Influence ofthe Courts of Law on Biologicals Development, Regulation, and Use WILLIAM J. CURRAN My assignment in this Conference is to growth in another type of personal injury discuss developments in the courts of law litigation of at least equal, if not greater, concerning biological agents intended for the importance to this meeting, that of product prevention of disease. I will begin with an liability in the medical field. This type of claim analysis of court cases in the legal system I is brought directly against the manufacturer of know best, that of the United States, where, I the product rather than against an intermediary have been assured by many international distributor or user, such as a hospital or a sources, the volume of litigation has been physician. It can be brought on a variety of greater and more influential in the biological legal theories of responsibility, whereas a suit products field than in any other country of the against a physician or hospital is nearly always world. From these cases I will try to derive based upon a single theory, that of negligence, general principles which could be applicable to or, a failure to exercise the required degree of other legal systems. Following this, 1 will care under the particular circumstances of the describe some legislative developments enacted case. and proposed in various countries of the world to cope with the problems posed in the court The first case-the Salk vaccine cases and also designed to deal with other legal Important cases reaching the appellate levels matters of concern to this Conference. of our American courts have marked the history of the development of vaccines in the AMERICAN CASE LAW United States all along its course in recent decades, beginning with the famous case of It seems to be quite well known to the Gottsdanker v. Cutter Laboratories in 1960 (1). medical community about the world that there This case involved Salk vaccine administered in has been a substantial amount of medical a mass-distribution program in the westem malpractice litigation in the U.S.A. in recent states of the U.S. in the early years of the polio years. The situation received worldwide notice uimunization program. A total of 54 claims in 1975 due to an economic crisis concerning were involved with the allegation that the the cost and availability of private malpractice method used in killing the virus in large batches insurance. Over 30 of our states enacted reform of the vaccine was unsuccessful. The plaintiffs legislation last year designed to relieve the all contracted the disease and there was no insurance crisis and also to deal with some of serious effort made to disclaim causation by the the underlying causes of the crisis in the legal vaccine. The manufacturer defended on the system and in medical practice. Much less basis that no negligence was involved in their noticed around the world has been a parallel processes which followed Federal government Frances Glessner Lee Professor ofLegal Medicine, Han'ard Medical School and School ofPublic Health, Cambridge, Massachusetts, US5A. S3 54 W. J. Cumn standards. The suit was won by the plaintiffs on more legal liability has been placed on rnore the basis that no negligence need be proved and more defendants over these years in an since the manufacturer was liable for any almost uninterrupted chain of cases, all built on personal injury caused by his product since it the single social theory of spreading the risk was "sold" under a guarantee or warranty of its through privately purchased insurance. Like the purity and safety for human consumption. The world's supply of oil, it has been thought that defendant had tried to avoid the application of this private insurance system was a bottomless this theory of liability by showing that it had and easily accessible pit of largesse from which not "sold" its product to the eventual users, to distribute justice through what our most but had sold it under specific written contracts influential legal philosopher, Roscoe Pound, of sale only to public health authorities which called the judiciary's "social engineering." had redistributed it in massimnmunization Insurance crises such as that of 1975 in medical programs, often without charge to the malpractice have proved its folly. recipients. The California Supreme Court refused to agree with this defense and instead The second wave-the Sabin vaccine applied a rule of "privity," or responsible The next major case arose out of the second relationship, as running directly and without wave of mass immunizations for poliomyelitis interruption from the manufacturer to the in the U.S. with the Sabin vaccine in the early eventual and foreseeable recipient. The 1960's. The process had become more financial loss of Cutter Laboratories from these sophisticated. The live vaccine was produced in cases eventually totalled over $3 milion. small batches under much stricter Federal The Cutter case settled in the United States supervision. There was no proof offered in the the issue of the responsibility of the case of any defect in the manufacture of the manufacturer to the individual who receives a product, in following the government's vaccine where the vaccine is defective in its standards, or in the efficacy of the manufacture; that is to say where something govenmment's performance of its duty of goes wrong in the process, or where the design inspection of the vaccine batches. Nevertheless, or process itself is found not to accomplish its a recipient contracted paralytic polio within a objective-as it failed here to kill the virus. I time span which could be associated with the cannot say that this result shocked anyone in vaccine. the United States at the time. The decision was In the trial of the case, this time in a Federal in general accordance with the trend of product court, the jury found no liability at all on the liability cases, especially where foods or drugs part of the manufacturer. were involved. ITie lawyers were quite content On review in the Federal Court of Appeals, to sue the manufacturers rather than to engage the decision was reversed by a divided court in arduous and difficult proof situations in suits (2-4) on the ground that the manufacturer had against intermediaries