, in the case of mass-administered vaccines, the recipient] about a drug's foreseeable adverse effects, he will escape liability unless the plaintiff can show that his injury was caused by some impurity or resulted from an unreasonably dangerous design" [Merrill, "Compensation for Prescription Drug Injuries," 59 Va. L. Rev. 1, 49 (1973~. In two decisions, the Fifth Circuit Court of Appeals, nominally applying the law first of Texas and then of Florida, imposed liability in circumstances that would not be covered by these rules. Both decisions have been subject to criticism,5 and it is not clear how many courts would follow them today. The first and most important of these decisions is Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974~. That case involved a young girl to whom Sabin oral polio vaccine was administered at a county department of health clinic in Mission, Texas. She developed polio, and her parents sued on her behalf for damages. The manufacturer's main line of defense at the trial was that the vaccine was not the cause of the disease. Experts testified that virus isolated from a specimen of the child's stool taken on the day after she was admitted to the hospital was "probably wilder i.e., naturally occurring and not the same strain as the vaccine [498 F.2d

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89 1270-12713. The jury found, however, that the vaccine was the cause of the child's disease, and found for the plaintiff under the district court's instructions. The critical issues decided by the court of appeals were two. First, had the manufacturer discharged its duty to warn? And second, was the failure to warn sufficiently connected to the occurrence of the child's disease to support liability? Judge Wisdom wrote a unique opinion strongly affirming the judgment for the plaintiff. In Reyes, Wyeth had played no role in the vaccination program, per- haps because it had changed procedures after its loss in Davis. It had simply shipped the vaccine in response to an order from the Texas State Department of Health. The package insert warned of the risk, and Wyeth argued that it was all that was required to discharge its responsi- bility. The procedures, forms, and warnings actually used in the immunization program were the responsibility of the Texas Department of Health, to which it had quite properly shipped the vaccine. Judge Wisdom answered this argument without really meeting it. Wyeth knew that the vaccine was customarily administered in mass administration programs staffed at least in part by volunteers and nonprofessionals. Knowing that each recipient would not have individualized medical advice, it "was required to warn foreseeable users, or see that the Texas Department of Health warned them" [498 F.2d 1277~. Exactly how Wyeth was to provide these warnings at distant clinics with which it had no connection, or why Wyeth was not entitled to rely upon the Texas Department of Public Health to do its j ob proper ly, Judge Wisdom did not clarify. To the argument that Davis was inapplicable because in that case Wyeth had actively participated in the program, Judge Wisdom observed that "the present controversy, however it differs from Davis factually, invites appl~ca- tion of the Davis principles, and the conclusion that Wyeth was under a duty to warn . . . [the recipient's parents [498 F.2d 12771. The second issue confronting the court of appeals was whether there was sufficient connection between the failure to warn and the injury to the child. There was no demonstration that had the child's mother been warned of the minute incidence of polio from the vaccine she would have decided not to have her child immunized. This possibility would seem to have been extremely unlikely because polio was occurring in the area. The court first looked to Texas cases for the following rule: Where a consumer, whose injury the manufacturer should have reasonably foreseen, is injured by a product sold without a required warning, a rebuttable presumption will arise that the consumer would-have read any warning provided by the manufac- turer, and acted so as to minimize the risks. In the absence of evidence rebutting the presumption, a jury finding that the defendant's product was the producing cause of the plaintiff's injury would be sufficient to hold him liable [498 F.2d 12811. In the normal product liability case, this rule makes sense. If the consumer is warned of a danger, he or she can take steps to avoid it.

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Do However, what was the parent confronted with the warning that Sabin polio vaccine might cause polio to do? Forgo vaccination and incur the risk of contracting polio naturally? No, said the court, take Salk killed-virus vaccine first. Buttressing the presumption that Mrs. Reyes might have taken preventive steps is the testimony of Reyes's expert, Dr. RamirO Casson, that some pediatricians in Hidalgo County, at least by the time of trial, had begun administering killed-virus vaccine to infants in order to build up their level of antibodies before feeding them the live-virus drug [498 F.2d 12821. This aspect of the decision has been vigorously criticized by Franklin and Mais in "Tort Law and Mass Immunization Programs: Lessons from the Polio and Flu Episodes," 65 Calif. _ Rev. 754 (19771: First, the court did not discuss the availability of Salk vaccine at the time plaintiffs' child was vaccinated. In fact, manufacturers discontinued making Salk vaccine and concentrated on the Sabin vaccine after the government selected Sabin vaccine for its mass immunization programs in the early 1960s. Indeed, from 1968 to 1975 no Salk vaccine was manufactured in the country, although small amounts were imported. Although the court referred to immunizations in Hidalgo County using Salk vaccine in the early 1970s, it is likely that these units were imported and not generally available. Thus, those who would have chosen Salk vaccine after being warned of the danger of Sabin vaccine would have had a difficult time obtaining the alternative. Second, the court did not discuss the significance of the fact that the plaintiffs' child was vaccinated during an outbreak of polio in her area. When quick protection is essential, Sabin vaccine has been preferred despite the risk from the live virus. Therefore, even if Salk vaccine had been available it is unlikely that a well-informed person seeking protection would have chosen it [65 Calif. L. Rev. 7611. _ The Oklahoma Supreme Court did not follow Reyes in Cunningham v. Pfizer & Co., 532 P.2d 1377 (Okra. 1976), because the evidence in that case showed that at the time of the plaintiff's vaccination in 1963, Oklahoma was in "an epidemic state." The court reversed a verdict for plaintiff and remanded, requiring the plaintiff to show that if the warning had been given, he would not have been vaccinated. In Reyes, the court imposed liability on the manufacturer for failing to warn the recipient directly of a risk of contracting poliomyelitis from the vaccine even though the warning accompanied the vaccine and would have been very unlikely to change the conduct of the recipient, or to have prevented the child from contracting polio. Judge Wisdom's opinion closed with an extraordinary section in which, in response to an amicus brief filed by the American Academy of Pediatrics and the Conference of State and Territorial Epidemiologists

