On December 10, 2020 a
Exhibit,Appendix
was filed
involving a dispute between
Patsy Young,
and
Aventis Inc.,
Avon Products, Inc.,
Block Drug Company, Inc.,
Block Drug Corporation,
Brenntag North America, Inc.,
Brenntag Specialties, Inc. F K A Mineral Pigment Solutions, Inc.,
Charles B. Chrystal Company, Inc.,
Chattem, Inc.,
Colgate-Palmolive Company,
Cyprus Amax Minerals Company,
Cyprus Mines Corporation,
Glaxosmithkline Llc (Sued Individually And As Successor-In-Interest To Block Drug Corporation, Successor-In-Interest To The Gold Bond Sterilizing Powder Company A K A The Gold Bond Company And As A Successor-In-Interest To Novartis Corporation And
Novartis Consumer Health Inc.),
Gsk Consumer Health, Inc. F K A Novartis Consumer Health Inc. F K A Ciba Self-Medication, Inc.,
Insight Pharmaceuticals Corporation, A Subsidiary Of Prestige Brands Holdings, Inc.,
Insight Pharmaceuticals Llc,
Macy'S Inc. F K A Federated Department Stores, Inc.,
Novartis Pharmaceuticals Corporation,
Prestige Brands Holdings, Inc.,
Prestige Consumer Healthcare Inc. F K A Prestige Brands, Inc.,
Sanofi-Aventis U.S. Llc,
Sanofi Us Services, Inc.,
Whittaker Clark & Daniels, Inc.,
for Torts - Asbestos
in the District Court of Erie County.
Preview
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023
EXHIBIT 78
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023
MASTER EXHIBIT 49
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023
Environmsntal Health Pmpectit~e~
VoL 9, pp. 119-lft. 1914
:Asbestos in Talc
! The mineral talc is a hydrous magnesium properties of particles. However, ln the instance
~theet silicate that occurs in both platy and of talc, the extremely fine grained intergrowths
fibrous crystal forms. Talc tends to occur in rock of different minerals and the extensive overlap.
masses coexisting with a number of other ping and similarities of their optical properlties
Jlydrous magnesium silicate minerals. Typical- limit this technique to a preliminary or screen-
ly, talc deposita consists of fine-grained, in· ing function. Since large numbers of fibers may
tergrown mixtures of minerals which may eon· go undetected, optical microscopy would not be
tain considerable amounta of asbestos. In addi· capable of quantitative analy,sls.
: tion, tale deposits often show complex mineral X-ray powder diffraction is a routine teclt·
zonation, which adds to the difficulty of selec- nique for analyzing crystalline. materials. It is
tive mining. For example, in the talc deposits of relatively simple in principle, but the results
the Gouveneur District of New York State, talc may be difficult to interpret. The limitations of
oecors with the asbestos mirierals chrysotile, precision and accuracy must be given careful
tremolite, and anthophyllite -in addition to consideration.
other silicate minerals; Tbe identification and quantitation of
Since the mining of tale rock almost in- asbestos fibers In talc by x-ray diffraction may
variably includes the mining of asbestos as well, be achieved by co~parison of known dilutions
the asbestos contaminant may be carried over (fiber type and quantity) of asbestos in a talc
into the consumer product and thus Introduce matrix with unknowns. The preparation of stan-
the risk of asbestos disease. This possibility dard dilutions of asbestos minerals in talc for
lead.a to an important public health question: is quantitative analysis requires: (1) a talc matrix
asbestos present in consumer tales, and if pre- completely free of contaminating asbestos
sent, which mineral fibers and in what concen- minerals, (2) pure asbestos fiber as the sought
trations? adventitious phase, (3) a preparation method for
Among the standard mineralogical tech· insuring homogeneity and reproducibility of the
niques wbicb may be used for identification and standard dilution material, and (4) selection of
quantitation of asbestos in talc are optical x-ray refl~tions with no superimposed In~
microscopy, ·x-ray diffraction, and electron terferences. Condition (1) requires the selection
:;: .·~
microscopy (EM). of pure talc matrix material. In the first stage of
..J •• Optical microscopy, employing polarized light screening, material was first scanned by x-ray
. • ·, t . f :
optics, is useful for determining the optical
:; f
diffraction to identify the major mineral phases
. ·I •Environmental Sciences Laboratory, Mount Sinai School rapidly, especially asbestos minerals. If no
.! or Medicine, New York, N.Y. 10029 . . .. asbestos phases were detected, the material was
December 1974 129
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023
re-examined in a more sensitive mode of x-ray diagnostic reflections were step-scannoo"" at
diffraction called step scanning, ·and finally by 0.01°20, in a fixed-count mode. This permits tlie
electron microscopy~ In this way a pure tale was weak reflections produced at low dilution levels
selected (pure with respect to asbestos; small to be determined with precision. From the fixed- ...
