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FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020
NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023
SUPREME COURT OF THE STATE OF NEW YORK
COUNTY OF ERIE
_____________________________________________
PATSY YOUNG, ATTORNEY AFFIRMATION
Plaintiff,
-vs-
Index No.: 815818/2020
AVENTIS, INC., et al. Assigned Justice:
Defendants. Hon. Raymond J. Walter, J.S.C
_____________________________________________
ROBERT J. MULLINS, II, Esq., an attorney admitted to practice law in the Courts of this
State, affirms the following to be true under the penalties of perjury:
1. I am a member of the law firm of Bennett Schechter Arcuri & Will, LLP, attorneys
for defendant, Insight Pharmaceuticals LLC (hereinafter “Insight”) in the above-captioned matter.
As such, I am fully familiar with the facts and circumstances of this case and the matters set forth in
this Affirmation.
2. This Affirmation, along with the applicable exhibits, statement of material facts and
memorandum of law, is submitted in support of Insight’s motion for summary judgment pursuant to
Civil Practice Law and Rules Rule 3212, dismissing the Plaintiff’s Complaint, including all cross-
claims, asserted against Insight in their entirety; or in the alternative Insight’s motion for summary
judgment seeks dismissal, at a minimum, of the claim for punitive damages, together with such other
and further relief as this Court shall deem just and proper.
3. This is a products liability action in which it is alleged that Plaintiff, Patsy Young,
was exposed to asbestos-containing products, materials and/or equipment manufactured, distributed
and/or sold by the various defendants. It is also alleged that Patsy Young’s exposure to asbestos-
containing products, materials and/or equipment was the proximate cause of her alleged asbestos -
related disease, i.e., mesothelioma.
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4. There is no basis to establish liability against Insight based on the fact that the record
is devoid of evidence that the Caldesene brand of talcum powder marketed and/or distributed by
Insight contained asbestos. It is axiomatic that a product which did not contain asbestos cannot, as a
matter of law, be a cause of any asbestos-related disease. Thus, each and every theory of liability
against Insight should be dismissed as against Insight because each and every theory of liability,
including those pled in any cross claim, are all premised upon asbestos exposure.
5. Further, Plaintiff’s claims are barred by the preemption doctrine which provides this
Court with a second, independent basis to grant summary judgment dismissing all claims, including
any cross claims, against Insight, as a matter of law.
6. Even if this Court does not grant Insight’s motion in its entirety, which under the law
and the facts of this case it should, the Court should at a minimum dismiss Plaintiff’s claim for
punitive damages because this is not one of those morally outrageous cases evincing near criminal
conduct sufficient to warrant punitive damages.
RELEVANT PROCEDURAL HISTORY
7. Plaintiff commenced this action with the filing of a Summons and Complaint with
the Erie County Clerk’s Office on December 10, 2020. See NYSCEF Doc. No. 1.
8. On or about January 21, 2021, Plaintiff served Plaintiff’s Answers to Interrogatories,
a copy of which is attached as Exhibit A.
9. On February 11, 12 and 16, 2021, Plaintiff, Patsy Young, appeared for her
examination before trial. Condensed copies of the transcripts of Plaintiff’s examination before trial,
Volumes I-III, are collectively attached as Exhibit B.
10. On April 28, 2021, Plaintiff, Patsy Young, appeared for her de bene esse videotaped
examination. A condensed copy of the transcript of Plaintiff’s de bene esse examination is attached
as Exhibit C.
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11. On March 1, 2021, a Stipulation of Discontinuance Without Prejudice was filed
dismissing without prejudice, Defendants, Insight Pharmaceuticals Corporation, Prestige Brands
Holdings, Inc., and Prestige Consumer Healthcare Inc (collectively referred to with Insight
Pharmaceuticals LLC as the “Insight Pharmaceuticals Defendants”). See NYSCEF Doc. No. 17. Per
the Stipulation, Insight Pharmaceuticals LLC agreed to stand in place and stead of Insight
Pharmaceuticals Corporation, Prestige Brands Holdings, Inc., and Prestige Consumer Healthcare
Inc. for all purposes in responding to alleged damages in connection with Plaintiff’s alleged exposure
to Caldesene talcum powder sold, supplied, or distributed by the Insight Pharmaceuticals
Defendants.
12. On March 4, 2021, Insight joined issue by service of its Answer to Plaintiff’s
Complaint. See NYSCEF Doc. No. 19.
13. On January 13, 2022, Plaintiff served Plaintiff’s Supplemental Interrogatories and
Requests for Production of Documents Propounded to Insight Pharmaceuticals Corporation, dated
April 7, 2021. See email correspondence from S. Kerley, dated January 13, 2022, with service of
Plaintiff’s Supplemental demands as Exhibit D.
14. On July 27, 2022, a fully executed Confidentiality Agreement and Stipulation was
filed. See NYSCEF Doc. No. 71.
15. On July 29, 2022, on extension from Plaintiff, Insight timely served its Responses to
Plaintiff’s Supplemental Interrogatories and Requests For Production of Documents. A copy of
Insight’s Responses to Plaintiff’s Supplemental Interrogatories and Requests for Production of
Documents is attached as Exhibit E.
16. Plaintiff filed the Note of Issue and Certificate of Readiness for Trial on January 18,
2023. See NYSCEF Doc. No. 74.
17. Under the 3rd Amended Discovery and Trial Scheduling Order, the trial of this matter
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is currently set for May 23, 2023. See NYSCEF Doc. No. 76.
18. No prior motion has been made seeking the relief sought herein.
ADDITIONAL EVIDENTIARY SUPPORT
19. A copy of the Affidavit of Alan M. Segrave, P.G., sworn to on the 30th day of
January, 2023, is attached as Exhibit F.