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91 opposing liability, he took on both-medical practice and the Congress. To the doctors he said: . . Obviously, however, one can choose to be inoculated with killed- virus Salk vaccine,~either to provide complete immunity or as a precautionary prelude to--ingesting oral vaccine. This position [that no warning should be required] raises a policy considera- tion scarcely less urgent than -the need for mass immunization from disease; the right of the individual to choose and control what risk he will take . . . ~498 F.2d 12941. To the Congress he said: Until Americans have a comprehensive scheme of social insurance, courts must resolve by a balancing process the head-on collision between the need for adequate recovery and viable enterprises. . . . [cite] Statistically predictable as are these rare cases of vaccine-induced polio, a strong argument can be advanced that the loss ought not lie where it falls (on the victim), but should be borne by the manufacturer as a foreseeable cost of doing business, and passed on to the public in the form of~price increases to his customers. Givens v. Lederle, 556 F.2d 1341 (Sth Cir. 1977), was a further extension of Reyes. Givens, like Reyes, involved Sabin oral polio vaccine. However, unlike Reyes, the vaccine had not been administered in a county health clinic, but by a pediatrician in his office. The victim was not the child but the child's mother, who had apparently contracted the polio from the vaccinated child. The pediatrician had given no warning of this or any other risk, although the risk was disclosed in the package insert. The case had concluded in a jury verdict for the defendant in the Middle District of Florida (then part of the Fifth Circuit), on the grounds that the vaccine could not have caused the polio [556 F.2d 13431. Reyes was handed down before the entry of judgment, however, and the trial judge granted a new trial in light of Reyes. On retrial, the verdict was for the plaintiff, and the defendant appealed. A remarkable aspect of the Givens opinion is that the court did not rely on-Florida law to support its judgment. In Reyes, the court had gone to great lengths to highlight a line of Texas cases concerning possible allergic reactions to a drug. In these cases, it was held unnecessary to warn recipients of possible allergic reactions if the number of people affected was not significant. It might appear that because the number of people who get polio from the vaccine is minute, this line of cases would suggest that no warning of the risk was necessary under the-controlling Texas law. The court, however, distinguished between the cases on the ground that an allergic reaction affected only a small group of recipients, while all recipients of the polio vaccine were apparently subject to the minute risk of vaccine-induced polio [498 F.2d 1278-12791. In contrast, the

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92 Givens opinion made no reference to Florida law. It simply followed Reyes--ostensibly applying Texas law--and treated it as Florida law. "FAN proposed major distinction is that a county health clinic ad- ministered the vaccine in Reyes, whereas a private pediatrician did so here," said the court [556 F.2d 13441. The manufacturer apparently was relying on the long line of authority indicating that the duty to warn in the case of prescription medicines prescribed by doctors belongs to the doctor, not the manufacturer. The pediatrician in Givens had an established doctor-patient relationship, was a trained and licensed professional, and had determined that the patient should receive the vaccine as part of her health care. This was not a case of an unadvised patient responding to the entreaties of a mass vaccination campaign. The court responded to this argument as follows: "The administra- tion of the vaccine by a public health nurse in Reyes is as close to the instant situation as it is to the Davis mass inoculation" [Ibid]. Testimony by the plaintiff's physician that n . . . the administration in his office 'really doesn't differ' from that of the Public Health Center; 'not in the administration at all"' emphasized the similarity to the Reyes situation, rather than his role as an informed intermediary [556 F.2d 13451. The defendant also argued that its warning to the doctor was adequate, and should protect it from liability. The warning stated: Paralytic disease following the ingestion of live polio virus vaccines has been reported in individuals receiving the vaccine, and in some instances, in persons who were in close contact with subjects who had been given live oral polio virus vaccine. Fortunately, such occurrences are rare, and it could not be definitely established that any such case was due to the vaccine strain and was not coincidental with infection due to naturally occurring poliomyelitis, or other enteroviruses [556 F.2d 13431. Of this warning, the plaintiff's doctor testified: "ET]he wording of the inserts states that it is a safe and effective means of immunizing the population and that the risk, if it exists, is no more than 1 in 3 million. I felt this was a very nebulous way of putting it, . . . and I did not feel there was sufficient evidence or warning to warn Mrs. Givens about this" [556 F.2d 134S]. The court held that this was sufficient evidence to sustain a jury verdict that the warning was inadequate. Thus, the court of appeals in Givens treated as factual questions for the jury whether or not the vaccine caused the polio, and whether or not the warning was adequate in light of the actual degree of risk that the vaccine might cause the polio. This situation, in which a jury confronted with a grievously ill child or adult (who has no other potential source of financial support or redress) is asked to judge - retrospectively the actions of the manufacturer, the regulatory authorities, and those responsible for the public health, tends toward a biased outcome in favor of the plaintiff.