amounts of chlorite and phlogoplte mica were count data a profile of the diagnostic reflection
tolerated). is obtained and the area above background is
In a similar way, pure samples of. taken to be proportional to the reflection iu~nÂ
anthophyllite, tremolite, and chrysotile were sity. The results of these analyses· are
given in
screened and selected for use in preparing the Table 1, which shows that: chi-ysotile at dllutlon
talc-asbestos standard dilutions. levels less than 0.26~ was not detected,
In x-ray diffraction the reproducibility of tremolite was detected down to 0.1% dilution
reflection intensities is strongly influenced by levet and anthophyllite was not detected at con·
the degree of cleavage of crystalline powders. eentrations below 2.0% (diagnostic reflectioJl is
The minerals under investigation exhibit a high at 8.26 A; III• = 55).
degree of platy and fibrous cleavage. A number In order to determine the !)umber of
of preparation techniques have been developed chrysotile fibers present at various. dUuti9n
for reducing preferred orientation effects. These levels, aliquots of the various dilutions were
were tested, but none were found to give prepared for EM scanning. A fairly sf.andaril
satisfactory reproducibility. Accordingly a technique called the rubout method was u8ed.
technique was developed and employed which For each dilution level, 20 fields fiom tbtee EM
gives a high degree of sensitivity for substances grids are photographed at constant ml!fPlifiea·
present in minute quantities and with a greater tion and the number of long unit fibrils per field
level of reproducibility of reflection intensities. are counted from printed enlargements (Fip. 2
Binary systems of three asbestos minerals in and 8). These fiber counts sliow fairly good
talc were prepared at varying levels of dilution correlation with levels of chrysotlle dllutidn.
concentrations. Standard weights of these miX· By using the fiber count d8ta, it is pO&sl»le to
tures were dispersed in water with ultrasonic calculate the number ·of fibers in a unit weight
energy to disperse the phases homogeneously. of sample. Thus, at a 1% dll!ltion lev~l there
This slurry was filtered through a membrane would be about 40 X 10" fibers/mg. Even at
filter by use of a hypodermic syringe (Fig. 1). the lowest level of detection by x-ray diffraction,
The residue forms a flat cake which is mounted i.e., 0.25%; there would be about 10' fibers/m8'.
for x-ray analySis. This technique has the ad· Cosmetic talcum powder, for example, which
vantage of uniformly preparing, mounting and had been step-scanned and chrysotile not found
measuring the tale-asbestos dilutions under might contain billions ~f fibers rel~ased dw:ing
identical conditions. dusting with a half-gram dose. · · ·
Because of the structural similarities between Thus, very large numbers of asbestot} fiber&
some of the minerals, there was considerable may be present in talc end products, 'yet they re.
overlapping or interference in many reflections, main Qndeteeted if only optical microscopy and
and this made it necessary to select reflections x-ray diffraction are used. On
the other bantt,
which could be unambiguously used as Jndiees EM can be a very sensitive method'for detecting
of the amount of each mineral present. These of
extremely minute amountS asbestos In talc.
. . . . .
FlGUJtE 1.
.
Membrane
.
tilter hol!fer-hypodermlc
. . . . ' .. .·
syringe
·.. .
eyatem of .ample
. .... ·~·,
prepar&tilln.
. . •. ;_ ...
. .
130 · Environmental Health Perspec~ves ..
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023
at
:he
,..... Table 1. Compariaon of tower llmit1 or detection of aabostoa mlnerala Jn talc
by atep acannlltl and oontinuou• ecanning.
els .....
• • # ..
...
~d. : Asbestos D1ajplo:otir
Detection limit c:onrvntration,"f
Step scanning Contilluous acannlilg
on mineral n1fiectlon, .&. 1001° 211)Q rt• 2~/mlnl"
is
n· Chryl!Otile 8.66 0.25 10
in Tn1mollte us 0.10 2.0
>n
d, AnthOJlh)·lllte 8.26 2.0 .1.0
•n
1· ~Operating conditions: tilted count rate .. 2000; ~5 k\',
20 mA.