20. A copy of the Affidavit of Jean Boyko, sworn to on the 9th day of May, 2022, is
attached as Exhibit G.
21. A copy of the Letter from J.W. Swanson, Acting Director of the FDA, to P. Douillet,
dated July 11, 1986, is attached as Exhibit H.
22. A copy of the Memo from Dr. Alfred Wiessler to Robert M. Shaffner, dated July 31,
1973, is attached as Exhibit I.
23. A copy of the 2010 FDA Survey of Talc in Cosmetics is attached as Exhibit J. A
copy is also publicly available at https://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/
ucm/293184.htm.
24. Relevant excerpts from the deposition of Sean Fitzgerald, in the matter of Winkel v.
Calaveras Asbestos Ltd., et al., Los Angeles Superior Court Case No. BC549253, dated March 17,
2015 is attached as Exhibit K.
25. A copy of USP 41 on talc, the current talc monograph from the United States
Pharmocopeia is attached as Exhibit L.
26. A copy of “Drug Applications for Over-the-Counter (OTC) Drugs” from the U.S.
Food and Drug Administration’s website is attached as Exhibit M. A copy is also publicly available
at https://www.fds.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
approvalapplications/over-the-counterdrugs.
27. A copy of a letter dated May 7, 2012 from LaTonya M. Mitchell, Denver District
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Director, Public Health Service, U.S.F.D.A. to Boyd Ronald Johnson, Chief Executive Officer,
Quadex Pharmaceuticals, LLC, retrieved from the FDA’s archived webpage is attached as Exhibit
N.
28. A copy of the Declaration of Michael Westhusing with corresponding exhibits, in the
matter of Dion Nordurft, et al. v. Heritage Consumer Products, and Dion Nordrufts, et al., v. Insight
Pharmaceuticals Corporation, U.S.D.C., Western State of Washington, Case No. 04-1578Z (TSZ)
is attached as Exhibit O.
29. A copy of the U.S. Patent & Trademark Office’s Trademark Assignment Abstract of
Title on the Caldesene Mark, is attached as Exhibit P. A copy is also publicly available at
http://tsdr.uspto.gov/#caseNumber=72024472&caseType=SERIAL_NO&searchType=statusSearc
h.
30. A copy of relevant excerpts from the videotaped deposition of Jean Boyko, PMK of
Insight Pharmaceuticals, LLC, in the matters of Kathryn Schnacke, et al. v. 3M Company a/k/a
Minnesota Mining & Manuf. Co., et al., Superior Court for the State of California, County of L.A.,
Case No. BC637974, and Gail Koretoff, et al. v. Arkema, Inc., f/k/a Pennwalt Corp., et al., Superior
Court for the State of California, County of L.A., Case No. BC656506 is attached as Exhibit Q.
31. A copy of the FDA Summary of Results from Testing of Official Samples of Talc-
Containing Cosmetics for Asbestiform Fibers by AMA Laboraorties During FY 20 – FY 21 is
attached as Exhibit R. A copy is also publicly available at https://www.fda.gov/cosmetics/cosmetic-
ingredients/talc.
32. A copy of the “OTC Drug Review Process” from the U.S. Food and Drug
Administration’s website is attached as Exhibit S. A copy is also publicly available at
https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs.
33. A copy of the Over-the-Counter Monograph M016: Skin Protectant Drug Products
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for Over-the-Counter Human Use (Sept. 24, 2021) is attached as Exhibit T.
RELEVANT FACTUAL HISTORY
34. It is alleged that Plaintiff, Patsy Young, was exposed to asbestos-containing products,
materials and/or equipment manufactured and/or distributed by the various defendants. See
NYSCEF Doc. 1.
35. As it relates to Insight, Plaintiff alleges she was exposed to asbestos-containing
talcum powder marketed and sold by Insight while applying Caldesene to her mother and
grandmother, and while in the presence of others who applied Caldesene, to her mother and
grandmother between approximately 2003 until 2008. See Ex. B at pp. 438-40, 478.
36. Caldesene is for the treatment and prevention of diaper rash and to protect against
minor skin irritation. See Ex. G at p. 2, ¶ 7.
A. Talc and Asbestos Generally
37. Talc is not asbestos. See Ex. F at p. 3, ¶ 10.
38. Talc is a magnesium silicate which is very commonly used in many different
industries including in the pharmaceutical context. See Ex. F at pp. 6, ¶23.
39. Asbestos is a group of six naturally occurring silicate minerals that form high length
to width aspect ratio (>20:1) fibers often occurring in bundles. See Ex. F at p. 3, ¶¶ 12-13.
40. The six asbestos types are defined as follows: chrysotile, a serpentine group mineral
that is always in the asbestiform habit, and five amphibole minerals – uncommon and rare actinolite
asbestos, tremolite asbestos, anthophyllite asbestos, the more common commercially mined amosite,
and crocidolite. See Ex. F at p. 3, ¶ 12.
41. The term “asbestiform” refers to a morphology originating from the natural
crystallization of a mineral into small crystals, appearing as hair-like fibers. See Ex. F at p. 3, ¶ 12.
42. Asbestos is defined where a population of fibers exists having an asbestiform
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morphology and exhibiting characteristics such as: (a) mean aspect ratios of 20:1 to 100:1 or greater
for fibers greater than 5 µm; (b) widths less than 0.5 µm; and (c) two or more of the following
defining characteristics: parallel fibers occurring in bundles; fiber bundles displaying splayed ends;
matted masses of individual fibers; and/or fibers showing curvature. See Ex. F at pp. 3-4, ¶ 13.
