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PRE-TRIAL
INVESTIGATION
Case evaluation and consulting
EI
scientists have the expertise to provide a
scientifically sound evaluation of the strengths and
weaknesses of individual cases. We are available to
assist you in a step-by-step evaluation of a case
including the components necessary for a successful
strategy.
Litigation Strategy
EI
scientists routinely advise on appropriate litigation
strategy and assist in assembling a team of experts to
best support a client’s case.
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LITERATURE REVIEWS
Our
depth of knowledge of biomedical and epidemiological
issues, and their application to the law, provides the
focused approach to our literature search, review, and
analysis.
In
considering the evidence for an association between a
risk factor and disease, it is important to use judgment
about the individual studies under consideration, as
well as the entire weight of evidence available from
other studies.
Epidemiology
as a practice utilizes evidence provided from a
multitude of disciplines in order to assess causation,
and recognizes that it is the collective weight of
evidence that drives conclusions as to causation.
A causation analysis inherently requires Epidemiologists
to methodologically review individual scientific
studies. Interpreting a scientific study requires
critical thinking to weigh the various factors that may
be responsible for observed associations. This
includes evaluating the role of study power, study
design, as well as bias, chance, and real effect,
together and separately, and making judgments as to
causal relationships.
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EPIDEMIOLOGICAL STUDIES
Human epidemiologic studies, along with toxicological
data and clinical observations, have been
extraordinarily powerful and informative about the risk
factors for human disease.
Most epidemiological studies of the relationship between
a risk factor and disease are observational in nature,
as opposed to experimental. Unlike toxicological
studies, which can control genetic, environmental,
dietary, and other exposure factors in animals, most
human studies must be designed to observe documented
exposures and their relationship to disease risk.
Controlled human epidemiological studies generally fall
into one of two categories: a) cohort studies, and
b) case-control studies. These types of studies,
both of which incorporate control populations, permit
the evaluation of the potential relationship between
exposure to a factor of interest and risk of disease.
In
order to identify groups at high risk of disease, it is
necessary to calculate rates of disease specific to
demographic, personal, and exposure characteristics
(i.e., age, race, sex, and risk factor exposure status).
The nature and form of the variables studied should
rationally serve the ultimate goal of identifying groups
at unusual risk, and identifying unusual patterns of
disease in a population. Measures of risk of
disease are associated with potential causal factors.
Epidemiologists study defined populations in order to
draw causal inferences for subgroups of the population.
There
are several ways to determine if a relationship exists
between exposure and disease: a) compare disease
rates in an exposed group to disease rates in an
unexposed group; b) examine how disease rates change
within a study group according to level of exposure.
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CAUSATION ANALYSES
Although various “guidelines” for assessing causality
have been proposed, there are in fact no sine qua non
requirements except that the cause must always precede
the disease (temporality). Other relevant criteria
may include replication of the findings, biologic
plausibility, and consistency with other knowledge.
It is
widely accepted that most, if not all, chronic diseases
have a multifactorial etiology and arise through
multiple mechanisms; that is, the ‘cause’ actually
consists of multiple components that act in concert.
Epidemiologic inferences on causation are based on a
mosaic of evidence. The derivation of such an inference
requires consideration of laboratory, experimental,
demographic, and epidemiologic data.
Weight-of-evidence
analyses
We are
acutely aware of the importance of epidemiological
research and weight-of- evidence analyses to establish
causation in legal cases.
Present day epidemiology focuses on many multifactorial
diseases and exposures to hazardous and pharmacologic
agents that are capable of inducing disease pathogenesis
in multiple organ systems. These and other
challenges require epidemiologists to evaluate with
careful consideration the collective weight of evidence
for causality.
Establishing that exposure to a substance is a cause of
adverse health effects involves consideration of the
general weight of the evidence. Such evidence is
accumulated across many areas of expertise, including
environmental sciences, toxicology, epidemiology,
medicine, and basic sciences, and the weight of evidence
is assessed by an evaluation and synthesis of
information from these multiple sources. Animal
and toxicological studies, clinical case reports, and
epidemiological studies are similar to the pieces of a
puzzle and can all contribute to a weight-of-evidence
analysis. The inclusion of a particular study as
part of the overall weight of evidence depends upon a
scientist’s experience, expertise, and judgment of both
the internal and external validity of that particular
study.
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EXPERT TESTIMONY
EI has
provided litigation support in numerous successful
environmental and toxic tort cases involving a range
biological, chemical, and pharmaceutical agents.
Dr. Shira Kramer has successfully served as a
testifying expert witness in
numerous cases during the past ten years.
It is important to note that Dr. Kramer has always
succeeded in Daubert challenges.
It is imperative that an expert
articulate and explain complex epidemiological concepts
to judges and juries. With over 20 years of trial
experience, EI scientists have the credentials,
expertise, experience and communication skills to
effectively present complex topics in a simplified
manner. We have a clear understanding of how
to effectively present complex medical information and
data analyses to a lay audience. In addition,
EI
scientists are available to assist in deposition
strategy and line of questioning preparation for
opposing counsel experts.
The
principals of EI have extensive teaching experience, are
published in peer-reviewed journals, and have broad
experience in conducting original epidemiological
studies.
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Litigation Support