NEW SCIENCE AND LAW IN ASBESTOS LITIGATION

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1 NEW SCIENCE AND LAW IN ASBESTOS LITIGATION Re-release of Sections Focused on Industrial and Cosmetic Talc In September, 2016 the firms of LSP Group, Innovative Science Solutions, and Assured Research collaborated to produce our second, in-depth and multidisciplinary analysis of the changes to and new directions in asbestos litigation. Our work included detailed thoughts on the scientific and legal developments, such as risks of more claims involving asbestos and cancers other than mesothelioma. In that context, we specifically focused on the possibilities related to claims involving ovarian cancer and the risks and science argued by litigants regarding use of talcum powder in both in industrial settings and for cosmetic uses. An overall point was that there many more "other cancers" than there are mesotheliomas, and that the numbers of "other cancer" claims could well rise. If the claims rise, defense costs for insurers also would rise due to the volume of claims and the need to come to grips with new science and related new case law. We were correct that claims might well rise regarding ovarian cancers. At that time, we did not try to forecast how many new claims would be filed, but we pointed out the possibilities for MDL litigation and more claims filings. Both have now occurred; Johnson & Johnson (JNJ) reported some 1,400 talc cases at the time of our report now over 9,000 (1Q Q). One of the factors we emphasized then, and repeat now, is that there are about 22,000 ovarian cancers annually in the U.S., compared to about 3,300 mesotheliomas. Our introduction is continued on the next page We re-release the talc sections of our 2016 report in light of this burst in legal activity. Readers with questions or those wanting more information should please contact any of the authors (links provided on the next page). AUGUST 1, 2018

2 Introduction continued As to financial costs, we predicted increasing defense expenses for primary insurers. On that topic, we recently learned that reinsurance industry stalwart Berkshire Hathaway specifically excluded talc-related claims from the asbestos reinsurance cover it sold to Hartford Financial Services with effect at year-end Apparently, we were not the only ones thinking about defense costs and more claims, and one wonders what was done (or not done) in similar reinsurance deals involving Berkshire and asbestos exposure. Moving to today, it is inevitable (in our view) that talc litigation will gain further momentum from the recent awards of very large amounts of compensatory and punitive damages. Certainly, there is a reasonable probability that the awards will be reversed on various procedural grounds, such as recent SCOTUS rulings limiting personal jurisdiction and Missouri rules on joining cases together. That said, the massive verdicts send a message that will encourage more and more investment in the litigation industry related to asbestos. From what we see, talc litigation is gaining momentum as to both "cosmetic use" and industrial use. By number of claims, the preponderance of today s litigation is focused on cosmetic (consumer) uses of talcum powder. Those may be personal uses (by both men and women) and others may make claims involving alleged exposures while diapering children. In addition, industrial use claims also matter because as we described in our study, talc has had and continues to have industrial uses as a filler, coating or dusting agent, pigment and extender in plastics, paint, ceramics, and roofing materials, among other products. Hundreds of thousands of employees work at large businesses using talc in their industrial process. Both cosmetic use and industrial use have a common point. The common point is that the scenarios are ones that offer plaintiff lawyers and others in the industry the chance to invest in and reuse fairly simple information about talc and asbestos. That business model can be lucrative for the claiming industry and expensive for the insurance industry. These common points also make it easier to advertise to and recruit potential plaintiffs. We re-release the talc sections of our 2016 report in light of this burst in legal activity. Readers with questions or those wanting more information should please contact any of the authors at the links following: LSP Group LLC Assured Research LLC Innovative Science Solutions LLC 1

3 New Science and Law in Asbestos Litigation A Multidisciplinary Look at Change and Future Directions September 2016 Research and Analysis by: LSP Group LLC Assured Research LLC Innovative Science Solutions LLC 2

4 Table of Contents (Highlighted Appears In this Excerpt) 1. Executive Summary Claims, Insurance and Money Insurance Company Reserves, Charges, and Changes Statutory filings reveal that asbestos payments continue to rise Reserve charges continued in 2015; more are expected in 2016 and beyond New Asbestos Data and Insurance Industry Reserve Shortfall Graphic view of SEER data and updated industry reserve shortfalls Industry asbestos reserves for mesothelioma claims estimated at $9 to $14 billion short What events could cause asbestos reserves charges to accelerate? Wave of Cancer Claims for Industrial Talc Overview Data Regarding Industrial Talc Claims Overview Data Regarding Cosmetic Talc Claims Plaintiff Attorney Advertising Increases Personal Jurisdiction Arguments Trigger Increased Defense Expenses Conclusion Notable Science Developments Related to Asbestos and Talc Claims Individual Variability and Susceptibility to Cancer A New Normal Emerges The First Mesothelioma Trial Focused on BAP1 Mutations Ortwein Trial Recap Genetic Variability and Cancer More Challenges and Expenses for Insurers Was Genetic Variability Foreseeable? Watch for Future Regulatory Focus on Asbestos and Individual Genetic 3