43. The most important characteristic of asbestos fibers is that they can separate into
fibrils of smaller diameter, often less than 0.5 µm, which is referred to as “polyfilamentous.” In the
asbestiform morphology, the crystals in the mineral grow by forming long and filiform uni-
dimensional fibers. These fibers are found in bundles that can separate into small fibers (fibrils)
which, during the crystal growth process, retain their surface and activity properties. When pressure
is applied to an asbestos fiber, it will bend rather than break. See Ex. F at pp. 3-4, ¶ 13.
44. Each of the five amphibole asbestos minerals have a corresponding non-asbestiform
variant (cleavage fragment) where the habit of morphology does not have the characteristics
described above. See Ex. F at p. 4, ¶ 16.
45. When pressure is applied, non-asbestiform minerals fracture easily along planes of
weakness into prismatic particles (also referred to as cleavage fragments), which result from the
fracture or cleaving of the particulars. Some particles are acicular (needle-like), and stair-step
cleavage on the edges of some particles is common. The difference is in their crystallization process.
In other words, cleavage fragments have the same chemical composition as the corresponding
asbestos fibers, but do not have the same dimensional characteristics (length, diameter, and aspect
ratio), physical properties, or mechanical performance of asbestiform fibers. See Ex. F at p. 4, ¶ 15.
46. Unlike asbestos, the non-asbestiform variant of these asbestos amphiboles is not a
regulated material. See Ex. F at p. 4, ¶ 16.
47. Talc forms by specific geological processes, from the alteration of other minerals.
Depending on the processes, the mineral content of talc mines or deposits within mines, will differ.
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See Ex. F at p. 5, ¶ 17.
48. By understanding the mineralogy of various minerals and the geological processes
that are associated with mineral formation, geologists can interpret characteristics of a deposit such
as talc. These characteristics are used to make decisions relative to locating a prospective deposition
and the viability for mining it. See Ex. F at p. 5, ¶ 19.
49. Geologists can also ascertain the likelihood of asbestos mineral formation in the
vicinity of a talc deposit. See Ex. F at p. 5, ¶ 17.
50. Talc deposits or any other economic mineral deposits are well characterized prior to
any mining activity in order to determine the viability for mining the deposit. Any mining company
would have taken these steps with the help of geologists to determine where to mine the talc. See
Ex. F at p. 5, ¶ 19.
51. One part of the assessment concerning where to mine talc is to determine the presence
of accessory minerals which serve as indicators for the geologist and aid in characterizing the
deposit. The relationships of accessory minerals are tied to “facies,” which are defined rock
formations formed under pressure and temperature gradients. See Ex. F at p. 5, ¶ 19.
52. Accessory minerals associated with the gradients help to delineate the location of
asbestos. Notably, asbestos occurs in distinct temperature and pressure gradients. All of these clues
help geologists determine the composition of a particular talc deposit and avoid other minerals in a
deposit that are undesirable. Before it is mined, a talc deposit can therefore be pre-screened to some
degree for the presence of asbestos. See Ex. F at p. 5, ¶ 19.
53. There are four general talc-forming environments based on the starting minerals and
their conditions of alternations. Each of these environments – Type 1 through Type 4 – is associated
with certain accessory minerals. In Type 1 and Type 2 deposits, the main accessory minerals are
serpentine (i.e., antigorite), magnesite and chlorite. For Type 3 formations, the accessory minerals
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are dolomite, chlorite, quartz and feldspar. For Type 4 formations, which reach higher temperatures
than Type 3, the accessory minerals are tremolite, serpentine, actinolite, carbonates, and quartz.
Tremolite, serpentine and actinolite can all occur in an asbestiform habit. Only some talc’s contain
tremolite; fewer still contain asbestiform tremolite. See Ex. F at p. 6, ¶ 20.
54. Historically, the U.S. Food and Drug Administration (FDA) has assessed whether or
not cosmetic talcum powder should include a warning label, and concluded that no warning label
was required, as the risk from worst-case estimate of exposure to asbestos from cosmetic talc would
be less than the risk from environmental background levels of exposure to asbestos over a lifetime.
See Ex. F at p. 11, ¶ 27.
55. The U.S. Food and Drug Administration (“F.D.A.”) considered talc as “Generally
Recognized as Safe” (“GRAS”) for the prevention and treatment of diaper rash, as well as for use in
food products, and had refused to require warnings on cosmetic and OTC drug products, such as
body powders that use talc as an ingredient. See Ex. F at p. 11, ¶ 27.
56. In an FDA-commissioned study in 1973 that tested almost two hundred samples of
cosmetic talcum powder, two samples of Caldesene were tested and determined to be asbestos-free.
See Ex F at p. 11, ¶ 28; Ex. H at HHS00000200 – HHS00000205, HHS00000209-HHS00000232.
57. In 1986, the FDA denied a Citizen’s Petition requesting that the agency require
manufacturers to include an asbestos warning on cosmetic talcum powder products, on the grounds
that a warning was not necessary because there was no basis for the agency to conclude that a health
hazard attributable to asbestos-contamination in cosmetic talcum powder existed. See Ex. F at fn.
41; Ex. H.
58. In 2012, the FDA published a study affirming its 1986 decision. In that study, the
FDA tested 27 samples of cosmetic grade raw talc and 34 samples of cosmetic talcum powder
products using polarized light microscopy (PLM) and transmission electron microscope/selected
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area electron diffraction (TEM/SAED). The survey found no asbestos fibers or structures in any of
the samples of cosmetic-grade raw material talc or cosmetic products containing talc. See Ex. F at
p. 12, ¶ 29; Ex. J.
59. In October 2021, the FDA released its most recent analysis and testing of samples of
50 different talc containing products for asbestiform fibers using both PLM and TEM testing
methods and announced it had not identified asbestos in any sample. See Ex. F at p. 13, ¶ 30; Ex. R.