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93 Although Reyes and Givens were decided in conformity with the verbal formulas of previous product liability law, the skeptical reader might easily conclude that they really stood for a different and simpler rule: the manufacturer is liable for all damages caused by a vaccine. Just such a rule for all prescription drugs had been advocated in Merrill's "Compensation for Prescription Drug Injuries," 59 Va. L. Rev. 1 (1973), and that article was cited by Judge Wisdom in the policy discussion in the Reyes opinion, 498 F.2d 1294 n. 57. Even though the Fifth Circuit had no power to make law on this point for Florida and Texas (the Texas or Florida courts could repudiate these decisions at any time if they had a case in point and chose to do so), the skeptical lawyer advising a manufacturer could take as the message from the judges: manufacturers are going to pay, one way or the other. Experience From the Swine Flu Vaccination Program These issues received highly publicized national attention in the summer of 1976. The discovery of swine flu virus in a human population with resulting illness (and one death) at Fort Dix, New Jersey, in January 1976, led the CDC to recommend a national program to provide immunizations against swine flu for the population.6 The need for the program was based on the extensive morbidity and mortality experienced during the disastrous pandemic of 1918, caused by an apparently identical strain of influenza virus. The proposals for such a vaccination program moved through the executive branch and the President to the Congress without a full appreciation of the problems presented by the threat of liability. The program was formulated and advanced on the assumption that the vaccine manufacturers would gladly produce for a fee close to cost the needed vaccine. The public health officials and government lawyers did not realize that Reyes and Givens in the district court represented an entirely new factor in the decision to produce and sell vaccines, particularly a vaccine proposed for administration to nearly the entire population in a short period. The manufacturers and their insurance carriers, on the other hand, no doubt resented the liability burdens placed upon them by Judge Wisdom, and were perhaps not unhappy about the opportunity to have their concerns addressed in a national forum. In any case, it became clear that the program would not go forward without some legal protection for the manufacturers, who were unable to obtain insurance at a price acceptable to them and refused to carry the risk themselves, in large part because of the limited time available for safety testing. Rapid congressional action necessitated by the need to manufacture and administer the vaccine before the onset of the flu season resulted in P.L. 94-380, effective August 11, 1976. The act provided for an exclusive remedy against the United States n for personal injury or death arising out of the administration of swine flu vaccine under the swine flu program and based upon the act or omission of a program participant" [P.L. 94-380 sec. 2(k)~2~(A)~. Program participant was defined broadly to include

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94 . . . the manufacturer or distributor of the swine flu;yaccine used in an inoculation under the swine flu program, the public: or private agency or organization that 'provided an inoculation under the swine flu program without charge for such vaccine 'or its administration and in compliance with the informed consent form and procedures requirements prescribed [in the statute!, and the medical and other health personnel who provided or assisted in providing an inoculation under the swine flu ; program without charge for such vaccine or its administration and in compliance with such informed consent form and procedures requirements. ; The statute left open the possibility of the manufacturer's or other participant's liability only in the form of a right of the United States to sue any participant for the amount it had paid and the costs of defending the litigation "resulting from the 'failure of any program participant to carry out any obligation or responsibility assumed by it under a contract with the United- States in 'connection with the program or from any negligent conduct on the part of any - program participant . . ." [Id. sec. 2(k)~7~. The Swine Flu Act had little to recommend it except that it made it possible to go ahead with swine flu vaccine production. The manufac- turers obtained protection for one vaccine under one temporary program, but no attention to the issues on any systematic basis. The law was criticized from many points of view but, in fact, it only changed the defendant and the rules, albeit unclear, remained the same. It also thrust the government into the unfamiliar role of product liability and malpractice defendant. The preamble to section 2(k) stated that the statute was necessary n in order to be prepared to meet the poten- tial emergency . . . until Congress develops a permanent approach for handling claims arising under programs of the Public Health Service Act." That "permanent approach" subsequently faded as rapidly as the swine flu emergency. The concern about the liability problems of vaccination programs so visible in the debate over swine flu carried over to the state level. To further the cause of universal vaccination and to protect partici- pants in the process, the manufacturers, the American Academy of Pediatrics, and others sought state legislation limiting liability. In the wake of the swine flu controversy, they were successful in two states: Maryland and California. Since then, no new, relevant state legislation has passed. The Maryland statute provides for immunity of all "program partici- pants," including manufacturers, if the state Secretary of Health and Mental Hygiene finds that an immunization project conforms to good medical and public health practice and gives written approval. No person is exempted from liability for gross negligence, and a manu- facturer is not exempted Strom the duty to use ordinary care in preparing and handling a drug or vaccine" [Maryland Code sec. 18-401, revised version of Ch. 238 of the 1977 laws]. The California statute mandated the creation of a special fund to provide for the medical, institutional, supportive, and rehabilitative

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95 care required "because of severe adverse reaction to any immunization required by state law to be administered to children under 18 years of age. n7 The statute also stated that "No person shall be liable for any injury caused by an act or-omission in the administration of a vaccine or other immunizing agent to a minor . . . if such immunization is required by state law and the act or omission does not constitute willful misconduct or gross negligence" [California Health and Safety Code sees. 429.35 and 429.36, passed as Ch. 1097, sees. 1 and 2 of the 1977 statutes]. A California trial court has held that this statute protects manufacturers from liability [Flood v. Wyeth Laboratories, Inc., No. SW C 58664 (Superior Court for the County of Los Angeles)~. The swine flu program was not a public health success. The vaccine was successfully manufactured, distributed, and administered to over 45 million~people in a relatively short period of time--a considerable administrative and logistical achievement. However, the virus did not reappear the following winter, for reasons that no one understands. Furthermore, it appeared that 1 out of 100,000 of the recipients developed Guillain-Barre syndrome (the most recent study reports a rate of 1 per 200,000~8, an unexpected and unique occurrence of unknown etiology. AS a result of the publicity about side effects and the documentation of the apparent relationship between the vaccine and Guillain-Barre syndrome (GBS), a large number of claims were filed. The special liability provisions of the swine flu statute, which very well might have faded into history, proved to be important. For the purposes of this study, the main importance of the provi- sions is that they resulted in a large body of litigation relating to the issue of liability for vaccine manufacture and administration. The claims and suits are summarized in Table 6.1, prepared by the Torts Branch of the Civil Division of the Department of Justice. The government has paid more than $73 million to claimants alleged to have been injured by the swine flu vaccination. Although this amount is large in absolute terms, it is less than $2 per vaccine recipient. Because there has been so little litigation directly relevant to the liability issue for vaccine manufacture and administration, the numerous swine flu cases provide the best guide to date on the legal rights of injured recipients, the liability risks of manufacturers, and the likely results of court action. It is useful, therefore, to describe this experience at some length and to-evaluate the factors that make it relevant to the general question of what vaccine manufacturers need or need not fear. The most important decision made in connection with the swine flu litigation was a decision by the government to stipulate to liability (accept liability responsibility) for damages caused by the GBS in any case where the plaintiff could show that the GBS was caused by the administration of the vaccine. What was the basis of this stipulation to liability? Was the U.S. government taking the position that the law imposed strict liability, that the warning had been inadequate, or that the vaccine was negligently manufactured or administered? - _ re Swine Flu Immunization Products Liability The court in Litigation, 533 following: Supp. 703, 718 (D. Utah 1982), reported

