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6
Liability for the Production
and Sale of Vaccines
Potential liability for vaccine-related injuries has received much
attention as a deterrent to vaccine manufacturing. A variety of
approaches to the issue have been suggested, but there have been few
attempts to determine the magnitude of the problem or to analyze basic
trends in the interpretation of laws in this area. This chapter
provides such an analysis and examines the ways in which the state of
the law influences decisions that ultimately affect vaccine
availability and innovation.
STATE OF THE LAW
Liability for injury resulting from vaccination is a matter of state
law. Thus, there are potentially 51 different sets of rules on this
subject in the United States. No vaccine-related product liability
litigation resulting in a publicly available opinion has occurred in
. · · · . · · . . . . . . . . . . . . . .
most ~urlsulctlons, and In many there nas Been no llanlllty litigation
related to drugs. Although it is possible by extrapolation from other
product liability cases to predict how these states would handle
vaccine cases, any such extrapolation might prove inaccurate.
The subject of product liability has become increasingly controver-
sial over the past few years. Manufacturers have complained about the
costs, the unpredictability of the law, and the unavailability and cost
of insurance. A majority of states have enacted statutes relating to
some aspect of product liability actions.1 Legislation at the feder-
al level has been considered extensively, but has not been passed.2
A manufacturer who produces and sells a defective vaccine that
creates a risk of significant injury to the recipient is liable to any
person injured by that defect under the principles stated in section
402A of the Restatement of Torts 2d.3 This is thought to be the law
in every American jurisdiction. ~ ~ ~ ~
states:
The key portion of section 40ZA
One who sells any product in a defective condition unreason-
ably dangerous to the user or consumer or to his property is
subject to liability for physical harm thereby caused to the
ultimate user or consumer. . . . [The rule applies although]
85
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86
the seller has exercised all possible care in the preparation
and sale of his product.
Cases holding manufacturers or others liable for allegedly defective
vaccines administered to humans are very rare.4 The reported cases
are:
· Griffin v. United States, in which the U.S. government was
held liable because the Division of Biologics Standards of the
National Institutes of Health released a batch of Sabin polio vaccine
that did not conform to its own regulatory standards (the manufacturer
settled), 351 F. Supp. 10 (E.D. Pa. 1972), aff'd in part, rev'd in
part and remanded, 500 F.2d 1059 (ad Cir. 1974~;
· Grinnell v. Charles Pfizer & Co., in which the manufacturer
was held liable for virulent particles in Salk killed-virus vaccine,
274 Cal. App. 2d 24, 79 Cal. Rep. 369 (Diet. Ct. App. 1969~;
· Four cases in which the manufacturers of quadrivalent vaccine
(diphtheria, tetanus, pertussis, and poliomyelitis) were held liable
because new preservative activated the pertussis component, Tinnerholm
v. Parke-Davis & Co., 285 F. Supp. 432 (S.D.N.Y. 1968), aff 'd, 411
F.2d 48 (2d Cir. 1969), Stromsodt v. Parke-Davis & Co., 257 F. Supp.
991 (D.N.D. 1966). aff 'd. 411 F.2d 1390 (8th Cir. 1969). Vincent v.
Thompson, 79 Misc. 2d 1029 (N.Y. 1974), and Ezagui v. Dow Chemical
Corn. 598 F.2d 727 (2d Cir. 1979);
· Gottsdanker v. Cutter Laboratories, in which live particles
were found in Salk killed-virus vaccine, 182 Cal. App. 2d 602, 6 Cal
Rptr. 320 (Diet. Ct. App. 1960); and
· Sandel v. State, in which pus was found in typhoid vaccine,
115 S.C. 168, 104 S.E. 567 (1920).
.
A manufacturer is not liable for harm caused by a nondefective
product due to its inherent or unavoidable dangerousness. Thus, if a
properly manufactured vaccine will cause harmful side effects in some
portion of the recipient population, the manufacturer of the vaccine
is not liable for those side effects. This principle is the subject
of comment k to section 402A.
k. Unavoidably unsafe products.
There are some products
which, in the present state of human knowledge, are quite
incapable of being made safe for their intended and ordinary
use. These are especially common in the field of drugs. An
outstanding example is the vaccine for the Pasteur treatment of
rabies, which not uncommonly leads to very serious and damaging
consequences -~hen it is injected. Since the disease itself
invariably leads to a dreadful death, both the marketing and
the use of the vaccine are fully justified, notwithstanding the
unavoidably high degree of risk which they involve. Such a
product, properly prepared, and accompanied by proper directions
and warning, is not defective, nor is it unreasonably dangerous.
The same is true of many other drugs, vaccines,-and the like,
many of which for this very-reason cannot legally be __1 ~&
, _ _
the like,
sold except
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87
to physicians or under the prescription
The seller of such products, again with
of a physician. . . .
the qualification that
they are properly prepared and marketed, and proper warning is
given, where the situation calls for it, is not to be held to
strict liability for unfortunate consequences attending their
use merely because he has undertaken to supply the public with
an apparently useful and desirable product, attended with a
known but apparently reasonable risk.
The qualification "proper warning is given is critically important
and a manufacturer will be liable if he markets a drug or vaccine with
known risks and fails to warn of them, and it can be shown that the
recipient would not have taken the drug or vaccine had he known of the
risks. An example of this situation involving polio vaccine is Davis
v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968~. In that
case, Sabin polio vaccine had been administered to the plaintiff, a
39-year-old male, in a mass immunization campaign conducted with the
assistance of a sales representative of the defendant. The plaintiff
had developed polio. The Surgeon General had recommended that mass
programs using Sabin Type III be limited to children because of the
risk of transmission of the disease to adult recipients. The mass
immunization campaign involved in the case, however, included adults.
The defendant's promotional materials failed to warn of the risk to
adults, although the package insert did. The pharmacist who dispensed
the oral vaccine did not read the package insert and did not warn the
plaintiff of the risk.
The duty to warn arises from the notion that the failure to inform
consumers of dangerous aspects of a product may render the product
unreasonably dangerous. For instance, if an electric device operated
in a certain way will blow up and cause harm to bystanders, a failure
to warn the consumer of this risk so that he can avoid the harm will
make the manufacturer liable for the harm. Or in the Davis case, if
the plaintiff had been warned of the risk, he could have chosen not to
take the vaccine, as was then recommended in the case of adults.
If a product is not sold directly to the public, but is distributed
through intermediaries who can be expected to know about the product
and its risks and to be responsible for informing the ultimate consumer
on its proper use, then the manufacturer does not have a duty to warn
the public (although it does have a duty to warn the intermediaries of
risks not known to them). Prior to Davis, this exception to the duty
to warn was thought to be applicable to drugs and vaccines distributed
through health professionals (as contrasted with over-the-counter
drugs, for which the manufacturer does have a duty to warn the user).