60. One of the regulatory pathways by which Over-the-Counter (“OTC”) drug products
may be approved for marketing by the United States Food Drug and Cosmetic Act (“FDCA” or the
“Act”) is the monograph process. See Ex. M.
61. The FDA’s Office of Drug Evaluation IV in the Center for Drug Evaluation and
Research has primary responsibility for OTC Drug review and approval. The Nonprescription Drug
Advisory Committee meets regularly to assist FDA in evaluating and reviewing OTC products.
Because of the significant number (300,000) of OTC products, in many cases FDA reviews the
active ingredients and labeling for therapeutic classes of drugs (e.g. analgesics or antacids) as
opposed to approving an individual product through the NDA or ANDA process. The end result of
that review is the publication of an OTC Drug Monograph in the federal register which is the “’recipe
book’ covering active ingredients, dose formulations and labeling.” See Ex. M.
62. The OTC drug review process was modified slightly with passage of the CARES Act
in March 2020, which replaced the public rulemaking steps with administrative orders. See Ex. S.
63. The FDA issued a Tentative Final Monograph (“TFM”) for “Skin Protectant Products
for Over-the-Counter Use: Proposed Rulemaking for Diaper Rash Drug Products” on June 20, 1990
(the “Diaper Rash Product TFM”). The FDA has not issued a final monograph for diaper rash
products. See 55 Fed. Reg. 119, 24204-25232 (June 20, 1990).
64. The FDA concluded that diaper rash products that contained talc as an active
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ingredient should have two specific warnings: “Do not use on broken skin.”; and “Keep powder
away from the child’s face to avoid inhalation, which can cause breathing problems.” See 55 Fed.
Reg. 119, 24204-25232 (June 20, 1990).
65. The FDA finalized the skin protectant monograph on September 24, 2021,
incorporating the June 20, 1990 Diaper Rash Product TFM and approving talc as a safe and effective
ingredient for use in skin protectant drug products in concentrations up to 100%. See Ex. T; 86
Federal Register 52474; 21 U.S.C. § 355h(b)(8).
66. The FDA and USP have rejected requests to change the labeling and specifications
for talc required to be used pursuant to the TFM. See Ex. M; Ex. P; Ex. F at p. 11, ¶ 27.
67. In the context of FDA regulation, monographs represent published standards by
which the use of one or more substances are automatically authorized. After the FDA approves a
monograph, the products that meet the labeling standards and the active ingredients under the
monograph are approved for sale. See Ex. Q at p. 173; Ex. M.
68. The USP monograph on talc contains detailed provisions regarding the identification,
labeling, microbial limits, and purity of talc, including specifications as to the microscopic levels for
testing talc for the presence or absence of various contaminants, including asbestos. See Ex. L.
69. The USP specifies certain “methods to determine the absence of asbestos” in talc,
including the microscopic ranges of detection to be used. See Ex. L at p. 3921.
70. A Certificate of Analysis is an authenticated document that is generally issued by a
company’s regulatory or quality assurance department that ascertains that a product has met its
predetermined product release specification(s) and quality. See Ex. G at p. 2, ¶10; Ex. F at p. 12, ¶
34.
B. Insight and Caldesene
71. Caldesene is for the treatment and prevention of diaper rash to protect against minor
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skin irritation. See Ex. G at p. 2, ¶ 7.
72. Insight acquired the Caldesene brand as of January 2001. See Ex. G at p. 2, ¶ 7.
73. Insight had no manufacturing facility and has never manufactured Caldesene talcum
powder or any other product. See Ex. G at p. 2, ¶ 8.
74. Insight has never mined, milled or processed raw talc or talc ore. See Ex. G at p. 2, ¶
8.
75. Insight had a written agreement with Pharma Tech Industries, Inc. (“Pharma Tech”),
a company which provides manufacturing and packaging services. See Ex. G at p. 2, ¶ 8.
76. Pharma Tech has at all times been the manufacturer of the Caldesene talcum powder
marketed and sold by Insight. See Ex. G at p. 2, ¶ 8.
77. The written material specifications for the talc that has been used in the manufacture
of Caldesene has, at all times since Insight acquired the brand, required the use of U.S. Pharmacopeia
(USP) grade talc, which meets the highest quality, purity and compliance standards. See Ex. G at p.
2, ¶ 9.; Ex. B to the Boyko Aff.
78. To the best of my knowledge and understanding, USP talc does not contain asbestos.
See Ex. G at p. 2, ¶ 10; Ex. C to the Boyko Aff.
79. Caldesene is classified as an OTC drug that is regulated by the FDA and sold pursuant
to an FDA monograph. See Ex. M; Ex. Q at p. 173.
80. At all relevant times, the Caldesene talcum powder marketed and sold by Insight was
manufactured and labeled in compliance with the FDA’s 1990 monograph for diaper rash drug
products, which has since been deemed a final order. See Ex. G at p. 2, ¶ 8; 86 Federal Register
52474; 21 U.S.C. § 355h(b)(8).
81. The supplier of the talc used by Pharma Tech to manufacture Caldesene from 2001
to 2014 was Barretts Minerals, located in Dillon, Montana. See Ex. G at pp. 2, ¶¶ 9-10, Exs. B & C
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to the Boyko Aff.
82. Barretts Minerals has sourced its talc from mines in Southwest Montana, specifically,
the Regal, Treasure and State mines. See Ex. F at p. 2, ¶ 9.
83. Talc mined in the southwest part of Montana is generally high purity talc that does
not contain asbestos, has been widely recognized by governmental agencies (including NIOSH,
USEPA and IARC) for being asbestos-free, and they have an extensive history confirming these
conclusions. See Ex. F at pp. 6-9, ¶¶ 22-26.
