AMERICAN JOURNAL OF EPTOEMIOLOGY
2
Copyright O 1984 by The Johns Hopkins University School of Hygiene and Public Health
All rights reserved
THE USE OF EPIDEMIOLOGIC DATA IN THE COURTS
RICHAED E. HOFFMAN1
On September 15, 1982, a cause of ac-
tion against the Federal government
brought by 1,192 current and former res-
idents of southern Utah and northern Ar-
izona began in Federal District Court in
Salt Lake City. The plaintiffs accused the
government of negligence in conducting
nuclear weapons testing and demanded
millions of dollars in compensation for ill-
ness and death suffered by approximately
400 people. The plaintiffs claimed that
the illness (leukemia and other cancers)
resulted from radiation fallout from nu-
clear bomb tests conducted in the 1950s,
yet none could document their own indi-
vidual radiation exposure. The crux of the
plaintiffs' case rested on scientific studies
which they claimed suggested "that there
is some association between the fallout
and a higher than usual incidence of some
cancers among people who lived or
worked downwind of the testa" (1). A 1980
Congressional investigation concluded
that "fallout from the tests 'more likely
than not' was responsible for the adverse
health effects suffered. .." (1). Conflicting
testimony by scientists at the trial gives
support to a New York Times reporter's
assertion that "most scientists have
stopped short of saying there is a direct
cause-and-effect relationship between ill-
ness and the radioactive fallout" (1). hi
May, 1984, a decision (67) was rendered
by the Court on claims of some of the
1
Department of Epidemiology, School of Hygiene
and Public Health, Johns Hopkins University, Bal-
timore, MD.
Reprint requests to Dr. Hoffman at his current
address: Missouri Division of Health, Post Office
Box 570, Jefferson City, MO 65102.
The author gratefully acknowledges the helpful
advice of Dr. B. Frank Polk, Stephen P. Teret, Peggy
M. Hoffman, Sarah E. McCulloch and Dr. Abraham
M. Lilienfeld, in the preparation of this manuscript.
190
Vol. 120, No.
Printed in USA.
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plaintiffs, and the Government was found
to be liable for a portion of these claims.
This case illustrates several aspects of
the use of epidemiologic data in courts of
law: (a) how courts may view the rele-
vance and admissibility of epidemiologic
studies when applied to individuals'
claims of damage; (b) how it is difficult to
prove causation when the first clinical
manifestation of personal injury occurs
years after exposure to a hazard; and (c)
how courts deal with risks of injury or ill-
ness at low levels of exposure to a hazard
that are extrapolated from risks based on
high levels of exposure. The purpose of
this paper is to discuss for epidemiologists
these three aspects and to illustrate how
epidemiologic data have been used in a
variety of cases including workmen's
compensation, product liability, claims of
damage from events in the distant past,
and disputes over environmental and oc-
cupational hazards. Epidemiologic data
have attained a central role in much cur-
rent litigation related to health because
of the complexity of emerging health and
legal problems, and epidemiologists are
frequently called on to testify in court in
these matters.
COMMENTS ON EPIDEMIOLOGIC AND
LEGAL PROOF
"Epidemiology is concerned with the
patterns of disease occurrence in human
populations and of the factors that influ-
ence these patterns" (2). The results of an
epidemiologic investigation may show a
statistical association between a disease
and an exposure or risk factor. The usual
criteria for inferring that such an associ-
ation is causal include the following: the
statistical strength of the association; the
occurrence of a dose-response relationship
 USE OF EPIDEMIOLOGIC DATA IN THE COURTS
(the response is proportional to the dose
of risk factor or exposure); observation
that a decrease in an exposure is followed
by a decrease in the frequency of a dis-
ease; the temporal sequence of the rela-
tionship (the risk factor or exposure al-
ways precedes the outcome or disease);
the consistency and reproducibility of the
association; the specificity of the associa-
tion; and the biologic plausibility of the
association (3). Evidence for a causal as-
sociation becomes stronger as more of
these criteria are met.
The relationship of the risk factor and
disease may be expressed in several ways:
absolute risk, relative risk, odds ratio,
and attributable risk or fraction. The ab-
solute risk in a defined time period for an
individual with a given risk factor is the
disease incidence in persons with the risk
factor. It is possible that an individual
with a risk factor or an exposure to a
hazard may have a very small absolute
excess risk but a large relative risk for
developing disease.
Whereas scientific proof and statistical
significance rest by convention on dem-
onstration of a 95 per cent or greater
probability that the results of an experi-
ment or investigation were not due to
chance, in civil tort cases the most widely
used standards of proof require a "prepon-
derance of evidence," "more likely than
not," a "50.1 per cent or more proba-
bility," "but for," or "reasonable medical
certainty." Probable is defined as "having
more evidence for than against" (4). "Pre-
ponderance of evidence" is defined as "ev-
idence of greater weight or more con-
vincing than the evidence which is offered
in opposition to it. . . "preponderance' de-
notes a superiority of weight" (5). In crim-
inal cases, the usual standard of proof is
"beyond a reasonable doubt." Therefore,
quantitative epidemiologic data must be
expressed more qualitatively in the court-
room (6).