In Davis the defendant manufacturer argued that its duty to warn
had been satisfied by the fact that it had informed the county medical
society sponsoring the mass immunization program of the risk that a
vaccines might develop polio. The court rejected this argument in the
context of the mass immunization program:
Here . . . although the drug was denominated a prescription
drug it was not dispensed as such. It was dispensed to all
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88
comers at mass clinics without an individualized balancing by a
physician of the risks involved. In such cases (as in the case
of over-the-counter sales of nonprescription drugs) warning by
the manufacturer to its immediate purchaser will not suffice.
. . . In such cases, then, it is the responsibility of the
manufacturer to see that warnings reach the consumer, either by
giving warning itself or by obligating the purchaser to give
warning. Here . . . [the manufacturer; knew that warnings were
not reaching the consumer. Appellee had taken an active part
in setting up the mass immunization clinic program for the
society and well knew that the program did not make any such
provision, either in advertising prior to the clinics or at the
clinics themselves. On the contrary, it attempted to assure
all members of the community that they should take the
vaccine. 399 F.2d 131.
The Missouri Supreme Court reached the same result in Stahlheber v.
American Cyanamid Co., 451 S.W. 2d 48 (Mo. 1970), involving another
mass administration of oral polio vaccine. Recipients included a
41-year-old adult who contracted polio. The manufacturer had not
warned that the vaccine should not be administered to adults other
than those facing special risks of contracting the disease.
The law summarized here appears to lead to the conclusion that a
vaccine manufacturer need not fear liability from injuries resulting
from the administration of the vaccine if (1) the vaccine is correctly
manufactured in accordance with regulatory standards and prudent
manufacturing practices and (2) the manufacturer has taken reasonable
steps to ensure that the recipient of the vaccine will be warned of
possible side effects. Merrill's comprehensive 1973 survey of the law
of liability for all drugs concludes: "If a manufacturer adequately
warns physicians [or, in the case of mass-administered vaccines, the
recipient] about a drug's foreseeable adverse effects, he will escape
liability unless the plaintiff can show that his injury was caused by
some impurity or resulted from an unreasonably dangerous design"
[Merrill, "Compensation for Prescription Drug Injuries," 59 Va. L.
Rev. 1, 49 (1973~.
In two decisions, the Fifth Circuit Court of Appeals, nominally
applying the law first of Texas and then of Florida, imposed liability
in circumstances that would not be covered by these rules. Both
decisions have been subject to criticism,5 and it is not clear how
many courts would follow them today.
The first and most important of these decisions is Reyes v. Wyeth
Laboratories, 498 F.2d 1264 (5th Cir. 1974~. That case involved a
young girl to whom Sabin oral polio vaccine was administered at a
county department of health clinic in Mission, Texas. She developed
polio, and her parents sued on her behalf for damages.
The manufacturer's main line of defense at the trial was that the
vaccine was not the cause of the disease. Experts testified that
virus isolated from a specimen of the child's stool taken on the day
after she was admitted to the hospital was "probably wilder i.e.,
naturally occurring and not the same strain as the vaccine [498 F.2d
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89
1270-12713. The jury found, however, that the vaccine was the cause
of the child's disease, and found for the plaintiff under the district
court's instructions.
The critical issues decided by the court of appeals were two.
First, had the manufacturer discharged its duty to warn? And second,
was the failure to warn sufficiently connected to the occurrence of
the child's disease to support liability? Judge Wisdom wrote a unique
opinion strongly affirming the judgment for the plaintiff.
In Reyes, Wyeth had played no role in the vaccination program, per-
haps because it had changed procedures after its loss in Davis. It had
simply shipped the vaccine in response to an order from the Texas State
Department of Health. The package insert warned of the risk, and Wyeth
argued that it was all that was required to discharge its responsi-
bility. The procedures, forms, and warnings actually used in the
immunization program were the responsibility of the Texas Department
of Health, to which it had quite properly shipped the vaccine.
Judge Wisdom answered this argument without really meeting it.
Wyeth knew that the vaccine was customarily administered in mass
administration programs staffed at least in part by volunteers and
nonprofessionals. Knowing that each recipient would not have
individualized medical advice, it "was required to warn foreseeable
users, or see that the Texas Department of Health warned them" [498
F.2d 1277~. Exactly how Wyeth was to provide these warnings at
distant clinics with which it had no connection, or why Wyeth was not
entitled to rely upon the Texas Department of Public Health to do its
j ob proper ly, Judge Wisdom did not clarify. To the argument that
Davis was inapplicable because in that case Wyeth had actively
participated in the program, Judge Wisdom observed that "the present
controversy, however it differs from Davis factually, invites appl~ca-
tion of the Davis principles, and the conclusion that Wyeth was under
a duty to warn . . . [the recipient's parents [498 F.2d 12771.
The second issue confronting the court of appeals was whether there
was sufficient connection between the failure to warn and the injury
to the child. There was no demonstration that had the child's mother
been warned of the minute incidence of polio from the vaccine she
would have decided not to have her child immunized. This possibility
would seem to have been extremely unlikely because polio was occurring
in the area. The court first looked to Texas cases for the following
rule:
Where a consumer, whose injury the manufacturer should have
reasonably foreseen, is injured by a product sold without a
required warning, a rebuttable presumption will arise that the
consumer would-have read any warning provided by the manufac-
turer, and acted so as to minimize the risks. In the absence
of evidence rebutting the presumption, a jury finding that the
defendant's product was the producing cause of the plaintiff's
injury would be sufficient to hold him liable [498 F.2d 12811.
In the normal product liability case, this rule makes sense. If the
consumer is warned of a danger, he or she can take steps to avoid it.
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Do
However, what was the parent confronted with the warning that Sabin
polio vaccine might cause polio to do? Forgo vaccination and incur
the risk of contracting polio naturally? No, said the court, take
Salk killed-virus vaccine first.
Buttressing the presumption that Mrs. Reyes might have taken
preventive steps is the testimony of Reyes's expert, Dr. RamirO
Casson, that some pediatricians in Hidalgo County, at least by
the time of trial, had begun administering killed-virus vaccine
to infants in order to build up their level of antibodies
before feeding them the live-virus drug [498 F.2d 12821.
This aspect of the decision has been vigorously criticized by Franklin
and Mais in "Tort Law and Mass Immunization Programs: Lessons from
the Polio and Flu Episodes," 65 Calif. _ Rev. 754 (19771:
First, the court did not discuss the availability of Salk
vaccine at the time plaintiffs' child was vaccinated. In fact,
manufacturers discontinued making Salk vaccine and concentrated
on the Sabin vaccine after the government selected Sabin vaccine
for its mass immunization programs in the early 1960s. Indeed,
from 1968 to 1975 no Salk vaccine was manufactured in the
country, although small amounts were imported. Although the
court referred to immunizations in Hidalgo County using Salk
vaccine in the early 1970s, it is likely that these units were
imported and not generally available. Thus, those who would
have chosen Salk vaccine after being warned of the danger of
Sabin vaccine would have had a difficult time obtaining the
alternative.
Second, the court did not discuss the significance of the
fact that the plaintiffs' child was vaccinated during an
outbreak of polio in her area. When quick protection is
essential, Sabin vaccine has been preferred despite the risk
from the live virus. Therefore, even if Salk vaccine had been
available it is unlikely that a well-informed person seeking
protection would have chosen it [65 Calif. L. Rev. 7611.