5 Variability Genetic Susceptibility, Mesothelioma and BAP Collected Data on Causal Inference Related to BAP1, Asbestos Exposure, and Mesothelioma Human molecular studies shed light on BAP1 mutations Animal studies on BAP1 mutant mice offer insight Analysis of the Potluck of Findings from Human and Animal Studies Scientific Advances in Mesothelioma A Sensitive Biomarker for Mesothelioma and Some Exposures: HMGB Experts make progress toward standardizing pathologic data on mesothelioma Results from Some Deeper Looks into Peritoneal Mesothelioma Researchers Find Differences between Pleural and Peritoneal Tissue Reactions to Asbestos During In Vitro Tests Immunotherapy May Emerge for Mesothelioma MesoBank UK Insulators Tissue Bank and National Mesothelioma Virtual Bank (NMVB) Science of Talc, Asbestos, and Ovarian Cancer Government and NGO assessments of the safety of talc Talc lawsuits involve variable diseases and alleged exposures Overview of Science Regarding Asbestos-contaminated Talc and Mesothelioma Link between inhalation of asbestos-contaminated talc and ovarian cancer is unclear Research on perineal use of talc invites debate Evolving Research on Genetic Mutations Related to Ovarian Cancer Developments in Lung Cancer Claiming Two sides to the story on lung cancer claims Broader Genomic Efforts Also Are Underway for Lung Cancers An Example of Experts Seeking Alternative causes for lung cancer

6 3.6 Watch the Other Cancers in Asbestos Litigation Legal Developments A year of Bad News For Defendants Due Process Rulings Protect Injured Persons Indiana Supreme Court knocked down asbestos statue of repose The Second Circuit invoked due process to allow successor liability claims by product liability claimants Bare Metal Defendants Take a Terrible Hit Defendants Suffer an Every Exposure Loss in California Mortimer Ruling Bolsters Plaintiffs Insurers Grapple with Take Home Asbestos Claims Garlock Bankruptcy An Isolated Incident New TSCA Statute Sparks renewed efforts to Ban Asbestos Conclusions References

7 2.3 Wave of Cancer Claims for Industrial Talc Last year we pointed out that insurance companies face the risk of expenses for claims for cancers other than mesothelioma and lung cancer, and notable amounts of other cancer claims potentially could arise from the very large groups of persons stricken by various other cancers. This past year highlighted that point, as at least three subsets of ovarian cancer claims related to talc became nationally prominent. Large jury verdicts thrust more than 1,400 pending talc cases into the limelight. Some statements attributed to the Beasley law firm suggest several thousand more talc claims could be on the way. 1 A further point here is that the talc cases are not just about talc. Some of the cases are about talc allegedly contaminated with minerals that some call asbestos; thus transaction costs for insurers will increase to some degree because claims about talc and mesothelioma are increasing. Insurers could also face enormous transaction costs related to talc and ovarian cancer. We present the following analysis of talc cases because of the many headlines about the cases and the confusion as to exactly what is (or is not) underway in the lawsuits. In doing so, we retain a focus on big picture numbers and the importance of transaction costs/defense expenses arising from sets of claims. A related point we explore in this section is that claims and expenses can grow quickly, driven by plaintiff attorney advertising and social media, among other factors. In addition, elsewhere, our co-authors explore in some detail the molecular science related to ovarian cancer, asbestos and talc Overview Data Regarding Industrial Talc Claims In this section, we focus first on the big picture fundamentals for possible claims about asbestos and industrial use of talc. The starting point for analysis is that for many decades talc has been taken from mines composed of deposits of talc contaminated by asbestos and/or other minerals. While the precise nature of the asbestos in the talc is debatable and argued by experts in articles and letters to journal editors (e.g. is it fibrous?), 2 the bottom line is that a substance plaintiffs refer to as asbestos has been found in industrial talc. In addition, from what we read, most talc buyers paid little or no attention to the presence of some form of asbestos because its presence did not interfere with the talc performing its desired functions as an ingredient in products or as a facilitator of industrial operations. Therefore, insurers will incur additional transaction costs as claims about industrial talc use may well become increasingly involved in mesothelioma claiming. It is also important to understand that some scientists and NGOs (e.g. IARC) assert that both asbestos and talc particles can cause (or are associated with) the development of ovarian cancer. (See section 3 for more specifics on the science.) We focus first on mesothelioma claims that may generate additional expenses for insurers through allegations about talc playing a role in the development of mesothelioma. For example, for some years now, mesothelioma claimants have been asserting workplace exposure to talc containing asbestos on top of more traditional claims of workplace exposure to asbestos (e.g. pipe insulation, gaskets, brake linings). These allegations can arise when a workplace included use of talc as an ingredient in a product or as part of a production process. Allegations of that sort may bring yet more defendants into mesothelioma litigation and thereby increase transaction costs for insurers. 1 ( Of the estimated 17,000 that contacted his law offices, Beasley said his team and partners are investigating close to 12,000. ) 2 6