84. Sean Fitzgerald, a geologist and microscopist, who has frequently been retained as
an expert witness on behalf of plaintiffs in asbestos/talc litigation, has testified that if he were to
advise a talc company where to find cosmetic talc, he would direct them to southwestern Montana,
where the mines at issue in this case are located. See Ex. K at pp. 257-58.
85. The Certificates of Analysis for the USP talc used by Pharma Tech in the manufacture
of Caldesene for Insight confirm that the talc does not contain asbestos. See Ex. G at p. 2, ¶10; Ex.
F at p. 11, ¶ 34.
86. The Caldesene sold, supplied or distributed by Insight was free of asbestos. See Ex.
G at p. 2, ¶ 10.
87. In other words, no samples of Caldesene talcum powder tested in the 1973 FDA-
commissioned study were found to contain asbestos. See id.
C. Plaintiff, Patsy Young’s, Use of Caldesene
88. With respect to the instant action, Plaintiff does not allege exposure from applying
Caldesene talcum powder directly to her own body. See Ex. B at p. 439.
89. Instead, Plaintiff’s alleged exposure it related to the application of Caldesene talcum
powder to her mother and grandmother. See Ex. B at pp. 438-39.
90. Plaintiff has no receipts reflecting the purchase of any Caldesene talcum powder. See
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Ex. B at pp. 469-70.
91. Plaintiff does not possess any of the actual containers of Caldesene talcum powder
that she allegedly applied to her mother or grandmother and/or which was applied to her mother or
grandmother in her presence. See Ex. B at pp. 464, 476-79.
92. Plaintiff has no personal knowledge that any of the Caldesene talcum powder that she
used contained asbestos. See Ex. B at pp. 481-82.
93. Plaintiff, nor anyone on Plaintiff’s behalf, ever had any of the bottles of Caldesene
she used tested for asbestos. See Ex. B at pp. 481-82.
94. The Plaintiff’s Answers to Interrogatories allege exposure to asbestos containing
products, including Caldesene; however, the Interrogatory responses do not provide any evidence
that the Caldesene talcum powder Plaintiff encountered actually contained asbestos. See generally
Ex. A.
95. Plaintiff has not produced in discovery any documents which support the allegation
that Caldesene talcum powder sold, supplied or distributed by Insight contained asbestos.
96. No treating doctor has advised Plaintiff that her alleged mesothelioma was caused by
her alleged exposure to Caldesene talcum powder. See Ex. B at pp. 583-84.
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WHEREFORE, for the reasons set forth in the accompanying memorandum of law, it is
respectfully requested that this Court enter an Order granting Insight’s motion for summary
judgment, pursuant to Civil Practice Law and Rules Rule 3212, dismissing the Plaintiff’s Complaint,
including all cross-claims, asserted against Insight in their entirety; or in the alternative Insight’s
motion for summary judgment seeks dismissal, at a minimum of the claim for punitive damages,
together with such other and further relief as this Court shall deem just and proper.
Dated: Buffalo, New York _____________________________________
March 3, 2023 Robert J. Mullins, II, Esq.
BENNETT SCHECHTER
ARCURI & WILL, LLC
Attorneys for Defendant
INSIGHT PHARMACEUTICALS, LLC
701 Seneca Street, Suite 609
Buffalo, New York 14210
(716) 242-8100
TO: John P. Comerford, Esq.
LIPSITZ PONTERIO & COMERFORD, LLC
Attorneys for Plaintiff
Office and P.O. Address
424 Main Street, Suite 1500
Buffalo, New York 14202
(716) 849-0701
Sean Kerley, Esq.
SIMON GREENSTONE PANATIER, P.C.
Attorneys for Plaintiff
1201 Elm Street, Suite 3400
Dallas, Texas 75270
(214) 276-7680
cc: All Known Remaining Defense Counsel of Record
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NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023
CERTIFICATION
I, Robert J. Mullins, II, Esq., certify that the attorney affirmation submitted in support of
the motion for summary judgement on behalf of Defendant, Insight Pharmaceuticals LLC,
complies with the word count limit pursuant to Section 202.8-b of the Uniform Civil Rules for the
Supreme Court and County Court.
