Science and Law
20th May 2015

Five Ways Genetic Information Can Be Applied to Toxic Tort or Pharmaceutical Litigation

All that we are is encoded in our DNA. Our DNA provides our biology with all the information it needs to separate man from the rest of the animal kingdom: snakes, mushrooms, sloths, trees, frogs, etc.

Five Ways Genetic Information Can Be Applied to Toxic Tort or Pharmaceutical Litigation

Our genes are made up of DNA—long strands of nucleotides (the G, C, A, and T sequences) that serve as our genetic code. The term genome refers to all the genes that make up an organism. Our genome is stored inside our cells. Cells make up tissues, tissues make up organs, and organs make up organisms.

All that we are is encoded in our DNA. Our DNA provides our biology with all the information it needs to separate man from the rest of the animal kingdom: snakes, mushrooms, sloths, trees, frogs, etc.

We are what we are because of our genes.

With this foundation in mind, it is not surprising that genetic testing has served as a powerful tool in the courtroom—see our recent interview with Gary Marchant. Most lawyers understand the power of genetic testing in criminal and forensic litigation (think CSI). However, genetic testing is just as powerful in many different forms of civil litigation, including toxic torts and pharmaceutical litigation.

Here are five ways that genetic testing has been used (and can be used) in these settings

1. Genetic Markers May be Characteristic of Disease Predisposition

When confronted with a plaintiff alleging that an exposure (either a chemical or a drug) caused an injury, defense lawyers instinctively want to find an alternate cause. What more compelling alternative cause than a genetic code? A genetic code that is causally related to a specific cancer is sometimes referred to as a driver mutation. These mutations are, in many ways, the Holy Grail to a civil lawsuit. Some driver mutations are so fundamental to a specific cancer that the likelihood of an individual with that mutation developing cancer approaches 100% (e.g., certain genomic sequences in relation to leukemia).

More commonly, however, driver mutations predispose an individual toward cancer. One commonly known mutation is BRCA1 (recently making headlines by Angelina Jolie), a mutation that predisposes individuals to breast cancer. The idea is that, independent of your chemical exposures, an individual with the BRCA1 gene is “predestined” to get breast cancer.

Similarly, specific genetic alleles are expressed at a much higher frequency in chronic beryllium disease patients compared to non-diseased individuals. Thus, demonstration that an individual had this genomic sequence (or didn’t have the sequence) could have a dramatic impact on a legal case.

2. Genetic Markers May Help Separate Environmentally Induced Disease from Idiopathic Disease

Some genomic sequences actually predict whether a tumor has an underlying environmental cause or whether the disease entity was more of an idiopathic mutation. A group of Finnish researchers has been investigating the link between specific genomic sequences and asbestos-induced lung cancer. Their work strongly suggests that specific tumors can be differentiated as to whether the tumor was caused by asbestos or whether it was a background phenomenon.

3. Precise Genetic Pathways for Disease Induction

In some instances, genomic sequences can help elucidate a clear pathway for disease induction, and developing a clear understanding of the genetic mechanisms of action can go a long way toward demonstrating causation in a legal case. This concept was recently demonstrated in an expert report in the Actos litigation. In her report, Jennifer Southgate, PhD, set forth the precise molecular mechanism of action through which the molecule at issue caused bladder cancer. This approach allowed plaintiffs to link a precisely defined mechanism of action in an individual to disease induction.

Because of the well-defined pathway which regulates the genes relevant to this case (known as PPARs), the court found it to be compelling and did not require the need for more phenomenological, observational epidemiological studies. Whether this type of mechanistic evidence will be sufficient to carry the day without the need for controlled epidemiological studies remains to be determined.

4. Genetic Markers May Be Characteristic of Exposures

Some genetic mutations appear to provide a definitive sign of exposure to an environmental agent. For example, the frequency of loss of a specific chromosome has been shown to be significantly greater among those with the highest benzene exposure levels. It should be noted, however, that there is a lot of variability in these data, and there is some debate as to how reliable this type of surrogate measurement is.

Thus, genetic factors may allow plaintiffs to document exposure through genetic testing as opposed to more traditional exposure assessment techniques. These same techniques may provide the defense with a rigorous means to refute exposure when no exposure occurred.

5. Exposure May Only Be Relevant in Specific Genetic Subtypes

Some exposures are only hazardous to individuals with a specific genetic subtype. For example, the only individuals at risk for phenylalanine toxicity are individuals with a genetic deficiency that makes them unable to metabolize phenylalanine. This has led to a warning label on certain diet sodas containing phenylalanine. This is essentially product labeling for a very specific genomic subtype. Our knowledge about genetics, therefore, allows us to precisely determine who is at risk (and who is not at risk) for specific exposures.

In the future, it is reasonable to predict that this genetic information will inform product labeling on drugs, foods, supplements, and cosmetics. This knowledge will also provide very effective product liability cases against certain products and very effective defenses against others.

 

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