8 The allegations also may apply to traditional asbestos defendants, and their lawyers may now need to investigate this alleged additional source of exposure to asbestos, and may need to retain additional or altogether new experts to opine about the facts or the outcomes. For example, we anticipate a need for analysis and testimony by experts in mineralogy, microscopy and related fields, with their testimony tied around issues about the presence or absence of asbestos in a talc mine or a talc product, and whether the alleged asbestos was or was not fibrous, and was or was not an amphibole form, typically tremolite. The latter topic is of special note because numerous experts say amphibole fibers are much more carcinogenic than chrysotile fibers, and many blame some mesotheliomas on tremolite contamination of chrysotile mines. In other words, some chrysotile defendants have argued that chrysotile fibers do not cause mesothelioma unless contaminated by tremolite (and maybe not even then). 3 The topic of tremolite fiber contamination of mineral deposits is far from new. 4 Indeed, tremolite contamination has been the subject of much argument and debate among lawyers and some experts. 5 Imagine what happens if some asbestos defendants actively start trying to blame mesotheliomas on talc contaminated by tremolite. Looking beyond transaction costs, one also should wonder if allegations of asbestos in talc could actually generate settlements and verdicts related to mesotheliomas. The answer is: Yes! In fact, some already have happened, as a defense law firm showed back in 2013 in an article describing trial wins by some plaintiffs in some industrial talc cases. 6 The other cancer concern also arises from the over one thousand cases with allegations that talc can cause ovarian cancer. And, more recently, at least two plaintiffs have alleged that talc causes uterine cancer. 7 The ovarian cancer issue already has been resolved against Johnson & Johnson (JNJ) by two juries that assessed significant damages awards in so-called cosmetic talc cases. Those ovarian cancer outcomes in cosmetic talc cases, however, may be irrelevant to outcomes in trials about ovarian cancer and industrial talc use. We leave it to our colleagues to address the science issues as to causation. What is important to note here is the scale of possibilities related to cases and expenses. There are 22,000+ ovarian cancers each year in the U.S. Some 1,400 claims already are in litigation, and plaintiff lawyers are actively publicizing a new proposed federal MDL proceeding for claims against JNJ. 8 That inventory of about 1,400 cases represents about two-thirds of mesothelioma cases filed annually. Furthermore, two trials against JNJ produced large losses for the defense. The cases have attracted enormous attention, with more or less daily media stories, plaintiff lawyer advertising, new case filings, and the Forbes article reporting that several thousand more talc cases are being investigated for filing. We cannot yet offer a quantitative assessment of the aggregate impact for insurers of the claims about talc as an alleged cause of ovarian cancer or uterine cancer. But the large possible numbers deserve attention, even if assumption is that the defendants will win perhaps 50% of the trials. Knowing that industrial talc causes claims can drive both defense costs and payments of verdicts or The Musgrove uterine cancer complaint is online

9 settlements, we invested in assessing numbers relevant to current and potential future claims about industrial talc use. The big picture answer is that the mineral known as talc is also used industrially as a filler, coating or dusting agent, pigment and extender in plastics, paint, ceramics, and roofing materials, among other products. End uses for domestic talc in the United States totaled some 560,000 tons in 2015, according the USGS Mineral Commodities Summary Domestic talc was used in ceramics (27%), paper (18%), paint (17%), and plastics (12%) according to this report. Imported talc, at some 310,000 tons in 2015, was used 75% in cosmetics according to the USGS report. Using these industry lists, we identified some of the largest publicly traded corporations (as measured by market capitalization) in each of these areas and reviewed their recent SEC filings for any disclosure regarding talc claims. We found no references in any filings of household names including Dow Chemical, Corning, Goodyear, and Sherwin Williams. But, as with JNJ and its cosmetic talc claims, the absence of disclosure should not be taken as a sign that there is no exposure or legal risk. Legal claims can be filed (and could be mounting) against any company; until one or more of those claims results in a jury verdict or settlement, the reporting company may opt to remain silent on the topic. As to potential industrial exposure it is substantial. In another exercise, we expanded our list of public companies to include three to five in each of the many industries where talc is used in the production process: paper making, plastics, paints and coatings, rubber, food, electric cables and ceramics. Our list of nearly 25 companies included 650,000 present employees. As to the number of persons exposed to talc over many past decades, the total figure would be a multiple of that because of employee turnover and the fact that our list is far from comprehensive. We re not suggesting that a large percentage of those current or former employees were actively handling or taking in talc as part of their job responsibilities. But asbestos litigation to date has included many verdicts and settlement payments for persons who were only secondarily exposed to asbestos, and so one cannot rule out claims of secondary exposure to talc containing asbestos. Moreover, with legal advertising on the rise (as discussed in the next section) we can be fairly certain that most of those employees will come across a talc litigation advertisement through TV, Internet, or social media. We also emphasize that use of industrial talc extends back for decades and continues today. That means that many years of older occurrence policies could well be triggered, although it s also possible some of the policies previously were settled out or used up through asbestos litigation deals. For more recent policies, one wonders about the amount of coverage, and the policy terms, including possible exclusions. As to asbestos exclusions, one could ask whether an asbestos exclusion would apply if the asbestos in talc does not meet mineralogical definitions of asbestos. We also note that a federal court recently refused to apply an asbestos exclusion in a policy issued by Aetna/Travelers, concluding the exclusion was ambiguous and should be construed against the insurer. The opinion relies on some reasoning about which party bears the burden of ambiguity, and the language could be troublesome to many insurers. The issues are now up on appeal by Travelers in the Third Circuit, and we will be watching for the outcome. A summary from LAW360 explains the trial court ruling as follows, and demonstrates why the outcome might be applied to any insurer that chose not to craft a precise asbestos exclusion term, and/or perhaps did not tie it to the presence of asbestos: According to the judge s order, the evidence shows that, between the late 1970s and 1985, six major insurers and other industry participants commonly used the term asbestos to refer to risks of loss tied to the raw mineral, while using asbestos-containing products to refer to 9 minerals.usgs.gov/minerals/pubs/mcs/2016/mcs2016.pdf 8