or practicing doctors. failed to warn the recipient of the inherent risk The courts believed that public policy was in the vaccine (2). This risk was calculated at served in holding the primary wrongdoer liable the time of its administration as about 1 per for all damages, especially since the million doses of the particular strain involved. manufacturer could be expected to insure This seemingly astonishing result was justified against the risk and thus spread the cost of the by the Court on the basis of another statistic, litigation and awards to all consumers in the that being that the risk of contracting polio price of the product. This attitude has, in fact, naturally in the environment at that time become traditional in our courts over most of (because of the success of the Salk and Sabin the decades of this century since the advent of vaccines) was down to about 0.9 per million, or casualty insurance underwriting. More and essentially the same as the recipient's risk from Influence of the Courts of Law on Blogicals Development, Regulation. and Use SS the vaccine itself. The Court ruled that the four antigens: diphtheria toxoid, tetanus individual should have been given this toxoid, pertussis vaccine, and poliomyelitis information of the relative risk. The failure to vaccine. It was prescribed and given in a single do so made the manufacturer liable for the dose by a private physician to a two-month old disease incurred. infant. Three days later the infant developed a The drug company had argued in the appeal fever alleged to reach 108° F. and was that it should not be required to give direct hospitalized. The child had recurrent seizures waring to the consumers of the vaccine since it and was rendered paralyzed on the right side, was clearly a prescription-drug product and the and in all probability mentally retarded to a law and practice of the industry was to wam considerable degree. only the medical and public health personnel Action was brought against the involved and to leave it to them to wam their manufacturer and evidence was produced that patients. The company showed that it had the product was defectively manufactured in provided a correct and proper waring to the that the preservative used was unstable and Medical Society through the package insert there was alleged to have been a release of the which was approved by the Federal endotoxin causing the child's condition. The government. Furthermore, the agent of the trial court agreed with this evidence and also company had called the attention of the found that the manufacturer's advertising to Society to the statements of the Surgeon the medical profession and its package insert General's Special Advisory Committee on were misleading. No liability was found on the Poliomyelitis which advised against including part of the attending physician. A sizeable adults in the mass immunization programs at award was granted. The decision and its that time. The plaintiff was an adult of 39 reasoning were affirmed by the highly respected years. If anyone was at fault, it was the local Second Federal Court of Appeals in New medical society which was in charge of the York (3). program and which decided to include all adults There are certain aspects of this case which in the mass distributions and which failed to should be observed. First, it involved warn them of the inherent risk of the product. administration of the product in a private This argument convinced one judge, but not doctor's office, without warnings being given two. A vigorous dissent was filed by the one by the doctor about the risks of the four judge out. A rehearing was requested because of different immunizations given at once. Second, the importance of the matter, but the it was a very sophisticated claim, a highly two-judge majority remained steadfast. technical evidential matter. with very Unlike the Cutter case, the Davis case was a competent trial attorneys preparing and considerable departure from the general trend offering their cases. Both sides had their experts of products liability cases in the U.S It was the giving opposite opinions on the causation of the first case to require the manufacturer of a injuries. on production methods and standards, medical prescription product to warn and on just about every other medical and consumers of inherent risks. It was also the first scientific issue in the litigation. Next, the case case to require a warning of such an extremely was heard by a Federal judge sitting without a slight risk, smaller in all likelihood than the jury. This judge plunged into the evidence and risks in most products on the market examined it deeply and critically. undaunted by considered quite "safe" by everyone. its complexity and teclinicality and unenchanted by the certainty and authority of Privately administered biologcals the opposing experts called before him. He The next major case involved the rendered a verdict in this extremely technical administration of a single product containing area on behalf of the injured party which, 56 W. J. Cunan under the law, had the burden of proof by a even involved the same manufacturer, Wyeth preponderance of the evidence of every one of Laboratories. In this case the Sabin vaccine had these elements in the case. been administered to an 8-month old child at a Note also that here, as in the Cutter case and public clinic by a public health nurse. The case the Davis case, the Federal government, which occurred in southern Texas near the Mexican was now so deeply involved in setting safety border at a time when this region was the only standards of production and conducting remaining site of any significant number of product inspection, was not sued, even though naturally-acquired polio cases in the United the judge found the product defective in its States. A periodic epidemic of the disease was manufacturing process-a fnding not made in in progress and public health authorities in the the Davis case. Depositions from Federal community were publicly urging parents to scientists and officials involved in the take their smal children to their private doctors biologicals regulatory program were submitted or to public clinics to be immunized, since in evidence at the trial on behalf of the drug