Science and Law
15th February 2017

USING GENOMICS TO PREVAIL IN YOUR NEXT TOXIC TORT CASE

As any good toxic tort litigator knows, it is not enough for a defendant to demonstrate that the alleged harmful chemical was not the cause of the injury. Rather, an effective defense provides the jury with a reasonable explanation as to what the cause of the injury was.

USING GENOMICS TO PREVAIL IN YOUR NEXT TOXIC TORT CASE

As any good toxic tort litigator knows, it is not enough for a defendant to demonstrate that the alleged harmful chemical was not the cause of the injury. Rather, an effective defense provides the jury with a reasonable explanation as to what the cause of the injury was. Genomic data offer the defense just such an opportunity. The National Academy of Sciences’ National Research Council describes toxicogenomics as one of the most discriminating, predictive, and sensitive tools available to evaluate toxic exposure and to predict effects on human health.

Next generation sequencing (NGS) is the most powerful technology currently available in the toxicogenomics toolkit. Genomic technologies have provided a nearly binary answer to many legal questions including the assessment of paternity (or the owner of DNA at a crime scene). Unlike the inferences from epidemiological data that are based on associations found in the general population, validated genetic signatures go one step further. They use well characterized associations to provide an answer specific to the individual. In addition, genetic data in toxic tort claims provide analytical and quantitative data.

Broadly speaking, there are two types of genomic data that can be developed to provide evidence that the injury was “in the genes”:

  1. DNA mutations: With whole genome DNA sequence information, researchers can look for DNA sequence variations (mutations) among and within populations and determine if there is a significant biological outcome connected to these mutations. Next generation sequencing (NGS) allows for this whole genome perspective in searching for possible DNA mutations that might be the cause of the disease in question.
  2. Gene expression data: Researchers are now able to characterize all the genes expressed in a certain tissue and under specific conditions. With mRNA expression information, it is possible to precisely characterize an individual’s response to environmental changes. Exposure to substances (medication, ionizing radiation, benzene, heavy metals, etc.) affects the expression of genes and leaves behind a measurable gene “signature.” Over the past decade, many research groups have developed validated gene signatures that allow the identification of such exposures. Using these published and validated gene signatures we can now, in some cases, differentiate exposed individuals from non-exposed individuals.

Based on well-established scientific evidence linking a specific toxicant to a specific disease, in many instances, genetic data can provide evidence that: (i) the individual was or was not actually exposed to the toxicant, and (ii) that the individual’s disease was or was not caused by the claimed exposure.

Working with counsel, an appropriate NGS laboratory can determine if there is an appropriate study that can be designed to query the specific mechanism of action (MOA) as well as disease states presented in a specific toxic tort or pharmaceutical claim. Utilizing a suite of genomics tools and specialized software, NGS laboratories analyze the relevant tissue samples available and generate the appropriate information (DNA sequence, mRNA expression, epigenetic gene regulation, and spontaneous or inherited gene mutations). This information is carefully analyzed and interpreted based on the most current scientific and medical literature and will guide counsel as to whether there is scientific evidence to support or refute the exposure and disease causation claims. Depending on the experimental design, the results can also indicate if there is scientific evidence to support or refute familial genetic predisposition to the disease.

Using GenomicsTo Defend Your Next Case or Controversy

ISS, in alliance with ArrayXpress and The LSP Group, can provide expert services related to genomic sequencing techniques to help defend your next case or controversy.

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