The Law of Vaccination - Toward Radical Reform

Stan Lippmann
University of Washington School of Law
Supervised Analytic Writing
June, 1998 www.rubella.net

Table of Contents:

Prologue

Part I.Introduction

Part II. The Development of 20th Century Vaccine Law

Part III. The Problem of Establishing Causality in Modern Vaccine Caselaw

Part IV Recommendations


Prologue

A basic question of justice is whether any harm can knowingly come to an innocent group member for the good of the group. As ILs, we were taught in our criminal law class of the case of the Regina v. Dudley & Stephens in which the castaways adrift in a lifeboat without food desire to and eat the cabin boy. [FN1] The majority resorts to the murder and ingestion of it's weakest member. When the party is rescued, the captain and mate are convicted of the murder. This case is included in the casebook to teach us that the very survival of the group is placed secondary in our system of justice to the principal of the sovereign rights of the individual to life. When faced with an imminent threat of death, human beings are pressed to the limits of their willingness to sacrifice themselves for the sake of another. Rationalizations begin to form about the inferiority of the intended victim. In the Open Boat case, the victim was seen as the weakest. Perhaps he was, but our system of justice requires an adjudicative process by an impartial jury because absent this process, it is impossible to determine the fitness of the survivors for society. The impression of this case is commonly one of incredulity: naturally, under such conditions the law of Social Darwinism will control, it is to be expected given our animal instincts for self-preservation. And the fact that the lifeboat represents its own microcosmic society calls into question the larger society's ability to judge the local justice carried out therein. A common inference drawn from this case becomes that the form of justice we are sworn to uphold being more than sand-blind, high gravel blind, knows reality not. The law students can picture themselves in a like situation and taking their chances for survival that they won't be the unlucky one who gets eaten. [refer to vail of ingorance]

The dictate against human sacrifice did not originate in Anglo-American jurisprudence. It is one of the cornerstones of Western civilization. In Greek Mythology, Agamemnon, the king of Mycenae and leader of the Greeks in the Trojan war is killed by his wife Clytaemnestra for the sacrifice of their daughter Iphigenia. He sacrificed his daughter to appease Aeolus, the wind god, so that his fleet could expedite the rescue of Helen. His fate indicates a rejection by our culture of human sacrifice. We normally classify human sacrifice as barbaric when there is a plausible motive for it, as in the case of the Open Boat, and as savage when the motive is to appease a Deity, which makes no sense to a modern thinker. We associate human sacrifice with primitive tribal culture in the jungles of Africa or the Amazon basin, untouched by the influence of Judeo-Christian morality. But insofar as Judaic morality is an authority in our culture today, the instruction of God to Abraham to not sacrifice Isaac represents a moral edict that we have nominally been following for millennia.

With such a clear moral standard in our religious, cultural, and legal traditions, how is it that we are sacrificing the lives of many American citizens every day under the auspices of the National Vaccine Program? The death toll acknowledged by the Program during the past 7 years is 1094, [FN2] and this excludes the death claims which fail under the strict legal rules for establishing causality. Former Food and Drug Administration Commissioner David Kessler said in 1993 that only about 1 percent of serious vaccine reactions are reported. [FN3] After two full years of speculation on this subject I have let myself believe that the serious adverse reaction rate is beween 1/3000 and 1/300, which would be from 333 to 3333 times more dangerous than the public health propaganda suggests. Suppose my worst case scenario is right and 36 babies a day are dying for the war machine. This would make women scared of having them in the first place if the odds of your government killing your child are such that 36 of his birthday perish each day. What odds are these? are they close to a hundred times the 1094 over seven years, over 100,000 dead babies. Lets take my independent worst case scenario of 36x365.25x7=92,043. So according to Dr. David Kessler, it's about as bad as I feared it might be. Assuming an an age cohort of 30 million, the odds of dying are 0.307%. or 1:326. Do we really lose 13,200 young children every year? According to the CDC SIDS deaths peaked in 1988 at 5476 out of 3.91 million live births yielding a mortality rate of 140.1 per 100,000. [FN4] It is reported that SIDS has recently shown a marked decline to a level not seen since 1980, falling to the third cause of death among post-neonatal children. If the other two are bigger, then there were more than 12,237 neonatal deaths in 1994. Also included is multi-year averaged deaths rate per month, seeming to asymptote at under 5 deaths per 100,000 per year after infancy, or 30 more deaths over six more years for a childhood death toll of about 15,000 small children lost each year. If vaccines were responsible for half of childhood deaths, this would correspond to a death to combined death-serious injury ratio of 7,500/109,400 or 1:14.6, using Kessler's estimate. The propaganda ratio at the extreme is 1,000,000:326 or about 3000:1. My Gestalt at the other extreme of likelyhood of vaccine injury is 3000:1, so perhaps three orders of magnitude or slightly higher to one is a fair estmate of the risk of serious adverse reaction to vaccination at about 1:1000, not the claimed 1:1,000,000 or even the marginally tolerable 1:250,000. It is clearly intolerable by at least two orders of magnitude.

The bulk of the vaccine injury in this century was in its latter half, coinciding with the post-war Cold War, beginning with the endorsement of the Committee on Infectious Diseases of the American Academy of Pediatrics in 1947 of the three-in-one DTP vaccine. [FN5]. Another major killer of the past half century is the rubella vaccine, which began life as a eugenics experiment in a Nazi germ warfare laboratory and was licensed for wholesale use in 1970 in this country. [FN6]

Although mandatory vaccination goes back into the nineteenth century and was upheld as constitutional by the U.S. Supreme Court in the 1905 Jacobson decision, it is under the motif of perpetual warfare: against Communism, Disease, Poverty, and Drugs; that whatever standards of medical ethics existed before have been thrown to the winds, perhaps to appease Aeolus? The problem with the War on Disease, as with any other type of war, is that the first victim is Truth. It is a postulate of war that one exaggerates one's successes and tries to bury ones failures. A further postulate is that the need for crash programs to develop new vaccines has stemmed from the need to obscure the fact that one of the prices of our proxy wars in Asia were epidemics of communicable diseases which were carried back home by our soldiers. The rationale for vaccination has always been that the alternative is worse: that more would die if the preventive measure of vaccination were not taken. Taken to its logical extreme, we today have the common opinion of medical doctors that to not have one's children vaccinated should be punished as a form of child abuse. [FN7] Yet recalling the Open Boat example, it is criminal to sacrifice the one for the sake of the many, no matter what the cost/benefit ratio is claimed to be. This type of utilitarian analysis is fundamentally against the Western cultural conception of justice.

