Download Draft amicus brief, June 21st

Possible Amicus brief in Brueewitz v Wyeth in the US Supreme Court,
Draft by Richard Wilson
June 22nd 2010
Brief due end of July 2010
Both the briefs by the petitioner and the defendant in this case emphasize the issue of whether
federal law preempts state law. But they say little about the public health and scientific issues
which the laws should be, and claim to be, addressing. These issues are fundamental in many
ways. The court will no doubt wish to divine the intent of congress in enacting the relevant
legislation. But it is important that the scientific and public health considerations that underlie
that intent be fully considered.
Mankind constantly faces the issue of how o balance the rights of an individual, and the role of
society and its institutions. It is vital to emphasize, and consider especially carefully, the
situations where the motives, the risks and rewards are different. The comparison of risks and
benefits is very old and has recently acquired some respectability in scientific an economic
circles. But in most cases it involves risks to an individual and benefits to the same individual.
Vaccination is one of these. There is no doubt of the fantastic success of vaccination since it was
first introduced a little over a century ago. Most of us will no longer die from infectious diseases
but from other causes. Indeed, in one case, small pox, the disease is wiped out in the last half
century except for a handful of laboratory samples. Al;as, in developing countries, particularly in
Africa, vaccines are not easily available and many people will die unnecessarily. Mankind
clearly needs to, and in the most part wants to, continue and expand vaccination. The motive for
society is clear: to develop a herd immunity. But an individual can gain much of the advantage of
the “herd immunity” without being vaccinated so long the neighbors are. Since every vaccine has
side effects, hopefully affecting a small group of people, largely at random, there is a small
incentive for an individual NOT to be vaccinated. The legislation addresses this conflict between
the motives.
Public health experts and authorities recommended a “no fault” compensation program to
compensate anyone who suffered these side effects and thereby to reduce the incentive for an
individual to refuse vaccination. Recognizing this, Congress, in 1996, passed the National
Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-1 et seq. (NCVIA) This creates a “Vaccine
Court” as a branch of the Court of Federal Claims. Although the required proof of injury is less
than the (nominal) requirement for a toxic tort claim, some requirement is necessary to eliminate
“frivolous” claims such as a claim that a vaccination in childhood caused a prostate cancer in old
age . This is a no-fault that assigns no fault to a manufacturer that manufactures the drug
according to approved regulations.
The criteria for accepting a claim are important. It is, however, important that all reasonable
claims be considered, even with a generous requirement for proof or many people will not get
vaccinated and the public health advantages of herd immunity will be lost. How generous should
they be? The criteria should, and probably will, change with time. Since many vaccines wee
made with a small amount of mercury, and it was claimed that mercury causes autism,
compensation for autism might have been reasonably considered. But now that a National
Academy of Sciences report has concluded that there is no evidence that mercury causes autism,
such a claim would reasonably be excluded, as it has been in several cases.
The procedure for deciding the cases is the Court of Federal Claims, of which a section is
colloquially called the “Vaccine Court”. Some diseases are listed in a “Table” and are
automatically compensable. In the case at hand, the symptoms are not in the table, and the court
considered whether there were nonetheless reasons for considering it compensable. Here the
standard of proof is necessarily higher than for mere existence in the table.
Plaintiffs are appealing this decision and in particular want to blame Wyeth for not using the best
vaccine available at the time. Amici do not question the judgement of the Vaccine Court on this
issue.. It is our view that the supreme court in deciding the present case examine carefully
society’s decisions on how to handle the complex balance between individual aims and societal
aims and the scientific and public health discussions which led to the present federal legislation.
The role of federal vs state jurisdiction has important public health implications also which have
changed with time. The states have traditionally had the authority to take forceful (even
draconian) action. Quarantine, rarely used now that infectious diseases have been reduced, is an
example. Movie goers will remember the 1938 movie “Jezebel” where the hero gets yellow fever
and is sent to an offshore island. As late as 1930 it was the local authorities that would not let a
child go to school without being vaccinated. But increasing travel has made the federal role
increasingly relevant and important. At the time of the SARS epidemic in China, travelers from
China were questioned, and in future situations are likely to be checked for fever with simple
thermometry. This would be far harder at every state border. With this in mind, it seemed highly
sensible for the federal government to take the lead in 1996 and essential to maintain some
degree of control, other than state control, in 2010.
The feature of the vaccine act that leads to the present case is that there is no fault to be assigned
to the vaccine manufacturers if he follows all the procedures, appropriate for the time, for
manufacture of the vaccine. The procedures are subject to approval by the US Food and Drug
Administration (FDA) and there s no suggestion that this should be replaced by state procedures
These procedures can never be perfect and constant improvements are to be expected with
constant reduction of side effects. It would defeat the purpose for a manufacturer to be liable for
manufacture according to approved FDA procedures even though improvements are in process.
More logical, perhaps but still not in the view of amici sensible, would be to hold a physician
liable if he fails to choose the “best” of all vaccines approved by the FDA,
But all regulations and laws should have a place where the individual, or sometimes society, can
appeal a judgement which all too often is arbitrary. That would presumably be for negligence
and ordinary tort law rules would apply. If the vaccine is defective, and was not manufactured
using (FDA) approved standards then an ordinary product liability suit would be reasonable. But
even here, the burden should be on the plaintiff to prove that the vaccine caused the injury
because it was defective In particular the rule, often stated but less often applied, that it be “more
likely than not”, (translated quantitatively to a probability of causation greater than 50%) would
normally apply. It would seem logical for that to be in state court if it were a state matter or a
federal court if a federal matter. This case is concerned with whether the federal law preempts
state law. There is an obvious slight preference for federal jurisdiction, because the advantages of
“herd immunity” might be lost if one or two states backed out of the agreements just as they
would be lost if too many individuals back out (refuse vaccination)..
In making the decision in this case amici urge the court to ensure that the fundamental imperative
of ensuring that there remains on overwhelmingly strong incentive for an individual to contribute
to the public good by agreeing to vaccination and that there exists an adequate supply of vaccines
for this purposes.