10 different risks of loss. Travelers chose not to define asbestos in the policies sold to GRC, Judge Restrepo wrote. Also, more precise, broader exclusionary language could have been but was not used. On these facts, it is fair to interpret asbestos in favor of coverage for the policyholder, GRC. 10 There are also insurance coverage cases to watch regarding policy terms and exclusions for talc. One of the major miners of talc is in litigation with Hartford regarding possible decades of coverage for talc claims. The trial court ruled in 2014, and the ruling is summarized and available online. 11 Following is the summary of the trial court s decision: Following a bench trial and post-trial briefing, the court rendered the following key decisions: (i) Vanderbilt should not be considered self-insured for the period 1986 to 2008 for claims alleging first exposure dates pre-march 3, 1986; (ii) the pollution exclusion is ambiguous; and, (iii) the occupational disease exclusion is unambiguous and only applies to preclude coverage for claims brought by Vanderbilt s own employees (the parties stipulated that no claims were brought by Vanderbilt s current or former employees). The issues are now on appeal to the Connecticut Supreme Court. Of course, a logical tactic is to look for specific information about insurers, such as how many policies they sold, which types of policies, over how many years, and to how many industrial users of talc. So far, we are not finding answers. But we are looking, and we expect some insights can be gleaned from court filings. However, analysts have the option to ask the question directly and we suggest taking that step Overview Data Regarding Cosmetic Talc Claims JNJ first brought baby power to the consumer market in But nearly 125 years would pass before the company disclosed in its 1Q16 10-Q on May 10th that some 1,400 plaintiffs have filed lawsuits alleging bodily injury specifically ovarian cancer caused by talc found in JNJ s Baby Powder products. The figure represents only a fraction of the 22,000+ ovarian cancers arising every year in the U.S., according to SEER estimates. JNJ s disclosure of the talc cases presumably was motivated by a highly publicized St. Louis, Missouri, case that went to verdict in February The jury awarded $72 million of compensatory and punitive damages to a woman (since deceased) who was diagnosed with ovarian cancer after using baby powder for 35 years. 12 This outcome was reported as the first time a jury awarded damages in a case regarding JNJ s talc products. In a prior verdict in South Dakota the jury decided not to award damages but 10 Jeff Sistrunk, Travelers Asbestos Exclusion Not Enforceable, Judge Says (March 3, 2015), online at With more than 22,000 annual diagnoses of ovarian cancer and 14,000 deaths annually, ovarian cancer is a leading cause of cancerdeaths among women. Considering the ubiquity of talc/powder products and the safe-enough-for-babies marketing angle; maybe it shouldn t be surprising that lawsuits are beginning to explode following a few multimillion dollar plaintiff verdicts. 9