_
The Oklahoma Supreme Court did not follow Reyes in Cunningham v.
Pfizer & Co., 532 P.2d 1377 (Okra. 1976), because the evidence in that
case showed that at the time of the plaintiff's vaccination in 1963,
Oklahoma was in "an epidemic state." The court reversed a verdict for
plaintiff and remanded, requiring the plaintiff to show that if the
warning had been given, he would not have been vaccinated.
In Reyes, the court imposed liability on the manufacturer for
failing to warn the recipient directly of a risk of contracting
poliomyelitis from the vaccine even though the warning accompanied the
vaccine and would have been very unlikely to change the conduct of the
recipient, or to have prevented the child from contracting polio.
Judge Wisdom's opinion closed with an extraordinary section in
which, in response to an amicus brief filed by the American Academy of
Pediatrics and the Conference of State and Territorial Epidemiologists
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91
opposing liability, he took on both-medical practice and the Congress.
To the doctors he said:
. .
Obviously, however, one can choose to be inoculated with killed-
virus Salk vaccine,~either to provide complete immunity or as a
precautionary prelude to--ingesting oral vaccine. This position
[that no warning should be required] raises a policy considera-
tion scarcely less urgent than -the need for mass immunization
from disease; the right of the individual to choose and control
what risk he will take . . . ~498 F.2d 12941.
To the Congress he said:
Until Americans have a comprehensive scheme of social insurance,
courts must resolve by a balancing process the head-on collision
between the need for adequate recovery and viable enterprises.
. . . [cite] Statistically predictable as are these rare cases
of vaccine-induced polio, a strong argument can be advanced that
the loss ought not lie where it falls (on the victim), but
should be borne by the manufacturer as a foreseeable cost of
doing business, and passed on to the public in the form of~price
increases to his customers.
Givens v. Lederle, 556 F.2d 1341 (Sth Cir. 1977), was a further
extension of Reyes. Givens, like Reyes, involved Sabin oral polio
vaccine. However, unlike Reyes, the vaccine had not been administered
in a county health clinic, but by a pediatrician in his office. The
victim was not the child but the child's mother, who had apparently
contracted the polio from the vaccinated child. The pediatrician had
given no warning of this or any other risk, although the risk was
disclosed in the package insert.
The case had concluded in a jury verdict for the defendant in the
Middle District of Florida (then part of the Fifth Circuit), on the
grounds that the vaccine could not have caused the polio [556 F.2d
13431. Reyes was handed down before the entry of judgment, however,
and the trial judge granted a new trial in light of Reyes. On retrial,
the verdict was for the plaintiff, and the defendant appealed.
A remarkable aspect of the Givens opinion is that the court did not
rely on-Florida law to support its judgment. In Reyes, the court had
gone to great lengths to highlight a line of Texas cases concerning
possible allergic reactions to a drug. In these cases, it was held
unnecessary to warn recipients of possible allergic reactions if the
number of people affected was not significant. It might appear that
because the number of people who get polio from the vaccine is minute,
this line of cases would suggest that no warning of the risk was
necessary under the-controlling Texas law. The court, however,
distinguished between the cases on the ground that an allergic
reaction affected only a small group of recipients, while all
recipients of the polio vaccine were apparently subject to the minute
risk of vaccine-induced polio [498 F.2d 1278-12791. In contrast, the
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92
Givens opinion made no reference to Florida law. It simply followed
Reyes--ostensibly applying Texas law--and treated it as Florida law.
"FAN proposed major distinction is that a county health clinic ad-
ministered the vaccine in Reyes, whereas a private pediatrician did so
here," said the court [556 F.2d 13441. The manufacturer apparently was
relying on the long line of authority indicating that the duty to warn
in the case of prescription medicines prescribed by doctors belongs to
the doctor, not the manufacturer. The pediatrician in Givens had an
established doctor-patient relationship, was a trained and licensed
professional, and had determined that the patient should receive the
vaccine as part of her health care. This was not a case of an
unadvised patient responding to the entreaties of a mass vaccination
campaign.
The court responded to this argument as follows: "The administra-
tion of the vaccine by a public health nurse in Reyes is as close to
the instant situation as it is to the Davis mass inoculation" [Ibid].
Testimony by the plaintiff's physician that n . . . the administration
in his office 'really doesn't differ' from that of the Public Health
Center; 'not in the administration at all"' emphasized the similarity
to the Reyes situation, rather than his role as an informed
intermediary [556 F.2d 13451.
The defendant also argued that its warning to the doctor was
adequate, and should protect it from liability. The warning stated:
Paralytic disease following the ingestion of live polio virus
vaccines has been reported in individuals receiving the vaccine,
and in some instances, in persons who were in close contact with
subjects who had been given live oral polio virus vaccine.
Fortunately, such occurrences are rare, and it could not be
definitely established that any such case was due to the
vaccine strain and was not coincidental with infection due to
naturally occurring poliomyelitis, or other enteroviruses [556
F.2d 13431.
Of this warning, the plaintiff's doctor testified: "ET]he wording of
the inserts states that it is a safe and effective means of immunizing
the population and that the risk, if it exists, is no more than 1 in 3
million. I felt this was a very nebulous way of putting it, . . . and
I did not feel there was sufficient evidence or warning to warn Mrs.
Givens about this" [556 F.2d 134S]. The court held that this was
sufficient evidence to sustain a jury verdict that the warning was
inadequate.
Thus, the court of appeals in Givens treated as factual questions
for the jury whether or not the vaccine caused the polio, and whether
or not the warning was adequate in light of the actual degree of risk
that the vaccine might cause the polio. This situation, in which a
jury confronted with a grievously ill child or adult (who has no other
potential source of financial support or redress) is asked to judge -
retrospectively the actions of the manufacturer, the regulatory
authorities, and those responsible for the public health, tends toward
a biased outcome in favor of the plaintiff.
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93
Although Reyes and Givens were decided in conformity with the
verbal formulas of previous product liability law, the skeptical
reader might easily conclude that they really stood for a different
and simpler rule: the manufacturer is liable for all damages caused
by a vaccine. Just such a rule for all prescription drugs had been
advocated in Merrill's "Compensation for Prescription Drug Injuries,"
59 Va. L. Rev. 1 (1973), and that article was cited by Judge Wisdom in
the policy discussion in the Reyes opinion, 498 F.2d 1294 n. 57. Even
though the Fifth Circuit had no power to make law on this point for
Florida and Texas (the Texas or Florida courts could repudiate these
decisions at any time if they had a case in point and chose to do so),
the skeptical lawyer advising a manufacturer could take as the message
from the judges: manufacturers are going to pay, one way or the other.
Experience From the Swine Flu Vaccination Program
These issues received highly publicized national attention in the
summer of 1976. The discovery of swine flu virus in a human population
with resulting illness (and one death) at Fort Dix, New Jersey, in
January 1976, led the CDC to recommend a national program to provide
immunizations against swine flu for the population.6 The need for
the program was based on the extensive morbidity and mortality
experienced during the disastrous pandemic of 1918, caused by an
apparently identical strain of influenza virus.
