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MICHAEL J. PIETRYKOWSKI (SBN: 118677)
mpiectrykowski@gordonrees.com
CHRISTOPHER D. STRUNK (SBN: 214110) ELECTRONICALLY
estrunk@gordonrees.com FILED
GORDON & REES LLP — Superior Court of California,
11 Broadway Sireet Suite 1700 County of San Francisco
Oakland, CA 7
Telephone: (510) 463-8600 JUN 24 2014
Facsimile: (510) 984-1721 oclerk of the Court
. Deputy Clerk;
Attorneys for Plaintiff in Intervention my
THE CHARTER OAK FIRE INSURANCE COMPANY, intervening
on behalf of A.B.C. MOBILE SYSTEMS, a suspended corporation.
SUPERIOR COURT — STATE OF CALIFORNIA
COUNTY OF SAN FRANCISCO
HAROLD KOEPKE and NANCY KARIDIS-
KOEPKE,
CASE NO, CGC-13-276217
Plaintiffs, DECLARATION OF CHRISTOPHER
D. STRUNK IN SUPPORT OF
DEFENDANTS’ JOINT MOTION IN
LIMINE TO EXCLUDE PLAINTIFFS’
SCIENTIFIC CAUSATION EVIDENCE
WHICH DOES NOT DEMONSTRATE
RELATIVE RISK GREATER THAN 2.0
[JOINT DEFENSE MOTION NO. 1]
Accompanying Documents:
1. Defendants’ Joint Motion in Limine
No. 5
FORD MOTOR COMPANY, et al,
Defendants.
THE CHARTER OAK FIRE INSURANCE
COMPANY
FAC Filed: May 2, 2014
Plaintiff in Intervention, .
Trial Date: June 16, 2014
ve
HAROLD KOEPKE and NANCY KARIDIS-
KOEPKE,
Defendants in Intervention
ee I i i el et ee ee ee ee
I, Christopher D. Strunk, declare:
1 ] am an attorney duly licensed to practice before the courts of the State of
California. | practice with Gordon & Rees LLP, counsel of record for Plaintiff in Intervention
The Charter Oak Fire Insurance Company, intervening on behalf of A.B.C. Mobile Systems, a
suspended corporation. The facts stated herein are true of my own personal knowledge. I make
1
DECLARATION OF CHRISTOPHER D. STRUNK IN SUPPORT OF DEFENDANTS’ JOINT MOTION IN
LIMINE TO EXCLUDE PLAINTIFFS’ SCIENTIFIC CAUSATION EVIDENCE WHICH DOES NOT
DEMONSTRATE RELATVIE RISK GREATER THAN 2.0 [JOINT DEFENSE MOTION NO. 1]Oo OW WH RHR BF YW NH
MRM NM NY DH DY LY ND RR a
eo YH A RB OB HS = SO OB MN DAH BF YB N &
this declaration in sepport of Defendants’ Joint Motion in Limine to Exclude Plaintiffs’
Scientific Causation Evidence Which Does Not Demonstrate Relative Risk Greater Than 2.0.
2. Attached hereto as Exhibit 1 is a true and correct copy of Exhibit N to the
deposition of Allan Smith taken in this action.
3. Attached hereto as Exhibit 2 is a true and correct copy of Exhibit O to the
deposition of Allan Smith taken in this action.
4. Attached hereto as Exhibit 3 is a true and correct copy of Exhibit P to the
deposition of Allan Smith taken in this action.
5. Attached hereto as Exhibit 4 is a true and correct copy of Exhibit Q to the
deposition of Allan Smith taken in this action.
6. Attached hereto as Exhibit 5 is a true and correct copy of the relevant pages of
the transcript of the deposition of Allan Smith, taken in this action on May 28, 2014.
I declare under the penalty of perjury under the laws of the State of California that the
foregoing is true and correct. Executed June 24, 2014 at Oakland, California.
4
Christi D. Strunk
2
DECLARATION OF CHRISTOPHER D. STRUNK IN SUPPORT OF DEFENDANTS’ JOINT MOTION IN
LIMINE TO EXCLUDE PLAINTIFFS’ SCIENTIFIC CAUSATION EVIDENCE WHICH DOES NOT
DEMONSTRATE RELATVIE RISK GREATER THAN 2.0 [JOINT DEFENSE MOTION NO. 1]EXHIBIT 1Data concerning brake lining work for the U.S, case-control study of 208 cases of mesothelioma
and 533 controls. The odds ratios given incorporate the data conceming no known exposure to
asbestos,
Cases Controls. OR t-sided Confidence
B-valne Interval
Total cases and controls 208 333
Brake lining work or repair 33 72 4.1 <0,001 2.5-6.8
No known asbestos exposure 22
198Weatet Ine, Rockville,
MD (corrent address}
Qonsarsie and
0
Siitcctelo gy Censer,
and
‘Women’s Houpital,
BLHorlow
Development, Room @B07,
ive Boulevard,
Betherds, MD 20892, USA.
‘Accepted 18 July 1994
Ovcupational and Enuinnmental Medicine 1994;51:804-B11
Malignant mesothelioma: attributable risk of
asbestos exposure
Robert Spirtas, Hllen F Heineman, Leslie Bernstein, Gilbert W Beebe, Robert J Keehn,
Adice Stark, Bernard L Harlow, Jacques Benichou
Abstract
Objectives--To evaluate a case-control
study of malignant mesothelioma
through patterns of exposure to asbestos
based upon information from telephone
interviews with next of kin,
Methods—Potential cases, identified
from medical files and death certificates,
included all peopie diagnosed with malig-
nant mesothelioma and registered during
1975-1980 by the Los Angeles County
Cancer Surveillance Program, the New
York State Cancer Registry (eacluding
New York City), and 39 large Veterans
Administration hospitals. Cases whose
diagnosis was confirmed in a special
pathology review as definite or probable
mesothelioma (nm = 208) were included in
the analysis. Controls (n = 533) had died
of other causes, exchading cancer, respi-
ratory disease, aulcide, or violence.