The jury system rests on qualitative, not quan-
titative evaluation of data... The closer a case
191
approaches final determination, the less scope
there is for scientific data, statistical or math-
ematical. The proposition that expert data can
'usurp the function of the jury' has little if any
weight.. .
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Considering that the "crux of medico-
legal causation is the occurrence of ag-
gravation of an underlying disorder. . .
by the one causative element under scru-
tiny independent of other co-existing
causes,. . .and not the degree to which the
disorder was aggravated" (7), it appears
that relative and attributable risk would
be more useful in providing the degree of
proof required for legal acceptance of cau-
sation than absolute risk or incidence.
This is because relative and attributable
risk focus attention on the contribution of
one factor to a person's chance of devel-
oping disease. For example, the annual
incidence of lung cancer in US whites who
smoke is approximately one per 1,000
persons. The proportion of lung cancer at-
tributable to smoking is close to 85 per
cent, and the relative risk of developing
lung cancer is 10 times greater in
smokers than in nonsmokers (8). Thus,
even though a white US smoker does not
have a 50.1 per cent or greater probability
of acquiring lung cancer (absolute risk),
it is probable that smoking is a cause of
lung cancer (relative and attributable
risks). Of course, not all epidemiologic
analysis can be expressed in terms of ab-
solute, relative, or attributable risk, and
sometimes the epidemiologist's opinion
may be no more than an educated guess.
As a result it is worth noting that testi-
mony of a "possibility" ("an uncertain
thing which may happen" (9)) is merely
speculative and is not sufficient to estab-
lish a causal relationship (10). The epi-
demiologist whose emphasis is on the
multiple risk factors for a disease and the
premorbid state of the plaintiff may find
himself or herself inadequate when
taking the witness stand, because he or
she is not oriented to the previously
stated crux of medico-legal causation.
192 HOFFMAN
EPIDEMIOLOGIC DATA AS EVIDENCE
Numerous legal problems may occur
when epidemiologic and biostatistical
data are introduced in the courtroom. An
initial concern is whether circumstantial
evidence ("testimony not based on actual
personal knowledge or observation of the
facts in controversy, but of other facts
from which deductions are drawn,
showing indirectly the facts to be proved"
(11)) such as probabilities based on pop-
ulation data is relevant evidence in
cases involving individual damages.
Black's Law Dictionary states that "the
basic test of admissibility is rele-
vance. . .and evidence is 'relevant' not
only when it tends to prove or disprove
precise fact in issue but when it tends to
establish fact from which the existence or
non-existence of fact in issue can be di-
rectly inferred" (12). Thus, it appears on
face value that probabilities derived from
population data may be relevant evi-
dence.
In criminal proceedings the epidemiol-
ogist may be asked to determine the prob-
ability that an identifying characteristic
of the defendant is related to a condition
the injured party has suffered. In New
Mexico vs. Sneed (13), the Supreme Court
of New Mexico held that statistical odds
used in homicide prosecution for purposes
of identification of the defendant were in-
admissible in criminal cases "so long as
the odds are based on estimates, the va-
lidity of which have not been demon-
strated" (14). In New Mexico vs. Sneed, a
mathematician presented probabilities of
persons having certain personal charac-
teristics; he then multiplied these proba-
bilities to obtain a final probability that
an individual would have all of the char-
acteristics. Because the final probability
was so small, he inferred that the odds
were great that the defendant, who had
all of the characteristics, was the only
person who could fit the description given
by the injured party. The court held that
the mathematician's testimony was not
admissible for the reasons given above.
This case is germane to epidemiologists
not only because of the attempted use of
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statistical evidence, but also because ep-
idemiologic investigations occasionally
parallel criminal investigations. The par-
allel investigations have occurred in two
instances following a cluster of unex-
plained deaths in a hospital (15, 16).
In general, when probability statistics
have been rejected as evidence, it has
been because "(a) the testimony itself
lacked an adequate foundation both in ev-
idence and in statistical theory and (b)
the testimony and the manner in which
the prosecution used it distracted the jury
from its proper and requisite function of
weighing the evidence on the issue of
guilt. . .and placed the jurors and defense
counsel at a disadvantage in sifting rele-
vant fact from inapplicable theory" (17).
Life expectancy probabilities, which
are derived from actual mortality data,
have been distinguished from more ab-
stract probability evidence such as that
used in New Mexico vs. Sneed. Examples
of cases in which life table expectancies
were admissible include O'Connor vs.
United States (18) and Kershaw vs. Ster-
ling Drug, Inc. (19). In the former case,
the evidence was used to estimate years
of life lost by the plaintiff. It would seem
likely that based on acceptance of life
table expectancies, courts would also ac-
cept clinical life table data. These data
are expressed in the same format as life
table expectancies, but are usually com-
puted as the survival expectancy of dis-
eased persons receiving a particular
treatment.