11 concluded JNJ acted negligently. In any event, the first large verdict was quickly followed by a verdict in May also in St. Louis where $55 million was awarded to an ovarian cancer survivor who had used JNJ s Baby Powder for decades. Of that, $50 million was awarded as punitive damages, a number that could satisfy SCOTUS general due process admonition (in 2003) against punitive awards that are 10X (or more) of the amount of the compensatory verdict. Based on information and belief, there are roughly 1,000 talc/ovarian cases filed against JNJ in St. Louis and 140 in New Jersey. The numbers in Los Angeles are much smaller at present, but seem bound to rise. Indeed, in an August 2, 2016 order, a state court judge in Los Angeles commented that 2,000 cases are expected, but did not explain the basis for the expectation. 13 The situation further shifted with a mid- July plaintiff filing seeking a federal MDL proceeding for ovarian cancer claims against JNJ, with the Southern District of Illinois sought as the proposed forum. 14 The Allegations Against Johnson & Johnson As documented in this paper and elsewhere, epidemiological studies dating back to the early 1970s found and asserted an association between repeated exposure to cosmetic talc and ovarian cancer. JNJ sent people to talk with one of the researchers, and he (Dr. Cramer) recommended adding a warning to the label or eliminating the talc by selling only a cornstarch product. Yet into the 1980s and 1990s, JNJ declined to take action despite more epidemiological studies connecting use of talc in cosmetic powder products to increased risk of ovarian cancer. In fact, the trials include evidence that during the mid- 1990s, the company redoubled its efforts to market Baby Powder to women in the African American and Hispanic communities despite an acceleration in studies connecting talc to ovarian cancer. 15 At trial, JNJ argued against talc causing ovarian cancer and perhaps is correct. Indeed, a review of expert reports from trials and our team s review suggests the science is indeed unsettled, at least about a mechanism by which talc would cause an ovarian cancer. In fact, the American Cancer Society acknowledges only the claims of a connection and calls for further study; it seems noncommittal on the linkage. However, two massive jury awards of punitive damages against JNJ indicate the story it has told so far was not well received by juries. And, it is not difficult to imagine that kind of reaction when/if a company does not have a demonstrable, written record of carefully following new science and then documenting the actual or perceived errors in or shortfalls of the existing studies. Certainly two trials are not the endgame, and no doubt JNJ will seek to improve its trial presentations. But, we also are told that a sage trial lawyer (defense side) recently observed: When you cannot defend the company s conduct, it becomes even harder to defend its products. That assessment perhaps applies to JNJ, at least judging by a Reuters article reporting the following juror comments: One juror in the [$72 million] Missouri case, Jerome Kendrick, said in an interview with Reuters that he and other jurors were especially swayed by testimony from plaintiffs medical experts and documents showing J&J employees discussing talc powder s possible cancer risk HarrisMartin s Talcum Powder Ovarian Cancer Litigation Conference. Presentation by representative of law firm Lieff, Cabraser, Heimann & Bernstein (May 17, 2016). 10

12 The problem I had is that, according to inter office documents, J&J was aware of the potential concerns, Kendrick said. And it really looked like instead of trying to investigate, they started talking about how to combat what would eventually be a court case. 16 Talc Verdicts Lead to Talc Case Disclosure By JNJ For several years JNJ has been disclosing the number of plaintiffs that have filed against the company in various products liability lawsuits, but not talc cases. The largest of these, to date, are for hip replacement devices, pelvic mesh, and drugs used for anti-psychotic and stroke prevention purposes. But with its first quarter, 2016 SEC filing (10-Q) JNJ disclosed some 1,400 talcum powder labeled as Johnson s Baby Powder. Why the Disclosure Now? We expect the catalysts were the two plaintiff verdicts issued in February and in May, with more cases set to be heard in the months ahead. And while JNJ disclosed the number of plaintiffs in various cases, the company makes no mention of potential damages. Accounting standards only require loss recognition when a loss is both probable and quantifiable, which means that for many legal cases accruals are not required until cases proceed further and more information is available; this despite their two losses in Missouri totaling more than $125 million. Note also that it takes little time on Google to find large verdicts against JNJ in other sets of cases arising from other products. Limited Insurance in Consumer Cases Maybe for Industrial Uses? Regarding insurance coverage, JNJ notes that it has not bought external insurance since (Although the company does purchase coverage from its Vermont captive, Middlesex Assurance, which we surmise has external reinsurance coverage. But Vermont captive laws allow the financials of VT-domiciled captives to be kept private). However, talc usage goes back decades, so we expect there is some exposure to the insurance industry from policies written in earlier years. Colgate-Palmolive (ticker CL) has been implicated in suits for selling an asbestos-contaminated talcum powder in its Cashmere Bouquet product. Sold from the late 1800s to 1995, Colgate disclosed some 51 suits in its 1Q16 10-Q with 13 suits filed in 4Q15 and 22 filed in 1Q16. We found no financial disclosures for the suits but can note the company lost at least one verdict in 2015 (California) and won another, also in California, in late June