children under 2 years of age-most of whom company. It was significant, though little had not been immunized-were the most noticed at the time, that the trial judge vulnerable group in the population at the time. commented adversely on much of the evidence No public warnings were given about inherent submitted in these depositions. nsks in the vaccine. The mother of the Reyes child took her to the public clinic in response to these public urgings. The nurse at the clinic The Government's liabflity gave her no warings about the vaccine. The But lawyers took the hint. These signs of child contracted paralytic polio of the Type 1 judicial attitude were followed up in a later case strain, which was the virus wild in the in the early 1970's, another polio case, this community at the time. It was calculated that time in eastem Pennsylvania. Suit was here the child's chances of getting the disease brought against the Federal government on the naturally from this virus in the community at theory of the negligence of Federal regulators the time was about 1 in 3,000. The risk from in certifying and releasing for sale a batch of the vaccine, based on all reported statistically vaccine which was defective in terms of compatible cases, was by then down to an neurovirulence exceeding the reference strain in estimated I per 5.8 million doses of the Type I violation of the governmental agency's own strain. These facts concerning risk were not in regulations. Action was again in a Federal trial dispute. court before a judge sitting without a jury, and A Federal trial court with a jury found that again the judge plunged into these deep and the child's polio was caused by the vaccine, treacherous technical waters and came up despite overwhelming expert testimony at the agreeing in full vwth the plaintiffs evidence. A trial by leading epidemiologists and virologists very sizeable verdict in seven figures was and government regulatory authorities that this rendered and was upheld by the Third Circuit was extremely unlikely. The plaintiffs only Court of Appeals (4). The Federal government rebuttal to this evidence came from the general decided to pay the award and did not appeal medical practitioner who treated the child only further to the Supreme Court of the United after the disease was full blown. Damages were States. awarded of $200,000. On review, a Federal Court of Appeals affirmed the decision largely on the basis of the Davis case that the Inherent risks and relative risks manufacturer should have warned the eventual The next case in our chain returns again to consumer of the inherent risk of the product, manufacturer's liability and was perhaps the then nearly six times more remote than in the most fiercely contested of all the cases in this Davis case (5). (The upper court itself called the series. It was an aftermath of the Davis case and risk "miniscule.") Influence of the Courts of Law on Biologicals Development, Regulation. and Use 57

The manufacturer was joined in the appeal instead of the Sabin product. The Court ruled of this case by two important groups offering that the failure to warn created a rebuttable amicus curiae briefs; the American Academy of presumption that if the parent had been Pediatrics (AAP), representing private warned, the Wyeth product would not have practicing physicians, and the Conference of been taken. Last, the Court concluded that State and Territorial Epidemiologists (CSTE), there was a policy factor involved in the case representing the public health community. All which it said the amici briefs had overlooked: argued that this case was quite different from This was that, in the event of such injuries or Davis, even if the Court were to follow that diseases, and in the absence of a case, in that the vaccine was admimstered to "comprehensive scheme of social insurance," the Reyes child in a medical clinic by medical the allocation of risk of loss should fall on the personnel, not in a mass distribution campaign; manufacturer. A petition for review of the under conditions where the drug company was decision under certiorari was made to the not involved in the distribution as it was in Supreme Court by the defendant and both Davis; and where it could not even know the amici, but was denied. circumstances under which the vaccine was Thus we come full circle. The rationale of used. The AAP indicated that the situation was the Reyes case in 1974 was the same as that of not different ftom a busy pediatrician's office the Cutter case, the first in the chain 14 years and that it was not medical custom to give earlier: Personal injury losses should be traced parents warnings of these extremely slight risks back to the manufacturer who has the capacity in so beneficial a vaccine as Wyeth's. The CSTE to "allocate the risk" through private insurance pointed out that a reasoned medical and public and the price of the commodity. All the rest of health judgment was made by public health the analysis, the considerations of medical authorities not to give this warning, despite the judgment, and the state of the science of Davis case, in the face of an on-going epidemic immunization, were largely beside the point. situation where the relative risk of contacting Someone should pay for this innocent child's polio in the community was so much, much grievous loss. a life of paralysis If there is no greater. govemmental social plan to take care of it, then The Court of Appeals took some time to the manufacturer should be made to pay. issue a decision, but when it did, the 3-judge To demonstrate the vagaries of the American bench was unanimous in its affirmation. It courts, however, a state court, the Oklahoma asserted it was bound by the finding of fact of Supreme Court. in the same year said it was for the jury that the chlld's disease was caused by the trial jury to decide whether the plaintiff the vaccine. In commenting on the weight of would have taken the same type of vaccine if the evidence, the Court referred to Wyeth's told of the risk, since the existence of an "parade of experts" as being "somewhat epidemic, as in Reyes, which changed the persuasive," but went on to say that the relative risk to favor the taking of the vaccine contrary opinion of the child's treating general