The proposals for such a vaccination program moved through the
executive branch and the President to the Congress without a full
appreciation of the problems presented by the threat of liability.
The program was formulated and advanced on the assumption that the
vaccine manufacturers would gladly produce for a fee close to cost the
needed vaccine. The public health officials and government lawyers
did not realize that Reyes and Givens in the district court represented
an entirely new factor in the decision to produce and sell vaccines,
particularly a vaccine proposed for administration to nearly the
entire population in a short period.
The manufacturers and their insurance carriers, on the other hand,
no doubt resented the liability burdens placed upon them by Judge
Wisdom, and were perhaps not unhappy about the opportunity to have
their concerns addressed in a national forum. In any case, it became
clear that the program would not go forward without some legal
protection for the manufacturers, who were unable to obtain insurance
at a price acceptable to them and refused to carry the risk themselves,
in large part because of the limited time available for safety testing.
Rapid congressional action necessitated by the need to manufacture
and administer the vaccine before the onset of the flu season resulted
in P.L. 94-380, effective August 11, 1976. The act provided for an
exclusive remedy against the United States n for personal injury or
death arising out of the administration of swine flu vaccine under the
swine flu program and based upon the act or omission of a program
participant" [P.L. 94-380 sec. 2(k)~2~(A)~. Program participant was
defined broadly to include
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94
. . . the manufacturer or distributor of the swine flu;yaccine
used in an inoculation under the swine flu program, the public:
or private agency or organization that 'provided an inoculation
under the swine flu program without charge for such vaccine 'or
its administration and in compliance with the informed consent
form and procedures requirements prescribed [in the statute!,
and the medical and other health personnel who provided or
assisted in providing an inoculation under the swine flu ;
program without charge for such vaccine or its administration
and in compliance with such informed consent form and
procedures requirements. ;
The statute left open the possibility of the manufacturer's or
other participant's liability only in the form of a right of the
United States to sue any participant for the amount it had paid and
the costs of defending the litigation "resulting from the 'failure of
any program participant to carry out any obligation or responsibility
assumed by it under a contract with the United- States in 'connection
with the program or from any negligent conduct on the part of any -
program participant . . ." [Id. sec. 2(k)~7~.
The Swine Flu Act had little to recommend it except that it made it
possible to go ahead with swine flu vaccine production. The manufac-
turers obtained protection for one vaccine under one temporary program,
but no attention to the issues on any systematic basis. The law was
criticized from many points of view but, in fact, it only changed the
defendant and the rules, albeit unclear, remained the same. It also
thrust the government into the unfamiliar role of product liability
and malpractice defendant. The preamble to section 2(k) stated that
the statute was necessary n in order to be prepared to meet the poten-
tial emergency . . . until Congress develops a permanent approach for
handling claims arising under programs of the Public Health Service
Act." That "permanent approach" subsequently faded as rapidly as the
swine flu emergency.
The concern about the liability problems of vaccination programs so
visible in the debate over swine flu carried over to the state level.
To further the cause of universal vaccination and to protect partici-
pants in the process, the manufacturers, the American Academy of
Pediatrics, and others sought state legislation limiting liability.
In the wake of the swine flu controversy, they were successful in two
states: Maryland and California. Since then, no new, relevant state
legislation has passed.
The Maryland statute provides for immunity of all "program partici-
pants," including manufacturers, if the state Secretary of Health and
Mental Hygiene finds that an immunization project conforms to good
medical and public health practice and gives written approval. No
person is exempted from liability for gross negligence, and a manu-
facturer is not exempted Strom the duty to use ordinary care in
preparing and handling a drug or vaccine" [Maryland Code sec. 18-401,
revised version of Ch. 238 of the 1977 laws].
The California statute mandated the creation of a special fund to
provide for the medical, institutional, supportive, and rehabilitative
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95
care required "because of severe adverse reaction to any immunization
required by state law to be administered to children under 18 years of
age. n7 The statute also stated that "No person shall be liable for
any injury caused by an act or-omission in the administration of a
vaccine or other immunizing agent to a minor . . . if such immunization
is required by state law and the act or omission does not constitute
willful misconduct or gross negligence" [California Health and Safety
Code sees. 429.35 and 429.36, passed as Ch. 1097, sees. 1 and 2 of the
1977 statutes]. A California trial court has held that this statute
protects manufacturers from liability [Flood v. Wyeth Laboratories,
Inc., No. SW C 58664 (Superior Court for the County of Los Angeles)~.
The swine flu program was not a public health success. The vaccine
was successfully manufactured, distributed, and administered to over
45 million~people in a relatively short period of time--a considerable
administrative and logistical achievement. However, the virus did
not reappear the following winter, for reasons that no one understands.
Furthermore, it appeared that 1 out of 100,000 of the recipients
developed Guillain-Barre syndrome (the most recent study reports a
rate of 1 per 200,000~8, an unexpected and unique occurrence of
unknown etiology. AS a result of the publicity about side effects and
the documentation of the apparent relationship between the vaccine and
Guillain-Barre syndrome (GBS), a large number of claims were filed.
The special liability provisions of the swine flu statute, which very
well might have faded into history, proved to be important.
For the purposes of this study, the main importance of the provi-
sions is that they resulted in a large body of litigation relating to
the issue of liability for vaccine manufacture and administration.
The claims and suits are summarized in Table 6.1, prepared by the
Torts Branch of the Civil Division of the Department of Justice. The
government has paid more than $73 million to claimants alleged to have
been injured by the swine flu vaccination. Although this amount is
large in absolute terms, it is less than $2 per vaccine recipient.
Because there has been so little litigation directly relevant to
the liability issue for vaccine manufacture and administration, the
numerous swine flu cases provide the best guide to date on the legal
rights of injured recipients, the liability risks of manufacturers,
and the likely results of court action. It is useful, therefore, to
describe this experience at some length and to-evaluate the factors
that make it relevant to the general question of what vaccine
manufacturers need or need not fear.
The most important decision made in connection with the swine flu
litigation was a decision by the government to stipulate to liability
(accept liability responsibility) for damages caused by the GBS in any
case where the plaintiff could show that the GBS was caused by the
administration of the vaccine. What was the basis of this stipulation
to liability? Was the U.S. government taking the position that the
law imposed strict liability, that the warning had been inadequate,
or that the vaccine was negligently manufactured or administered?
- _ re Swine Flu Immunization Products Liability
The court in
Litigation, 533
following:
Supp. 703, 718 (D. Utah 1982), reported
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112
Although there are distinguished state judiciaries, in a Worst case"
scenario a vaccine manufacturer from a distant state would face trial
in a state court located in the hometown of the plaintiff, and
controlled by a judge subject to frequent elections before that
hometown electorate. The plaintiff's case is likely to be supported
by ~expert" testimony from the treating doctor, perhaps well known and
respected in the community.