13 3. Notable Science Developments Related to Asbestos and Talc Claims The past year brought several notable developments in the genetic and other molecular science fields relevant to asbestos claiming and talc claiming. Below, we present information about the continuing, rapid increase in genetic analysis related to when and how mesotheliomas arise, and recent statements by litigation experts about individual variability as to cancer. These big picture points are important for the long term, are related to each other, and cut across most or all types of cancer litigation. The following sections cover new science in mesothelioma, lung cancer, and talc. 3.4 Science of Talc, Asbestos, and Ovarian Cancer The talc litigation topic presents some complexity because of the various uses/applications for the many different products (and product components) commonly referred to as talc. In the initial section of this paper, we provided a big picture overview of some of the litigation claims and issues. Here, we focus on providing more in depth background on talc because we think the facts help when trying to see the big picture. Then we present key parts of the science related to ovarian cancer, with some focus on the molecular and genetic aspects of the various different diseases typically lumped together as ovarian cancer. Keep in mind that labels for cancers continue to change, and more precise molecular definitions of cancer are occurring all the time. Thus, breast cancer was once thought of as one type of cancer, but today molecular researchers break it down into ten or more different types of cancer. 17 The use of talc has a long history. In 1890, the powdered form of talc talcum powder was found to relieve skin irritations caused by JNJ medicated plasters and was soon used in many other plaster mixes. JNJ also realized that talc mitigated diaper rash, leading to the invention of Johnson s Baby Powder in 1894, which is still used today (Sinniah, 2011). What is talc? Talc consists of hydrated magnesium silicate, and is formed from soapstone, which is made of talc and other minerals. Talc deposits are found throughout the world, and the talc mined in each deposit has unique characteristics. These defining characteristics often determine which commercial applications the talc will be best suited for (e.g. paper, ceramic, paint, roofing products, toothpaste, cosmetics, etc.). Basically, the term talc is used to refer to both mineral talc, and industrial mineral products that are marketed under the name talc. The proportion of mineral talc found in these products range from approximately 35% to 100%. While industrial talc generally refers to products that contain abundant minerals other than talc, cosmetic talc by today s standards (also referred to as talcum powder) contains > 98% talc mineral, and pharmaceutical talc contains > 99% talc (Zazenski, 1995; IARC, 2010). Talc may also form as mineral fibers that are asbestiform a general term that refers to a pattern of growth of a mineral. Asbestiform talc fibers are long and thin and occur in parallel bundles. However, 1976 specifications for cosmetic talc state that cosmetic talc must be free of detectable asbestos and other asbestiform fibers. Thus, as noted by Fiume et al., 1976 is a useful cut-off in determining which data are relevant to the safety of cosmetic talc since studies before that date may have limited relevance

14 to talc as it is currently used in cosmetics (Fiume, 2015). To provide a sense of the variable composition of talc depending on where it was or is mined, we includethe following chart cited by IARC, which depicts the mineral composition of talc from various U.S. mines and a French mine. Figure from Harben & Kuzvart (1996), as cited in IARC Historically, some cosmetic talcum products were found to contain materials that fell within some definitions of minerals classified as asbestos under some definitions (e.g. tremolite, anthophylite, and chrysotile). For example, a 1968 study reported that after analyzing 22 commercially available talcum powder products, researchers found fiber contents of these products averaged about 19%. While the fiber content was mostly talc, the authors reported that low levels of asbestiform fibers were found (Cralley, 1968; Fiume, 2015). In addition, another study tested a representative sample of consumer talcums and powders (including 20 body powders, baby powders, facial talcums, and one pharmaceutical talc), to determine their mineralogical and chemical composition. The authors found that 50% of the products contained detectable amounts of tremolite and anthophyllite. According to the authors, the levels ranged from tenths of a percent to over 14% by weight; two contained detectable amounts of chrysotile asbestos fiber. The investigators noted that the consumer products examined were rarely composed of pure mineral talc, but rather, were mixtures of various minerals including some samples that consisted of three to five minerals, only one of which was talc (Rohl, 1976; Fiume, 2015). The later study provides additional history and nuances that were identified over time. More recently, the FDA conducted an investigation to determine whether the thing it defines as asbestos was present in a sample of currently marketed cosmetic-grade raw material talc, as well as some cosmetic products containing talc. Overall, nine cosmetic talc suppliers were asked for samples of their talc, and four complied with the request. The FDA also selected and analyzed 34 retail products containing talc. The analyses of the raw material and retail products were conducted by a contract laboratory using transmission electron microscopy and polarized light microscopy. Overall, the FDA ultimately reported that no asbestos fibers or structures were detected in any of the samples of cosmeticgrade raw material talc or cosmetic products containing talc. 18 However, the FDA also noted that there are limits to the study because they did not test all available commercial products from all the different talc suppliers; thus the study cannot conclusively demonstrate that most or all talc or talc-containing cosmetic products currently marketed are likely to be free of asbestos contamination. According to