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112 Although there are distinguished state judiciaries, in a Worst case" scenario a vaccine manufacturer from a distant state would face trial in a state court located in the hometown of the plaintiff, and controlled by a judge subject to frequent elections before that hometown electorate. The plaintiff's case is likely to be supported by ~expert" testimony from the treating doctor, perhaps well known and respected in the community. Fourth, the swine flu program was accompanied by much more intense publicity and news coverage than regular, ongoing vaccination programs. That news coverage may have made many more people aware of the possible connection between the vaccine and GBS, it may have made more recipients consider filing claims, and it may have made doctors more sensitive to the possibility of a GBS diagnosis in persons who received a vaccination.13 Fifth, there is a difference between the swine flu claims and the claims that would confront a manufacturer of pediatric vaccines in an analogous situation. The swine flu vaccination program was focused on adults and particularly on older persons more likely to incur serious complications from the disease. This affected the litigation in two ways. First, older people have shorter life expectancies and any element of damages calculated over life expectancy is reduced. Second, in many states, a statute of limitations does not run against a minor. Thus, a 1-year-old who suffers injuries as the result of a vaccination may have more than 20 years before any claim is cut off by the passage of time. This makes it more difficult for the manufacturer in the pediatric case to estimate the amount of potential outstanding claims. Sixth, it is hard to overlook the fact that the defendant in the swine flu litigation was the ultimate "deep pocketn--the government of the United States. The judges in the swine flu litigation were not confronted by a vaccine producer whose solvency and future ability to provide vaccines would be critically affected by the outcome of the litigation. The-defendant, instead, was the United States, which would hardly notice the difference. This fact affected not only the reactions of the judges, but the decision to stipulate to liability, the resources dedicated by the Department of Justice to the defense of the cases, and the style of argument that could be made to the courts.l4 Indeed, in retrospect it may become clear that the major mistake of the swine flu statute was to place the defense in the hands of a bureaucracy without any long-term stake in the controlling rules. What can be concluded from the swine flu litigation? First, the professionals close to the plight of a particular victim find it hard not to support the merits of the claim. The treating doctor, perhaps not unhappy to direct a potential malpractice claim elsewhere, provides supportive testimony. Trial judges, confronted by the hardship the plaintiff has experienced, are tempted to adopt new interpretations of the law. Second, doctors and lawyers prefer to treat the issues as the other profession's problem. The lawyers and judges involved with a particu- lar case focus their discussion on issues of medical fact, and ostensibly base their decisions on which medical expert's testimony is

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113 more believable. Many doctors, on the other hand, think the law should provide a solution to the problem: some are unwilling to testify, and others fail to differentiate in their testimony between established effects and ideas outside the scientific mainstream. Third, the reaction of the courts who found liability to Secretary Califano's stipulation vividly illustrates the problem facing the manufacturers. One might argue that the manufacturers have a simple solution to the liability burden and the costs of litigation. Instead of strongly resisting liability, as they have, they could simply concede liability and settle, recovering the costs of their settlements in higher vaccine prices and avoiding all the costs of extended and unproductive disputes over issues of esoteric medical fact. That is what Secretary Califano basically did when he supported the govern- ment's stipulation of liability for GBS, but a concession of liability Delilah ~lr~r, ;Ecc~lf The r~r=~:c~lr" t-^ 1-r=AP 1 ;k" ~l=;m~ :~1 ;k" r'=n~r~t-~.~: CALL ~ Aim "~VI! ~ "~= ~ ~ ~ &~= ~ C - D"= ~ "~ ". C" ~ ~ ~ ^= ~ ~ ~ ~ ill~ ~ ~ ~ ^= it "~ an ever-expanding pool of liability if the original concession of liability is based upon no identifiable theory or principle. Finally, the Unthank and Petty opinions seriously erode any confidence that in the future a defendant faced with substantial claims could duplicate the government's basic success. In spite of the fact that the government won almost all of the cases it contested, Unthank and Petty are court of appeals' opinions strongly favoring liability. If they had been handed down early in the litigation, they might have been viewed as setting a precedent in favor of recovery for the plaintiff. Recently, a few other cases relating to liability for the manufac- ture of vaccines have been reported. One is a flu vaccine case, involving an administration during the same fateful fall of 1976, but of a monovalent vaccine (Victoria A strain only) administered in a doctor's office and thus not falling within the swine flu statute [Stanback v. Parke-Davis & Co., 657 F.2d 642 (4th Cir. 19811. The plaintiff had contracted GBS, and the defendant had not warned of the risk of GBS. The doctor testified that it was his practice not to warn patients of the type of risk, and that, although he was aware of a possible risk of GBS in the fall of 1976, he did not warn the patient and would not have warned the patient even if the package insert had been different. The district court granted a summary judgment to the defendant for failure of the plaintiff to prove a causal connection between the manufacturer's failure to warn and the plaintiff's injury. The court of appeals affirmed. There also have been additional polio cases. The most notable is Schindler v. Lederle Labs., 725 F.2d 1036 (6th Cir. 1983), which ~- affirmed a judgment in favor of the manufacturer on the grounds that its package insert provided adequate warning of the risk of contracting polio. The doctor had administered the vaccine under conditions that are contraindicated. Dunn v. Lederle Laboratories, 121 Mich. App. 73 . (1982), also affirmed a verdict for the defendant. In Loge v. united States, 662 F.2d 1268 (8th Cir. 1981), the district court had dismissed the complaint against the United States. The court of appeals reversed on the grounds that the plaintiff's allegations that the United States had approved the vaccine in violation of its own