How has this corruption of our ideal of justice as represented in the case of the Open Boat taken place? At the root of the problem lies the U.S. Constitution. The creation by the legislative of the coequal executive and judicial branches laid the foundation for the establishment of an aristocratic class. This encouraged the division of society into a hierarchical system which depended on experts whose authority had to be taken as given. In particular, the rise of the status of medical doctors in America was acknowledged through the acceptance by the U.S. Supreme Court of the doctrine of "high medical authority". [FN8] In Jacobson and its progeny, the doctrine of high medical authority is used to preclude new countervailing medical evidence, and thus presents the root of the problem of obtaining private justice in the modern Vaccine Court, i.e. the legal establishment of causation of the vaccine as the source of the injury or death. To really address the root of our problems as a society we need to reconsider our form of government. But it is a long term project to convince enough people that the United States Constitution is fundamentally immoral and illegitimate. In the absence of more practical legal tactics, the Vaccine Program will continue to maim and kill masses of people, mostly but not all of them children. Thus the purpose of this paper is not to directly cause the collapse of the United States Federal Government. Here it will be enough to demonstrate some of the flaws in the law and flaws in the utilitarian medical analysis of costs and benefits of the Vaccine Program, in the hope that a more rational vaccine policy than the one we have at present could be accepted by high medical authority.

We are not in an Open Boat. We are not all about to die immediately if we change vaccine policy. We have other ways of preventing epidemics, such as not having our armed forces roving the planet, not having a virtually open border with Mexico, and not mass institutionalizing our infants and children. And we have highly developed techniques for treating illnesses when epidemics do break out which have not historically existed. And we need to turn away from the activist approach toward health typified by American medical practice, toward a more respectful attitude toward the will of the patients.

The bulk of this paper adopts a utilitarian approach to the vaccine dilemma we face. The first steps on the path toward healing the wounds is to present a reasoned argument that doctors and lawyers could accept. All they must do is consider evidence that benefits of the National Vaccination Program are exaggerated by an unknown amount, and that the costs are underestimated by a factor of somewhere between 300 to 3000. From the legal point of view, the manifest injustice of the current system of compensation leads to recommendations for legislative reform. Increased visibility and success rates for vaccine injury cases would raise more public awareness of the threat posed by vaccines, and would someday lead the Supreme Court to overturn mandatory vaccination laws as violative of human rights to life and liberty. This would lead to the possibility of a fair assessment of relative morbidity and mortality of those who voluntarily choose vaccination to those who decline vaccination. This would then lead to profound revulsion at how sadly mistaken high medical authority has been, which in turn might cause enough general doubt about the U.S. Federal Government for the people to call a constitutional convention to establish a replacement.

Part I - Introduction

In reviewing the legal, medical, and popular literature on the subject of vaccination one finds near universal agreement that in the balance, the world is a better place with the practice of vaccination than without it. Universally, in all the legal and legislative materials I have seen, it is announced at the outset that vaccination has been a good thing for the public health. For example, the two most recent comprehensive law review articles which analyze the National Vaccine Injury Compensation Program (NVICP) [FN9] begin with such declarations. In Striking a Balance Between Product Availability and Product Safety: Lessons From the Vaccine Act [FN10] author Daniel A. Cantor quotes the House Report which was the basis for the establishment of the NVICP:

During the twentieth century, America has developed a childhood immunization program that many praise as the most spectacular public health success in history. [FN11] In Note: Is This The Best We Can Do For Our Children? [FN12] author Lisa Steel acceptingly cites the leading Jacobson case which established the constitutionality of mandatory vaccination under the police power of the states:

The constitutionality of required immunization is well established. [FN13] Such an infringement on individual liberty is justified because immunization programs benefit all of society by decreasing the number of carriers of diseases and eventually eradicating certain viruses. [FN14] Even in a democracy such as ours, the government must ensure that the welfare of society is not jeopardized for the comfort of a few; this principle applies to the public benefit provided by mass immunization programs. [FN15]

Even Barbara Loe Fisher, who co-founded the National Vaccine Information Center (NVIC) as a resource center for parents whose children have been injured or killed by vaccines after her son suffered brain damage from a DPT shot [FN16], has not taken an anti-vaccinationist position, but merely urges that vaccination be voluntary with informed consent. [FN17] Yet, even though Ms. Fisher is generally considered a legitimate player within the system, she has recently been demonized in the New Republic magazine by Arthur Allen by being lumped together with an outright anti-vaccinationists such as Dr. Len Horowitz [FN18]. The cover of the March 23, 1998 issue of the magazine shows a girl from the back and a doctor's hands; one hand holds out the girl's arm and in the other holds a syringe which points to her arm. The caption reads "This Won't Hurt a Bit ... So Why Are Conspiracy Theorists Attacking Childhood Vaccinations?" The article begins:

President Clinton's ongoing initiative to immunize every American child against infectious disease seems like the kind of safe-as-milk, baby-step health policy that everyone should love. The ultimate motherhood issue. But Clinton, presumably, didn't consult Len Horowitz. A former dentist-turned-"healthcare motivational speaker," Horowitz is carving out a new niche in the history of the paranoid style in American politics. His message: The AIDS and Ebola epidemics resulted from the contamination-- possibly intentional--of common vaccines by the military-medico-industrial complex. The Rockefeller Foundation, the Centers for Disease Control, famed AIDS researcher Dr. Robert Gallo, and--yes--Henry Kissinger all figure in Horowitz's gallery of germ-warfare conspirators. Horowitz, who apparently honed his expertise on such matters by drilling teeth in Gloucester, Massachusetts, has urged the government to stop immunizing children until independent researchers can determine if the shots are spreading disease. The article goes on to explain that although there have been 63,000 adverse reactions, including 1094 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) [FN19] over the past seven years, it still may be that all of these events may be purely coincidental and that there is still no proof of the danger of vaccination.

