Genomics and Genetic ...

Genomics and Genetics – Helping to Remove Inferences and Possible Litigation Bias

April 3, 2018 | by James H. (Jay) Bolin

It is no secret that every lawsuit attributing the development of disease to an alleged exposure to a toxic substance requires early consideration of alternate causes. One powerful tool being used more frequently to do this in toxic tort cases is the use of genetic data. Genomics has dramatically improved the treatment of certain diseases and has provided reliable information in paternity and criminal cases for years. More recently, testing for certain genetic mutations and the presence, or absence, of biomarkers is becoming increasingly important in the context of toxic tort litigation to provide information about other likely causes of certain diseases. In fact, most believe use of genetic data will soon be indispensable in addressing causation and in confirming, or confidently denying, alleged exposure to a particular toxic substance.

Assessment of whether genomics is useful in a case is generally possible after an early review of the available medical records and receipt of sufficient information or testimony about the individual’s occupational and environmental exposures and their family medical history. Existence of a family history of certain disease, multiple types of cancers among multiple generations and early age diagnosis are red flags that genetic data should be considered as part of your defense effort. Fortunately, in some instances, relevant genetic testing and analysis is already part of the medical workup for diagnosis and treatment purposes and needed samples and specimen are readily available for additional analysis if needed.

Genetic analysis can be a powerful litigation tool in a variety of ways. Certain mutations are associated with specific types of cancer, including but not limited to ovarian, mesothelioma, acute leukemia, breast, lung, lymphoma, and skin cancer. As a result, the existence of certain mutations can provide support for and against causation. Likewise, exposure to certain toxicants leaves a fingerprint in the form of a biomarker. The existence or absence of certain biomarkers can allow an expert to “rule in” or “rule out” certain substances as a likely cause of disease. In certain toxic tort cases where alleged exposures are sketchy at best, the existence or absence of biomarkers can greatly affect the defense of a case. Genetic data allows for individual specific evidence in a case that might otherwise rely upon epidemiology alone, which looks at populations. In essence, reliable facts are replacing theories.

Genetic mutations consist primarily of those inherited from ones parents (father and/or mother) and those acquired over a person’s lifetime. Those inherited are “germline” or “inherited” and those acquired over a lifetime are “somatic”. Germline mutations are present in every cell. Somatic mutations are the result of de novo mutations, which might be sporadic or the result of certain behaviors, occupational and/or environmental exposures, or infectious agents and occur in a subset of cells. This distinction is important as it can indicate whether an individual is predisposed to develop a certain disease or if an individual is more susceptible to developing a particular disease.

The nature and extent of alleged environmental exposures are more frequently disputed, suspect or unknown. Often, the nature and extent of these alleged toxic exposures is unsupported by reliable testimony or any objective medical evidence in the case. Without evidence to point to a likely culprit (e.g. smoking), genomics is providing helpful information to plaintiffs and defendants alike. While genetic data might uncover a clear alternate cause, it might also confirm the suspected exposure and thus cause at issue in the litigation. Not only is the existence of a certain genetic mutation useful, but the absence is in some instances equally important in causation analysis. Use of this data is not always a good fit, but early evaluation allows for an informed decision.

One example of how this is used is in litigation alleging lung cancer. Cigarette smoking is by far the leading cause of most lung cancers in both men and women. In litigation involving a plaintiff suffering from lung cancer who has never smoked (or who has a de minimis smoking history), the next most likely culprit for litigation purposes is an alleged toxic exposure. Recently, advances in DNA mutation analysis have revealed that the cause of certain lung cancers in “never smokers” and in former smokers after lengthy periods of cessation is not exposure to a toxicant at all but rather the presence of a particular genetic mutation.

Use of genetics in civil litigation is far from limited to lung cancer cases involving “never smokers’. Depending upon the alleged disease and exposure at issue, other examples exist where specific genetic mutations are associated with the development of disease in the absence of any particular exposure and more are on the horizon as the scientific and medical information available is rapidly increasing. Advances in diagnosis and treatment of disease continues at a rapid pace and continues to provide new reliable quantitative data for use in civil litigation instead of educated inferences or theories which is subject to litigation bias. If you have not already used genetic data in the defense of a case, you soon will and likely to your benefit on the right case.