Fourth, the swine flu program was accompanied by much more intense
publicity and news coverage than regular, ongoing vaccination
programs. That news coverage may have made many more people aware of
the possible connection between the vaccine and GBS, it may have made
more recipients consider filing claims, and it may have made doctors
more sensitive to the possibility of a GBS diagnosis in persons who
received a vaccination.13
Fifth, there is a difference between the swine flu claims and the
claims that would confront a manufacturer of pediatric vaccines in an
analogous situation. The swine flu vaccination program was focused on
adults and particularly on older persons more likely to incur serious
complications from the disease. This affected the litigation in two
ways. First, older people have shorter life expectancies and any
element of damages calculated over life expectancy is reduced.
Second, in many states, a statute of limitations does not run against
a minor. Thus, a 1-year-old who suffers injuries as the result of a
vaccination may have more than 20 years before any claim is cut off by
the passage of time. This makes it more difficult for the manufacturer
in the pediatric case to estimate the amount of potential outstanding
claims.
Sixth, it is hard to overlook the fact that the defendant in the
swine flu litigation was the ultimate "deep pocketn--the government of
the United States. The judges in the swine flu litigation were not
confronted by a vaccine producer whose solvency and future ability to
provide vaccines would be critically affected by the outcome of the
litigation. The-defendant, instead, was the United States, which
would hardly notice the difference. This fact affected not only the
reactions of the judges, but the decision to stipulate to liability,
the resources dedicated by the Department of Justice to the defense of
the cases, and the style of argument that could be made to the
courts.l4 Indeed, in retrospect it may become clear that the major
mistake of the swine flu statute was to place the defense in the hands
of a bureaucracy without any long-term stake in the controlling rules.
What can be concluded from the swine flu litigation?
First, the professionals close to the plight of a particular victim
find it hard not to support the merits of the claim. The treating
doctor, perhaps not unhappy to direct a potential malpractice claim
elsewhere, provides supportive testimony. Trial judges, confronted by
the hardship the plaintiff has experienced, are tempted to adopt new
interpretations of the law.
Second, doctors and lawyers prefer to treat the issues as the other
profession's problem. The lawyers and judges involved with a particu-
lar case focus their discussion on issues of medical fact, and
ostensibly base their decisions on which medical expert's testimony is
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113
more believable. Many doctors, on the other hand, think the law should
provide a solution to the problem: some are unwilling to testify, and
others fail to differentiate in their testimony between established
effects and ideas outside the scientific mainstream.
Third, the reaction of the courts who found liability to Secretary
Califano's stipulation vividly illustrates the problem facing the
manufacturers. One might argue that the manufacturers have a simple
solution to the liability burden and the costs of litigation. Instead
of strongly resisting liability, as they have, they could simply
concede liability and settle, recovering the costs of their settlements
in higher vaccine prices and avoiding all the costs of extended and
unproductive disputes over issues of esoteric medical fact. That is
what Secretary Califano basically did when he supported the govern-
ment's stipulation of liability for GBS, but a concession of liability
Delilah ~lr~r, ;Ecc~lf The r~r=~:c~lr" t-^ 1-r=AP 1 ;k" ~l=;m~ :~1 ;k" r'=n~r~t-~.~:
CALL ~ Aim "~VI! ~ "~= ~ ~ · ~ &~= ~ C - D"= ~ "~ ". C" ~ ~ ~ ^= ~ ~ ~ ~ ill~ ~ ~ ~ ^= it "~
an ever-expanding pool of liability if the original concession of
liability is based upon no identifiable theory or principle.
Finally, the Unthank and Petty opinions seriously erode any
confidence that in the future a defendant faced with substantial
claims could duplicate the government's basic success. In spite of
the fact that the government won almost all of the cases it contested,
Unthank and Petty are court of appeals' opinions strongly favoring
liability. If they had been handed down early in the litigation, they
might have been viewed as setting a precedent in favor of recovery for
the plaintiff.
Recently, a few other cases relating to liability for the manufac-
ture of vaccines have been reported. One is a flu vaccine case,
involving an administration during the same fateful fall of 1976, but
of a monovalent vaccine (Victoria A strain only) administered in a
doctor's office and thus not falling within the swine flu statute
[Stanback v. Parke-Davis & Co., 657 F.2d 642 (4th Cir. 19811. The
plaintiff had contracted GBS, and the defendant had not warned of the
risk of GBS. The doctor testified that it was his practice not to
warn patients of the type of risk, and that, although he was aware of
a possible risk of GBS in the fall of 1976, he did not warn the
patient and would not have warned the patient even if the package
insert had been different. The district court granted a summary
judgment to the defendant for failure of the plaintiff to prove a
causal connection between the manufacturer's failure to warn and the
plaintiff's injury. The court of appeals affirmed.
There also have been additional polio cases. The most notable is
Schindler v. Lederle Labs., 725 F.2d 1036 (6th Cir. 1983), which
~-
affirmed a judgment in favor of the manufacturer on the grounds that
its package insert provided adequate warning of the risk of contracting
polio. The doctor had administered the vaccine under conditions that
are contraindicated. Dunn v. Lederle Laboratories, 121 Mich. App. 73
.
(1982), also affirmed a verdict for the defendant. In Loge v. united
States, 662 F.2d 1268 (8th Cir. 1981), the district court had
dismissed the complaint against the United States. The court of
appeals reversed on the grounds that the plaintiff's allegations that
the United States had approved the vaccine in violation of its own
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114
regulations were sufficient to state a cause of action. In FraleY v.
American Cyanamid Co., 570 F. Supp. 497 (D. Colo. 1983), the court
held that the defendant was collaterally estopped from contesting the
adequacy of a warning accompanying a dose administered in 1971 and
identical to the warning in Givens.
There are two reported decisions relating to DTP. Walton v.
Charles Pfizer & Co., Inc., 590 P.2d 1190 (Okra. 1979), affirmed a
verdict (of $2,000, a statutory limit) against the City of Tulsa for
the 1966 administration of pediatric vaccines (probably DTP, but not
clear). Morris v. Parke-Davis & Co., 573 F. Supp. 1324 (C.D. Cal.
1983), an ongoing case, involves a claim based on a DTP vaccination
given in 1965. The plaintiff seeks actual and punitive damages. All
manufacturers who produced DTP at the time are joined as defendants
because the source of the DTP is not known. A motion to strike the
claim for punitive damages was denied by the court.
Caron v. United States, 548 F.2d 366 (1st Cir. 1976), affirmed a
judgment of $705,606 for immunization of a 4-month-old baby with DTP,
oral polio vaccine, and typhoid vaccine leading to convulsions, grand
mal seizures, and permanent mental retardation. The typhoid given was
an adult dose. The claim was brought 10 years after the vaccination
on the theory that the typhoid vaccine was administered negligently,
both because the dosage was improper and because in the absence of a
special risk of typhoid, it should not be given to a baby.
Lemar v. United States, 580 F. Supp. 37 tW.D. Tenn. 1984),
dismissed a suit against the government for encouraging pediatric
vaccination without warning of possible adverse consequences.