Another potential concern regarding
the courtroom use of epidemiologic data
is whether they may be excluded on the
basis that they are hearsay evidence.
"Hearsay evidence" is defined as "testi-
mony in court of a statement made out of
court, the statement being offered as an
assertion to show the truth of matters as-
 USE OF EPIDEMIOLOGIC DATA IN THE COURTS 193
serted therein, and thus resting for its ever, granted the Centers for Disease
value upon the credibility of the out-of- Control's motion for a protective order to
court testifier" (20). Despite the fact that prevent the release of the names of the
epidemiologic analysis is frequently toxic shock victims to Procter and Gamble

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based on grouped, confidential data, this Company because of the highly personal
concern is more theoretical than actual information about sexual activity,
for two reasons: (a) in the courtroom the tampon usage, and hygiene (24). Subse-
evidence is given by a declarant, the ep- quently, the original cause of action was
idemiologist, who has personal knowl- settled out of court, and the litigation
edge of the subject, who is under oath, over release of names of the toxic shock
whose demeanor can be evaluated by the victims became a moot issue.
jurors, and who is subject to cross-exam-
ination, thus fulfilling the usual stan- PROOF OF DAMAGES ALREADY INCURRED
dards for testimony (21); and (b) many ep- This section discusses several examples
idemiologic investigations are conducted of litigation in which damages had al-
by state and federal health officers whose ready occurred. This is in contrast to the
records and investigative reports are com- proof of future damages which will be dis-
piled pursuant to their duty and au- cussed in the next section of this paper.
thority, and, thus, are excepted from the The purpose of discussing the cases is to
hearsay rule (22). The rule is one of the show the interesting range of experience
Federal Rules of Evidence, and it states of epidemiologists and epidemiologic evi-
that hearsay evidence is inadmissible ex- dence in the courtroom, rather than to
cept as provided in the rule. Even if the make generalizations or determine trends
report contains evaluation and interpre- based on these cases.
tation of data, the report is admissible in Two workmen's compensation cases
federal courts "in civil cases and against demonstrate the use of relative risk to
the government in criminal cases" (22). prove that an infectious disease con-
A concern similar to whether the evi- tracted by workers was proximately
dence is hearsay is that the admission of caused by a risk incident to employment.
grouped, confidential epidemiologic data The first case, Bethlehem Steel Company
may deny the defendant Sixth Amend- vs. Industrial Accident Commission (25),
ment rights permitting the defendant to was argued before the California Su-
cross-examine witnesses. This became an preme Court in 1943. Ten employees
issue recently following the case of Lamp- working in Bethlehem Steel's San Fran-
shire vs. Procter and Gamble Company, in cisco shipbuilding yard claimed that they
which the plaintiff suffered from toxic contracted keratoconjunctivitis while
shock syndrome. The plaintiffs case working. Although Bethlehem Steel
rested in part on confidential data from Company did not dispute that there was
epidemiologic studies by the Centers for an epidemic of the disease among its
Disease Control which demonstrated a employees—280 cases in 13,000 em-
statistical association between the use of ployees—the company argued that the
Rely tampons and subsequent develop- disease was also epidemic in San Fran-
ment of toxic shock syndrome. Procter cisco and that the eye infection, therefore,
and Gamble Company applied to the US did not arise from a special risk incurred
District Court in Atlanta to obtain the by working at the shipyard. The Indus-
names of the individual toxic shock vic- trial Accident Commission, which prior to
tims, "saying that without this informa- the case had awarded compensation to the
tion, it cannot effectively cross-examine workers, argued successfully that if the
experts" (23). The District Court, how- incidence in San Francisco were the same
194 HOFFMAN
as for the shipyard, then there would be
14,000 cases in the 700,000 people living
in San Francisco. Subsequent testimony
from practicing ophthalmologists dis-
closed that there were considerably less
than 14,000 cases in the community and
that the disease of the claimants was
probably acquired at the place of employ-
ment. Thus, the relative risk of devel-
oping keratoconjunctivitis was consider-
ably greater for shipyard workers than
for the general population of San Fran-
cisco. The court ruled in favor of the In-
dustrial Accident Commission.
The second case, Sacred Heart Medical
Center vs. Washington State Department
of Labor (26), concerned the claim by an
intensive care unit nurse in 1979 that she
contracted hepatitis B as a result of her
employment even though she had no
known exposure to anyone with the dis-
ease either in the hospital or while off
duty. Nevertheless, she concluded she
was infected in the course of her nursing
work from an unidentified carrier of hep-
atitis B. The case differs from the first one
in that expert medical witnesses did not
testify directly on the ultimate issue of
the causal connection between employ-
ment and the injury, i.e., no physician
specifically stated that the nurse prob-
ably acquired the disease while working
in the hospital. Instead, the causal con-
nection was inferred from epidemiologic
studies which showed that hospital
workers who handle blood, blood prod-
ucts, and certain body secretions are at
increased (relative) risk of contracting
serum hepatitis. The court held that "if,
from the medical testimony given and the
facts and circumstances proven by evi-
dence, a reasonable person can infer that
the causal connection exists, we know of
no principle that would forbid drawing of
that inference" (27). The court ruled in
favor of the nurse.
