Lung Cancer. Background and Developments Regarding the Role of Asbestos as a Cause of Lung Cancer and New Lung Cancer Claims

Transcription

1 Lung Cancer Background and Developments Regarding the Role of Asbestos as a Cause of Lung Cancer and New Lung Cancer Claims

2 Smoking

3 Smoking

4 Smoking as a Cause Approximately 90% of all Lung Cancers are caused by active smoking.

5 Smoking as a Cause Other agents Second-hand smoke Radon Silica Diesel Exhaust Industrial Plant Exposures (Refinery and Others?) Others (Tar and Soot; Arsenic; Chromium, Nickel, Cooking fumes, and Cooking fuels; Marijuana?)

6

7 Lung Cancer: Medical Aspects of Causation Changes on the Cellular Level Interference with Cell Reproduction and DNA Aneuploidy Abnormal Daughter Cells Growth-Control Genes Failure of Cell Death and Uncontrolled Cell Growth

8 Development of Aneuploidy

9 Chrysotile Induced Aneuploidy

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11 Lung Cancer: Medical Aspects of Causation Basic Toxicology Animal Studies Human Epidemiology

12 : Asbestos as a Cause? Lung cancer has long been associated with cigarette smoking; Lung cancer has historically (Mid-to-Late 20 th Century) been associated with certain exposures to asbestos; Doll; Selikoff articles on Insulators; Historical heavy amphibole exposure studies Useful for lung cancer causation in 2014?

13 New Data on New Studies New Statistics Number of cases Years since cessation New Research on DNA and toxicology EGFR or ALK P53

14 Plaintiffs Arguments on

15 Plaintiffs Arguments on A diagnosis of lung cancer and an occupational / paraoccupational / environmental exposure to asbestos is sufficient to link the two Every exposure contributes to dose Every exposure above background to asbestos is causative / contributes / a substantial contributing factor

16 Plaintiffs Arguments on Do NOT need underlying Asbestosis or any markers to Attribute Lung Cancer to Asbestos If you have asbestos exposure and cigarette smoking, the two exposures to carcinogens combined together caused the lung cancer There is synergy between smoking and asbestos

17 Plaintiffs Arguments on Asbestos is asbestos Studies that link asbestos and lung cancer are sufficient to demonstrate causation You don t need an epidemiological study of each type of asbestos You don t need an epidemiological study of every product that has asbestos in it

18 Plaintiffs Arguments on The Role of Animal Studies Dr. Brody and Photomicrographs

19 Plaintiffs Arguments on The Role of Epidemiology Case Reports are included Animal Studies are included Which studies best support the link? Are some studies better than others? If so, which ones and Why?

20 Plaintiffs Arguments on At What Level of Exposure can one attribute Lung Cancer to Asbestos? Reasoning and Authority Increased Risk Does Doubling of Risk Bear on Causation?

21 Plaintiffs Arguments on The Role of Synergy Old v. New Studies Levels of Exposure

22 Plaintiffs Arguments on The Role of Governmental Regulatory Agency Papers What is the science? When can they Inform on Causation?

23 Defendants Arguments on

24 Defendants Arguments on A diagnosis of lung cancer and an occupational / paraoccupational / environmental exposure to asbestos is insufficient to link the two Every exposure above background to asbestos cannot be causative / contribute / be a substantial contributing factor

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26 Defendants Arguments on Must have asbestosis, pathologically, or a lung asbestos burden sufficient to cause asbestosis in order to attribute Lung Cancer to asbestos If you have a smoker exposed to asbestos you need to examine each of the exposures to determine whether the exposure was sufficient to cause the lung cancer IF there is a combined effect between smoking and asbestos, it is only demonstrated in certain cohorts at VERY high doses of exposure to amphibole asbestos.

