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Talc Litigation: The Big Picture

May 20, 2016

In 2015 and 2016, juries awarded $13 million in a talc case in California, and $72 million and $55 million in talc cases tried in Missouri.

The California plaintiff argued that she used talcum powder which contained asbestos and the asbestos in the talc was a cause of her disease, mesothelioma. The Missouri verdicts arose from plaintiffs’ claims that ovarian cancer was causally linked to the use of talcum powder. These verdicts received wide media coverage, coupled with assertions from the plaintiffs’ bar that thousands of claims are in line to be filed or tried. In each case the jury believed talc was a cause of plaintiff’s injuries. But the underlying liability theories, and the defenses, are different. The California mesothelioma case presents a new asbestos exposure source, not a new risk. The Missouri cases, on the other hand, presuppose a new carcinogenic link.

The common consumer’s perception of talc is a white, dry powder used to keep skin dry and reduce chaffing. The products are generically called “talcum powder” or “baby powder”. In actuality, personal care powder products are now exclusively or predominately corn starch. Little or no talc is found in these products today. Talc is also widely used as an ingredient in cosmetics.

In the United States cosmetics are regulated by the Food and Drug Administration (“FDA”), pursuant to the power delegated to it by the 1938 Federal Food, Drug, and Cosmetic Act. But FDA regulations do not require testing or approval of cosmetics prior to marketing. The FDA allows cosmetics to be sold without testing so long as the product does not contain specific, disallowed ingredients.

Safety data available to the FDA comes from voluntary reporting of product formulations, findings of the Cosmetic Ingredient Review panel, internal testing and sampling, and reports from consumers and health care providers. The Cosmetic Industry Review (“CIR”) is a panel established by the cosmetic industry trade association 40 years ago. The CIR now operates independently from cosmetic trade associations.

The FDA allows, or more specifically does not disallow, the use of refined talc in personal care products.

Talc is a mineral, a naturally occurring inorganic solid found throughout the world. It is usually categorized as a magnesium silicate. Talc is the softest mineral known. According to data from the US Geological Survey, only 7% of the talc used in the US is used for cosmetics. The vast majority of talc is used in plastics, paint, paper, and ceramics. Refined talc, talcum powder, is highly absorbent and soft, making it a useful ingredient for cosmetics. Talcum powder creates a product which is simultaneously absorbent and non-abrasive.

Talc is mined. China, South Korea, India, and the United States are respectively the largest commercial miners. The precise physical makeup of raw talc varies from site to site, which is a significant threshold issue if a claim alleges the talc at issue contained asbestos. And not all products that look like talc are talc. Rosin, used in baseball and by bowlers, is resin, a refined organic product. Magnesium carbonate, the white powder used by gymnasts and other athletes, has the same appearance as talc but is a completely different product that supplements adhesion.

Returning to recent litigation, a mesothelioma case filed today, decades after asbestos was banned, focuses on identification of exposure sources and the amount and extent of exposures. The medical link between asbestos and lung disease, including mesothelioma, is established. The risks of exposure were universally recognized decades ago, resulting in the regulation of exposure limits and a ban on the use of asbestos by governments worldwide. The dangers of exposure to asbestos are well known and accepted by the medical and scientific community. This knowledge is based on decades of medical and epidemiological research. The issue is no longer which defendants knew what and when, but rather identifying credible exposures which occurred decades earlier. If the pathology establishes mesothelioma, the case revolves around establishing an actual, sufficient exposure, not medical causation.

A plaintiff alleging exposure to asbestos through contaminated talc must focus on the composition of the product when it was manufactured, the source of the talc, the refining processes used, and the ongoing question of what amount of exposure is needed to prove causation. Stated differently, the plaintiff must show a legally sufficient exposure to an asbestos containing product. The test for legal sufficiency varies: a representative example is the Fourth Circuit’s requirement of “frequency, regularity, and proximity.”

Cases arguing a causal link between talc and ovarian cancer present completely different issues. Any link between talc and ovarian cancer is an open question at best. There is no comprehensive body of epidemiological research and medical literature that conclusively supports a causal relationship between the use of talc by women in their genital area and ovarian cancer. This is true whether one is arguing that talc itself is carcinogenic or that impurities or contaminants exist or existed in talc, and the impurities are the causal agent for the disease.

