The Law of Vaccination: Toward Radical Reform

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The Law of Vaccination - Toward Radical Reform

Stan Lippmann

University of Washington School of Law

Supervised Analytic Writing

June, 1998

Table of Contents:

Prologue

Part I.Introduction

Part II. The Development of 20th Century Vaccine Law

* A. From son to Whitecotton

* B. The Wakefield Study

* C. The Tingle Example

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

Part IV Recommendations

* A. Recommendations for Legislative Reform

* B. Setting a limitation on son

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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 & s 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 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. 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 son

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 son 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 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 Steel acceptingly cites the leading son

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 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. 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 son to Whitecotton

The leading case in the area of vaccine law is son 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 son, 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 son 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 son, 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] son 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. 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 son case how

thoughtless and harmful an overly broad public health measure can turn out

to be.

son 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. "

son 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 son'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 son'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. 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

son 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. son 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 son 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 son 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, 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. 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 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 son

son 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

son ought to be overturned on moral grounds. But the endgame of the

vaccine racket may be achieved within the framework of son. 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 , 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. 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. E. Weibel et al., Influence of Age on Clinical Response to

HPV-77 Duck Rubella Vaccine, 262 JAMA 805, 806 (1972).

FN28. 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. Ann 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. 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. Ann , 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 ls of the Rheumatic Diseases 110

(1986).

FN45. 42 §300aa-11©(i) and (ii).

FN46. §300aa-14(a).

FN47. §300aa-14©.

FN48. §300aa-14.

FN49. Adverse Events Associatee with Pertussus and Rubella Vaccines

( P. Howson, J. Howe, Harvey V. Fineberg eds., 1991).

FN50. Adverse Events Associated with Childhood Vaccines - Evidence bearing

on Causality (Kathleen R. Stratton, J. Howe & B. ston,

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.

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