was enough to rebut the presumption of refusal practitioner was "substantial and at least as which the Reyes case allowed to stand (6). persuasive, looking at the record coldly." On the merits of the case under product International significance of the cases liability law, the Court found that the failure to These are the American cases to date. Do wam was itself a "defect" in the product and, they represent an anomalous situation, a "without more," rendered the vaccine peculiarity of the compensation system in use "unreasonably dangerous as marketed." The at the present time? I rather doubt it. The Court felt that there was another choice for the principles laid down, if not their specific child here, according to the testimony of the application, are not unique to Amencan law. general practitioner: It was to take Salk vaccine Any nation, or group of nations, adopting a 58 W. J. Cuman products liability code is apt to adopt or move even the small world before them in the case at toward a strict liability or warranty rule for hand. manufacturers, if for no other reason than to For example, in some of these American avoid huge diffliu}ties in proof of actual cases, the courts seized upon the failure to wam negligent manufacture in thousands of of very remote risks as a basis for making a marketed products. I understand that the financial award. But these decisions do not European Coimnon Market is currently mean that a similar result would not have been considering a products liability law which could reached even if a warning were given. Another well contain some of these principles. I must basis of liability might well have been found. admit, however, that reaching as far and wide as Thus, the public health authorities should-not the American cases in finding products such as base their own decisions about public warnings the Sabin vaccine to be "unreasonably solely on the grounds of avoiding liability for dangerous" might take as complex a line of adverse reactions. These decisions should be decisions as I have described, or might not made in the best interests of the people being happen at all, particularly if the wording of the served and in the interests of the protection of relevant statute precluded interpreting extrinsic the community. Conversely, a public factors such as failure to warn as coming within compensation system could well allow for the statutory definition of "defective financial awards to persons suffering adverse manufacture." Nevertheless, it does not seem to reactions to vaccines, even though they were me out of the question for any independent warned of the risk. The compensation system court system of any nation to declare a product may well be designed to encourage people to dangerous as long as there is any inherent rins receive the vaccine despite the known risk. The provable as remaining in the product and rationale of compensation in such cases is based capable of causing so tragic and catastrophic a at least in part on the fact that the community personal injury as can be the result of paralytic has benefitted from vaccination along with the poliomyelitis. individual. My next point: In the Common Law system THE USE OF THE COURTS RECONSIDERED at least, the courts are not at their best in I would like to make some fairly general considering and weighing highly specialized observations about the use of the courts, the scientific and medical matters. We apply the influence of the courts, in the field of adversary approach to all litigation. Science, as biologicals. all other matters, is before the court only to the Law courts are not the best legal vehicle for extent that the opposing parties accurately or laying down general rules of conduct of a inaccurately display it. detailed, or even a semi-detailed, nature in a Only such a rationale as this can explain the scientific field so complex and ever-changing, Reyes case, for example, where the whole ever-evolving, as the development of biological battery of scientific and medical experts, plus products for the prevention of disease. The the govemmental authorities involved, were all courts, in personal injury cases at least, deal ranged on one side and were found by the with specific instances, not generalities, and appellate court judges to be at least balanced, most judges try to limit the implications of mind you, by one general practitioner from a their decisions Within fairly narrow confines. small town on the Mexican border. I submit The courts seek to do justice as between that the general practitioner wasn't remotely litigating parties. They are often unable to qualified to give an opinion on the cause of the measure the generalized effects of their child's illness, especially when he picked, not a "allocation of risk" as between the parties. nice, simple etiology which he might at least Most judges do not try to remake the world, have dealt with in a lifetime of family medicine, Influence of the Courts of Law on Biologicals Development, Regulation, and Use 59 but a "cause" based in virology, vaccine convenient) experts and the well-respected production, and worldwide epidemiology to academic institutes of legal mnedicine are quite which he had never been exposed. In addition capable of providing theiT local courts with to this testimony on this issue, he was able to unbiased and quite reliable evaluations. In get into the record the "reasonable altemative" highly specialized. advanced areas of science of taking Salk vaccine. This evidence was very where the very state of knowledge is not very influential with the upper court, as we have great and not very settled (i.e., generally agreed pointed out. Yet, in terms of the real world upon), I would suggest that the Civil Law outside the courtroom, it was highly suspect. systems also would have their difficulties The Salk vaccine was hardly available in Texas, arriving at the "correct decision." Advocacy or anywhere else in the United States at that can have its uses, even in science. It was Charles time. It was not in general use by pediatricians. Darwin who observed, "How odd it is that Public health authorities were distributing only anyone should not see that all observation must live vaccine to both practitioners and public be for or against some