Ovarian cancer cases can proceed along two tracks. The first would be based on the assertion that talc itself is carcinogenic and can cause ovarian cancer. This argument has been made but at this time lacks an empirical foundation. Studies have looked for a link between talc and ovarian cancer, so one can truthfully say there is knowledge that a link may exist. But simply posing the question does not mean the causal link actually exists. The fact that the question is raised does not mean the answer must be that talc is carcinogenic. But the fact that no definitive link has been shown does not mean talc is risk free.

There are numerous epidemiological studies assessing the risks of exposure to talc, either through application or inhalation. In 2013 the Cosmetic Industry Review issued the “Safety Assessment of Talc as Used in Cosmetics”. The abstract states:

The CIR Expert Panel assessed the safety of talc for use in cosmetics and concluded it is safe in the present practices of use and concentration: talc is reported to be used as up to 100% in cosmetics. Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amounts of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos.
Cosmetic Industry Review, Final Report, April 12, 2013.

The Assessment was published in its entirety in 2015 in the International Journal of Toxicology 2015, Vol. 34 (Supplement 1) 665-1295.

The Environmental Protection Agency published its “Health Assessment Document for Talc”, EPA-600/8-91/217, March 1992. In the Summary the Document states: “The above findings indicate that the evidence for carcinogenity of talc depends on the presence of other contaminants, such as asbestos or crystalline silica. For talc without asbestos contamination, the International Agency for Research on Cancer (IARC) has concluded that the available epidemiological and animal toxicity data are inadequate to demonstrate or refute the potential for carcinogenity.”

The American Cancer Society (ACS) acknowledges that some unrefined talc may contain asbestos that can cause cancer in the lungs. The ACS states there is no reported increased risk of lung cancer caused by the used of cosmetic talcum powder.

The ACS notes that it suggested that talcum powder may cause ovarian cancer. Studies to date show little or no increased risk of cancer from the use of talcum powder, though research into this question is ongoing.

In addition to these there are more than a dozen addition studies publicly available conducted from the late 1980’s to the present.

The alternate track is to argue that ovarian cancer may be caused by contaminants now or formerly found in talc. The difficultly in the second track is the current science does not support any causal link between asbestos exposure in the ovaries and cancer.

A lawsuit which alleges a plaintiff’s lung disease was caused by talc contaminated with asbestos proceeds along the usual path of any asbestos case. The plaintiff will testify to his or her use of talcum powder in the past. Plaintiff’s counsel will look for evidence that the product contained talc and the product may have contained impurities, including asbestos. This could include linking the talc to mines or countries where asbestos is naturally found in the mineral and challenging the effectiveness of the refining process. At the same time, the defendant will offer testing records and certifications of analysis to prove their product did not contain any impurities. In the end, the central questions are whether one may prove or disprove that the plaintiff used a product which contained asbestos containing talc and whether there was sufficient exposure to cause the disease.

The alleged link between talc use and ovarian cancer is a new legal argument. As the lawsuits continue, they will become a battle of experts. This is not a new phenomenon. Litigation may show that science definitively established a causal link between the use of a product and disease: smoking and lung cancer and asbestos exposure and mesothelioma are two examples. On the other hand, in some instances the theory, the causal allegation, falls apart. An example is the alleged link between thiomersal in MMR vaccines and autism. The underlying research was fraudulent. And in the middle, there are products such as Agent Orange, which has been the object of multiple studies and lawsuits for decades. The core issue, whether the compound causes particular cancers, remains unclear.

Finally, despite the verdicts, it is entirely possible that properly refined talc is benign and it may be that the amount and nature of contaminants found in talc is insufficient to cause disease.

In the courtroom the burden of proof is not scientific certainty. It is maxim of statistics that association is not causation, but a lawsuit is won or lost by persuasive evidence. A competent advocate will use association as evidence of a causal link between talc and the disease in question. The defense must challenge the exposure and convince the jury that the science is insufficient to support liability. The defendant’s burden is greater since the issues are argued with the context of a plaintiff with an incurable disease.

In summary, a case may focus on talc as an asbestos source or talc itself as a cause of cancer. This fundamental difference will determine the future course of the litigation.