Most of the legal commentary acknowledges that the NVICP has failed in being what Congress intended as a generous, non-adversarial system [FN20]. The difference between the present and previous commentary is that whereas within the academic legal community there is a feeling that the overall awarded damages should be perhaps 5 times what they are at present, this author will try to demonstrate below that they should be roughly 1000 times what they are at present, consistent with the belief that the risks of damage associated with vaccines have been underestimated by roughly a factor of 1000. The annual payout from the NVICP is about $110 million a year. A payout of $110 billion a year is feasible if we adjust our current budget priorities. For example, we could take this entire amount from the defense budget, and still surpass military spending by any other nation on earth. And it would be a small payout to actual victims compared to the largely redistributionary Social Security and Medicare programs. It would involve expanding the Table Injury categories [FN21], which spells out when there is a presumption of vaccine injury, to basically include the diagnosis of any chronic illness, including allergies, within two years of the receipt of any vaccination.

Changes to the table of this magnitude would obviously need to be made with a Congressional vote, so to achieve such an outcome will require a serious public awareness campaign. Yet at the margins of the program, the same thorny problem of causality for injuries which will fall outside of the table will remain. Conventional commentary [FN22] holds causality to be the main problem responsible for the failure of a majority of worthy claims. This central problem to practice in this area of law is discussed in part III. Part II presents the doctrine of Vaccine Law in order to properly inform the subsequent legal analysis of the causality problem.

Part II - The Development of 20th Century Vaccine Law

A. From Jacobson to Whitecotton

The leading case in the area of vaccine law is Jacobson v. Massachusetts in which a local mandatory smallpox vaccination law was upheld under the police power applied to public health. [FN23] It is noteworthy that the famous Lochner v. New York case was decided differently during the following term. [FN24]. In Lochner, the police power of the state to promote public health was denied when it attempted to set limits on hours worked in New York bakeries. The Court ruled this to be an impermissible interference with the right of contract between the bakers and the bakery owners. An essential difference between the cases is that in Jacobson, he was required by law to be acted upon, whereas in Lochner the bakers were forbidden by law from doing something. The court is placing greater weight with freedom to act than in freedom to refrain from acting. This is a slim distinction, since freedom to refrain from acting really is a form of freedom to act in accord with one's wishes. A more realistic differentiation which renders the two decisions intelligible with reference to one another is that in both cases, the commercial interests prevailed, that the economic activity, whether baking or injecting, was furthered by the decision. Implicit in both of the Court's decisions is the belief that baking and being injected with smallpox are risks too small about which to be overly concerned. Indeed, a large portion of the Jacobson case concerns itself with just this question of costs v. benefits of vaccination, and as such it set many of the standards for what are permissible demonstrations of the costs and benefits.

In Jacobson, the Revised Laws of the Commonwealth provided that 'the board of health of a city or town, if, in its opinion, it is necessary for the public health or safety, shall require and enforce the vaccination and revaccination of all the inhabitants thereof, and shall provide them with the means of free vaccination. Whoever, being over twenty-one years of age and not under guardianship, refuses or neglects to comply with such requirement shall forfeit $5.' [FN25] Jacobson is obviously arguing on principal, not over the size of the fine but his right to life and liberty. As it happened, he and his son had had the direct experience of having already been seriously injured by previous smallpox injections. An exception was made in favor of 'children who present a certificate, signed by a registered physician, that they are unfit subjects for vaccination.' [FN26] From this limited exception we already see the illogic of setting fixed sets of rules. Why should an unfit 17 year old automatically become a fit 18 year old.

In fact the risk of serious adverse events at least in some vaccines increases with age. For example, it was established over a quarter century ago that there is a large increase in the development of arthralgia and fibromyalgia following rubella-containing vaccination of roughly an order of magnitude. [FN27] A review of 124 such claims to the vaccine court also showed an order of magnitude increase in the number of such claims filed associated with adult versus child rubella immunization. [FN28] At a recent meeting of the Advisory Committee on Childhood Vaccines, established under the Vaccine Act of 1986, as a source of non-binding advice for the Secretary of HHS, in regard to a question about whether straight measles or MMR should be used in the newly instituted college vaccination programs, Dr. Stephen Hadler, chief epidemiologist for the CDC, stated 'there was a higher incidence of acute arthritis at 18 [than as a child], but far less than the 20 to 25 years of age'. [FN29] Nonetheless the University of Washington's policy, based on advice from the CDC, is irrational in that it sets a age requirement that is fixed by year born after 1957, meaning that each year it becomes a riskier policy, which now includes entering students over 40, which is twice the acknowledged unsafe age.