WORD COUNT: 4,193 words (excluding caption, signature block, and certification)
16
16 of 16
Preview
FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF ERIE _____________________________________________ PATSY YOUNG, ATTORNEY AFFIRMATION Plaintiff, -vs- Index No.: 815818/2020 AVENTIS, INC., et al. Assigned Justice: Defendants. Hon. Raymond J. Walter, J.S.C _____________________________________________ ROBERT J. MULLINS, II, Esq., an attorney admitted to practice law in the Courts of this State, affirms the following to be true under the penalties of perjury: 1. I am a member of the law firm of Bennett Schechter Arcuri & Will, LLP, attorneys for defendant, Insight Pharmaceuticals LLC (hereinafter “Insight”) in the above-captioned matter. As such, I am fully familiar with the facts and circumstances of this case and the matters set forth in this Affirmation. 2. This Affirmation, along with the applicable exhibits, statement of material facts and memorandum of law, is submitted in support of Insight’s motion for summary judgment pursuant to Civil Practice Law and Rules Rule 3212, dismissing the Plaintiff’s Complaint, including all cross- claims, asserted against Insight in their entirety; or in the alternative Insight’s motion for summary judgment seeks dismissal, at a minimum, of the claim for punitive damages, together with such other and further relief as this Court shall deem just and proper. 3. This is a products liability action in which it is alleged that Plaintiff, Patsy Young, was exposed to asbestos-containing products, materials and/or equipment manufactured, distributed and/or sold by the various defendants. It is also alleged that Patsy Young’s exposure to asbestos- containing products, materials and/or equipment was the proximate cause of her alleged asbestos - related disease, i.e., mesothelioma. 1 1 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 4. There is no basis to establish liability against Insight based on the fact that the record is devoid of evidence that the Caldesene brand of talcum powder marketed and/or distributed by Insight contained asbestos. It is axiomatic that a product which did not contain asbestos cannot, as a matter of law, be a cause of any asbestos-related disease. Thus, each and every theory of liability against Insight should be dismissed as against Insight because each and every theory of liability, including those pled in any cross claim, are all premised upon asbestos exposure. 5. Further, Plaintiff’s claims are barred by the preemption doctrine which provides this Court with a second, independent basis to grant summary judgment dismissing all claims, including any cross claims, against Insight, as a matter of law. 6. Even if this Court does not grant Insight’s motion in its entirety, which under the law and the facts of this case it should, the Court should at a minimum dismiss Plaintiff’s claim for punitive damages because this is not one of those morally outrageous cases evincing near criminal conduct sufficient to warrant punitive damages. RELEVANT PROCEDURAL HISTORY 7. Plaintiff commenced this action with the filing of a Summons and Complaint with the Erie County Clerk’s Office on December 10, 2020. See NYSCEF Doc. No. 1. 8. On or about January 21, 2021, Plaintiff served Plaintiff’s Answers to Interrogatories, a copy of which is attached as Exhibit A. 9. On February 11, 12 and 16, 2021, Plaintiff, Patsy Young, appeared for her examination before trial. Condensed copies of the transcripts of Plaintiff’s examination before trial, Volumes I-III, are collectively attached as Exhibit B. 10. On April 28, 2021, Plaintiff, Patsy Young, appeared for her de bene esse videotaped examination. A condensed copy of the transcript of Plaintiff’s de bene esse examination is attached as Exhibit C. 2 2 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 11. On March 1, 2021, a Stipulation of Discontinuance Without Prejudice was filed dismissing without prejudice, Defendants, Insight Pharmaceuticals Corporation, Prestige Brands Holdings, Inc., and Prestige Consumer Healthcare Inc (collectively referred to with Insight Pharmaceuticals LLC as the “Insight Pharmaceuticals Defendants”). See NYSCEF Doc. No. 17. Per the Stipulation, Insight Pharmaceuticals LLC agreed to stand in place and stead of Insight Pharmaceuticals Corporation, Prestige Brands Holdings, Inc., and Prestige Consumer Healthcare Inc. for all purposes in responding to alleged damages in connection with Plaintiff’s alleged exposure to Caldesene talcum powder sold, supplied, or distributed by the Insight Pharmaceuticals Defendants. 12. On March 4, 2021, Insight joined issue by service of its Answer to Plaintiff’s Complaint. See NYSCEF Doc. No. 19. 13. On January 13, 2022, Plaintiff served Plaintiff’s Supplemental Interrogatories and Requests for Production of Documents Propounded to Insight Pharmaceuticals Corporation, dated April 7, 2021. See email correspondence from S. Kerley, dated January 13, 2022, with service of Plaintiff’s Supplemental demands as Exhibit D. 14. On July 27, 2022, a fully executed Confidentiality Agreement and Stipulation was filed. See NYSCEF Doc. No. 71. 15. On July 29, 2022, on extension from Plaintiff, Insight timely served its Responses to Plaintiff’s Supplemental Interrogatories and Requests For Production of Documents. A copy of Insight’s Responses to Plaintiff’s Supplemental Interrogatories and Requests for Production of Documents is attached as Exhibit E. 16. Plaintiff filed the Note of Issue and Certificate of Readiness for Trial on January 18, 2023. See NYSCEF Doc. No. 74. 17. Under the 3rd Amended Discovery and Trial Scheduling Order, the trial of this matter 3 3 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 is currently set for May 23, 2023. See NYSCEF Doc. No. 76. 18. No prior motion has been made seeking the relief sought herein. ADDITIONAL EVIDENTIARY SUPPORT 19. A copy of the Affidavit of Alan M. Segrave, P.G., sworn to on the 30th day of January, 2023, is attached as Exhibit F. 20. A copy of the Affidavit of Jean Boyko, sworn to on the 9th day of May, 2022, is attached as Exhibit G. 21. A copy of the Letter from J.W. Swanson, Acting Director of the FDA, to P. Douillet, dated July 11, 1986, is attached as Exhibit H. 22. A copy of the Memo from Dr. Alfred Wiessler to Robert M. Shaffner, dated July 31, 1973, is attached as Exhibit I. 23. A copy of the 2010 FDA Survey of Talc in Cosmetics is attached as Exhibit J. A copy is also publicly available at https://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ ucm/293184.htm. 24. Relevant excerpts from the deposition of Sean Fitzgerald, in the matter of Winkel v. Calaveras Asbestos Ltd., et al., Los Angeles Superior Court Case No. BC549253, dated March 17, 2015 is attached as Exhibit K. 25. A copy of USP 41 on talc, the current talc monograph from the United States Pharmocopeia is attached as Exhibit L. 26. A copy of “Drug Applications for Over-the-Counter (OTC) Drugs” from the U.S. Food and Drug Administration’s website is attached as Exhibit M. A copy is also publicly available at https://www.fds.