15 Fiume et al., representatives of the talc industry argue that even though only 4/9 of cosmetic talc suppliers participated in the FDA study, the study can be considered representative of the U.S. cosmetic talc market since the majority of U.S. cosmetic products were represented (Fiume, 2015). Finally, some of these products were created from talc mined outside the U.S., according to international studies. For example, in 2009, Korea s Food and Drug Administration (KFDA) determined that 11 talc powder products for babies were contaminated with asbestos. Sales of the identified products were banned and the use of talc in other products was prohibited. In Korea, it was estimated that approximately 1,100 drugs and medical goods contained talc contaminated with asbestos (Kim, 2009). Bottom line, talc is used in a wide variety of products, and recently sold U.S. and Korean cosmetic talcum powder are not likely to contain asbestos or asbestiform fibers. However, industrial grade talc, as well as older cosmetic talcum products (e.g. Cashmere Bouquet talcum powder), may contain or have contained some level of asbestos. Presumably there also are other variables for other talc products mined and used in other countries. We point out these variables because they may matter when assessing how much one can infer from data gathered in studies of cohorts outside the U.S Government and NGO assessments of the safety of talc The potential health effects of all forms of talc have been scrutinized by various authorities across the globe. In the most recent of these assessments, the International Agency for Research on Cancer (IARC) concluded that for humans, the perineal (genital) use of talc-based body powder is possibly carcinogenic (Group 2B), while inhaled talc (not containing asbestos or asbestiform fibers) is not classifiable as to its carcinogenicity (Group 3) (IARC, 2010). In addition, The National Toxicology Program (NTP) issued a 1993 report titled Toxicology and Carcinogenesis Studies of Talc (CAS No ) in F344/N rats and B6C3F1 Mice (Inhalation Studies). This report concluded that there was some evidence of carcinogenic activity in male F344/rats, clear evidence of carcinogenic activity in female F344/N rats, and no evidence of carcinogenic activity in male or female B6C3F1 mice exposed to aerosols of non-asbestiform cosmetic-grade talc in a lifetime study (NTP, 1993). Lastly, in 1992, the Environmental Protection Agency (EPA) issued a Health Assessment Document for Talc that reported talc was not carcinogenic following inhalation exposure or intraperitoneal, intrapleural, or intrabursal administration to rats, hamsters, and mice. Overall, however, the report stated the available data were not considered fully adequate to evaluate the carcinogenic potential of talc (EPA, 1992) Talc lawsuits involve variable diseases and alleged exposures Talc lawsuits focus on different diseases and alleged exposures. In the asbestos-contaminated talc suits, plaintiffs allege that use of contaminated talc was the cause of their mesothelioma or ovarian cancer. These claims are essentially asbestos lawsuits. In other pure talc talc cases (not containing asbestos), plaintiffs allege that the perineal/genital use of talc was the cause of their ovarian cancer. Therefore, at a high-level, talc legal cases can generally be categorized into the following three categories: Allegations that inhalation of asbestos-contaminated talc caused mesothelioma Allegations that inhalation of asbestos-contaminated talc caused ovarian cancer 14

16 Allegations that perineal use of talc (independent of asbestos) caused ovarian cancer Below, we provide some of the scientific evidence relevant to each of these three categories. In general, the evidence is organized into the following categories: epidemiological studies, case reports, mechanism-of-action studies, evidence for migration, and animal data. Note, however, the purpose of this paper is to provide the reader with a representative overview of these topics, and is certainly not intended to be a comprehensive review of all of the available science related to ongoing talc lawsuits. This overview instead is presented to help insurance analysts and others recognize the relevant science is complex, incomplete and evolving. In other words, for most defendants and their insurers, there are no easy answer cases, and so the litigation could drag on and expand for years unless multiple defendants make business decisions to settle some subset of the claimants. However, decisions to settle a subset of claims seem unlikely, at least for now, because there are so many possible claimants (22,000+ ovarian cancers per year) in the U.S., and the defense expert reports we ve seen do not present epidemiologic or molecular science sufficient to knock out material subsets of claims. Why can t defense experts make more compelling presentations? Because they are scientists and not magicians. Go back to where we started: the science is complex, incomplete and evolving. Much scientific thinking, planning, and work is needed to frame better questions and studies that will provide more answers about talc and the various cancers for which talc defendants are being targeted. In our view, major expenses lie ahead for insurers with notable talc defense obligations Overview of Science Regarding Asbestos-contaminated Talc and Mesothelioma Some talc lawsuits include allegations that inhalation of asbestos-contaminated talcum powder caused mesothelioma, and possibly other respiratory tract diseases, such as lung cancer. As noted earlier, these allegations are largely based on studies finding small or modest levels of asbestos contamination in cosmetic talc, as well as studies of talc miners and millers. When considering the suits, it s important to keep in mind the alleged dates of exposure to talc and the source of the talc. As discussed earlier, 1976 brought relatively rigorous quality standards for pharmaceutical and cosmetic grade talc, meaning that post-1976 products likely were free from asbestos and asbestiform fibers. Thus, talc and mesothelioma legal cases primarily allege that a plaintiff s historical use of talcum powder products (from the 1960s and 70s) was the cause of their mesothelioma. However, industrial grade talc was not subject to similar controls, and so asbestiform or asbestos-like talc particles may be present from any era, including products sold even today. Also, the constituent components may include other minerals that may be relevant to cases of disease involving talc miners and millers, as well as individuals in occupations that may be exposed to talc, such as the ceramics and plastics industries. Mechanism of Action When a case alleges that talc contributed to the development of a mesothelioma, the litigants may choose to argue about the evolving science surrounding the carcinogenic mechanisms of asbestos fibers. Our earlier sections on mesothelioma present some recent information relevant to the topic, but the science continues to develop and we did not seek to review the entire historic literature. For those interested in learning more about the potential mechanisms underlying the role of asbestos fibers in the development of mesothelioma, there are many great resources, including the following suggested review articles: Røe, 2015; Assis, 2014; Barlow, When considering mechanism and the literature, readers should keep in mind the arguments and data 15