Reyes vs. Wyeth Laboratories (28) was
an important case involving product lia-
bility decided in 1974 by the Fiah Circuit
Court of Appeals. The case was signifi-
cant not only for the lack of weight given
to epidemiologic data and expert testi-
mony during the trial, but also because of
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the impact of the majority opinion on im-
munization and communicable disease
control practice in this country. A young
child living in Mission, Texas, developed
paralytic polio two weeks after receiving
live, attenuated polio vaccine at a Hi-
dalgo County Health Department clinic
in May 1970. Her father, the plaintiff, al-
leged that the illness was the result of the
vaccine and that the manufacturer failed
to warn the child or her mother of this
risk. The plaintiff argued that the man-
ufacturer was liable because it had a duty
to provide warning to the consumer in a
setting in which individual medical judg-
ment was not provided. The principal de-
fense of Wyeth Laboratories, manufac-
turer of the vaccine, was that an epidemic
was occurring in Hidalgo County at the
time of the child's vaccination and that
laboratory studies performed on the child
showed that the virus which caused her
illness was probably the epidemic "wild"
virus strain, not a vaccine virus strain.
The trial court's verdict was in favor of
the plaintiff. Over the objections of the
American Academy of Pediatrics and the
Conference of State and Territorial Epi-
demiologists, two of the three principal
immunization policy-making organiza-
tions in this country, the Appeals Court
held that "in the case of a prescription
drug which is unavoidably unsafe. . .
there must be either a warning. . . or an
individualized medical judgment that
this treatment or medication is necessary
and desirable for this patient" (29).
Although the defendant brought at
least eight expert epidemiologic and lab-
oratory witnesses before the court, the
crucial witness in the trial was the child's
attending physician. He testified that it
was probable that the child acquired polio
from the vaccine. Hassman (30), writing
on expert medical testimony, states:
 USE OF EPIDEMIOLOGIC DATA IN THE COURTS
. . .the attending physician is the medical ex-
pert who is most widely accepted by the courts,
and who ia given the widest latitude in testi-
fying. .. The testimony of even the most rep-
utable expert whose only interest is that of a
witness is often viewed with greater skepti-
cism than that of the old family physician.
The trial judge instructed the jurors to
use the attending physician's definition of
"epidemic" (taken from a medical dictio-
nary), rather than the US Public Health
Service definition of a polio epidemic
(based on perceived disease control pro-
gram needs). The trial judge also refused
to allow the chief of the Centers for Dis-
ease Control polio virus laboratories to
give his opinion as to whether the child's
disease was caused by a wild or vaccine
virus strain because the witness was not
a physician. In addition, the judge refused
to instruct the jury to consider the rela-
tive risk of the vaccine causing disease
versus the risk of the wild strain causing
disease. Instead, he focused on absolute
risk and instructed the jurors to deter-
mine if there was a preponderance of ev-
idence that there was a medically cogni-
zable risk that the vaccine might cause
paralytic polio. Finally, one expert wit-
ness, an experienced epidemiologist, was
impeached, i.e. the testimony of the wit-
ness was challenged or called into ques-
tion, because of apparent inconsistency.
The witness had testified at a previous
trial for Wyeth, and an uncertified tran-
script of the trial was used by the plaintiff
to show that the expert had stated type
HI polio virus was the least stable vaccine
component in the first case and that type
I virus was the least stable component in
the second case. The defense argued that
the plaintiffs use of an uncertified tran-
script to impeach or discredit the expert
was improper. However, the trial judge
overruled this objection, allowed the use
of the uncertified transcript, and per-
mitted the jurors to consider all of the tes-
timony. The witness denied the inconsis-
tency, stating he was referring in the ear-
195
lier case to antigenic character and in the
Reyes case to pathogenicity.
Upholding the trial judge, the Appeals
Court stated that "an expert in medicine
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is not exempt from the use of prior testi-
mony to prove his fallibility" (31). The
Appeals Court upheld all of the trial
judge's actions. Commenting on the de-
fendant's complaints that the jury cred-
ited testimony of the attending physician
rather than the evidence offered by
Wyeth's expert witnesses, the court noted
that "presented with conflicting credible
evidence, such a determination was
within the jury's prerogative; expert wit-
nesses appear to assist in the court's de-
cision-making process, not to control it"
(32).
Three recent cases related to the Na-
tional Swine Flu Immunization Program
are good examples of the central role that
epidemiologic data have attained in cur-
rent litigation. The cases were tried in
three different federal district courts. In
all three cases—Alvarez vs. USA (33),
Thompson vs. USA (34), and Padgett vs.
