This article discusses how genomics and individualized genetic testing could transform the evaluation of causation in toxic tort litigation. Currently, experts rely on population-level epidemiological studies that have limitations and do not prove specific causation for an individual plaintiff. Emerging technologies allow analysis of an individual's entire genome and biomarkers to identify predispositions, mutations, and evidence of exposure. This could eliminate reliance on statistical studies and establish causation through direct genetic evidence. However, using genetic testing also raises ethical, legal and privacy issues that courts will have to address. As costs go down, genomic analysis is predicted to become routine in proving or disproving causation in toxic tort cases.

1. T h e O l d e s t L a w J o u r n a l i n t h e U n i t e d St a t e s 1 8 4 3 - 2 0 1 6
philadelphia, Tuesday, July 26, 2016
By Dean C. Seman
Special to the Legal
T
he current state of causa-
tion evidence in toxic tort
litigation has generated
grumbles of unreliability, under-
standable controversy and the
feeling of a jury crap shoot. Jurors
are often left weighing statistical
evidence containing large data
gaps and speculative extrapolations
versus sympathetic claims often
involving debilitating or fatal dis-
eases. However, the emerging
advances in genomics, the ever-
increasing compilation of genetic
data and the lower costs of indi-
vidualized testing has opened the
door for the use of individualized
genetic evidence to support and
defend toxic torts with a level of
unprecedented reliability.
Genomics is the study of human
genes, their interactions with other
genes and the impact of environ-
mental factors. DNA is the road
map guiding and directing all liv-
ing organisms. DNA regulates
protein production, which affects
body’s cell, tissue and organ forma-
tion and function. Humans, in
general, have tumor suppression
genes, DNA repair genes, genes
that control cell growth and genes
that affect the metabolism of toxic
substances in your body. When
“normal” genes are damaged
(mutated) through multifactorial
source(s), discussed below, your
ability to combat disease is com-
promised, potentially leading to
the development of cancer and
other illnesses. While more sim-
plistic DNA and genetic evidence
is commonplace in criminal cases,
paternity disputes and medical
malpractice litigation, the emerg-
ing genomic-based evidence will
predictably become a critical and
routine practice in toxic torts.
Toxic torts are a type of personal
injury suit whereby a plaintiff
claims that exposure to a substance
or chemical has caused a particular
injury or disease. The more com-
mon toxic tort claims arise from
cancers allegedly caused by expo-
sure to asbestos, tobacco, benzene,
pesticides, herbicides or more
recently talcum (baby powder).
For example, in February and May
2016, juries awarded verdicts of
$72 million and $55 million against
Johnson & Johnson (J&J), respec-
tively, to plaintiffs who claimed
their personal use of talcum pow-
der caused gene mutations in their
ovary tissue leading to cancer. The
overwhelming percentage of these
verdicts were for punitive damages
due to the jurors’ belief that J&J
failed to warn its consumers,
despite 40 years of statistical evi-
dence, of an increased risk (up to
33 percent) associated with femi-
nine genital use of talcum powder
and ovarian cancer. J&J argued
that available studies prove that
talc, which has been used for over
100 years, is safe. J&J also argued
that the plaintiffs’ statistical
Will Genomics Become Routine in Toxic
Torts Causation Evaluation?
E n e r g y a n d E n v i r o n m e n t a l L a w
DEAN C. SEMAN is a
partner at Weber
Gallagher in the envi-
ronmental/toxic tort
group and a former
environmental engi-
neer in the tri-state area. Seman defends
business owners and companies in envi-
ronmental matters, toxic torts and con-
struction defect and accident cases. He
may be reached at dseman@wglaw.com.

2. evidence was inaccurate, mislead-
ing and unreliable. There are
about 1,200 talcum powder cases
pending with a threat of large ver-
dicts despite no definitive under-
standing exactly how talc may
cause cancer. Perhaps genomics
and individual genetic data will
provide definitive answers to the
statistical causation evidence
debate in analogous future cases.
To prove the causal link in toxic
torts between exposure and injury,
a plaintiff must prove that, first, the
substance may cause the claimed
injury in the general population
(general causation); and that, sec-
ond, the exposure did, in fact, cause
the individual’s injury (specific cau-
sation). Experts typically rely on
epidemiological studies (trends of
exposure and disease in the general
population) to prove or refute gen-
eral causation. While there are an
ever-increasing number of epide-
miological studies, courts have
shown a reluctance to allow experts
to broadly rely on this data, as in
Burst v. Shell Oil, No. 15-30592,
2016 U.S. App. LEXIS 9386 (5th
Cir. May 23, 2016) (precluding the
plaintiff’s expert opinion relying
on “pure benzene” exposure stud-
ies in an attempt to link the plain-
tiff’s occupational gasoline fume
exposure to his acute myeloid leu-
kemia, rather than any “gasoline
containing benzene” exposure
studies). Even when respected
epidemiological studies substanti-
ate general causation—specific
causation often becomes an
insurmountable burden leading to
the preclusion of experts under
Frye or Daubert challenges or
admissibility challenges under
Federal Rule of Evidence 702 or
the states’ equivalent.
To support specific causation
arguments, the experts generally
evaluate “relative risk,” “differential
diagnoses” and dose-response data.
Most courts require a relative risk
of two or greater, which means that
an “exposed” group is at least twice
as likely (“more likely than not”) to
develop a disease than the general
“unexposed” population. The
specific causation arguments are
complex considering that diseases
alternatively originate from gene
mutations (improperly functioning
genes) caused by multi-factorial
sources including: inherited
(germline) mutations; acquired
(somatic) mutations that occur from
natural or unknown reasons during
cell division or DNA replication;
and/or through environmental fac-
tors such as nutrition, lifestyle and
exposure. For example, in Milward
v. Rust-Oleum, No. 13-2132, 2016
U.S. App. LEXIS 7470 (1st Cir.
Apr. 25, 2016), the plaintiff alleged
that his occupational exposure to
benzene caused acute promyelo-
cytic leukemia. The court preclud-
ed the plaintiff’s expert’s specific
causation testimony on unreliable
methodology grounds because she
failed to explain why she relied on
favorable studies to establish an
increased relative risk between an
individual’s exposure to benzene
and APL, while completely ignor-
ing contrasting studies. Emerging
genomics may eliminate the need
for the statistical approach to
causation evidence.
In 2003, an international
collaboration of scientists com-
pleted the revolutionary Human
Genome Project (HGP), which
Two key emerging areas
providing individualized
and reliable evidence are
biomarkers and predisposi-
tion or susceptibility genes.