Direct exposure to atbestos was deter~
mained from responses to three types of
questions: specific queries as to any
exposure to asbestos; occupational or
non-vocational participation in any of
nine specific activities thought te entril
exposure to asbestos; and analysis of life-
time work histories. Indirect exposures
were assessed through residential histo-
ries and reported contact with family
members exposed to asbestos,
Resulte—-Among men with pleural
mesothelioma the attributable risk (AR)
fox exposiire to asbesths wad 88% (85%
confidence. interval (5% CI) 16-95%).
For men, the AR of peritoneal cancer was
58%: (95% CI 20-89%), For women (both
sites combined), the AR was 23% (95%
C13~72%). The large differences in AR by
greater misclasaification among women.
Conclusions—Moxt of the pleural an
peritoneal mesotheliomas in the men
studied were attributable to expesure to
asbestos, The situation in women waz less
definitive.
(Qeeup Brviron Med 1954;51:804-81 1)
Keywords: asbestos, cpidtmiological factors, mesethe-
Eom, occupational exposure, peritoneal, pleural
The incidence of mesothelioma has been
increasing throughout the industrialised
world," The overall upward trend in inci-
dence of mesothelioma in the United States
from 1974-1990 is primarily due to increased
incidence among men." Although asbestos
exposure is generally accepted as the primary
cause of this tumour, other agents are sus-
pected of causing or promoting mesothelioma
in experimental studies of animuls.*4 A.
review of the scientific literature on animals
and humans indicated that a significant pro-
portion of mesotheliomas may be duc to fac~
tors other than exposure to asbestos," In this
paper, we estimate the proportion of mesothe-
Homa.cases in the United States diagnosed
between 1975 and 1980 that can be attributed
to asbestos, and compare the proportions of
mesotheliomas explained by four differenr
mneasures of exposure,
Marteriais and methods
STUDY SAMPLE
Potential cases were identified from the New
York ‘State Health Department Cancer
Registry, the Loe Angeles County Cancer
Surveillance Program, and 39 large Veterans
Administration hospitals, and were diagnosed
between } January, 1975 and 31 December,
1980, Those from Los Angeles County and
New York Staté (population based cancer
registries) included all incident cases whose
registry files Gncluding hospital, clinical,
pathology, and death certificate reports) men-
tioned the word mesothelioma; and from the
Veterans Administration hospitals afl pleural
and peritoneal mesothelioma cases for whom.
pathology slides or tissues were available for
study, For the Veterans Administration,
Pathology services et individual hospitals
selected potential cases in response to a leer
sent from the pathology service in the
‘Veterans Administration Central Office.
Telephone interviews were conducted with
the next of kin of eligible cases and controls,
berween 1982 and 1984, Of the 720 eligible
cases, next of Kin of 536 (75%) were
successfully interviewed and 184 respondents
(25%) were not interviewed: 106 were not
located, 64 refused to be interviewed, eight
were not approached due to refusal by the
physician to-allow contact, and six had par-
ally completed interviews. Gf these 536Malignant mesothelioma: armburcble risk of asbestor exporure
completed interviews, 268 pleural or peri-
toneal cancers were confirmed by an expert
pathology review (see next section) as definite
or probable mesotheliomas. These 208 con-
firmed cases form the case group for this
study.
Controls were selected from people who
died of causes other than cancer, respiratory
disease, suicide, or violence. Cancer and res-
piratory disease were excluded because sev-
eral cancers and respiratory diseases may be
related to asbestos exposure.!? Suicide and
violence were omitted because of concern ‘for
the potential trauma involved in interviewing
next of kin of people who died from violent
deaths. Controls from New York State and
Los Angeles County were selected from death
certificate files, Controls from the Veterans
Administration .were selected from deaths in
the beneficiary identification and records
location subsystem (BIRLS), a computerised
file of veterans who received medical and
financial benefits. The controls from the
Veterans Administration are representative of
all veterans who have sought benefits from the
Veterans Administration. Originally, pair
matched controls (matched to cases on date
of birth, race, sex, year of death, and county
of residence (New York State, Los Angeles
County) or hospital (Veterans Admin-
istration) had been selected for the 208 con-
firmed cases who were used in the analysis.
A larger group of controls was available,
however, the 678 eligible controls were
matched to the original 720 eligible cases
(before review of histological slides), Of these
678, next of kin of 533 (79%) were inter-
viewed, and 145 respondents (21%) were not
interviewed: 138 were not located, four had
partially completed interviews, and three
refused,
‘To take advantage of the information avail-
able from the controls metched to uncon-
firmed cases, these 533 subjects were used in
the analysis as the contro! group, Adjustment
for age, geographic area, and smoking by
stratification und logistic regression, rather
than with a matched analysis, enabled us
to control confounding while maximising
precision?