The reason that the policy was set at 1957 is because it is presumed that those born earlier were exposed to natural measles and thus are presumed to be immune, whereas those born later were probably vaccinated, and since it turns out that the vaccine-induced immunity is temporary compared to the permanent immunity conferred by the natural disease, a "booster shot" is needed for everyone under 41. A problem here is that the claimed need for a measles booster can be had for colleges for free or at negative cost only if it is in the form of the so called 'preferred vaccine', MMR, which is known to be unsafe, untested, and unapproved for use by the FDA because of the arthropathic tendencies of the R component. In truth, enormous monetary waste goes into the program by giving MMR when only the measles is needed since the manufacturer receives about $12 for an measles shot and $36 for an MMR. When the University of Washington immunization program was set up, no consideration at all was given to the known possibilities of vaccine injury, so in effect potentially deadly rubella vaccine is currently being injected into every student who cannot demonstrate two prior measles shots, for no public health reason at all, but simply to save the University $12 for a straight measles shot and let the federal taxpayer pay $36. The point of this digression is that we can see as early as in the Jacobson case how thoughtless and harmful an overly broad public health measure can turn out to be.

Jacobson defended his refusal on three separate grounds. He claimed that the particular section of the statute of Massachusetts in question [FN30] was in derogation of rights secured by the preamble of the Constitution of the United States; that one of the declared objects of the Constitution was to secure the blessings of liberty to all under the sovereign jurisdiction and authority of the United States, no power can be exerted to that end by the United States, unless, apart from the preamble, it be found in the body of the Constitution. Knowing from his own experience that he would place his own life in jeopardy by obeying, he knew he was in the Open Boat dilemma. But the Supreme Court declined to give credence to his assertion. The court also passed without discussion the suggestion that the statute is opposed to the spirit of the Constitution. Was the spirit of the Constitution, as argued by the Federalist Papers to protect the minority from the democratic majority? In historical realty protection of minority rights began as protecting the property owners, who are the minority. Since the modern civil rights movement, the idea of the protection of minorities has been reinterpreted to extend protected status to blacks, Hispanics, and women. It is yet to consider the special protection for genetic minorities, who are more real than racial minorities in a biologic sense. As will be discussed below, the susceptibility to harm from the rubella virus seems to be related to the presence of certain genes in the individual. [FN31] But in 1905, the Court, finding no violation of the Constitutional spirit apparent to it, quoted an earlier case in answer, "Undoubtedly, as observed by Chief Justice Marshall, speaking for the court in Sturges v. Crowninshield, 'the spirit of an instrument, especially of a constitution, is to be respected not less than its letter; yet the spirit is to be collected chiefly from its words.' [FN32] We have no need in this case to go beyond the plain, obvious meaning of the words in those provisions of the Constitution which, it is contended, must control our decision." Jacobson also defends his action under the due process clause of the 14th amendment. The Court does not answer this defense meaningfully either.

The Court then proceeds to consider Jacobson's offers of proof why he should not be compelled to take the smallpox vaccine. The Court found that the ninth of his propositions which he offered to prove, as to what vaccination consists of, was nothing more than a fact of common knowledge, upon which the statute is founded, and proof of it was unnecessary and immaterial. The court here demonstrates how a little knowledge is a dangerous thing. It is still to this day not a clear what vaccine is made of. It is highly secretive business; in the case of the polio vaccine, it has turned out to have been contaminated with SV40 monkey virus. [FN33] And it can be reasonably inferred that there are other as yet undiscovered organisms grown in the petri dish in the laboratory.

The court then considers Jacobson's thirteenth and fourteenth offers of proof involved matters depending upon his personal opinion, which could not be taken as correct, or given effect, merely because he made it a ground of refusal to comply with the requirement. Moreover, his views could not affect the validity of the statute, nor entitle him to be excepted from its provisions. [FN34] I doubt any of these cases involved the potential loss of life of the citizen. It's true that drafting soldiers puts them at risk. But even in that case there is some causal distance, unlike in the case of vaccination.

Next, the court considered the other eleven propositions which all relate to alleged injurious or dangerous effects of vaccination. The defendant 'offered to prove and show by competent evidence' these so called facts. But the court declared that the only 'competent evidence' that could be presented to the court to prove these propositions was the testimony of experts giving their opinions. The Court declares that for nearly a century most of the members of the medical profession have regarded vaccination, repeated after intervals, as a preventive of smallpox; that, while they have recognized the possibility of injury to an individual from carelessness in the performance of it, or even in a conceivable case without carelessness, they generally have considered the risk of such an injury too small to be seriously weighed as against the benefits coming from the discreet and proper use of the preventive; and that not only the medical profession and the people generally have for a long time entertained these opinions, but legislatures and courts have acted upon them with general unanimity. If the defendant had been permitted to introduce such expert testimony as he had in support of these several propositions, it could not have changed the result. [FN35]

The court seems to be saying a number of interesting things here. The court declares a priori that it is impossible to prove that vaccines are dangerous. Why should not the individual confronted with authority be free from the possibility of harm. How is it that we allow human sacrifice? It seems incongruent with the radical individualism. But part of the resolution of this puzzle is in that we are forced to be gamblers to be winners. And we can say, it won't happen to me, the odds against are 1 in a million. And tough luck on that loser, I'm not going to get this disease. Furthermore, when V.P. Morris changed the University of Washington vaccine policy, he was pleasing his boss and wasn't even told that anybody might get hurt Also we see here that only the testimony of experts can be admissible. Here again it's the doctrine of high medical authority, even necessarily overriding whatever experts had to say, weighed against what "everybody knows". This standard is striking in that the standard proof necessary to prevail is impossible to achieve, and that everybody accepts it. But this everybody accepts it doctrine is weak. It disallows the discovery of new evidence of risk. And it accepts without question the idea that human sacrifice is an acceptable social regulation. But human sacrifice is ultimately an anti-social act. Over the past seven years, US courts have now found vaccine responsible for more than a thousand dead and 7,000 wounded. How can secular authority play G-d? Is the court here trying to say that every state welfare demand is permissible? Certainly this is not the case in 1998. A factor to be kept in mind is that it is mostly children who suffer the consequences of vaccination; there may be less consideration for infants just as there is tolerance for abortion or euthanasia: that there has yet been little social investment made or social utility remaining in the social member, so that if they are genetically susceptible, minimal capital needs to be expended on them.