Is ,.. Operating conditions: 500 couata/aec: time constant
• 2 0; .tG k\', 20 mA.
1f
n
e .
i
I
,.
I
/.
....
..
......,.. '
'
....
~
• ..--·
l~m
F!llt'/1~: l. F.ll'l'tmn. photomlcrouraph of chr~~otilf-ta.lc 1997. tal~, 1r; chrysotll~l.
't
December 1P74 131
·j..
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023
FIGU.BE 8. Electron
. '
photomicrograph
. ·; . .
of. chrysotile-talc
' . .
(95~ talc,
. 5~
. cbeyaotile).
. . . .
132 ·.Enru.onm~tal Health Perspectiyes
Preview
FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023 EXHIBIT 78 FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023 MASTER EXHIBIT 49 FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023 Environmsntal Health Pmpectit~e~ VoL 9, pp. 119-lft. 1914 :Asbestos in Talc ! The mineral talc is a hydrous magnesium properties of particles. However, ln the instance ~theet silicate that occurs in both platy and of talc, the extremely fine grained intergrowths fibrous crystal forms. Talc tends to occur in rock of different minerals and the extensive overlap. masses coexisting with a number of other ping and similarities of their optical properlties Jlydrous magnesium silicate minerals. Typical- limit this technique to a preliminary or screen- ly, talc deposita consists of fine-grained, in· ing function. Since large numbers of fibers may tergrown mixtures of minerals which may eon· go undetected, optical microscopy would not be tain considerable amounta of asbestos. In addi· capable of quantitative analy,sls. : tion, tale deposits often show complex mineral X-ray powder diffraction is a routine teclt· zonation, which adds to the difficulty of selec- nique for analyzing crystalline. materials. It is tive mining. For example, in the talc deposits of relatively simple in principle, but the results the Gouveneur District of New York State, talc may be difficult to interpret. The limitations of oecors with the asbestos mirierals chrysotile, precision and accuracy must be given careful tremolite, and anthophyllite -in addition to consideration. other silicate minerals; Tbe identification and quantitation of Since the mining of tale rock almost in- asbestos fibers In talc by x-ray diffraction may variably includes the mining of asbestos as well, be achieved by co~parison of known dilutions the asbestos contaminant may be carried over (fiber type and quantity) of asbestos in a talc into the consumer product and thus Introduce matrix with unknowns. The preparation of stan- the risk of asbestos disease. This possibility dard dilutions of asbestos minerals in talc for lead.a to an important public health question: is quantitative analysis requires: (1) a talc matrix asbestos present in consumer tales, and if pre- completely free of contaminating asbestos sent, which mineral fibers and in what concen- minerals, (2) pure asbestos fiber as the sought trations? adventitious phase, (3) a preparation method for Among the standard mineralogical tech· insuring homogeneity and reproducibility of the niques wbicb may be used for identification and standard dilution material, and (4) selection of quantitation of asbestos in talc are optical x-ray refl~tions with no superimposed In~ microscopy, ·x-ray diffraction, and electron terferences. Condition (1) requires the selection :;: .·~ microscopy (EM). of pure talc matrix material. In the first stage of ..J •• Optical microscopy, employing polarized light screening, material was first scanned by x-ray . • ·, t . f : optics, is useful for determining the optical :; f diffraction to identify the major mineral phases . ·I •Environmental Sciences Laboratory, Mount Sinai School rapidly, especially asbestos minerals. If no .! or Medicine, New York, N.Y. 10029 . . .. asbestos phases were detected, the material was December 1974 129 FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023 re-examined in a more sensitive mode of x-ray diagnostic reflections were step-scannoo"" at diffraction called step scanning, ·and finally by 0.01°20, in a fixed-count mode. This permits tlie electron microscopy~ In this way a pure tale was weak reflections produced at low dilution levels selected (pure with respect to asbestos; small to be determined with precision. From the fixed- ... amounts of chlorite and phlogoplte mica were count data a profile of the diagnostic reflection tolerated). is obtained and the area above background is In a similar way, pure samples