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/ approvalapplications/over-the-counterdrugs. 27. A copy of a letter dated May 7, 2012 from LaTonya M. Mitchell, Denver District 4 4 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 Director, Public Health Service, U.S.F.D.A. to Boyd Ronald Johnson, Chief Executive Officer, Quadex Pharmaceuticals, LLC, retrieved from the FDA’s archived webpage is attached as Exhibit N. 28. A copy of the Declaration of Michael Westhusing with corresponding exhibits, in the matter of Dion Nordurft, et al. v. Heritage Consumer Products, and Dion Nordrufts, et al., v. Insight Pharmaceuticals Corporation, U.S.D.C., Western State of Washington, Case No. 04-1578Z (TSZ) is attached as Exhibit O. 29. A copy of the U.S. Patent & Trademark Office’s Trademark Assignment Abstract of Title on the Caldesene Mark, is attached as Exhibit P. A copy is also publicly available at http://tsdr.uspto.gov/#caseNumber=72024472&caseType=SERIAL_NO&searchType=statusSearc h. 30. A copy of relevant excerpts from the videotaped deposition of Jean Boyko, PMK of Insight Pharmaceuticals, LLC, in the matters of Kathryn Schnacke, et al. v. 3M Company a/k/a Minnesota Mining & Manuf. Co., et al., Superior Court for the State of California, County of L.A., Case No. BC637974, and Gail Koretoff, et al. v. Arkema, Inc., f/k/a Pennwalt Corp., et al., Superior Court for the State of California, County of L.A., Case No. BC656506 is attached as Exhibit Q. 31. A copy of the FDA Summary of Results from Testing of Official Samples of Talc- Containing Cosmetics for Asbestiform Fibers by AMA Laboraorties During FY 20 – FY 21 is attached as Exhibit R. A copy is also publicly available at https://www.fda.gov/cosmetics/cosmetic- ingredients/talc. 32. A copy of the “OTC Drug Review Process” from the U.S. Food and Drug Administration’s website is attached as Exhibit S. A copy is also publicly available at https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs. 33. A copy of the Over-the-Counter Monograph M016: Skin Protectant Drug Products 5 5 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 for Over-the-Counter Human Use (Sept. 24, 2021) is attached as Exhibit T. RELEVANT FACTUAL HISTORY 34. It is alleged that Plaintiff, Patsy Young, was exposed to asbestos-containing products, materials and/or equipment manufactured and/or distributed by the various defendants. See NYSCEF Doc. 1. 35. As it relates to Insight, Plaintiff alleges she was exposed to asbestos-containing talcum powder marketed and sold by Insight while applying Caldesene to her mother and grandmother, and while in the presence of others who applied Caldesene, to her mother and grandmother between approximately 2003 until 2008. See Ex. B at pp. 438-40, 478. 36. Caldesene is for the treatment and prevention of diaper rash and to protect against minor skin irritation. See Ex. G at p. 2, ¶ 7. A. Talc and Asbestos Generally 37. Talc is not asbestos. See Ex. F at p. 3, ¶ 10. 38. Talc is a magnesium silicate which is very commonly used in many different industries including in the pharmaceutical context. See Ex. F at pp. 6, ¶23. 39. Asbestos is a group of six naturally occurring silicate minerals that form high length to width aspect ratio (>20:1) fibers often occurring in bundles. See Ex. F at p. 3, ¶¶ 12-13. 40. The six asbestos types are defined as follows: chrysotile, a serpentine group mineral that is always in the asbestiform habit, and five amphibole minerals – uncommon and rare actinolite asbestos, tremolite asbestos, anthophyllite asbestos, the more common commercially mined amosite, and crocidolite. See Ex. F at p. 3, ¶ 12. 41. The term “asbestiform” refers to a morphology originating from the natural crystallization of a mineral into small crystals, appearing as hair-like fibers. See Ex. F at p. 3, ¶ 12. 42. Asbestos is defined where a population of fibers exists having an asbestiform 6 6 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 morphology and exhibiting characteristics such as: (a) mean aspect ratios of 20:1 to 100:1 or greater for fibers greater than 5 µm; (b) widths less than 0.5 µm; and (c) two or more of the following defining characteristics: parallel fibers occurring in bundles; fiber bundles displaying splayed ends; matted masses of individual fibers; and/or fibers showing curvature. See Ex. F at pp. 3-4, ¶ 13. 43. The most important characteristic of asbestos fibers is that they can separate into fibrils of smaller diameter, often less than 0.5 µm, which is referred to as “polyfilamentous.” In the asbestiform morphology, the crystals in the mineral grow by forming long and filiform uni- dimensional fibers. These fibers are found in bundles that can separate into small fibers (fibrils) which, during the crystal growth process, retain their surface and activity properties. When pressure is applied to an asbestos fiber, it will bend rather than break. See Ex. F at pp. 3-4, ¶ 13. 44. Each of the five amphibole asbestos minerals have a corresponding non-asbestiform variant (cleavage fragment) where the habit of morphology does not have the characteristics described above. See Ex. F at p. 4, ¶ 16. 45. When pressure is applied, non-asbestiform minerals fracture easily along planes of weakness into prismatic particles (also referred to as cleavage fragments), which result from the fracture or cleaving of the particulars. Some particles are acicular (needle-like), and stair-step cleavage on the edges of some particles is common. The difference is in their crystallization process. In other words, cleavage fragments have the same chemical composition as the corresponding asbestos fibers, but do not have the same dimensional characteristics (length, diameter, and aspect ratio), physical properties, or mechanical performance of asbestiform fibers. See Ex. F at p. 4, ¶ 15. 46. Unlike asbestos, the non-asbestiform variant of these asbestos amphiboles is not a regulated material. See Ex. F at p. 4, ¶ 16. 47. Talc forms by specific geological processes, from the alteration of other minerals. Depending on the processes, the mineral content of talc mines or deposits within mines, will differ. 7 7 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 See Ex. F at p. 5, ¶ 17. 