3. sequenced and mapped the com-
plete set of human DNA, see
www.genome.gov. The HGP has
estimated that a human has up to
25,000 genes. The HGP has cur-
rently spawned over 2,000 genetic
condition tests, has led to the dis-
covery of over 1,800 disease
(mutated) genes and has led to
numerous other comprehensive
studies and databases that identify
and categorize mutated genes
and/or associated diseases. See
report.nih.gov/NIHfactsheets,
and then access the HGP link.
The Million Veteran Program
(MVP) is one such ongoing study
where veterans within the Veterans
Affairs Healthcare System provide
genetic samples allowing the study
of, among other things, disease
genes in order to identify and cat-
egorize illnesses, associated mutat-
ed genes, and causation factors
such as toxic exposure. While not
directly related to the MVP, to
understand the types of studies in
the MVP, see Page v. McDonald,
No. 15-0778, 2016 U.S. App. Vet.
Claims LEXIS 424 (Vet. App.
Mar. 23, 2016) (vacating denial of
no medical examination determi-
nation for claim that exposure to
Agent Orange mutated a tumor
suppressor gene and caused colon
cancer). Emerging genomic sci-
ence will allow experts to steer
away from statistical or general
population studies and speculative
extrapolations by explaining the
individualized gene mutations, the
multi-factorial sources thereof and
resultant diseases. These studies
and databases will be powerful and
effectivetoolsinprovingorrefuting
exposure claims by making causa-
tionargumentsmoreindividualized,
accurate and reliable.
Two key emerging areas provid-
ing individualized and reliable
evidence are biomarkers and pre-
disposition or susceptibility genes.
For example, a plaintiff may be
able to offer proof of biomarkers,
which are telltale evidence at the
cellular level that affirmatively
prove and even quantify toxic
exposure. Additionally, a plaintiff
may be able to show that he or she
was predisposed to a specific ill-
ness irrespective of any general
population trends thereby elimi-
nating the need for a relative risk
evaluation. For example, if your
family has a history of breast can-
cer, then you are likely to carry
genes that make you susceptible
to an increased risk of breast can-
cer. The plaintiffs will attempt to
use analogous arguments support-
ed by individualized genetic data
to show that he or she had a
heightened sensitivity to a partic-
ular substance, and the exposure
was the specific cause of the inju-
ry. On the other side, the defen-
dants will argue that the injury
had nothing to do with an alleged
toxic exposure, but rather that the
injury was inevitable due to the
inherited predisposition gene.
The use of individualized genet-
ic information will be contentious.
Plaintiffs who put their physical
condition at issue must be willing
participants in genetic sampling
that can open a Pandora’s Box of
other legal, moral, discriminatory
and ethical issues. For example,
think of scenarios that may arise
under the Genetic Information
Nondiscrimination Act of 2008,
122 Stat. 881, which prohibits the
use of genetic information in
health insurance and employment.
Federal Rule of Civil Procedure
35, and states’ equivalents, allows a
party to compel genetic testing.
On the other hand, the U.S.
Supreme Court has recognized
that blood draws are “an invasion
of bodily integrity implicat[ing] an
individual’s most personal and
deep-rooted expectations of pri-
vacy,”asheldinMissouriv.McNeely,
133 S. Ct. 1552, 1558, 185 L. Ed.
2d 696 (2013).
In Meyers v. Intel, No. N11C-07-
009 JRJ, 2015 Del. Super. LEXIS
285 (Super. Ct. June 11, 2015), a
mother brought an action claiming
that the parents’ occupational
chemical exposures caused her
child’s birth defects. The court
denied the defendant’s motion to
compel “state-of-the-art” genetic
testing of the nonparty father on
the basis that the court lacked
authority to compel such highly
invasive testing compared to his
significant privacy concerns.
Because both parents’ genetics were
required, the defendants could not
complete the desired testing.
The application of genomics and
individualized genetic testing to
toxic torts will become routine
practice to support and defend
toxic tort claims and will almost
certainly create some controversial
precedents in the near future. •
Reprinted with permission from the July 26, 2016 edition of The
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