17 that already exist about tremolite and the different types of asbestos fibers. To oversimplify, for many years, some asbestos defendants and some plaintiffs have vigorously asserted that amphibole asbestos fibers are far more carcinogenic than are chrysotile fibers. Those arguments matter, when thinking about talc, because some of the talc mines are said to include bodies of ore contaminated with purported tremolite fibers, which are an amphibole fiber. Therefore, litigants can become involved in detailed inquiries into the sources for the talc used in a talcum-containing product. If the product can be been shown to have contained amphibole asbestos, it will be more difficult for the defendant to challenge arguments about the mechanism through which a talc product may have contributed to the development of a mesothelioma. On the other hand, challenges that address the type of fiber and levels may prove to be a viable defense. Either way, the point is that the specifics can matter, and all litigants will face challenges in presenting the science and variables in ways that judges and juries will appreciate. Epidemiology Among talc miners and millers, asbestos-related diseases, including mesothelioma, have been reported. Many of the studies focused on workers from talc mines located in two counties of northern New York State, one of which was identified as among the 10 counties in the U.S. with the highest mesothelioma mortality up to 1981 (Hull, 2002). With regard to mesothelioma, more recent analyses have reported that thirteen talc miners from this area were identified as having the disease (Hull, 2002; Finkelstein, 2012), while other investigators suggest that some of the diagnosed mesotheliomas were not due to talc exposure (Honda, 2002). In another study, investigators evaluated an Italian cohort of talc miners and millers, where the talc is known to be free from asbestiform fibers, and observed that no mesotheliomas were reported (Coggiola, 2003). This provides some evidence that asbestos-free talc is not associated with the development of mesothelioma. Case Reports A recent plaintiff-attorney funded study attempted to address some outstanding issues in an ongoing case, and described the results of an investigation of a deceased woman, who they allege, through many applications of a particular brand of talcum powder, inhaled asbestos fibers, which then accumulated in her lungs and likely caused or contributed to her mesothelioma (Gordon, 2014). According to the study, lung and lymph node tissues confirmed a diagnosis of pleural mesothelioma, and tissue samples were also found to contain anthophyllite and tremolite asbestos. According to the authors, one of their conclusions was that these findings indicate historic talcum powder exposure is a causative factor in the development of mesotheliomas and possibly lung cancers in women (Gordon, 2014). However, experts retained by the defendants responded to the findings of this study in a Letter to the Editor in which they pointed out numerous limitations of the study, as well as concerns that Gordon et al. undermined the scientific process and the integrity of the scientific peer-review process (Lee, 2015). Another case report discussed the diagnosis of pneumoconiosis (asbestosis) and mesothelioma in a husband and wife who operated a small metal casting business that used industrial talc mined from Upstate New York (Finkelstein, 2013) Link between inhalation of asbestos-contaminated talc and ovarian cancer is unclear Inhalation of asbestos-contaminated talcum powder has also been alleged to have caused or contributed 16

18 to the development of ovarian cancer. These allegations are largely based on the data from numerous asbestos exposure studies that reported an increased risk for ovarian cancer. However, the relationship between inhaled asbestos exposure and ovarian cancer is not well understood, primarily because of the small number of cases, and difficulties associated with distinguishing peritoneal mesothelioma from ovarian cancer (i.e. due to tumor misclassification, which could lead to false-positive or false-negative diagnoses) (e.g. Reid, 2011; Camargo, 2011). This literature has been reviewed in some detail by various investigators (e.g. Reid, 2011). Asbestos Migration From Respiratory Tract to Ovaries It has long been thought that the migration of asbestos fibers in the body can occur via the blood and/or lymphatic systems (e.g. Holmes, 1967; Westlake, 1965; Kanazawa, 1970). For example, in a study by Kanazawa et al., it was reported that after injection of asbestos fibers in mice, some migration of fibers away from the injection site took place, and the dissemination occurred mostly along lymphatic pathways. Additionally, some fibers were also observed in the spleen, liver, kidneys and brain of the animals (not the ovaries), suggesting that some asbestos may enter the blood stream (Kanazawa, 1970). The following is a schematic depicting various pathways by which inhaled asbestos fibers may travel in the body. While the ovaries are not shown on this diagram, the ovaries are known to contain blood vessels and lymphatics, which may provide avenues for asbestos fiber travel to this organ. In addition, some have proposed that inhaled asbestos fibers may traverse the diaphragm through the peritoneal cavity, and subsequently penetrate the ovaries (Reid, 2011). At this point, it seems plain asbestos fibers can and do migrate around the body, including to organs in the female pelvis. Thus, numerous reports have described the detection of asbestos fibers in the ovaries and fallopian tubes of women. For instance, one study evaluated the ovaries from 13 women with household contact with men with known asbestos exposure and 17 women undergoing incidental oophorectomy (removal of the ovaries). Ovarian tissue was examined by electron microscopy, and the authors found significant asbestos fiber burdens in 9 out of 13 women with household asbestos exposure (69.2%), and in 6 out of 17 women who gave no exposure history (35%). According to the authors, this study demonstrates that asbestos can reach the ovary, and asbestos appears to be present in ovarian tissue more frequently and in higher amounts in women with a documentable exposure history (Heller, 17