27 Asbestosis is needed to attribute Lung Cancer to Asbestos Weight of Science

28 Defendants Arguments on Asbestos is NOT asbestos. Studies that link high levels of exposure to amphibole asbestos and lung cancer are NOT sufficient to demonstrate a link between ALL levels of exposure to ALL types of asbestos

29 Defendants Arguments on The Role of Animal Studies

30 Defendants Arguments on The Role of Epidemiology You need an epidemiological study showing the dose of exposure to chrysotile asbestos more than doubles the risk of lung cancer You need an epidemiological study showing that the dose of exposure to chrysotile asbestos in a smoker creates an greater increased risk due to the combined effect

31 Defendants Arguments on The Role of Epidemiology Case Reports are included Animal Studies are included Which studies best disprove the link? Are some studies better than others? If so, which ones and Why?

32 Defendants Arguments on At What Level of Exposure can one attribute Lung Cancer to Asbestos? Reasoning and Authority Increased Risk Does Doubling of Risk Bear on Causation?

33 What is Asbestosis? Pathology Roggli Standard Radiology CT and HRCT scans PFT/Other clinical data Confounding data UIP Smoking related Interstitial fibrosis CHF

34 Defendants Arguments on If Asbestosis is not Found, one needs to find Significant Exposure to Asbestos 25 f/cc-years of exposure or more Hammar Helsinki Others

35 Defendants Arguments on The Role of Combined Effect Old v. New Studies Levels of Exposure Types of Asbestos

36 Defendants Arguments on The Role of Governmental Regulatory Agency Papers What is the science? When can they Inform on Causation?

37 Does Synergy Exist? Selikoff Markowitz Others: Additive v. multiplicative

38 Use of Industrial Hygiene Data to Prove Exposure Usefulness of Retrospective Studies What is a fiber/cc-year and how does this fit with causation?

39 Treatment of Low Dose Asbestos Exposure and Lung Cancer Medical v. Legal Cause Differences between states Increased risk v. doubling of risk Effect of smoking on asbestos causation Does fiber type matter? Ambient Air levels

40 Lung Cancer is not Mesothelioma Amphiboles and Mesothelioma: as little as.1 f/cc-year may cause mesothelioma Amphibole and Lung Cancer: a mixed exposure of 25 f/cc-year exposure or more? Can Chrysotile alone cause Lung Cancer and, if so, at what dose? Helsinki Criteria

41 The Role of Cigarette Warnings Post 1966 Post 1985 Complete Defense in warnings cases?

42 Effective 1/1/66-10/31/70 WARNINGS

43 WARNINGS Effective 11/1/70-10/11/85

44 WARNINGS Effective 10/12/85 present

45 Venue for Lung Cancer Madison County California New York Pennsylvania Delaware Forum Non conveniens

46 Other Cancers 2006 National Academy of Science Data Laryngeal and Ovarian Cancer - epidemiology Other cancers

47 Laryngeal Cancer 1< RR <2 Assuming RR=1.5 Assuming sample size =10 Laryngeal Cancer Risk Present Absent Exposure 6 4 Control 4 6 No disease Disease w/ Asbestos Disease w/ OR w/o Asbestos Exposure Control Among the 6 cases in exposure group, 4 cases will occur even without asbestos exposure

48 Laryngeal Cancer 4/6 in Asbestos group will have Laryngeal cancer with or without Asbestos Due to Asbestos w/ or w/o Asbestos No disease Disease w/ Asbestos Disease w/ OR w/o Asbestos Exposure Control Due to Asbestos v. Other causes = (6-4)/6 = 33.3% --- <50%

49 CONCLUSIONS

50 Plaintiffs Arguments on Some exposure to above background to asbestos is sufficient to cause lung cancer, even in a smoker Neither asbestos nor any markers of exposure are necessary to link asbestos and a lung cancer

51 Plaintiffs Arguments on With both exposures, each is a substantial contributing factor A former smoker s lung cancer is even less likely to be caused by smoking

52 Defendants Arguments on Lung Cancer with sufficient smoking history is caused by smoking in the absence of asbestosis or an asbestos burden sufficient to cause asbestosis Merely because one has both exposures, does not mean each is a substantial contributing factor

53 Defendants Arguments on In the absence of other causes of lung cancer, a Plaintiff must demonstrate a sufficient dose of exposure to (chrysotile) asbestos that is shown in the science to double the risk of lung cancer A former smoker s risk of lung cancer never returns to that of a never smoker

54 Lung Cancer Claims QUESTIONS?