Proving causation is crucial to litigating personal injury cases, particularly toxic torts—cases regarding allegations of harm caused by exposure to a dangerous substance, such as a pharmaceutical drug, pesticide, or chemical. Plaintiff and defense counsel alike are challenged with understanding numerous pathways of exposure and causation and then teaching jurors about the science involved. Toxic torts are often regarded as cases that are hard to litigate given the enormity of details involved and the layers of complexity.
So, how can counsel leverage innovative ways to prove or disprove causation?
Omics refers to the study of the complete set of a family of molecules. The most famous omics discipline is genomics, the study of genes and their functions and their combined influence as a group on the growth and development of an organism. Genomics is different from genetics. Think of it this way: someone taller than average may have a gene to produce a higher level of human growth hormone than someone without that gene. Studying that specific gene and its effects is genetics. However, the difference in people’s heights will depend on a lot more genetic factors than a single gene. Studying all of a person’s genes—including not only the one for growth hormone production but all of those related to collagen production and bone mineralization, basal metabolism and nutrient uptake, immune responses, and other hormones connected to height—is genomics. In this example, a look at all related genes for height can provide a more accurate assessment of why someone is taller. Accordingly, looking at evidence of causation more broadly can be a more comprehensive and persuasive way to prove a position.
Beyond genes, the omics method of analysis has been applied to an array of other biological molecules. They include disciplines like proteomics (proteins), transcriptomics (RNA transcripts), glycomics (sugars), and other fields that focus on a specific type of interaction, such as pharmacogenomics (studying the interaction of drugs with different genomes).
There is growing interest in omics analysis and the different types of experts who understand the science.
We are starting to see an increasing number of requests for bioinformaticians and biostatisticians who have developed algorithms for omics analysis in patent and trade secret matters. We are also seeing a demand for clinicians and epidemiologists who have developed specific uses for these tools. The availability of engineers or pathologists who have developed machines and tests for gathering the raw data used in these analyses has proven advantageous to our clients, too. More interestingly, we are starting to see the use of omics analysis to provide decisive evidence on issues in tort matters that would have been impossible to address just years ago.
The revolutionary potential uses for omics in litigation are remarkably like those for identifying DNA. DNA was discovered in the 1860s, its structure was discovered in the 1950s, and its first use in court was in the 1980s. At that time, the expense of using the technology and the relatively small number of people familiar with it meant that it was briefly a strange niche technology. Soon, its incredible power led to an explosion in its use that drove down costs and drove up awareness. Within a few years, DNA went from something that might only be used in a high-profile murder case with a particularly savvy investigator to something routinely used in burglaries and other relatively low-level crimes.
Much as with DNA identification, the laboratory procedures necessary to conduct omics analysis are dropping rapidly in price. According to the NIH’s National Human Genome Research Institute, the average cost of compiling a human genome fell from around $300 million just before the turn of the century to around $1,500 by 2016.* This price drop (along with price drops in other omics disciplines) makes it feasible to use this technology in litigation to answer questions that could only have been guessed at before. For example, I recently spoke to one of our experts in epidemiology, who explained that they had recently provided decisive evidence in a toxic tort matter using transcriptomics. In the matter, a plaintiff had been exposed to a chemical known to cause a particular form of cancer to develop at several times the background rate at which it develops in the general public. In the past, this might have been the end of the story in an open and shut case; the plaintiff got a usually rare cancer common in those exposed to a chemical the defendant made. However, a more detailed study of the relationship between the chemical and the cancer had shown that exposure sometimes caused a change in the way RNA was transcribed, which ultimately led to the cancers. The particular form of the chemical the plaintiff had been exposed to did not cause the particular change in RNA transcription that caused the cancer. This was, in fact, a case where the plaintiff had been one of the unfortunate people who develop the cancer without an environmental trigger—a fact which could only be demonstrated by looking at the transcriptome.
We are likely to see more and more of these cases in the same way that DNA is now a standard part of the forensic toolkit. With time, juries may even come to expect an omics analysis as a standard part of toxic tort causation.