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114 regulations were sufficient to state a cause of action. In FraleY v. American Cyanamid Co., 570 F. Supp. 497 (D. Colo. 1983), the court held that the defendant was collaterally estopped from contesting the adequacy of a warning accompanying a dose administered in 1971 and identical to the warning in Givens. There are two reported decisions relating to DTP. Walton v. Charles Pfizer & Co., Inc., 590 P.2d 1190 (Okra. 1979), affirmed a verdict (of $2,000, a statutory limit) against the City of Tulsa for the 1966 administration of pediatric vaccines (probably DTP, but not clear). Morris v. Parke-Davis & Co., 573 F. Supp. 1324 (C.D. Cal. 1983), an ongoing case, involves a claim based on a DTP vaccination given in 1965. The plaintiff seeks actual and punitive damages. All manufacturers who produced DTP at the time are joined as defendants because the source of the DTP is not known. A motion to strike the claim for punitive damages was denied by the court. Caron v. United States, 548 F.2d 366 (1st Cir. 1976), affirmed a judgment of $705,606 for immunization of a 4-month-old baby with DTP, oral polio vaccine, and typhoid vaccine leading to convulsions, grand mal seizures, and permanent mental retardation. The typhoid given was an adult dose. The claim was brought 10 years after the vaccination on the theory that the typhoid vaccine was administered negligently, both because the dosage was improper and because in the absence of a special risk of typhoid, it should not be given to a baby. Lemar v. United States, 580 F. Supp. 37 tW.D. Tenn. 1984), dismissed a suit against the government for encouraging pediatric vaccination without warning of possible adverse consequences. Calabrese v. Trenton State College, 162 N.J. Super. 145 (1978), held the manufacturer, distributor, and seller not liable for damages allegedly caused by rabies vaccine, but denied the physician's motion for summary judgment because a fact issue existed as to whether he had disclosed possible adverse side effects. Hitchcock v. United States, 479 F. Supp. 65 (D.D.C. 1979), awarded $519,051 against the united States to the wife of a foreign service officer who was given anti-rabies vaccine as "pre-exposure prophylaxis" by government doctors prior to a foreign posting. The liability was based on the failure of the government to warn of the benefits and risks of the vaccine. Recent Trends As the committee completed its work, it became aware of two recent, substantial verdicts against Lederle Laboratories. It will be impossible to assess the long-term importance of these verdicts until the appeal process has been completed, because they may not, in fact, reflect the current state of the law (although the ability of plaintiffs to obtain substantial verdicts in trial courts itself reflects the present unstable state of the decisional law). In both cases, the plaintiffs advanced theories that went beyond the adequacy of the warning; they asked the juries to rule on issues of social

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115 benefit and harm and on the underlying scientific factors that contribute to the basic public policy decision to use a particular vaccine. Juries making such decisions in the liability context easily could become the de facto regulators of immunization practices in the United States: verdicts unfavorable to the manufacturers could effectively stop production of a vaccine even if a majority of juries decided against liability. In Toner v. Lederle Laboratories, No. CV 80-1245 (D. Idaho), a jury returned a~verdict of $1,131,200 in April 1984, based on the theories that the defendant's DTP preparation caused the plaintiff child's transverse myelitis and that the defendant could have marketed a safer pertussis vaccine. The plaintiff pointed to the pertussis vaccine marketed until 1975 by Eli Lilly and Company. Eli Lilly sold its rights in the vaccine to Wyeth Laboratories after questions were raised about its efficacy by a review panel of the FDA, and Wyeth never obtained a license to manufacture and market it. An appeal to the U.S. Court of Appeals for the Ninth Circuit is pending [No. 84-39061. In Johnson v. American Cyanamid Co., No. 81 C 2470 (18th Jud. Dist., Sedgwick Co. Kansas), the jury on June 1, 1984 returned a verdict of $2 million for compensatory and $8 million for punitive damages for a parent-contact of a child who received Sabin (attenuated live virus) polio vaccine. The plaintiff argued that marketing the vaccine was negligent because the Salk (inactivated virus) vaccine is safer, and the parent was not informed that this alternative was available and equally efficacious. An appeal to the Kansas Supreme Court is pending. The Issue of Punitive Damages If the Johnson punitive damage verdict is affirmed on appeal, it could significantly affect future vaccine litigation. Prior to the Johnson verdict, punitive damages were not a prominent factor in vaccine cases. Most plaintiffs' complaints did not even ask for punitive damages (information supplied to the committee by one manufacturer indicated that only IS percent of suits involved claims for punitive as well as compensatory damages). If the verdict is affirmed, claims for punitive damages may become more prevalent. Affirmation of the punitive damage verdict in Johnson could be interpreted as a determination by a powerful regulatory body (the common law court and lay jury) that Sabin vaccine should not be administered in the United States unless preceded by an administration of Salk vaccine to unimmunized contacts, and perhaps to the child as well. However, society generally has deemed it desirable to delegate decisions on such health policy issues to specialist groups, such as those advising the FDA and CDC--an approach viewed as appropriate by the committee. Punitive damage awards would greatly increase the magnitude of financial risk for manufacturers because such damages can be almost unlimited in amount and can be duplicative. (Each jury, in each case,