The court goes on to argue that the welfare of the many should be honored by restraining the non-complying social members. The problem here is that Jacobson was not doing anything to hurt anyone else, he was just existing in Cambridge. It is he who sought to restrain the authorities. The court mention that there are some times when a man is free to submit to authority, but it just doesn't go deep to the essence of when such a condition obtains. Jacobson felt that his life was in immediate danger based on his own concrete experiences. If there is any time for the exercise of this form of resistance, this is it. It is interesting to see how the court says what everybody knows, the state court must know and we must know. What it is that everyone must know is what high medical authority states. Again there is no consideration to the fundamental right to life.

The Court then goes through an exhaustive list of cost/benefit studies to justify its conclusion that the vaccine program must continue. But a republican form is opposed to the tyranny of the majority. It is the protection of the minority upon which the whole concept of federalism rests. In this case, it is a genetic minority, let's say. Should they be rubbed out of the gene pool? Then the Court claims that the many will really be hurt by the few who don't participate in the vaccine program.

This is totally false. An exemption could be made for those who claim previous adverse reactions. The herd immunity theory does not require all to be vaccinated. As will be described shortly in the Whitecotton case, the Courts policy translates into the grotesquely injustice situation where baby Maggie was born neurologically defective, was damaged by DPT and later damaged again by DT! Besides, if the program were voluntary, the people would make an educated choice as to whether they want the shot or to risk getting the disease naturally.

The one saving grace of the Jacobson decision which would allow a new case to be made to limit a program such as UW's vaccine program is that it requires that the general terms of the local law should be so limited in their application as not to lead to injustice, oppression, or an absurd consequence. [FN36] So ultimately, the Jacobson case, which is still controlling vaccine law after more than 90 years, may be ripe for a case which would limit the holding by establishing a boundary beyond which the court would find unjust, oppressive or absurd. As implemented, the University of Washington program is unjust in that it discriminates against students in favor of faculty, and is absurd since potentially fatal viruses (rubella and mumps) are being given to the students with no public health justification at all.

Moving from the turn of the 20th century to the turn of the 21st, we find very little change in the Supreme Court's attitude toward vaccination. As will be described in part III, the problem of proving causation with the expert witnesses and the available research is a difficult one. The recent Whitecotton case is the only post-National Vaccine Compensation Fund case to reach the Supreme court (twice). [FN37] Margaret Whitecotton was born on April 22, 1975 with evidence of microcephaly (small head size). There was a controversy over whether one has to be 2.5 or 3.5 standard deviations below mean head size to be considered microencephalic. She received her third DPT vaccination on August 18, 1975 and was hospitalized thereafter with a seizure disorder. Over the next several years, she experienced additional seizures, was formally diagnosed with microcephaly and cerebral palsy, and had episodes of febrile convulsion and limpness. Her parents filed a claim alleging that she suffered from an impairment of brain function known as encephalopathy, as a result of the DPT vaccine.

Recovery of compensation pursuant to the Vaccine Act is possible in three ways: (1) through a rebuttable presumption of causation, in which petitioner shows that the initial onset of an injury listed in the statute's Table occurred as a result of the vaccine, within the time period after vaccination that is listed in the Table, prevailing over the government's rebuttal that the injury was caused by a factor unrelated to the vaccine; (2) through a rebuttable presumption of causation, in which petitioner shows that the vaccine caused a "significant aggravation" of an injury listed in the Table, within the time period after vaccination that is listed in the Table, including a showing that the first symptom or manifestation of the significant aggravation occurred with the Table's time period, prevailing over the government's rebuttal that a pre-existing condition, not the vaccine, was the cause of the significant aggravation of the injury; or (3) through a showing that the vaccine was the actual cause of the injury. With respect to the Whitecottons' "initial onset" claim, the Special Master determined that no compensation was due because microcephaly was a symptom of the encephalopathy pre-dating the vaccination. Therefore, in the view of the Special Master, the child already had encephalopathy prior to the DPT vaccination. The Whitecottons challenged this determination.

The Federal Circuit affirmed the Special Master. The court noted its review of fact-finding to be limited to whether the Special Master was arbitrary and capricious or committed an abuse of discretion (citing the previous vaccine compensation cases of Hodges and Knudsen). Although the evidence before the Special Master was conflicting, the court cited the substantial expert testimony supporting the Special Master's decision as precluding a finding of arbitrary and capricious or abuse of discretion. Of particular interest is the Federal Circuit's statement that it can only consider in its review the evidence that was originally before the Special Master, and not evidence (including scientific studies) outside of the earlier record. While this makes sense as an element of the law of evidence and due process, it may not comport with the ever-advancing scientific knowledge base of the relationship, or lack thereof, between vaccines and medical injuries.

With respect to the petitioners' claim on the "significant aggravation" theory, the Federal Circuit established the following four-part test for special masters to use in deciding whether compensation should be awarded: (1) assess the person's pre-vaccination condition, (2) assess the person's post-vaccination condition, (3) determine if the current condition is a "significant aggravation" of the pre-vaccine condition, using the definition in the Vaccine Act ("any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health"), and (4) determine whether the first symptom or manifestation of the significant aggravation occurred within the time period specified in the Table. The government may still rebut petitioner's causation claim by showing that the pre-existing condition was the cause of the significant aggravation post-vaccination. Since the Special Master in the Whitecotton case did not use this type of test, but instead applied a theory that the Federal Circuit characterized as overly burdensome to the petitioner in establishing causation, the court reversed the decision of the Special Master that had denied compensation and remanded for additional fact-finding and determination consistent with the new four-part test.

The Federal Circuit specifically directs the Special Master to consider on remand a piece of evidence that the court believes was not considered previously -- the first abnormal electroencephalogram (brain wave test) taken four days after the time period specified in the Table. The court expresses concern that this evidence was not evaluated by the Special Master in reaching the conclusion that there was no "significant aggravation" in this case.