USA (35)—the plaintiffs argued that
they developed Guillain-Barr6 Syndrome
(GBS) secondary to receiving swine flu in-
oculation. Unlike Reyes vs. Wyeth Labo-
ratories, the US Government rather than
the vaccine manufacturer assumed lia-
bility in instances of personal injury or
death as a result of swine flu vaccination,
in accordance with the Swine Flu Act of
1976. The plaintiffs had to prove only that
their illness was caused by swine flu vac-
cination. The latent period from vaccina-
tion to onset of symptoms of Guillain-
Barre" Syndrome was the key issue in
each case. In Alvarez vs. USA, the latency
was reported as seven months; in
Thompson vs. USA, it was 11 weeks; and
in Padgett vs. USA, it was 16 weeks. Be-
cause it was established in each case that
the underlying cause of Guillain-Barre'
Syndrome was unknown, the Courts
turned to epidemiologic data to determine
if the plaintiffs' latent periods were con-
196 HOFFMAN

sistent with the assertion that swine flu laboratory testimony from numerous ex-
vaccination caused their illness. The perts, the trial judge found and the Court
Courts relied primarily on a study con- of Appeals later affirmed that the plain-
ducted by Schonberger et al. (36) from the tiff died from lung cancer caused by

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Centers for Disease Control. One finding smoking the named cigarettes. However,
of the study was that more than 10 weeks the Appeals Court ruled that the manu-
after vaccination the relative risk of de- facturer was not liable, in part because
veloping Guillain-Barr6 syndrome for the majority of persons who smoke ciga-
persons who had received the vaccine was rettes do not develop lung cancer and per-
not statistically significantly different sons who have never smoked cigarettes
from persons who had not been vacci- may acquire the disease. The dissenting
nated. Because the plaintiffs' latent pe- opinion (41) discusses this issue:
riods were greater than 10 weeks in each
case, the Courts ruled that there was not If every user of the product is thus exposed to
cancer and death, then how, as a fact, can it
a preponderance of evidence showing the be reasonably fit—for one or for a million? The
illness was caused by swine flu vaccina- inquiry is not answered by proclaiming that a
tion (37-39). known killer failed to infect or to kill millions
of others, who fortunately escaped its effects. . .
Yet, it seems quite clear that if we had a seller
The increased incidence of GBS as a result of of canned meat before us he would get nowhere
the swine influenza vaccination ends at most in an absolute liability case by claiming that
ten weeks after inoculation. Since the plain- only one container in a million contained
tiff's GBS occurred sixteen weeks after his in- poison and he is not liable since only a few
oculation, the vaccination did not cause or con- people were killed. Why the legal distinction
tribute to plaintiffs GBS. between a package of cigarettes and a can of
meat? I submit that there is none.
In light of the present state of medical knowl-
edge, and the more persuasive and credible Perhaps one reason the Appeals Court
testimony, we are of the view that ten weeks chose to overlook the relative and attrib-
is the acceptable medical and scientific opinion
as to an outside parameter of causation. utable risk calculations may be the long
latent period from first exposure to onset
As a result of Dr. Schonberger's study, it has of disease for lung cancer. In Mr. Green's
been suggested that the temporal relations can case, it was 56 years, and it must be as-
be ten weeks. In the instant case, we believe
seven months is too long an interval to caus- sumed that in that time he received a sub-
ally connect the vaccine and plaintiffs GBS. stantial dose of carcinogen from the cig-
arettes. Because there is no known
Green us. American Tobacco Company threshold level of exposure below which
(40) is an interesting example of a case of the risk of cancer from smoking is nil, it
personal illness developing decades after may be difficult for courts to understand
an alleged damaging event. It was de- why some long-term smokers, receiving
cided by the Fifth Circuit Court of Ap- nearly the same dose as Mr. Green, do not
peals in 1969. In the final decision rela- develop cancer when the relative and at-
tive risk was disregarded in favor of em- tributable risks are so large. This distin-
phasis on absolute risk. The case was guishes lung cancer from food poisoning
based on a claim by Mr. Green that he by canned meat. In the latter instance, it
contracted lung cancer as a result of is intuitively easier to see the danger due
smoking the defendant company's ciga- to the short incubation period and to
rettes for 56 years and that the defendant, guess that only one in a million was af-
the manufacturer, should be held liable fected because either the poisoned person
on grounds of a breach of implied war- received an exceptionally large dose or
ranty of the product. The court ruled in that the poison was in only one can. With
favor of the defendant. Although there regard to lung cancer, rather than ac-
was much conflicting epidemiologic and cepting the deductive logic of statistical
 USE OF EPIDEMIOLOGIC DATA IN THE COURTS
inference, the court essentially ruled that
Mr. Green was a special case.