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116 could assess an amount measured by the nature of the defendant's total conduct.) ~ Punitive damages generally are awarded to punish defendants for conduct that could be characterized as outrageous or as showing a reckless disregard for the safety of others. In Johnson, the argument was based on the wording of the package insert. In addition to disclosing the risk of contact polio, should the insert also have described the option of administering Salk vaccine first? The Immunization Practices Advisory Committee did not (and still does not) recommend this procedure. The Kansas court's judgment that Lederle's failure to suggest preimmunization with the Salk vaccine in its package insert meets the criteria for punitive damages is currently being appealed. In a previous case, however, the Kansas Supreme Court affirmed a punitive damage award by a jury that determined retrospectively that a package insert was insufficient [Wooderson v. Ortho Pharmaceutical Corp., 235 Ran. 387, 681 P.2d 1038 (19841*~. - The Johnson verdict again shows that the manner in which courts . rule on questions involving a manufacturer's responsibility is highly unpredictable. Summary of the Legal Situation Under well-established legal principles, a vaccine manufacturer is not liable for injuries caused by a properly manufactured and labeled vaccine. In recent years, however, a few courts have acted contrary to these principles and found manufacturers liable for such injuries, possibly because the injured individual had been urged (or required) by the government to participate in the immunization program and appeared to have no other recourse for compensation. In general, these vaccine injury claims have been decided on the basis of the doctrine of the duty to warn. This doctrine provides that, prior to the use of an unavoidably unsafe product, the user must be warned of the risks associated with it. In the case of medicines administered by health professionals, the courts generally have placed this responsibility on the health care provider. For vaccines, however, some courts have ruled that the duty to warn resides with the manufacturer, even though the manufacturer is not involved in admini- stration. It is unclear whether the courts that have ruled in this fashion would permit the manufacturer to avoid such responsibility by obtaining a formal agreement from the purchaser stating that a warning would be given prior to administration. In two very recent cases (presently on appeal), the plaintiffs prevailed by advancing theories of liability that went beyond the *There are numerous differences between the two cases. One that is important for the punitive damage issue is that the package insert for the Sabin polio vaccine did warn of the risk of contact polio, while the insert in Wooderson did not warn of the possibility of the condi- tion that actually beset the plaintiff.

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117 adequacy of the warning and asked juries to rule on the issues of social benefit and harm, and the underlying scientific factors that contribute to decisions to use a particular vaccine. In one of these cases, punitive damages were awarded; however, punitive damages previously have not been a significant factor in vaccine-related injury litigation. This review demonstrates that the limits of a manufacturer's responsibilities (beyond safe manufacturing and adequate package labeling) are unclear. Some decisions appear to suggest that the manufacturer can be held strictly liable in all cases. At the time this report was compiled, the committee was not aware of any cases holding health care providers liable for vaccine injury, except for situations involving failure to follow accepted medical procedures. It does not presently recommend any change in the rules applicable to health professionals because liability for improper administration is appropriate;* it recognizes, however, that if any proposal limiting recovery against manufacturers were adopted without provision for reasonable compensation, lawsuits might simply be redirected from the manufacturer to the administering professional This could have deleterious effects on the willingness of health care providers to participate in immunization programs. Such a situation would require careful monitoring. Tracking shifts in litigation and recommending remedial action would be one of the functions of the proposed vaccine commission (see Chapter 7~. C ONSEQUENCES OF THE STATE OF VACCINE INJURY LIABILITY LAW FOR VACCINE PRODUCTION AND INNOVATION Despite clear legal rules, the manner in which claims against manufacturers alleging liability for suspected vaccine-related injuries have been handled by the courts does not provide reliable guidelines for predicting the limits and magnitude of their liability. This combines with other organizational and scientific factors to create a situation in which vaccine supply may be threatened.15~16 Causation is difficult, if not impossible, to determine with certainty in specific cases, and there is usually no other recourse to compensa- tion for injured individuals. In the committee's judgment, this has led to a situation in which~jurors and courts may be inclined to view tort awards as a means of providing compensation, irrespective of misconduct or scientific considerations. These circumstances require the manufacturer of a vaccine known to have certain adverse effects to engage in a gamble with very large financial stakes. If an increasing number of courts impose liability, the costs will be enormous because claims average several million dollars per case. The only way to eliminate the risk is to stop *The committee recognized that malpractice claims, in general, represent a major concern of the medical profession, but it did not feel that the malpractice issue was within the scope of its charge.