The Whitecotton case demonstrates how aggressive the government and the medical communities are about forcing literally every child to be vaccinated, and how difficult they make it to collect when damage occurs. Given the known neuropathic potential of DPT vaccine, why a microencephalic baby would ever be subject to the normal vaccine regime makes one question the intelligence of the health care providers and the government who ought to be provide guidance critical situations such as this one. Even after Maggie Whitecotton's condition was arguably made worse by a DPT shot, her doctor presumed the danger was from the pertussus component, but low and behold, when a DT shot was administered instead, more apparent damage resulted. [FN38] Though it's rather obvious that Maggie was injured by the DPT, the government uses esoteric language to argue that her small head size was to blame for her condition. One should properly ask, if it cannot be determined a posteriori whether a pre-existing defect in the child or the vaccine was a primary factor in the neurological injury, how is it fair to subject the child to the risk for which there is little chance of compensation?

B. The Wakefield Study

It is perhaps not coincidental that the New Republic vaccine conspiracy cover story appeared just a month after an article by Wakefield et al. appeared in the Feb. 28, 1998 edition of the Lancet. [FN39] The article strongly suggests that the large majority of children coming to the hospital with a syndrome including Ileal-lymphoid-nodular hyperpasia, non-specific colitis, and pervasive developmental disorder (autism) had come down with the disease within two weeks after receiving MMR vaccination. As always happens in a case of a publication such as this, the medical authorities, in this case in Britain, vigorously denied there was any significant danger from the MMR vaccine. In the month following the Lancet article, there were many of reports in the popular press of either doctors discounting the danger, or the public taking matters into their own hands by refusing to have their children injected with MMR. According to one report, about 25% of British parents have currently lost faith in this vaccine. [FN40] If the percentage remained fixed at such a high rate of non-compliance, the this might be the beginning of the end for the worldwide DPT and MMR programs. It would give rise to a cohort of unvaccinated children who could be compared as a group to the vaccinees. It would allow the world to see for the first time which group subsequently suffered more from those suggested in the Wakefield article as well as from other forms of illness such as myopia, MS, asthma, diabetes, and arthritis. Thus there was need for a media barrage to restore confidence in the vaccines. There was the New Republic conspiracy cover story. And then in the May 2, 1998 Lancet appeared a research letter, claiming "No evidence for measles, mumps and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study." [FN41] Unlike the Wakefield paper which included very complete clinical and laboratory investigation, the Peltola letter simply looked back through the past 14 years of Finnish MMR immunization, looking for children who had reported gastro-intestinal disorder following MMR injection. Of the thirty reports of stomach ache, they tracked the children down and interviewed them about autism Crohn's disease and found no such cases, which lead them to their conclusion. Wakefield replied in the press that their methodology in no way undermined his assertion, which seems obvious by comparing the two papers. But perhaps what matters more in the near term is the fact that the press seized on the Finnish letter as a sign that there really was nothing wrong with the MMR vaccine. The number of articles on LEXIS citing the Finnish article and trying to call off the scare was about 5 times higher than the original reports about Wakefield's research of the concern. It seems to me that what is happening is that there is a systematic bias in the media which is controlled in part by vested interests in maintaining the status quo. In this light, the New Republic article seems to be a hit piece designed to keep the petty intelligentsia hooked into believing in the system.

It has been estimated that autism alone costs our economy $12 billion a year in labor and lost productivity. [FN42] If it turns out after sufficient study to be so that most childhood autism, asthma, arthritis, diabetes, Crohn's disease, myopia, MS, and other neurologically related disorders would not have occurred had we not had a vaccination program, the potential annual cost of the vaccine program could be on the order of $100 billion a year, rather than the nominal $100 million that is figured as the programs cost. If we found this to be the case, then it would be a much better world in which that portion of the economy was used to treat many of the newly created cases of chronic illness could be focused on the already damaged.

C. The Tingle Example

The recent media smoke screen to cover-up the revelation over the connection between MMR and autism is just the latest in a familiar pattern. Over the past year there have been new reports of a connection between MMR and arthritis. Each time such a report comes out, a counter study appears purporting to deny the link and the media tend to trumpet the counter studies which deny the link. Thus the game continues. But eventually the truth of the science will win out, because the reports showing the links are becoming more mature scientifically. For example, Mitchell et al. have recently published a study of 283 white women in a double blind study who were given RA27/3 rubella vaccine or saline placebo injection. [FN43]. The odds of developing arthropathy were 1.9 times greater (confidence interval [CI] 1.07-3.44) in the women who received the rubella vaccine. This rather conclusive evidence was not done three decades ago as it should have been done because to obtain funding for a study like this is practically impossible. Mitchell et al. actually looked for and found certain genetic markers in their patients which disposed them toward arthropathy. Leukocyte DNA was molecularly typed for HLA-DRB1 gene expression. Univariate analysis revealed higher frequencies of DR2 (odds ratio [OR], 4.8;95% CI 1.2-18.8) and DR5(OR 7.5;95% CI 1.5-37.5) but lower frequencies of DR4(OR, 2.3; 95% CI 1.1-4.9) and DR6 (OR 2.8; 95% CI 1.4-5.8). Risk of arthropathy was influenced by DR interactions; odds were 8 times greater in individuals with both DR1 and DR4 (95% CI 1.45-44.03) and 7.1 times greater with both DR4 and DR6 present (95% CI, 1.85-27.54). These advanced genetic studies begin to give a hard scientific basis to the tangible risks of rubella vaccination. They also reify the notion that what is being done through the vaccine program is a form of genetic weeding out of the human race, with the potential for targeting with what that implies.