PROOF OF FUTURE DAMAGES
Just as epidemiologists may be pushed
to the limit of their methods in trying to
determine if and at what level a health
risk exists, so the courts have had to forge
new legal paths in considering whether
epidemiologic evidence is sufficient to es-
tablish a causal relation between expo-
sure to a substance and ill health. In the
past 15 years courts have increasingly re-
lied on epidemiologic data to help resolve
litigation concerning both the chance of
illness in the future resulting from expo-
sure to a known health hazard and dis-
putes about environmental regulatory
standards. In these types of litigation, the
damages are not nearly as easily associ-
ated in time or by dose as in illness re-
sulting from food poisoning, adverse drug
effects, or acute physical trauma. Indeed,
it has been written that "there is probably
no more difficult problem in the area of
medical proof than the proof of the like-
lihood of future injury or disease" (42). In-
stead of proving a direct causal relation
between an event and injury, the plain-
tiffs have the burden of proving that they
have an increased risk of disease re-
sulting from an exposure. "Plaintiff has
but one day in court and he is bound at
his peril to foresee all that can happen to
him on account of defendant's original
act, for he must recover in one lump sum
all his damages, past and future in one
trial" (43). Litigation involving future
damages includes not only future injury
arising out of past accident (e.g., future
epilepsy from head injury), but also sus-
ceptibility to future disease or injury (e.g.,
future cancer secondary to asbestos ex-
posure), fear of future disability (e.g.,
anxiety from knowledge of increased risk
of cancer), and shortened life expectancy
as a result of exposure to a toxin (44). In
75 American Law Reports 3d Series, it is
stated that "reasonable probability" or its
197
equivalent is a sufficient standard of
proof for medical testimony in cases of fu-
ture damages and that "possibility" is
merely speculative and not sufficient ev-
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idence by itself (45). It will be shown later
in this paper that satisfying this standard
is becoming increasingly complex.
Ethyl Corporation vs. Euvii onmental
Protection Agency (46) and Reserve
Mining Company vs. Environmental Pro-
tection Agency (47), cases decided in 1975
and 1976, were especially important for
public health workers trying to take reg-
ulatory or injunctive action to prevent
possible future health damages. The sum
effect of both decisions was to redefine the
kind of evidence necessary to prove risk
of harm and endangerment to the public
health. The decisions at various stages in
both cases were temporally intertwined,
and the final opinion in each explicitly
relies in part on the other.
In an article in the Journal of Urban
Law, Brown states that the decisions in
Ethyl Corporation vs. Environmental Pro-
tection Agency and Reserve Mining Com-
pany vs. Environmental Protection Agency
are "extremely significant" because of the
judicial "recognition of the propriety of a
concept of uncertain risk" (48). Whereas
courts had previously concluded that de-
cisions concerning endangerment of
public health were arbitrary and specu-
lative without proof of actual damages in
the past, according to Brown, these cases
were "authority for the view that it is pos-
sible and wise to operate from inconclu-
sive evidence, not only in regulating toxic
substances, but also in assessing other
hazards to human health and the envi-
ronment" (49). In these two cases the
Courts accepted and relied upon infer-
ences from several epidemiologic studies
none of which addressed exactly the cir-
cumstances of the situation in dispute.
Thus, in both cases, actual harm had not
previously occurred, and the trial and ap-
pellate courts were forced to consider un-
certain risk of future health damages. In
Ethyl Corporation vs. Environmental Pro-
198 HOFFMAN
tection Agency, the Court concluded that
endangerment is "composed of reciprocal
elements of risk and harm, or probability
and severity" (50) and that ". . .the mag-
nitude of risk sufficient to justify regula-
tion is inversely proportional to the harm
to be avoided" (51). In both Ethyl Corpo-
ration vs. Environmental Protection
Agency and Reserve Mining Company vs.
Environmental Protection Agency, the
Courts determined the probability of
danger to be small, but because the se-
verity of the danger, lead intoxication in
the former and cancer in the latter case,
was considered to be great, the Courts
chose to take precautionary action.
Ethyl Corporation vs. Environmental
Protection Agency was decided in 1976 by
the D.C. Circuit Court of Appeals, where
much litigation involving regulatory
standards is argued. In this case, the pe-
titioner, Ethyl Corporation, challenged
an Environmental Protection Agency
order requiring annual reductions in the
lead content of leaded gasoline. Ethyl
Corporation argued that the Environ-
mental Protection Agency order was ar-
bitrary and capricious because it was not
supported by sufficient scientific evidence
demonstrating that automotive lead
emissions endanger the public health.
The Court's task was to determine if the
basis of the regulatory agency's order was
rational. The Environmental Protection
Agency had relied on several epidemio-
logic studies which showed (a) a consis-
tent correlation of atmospheric and blood
lead levels within particular metropol-
itan areas and in certain occupational
groups; (b) a correlation between blood
lead levels in black females and prox-
imity of residence to a major highway;
and (c) a correlation of blood lead levels
in children living near highways and
traffic density. The Court agreed with
Ethyl Corporation's criticism that the in-
tracity and occupational studies failed to
document individual lead exposure in
persons for whom blood lead levels were
measured, and it observed that "inability
to prove conclusively cause and effect re-
lationships is an inherent limitation of
epidemiological research'-1 (52). Neverthe-
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less, it concluded that because of the con-
sistent relationship of air and blood lead
levels found, "we cannot find the (Envi-
ronmental Protection Agency) adminis-
trator's reliance on these data. . .to be ar-
bitrary and capricious" (53). The Court
noted that all of the epidemiologic studies
were "confounded by the multiple sources
of lead. . .none of the epidemiologic
studies could control or measure dietary
lead intake. . .and this uncertainty. . .led
the administrator to rely instead on data
limited to situations in which dietary ex-
posure could roughly be termed constant"
(54). However, the Court did not discount
these studies. Instead, it focused on the
Environmental Protection Agency's cu-
mulative impact approach (55).
