Diane Whitney ()
Perhaps there has always been an uneasy relationship between science and the law. Though Daubert ostensibly governs the use of scientific evidence in litigation in most, if not all, jurisdictions, use of the Daubert procedures has not lead to uniform results nor consistent fairness. Astonishing developments in genomic research now stretch the ability of the law to put new scientific evidence into use and of both the regulated communities and private citizens to understand and respond to it. This article is a very brief survey of some of the many areas where genomic information may change the way evidence is presented and understood and also the way the use of this information may apply to a few of the varied and disparate parts of our lives.
Perhaps the most obvious use of genomic evidence is in the area of toxic torts, where plaintiffs must prove that a substance has caused them injury. Traditional causation evidence usually employs differential diagnosis—nothing else appears to have caused this injury, so the cause must be the substance under inquiry—or statistical analysis, both of them blunt instruments so far as proof is concerned. Genomic evidence gives much more precise proof of exposure and can also reveal whether the injured person has a predisposition to the condition complained of. That can cut two ways, of course, but may be more helpful to defendants than to plaintiffs. In Easter v. Aventis Pasteur, 358 F. Supp. 2d 574 (E.D. Tex. 2005), the defense proved that thimerosal in a vaccine did not cause autism in a child because he lacked a genetic susceptibility to mercury poisoning; in Cavallo v Star Enterprise, 100 F.3d 1150 (4th Cir. 1996), a plaintiff was unable to prevail on her claim of being highly sensitive to vapors from an oil spill when the court found that the standard for such proof had to be the normal general population, not a person highly susceptible to the contamination in question.
Genetic changes caused by exposure to a contaminant can be powerful proof, but the change may be limited in time, and the proof will require genetic testing that raises many issues. A plaintiff wishing to raise such proof will have to undergo testing that may reveal additional information both damaging to the case in question and sensitive to the patient. If the defense requires such testing, issues of privacy have to be considered, the scope of the testing should be narrowly focused on the issue in litigation, and the applicability and dissemination of the information should be strictly limited. Also to be considered is whether the testing will reveal a latent risk that could both defeat the litigated claim and complicate life for the client. If a latent risk unrelated to the injury under investigation reveals that the client’s life expectancy is limited, will that reduce an award of damages? On the other hand, if the testing reveals risk of future health issues caused by the substance under investigation, that could support a reliable claim for medical monitoring because it could constitute proof of the present injury generally required for such a claim.
If a manufacturer of a product knows that the product will, or could, cause harm to people with a genetic sensitivity to it, must it issue a warning? That question opens up a whole panoply of concerns. If the product is fatal to people with the sensitivity, a warning seems prudent. But if the harm is less severe, what percentage of the population needs to be affected and how severe must the harm be before a warning is necessary? And to step back a bit, when a product is tested before release, must it be tested on those with a known sensitivity to ingredients in the product? At some level, most people are sensitive to some product or material, whether the injury is severe or something tolerable such as a temporary rash. At what point is that sensitivity just a part of daily life and at what point does it pass into the arena of serious harm? What about the consumer seriously injured but not aware that he or she has a susceptibility to a certain product? Where is the line between the consumer’s responsibility and the manufacturer’s? While always a question with product safety, the more precise and correct knowledge possible with genomic testing raises the question to new levels of complication.
Really, real estate? Yes, very possibly. Suppose you have applied for a 30-year jumbo mortgage. The lender has a very real reason to care about the state of your health. She will certainly check your credit history. Does she have the right to check your health also? If genomic testing reveals a latent risk, say of Alzheimer’s, that is likely to be triggered long before that loan is paid off, can you be denied that mortgage? If you are predisposed to a condition that will affect your mobility or cognition, can you be denied a place in the over-55 community that stresses an active, lively, intellectually stimulating lifestyle? Certain insurance coverage has always required a physical exam, can that requirement be extended to include genomic testing?
Does this all, or any of it, sound far-fetched? It shouldn’t. For some of it, especially in the realm of toxic tort litigation, the future is now. In other areas the influence of genomic data is newer and still developing. One thing can be confidently predicted—in several areas of law, and not just those mentioned above—changes will have to be made to take this new data into account and we can expect the law and the lawyers to stretch and twist as they accommodate new science.