INTERVIEWS
For each deceased case or control, the next of
kin listed on the death certificate was con-
tacted by letter and telephone to identify an
appropriate respondent. The sequence of pre-
ferred respondents was spouse, child, sibling,
other relative, or friend. One living case self
responded, Four questionnaires'**) were
reviewed in developing the instrument used
for this smdy. The telephone interview
solicited information on lifetime exposures to
chemical and physical agents, disease history,
smoking history, and demographic back-
und,
Potential direct exposure to asbestos was
defined.in three ways based on interview data:
(a) ever or never, according to the response to
the question: “Was the study subject ever
exposed to asbestos?”; (6) by any one or a
80S
combination of nine predetermined eccupay
tional or non-vocationel activities in which
asbestos exposure was thought likely (brake
lining installation or repair, furnace or boiler
installation or repair, building demolition,
plumbing or heating repair, insulation work,
shipbuilding, ship demolition, or shipyard
work, elevator installation or repair, textile
production, and paper production); and (c) by
job-exposure matrix, based on lifetime work
histories, For the job-exposure matrix, each
job held by 2 subject was classified as involy-
ing none, <10%, 10-19%, 20-49%, or
250% likelihood of asbestos exposure,
according to the results of the National
Instivate for Occupational Safety and Health
(NIOSH) National Occupational Hazard
Survey (NOHS).” The NOHS reported esti~
mates of proportions of workers exposed to a
variety of physical and chemical agents, based
on walk through surveys by industrial bygien-
ists of about 5000 non-agricultural businesses
in 67 metropolitan areas conducted in
1972-4. NIOSH provided tables (Pederson,
personal communication, 1982) which cate~
gorised likelihood of asbestos exposure for
combinations of four digit 1972 standard
industrial classification (SIC) industry codes”
and three-digit 1970 census occupation
codes.# We converted these categories to
three-digit 1980 census industry and three-
digit 1980 census occupation codes* to be
compatible with the data files for the current
study, Bach study subject was classified into
the highest achieved exposure category (with-
out consideration of time weighting) based on
the NOHS estimate for the entire work his-
tory, Indirect exposure was measured by
questions about residence of stady subject
and exposures of cohabitants.
PATHOLOGY REVIEW
All available pathology material was initially
reviewed by pathologists, one of whom was
chosen by each of the three participating
study centres, No review was possible for 110
of the interviewed cases, due to lack of pathol
ogy material, ‘The standard five category sys-
tem. was used for recording the certainty of
malignant mesothelioma (definite, probable,
possible, unlikely, riot mesothelioma). As
differences were noted among the three study
centres in the percentage of potential cases
judged to be tue mesotheliomas, a more
extensive pathological review of a sample of
cases was conducted by a panel composed of
five pathologists: the original three patho-
logists from the three study centres plus two
referee pathologists recognised internationally
as expert in the diagnosis of mesothelioma,
Based on the resulrs of this panel review,” and
TO assure consistency of diagnosis, it was
decided to have all slides re-reviewed by the
two referee pathologists, Only the 208 cases
deemed definite or probable mesotheliomas in
the final. expert review were included in this
analysis.
STATISTICAL METHODS
Crude and stratified adds ratios (ORs) andSpintas, Heineman, Bernstein, Beebe, Keehn, Stark, Harlow, Benickou
95% confidence intervals (95% Cls), con-
trolled for age in four categories, geographic"
area, and cigarette smoking (ever or never),
were calculated for the association of each
index of exposure and mesothelioma. We
controlied for smoking because it confounded
the association of mesothelioma and asbestos
exposure (controls were mote likely than
cuses to have been cigarette smokers and to
have died of tobacco related causes), Six
subjects without information on smoking
were excluded from the analyses, The
maximum likelihood method was used to esti-
mate the OR and the method of Comfield as
modified by Gart™? was used to estimant
95% Cis. Tests for trend over duration of
exposure were conducted with the method of
Mantel,
Bor. calculations of ORs and auributable
visks, the unexposed group (never exposed)
was defined as those subjects with no reported
exposure to asbestos, none of the nine speci-
fied activities, no jobs with NOHS likelihood
of exposure >0, no cohebitants with asbestos
exposure, and no residence within two miles
of an asbestos mine or mill. Blank responses
to questions on exposure were treated as ifthe
subject was not exposed, based on our judg-
tuent that such a response was closer to a neg-
ative answer,
Attributable risk (AR) was defined as the
Proportion of disease burden that can be
related to asbestos exposure, Adjusted overall
and partial ARs for asbestos and correrpond-
ing 95% Cle were besed on a computed
unconditional logistic regression! The
models controlled for the mein effects and
interactions of age (our levels), geographic
area, and sex, and for the main effect of smok-
ing (ever or never). Age, area, and sex specific
models, of course, omitted the respective
covariate. The overal! AR compared those
never exposed with the remaining subjects,
exposed by ¢ny measure: of exposure to
asbestos, Partial ARs were calculated to evalu-
ate the proportion of mesothelioma related to
the individual measures of ‘agbestos, Partial
AR is defined as the proportion of disease
burden that can be related to asbestos expo-
sure captured by the particular messure. For
the partial ARs, three categories of exposure
had to be considered in the model; subjects
exposed 10 the measure of interest, those
never exposed, and those neither exposed to
that measure nor unexposed. ‘Thus, each
logistic model included two dummy variables
(one for the measure of interest, and another
for any other exposure to asbestos) and
yielded an OR for the exposure of interest
adjusted for covariates and the other mexsures
of asbestos exposure. The prevalence for each
AR was the proportion of cases exposed by
the measure of interest compared with the
total number of cases, For the NOHS classifi-
cation, four categories, including two exported
levels (1-19% likelihood, and 20-99% likeli-
hood), never exposed, and those neither
exposed nor not exposed were considered in
the computation of partial ARs.