Calabrese v. Trenton State College, 162 N.J. Super. 145 (1978),
held the manufacturer, distributor, and seller not liable for damages
allegedly caused by rabies vaccine, but denied the physician's motion
for summary judgment because a fact issue existed as to whether he had
disclosed possible adverse side effects. Hitchcock v. United States,
479 F. Supp. 65 (D.D.C. 1979), awarded $519,051 against the united
States to the wife of a foreign service officer who was given
anti-rabies vaccine as "pre-exposure prophylaxis" by government
doctors prior to a foreign posting. The liability was based on the
failure of the government to warn of the benefits and risks of the
vaccine.
Recent Trends
As the committee completed its work, it became aware of two recent,
substantial verdicts against Lederle Laboratories. It will be
impossible to assess the long-term importance of these verdicts until
the appeal process has been completed, because they may not, in fact,
reflect the current state of the law (although the ability of
plaintiffs to obtain substantial verdicts in trial courts itself
reflects the present unstable state of the decisional law). In both
cases, the plaintiffs advanced theories that went beyond the adequacy
of the warning; they asked the juries to rule on issues of social
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115
benefit and harm and on the underlying scientific factors that
contribute to the basic public policy decision to use a particular
vaccine. Juries making such decisions in the liability context easily
could become the de facto regulators of immunization practices in the
United States: verdicts unfavorable to the manufacturers could
effectively stop production of a vaccine even if a majority of juries
decided against liability.
In Toner v. Lederle Laboratories, No. CV 80-1245 (D. Idaho), a jury
returned a~verdict of $1,131,200 in April 1984, based on the theories
that the defendant's DTP preparation caused the plaintiff child's
transverse myelitis and that the defendant could have marketed a safer
pertussis vaccine. The plaintiff pointed to the pertussis vaccine
marketed until 1975 by Eli Lilly and Company. Eli Lilly sold its
rights in the vaccine to Wyeth Laboratories after questions were
raised about its efficacy by a review panel of the FDA, and Wyeth
never obtained a license to manufacture and market it. An appeal to
the U.S. Court of Appeals for the Ninth Circuit is pending [No.
84-39061.
In Johnson v. American Cyanamid Co., No. 81 C 2470 (18th Jud.
Dist., Sedgwick Co. Kansas), the jury on June 1, 1984 returned a
verdict of $2 million for compensatory and $8 million for punitive
damages for a parent-contact of a child who received Sabin (attenuated
live virus) polio vaccine. The plaintiff argued that marketing the
vaccine was negligent because the Salk (inactivated virus) vaccine is
safer, and the parent was not informed that this alternative was
available and equally efficacious. An appeal to the Kansas Supreme
Court is pending.
The Issue of Punitive Damages
If the Johnson punitive damage verdict is affirmed on appeal, it
could significantly affect future vaccine litigation. Prior to the
Johnson verdict, punitive damages were not a prominent factor in
vaccine cases. Most plaintiffs' complaints did not even ask for
punitive damages (information supplied to the committee by one
manufacturer indicated that only IS percent of suits involved claims
for punitive as well as compensatory damages). If the verdict is
affirmed, claims for punitive damages may become more prevalent.
Affirmation of the punitive damage verdict in Johnson could be
interpreted as a determination by a powerful regulatory body (the
common law court and lay jury) that Sabin vaccine should not be
administered in the United States unless preceded by an administration
of Salk vaccine to unimmunized contacts, and perhaps to the child as
well. However, society generally has deemed it desirable to delegate
decisions on such health policy issues to specialist groups, such as
those advising the FDA and CDC--an approach viewed as appropriate by
the committee.
Punitive damage awards would greatly increase the magnitude of
financial risk for manufacturers because such damages can be almost
unlimited in amount and can be duplicative. (Each jury, in each case,
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116
could assess an amount measured by the nature of the defendant's total
conduct.) ~
Punitive damages generally are awarded to punish defendants for
conduct that could be characterized as outrageous or as showing a
reckless disregard for the safety of others. In Johnson, the argument
was based on the wording of the package insert. In addition to
disclosing the risk of contact polio, should the insert also have
described the option of administering Salk vaccine first? The
Immunization Practices Advisory Committee did not (and still does not)
recommend this procedure. The Kansas court's judgment that Lederle's
failure to suggest preimmunization with the Salk vaccine in its
package insert meets the criteria for punitive damages is currently
being appealed. In a previous case, however, the Kansas Supreme Court
affirmed a punitive damage award by a jury that determined
retrospectively that a package insert was insufficient [Wooderson v.
Ortho Pharmaceutical Corp., 235 Ran. 387, 681 P.2d 1038 (19841*~.
-
The Johnson verdict again shows that the manner in which courts
.
rule on questions involving a manufacturer's responsibility is highly
unpredictable.
Summary of the Legal Situation
Under well-established legal principles, a vaccine manufacturer is
not liable for injuries caused by a properly manufactured and labeled
vaccine. In recent years, however, a few courts have acted contrary
to these principles and found manufacturers liable for such injuries,
possibly because the injured individual had been urged (or required)
by the government to participate in the immunization program and
appeared to have no other recourse for compensation.
In general, these vaccine injury claims have been decided on the
basis of the doctrine of the duty to warn. This doctrine provides
that, prior to the use of an unavoidably unsafe product, the user must
be warned of the risks associated with it. In the case of medicines
administered by health professionals, the courts generally have placed
this responsibility on the health care provider. For vaccines,
however, some courts have ruled that the duty to warn resides with the
manufacturer, even though the manufacturer is not involved in admini-
stration. It is unclear whether the courts that have ruled in this
fashion would permit the manufacturer to avoid such responsibility by
obtaining a formal agreement from the purchaser stating that a warning
would be given prior to administration.
In two very recent cases (presently on appeal), the plaintiffs
prevailed by advancing theories of liability that went beyond the
*There are numerous differences between the two cases. One that is
important for the punitive damage issue is that the package insert for
the Sabin polio vaccine did warn of the risk of contact polio, while
the insert in Wooderson did not warn of the possibility of the condi-
tion that actually beset the plaintiff.
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adequacy of the warning and asked juries to rule on the issues of
social benefit and harm, and the underlying scientific factors that
contribute to decisions to use a particular vaccine. In one of these
cases, punitive damages were awarded; however, punitive damages
previously have not been a significant factor in vaccine-related
injury litigation.
This review demonstrates that the limits of a manufacturer's
responsibilities (beyond safe manufacturing and adequate package
labeling) are unclear. Some decisions appear to suggest that the
manufacturer can be held strictly liable in all cases.
At the time this report was compiled, the committee was not aware
of any cases holding health care providers liable for vaccine injury,
except for situations involving failure to follow accepted medical
procedures. It does not presently recommend any change in the rules
applicable to health professionals because liability for improper
administration is appropriate;* it recognizes, however, that if any
proposal limiting recovery against manufacturers were adopted without
provision for reasonable compensation, lawsuits might simply be
redirected from the manufacturer to the administering professional
This could have deleterious effects on the willingness of health care
providers to participate in immunization programs. Such a situation
would require careful monitoring. Tracking shifts in litigation and
recommending remedial action would be one of the functions of the
proposed vaccine commission (see Chapter 7~.