He (the Environmental Protection Agency ad-
ministrator) determined that absorption of
lead automobile emissions, when added to all
other human exposure to lead, raises the body
lead burden to a level that will endanger
health. He realized that lead automobile emis-
sions were, far and away, the moat readily re-
duced significant source of environmental
lead. And he determined that the statute au-
thorized him to reduce those emissions on such
a finding. We find no error in the
. . .cumulative impact approach.
Although there is no mention in the
majority opinion of studies which mea-
sured the attributable risk or fraction of
automotive lead emissions in persons
with elevated blood lead levels, it seems
clear that the Court would be receptive to
such data because attributable risk would
focus attention on that part of the cumu-
lative impact due to automotive emis-
sions.
The final decision in Reserve Mining
Company vs. Environmental Protection
Agency was made by the Eighth Circuit
Court of Appeals in 1975. The defendant,
Reserve Mining Company appealed the
ruling of a district court which ordered
the immediate closure of the company fa-
 USE OF EPIDEMIOLOGIC DATA EM THE COURTS 199
cility. The closure of the taconite iron ore well established, whereas gastrointes-
processing plant was ordered because of tinal cancer caused by ingestion of as-
potential harm to the public caused by bestos fibers was hypothetical, it ordered
emission of asbestiform particles into air immediate implementation of air emis-

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near Duluth, Minnesota, and into water sion controls, but gave the company "a
of Lake Superior. The crucial question in reasonable time to stop discharging its
the case was whether the emissions posed wastes into Lake Superior" (58).
an imminent, substantial danger to In the mid-1970s, two more cases in-
health. On the basis of testimony from a volving uncertain risk were brought be-
court-appointed consultant and an occu- fore the D.C. Circuit Court of Appeals.
pational health expert who conducted ep- The cases—Industrial Union Department,
idemiologic studies of asbestos workers, AFL-CIO vs. Hodgson (59) and The So-
the judges ruled that the "risk to the ciety of the Plastics Industry us. Occupa-
public justifies an injunction decree re- tional Safety and Health Administration
quiring abatement of the health hazard (60)—involved regulations of asbestos
on reasonable terms as a precautionary and vinyl chloride, respectively. Unlike
and preventive measure to protect the Ethyl Corporation vs. Environmental
public health" (56). The majority opinion Protection Agency and Reserve Mining
noted (57) that: Company vs. Environmental Protection
. . .the trial court, not having proof of actual
Agency, it was not disputed that occupa-
harm was faced with a consideration of (1) the tional exposure to asbestos and vinyl
probabilities of a health harm and (2) the con- chloride was harmful. Instead the argu-
sequences, if any, should the harm actually ment was concerned with the determina-
occur. . . In assessing probabilities in this case,
it cannot be said that the probability of harm tion of a safe level of occupational expo-
is more likely than not. Moreover, the level of sure to the toxins. For both toxins, ad-
probability does not readily convert into a pre- verse health effects following high levels
diction of consequences. On this record it
cannot be forecast that the rates of cancer will of exposure to the substance were as-
increase from drinking Lake Superior water or serted using epidemiologic evidence. The
breathing Silver Bay air. The best that can be
said is that the existence of this asbestos con- Court upheld the Occupational Safety
taminant in air and water gives rise to a rea- and Health Administration (OSHA) stan-
sonable medical concern for the public health. dards in both cases despite the lack of fac-
The public's exposure to asbestos fibers in air
and water creates some health risk. tual evidence of harm at the exposure
levels in dispute. The risk of harm was
The demonstration of potential harm uncertain, but the Court concurred with
was based on epidemiologic studies of oc- OSHA that there was a reasonable
cupational exposure to asbestos. Evidence probability of harm based on extrapola-
was presented demonstrating the strong tion from epidemiologic and laboratory
association of inhalation of asbestos fibers studies.
and lung cancer and an increased inci- In two subsequent US Supreme Court
dence of gastrointestinal cancer among decisions, a greater burden was placed on
workers occupationally exposed to as- the plaintiff to prove future damages. In
bestos. The Court decided that the pres- essence, the Supreme Court declined to
ence of a human carcinogen in the envi- extrapolate a safe level of exposure to a
ronment was a reason for preventive ac- toxin from data based on high levels of
tion even if the probability of future exposure.
damage was not necessarily greater than The 1980 case, Industrial Union vs.