Results
Of the 208 cases that were confirmed as defi-
nite or probable mesothelioma, 183 (162
men, 21 women) were classified as pleural or
pleural and peritonen!, and 25 (21 men, four
women) were classified 2s peritones! only,
‘Fable 1 shows the demographic characteris-
tics of the cases’ and controls. Most cases and
controls were white men (86% of cases, 76%
of controls), Sixty five per cent of cases and
75% of controls were past or current cigarene
smokers (not shown in table), Next of kin
respondents were primarily spouses (55% of
cases and 47% of controls), sons or daughters
(24% of cases and 27% of controls), and sib-
Engs (7% of cases and 12% of controls), The
remaining respondents were other relatives,
friends, and one self reporting case, All
Veterans Administration cases were men
and fended to be older at diagnosis than
cases from New York State or Los Angeles
County.
Table 2 shows the number and percentage
of cases and controls exposed to asbestos,
More next of kin of cases than of controls seid
Toble ! | Demographia characteristics of canes and controls, ky geogvaphis location
New York Ste “as Angeles Couey Vamans Adrminrcion
Caser Conarae Gases Conarals Caves Coneet
HGooy 38000 boy 1 tso00 Henn toon
Ae So. 4 (4-2) (2 (6"3) it 2
© 5
so-39 2 Sh Bare bdse 4S 8 2 18 ER
60-69 ‘35 G6-8) 10) Bs (32-5) 53 (40-1) ab ey 3 (44-3)
THES 24 (25-3) 3-3) 20 (25:3) 39 (22-2) [20°6) 6 (86)
toe pay: as 1a
8 (BH 38 (83-2) 1203. 37 2D0) 823-5) 13 (18-6)
Race and nex groupe
‘White M 78 O21) 203 (D- 69 (87-3) 139 (79-0) 32 64n 64 (he
Nonmwhire M_ « 2 6 t 3 7 ° a3 2 “a3 4 org
Whi E 17 GR) 78 (27-2) BURR) 27 (15-3)
Of the five non-white women who wexe originally
‘This case war not:
controls with unknown rade,
ddagnored a3 having mevorh
os having mesothelioma and was not included in the
lloras, anly one completed he quewionmal,
tras Not Wed wr cos aoeMalignant mesothelioma: atoibutable rish of asbestos exposure 807
Table? Frequency and percentages of cases and controls the study subject was ever exposed to
with reported exposure to asbestos asbestos, gave a positive response t6 questions
Cases Comzrols on occupational or non-vocational exposure
Too aep:~SC«CO BY of the nine activities involving sus-
208 (100-2) S33(100-) pected asbestos exposure, or were classified
by the NOHS as being employed in a job with
Ever (62-0) 90 16 es
ee eer meenee 1291620) 90.0009) 0% likelihood of asbestos exposure. Reports
iver performed: of ever living within two miles of an asbestos
Brake lining work 33058) 72.015 oF ae
Bumnses or Ser ination or 0 ° ; mine or mill were similar for cases and con-
39 (7
Bae mol 5 2 2 ols. No known soutce of asbestos exposure
Plarble or heseire dee 135 gs was reported for 22 cases (11%) and 198
cee” 4 Beem Se Oek (37%) controls,
or yard or ty 2 1
Seo Sig oo 2 (2 G8 Table 3 shows ORs and 95% Cis for the
Brodueron of texules reduerT gS 2 £3 tisk of mesothelioma from cxposure to
Av ieust one of these nine 150721) 238447) asbestos by sex, age, and tumour site (men
‘ighet lieibood o¢ only). The ORs were nearly an order of mag-
fe iy snd NOE O) ” nitude higher for men than for women for all
a "gga 328 measures of asbestos exposure. None of the
10-19 2-0) 10-9) ORs among women was significantly different
ae BOER 4 GS) from unity, but female cases were few, Among
. men, pleural mesothelioma was more strongly
Cobsbitant ever exposed. 16 @7 7% 5) ssociared with asbestos exposure than was
Cenabtane ang of ne activiies 37078) 930174) peritoneal mesothelioma. Among the mea-
Lived snes of ab sures of asbestos exposure, the question,
he oralh TOMER oo) 8 as) “Wes the smdy subject ever exposed to
° a 2 asbestos?”, generally yielded higher ORs than
ed exporscto athe (ao) 235 (62-9) the other measures, followed by the subgroup
2006) 188071) of jobs for which the likelihood of exposure to
‘each study subject, highest likelinood of exposure war asbestos was at least 20%. When ORs for age
TNOHS categorization of all jobs (soe. at death <65 and 265 were compared, there
Pponaral ox ‘exposure = reports ever exported ro asbestos, any were no important differences. Many subjects
tema epee acotcy eaten bib NOHS had multiple activities involving asbestos
aldence wich two walle ‘of asbeatox mill, be exposure. Ror example, among subjects with
o Yaown exponure = reports never exporcd 80 wbeates, brake lining installation or repair history, 33%
‘of the ibs with NOHS aa ge 3
Rahoods Onccbianm in ebame cpu and ac ls0 bad shipbuilding or shipyard work and
esidense with tera vniles of asbestos mine or mill 55% had performed insulation work. For this
Table 3 Odds ratios (95% Cs) for the association of asbestos exposure with malignant mesothelioma, by sex, age, and by sumour nite for men*
Mert Woment Age <6 Age 265% ‘Aden pleural ‘Mon peroneal
2 179) (225) = 86) GE 1D (n= 159) G20)
OR@SHCD on ORGSKCD x ORPSCD nn ORGSHCD 0 OROSHCD n OROSHCD
Over exposure
reporedg 1699-8 (27-215) THB (EGO) 79 GB (VH-20-0) 104 G2GA-IE) 1s2 1F6 (4TH) IT 31 O--149)
Bver exposed
toasbestor 121 265(019-61-5) 6 2R(OF1G0) 5B 228 GHB) 69 HG (TEGES) 107 343 (155-1-8) 4 106 E574)
Byer any of nine
petivides 142 10-7 (51-235) 52S (CHAT) 62 FE GARGH) BF HHE-ZOD) 1A 13-9 SGFET) 1S 3007-165)
Highest likelbood
ofexposure with
feb blaton and
19%. #2 Te GoweH 1 12 Oo) 19 59 {oss 3 Tee 7 7-30-03
20-90% «54 160 GE2B9) 0 24 359 GO-3475) 30 12-8 47-360) 4 7-292)
Cobabieant
ever exposed.