C ONSEQUENCES OF THE STATE OF VACCINE INJURY
LIABILITY LAW FOR VACCINE PRODUCTION AND INNOVATION
Despite clear legal rules, the manner in which claims against
manufacturers alleging liability for suspected vaccine-related
injuries have been handled by the courts does not provide reliable
guidelines for predicting the limits and magnitude of their liability.
This combines with other organizational and scientific factors to
create a situation in which vaccine supply may be threatened.15~16
Causation is difficult, if not impossible, to determine with certainty
in specific cases, and there is usually no other recourse to compensa-
tion for injured individuals. In the committee's judgment, this has
led to a situation in which~jurors and courts may be inclined to view
tort awards as a means of providing compensation, irrespective of
misconduct or scientific considerations.
These circumstances require the manufacturer of a vaccine known to
have certain adverse effects to engage in a gamble with very large
financial stakes. If an increasing number of courts impose liability,
the costs will be enormous because claims average several million
dollars per case. The only way to eliminate the risk is to stop
*The committee recognized that malpractice claims, in general,
represent a major concern of the medical profession, but it did not
feel that the malpractice issue was within the scope of its charge.
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manufacturing the vaccine. If the manufacturer chooses to continue to
market the vaccine, its only options are to attempt to settle claims,
a strategy that could produce a general expectation of liability, or
to resist claims in litigation, with the risk that unfavorable outcomes
could establish liability. The cost of either strategy will be high
(even if claims are defended successfully) and will have to be passed
on to consumers via price increases.
To determine the exact nature of concerns over potential liability
for vaccine-related injury, the committee conducted an informal survey
of vaccine manufacturers. The goal was to solicit information (much
of which was commercially sensitive) on the number and size of vaccine
injury claims and settlements over the past decade, and on the
provisions made by manufacturers for dealing with such eventualities
(e.g., insurance) e The committee received information from most major
companies actively involved in vaccine production. The manner in
which the information on these issues was available did not always
permit comparisons or aggregation for publication, which was a
condition agreed upon for providing such data. For these reasons, the
information summarized below should not be taken as a totally
comprehensive picture of the situation.
At the time of the initial survey (spring 1984), 166 suits were
pending against the four responding manufacturers. The total amount
paid in settlements in the previous decade for completed cases (settled
or finished with the appeal process) had been $2 million, and about
another $1.8 million had been spent on legal defense, not in all cases
including n in-house" counsel.
The information gathered in a follow-up effort (spring 1985)
revealed that about 65 additional suits had been filed in the
intervening year (only a few of the previous total had been settled,
some for amounts averaging $1 million; some trial verdicts were on
appeal). Legal costs for the 1-year period ranged up to "several
million dollars" for some manufacturers. Time series information
supplied by two manufacturers indicated a sharp increase in the number
of claims filed; their experiences varied considerably, but the total
number of reported claims filed against them in 1983 was more than
twice that filed in 1980.
Over the past two decades, pharmaceutical companies have been
withdrawing from vaccine manufacturing and marketing. Increasingly,
the liability situation and its consequences (i.e., litigation costs
or difficulty in obtaining insurance coverage have been cited as
major factors in the decision to withdraw.] ~ 9 These decisions
seem to indicate that present or anticipated vaccine-related injury
liability expenses are seen as an unreasonable burden (or an
unacceptably risky gamble) in relation to the costs of product
development and the income from sales. Such decisions threaten the
nation's supply of vaccine because vaccine production in the united
States is overwhelmingly dependent on commercial manufacturers.
From the data and comments submitted by manufacturers and from
testimony before congressional committees,20~21 the committee
concluded that the precise nature of the problem arising from vaccine
injury liability cannot necessarily be measured solely in terms of
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119
data reflecting past experiences. Litigation over medical injuries in
general has increased substantially during the past 10 years. The
rate of malpractice claims against physicians during the 5 years
between 1978 and 1983 was more than twice that of the preceding 5
years.22 The swine flu episode and publicity about pertussis
vaccine risks have drawn attention to the fact that vaccines may cause
injury. Also, in many states, the statute of limitations for alleged
injury in childhood does not operate while the individual is a minor,
thus vaccine manufacturers may be at risk of claims for many years.
Manufacturers are apprehensive that without some means of compensa-
tion for unavoidable vaccine injury and temporally related conditions,
the present unclear state of the law will continue to allow them to be
held liable for such conditions and penalized financially.
The future behavior of the courts and the responses of the manufac-
turers cannot be predicted with certainty, but the committee is
concerned that the apprehensions themselves might have a negative
effect. Earlier withdrawals from the market have created a situation
in which the United States is reliant on one manufacturer for polio
vaccine and most of its DTP vaccine (Lederle), and on another for
measles, mumps, and rubella vaccines (Merck Sharp & Dohme). If
apprehensions about the current unclear state of the law caused these
manufacturers to withdraw, the vaccine supply and immunization
programs could be jeopardized, leading to possible resurgence of these
diseases. Also, the apprehensions discussed above are a disincentive
to investment in the development of new (or improved) immunizing
agents and to competition from new or foreign firms.23~24
Proposals to remedy the compensation and liability problems
connected with vaccine injury are discussed in Chapter 8.
REFERENCES AND NOTES
See, e.g., Prod. Limb. Rep. (CCH) Par. 90,110-195,270 for a
listing of state product liability statutes; see, generally, L.R.
Frumer and M.I. Freidman, Products Liability (1984~.
2. Prod. Liab. Rep. (CCH) Par. 90,000; but see Product Liability
Risk Retention Act, P.L . 97-45 (allows groups of companies to
form captive insurance companies and exempts such activity from
certain state regulations).
3. American Law Institute. 1965. Restatement of Torts 2d. St.
Paul, Minn.
4. There are also cases involving animals: Lovington Cattle Feeders
Inc. v. Abbott Labs., 97 N.M. 564 (1982~; Pearson v. Franklin
Labs. Inc., 254 N.W. 2d 133 (S. Dak. 1977~; Colorado Serum Co. v.
Arp, 504 P.2d 801 (Wyo. 1972~; Waller v. Fort Dodge Laboratories,
356 F. Supp. 413 (E.D. Mo. 1972~; Alman Bros. Farms & Feed Mill,
Inc. v. Diamond Lab., Inc., 437 F.2d 1295 (5th Cir. 1971~; and
Anderson v. Blackfoot Livestock Commission Co., 375 P.2d 704, 85
Idaho 64 (1962~.
5. See Marc A. Franklin and Joseph E. Mais, Jr. "Tort Law and Mass
Immunization Programs: Lessons from the Polio and Flu Episodes, n
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120
65 Calif. L. Rev. 754 (1977) "written before Givens); see also
Richard A. Epstein, Modern Products Liability-Law 107-110
(Westport, Conn.: Richard A. Greenwood Press, 1980~.