Tingle has shown that the intrinsic arthropathy-inducing properties of rubella virus differ only by a factor of two when the wild strain is compared to the vaccine strain. [FN44] Coupled with the genetic susceptibility, what this implies is that those who are genetically susceptible to rubella arthropathy are more at risk in taking the vaccine than if their chances of catching the virus naturally are less than one half. Extending this logic to the population as a whole, the whole premise of mass vaccination can be questioned if the truth is that there are no significantly population averaged less serious adverse reactions from the vaccine or the wild strain by probability of infection product. In other words, the premise of the Vaccine Program is that there are devastating consequences if an outbreak were to occur. But if the ones who would have gotten sick in an outbreak are the genetically susceptible ones, then giving a vaccine to them might make them just as sick with a significant probability, only their illness will not be associated with the virus because there is no sudden outbreak.

There is an addition danger of the vaccine program which has not been investigated which is that total viral load is not being considered as more and more vaccines are mandated. Also it is at least plausible that multiple strain infection takes place with intimate contact, thereby multiplying the viral load, and that the vaccine strain of rubella may actually be causing unacknowledged birth defects by casual contact between a pregnant women and a recent vaccinee.

Part III - The Problem of Establishing Causality in Modern Vaccine Caselaw

There are two basic types of claim under which a petition may be filed with the Program. [FN45] There are the injuries which fit the prescribed conditions of the Vaccine Injury Table [FN46], and those which fall outside the narrow criteria of that table. The table lists the various injuries which have been accepted by the Secretary as having been established to her satisfaction by the medical community to allow a presumption of causation if the injury can be shown to have occurred within the time period specified in the table. The initial Table has been modified a few times since the law was passed in 1988, in accordance with the part of the Vaccine Act which calls for her to direct the Institute of Medicine of the National Academy of Sciences to review the medical literature and make recommendations for expanding the Table of presumptive injuries. [FN47] The most recent emendation of the table was made in March, 1995, and primarily added chronic arthritis resulting from the MMR vaccine. [FN48]. The secretary made the changes in response to an Institute of Medicine report. [FN49] But the Secretary did not follow the recommendation that the onset of chronic arthritis occur within six months of vaccination, but rather limited the onset to 42 days, simply for the stated purpose of limiting the number of claims that would qualify for the table, under the theory that to accept the recommendation would be too costly to the program. She acted for this reason even though the program has a $1.2 billion dollar surplus which is rapidly rising since only about half of the excise tax is currently being awarded. It is unclear that this money will ever get to it's intended beneficiaries, as an attempt was made last year by the Secretary of the Treasury to reclaim this surplus for use in the general budget, arguing that it is obviously unneeded to pay out vaccine injury claims. The action by the HHS Secretary is an perfect example of how the law fails to ensure a fair compensation system. Although she is the adverse party to the claimant, a Federal Court of Appeals has found she is free to do unconditionally as she pleases in changing the vaccine table, thereby making her case against the claimant much easier in many cases.

Not only does the Secretary take a more conservative line in setting policy on presumptive injury than does the Institute of Medicine, but the IOM itself is very conservative on admitting causation of injury due to vaccination. In its definitive 1994 treatise, the IOM in most suggested categories takes a non-affirmative position on most injuries. [FN50] Its standard conclusion is "The evidence is inadequate to accept or reject a causal relation between..." vaccine X and condition Y. [FN51] Not only does this conclusion result in the condition being excluded from the vaccine injury table, but makes it very difficult to argue in court that there is proof of a causal relation, since the experts have suggested that there is no conclusive proof, and the vaccine act has been interpreted to require such proof. [FN52][FN53] For example in Johnson v. Sect'y HHS, although the plaintiff had three experts opining that her fibromyalgia (FMS) was caused by an MMR vaccine, it was deemed by the Special Master that a causal connection between the rubella vaccine and chronic arthropathy is tenuous and has not been medically established. [FN54] This was upheld by the Federal Circuit, under the Overton Park arbitrary and capricious standard of review. [FN55] This is a good example of the injustice of the system because this author personally knows as he sits here typing this paper that, with absolute certainty, the MMR vaccine does cause FMS.

Just as the recent controversy causally relating to MMR and autism, described in Part II of this paper suggests, establishing scientific causation for any iatrogenic injury is extremely difficult. The standard that the Federal Circuit has adopted follows the reasoning of the Supreme Court's Daubert decision. [FN56] Daubert nominally advantages plaintiffs in toxic tort suits over the previous Frye standard [FN57] in applying Rule 702 of the Federal Rules of Evidence, which permits testimony as long as it follows a scientific methodology and is relevant to the inquiry. One of the factors which are not determinative but demonstrative of scientific validity is publication. The Special Masters in the Vaccine program do not have to follow the rules of evidence, but they generally do allow the plaintiffs experts to testify.

Part IV - Recommendations

A. Recommendations for Legislative Reform

By most accounts, the National Vaccine Injury Compensation program has not been adequate to the task of fairly compensating the vaccine programs victim's. The basic problem is that the Secretary of Health sets the all important vaccine table however she pleases. She naturally has an incentive to save her department's money to spend in more politically rewarding projects. Therefore, Congress should recognize the injustice of the current situation and construct a much more liberal injury table.

There is nothing approaching informed consent in the vaccine clinics. Mandate that every new parent receive a copy of the injury table and an fair assessment of the risks of vaccination.

Declare a 2 year moratorium on vaccination to determine what the risk are of an outbreak of disease and how much harm such an outbreak would bring, versus observed reduction in new chronic illness.

Create a national study of chronic illness in these babies compared to year 1999 and year 2001 babies. The infant chronic illness database. There is already a nation vaccine database being created, and this should be expand this to mandate the reporting off all illness into the record. Have a toll free number where the parent directly reports illness to the database.

Make reasonable exceptions from mandatory vaccination for weaker or more delicate children.