Darbar 12 132 G4547) 2 34 O36r3) 9 94 BO497) 6 BME) 12 169 GO-TO
Cobabitant “ .
any of nine
feuvities = 38122 (46-353) 9 Ld (ORTH) 24 SP (PABA «23 SECATARA) «34 14B (FOE) 496 (05-620)
Mo known,
cxpomrs 100 Moe 7 1410 740 3 10
"Al Sonpariscon sep made wide people with no reported caponats 7 atbeatb, none of nine species artvi, po jabs with NOHS Gkeixvgd of etberto
rina cohabansa wei avuceior erporie, and ny rendence wien wo mses of mbertoe mine or mil. Blank response weated ar Foot expored. Cestt
exposure >
Shi controls wih misring data on wnoking have beet excluded Gow analyri, Subject ney have enswered yet co mote chan one question; measures of anbestor
cxppeire are not controlled for each other,
‘wo miles of asbestos tate oc mil,
‘lob Rintorica Guarded vith the sesale ofthe NOHS survey of workplaces conducted by NIOSH in 1972-1974 (Pedervem, personal communications, 1992). Each
subject was clarrified inta the highest arcained exporure category,808 Spircas, Heineman, Bemstein, Beebe, Keehn, Stark, Harlota, Benichow
Table Adiuae dis ravos (95% CL forthe auolation of abet ets eon with plowral malignant mesarhelioma among men, by duration lasency,
age at first exposure, decade of first exponrs, and decade af last
‘NOHE bkeithood of asbertar expasuarct
‘Ever expored to ashertor Ber any of 9 activiies (61H 220%
“Exposed . ‘Bapored Beposed
OR (85 OD * OR (95% CD & OR GSK CD ” OR (95% CD mo
Donation of wo:
<10 Sh4 (TRIBE) 35 15:6 8-43 « eo 3413) Ib 21-2 GO-80-9) 14
106-19 607 (140-298: we 18-4 (52-525) it 16-6 (3-5-85-5) 7 152 G3-73-4) 6
#20 308 Caos 43 142 (5-9-35-8) 5o 109 33-37-8} 12 42-1 ($3-1=145-0) 27
‘Trend P value O07 45 O43 O05
Lauer foe cxponorg 30 diagno
oe “ ay eee: 3 4 B{3-5-43-9) Ww 6 PE 06-53-03 2
339 63-1263) 61 Gabean a 2 303 O07) 26
BAe 3 st (UL2-106-9) 26 12-9 (50-34-86), 4 is 227 (h2-743) 18
‘Age at first expomure:
<25 727 94 sae 9 36 12-2: GSE a 13 2TR {B-R-93-3) 25
28-34 396 O 2) 8 19-7 (75-54: a ib BES (H2-15}-4) 17.
¥35 Ns O2eiss 2B 248331) 37 7 148 "G5-59-2) 10
‘Deaade of first exposure:
3909-38 384 24-126" 2 1-8 (47-30-99 a Bs eee 12 267 (6-871) 26
194049 SET O40-1F-2 40 1DT (PB-51-9) oT 7-0 (194265) 9 BET 4-799) 26
1950+ OFS PRBS) 20 Ubl GG-334) 28 G3 (18-226) 10 18 GET 8
Decade of fh jasc exposure:
BEZ (7-3-2372-2) 5 144 G2-49-0) 7 BL O4-21-0) 2 ITT GA-l084) 5
i peoas 566 (64-2103) 24 ia fees: 16 8429-393) 6 160 B-70-0) 7
1950-4 B95 G5I-t0a2) 67 138 733-0) 97 B2G2-281) 2h 2G (5-8-345) 36
‘All comparinony sre made with
‘exposure > 0, ne cobmbitanes
and controls with missin,
‘fF or each study subject, hi
with no reported exporure fo asbestos, none of
fopenire, and no reidence widhin to et
data on smoking were excluded. P value tated on Mantel
has Reanood of xporure wee anced bared upon NOV catopessaton of ul jobs Pederson D, personal communisatioe 1982),
reason, results are not presented individually
for each of the nine activities.
For the three methods of classifying
asbestos exposure, table 4 shows patterns of
risk of pleural mesothelioma among men by
duration, latency, age at first exposure, and
decade of first and last exposure. Dares when.
first and last exposed for each measure were
obtained from reported start and stop dates
for jobs held by the subject, or from dates
during which the subject lived with e cohubi-
tant who was reportedly exposed. Reported
asbestos exposure that was related to neither
job nor cohabirant lacked dates and thus
could not be considered in these analyses.