6. There are two extended accounts of the swine flu episode and the
government's reaction to it. The first, Richard Neustadt and
Harvey Fineberg, The Swine Flu Affair: Decision-Making on a
Slippery Disease (U.S. Department of Health, Education and
Welfare, 1978), was written by two Harvard professors for
Secretary of Health, Education and Welfare Joseph Califano, the
appointee of newly elected President Jimmy Carter. The study is
in very much the show we can learn from the mistakes of the past
and do it better n style, and strongly criticizes the officials of
the Ford administration for having committed too early and too
irrevocably to the manufacture and administration of the vaccine,
so that when negative information such as the lack of further
confirmations of the disease or problems in its distribution
began to develop, it was impossible to reverse course and call
off the program. Arthur M. Silverstein, a m~cron~o~og~st at
Johns Hopkins University, who had served as a congressional
fellow during the episode, felt the Neustadt-Fineberg study
greatly oversimplified the problem and the reasons the government
reacted as it did. His study, Pure Politics and Impure Science
(Baltimore: Johns Hopkins University Press, 1981) is more
thorough. Although Secretary Califano attempted to deal
vigorously with the issues created by the swine flu program and
its problems, in the end he, too, was unsuccessful in achieving
significant gains in the institutional and legal framework within
which these questions arise. It remains to be seen whether some
future epidemic threat will become a tragic reality because the
lesson learned from swine flu will be thought to have been:
Don't act too soon.
Esmond S. Smith, M.D., chief of California Children Services,
reported in a letter to the committee November 21, 1984 that
California's Immunization Adverse Reactions Fund has paid the
claims of two children ($1,644.73 and $2,064.59~. One claim is
pending for an immunization in 1973.
8. The entire Matter was restudied in A.D. Langmuir, D.J. Bregman,
L.T. Rurland, N. Nathanson, and M. Victor, "An Epidemiological
and Clinical Evaluation of Guillain-Barre Syndrome Reported in
Association with the Administration of Swine Influenza Vaccines, n
119 Ame J. Epidemiol. 841 (1984~. It concluded that the rate was
less than previously thought, 1 out of 200,000 (a total of
between 211 and 246 cases), and that an incidence rate above the
background rate was confined to the first 6 weeks after
administration. This study explicitly recognized that these
results may have been inflated by the publicity.
9. The document referred to is a press release issued by Secretary
Califano's office in connection with the announcement that the
government would agree to accept liability for cases of
Guillain-Barre syndrome that arose in the first 10 weeks after
vaccination. The press release was not in the record of the
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case. When, at Secretary Califano's deposition, the plaintiffs
attempted to inquire into the reasons for the government's
stipulation, counsel for the government successfully objected to
the line of questioning.
10. The n just compensation" provided by the stipulation in the swine
flu litigation is substantially different from the compensation
recommended by this committee because it included all the
traditional elements of tort damages.
11. These problems may explain why counsel, as reported in No. 9,
desired to prevent deposition testimony by the Secretary on these
issues.
12. The information underlying Table 6.2 was assembled by Mary
Koelbel, a second-year student at the University of Virginia Law
School using LexisiM. There are additional swine flu decisions
that are not reported either in print or in the LexiSTM data
base. The Torts Section of the Civil Division, Department of
Justice (DOJ), has a comprehensive litigation file of all
decisions made in the swine flu litigation. Jeffrey Axelrad,
director of the Torts Branch, permitted Kitch, a member of the
committee, to examine this file on February 6, 1984. To base
this report on information that could be easily verified by
others, the summaries here are based only on publicly available
information. Review of the DOJ files led Professor Kitch to
conclude that there were no important differences between the
outcomes reflected in the published and unpublished decisions,
except that the unpublished decisions tend to be briefer, less
notable, and more overwhelmingly in favor of the government.
Publicly available decisions relating to procedural matters are
not reflected in Table 6.2. Axelrad also prepared Tables 6.1 and
6.3. The committee appreciates the assistance provided by
13.
Axelrad.
The CDC study attempted to determine the rate of vaccine-induced
GBS by comparing rates for the vaccinated and unvaccinated
populations. It then attempted to check for the possibility that
doctors had been more ready to make a GBS diagnosis of patients
who had been vaccinated by comparing objective measures of the
severity of the condition in the vaccinated and unvaccinated
victims. GBS is not a well-defined disease complex. The study
found that these measures were on average the same in the two
populations. That check, however, does not rule out the
possibility that medical personnel were quicker to consider a
possible GBS diagnosis in the vaccinated population after the
widespread publicity about the possible connection. Langmair,
Bregman, Kurland, Nathanson, and Victor, "An Epidemiological and
Clinical Evaluation of Guillain-Barre Syndrome Reported in
Association with the Administration of Swine Influenza Vaccines,"
119 Am. J. Epidemiol. 841, 865-866 (1984), explicitly recognizes
this problem. "However, it is only reasonable to believe that
the history of a swine influenza vaccination in the individual
patient may well have influenced his physician to more seriously
consider both the diagnosis of Guillain-Barre' syndrome and the
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122
reporting of the case if so diagnosed. In addition, patients who
had received swine influenza vaccine may well have sought medical
care more promptly" [Id. at 865-8661.
14. Indeed, it is telling that when the General Accounting Office
studied the processing of swine flu claims at the request of Rep.
John A. Durkin, no attention was paid to the question of whether
the claims being paid were valid claims under the statute, but
only to why the Department of Justice was taking so long before
it authorized payment [U.S. GAO letter B-199297 (January 14,
1981~.
15. National Immunization Work Groups. 1977. Reports and Recommenda-
tions of the National Immunization Work Groups. McLean, Virginia:
JRB Associates.
16. U.S. Congress, Office of Technology Assessment. 1980. Compensa-
tion for Vaccine Related Injury. Washington, D.C.: U.S. Govern-
ment Printing Office.
17. Pettinga, C.W. 1983. Vaccine Innovation in the Private Sector.
Paper prepared for an Institute of Medicine Conference on
Barriers to Vaccine Innovation, November 28-29, 1983, Washington,
D.C.
18. Mason, J.O. 1984. Testimony on H.R. 5810 before the Subcommittee
on Health and the Environment, Committee on Energy and Commerce,
U.S. House of Representatives, December 19, 1984, Washington, D.C.
19. Shaw, D. 1984. Testimony for Wyeth Laboratories on H.R. 5810
before the Subcommittee on Health and the Environment, Committee
on Energy and Commerce, U.S. House of Representatives, December
19, 1984, Washington, D.C.
20. Johnson, R.B. 1984. Testimony for Lederle Laboratories on H.R.
5810 before the Subcommittee on Health and the Environment,
Committee on Energy and Commerce, U.S. House of Representatives,
December 19, 1984, Washington, D.C.
21. Sarett, L.H. 1982. Testimony for Merck & Company before the
Subcommittee on Investigations and General Oversight, Committee
on Labor and Human Resources, U.S. Senate, July 22, 1982.
22. American Medical Association. 1983. Physicians' Professional
Liability Experience, Socioeconomic Monitoring Systems Detailed
Tabulations. Chicago, Ill.: American Medical Association.
23. Beale, A.J. 1985. Modern approaches to the development of
vaccines: perspective of a traditional manufacturer. Pp.
377-381 in Vaccines 85. Molecular and Chemical Basis of
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Representative terms from entire chapter:
district court
