It appears that 2016 may be the year that genomics and other aspects of molecular science make a big splash in “mass tort” litigation. While genomic analysis has long been used in forensics, it has also made its way into toxic tort cases, such as benzene exposure cases, and asbestos and mesothelioma cases. Indeed, the first BAP1 and mesothelioma case is now on the books (see our recent post on this here).
Recently, Johnson & Johnson (J&J) was ordered to pay $72 million in a suit that linked the use of talcum powder to ovarian cancer. According to some sources, this is just scratching the surface. By some estimates, more than 1,100 cases have been filed against Johnson & Johnson in courts in Missouri and New Jersey. The science supporting talcum powder as a causative factor in the development of these adverse health effects is sparse and conflicting. In light of this recent talc verdict for a plaintiff, it is worthwhile to at least consider the role genetics and other molecular science may play in talcum litigation.
What Facts & Science Lie Behind Talcum Litigation Headlines?
The talcum powder litigation raises yet another example of new issues that face both defendants and plaintiffs. Specifically, a large set of product liability cases arising from a long used product and arguments about whether that product use is a cause of an increased cancer risk. For many years, litigation attorneys have rightly focused on epidemiology as the best tool to “answer” this question. But, recently, molecular science is being brought to bear on the issues.
In addition, it is noteworthy that scientists, non-governmental organizations (NGOs) and leaders of both political parties seek additional funding for scientific research on ovarian cancer. Just last month, the National Academy of Sciences published a report discussing the evolving paradigms related to this disease and calls for additional research on the potential causes of ovarian cancer.
Repeating Fact Pattern in Talcum Powder Litigation
Stepping back, there have been decades of apparently safe use of cosmetic talcum powder products. However, some studies have purported to show that inhalation or perineal use of talcum powder can lead to various adverse health effects such as ovarian cancer, including a new retrospective case-control study published by Daniel Cramer et al. that purports to show an association between talc and ovarian cancer, which was limited to premenopausal women and postmenopausal women who used hormone replacement therapy.
In many instances, distinguishing whether a disease was caused by some natural process (such as a genetic mutation) or by exposure to a toxin can be very challenging. For a plaintiff that carries a predisposing mutation and was exposed to a toxin, genomic techniques allows for attorneys to begin asking questions related to whether it was the toxin, the gene, or a genetic predisposition. In essence, the answers to these questions can open up new potential avenues for both plaintiff and defense attorneys.
Genomics May be Key
One area that has not garnered much attention in the talc litigation is the possibility that some of the plaintiffs may harbor one or more well-described ovarian cancer susceptibility genes (in addition to other potential factors that have been associated with an increased risk of developing ovarian cancer). It has long been recognized that certain diseases are known to naturally occur via mutations in some genes and that inheriting certain genetic mutations predispose an individual to an increased risk of developing a given disease (independent of any toxic exposure), such as ovarian cancer. Of course, diseases may also arise from exposure to some toxins, such as lung cancer arising from cigarette smoking.
Assessing Populations vs. Individuals
While epidemiological studies have proven valuable for investigating causes and patterns of diseases in groups of people, they are not designed to distinguish differences between individuals in the groups that are studied. For example, these epidemiological studies do not tend to parse out individuals with different genetic factors.
Genomic techniques provide powerful tools that can potentially shed light on specific predisposing molecular factors that might allow for the attribution of disease causation at the individual level. To be clear, however genomic science is not new. Indeed, it is widely used in medicine for a variety of purposes, such as predicting a patient’s response to a drug. Genomic analyses have also been used historically in legal cases, with genetic evidence admitted and considered by the jury (e.g., in paternity cases or in cases assessing whether an individual’s DNA was left at a crime scene).
Genomic Techniques Allow Causal Attribution
Because of the revolution in molecular science over the past decade, there has been a dramatic drop in the cost of genetic sequencing. This cost reduction his has made it possible to take a close look at the DNA sequence of an individual in order to assess the presence or absence of genetic mutations that can, in turn, predispose an individual to cancer or other adverse health conditions. In other words, genomic techniques are becoming a cost effective tool for investigating potential attributable cause in cases of ovarian cancer.
Two good examples are mutations in the BRCA1 and BRCA2 genes.
If an individual is born with a defective BRCA1 gene, the lifetime risk that he will develop ovarian cancer by the age of 70 – independent of any toxic exposures – has been determined to be in the range of 30 percent and 70 percent (see summaries at the American Cancer Society and CDC website).
According to the American Cancer Society, “This means that if 100 women had a BRCA1 mutation, between 35 and 70 of them would get ovarian cancer.”
For women with BRCA2 mutations, it is estimated that between 10 percent and 30 percent will develop ovarian cancers by the age of 70. In addition, other gene mutations may also increase the risk for developing ovarian cancer.
Overall, there is a solid body of scientific literature describing an increased lifetime risk of developing ovarian cancer in women who have inherited mutations in particular genes. The most commonly inherited mutations discovered to date seem to occur in tumor suppressor genes (e.g. BRCA1 and BRCA2), which normally function to protect against the development of cancer. Furthermore, the genetic tests for these mutations are commercially available and utilize methods that have been accepted and proven reliable by the scientific, medical and legal communities.
As talcum powder litigation progresses, it will be important to follow this genomic science related to ovarian cancer, including whether either side has tried or will try to perform genetic testing of plaintiffs.
How Are You Monitoring the Science?
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David H. Schwartz, Ph.D.
Kirk Hartley, Esq.
Giovanni Ciavarra, PhD