‘The measures of exposure in table 4 are not
controlled for each other. Patterns of risk with
latency, age at first exposure, and decades of
first and last exposure were similar among dif-
ferent durations of expoyuie categories (not
shown). Although risk of mesothelioma is
increased in all categories for every measure,
patterns differ between measures. Risk
decreases with length of reported exposure
to asbestos for the ever exposed to asbestos
category, is unchanged with time engaged
in the nine suspect activities, and is incon-
sisteat with time in jobs judged to have
1-19% or 220% likelihood of exposure to
asbestos, Only the increase with duration of
exposure in the %20% likelihood category is
significant,
Responses to the ever or never exposed to
asbestos question yielded the highest risk (OR
= 234-7, 95% CI 17-6-9318-1) among gub-
jects most recently exposed, and lower risks
with longer latent periods. In contrast, risks
were similar for all intervals since first expo-
sure to any of the nine activities, and higher
for longer latency periods for the two likeli-
rotate aioe oral
ios, no fobs whts NOHS Uksihood of aeberras
|, Odds raxios adjusted for age and smoking, Cases
hood categories, The ORs based on the nine
suspected activities gave inconsistent results
for age at first exposure. According to the ever
or nevér question, the risk was higher with
younger age at first exposure. For both cate-
gories of likelihood of asbestos exposure, sub-
jects had lower risks if they were exposed after
the age of 35, but the pattern was not consis-
tent in younger age groups,
Results by decade of first exposure were
complementary co those for latency, with the
two likelihood measures showing higher risks
for subjects exposed earlier, and the ever or
never questions showing highest risk arnong
subjects beginning exposure most recently.
Risks were not relatively higher for first expo~
sure during the 1940s, except for those sub-
jects who were involved in at least one of the
nine suspect activities, Of the men with
pleural mesothelioma 70-89% were judged to
have been still exposed in the 1950s and later
by each of the meusures of asbestos exposure.
Risk patterns were inconsistent across cate.
gories of decade of last exposure by the differ
ent measures.
Table 5 shows the overall AR of mesothe-
Homa thet can be related to asbestos and par-
tial ARs for each individual measure of
exposure. Among men, pleural mesothelioma
was associated with higher ARs than was peri-
toneal mesothelioma. A substantially emaller
percentage of the cases among women were
auributable to’ asbestos, both overall (AR =
225) and for individual measures of expo-
gure. Except for the ever or never question,
ARs for women were not detectably different
from zero. Overall and partial ARs were
higher among the all male Veterans
Administration population than among the
‘New York State or Los Angeles County totalMalignant mesoshalioma: attributable risk of asbestos exposure 809
Table 5 Percentage of overall and partial atribusable risk (95% Gls) of malignant mesothelioma due wo asbestos exposure by geographic location, site,
sex, and age*
Ne Les
Sie Se, teat ett Woon 655 ess Heat fetlonatt
ah «
(ey re) fend eI m=2) (eR) ali) e159) 20)
“Argue risk rtk for subertor:
exposure 7185 263 87 225 1 D6 88-0 561
repo GBker4 Gb-910) Belo dieern Garvn dessa Gree) 55-945) (197-889)
Pargial areiburabie risks:
Ever exposed to SU+2 690 592 53 14 $52 655 syst
asbesTOR 890-614) GO1-794) GO-B7S3) GTE7H4) (27505) ee brs) Geese) GreT2s) GIa-83-6)
Bverany ofnine 549 617 659 78 70 619 3 89
seivides (40-2687) (9-7-8190) (250-820) GPE-80) (2-757 Gberze) Geiray G4oes2) dete)
Meer Bon oe
exposure from jot
iSeory end NOHBsh
19% 15-7 se 15 rer ” 146 49 182
63-278) GT) (70-37) (1322-268) 9-318) 6-264) 23-2641)
20-99% 237 194 353 204 tt 254 2 3o1
: 553465) 126-407) BPSSE6) — I9-35-9) 153-392) 056-322) @3-1-38-0)
Cohsbitant ever 52 ad ao 63 1s 5 as 12
cxpored + 91S) | TABOO) HEALY «OMG S1ES) IOS) (0-126)
Cobsbitant eny of 165 IBL 227 1B 19 235 1S7 19-5 13-6
nine activities B24) G6-31-4) | CISAO2) — UHR2EN) — (O97) GZ0-4D8) (92-253) BST) BB-45-9)
TAributable nk 9 calculated with an apzrosth bated ov logic epesden (He Methods ston), All comparzond are made wit people with no reperted
‘exposure to atbestor, none af nine specified uctivides, ao "ab ws NOES thaisond fos exposize >0, no cohabitants with esbestos exposure, and no
rtdidence within two milct of atbestos mine or mill. Cases and contrals with missing nares saanobing nove been cvchoded fom analyos, Paral arate sks
‘add to >100 because rubjects may be classified as expored by move than Ons measure,
ied for age, sex xcept Vensrans Adminiyiraton
Adjusted for ene, smoking starus, a eat ‘ares.
eel ‘and smoking stan.
populations, but are comparable with those
for all men in the study. For cases <65 years
old ARs are consistently higher than for cases
365, but there is considerable overlap in 95%
Cis.
Discussion
Previous estimates of the percentage of cases
of mesothelioma that had had asbestos expo-
sure have varied from 13-100%."209-
Among these studies the paper by McDonald
et al provided a formal measure of risk
attributable to type of asbestos fibre. No other
study gave any measure of attributable risk,
‘The results of our stedy found the overall AR
to be highest among male pleural cases, Which
is also the group with greatest frequency of
asbestos exposure. Previous analyses of inc
dence and of mortaliry from mesothelioma
found the highest rates and increasing tends
for older men with pleural mesothelioma.”
