Science and Law
4th March 2016

Ovarian Cancer, Genetic Testing and Talcum Powder Litigation

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.

Ovarian Cancer, Genetic Testing and Talcum Powder Litigation

This article was authored by Giovanni Ciavarra, PhD and Kirk Hartley, Esq. 

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).

Last week, 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?

We have not been retained in the litigation, and certainly do not claim to know all the facts or the science. However, the talcum example raises yet another example of new issues that are facing both defendants and plaintiffs. Briefly, a repeating fact pattern is a set of large set of product liability cases that stem from a long used product and arguments about whether product use is the “cause” of a cancer or an actionable (or not) increased risk of cancer. For many years, attorneys in litigation referred primarily to epidemiology to “answer” these questions. But, recently, more and more molecular science is being brought to bear on the issues.

At the same time, for other reasons, molecular science also enters the equation for other reasons. Today, many are concerned about Alzheimer’s disease, cancer, diabetes and other debilitating diseases. As a result, scientists, non-governmental organizations (NGOs) and leaders of both political parties are seeking additional funding for scientific research. Indeed, as to ovarian cancer, just this week, the National Academy of Sciences published a report discussing the evolving paradigms related to this disease and advises for additional research on the potential causes of ovarian cancer.

Repeating Fact Pattern in Talcum Powder Litigation

Stepping back, the big picture begins with 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. 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, using genomics allows for attorneys to at least begin asking questions related to: was it the toxin or the genetic predisposition? In essence, these types of 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 is the possibility that some of the plaintiffs may harbor one or more well-described ovarian cancer susceptibility genes (in addition to the 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. For example, to oversimplify, these studies do not distinguish between an individual whose disease was caused by a toxin and an individual whose disease is unrelated to the exposure (for example, due to a predisposing genetic mutation).

Genomics can potentially help resolve this issue, and may allow for the attribution of disease causation at the individual level, depending on what judges decide about evidence and legal issues. To be clear, genomics is not a new science and is actually widely used in medicine for a variety of purposes, such as predicting a patient’s response to a drug. Genomic analyses have been used in many legal cases, with genetic evidence admitted and considered by the jury as to paternity or whether an individual’s DNA was left at a crime scene.

What has led to an increase in the use of genetic technology? The short answer is that the ongoing revolution in molecular science has led to a dramatic drop in the cost of genetic sequencing. This 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 address the question of predisposition. In other words, this technique is a potentially great tool for investigating potential attribution to genetic causes in cases of ovarian cancer. For instance, mutations in the BRCA1 and BRCA2 genes (the proteins these genes encode are known to participate in a variety of cellular processes, including recognition or repair of certain forms of DNA damage). If an individual is born with a defective BRCA1 gene, the lifetime risk that they will develop ovarian cancer by the age of 70, independent of any toxic exposures, has been determined to be in the range of between 30% and 70% (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% and 30% 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. These mutations predisposed them to the disease, independent of any toxic exposure. 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 litigations proceed, it remains to be seen whether either side has tried or will try for (or oppose) genetic testing of plaintiffs.

Genomics is Changing Causation Evidence in the Courtroom Forever.

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