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118 manufacturing the vaccine. If the manufacturer chooses to continue to market the vaccine, its only options are to attempt to settle claims, a strategy that could produce a general expectation of liability, or to resist claims in litigation, with the risk that unfavorable outcomes could establish liability. The cost of either strategy will be high (even if claims are defended successfully) and will have to be passed on to consumers via price increases. To determine the exact nature of concerns over potential liability for vaccine-related injury, the committee conducted an informal survey of vaccine manufacturers. The goal was to solicit information (much of which was commercially sensitive) on the number and size of vaccine injury claims and settlements over the past decade, and on the provisions made by manufacturers for dealing with such eventualities (e.g., insurance) e The committee received information from most major companies actively involved in vaccine production. The manner in which the information on these issues was available did not always permit comparisons or aggregation for publication, which was a condition agreed upon for providing such data. For these reasons, the information summarized below should not be taken as a totally comprehensive picture of the situation. At the time of the initial survey (spring 1984), 166 suits were pending against the four responding manufacturers. The total amount paid in settlements in the previous decade for completed cases (settled or finished with the appeal process) had been $2 million, and about another $1.8 million had been spent on legal defense, not in all cases including n in-house" counsel. The information gathered in a follow-up effort (spring 1985) revealed that about 65 additional suits had been filed in the intervening year (only a few of the previous total had been settled, some for amounts averaging $1 million; some trial verdicts were on appeal). Legal costs for the 1-year period ranged up to "several million dollars" for some manufacturers. Time series information supplied by two manufacturers indicated a sharp increase in the number of claims filed; their experiences varied considerably, but the total number of reported claims filed against them in 1983 was more than twice that filed in 1980. Over the past two decades, pharmaceutical companies have been withdrawing from vaccine manufacturing and marketing. Increasingly, the liability situation and its consequences (i.e., litigation costs or difficulty in obtaining insurance coverage have been cited as major factors in the decision to withdraw.] ~ 9 These decisions seem to indicate that present or anticipated vaccine-related injury liability expenses are seen as an unreasonable burden (or an unacceptably risky gamble) in relation to the costs of product development and the income from sales. Such decisions threaten the nation's supply of vaccine because vaccine production in the united States is overwhelmingly dependent on commercial manufacturers. From the data and comments submitted by manufacturers and from testimony before congressional committees,20~21 the committee concluded that the precise nature of the problem arising from vaccine injury liability cannot necessarily be measured solely in terms of

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119 data reflecting past experiences. Litigation over medical injuries in general has increased substantially during the past 10 years. The rate of malpractice claims against physicians during the 5 years between 1978 and 1983 was more than twice that of the preceding 5 years.22 The swine flu episode and publicity about pertussis vaccine risks have drawn attention to the fact that vaccines may cause injury. Also, in many states, the statute of limitations for alleged injury in childhood does not operate while the individual is a minor, thus vaccine manufacturers may be at risk of claims for many years. Manufacturers are apprehensive that without some means of compensa- tion for unavoidable vaccine injury and temporally related conditions, the present unclear state of the law will continue to allow them to be held liable for such conditions and penalized financially. The future behavior of the courts and the responses of the manufac- turers cannot be predicted with certainty, but the committee is concerned that the apprehensions themselves might have a negative effect. Earlier withdrawals from the market have created a situation in which the United States is reliant on one manufacturer for polio vaccine and most of its DTP vaccine (Lederle), and on another for measles, mumps, and rubella vaccines (Merck Sharp & Dohme). If apprehensions about the current unclear state of the law caused these manufacturers to withdraw, the vaccine supply and immunization programs could be jeopardized, leading to possible resurgence of these diseases. Also, the apprehensions discussed above are a disincentive to investment in the development of new (or improved) immunizing agents and to competition from new or foreign firms.23~24 Proposals to remedy the compensation and liability problems connected with vaccine injury are discussed in Chapter 8. REFERENCES AND NOTES See, e.g., Prod. Limb. Rep. (CCH) Par. 90,110-195,270 for a listing of state product liability statutes; see, generally, L.R. Frumer and M.I. Freidman, Products Liability (1984~. 2. Prod. Liab. Rep. (CCH) Par. 90,000; but see Product Liability Risk Retention Act, P.L . 97-45 (allows groups of companies to form captive insurance companies and exempts such activity from certain state regulations). 3. American Law Institute. 1965. Restatement of Torts 2d. St. Paul, Minn. 4. There are also cases involving animals: Lovington Cattle Feeders Inc. v. Abbott Labs., 97 N.M. 564 (1982~; Pearson v. Franklin Labs. Inc., 254 N.W. 2d 133 (S. Dak. 1977~; Colorado Serum Co. v. Arp, 504 P.2d 801 (Wyo. 1972~; Waller v. Fort Dodge Laboratories, 356 F. Supp. 413 (E.D. Mo. 1972~; Alman Bros. Farms & Feed Mill, Inc. v. Diamond Lab., Inc., 437 F.2d 1295 (5th Cir. 1971~; and Anderson v. Blackfoot Livestock Commission Co., 375 P.2d 704, 85 Idaho 64 (1962~. 5. See Marc A. Franklin and Joseph E. Mais, Jr. "Tort Law and Mass Immunization Programs: Lessons from the Polio and Flu Episodes, n

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120 65 Calif. L. Rev. 754 (1977) "written before Givens); see also Richard A. Epstein, Modern Products Liability-Law 107-110 (Westport, Conn.: Richard A. Greenwood Press, 1980~. 6. There are two extended accounts of the swine flu episode and the government's reaction to it. The first, Richard Neustadt and Harvey Fineberg, The Swine Flu Affair: Decision-Making on a Slippery Disease (U.S. Department of Health, Education and Welfare, 1978), was written by two Harvard professors for Secretary of Health, Education and Welfare Joseph Califano, the appointee of newly elected President Jimmy Carter. The study is in very much the show we can learn from the mistakes of the past and do it better n style, and strongly criticizes the officials of the Ford administration for having committed too early and too irrevocably to the manufacture and administration of the vaccine, so that when negative information such as the lack of further confirmations of the disease or problems in its distribution began to develop, it was impossible to reverse course and call off the program. Arthur M. Silverstein, a m~cron~o~og~st at Johns Hopkins University, who had served as a congressional fellow during the episode, felt the Neustadt-Fineberg study greatly oversimplified the problem and the reasons the government reacted as it did. His study, Pure Politics and Impure Science (Baltimore: Johns Hopkins University Press, 1981) is more thorough. Although Secretary Califano attempted to deal vigorously with the issues created by the swine flu program and its problems, in the end he, too, was unsuccessful in achieving significant gains in the institutional and legal framework within which these questions arise. It remains to be seen whether some future epidemic threat will become a tragic reality because the lesson learned from swine flu will be thought to have been: Don't act too soon. Esmond S. Smith, M.D., chief of California Children Services, reported in a letter to the committee November 21, 1984 that California's Immunization Adverse Reactions Fund has paid the claims of two children ($1,644.73 and $2,064.59~. One claim is pending for an immunization in 1973. 8. The entire Matter was restudied in A.D. Langmuir, D.J. Bregman, L.T. Rurland, N. Nathanson, and M. Victor, "An Epidemiological and Clinical Evaluation of Guillain-Barre Syndrome Reported in Association with the Administration of Swine Influenza Vaccines, n 119 Ame J. Epidemiol. 841 (1984~. It concluded that the rate was less than previously thought, 1 out of 200,000 (a total of between 211 and 246 cases), and that an incidence rate above the background rate was confined to the first 6 weeks after administration. This study explicitly recognized that these results may have been inflated by the publicity. 9. The document referred to is a press release issued by Secretary Califano's office in connection with the announcement that the government would agree to accept liability for cases of Guillain-Barre syndrome that arose in the first 10 weeks after vaccination. The press release was not in the record of the