view if it is to be of any health programs. The comparative safety of the service (7). Sabin and Salk vaccines was not otherwise made an issue in the case, although the general STATUTORY ALTERNATIVES practitioner certainly gave the impression that the Salk vaccine was safer than Sabin. Compensation plans In the Common Law system, the above There are other ways of handling claims for results are often explaned by the suspicion of compensation than directly through the courts the judges and many juries of all "expert against manufacturers. A few nations of the opinion." It is feared that such witnesses may world have installed public compensation plans be arrayed in court by a party to the litigation, which replace or supplement the court action not because of the merits of the case but against the manufacturers or against because the testimony was privately sought and government-operated laboratories. At present paid for by the party. these are Denmark. Hungary. Japan, Monaco, Switzerland. and dile Federal Republic of Ger- The continental Civil Law systems many. These special laws apply to compulsory The European Continent systems of justice, immunization programs and, in some, to those and those Civil Law systems close to them "reconmmended" by public authorities. (such as in South America). based more on The Danish law, for example, covers Roman Law than the Common Law has been, smallpox. diphtheria, whooping cough, take evidence in a different manner. It is less poliomyelitis. tuberculosis, and tetanus, if the adversary, at least in form. The courts rely latter is given with one of the other vaccines, as more on depositions from experts. rather than it usually is (8) The Japanese law is also broad courtroom testimony. and the experts are often in scope and covers the usual vaccinations plus drawn from neutral sources appointed by the tuberculosis and intluenza (9). courts themselves or by other governmental The rationale behind these laws is quite bodies. These systems may well avoid some of clear. They are intended to provide public the problems with scientific issues which plague compensation in programs which benefit the the Common Law courts. community as well as individuals. Therefore, I would suggest, however, that the Civil Law the community owes an obligation to the system probably works best for expert opinion injured person. This obligation is strongest evidence in fairly traditional areas of science, when the person has no choice but to receive technology, medicine. and commerce where the the vaccine. It is perhaps somewhat weaker average court-appointed (and geographically when the immunization is only 60 W. J. Cumran

"recommended," but the community-beneflt whether these compensation systems are argument remains the strongest support for the intended as exclusive legal remedies. The Swiss programs. Federal statute provides that the cantons are The methods and amounts of compensation required to pay for the loss only where it is not actually awarded are vaguely worded in these "otherwise covered." The implication of this statutes which are often brief in content. The language, confirmed to me by a lawyer for a compensation scheme is not specially designed Swiss drug firm, is that legal action is still for these prograns but is generally attached to available against the manufacturer and also other social insurance systems, such as military under other cantonal social welfare programs. service pensions, employment compensation, or The other statutes I have read for the Federal social pensions. In Switzerland, payment is the Republic of Germany, Hungary, and Denmark responsibility of the cantons and the methods are silent on this issue. At the Monaco meeting, and amounts of the payment are not spelled Danish speakers and speakers from the Federal out in the Federal law (10). Republic of Germany observed that the plans in This cross-reference method of their countries were exclusive and that actions compensation can cause difficulties in could not be brought against the manufacturer. application to specific cases and may be In countries where the biological products are questionable in its benefit structure. manufactured and supplied by governzment particularly when the injured person is a young bodies, such as in Deninark and Hungary in this child, as is so often the case in immunization group, there may be limitations or complete programs. The "borrowed" compensation bars to civil law suits for damages against such systems are intended primarily to benefit adults bodies. The existance of special compensation in employment, in military service, or at older legislation for immunization programs in such ages in pension plans. The result may be that no countries may imply exclusivity of legal remedy payments at all, even for medical expenses, are against the government where no such implica- paid to the child victim or his parents. The tion necessarily arises when the product is pn- family is thus dependent upon other available vately manufactured and sold. medical and social benefit systems in these Problems of proof of causal relationship can countries. These may or may not be adequate occur under any of these laws. The basic to meet the family's needs at the time of a intention of all of the programs is to provide severe illness and hospitalization of an infant. compensation, however, so that the benefit of One can hope that social and medical the doubt may be expected to be exercised in counselling is given to these families when the favour of the applicant. This is most apt to public agency deals with these cases. The occur- when the program is administered by a emotional trauma could be very great. One can social welfare agency. However, we would imagine the feeling of the family when they imagine that these agencies act under medical receive a letter from the social insurance agency advice in each claim for compensation. The concluding that their child's severe illness was statutes by their language do seem to encourage (reasonably or probably) caused by a vaccine, some leniancy in applying strict rules of with the same letter saying no benefits would scientifi'c causation. The Danish statute allows be paid unless and until the child reaches 15, compensation for cases "reasonably" thought 18, or 21 years of age, depending on the to be causally related to an immunization. Mr. applicable law. It is certainly better than Schumacher indicated at the Monaco Meeting receiving nothing, but a personalized handling that the law ofthe Federal Republic ofGennany of each report, since the volume of cases in all required only a "probability" of causal relation. countries is very snall, seems highly desirable. He also said that where the only reason for not Another matter requiring clarification is being found probably related is uncertainty in Influence of the Cousts of Law on Biologcals Development, Regulation, and Use 61 the state of medical science, the program can providing awards to people, even under a nevertheless award compensation (11). Under program so apparently limited in scope as the Danish law, disputes over compensation immunization compensation. could formerly have been refefred to the Danish Two of the statutes deny compensation if Council of Forensic Medicine, a national body the recipient contributed to his injury or of impartial experts available to answer techni- disease by his own fault. The Swiss law asserts,, cal medical questions for the courts. At present, "The obliption to grant compensation there is an administrative tribunal to which shall be waived or shall diminish should the vaccinated person have caused or appeals can be made from decisions ofthe social intensified the lesion by a flagant welfare agency handling these claims. error (12)." An interesting case of causation handled The Hungarian law provides, under the Danish law was described to me on a 'The State shall not be required to pay recent trip to D)enmark. An adult claimant compensation if the injury resulted from suffered pain in a shoulder some time after the behaviour of the person. Partial receiving a BCG vaccination at her place of compensation shall be paid if only part of the injury is attributable to the work. The vaccination was suggested by her behaviour of the injured person (13)." employer because of some increased danger of Neither of the above laws spells out what tuberculosis in the business activity. At first a behavior would be detrimental to the claim for employment disability compensation individual's claim. At least, in most legal was made, but it was referred to the systems, court review would be necessary to immunization compensation plan. The claim provide an authorized interpretation of such was originally denied as not causally related to provisions in cases of dispute. the BCG vaccination. It was reheard and a consultation was sought by the agency from Some indirect objectives two neurologists, both of whom concluded that The above special laws could be said to the pain, alleged to be in both shoulders, was accomplish some indirect objectives beyond the not caused by the BCG. The claimant was obvious one of providing a relatively secure nevertheless compensated to the extent of 5 per means of providing at least some basic level of cent disability on the basis that she was now compensation to victims of adverse reactions to suffering a traumatic neurosis which reasonably immunizations. I propose to describe some of could have been caused or precipitated by the these briefly as I see them. immunization. However, the plan made an First, these statutes remove the law courts award only of the excess over regular from the need-and the opportunity-of setting employment insurance disability, since the broad policy, or restricting it, in regard to disability was found work-related due to the public inmunization goals. fact that the employer suggested the Second, these statutes tend to remove vaccination. The remainder of the 5 per cent instances of personal injury due to adverse disability payment would be received from the reactions to immunizations from the public employment compensation system. (The excess view via the public courtrooms where news is from the fact that the immunization media may exaggerate their number and compensation plan uses the payment schedule significance and may unnecessarily alarm the for military service disabilities, which pays public about the risks of the procedures. slightly higher benefits than the employment insurance compensation scheme.) I understand protection ftom vexatious lawsuits against that this case is now on appeal by the claimant. physicians and scientists and other public This type of case illustrates the ingenuity of the health personnel involved in the immunization officials operating social insurance systems in programs or in private medical practice. 62 W. J. Curia

Fourth, these statutes may provide legal Federal Government to take control of any protection from compensation actions against negotiation or litigation of a claim and would the private pharmaceutical concerns authorize informal settlements where the claim manufacturing biological products in various is legtimate and is found reasonably causally countries, thus encouraging these companies to related. This system does have the advantage of stay in the business, currently not a very highly compensating parents of young children at the profitable area for private enterprise, or for time of their greatest need in a lump-sum private research efforts. arrangement. It can be hoped that the Fifth, these statutes remove from the Government will also direct the family to scientists and public health authorities the need adequate and appropriate medical service and to handle such claims by placing them in a counselling. social agency. The advantage to the scientific group is that they don't necessarily have to spend time and effort exploring these claims. PUBLIC WARNINGS AND DEGREES The benefit for the claimants is that the social OF PRODUCT SAFETY agencies probably apply less stringent tests of It should be noted that none of the laws causal relationship than would the scientists cited above requires warings of inherent risk, and public health personnel. In regard to this or relative risk, in immunization products latter point, care should be taken that the covered under the compensation plans. Perhaps awarding and denial of claims under these plans this is to be expected where the immunization should not influence the public health programs themselves