Bnrerline and Henderson studied United
States death rates for malignant neoplasms.of
the pleura (the disease classification closest to
mesothelioma of the pleura) during the years
1968-81. They found an increase in death
rates for men aged >65, but not for younger
men or for women. We found slightly, bur
generally higher partial ARs among the
younger male cases. There may have been
better reporting by respondents for younger
cases. Also, very high exposures, which were
likely to have occurred in the 1930s and
1940s, may have resulted in hing cancer or
asbestosis before mesothelioma could.
develop,
Studies that showed a high percentage of
cases exposed to asbestos (>86%) have
tended to come from geographic areas near
shipyards**!77* or crocidolite. asbestos
mines.** In our study, 20%, 46%, and 35%
of the respondents for cases from New York
State, Los Angeles County and the Veterans
Administration reported exposure in ship-
yards, shipbuilding, or ship repair. The rela~
tively bigh percentage of ceses from Los
Angeles County with shipyard exposure is
consistent with the large shipyard industry in
that area. Studies that reported a low percent-
age (<30%) of mesothelioma cases exposed to
asbestos have tended to come from geo-
graphic areas remote from a main source of
asbestos exposure.®® The ARs calculated
from the two population based registries are
likely to be representative of their geographic
areas, Data from the Veterans Administration
(all men), which. were included for compari-
son, provided results that were similar to
results for men from the two population based
cancer registries. They are not representative,
however, of an easily defined population and
the BIRLS controls are likely to be more simi-
far to all veterans than are the Veterans
Administration cases, who may have lacked
access to other medical care.
Mesothelioma was not significantly associ~
ated with asbestos exposure among women in
‘our study, although the OR for ever exposed.
women was 2-7, Although over 50% of the
female cases reported some exposure to
asbestos, the number of female cases was
small, and women were less likely than men to
be employed in jobs expected to have theSpirtas, Heineman, Beraxtein, Beebe, Keehn, Stark, Harlow, Bertichou
highest exposure to asbestos, such aa ship-
building and insulation work, Iv is generally
accepted that <10% of the workforce exposed
to asbestos is female.‘ Vianna and Polan, in a
suudy restricted to women, reported a signifi-
cant association with indirect exposure 10
asbestos (husband or father had occupational
exposure; OR = 10 for pleural and peritoneal
cases combined),* Our results are consistent
with previous studies in suggesting that differ-
ences in incidence rates of mesothelioma by
sex anid geographic site may be due to differ-
ences in exposure to asbestos,
In « previous stady of a cohort of asbestos
insuletion workers the incidence of mesothe~
lioma increased with time since firet exposure,
bur not age at first exposure. For most
measures we found ORs were higher for
younger ages at firet exposure, The wide Cls
around the ORs for age at first exposure, indi-
cate that onr study has limited power to assess
this issue. The relation between ORs and
latency (time since first exposure) differed for
the various ‘meusures of exposure. Results for
the NOS likelihood messurea were consis-
tent with previous findings, whereas those of
the other two measures were not.
McDonald and McDonald deseribed larger
relative risks with selected occupations that
have been associated with mesothelioma than
by assigning probability of exposure to all jobs
Usted."? Their controls consisted of people
matched to given cases on age, sex, and year
of death, and were restricted to people dying
of pulmonary metastases from a non-pul-
monary malignant tumour. They included a
small group of jobs that had possible asbestos
sxposure a§ non-exposed in their analysis. In
our study, the largest ORs come from the ever
exposed question, then from the NOHS rat-
ing of the likelihood of asbestos exposure,
which acsigned probabilities of te
tach job, for jobs where the probability of
exposure to asbestos was >20%.
In our study, the definition of non-exposed
was made as restrictive as possible and
excluded any study subject ever exposed who
had any of nine specified activities, any job
with NOHS likelihood of exposure >0, ever
cohabited with someone exposed-to asbestos,
or ever resident within two miles of en
asbestos mine or mill, Because of the well
known association between asbestos exposure
and mesothelioms, there may have been
reporting bias by next of kin of cases in
responding to the question: “Was (smdy sub-
ject) ever exposed to asbestos?” Such a bias
would result in artificially high estimates of
OR and AR.
Ail menaures of esbestos exposure show the
expected gradients in ORs for nmour site and
sex. The NOHS, used to estimate likelihood
of asbestos exposure in tables 2-5, was based
on surveys conducted in 1972-74 and seemed
not to have captured all exposures in the
19408 to the 1960s, the ‘aetiologically mean-
ingful period for our study, as noted by previ-
ous researchers.“ Also, it omitted subjects
who performed some activities—for example,
insulation work--outside work and lacked any
measure of intensity, On the other hand, both
the NOHS evaluation and involvement in the
nine specified activities would be expected to
include subjects with litte or no exposure to
asbestos, Such misclassification would tend to
bias the estimates of risk toward the null,
None of these measures is ideal, as the next
of kin could not be expected to recall all jobs
and exposures for the study subject." In
particular, it is possible thar exposures and
jobs in the more distane past may have been
missed, As none of the measures of asbestos
cxposure used in our study can be considered
ag the gold standard, it is impossible to mea-
sure sensitivity or specificity. Because of the
presence of a large shipyard industry in the
Los Angeles County area and the uniqueness
of the Veterans Administration ceses and con-
trols, we do not consider these ARs to be
directly representative of the whole popula~
tion of the United States.