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121 case. When, at Secretary Califano's deposition, the plaintiffs attempted to inquire into the reasons for the government's stipulation, counsel for the government successfully objected to the line of questioning. 10. The n just compensation" provided by the stipulation in the swine flu litigation is substantially different from the compensation recommended by this committee because it included all the traditional elements of tort damages. 11. These problems may explain why counsel, as reported in No. 9, desired to prevent deposition testimony by the Secretary on these issues. 12. The information underlying Table 6.2 was assembled by Mary Koelbel, a second-year student at the University of Virginia Law School using LexisiM. There are additional swine flu decisions that are not reported either in print or in the LexiSTM data base. The Torts Section of the Civil Division, Department of Justice (DOJ), has a comprehensive litigation file of all decisions made in the swine flu litigation. Jeffrey Axelrad, director of the Torts Branch, permitted Kitch, a member of the committee, to examine this file on February 6, 1984. To base this report on information that could be easily verified by others, the summaries here are based only on publicly available information. Review of the DOJ files led Professor Kitch to conclude that there were no important differences between the outcomes reflected in the published and unpublished decisions, except that the unpublished decisions tend to be briefer, less notable, and more overwhelmingly in favor of the government. Publicly available decisions relating to procedural matters are not reflected in Table 6.2. Axelrad also prepared Tables 6.1 and 6.3. The committee appreciates the assistance provided by 13. Axelrad. The CDC study attempted to determine the rate of vaccine-induced GBS by comparing rates for the vaccinated and unvaccinated populations. It then attempted to check for the possibility that doctors had been more ready to make a GBS diagnosis of patients who had been vaccinated by comparing objective measures of the severity of the condition in the vaccinated and unvaccinated victims. GBS is not a well-defined disease complex. The study found that these measures were on average the same in the two populations. That check, however, does not rule out the possibility that medical personnel were quicker to consider a possible GBS diagnosis in the vaccinated population after the widespread publicity about the possible connection. Langmair, Bregman, Kurland, Nathanson, and Victor, "An Epidemiological and Clinical Evaluation of Guillain-Barre Syndrome Reported in Association with the Administration of Swine Influenza Vaccines," 119 Am. J. Epidemiol. 841, 865-866 (1984), explicitly recognizes this problem. "However, it is only reasonable to believe that the history of a swine influenza vaccination in the individual patient may well have influenced his physician to more seriously consider both the diagnosis of Guillain-Barre' syndrome and the

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122 reporting of the case if so diagnosed. In addition, patients who had received swine influenza vaccine may well have sought medical care more promptly" [Id. at 865-8661. 14. Indeed, it is telling that when the General Accounting Office studied the processing of swine flu claims at the request of Rep. John A. Durkin, no attention was paid to the question of whether the claims being paid were valid claims under the statute, but only to why the Department of Justice was taking so long before it authorized payment [U.S. GAO letter B-199297 (January 14, 1981~. 15. National Immunization Work Groups. 1977. Reports and Recommenda- tions of the National Immunization Work Groups. McLean, Virginia: JRB Associates. 16. U.S. Congress, Office of Technology Assessment. 1980. Compensa- tion for Vaccine Related Injury. Washington, D.C.: U.S. Govern- ment Printing Office. 17. Pettinga, C.W. 1983. Vaccine Innovation in the Private Sector. Paper prepared for an Institute of Medicine Conference on Barriers to Vaccine Innovation, November 28-29, 1983, Washington, D.C. 18. Mason, J.O. 1984. Testimony on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 19. Shaw, D. 1984. Testimony for Wyeth Laboratories on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 20. Johnson, R.B. 1984. Testimony for Lederle Laboratories on H.R. 5810 before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, December 19, 1984, Washington, D.C. 21. Sarett, L.H. 1982. Testimony for Merck & Company before the Subcommittee on Investigations and General Oversight, Committee on Labor and Human Resources, U.S. Senate, July 22, 1982. 22. American Medical Association. 1983. Physicians' Professional Liability Experience, Socioeconomic Monitoring Systems Detailed Tabulations. Chicago, Ill.: American Medical Association. 23. Beale, A.J. 1985. Modern approaches to the development of vaccines: perspective of a traditional manufacturer. Pp. 377-381 in Vaccines 85. Molecular and Chemical Basis of Resistance to Parasitic, Bacterial, and viral Diseases, R.A. Lerner, R.M. Chanock, and F. Brown, eds. Cold Spring Harbor, N.Y.: Cold Spring Harbor Laboratory. 24. Medicine in the Public Interest. 1984. Impediments to Vaccine Research. Boston, Mass.: Medicine in the Public Interest, Inc.