are compulsory. Is the authorities in their own assignment of causal same rationale available where the relation in tabulating adverse reactions. A immunizations are only "recommended by separate system of reporting should be used for official authorities," or where the products are these purposes. distributed free of charge, or are obtained in I do not mean to say that I agree with these private drug stores or chemist shops, as they are objectives. However, all of them have the in some countries of Europe? (They are in potential for being achieved through these Switzerland, which has a compensation plans. I do not know whether these objectives statute.) were present at the time of the passage of these We may also ask if any public warnings, laws in the various nations, although I have whether by package inserts given to consumers, heard many of them discussed informally in or in advertising, are at all feasible in the field these countries. of immunization where the consumers are not sick and do not derive immediate benefit from American efforts in this direction the product. Also, will not "oversell" of the At the present time, the U.S. Government is merits of the product become a clear danger considering propdsals made to it for a here, since we must expect the "relative risk" compensation plan for persons suffering adverse theory to allow not only an extolling of the reactions to polio vaccines inspected by the product's inherent quality, but possibly U.S. Govemment and manufactured under exaggerated pictures of the natural dangers of Federal standards. Because the U.S. does not remaining unimmunized? have a comprehensive social insurance system It is entirely clear, of course, that readily adaptable to cover this area, the plan manufacturers should be required to provide may take the form of an indemnification to full information to health authorities and manufacturers for their actual out-of-pocket physicians of side-effects and contraindications losses due to costs of litigation, settlements, or and other inherent risks of the vaccine. It is court awards. The proposal would allow the realized that the defi'nition of these "risks" is Influence of the Courts of Law on Biologcals Development, Regulation, and Use 63 very problematical. Adverse reactions are restriction and some degree of danger to the usually associated with a biological product on individual (1 7). a time-compatibility basis, or through some All of the above factors seem to me to argue examinations, in relation to doses distributed. that for all immunization programs where Dr. I. Jo6 of the Hungarian Institute for public warnings are not feasible, or where the Serobacteriological Production and Research programs are compulsory or highly discussed this subject at the Monaco meeting recommended and sponsored by the public and advised a great deal of caution in dealing authorities, the safety of the vaccine should be with these questions (14). Dr. Stones of Pfizer, very great before marketing and distribution is Ltd., agreed that warnings should be given to allowed. Only under these conditions would it local health authorities and to physicians, but seem to me that public health authorities would he felt that direct warmngs to recipients and be morally and ethically justified in urging their parents or guardians were ridiculous and use on a wide scale with public distribution. impractical. He pointed out that health The trouble with this position, of course, is authorities might be urging the population to that it can be taken to require "zero risk" in a be immunized in an epidemic situation while product-a virtual impossibility. In the United the individual was being "bombarded by States, the series of vaccine cases herein messages from the manufacturer warning of the reviewed could be taken to mean just this. risk involved (I5)." Certainly some United States Congressmen in One of the reasons for the policy against their public statements to the mass media and requiring wamings from manufacturers to the in their attacks upon our Food and Drug recipient in the United States of America has Administration seem to display the attitude been the law and practice of not allowing direct that "zero risk" should be required on all foods advertising of prescription drugs to consumers. and drugs approved by the Federal govermment. A case is now before the United States Supreme Court challenging this law. The United States IMPLICATIONS FOR RESEARCH District Court for Eastem Virginia has found IN BIOLOGICALS the Virginia law prohibiting such advertising to be unconstitutional as a violation of the Most of what has been said above does not citizen's "right to know" under the First relate directly to research m the development Amendment to the Constitution (16). If this of biological products, an important focus of case is upheld, can we not say that the citizen is this meeting. However, I do believe that some also entitled to know of inherent risks in the of the legal pnnciples do apply to research products sold or distributed? efforts. For examnple, any requirement of a very I would like to return again to the subject of high level of safety for mass-distribution safety of biological products. Where an immunization agents (for diseases affecting immunization program is compulsory, a public large numbers) must have its effects on the judgment must be made that any individual risk testing of products and upon licensing for the in the taking of the agent is outweighted first market. In actuality, this very high level of by the potential personal benefit obtained in safety is already required by the drug and the vast majority of cases and by the clear biologicals licensing agencies of many, if not community benefit of widespread most, countries. However, there are weaknesses immunization. The early American cases in the in the testing and licensing systems in some first years of the nineteenth century upheld the countries, caused in part, I fear, by other moral constitutionality of compulsory smallpox and ethical restrictions (now made legal) vaccination on the grounds of the need for concerning testing on prepant women and on general community protection which justified children. I do hope that this Conference will 64 W. J. Curran