B. Setting a limitation on Jacobson

Jacobson grants the states police power to mandate vaccination. Unless vaccines could be marketed which to not kill or seriously maim certain individuals, the Open Boat case discussed in the prologue should govern: society has no right to kill its genetically susceptible members, so Jacobson ought to be overturned on moral grounds. But the endgame of the vaccine racket may be achieved within the framework of Jacobson. It should be possible to find a test case which the Supreme Court would find to be unjust and absurd. In fact, I think the University of Washington vaccine rules fit such criteria. By winning such a case, a milepost would be set on what is permissible and what is not. For example, using MMR on adults for no really valid reason when it has never been tested on adults in a controlled study and is known to be dangerous to a significant fraction of the adult public is absurd and unjust. 


Footnotes

FN1. 14 Q.B.D. 273 [1884].
FN2. Arthur Allen, Injection rejection: the dangerous backlash against vaccination, The New Republic, March 23, 1998, at 21. FN3. Chicago Sun-Times, January 4, 1998 (Editorial page).
FN4. 45 MMWR 860.
FN5 Private Communication.
FN6. James D. Cherry, The Epidemiology of Pertussis and Pertussis Immunization in the United Kingdom and the United States: A Comparative Study, Current Probs. Pediatrics, Feb. 1984, at 32.
FN7. Vaccine Boycott Threat Raises Epidemic Fears; Chief Medical Officer Concerned At Parents Abandoning MMR Jab, Belfast News Letter, March 25, 1998, at 15.
FN8. 197 U.S. 11, at 30.
FN9. 42 U.S.C. 300aa 6-32.
FN10. 44 AM. U. L. REV. 1853.
FN11. See H.R. Rep. No. 908, 99th Cong., 2d Sess. 4 (1986) (stating that childhood vaccination has saved thousands of lives and billions of health care dollars), reprinted in 1986 U.S.C.C.A.N. 6344,6345.
FN12. 63 GEO. WASH. L. REV. 144,145.
FN13. 197 U.S. 11, at 26-27.
FN14. Id. at 26-28.
FN15. Id.
FN16. Peoria Journal Star, February 27, 1998.
FN17. NBC Today Show, March 19, 1997.
FN18. 42 U.S.C. 300aa-23.
FN19. See Bunting v. Secretary of Dep't of Health & Human Servs., 931 F.2d 867, 869 (Fed. Cir. 1991).
FN20. 42 U.S.C. 300aa-24.
FN21. 42 U.S.C. 300aa-14.
FN22. Margaret G. Farrell, Daubert V. Merrell Dow Pharmaceuticals, Inc.: Epistemiology And Legal Process, 15 CARDOZO L. REV. 2183 (1994).
FN23. 197 U.S. 11.
FN24. 198 U.S. 45.
FN25. Mass. Gen. L. ch. 75, 137.
FN26. Mass. Gen. L. ch. 75, 139.
FN27. Richard E. Weibel et al., Influence of Age on Clinical Response to HPV-77 Duck Rubella Vaccine, 262 JAMA 805, 806 (1972).
FN28. Richard E. Weibel et al., Chronic Arthropathy and Musculoskeletal Symptoms Associated with Rubella Vaccines, 39 Arthritis and Rhuematism 1529, 1531 (1996).
FN29. Minutes of the 27th Meeting of the Advisory Comittee on Childhood Vaccines. (For recent minutes, see http://www.hrsa.dhhs.gov/bhpr/vicp/minutes.htm).
FN30. Leslie Ann Mitchell et al., HLA-DR Class II Associations with Rubella Vaccine - Induced Joint Manifestations, 177 Journal of Infectious Diseases,5 (1998).
FN31. Mass. Gen. L. ch. 75, 137.
FN32. 4 Wheat. 122.
FN33. Andrea Rock, The Lethal Dangers of the Billion-Dollar Vaccine Business, Money, Dec. 1996, at 148.
FN34. 197 U.S. 11, 23.
FN35 Id.
FN36. Id. at 39.
FN37. 514 U.S. 268.
FN38. 81 F.3D 1099, 1102.
FN39. A.J. Wakefield et al., Ileal-lymphoid-nodular Hyperplasia, Non-specific Colitis, and Pervasive Developmental Disorder in Children, 351 Lancet 637 (1998).
FN40. Alison Little, Health Chief Warns Of Epidemic, Press Association Newsfile, April 3, 1998.
FN41. Heikki Peltola et al., No Evidence for Measles, Mumps, and Rubella Vaccine-associated Inflammatory Bowel Disease or Autism in 14-year Prospective Study, 351 Lancet 1327 (1998).
FN42. 19 Alternative Medicine Digest 38.
FN43. Leslie Ann Mitchell, HLA-DR Class II Associations with Rubella Vaccine-Induced Joint Manifestations, 177 Journal of Infection Disieses 5 (1998).
FN44. Aubrey J. Tingle et al., Rubella-associated Arthritis. I. Comparative Study of Joint Manifestations Associated with Natural Rubella infection and RA 27/3 Rubella Immunisation, 45 Annals of the Rheumatic Diseases 110 (1986).
FN45. 42 300aa-11(c)(i) and (ii).
FN46. 300aa-14(a).
FN47. 300aa-14(c).
FN48. 300aa-14.
FN49. Adverse Events Associatee with Pertussus and Rubella Vaccines (Christopher P. Howson, Cynthia J. Howe, Harvey V. Fineberg eds., 1991).
FN50. Adverse Events Associated with Childhood Vaccines - Evidence bearing on Causality (Kathleen R. Stratton, Cynthia J. Howe & Richard B. Johnston, Jr. eds., 1994)
FN51. Id. 333.
FN52. 940 F.2d 1518.
FN53. 37 Fed.Cl. 314.
FN54. 33 Fed.Cl. 712.
FN55. 99 F.3d 1160, citing Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971).
FN56. 509 U.S. 579.
FN57. 293 F. 1013, 1014.