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 Jacobson 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 Jacobson
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.