address these difficult issues, not only in regard products liability, in compensation plans, or in to their ethical justification, but in regard to the morality, ethics, and law of clinical their effects upbn the eventual safety of investigation in man. The measurement of marketed vaccines. individual risk-benefit ratios which apply to The special compensation statutes discussed these matters in other situations don't apply earlier do not include adverse reactions to here. For example, people taking vaccines are vaccines administered in clinical trials. It seems rarely ever sick, not only sick from the disease to me that they ought to be expanded to related to the immunization, but Ill at all. (Most include at least the ulpge community field trials immunization programs advise against giving of vaccines at that stage in their development. polio vaccine to people with upper respiratory The reasons for doing so would be quite similar infections, or otherwise ill with colds, and so to those described above for marketed on.) Furthermore, due to the reduction of the products. natural risk in the community, the more It would not seem advisable, however, to successful the immunization program, the allow the existence of such special greater the relative risk of the vaccine to the compensation plans to excuse investigators next group of recipients. But if this fact is from informing subjects of field trials of allowed to have an effect, and people can vaccines concenming known or reasonably refuse, what happens to "herd immunity?" suspected significant risks of the tested agent. Won't the dangers of the disease climb right Providing compensation even though the back up again? Why should the later recipients subjects were aware of the risks and accepted be able to refuse when the first recipients did them in the experimental situation would seem take the vaccine for everyone's benefit? The to me to be justified, nevertheless, because the chuldren of these first recipients will be subjects in such a study would be volunteering endangered by the "maverick few" who refuse to engage in a study of general community (an American phrase used in some smallpox benefit-a situation not as clearly applicable to cases) until the first recipients get their children other types of clinical trils where the person in for their immunizations. himself may well be benefited concering his The modem consumer movement in own fllness, or where the public benefit Is quite America, and in Western Europe at least, is limited. essentially dedicated to individual rights, not to Support for the general idea of providing coznmunity benefit or sacrifice. The idea of the no-fault compensation for any and all injunies government asking people to sacriflce for others of any and all research subjects is growing in is suspect-and rightly so-by many intelligent the United States, so that the above idea is not people. The current attack of consumer groups too far-fetched. and the mass media on human experimentation is an example of this phenomenon. I know COMMUNITY BENEFIT many people, including lawyers, who believe AND INDIVIDUAL RESPONSIBILITY that the very defmition of human experimentation in medicine always means that In these last sections of my paper there has no personal benefit can be expected by the been a recurrent theme which I would like to subjects in the study and that the prime articulate to some greater degree as a closing beneficiaries of most research are the careers of commentary. the investigators. Most of these people have There is something different about the field never been patients, or rarely have been, and of preventive medicine, about the dangers and have little or no education in science. There is a the benefits of Immunization agents, which is knowledge gap and a credibility gap between currently not well recognized in the law of science, including medical science, and a great Influence of the Courts of Law on Biologicals Development, Regulation, and Use 65 deal of the important "opinion-forners" of the 5. Reyes v. Wyeth Laboratories 498 F.2d 1264, modern world. One area that can be harmed 1974. most by this situation is preventive medicine 6. Cunningham v. Charles Pfizer Co., Inc.: 532 P.2d 1377 (Oklahoma Supreme Court, 1974). where personal benefit is most difficult to 7. Darwin, Charles: More Letters of Chades Darwn, prove and to sustain over years of time. Yet I Sir Francis Darwin, Ed., London: Butterworth, believe we must try. We all must do a betterjob 1903. of public education in science, and about the 8. Act of June 1972, Danish Laws; See also needs and relative risks of the Discussion in British Medical Journal, 1973, search for 1:794-795. knowledge in science, particularly the biological 9. Japanese Public Health Report No. 672, (Septem- sciences. This Conference can be an inportant ber 28, 1970); Cited in Curran, W.I. and Pies, step in that direction in regard to the need to H.E., Final Report, Contract No. 200-75-0413, develop public policy and professional Center for Disease Control, U.S. Public Health in human research in Service, June 1975. (Unpublished contract guidelines the field of research.) human immunology. 10. Fenille Federale, No 52, 31 December 1970, pp. 1630-1640. 11. International Symposium on Vaccination Against References Communicable Diseases, Proceedings, Symposia Series in Immunobiological Standardization, Vol. 1. Cal. Rptr. 320 (1960): Reprnted in Curran, W.J. 22, Basel: S. Karger, 1973, p. 338. and Shapiro, E.D., Law, Medicine & Forensic 12. Fenmlle Federale, No. 52, 31 December 1970, Science. Boston: Little, Brown & Co., 2nd Ed., Section 23 (3). 1970, pp. 722-728. 13. Laws of Hungary, No. II of 1972 on Health, 2. Davis v. Wyeth Laboratories 399 F.2d 121 (9th Magyar Kozlony, 29 April 1972, No. 34. Circuit, 1968): Reprmted in Curran and Shapiro, 14. Note I1, supra, pp. 333-3 34 Law, Medicine and Forensic Science, supra 15. Note I1, supra, p. 332. note 1, pp. 762-773. 16. Virginia State Bd. of Pharmacy v. Virginia 3. Tinnerholrn v. Parke-Davis & Co: 411 F.2d 48 Citizens Consumer Council, Inc.: 373, F. Supp. (2nd Circuit, 1969). 683. 1975 4. Griffm v. United States: 400 F.2d 1059 (3rd 17. See particularly Jacobson v. Massachusetts: 197, Circuit, 1974). U.S. 1I, 1905.