of. taken to be proportional to the reflection iu~n anthophyllite, tremolite, and chrysotile were sity. The results of these analyses· are given in screened and selected for use in preparing the Table 1, which shows that: chi-ysotile at dllutlon talc-asbestos standard dilutions. levels less than 0.26~ was not detected, In x-ray diffraction the reproducibility of tremolite was detected down to 0.1% dilution reflection intensities is strongly influenced by levet and anthophyllite was not detected at con· the degree of cleavage of crystalline powders. eentrations below 2.0% (diagnostic reflectioJl is The minerals under investigation exhibit a high at 8.26 A; III• = 55). degree of platy and fibrous cleavage. A number In order to determine the !)umber of of preparation techniques have been developed chrysotile fibers present at various. dUuti9n for reducing preferred orientation effects. These levels, aliquots of the various dilutions were were tested, but none were found to give prepared for EM scanning. A fairly sf.andaril satisfactory reproducibility. Accordingly a technique called the rubout method was u8ed. technique was developed and employed which For each dilution level, 20 fields fiom tbtee EM gives a high degree of sensitivity for substances grids are photographed at constant ml!fPlifiea· present in minute quantities and with a greater tion and the number of long unit fibrils per field level of reproducibility of reflection intensities. are counted from printed enlargements (Fip. 2 Binary systems of three asbestos minerals in and 8). These fiber counts sliow fairly good talc were prepared at varying levels of dilution correlation with levels of chrysotlle dllutidn. concentrations. Standard weights of these miX· By using the fiber count d8ta, it is pO&sl»le to tures were dispersed in water with ultrasonic calculate the number ·of fibers in a unit weight energy to disperse the phases homogeneously. of sample. Thus, at a 1% dll!ltion lev~l there This slurry was filtered through a membrane would be about 40 X 10" fibers/mg. Even at filter by use of a hypodermic syringe (Fig. 1). the lowest level of detection by x-ray diffraction, The residue forms a flat cake which is mounted i.e., 0.25%; there would be about 10' fibers/m8'. for x-ray analySis. This technique has the ad· Cosmetic talcum powder, for example, which vantage of uniformly preparing, mounting and had been step-scanned and chrysotile not found measuring the tale-asbestos dilutions under might contain billions ~f fibers rel~ased dw:ing identical conditions. dusting with a half-gram dose. · · · Because of the structural similarities between Thus, very large numbers of asbestot} fiber& some of the minerals, there was considerable may be present in talc end products, 'yet they re. overlapping or interference in many reflections, main Qndeteeted if only optical microscopy and and this made it necessary to select reflections x-ray diffraction are used. On the other bantt, which could be unambiguously used as Jndiees EM can be a very sensitive method'for detecting of the amount of each mineral present. These of extremely minute amountS asbestos In talc. . . . . . FlGUJtE 1. . Membrane . tilter hol!fer-hypodermlc . . . . ' .. .· syringe ·.. . eyatem of .ample . .... ·~·, prepar&tilln. . . •. ;_ ... . . 130 · Environmental Health Perspec~ves .. FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023 at :he ,..... Table 1. Compariaon of tower llmit1 or detection of aabostoa mlnerala Jn talc by atep acannlltl and oontinuou• ecanning. els ..... • • # .. ... ~d. : Asbestos D1ajplo:otir Detection limit c:onrvntration,"f Step scanning Contilluous acannlilg on mineral n1fiectlon, .&. 1001° 211)Q rt• 2~/mlnl" is n· Chryl!Otile 8.66 0.25 10 in Tn1mollte us 0.10 2.0 >n d, AnthOJlh)·lllte 8.26 2.0 .1.0 •n 1· ~Operating conditions: tilted count rate .. 2000; ~5 k\', 20 mA. Is ,.. Operating conditions: 500 couata/aec: time constant • 2 0; .tG k\', 20 mA. 1f n e . i I ,. I /. .... .. ......,.. ' ' .... ~ • ..--· l~m F!llt'/1~: l. F.ll'l'tmn. photomlcrouraph of chr~~otilf-ta.lc 1997. tal~, 1r; chrysotll~l. 't December 1P74 131 ·j.. FILED: ERIE COUNTY CLERK 03/17/2023 08:48 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 287 RECEIVED NYSCEF: 03/17/2023 FIGU.BE 8. Electron . ' photomicrograph . ·; . . of. chrysotile-talc ' . . (95~ talc, . 5~ . cbeyaotile). . . . . 132 ·.Enru.onm~tal Health Perspectiyes