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Analyzing the Use of Genetics in

Determining Causation in Toxic Tort Cases

American Conference Institute | Toxic Tort & Environmental Litigation | June 23, 2017

Howard E. JarvisWoolf, McClane, Bright, Allen & Carpenter, PLLC (Knoxville, TN)

jarvish@wmbac.com

E. Paige SensenbrennerAdams and Reese LLP

(New Orleans, LA)

paige.sensenbrenner@arlaw.com

Presented by

The Honorable Richard KramerJAMS

(San Francisco, CA)

Glossary of terms

Gene is composed of DNA and is the basic

physical and functional unit of heredity. They act

as instructions to make proteins (antibodies,

enzymes, structural components)

Genetics is the study of heredity.

Glossary of terms

Genomics is the study of genes and their

functions.

Genome is the complete DNA complement of an

organism and includes a complete set of its genes.

Genomes contain all the information needed to

build and maintain an organism. 1

1 World Health Organization

Genetics concerns the function and composition

of a single or limited number of genes, whereas

Genomics addresses all genes systematically,

how they interact and function within and between

themselves and the environment to effect the

growth and development of the organism.2

2 World Health Organization

Human Genome Project

Launched in 1990 and funded by NIH

and DOE

At its start, the project was expected to

take 15 years, but completion was

announced on April 14, 2003.

Human Genome Project Findings

Human genome contains 46

chromosomes and approximately 3.5

billion base pairs.

Approximately 20,500 genes in each

human.

Epigenetics

The study of potentially heritable changes in

gene expression that does not involve changes

to the underlying DNA sequence — a change

in phenotype without a change in genotype

— which in turn affects how cells read genes.

Toxicogenomics

The application of genomic technologies (e.g.,

genetics, sequence analysis, gene expression

profiling, proteomics, metabolomics, etc.) to study

the effects of chemical and pharmaceutical agents

on human health and the environment.3

3 Application of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment. National Academies Press (US) 2007.

Genetics and Alternative Causation

in Litigation

• Genetic markers may be characteristic of disease predisposition.

• Genetic markers may separate toxicant-induced disease from

idiopathic disease.

• Genetic markers may be characteristic of exposure.

• Exposure may only be relevant in specific genetic subtypes.

All Driven By The Research

When you’re finished changing,

you’re finished.Benjamin Franklin

Genomics can provide sufficient

scientific evidence for and against

causation, for and against susceptibility

risk, for and against predisposition

risk, and for or against exposure to the

claimed agent.

Plaintiff DefendantAge at

DiagnosisCancer Toxicant

Cacoilo Sherwin-Williams et al. 24 AML Benzene

Blackford-Cleeton Marathon Oil et al. 32 Mesothelioma Asbestos

Leach BP et al. 58 AML Benzene

Guzman Exxon Mobil et al. 28Papillary thyroid

cancerRadium

Harvey Sunoco et al. 34 AML Benzene

Defense Strategies:

“Every Case is Unique”■ Disprove exposure

■ Use medical/family history, low exposure

■ Epidemiological evidence – problem not looking

at the individual-epidemiology only does

population wide estimates

■ For clinical genetic testing … alternative models

of causation based on literature

Information available from primarily

plaintiff’s medical records: ■ Family cancer history

■ Behavior (lifestyle)

■ Exposure information

■ Employment history

■ Diagnosis and treatment of cancer

■ Past patterns of illness/infection

■ Genetic testing

• Predisposition to a disease, if identified by

genomics and germline tissue, has nothing to do

with susceptibility.

• Susceptibility is increased risk of developing the

disease from THE EXPOSURE AGENT.

• Predisposition is a risk of developing a disease

NOT FROM THE EXPOSURE AGENT.

Predisposition genes ARE

ALTERNATIVE CAUSES and they

CANNOT BE ARGUED TO BE THE

SAME AS SUSCEPTIBILITY TO

THE CLAIMED EXPOSURE AGENT.

A germline mutation is taking the

person as you find him.

“Making the invisible visible”

Thank you.

American Conference Institute | Toxic Tort & Environmental Litigation | June 23, 2017

Howard E. JarvisWoolf, McClane, Bright, Allen & Carpenter, PLLC (Knoxville, TN)

jarvish@wmbac.com

E. Paige SensenbrennerAdams and Reese LLP

(New Orleans, LA)

paige.sensenbrenner@arlaw.com

The Honorable Richard KramerJAMS

(San Francisco, CA)