50 per cent. Because the Court deter- American Petroleum (61), involved a
mined that the danger of lung cancer human carcinogen—benzene—while
from inhalation of asbestos fibers was American Textile Manufacturer's Institute
200
vs. Donovan (62), decided in 1981, in-
volved airborne cotton-dust particles, ex-
posure to which may induce a respiratory
disease known as byssinosis. In the
former case, OSHA was challenged when
it lowered the exposure limit for benzene
from 10 parts per million (ppm) to 1 ppm.
At that time OSHA's standard policy with
respect to carcinogens was that in the ab-
sence of definitive proof of a safe level of
a carcinogen, it must be assumed that any
level above zero presents some risk of
cancer. The agency did not lower the ben-
zene standard below 1 ppm because of eco-
nomic and technologic reasons. The pri-
mary issue in the analysis of the epide-
miologic evidence presented in the case
was determining the risk of cancer re-
sulting from exposure to benzene at levels
less than 10 ppm. The Supreme Court
ruled that the burden of proving that a
significant risk of harm existed was on
OSHA. Because there were no reliable
dose-response data for low levels of ben-
zene, the Court decided that OSHA had
not demonstrated that "it is at least more
likely than not that long-term exposure
to 10 ppm of benzene presents a signifi-
cant risk of material health impairment"
(63). The Court held the OSHA benzene
standard to be invalid, and following the
decision, "OSHA deleted those provisions
of the Cancer Policy which required the
'automatic setting of the lowest feasible
level' without regard to determination of
risk significance" (64).
In contrast to evidence presented by
OSHA to support its benzene standard, in
American Textile Manufacturer's Institute
vs. Donovan, the majority opinion stated
(65) that:
. . .in asserting the health risks from cotton
dust and the risk reduction obtained from low-
ered exposure, OSHA relied particularly on
data showing a strong linear relationship be-
tween prevalence of byssinosis and the concen-
tration of lint free respirable cotton
dust.. .cotton dust produced significant health
effects at low levels of exposure. . .it is difficult
to imagine what else the agency could do to
comply with this Court's decision in Industrial
Union Dept. v. American Petroleum Institute.
HOFFMAN
The Court held the OSHA cotton dust
standard to be valid because it was sup-
ported by substantial evidence, which it
defined as "such relevant evidence as a
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reasonable mind might accept as ade-
quate to support a conclusion" (66).
SUMMARY
It is difficult to make generalizations
concerning the type of epidemiologic data
currently preferred in the courts because
trial judges' decisions are infrequently
published, appellate judges' decisions are
not always accompanied by an opinion,
and there is often disparity between the
opinions and standards of different
courts. In this paper I have chosen cases
either for their legal significance or their
illustrative nature. The cases essentially
represent numerator data, and therefore,
I cannot determine definite trends in the
courtroom use of epidemiologic data.
When trying to determine if a causal
relationship exists between an exposure
and illness, epidemiologists attempt to
examine the statistical strength, consis-
tency, specificity, temporal sequence,
dose-response characteristics, and bio-
logic plausibility of the association. In
contrast, a widely used legal standard of
proof of association is "reasonable proba-
bility." However, the interpretation of
"reasonable probability" is evolving. And
just as epidemiologists may be pushed to
the limit of their methods in trying to de-
termine if and at what level a health risk
exists, so the courts have had to forge new
legal paths in considering whether epi-
demiologic evidence is sufficient to estab-
lish a causal relation between exposure to
a substance and ill health.
Furthermore, it is not certain what
standard of significance the courts will re-
quire in the future. In 1975 in Reserve
Mining Company vs. EPA, and Ethyl Cor-
poration vs. EPA, the theoretical exis-
tence of risk was adequate to move the
Appeals Courts to take precautionary ac-
tion. But when considering a standard for
safe levels of an occupational toxin, the
 USE OF EPIDEMIOLOGIC DATA IN THE COURTS
Supreme Court has rejected a theoretical
risk as significant (in Industrial Union vs.
American Petroleum Institute) and in-
stead, has required factual evidence of a
dose-response relationship (as in Amer-
ican Textile Manufacturer's Institute vs.
Donovan) because it did not want to ex-
trapolate the risk of low levels of exposure
from data based on high levels of expo-
sure. Since demonstration of a dose-re-
sponse relationship, although rarely ob-
tained easily, is one of the criteria used
by epidemiologists to infer a causal rela-
tionship, there can be no doubt that such
evidence will strengthen any attempt to
prove future damages from low level ex-
posure to toxins. In addition, I predict ev-
idence of attributable risk or attributable
fraction will be useful in determining the
extent of potential losses and, therefore,
the value of future damages. This is be-
cause the attributable risk provides that
which the court needs to know (although
the attributable risk is for a specific pop-
ulation, not an individual): what propor-
tion of the outcome (damages) is attrib-
utable to the exposure (damaging event)
and not to other causes.
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