Conclusions
Jn our study nearly 90% of incidences of
pleural mesothelioma among men were
directly atriburable to past exposures to
asbestos, Although there were only a small
number of peritoneal mesotheliome cases
among men available for study, it seems that a
substantial percentage of these cases, perhaps
60%, also could be attributed to asbestos
exposure. Among’ women, however, only
about 20% of the cases were attributable to
asbestos exposure. As the incidence of
mesothelioma among women (about thre
cases per milion women per year for all
primary sites combined) is much lower than
smong men and has remained reasonably
constant over time, it is possible that the
incidence in women may be close to the back-
ground level, Alternatively, exposure to
asbestos is lower and misclassification of
exposure may be greater among women,
which would also reduce their AR. Use of
next of kin interviews may have resulted in
biased responses. If time dulled the memories
of next of kin of controls more than cases, the
resulting ORs and ARs would be artificially
inflated, The large percentage of cases first
exposed in 1950 or later, argues for continued
surveillance of future mesothelioma cases,
‘We thank Drs | C Wagner and L Hochholeer for review of
Bistopathology alides,
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3 provided by a surviving spouse.
foams 12S ABI~B,EXHIBIT 2Data concerming all motor vehicle mechanics, those among them who definitely engaged in.
brake service, and those with no other asbestos exposure from the German mesothelioma case-
control study. Odds ratios estimated incorporate data concerning no exposure to asbestos,
Cages Controle OR isided p- Confidence
value interval G0%)
Total cases and controls 324 497
Motor vehicle mechanics 16 28 5.3 <0,001 2.9-9.8
“Definitely” did brake work 6 12 46 0.002 1.9-11.3
Brake work, no other exposure 3. 4 7.0 0.007 1.9-25.7
Estimates of numbers with
no exposure to asbestos * 28.5 266.4
* Estimated using data from [Rodelsperger, et al. 2001] Table VII where 11 of 125 cases and 67
of 125 controls were not exposed to asbestos.:
3
0003~4878(94)E0032-U7
MESOTHELIOMA AMONG CAR MECHANICS?"
H.-J, Worrowrrz and K. Réversrercen
(Receioad 30 November 1993 und i final form 18 Febevarp 1994)
Paper read at the Workshop on Health Risks Associated with Chrysotile Asbestos,
held in Jersey, Channel Islands, 14-17 November 1993,
No Astrect,
IN 199! and 1992 preliminary information was given on an. on-goitig case-coatrel study
of mesothelioma, which Up to that time involved 174 cases, of whom 14 wore car :
mechanics (Worrowrrz and Ropetsrercen, 1991, 1992). This study hes sow been '
finished (Worrowrrz et ai, 1994) and the final results relating to car mechanics cag be
reported.
“Kraftishrzeug-Instan
Federal Statistical Office).
‘most iristances be Mung:
the cecupational histories of.
mesothelioma cases and one of the haspii
ee ae
“Supported by the German Federai Ministry of Science and Technology, Project No. OF HK 076 ag.
638 . Sus~ FOG eta win
Hel. Worrewirz and K, Réoesrmgen
Sor98 331849 U) palledua jou oom soqueysow 22410 184) Weaw you 0p YL,
eyo (ss63-ez61)-
at s vr t t 5 t Sv6t ) a9 a wr sfonwos wansindog
cf t96t-s763: .
oF = 6% 6 t $ 6rS1 ) vs un sit ‘Mose jendsoyy
ee) (2e61-9c61
ee ’ oF 3 y 8r61 oy a vee Squsped suzoyayjoroyy
% N % a Sunn pur ones uejpaus % on N dnote
ainsodys Sta lay 240g {sinady wsuiZoydura jo Ryueypow quAW
“SOIATEAYIOON — peta Apannuysg: Wautforduta 0. ‘TuyuujFog” —sporyon 401K RIOD
vopeng
AUDSSIH IWHONLYEND00 Hows °
NOUViRdON] “SromND ORV INIOS 28) ORY SOwNos. ‘WaHton $16 ‘sasva. YRONLLOSIN 976 ONOTY SOW YHOaK TOngA wOLoyy +} avga
hospital contrets and two
engaged in brake repairs,
Lung tissue analysis was availabl
the hospital controls (ROpetsperg:
Taste 2. Lun Tssug awatyas oF
Mesothelioma among car mechanics?
67
of the five population controls, stated that they had been
le for two of the mesothelioma cases and for one of
ER et al., 1993, see Table 2). For mesothelioma
MESOTHELIOMA CASES AND WOIPITAL CONTROLS,
ENGATED 3S HOTOR VEHICLE MECHANICS. THE ANALYTICAL SENSITIVITY IS DEFINED ab
CONCENTRATION Pam Frome
Lurig dus lve eonseatration £2 § pet
MP fe"? tary)
Analytical Other
No. Status sensitivity, Chrysotile Amphibole minerals
t Case 2 Q o : o
2 Cae 14 o . 282 4
3 Controt 235 1.630 o 1%
patient No. 1 no fibres longer than $ um were found. Since 1972 he had worked for
8 yearsasacar mechanic and was engaged in brake repair work during this time. There
was 00 suggestion of any other asbestos exposure,
For mesothelioma patient No.
were observed. He had worked asa.
Luftwaffe pilot from 1941
employment.
Control patient No, 3 had numerous io
He had warked as car mechani¢ from 1
2 characteristic amphibole fibres longer than 5 jam
carmechanicfor only! yearin 1940 and had been a
to 1945; he had no known asbestos exposure frora other
ng chrysotile fibres but no. amphibole fibres. |
934 to 1939. From 1945 to 1950 he was a
Prisoner of war in Russia where he had to arc-weld steel structures and to install Slass
Bbre insulation. Subsequently he is assumed to have had
exposure to asbestos.”
From these results there
CONCLUSIONS
no evidence that car mechanics are e3
fo further occupational
possibility that, decades before, chrysotile fibres were active
other hand, it is doubtful that the amphibole a:
two other patients, can be
{For the discussion of th
Pp. 407-425.)
Réogisrexces, K., Worrowrre,
K.-H. 11993) Fall-Kontroll.St
related to their em
e issues raised in this and the other allied papers see
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HJ, BrOceeL. 8. Anwencen.: R., Roane,
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Edaae] A tad, ated 1, $51
Worrewsrz, Bcd. nnd ROsesrencen, KC. (1992) Chrysotile asbestes, mesothelioma and garage mechaniés:
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