48. By understanding the mineralogy of various minerals and the geological processes that are associated with mineral formation, geologists can interpret characteristics of a deposit such as talc. These characteristics are used to make decisions relative to locating a prospective deposition and the viability for mining it. See Ex. F at p. 5, ¶ 19. 49. Geologists can also ascertain the likelihood of asbestos mineral formation in the vicinity of a talc deposit. See Ex. F at p. 5, ¶ 17. 50. Talc deposits or any other economic mineral deposits are well characterized prior to any mining activity in order to determine the viability for mining the deposit. Any mining company would have taken these steps with the help of geologists to determine where to mine the talc. See Ex. F at p. 5, ¶ 19. 51. One part of the assessment concerning where to mine talc is to determine the presence of accessory minerals which serve as indicators for the geologist and aid in characterizing the deposit. The relationships of accessory minerals are tied to “facies,” which are defined rock formations formed under pressure and temperature gradients. See Ex. F at p. 5, ¶ 19. 52. Accessory minerals associated with the gradients help to delineate the location of asbestos. Notably, asbestos occurs in distinct temperature and pressure gradients. All of these clues help geologists determine the composition of a particular talc deposit and avoid other minerals in a deposit that are undesirable. Before it is mined, a talc deposit can therefore be pre-screened to some degree for the presence of asbestos. See Ex. F at p. 5, ¶ 19. 53. There are four general talc-forming environments based on the starting minerals and their conditions of alternations. Each of these environments – Type 1 through Type 4 – is associated with certain accessory minerals. In Type 1 and Type 2 deposits, the main accessory minerals are serpentine (i.e., antigorite), magnesite and chlorite. For Type 3 formations, the accessory minerals 8 8 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 are dolomite, chlorite, quartz and feldspar. For Type 4 formations, which reach higher temperatures than Type 3, the accessory minerals are tremolite, serpentine, actinolite, carbonates, and quartz. Tremolite, serpentine and actinolite can all occur in an asbestiform habit. Only some talc’s contain tremolite; fewer still contain asbestiform tremolite. See Ex. F at p. 6, ¶ 20. 54. Historically, the U.S. Food and Drug Administration (FDA) has assessed whether or not cosmetic talcum powder should include a warning label, and concluded that no warning label was required, as the risk from worst-case estimate of exposure to asbestos from cosmetic talc would be less than the risk from environmental background levels of exposure to asbestos over a lifetime. See Ex. F at p. 11, ¶ 27. 55. The U.S. Food and Drug Administration (“F.D.A.”) considered talc as “Generally Recognized as Safe” (“GRAS”) for the prevention and treatment of diaper rash, as well as for use in food products, and had refused to require warnings on cosmetic and OTC drug products, such as body powders that use talc as an ingredient. See Ex. F at p. 11, ¶ 27. 56. In an FDA-commissioned study in 1973 that tested almost two hundred samples of cosmetic talcum powder, two samples of Caldesene were tested and determined to be asbestos-free. See Ex F at p. 11, ¶ 28; Ex. H at HHS00000200 – HHS00000205, HHS00000209-HHS00000232. 57. In 1986, the FDA denied a Citizen’s Petition requesting that the agency require manufacturers to include an asbestos warning on cosmetic talcum powder products, on the grounds that a warning was not necessary because there was no basis for the agency to conclude that a health hazard attributable to asbestos-contamination in cosmetic talcum powder existed. See Ex. F at fn. 41; Ex. H. 58. In 2012, the FDA published a study affirming its 1986 decision. In that study, the FDA tested 27 samples of cosmetic grade raw talc and 34 samples of cosmetic talcum powder products using polarized light microscopy (PLM) and transmission electron microscope/selected 9 9 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 area electron diffraction (TEM/SAED). The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. See Ex. F at p. 12, ¶ 29; Ex. J. 59. In October 2021, the FDA released its most recent analysis and testing of samples of 50 different talc containing products for asbestiform fibers using both PLM and TEM testing methods and announced it had not identified asbestos in any sample. See Ex. F at p. 13, ¶ 30; Ex. R. 60. One of the regulatory pathways by which Over-the-Counter (“OTC”) drug products may be approved for marketing by the United States Food Drug and Cosmetic Act (“FDCA” or the “Act”) is the monograph process. See Ex. M. 61. The FDA’s Office of Drug Evaluation IV in the Center for Drug Evaluation and Research has primary responsibility for OTC Drug review and approval. The Nonprescription Drug Advisory Committee meets regularly to assist FDA in evaluating and reviewing OTC products. Because of the significant number (300,000) of OTC products, in many cases FDA reviews the active ingredients and labeling for therapeutic classes of drugs (e.g. analgesics or antacids) as opposed to approving an individual product through the NDA or ANDA process. The end result of that review is the publication of an OTC Drug Monograph in the federal register which is the “’recipe book’ covering active ingredients, dose formulations and labeling.” See Ex. M. 62. The OTC drug review process was modified slightly with passage of the CARES Act in March 2020, which replaced the public rulemaking steps with administrative orders. See Ex. S. 63. The FDA issued a Tentative Final Monograph (“TFM”) for “Skin Protectant Products for Over-the-Counter Use: Proposed Rulemaking for Diaper Rash Drug Products” on June 20, 1990 (the “Diaper Rash Product TFM”). The FDA has not issued a final monograph for diaper rash products. See 55 Fed. Reg. 119, 24204-25232 (June 20, 1990). 64. The FDA concluded that diaper rash products that contained talc as an active 10 10 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 ingredient should have two specific warnings: “Do not use on broken skin.”; and “Keep powder away from the child’s face to avoid inhalation, which can cause breathing problems.” See 55 Fed. Reg. 119, 24204-25232 (June 20, 1990). 65. The FDA finalized the skin protectant monograph on September 24, 2021, incorporating the June 20, 1990 Diaper Rash Product TFM and approving talc as a safe and effective ingredient for use in skin protectant drug products in concentrations up to 100%. See Ex. T; 86 Federal Register 52474; 21 U.S.C. § 355h(b)(8). 66. The FDA and USP have rejected requests to change the labeling and specifications for talc required to be used pursuant to the TFM. See Ex. M; Ex. P; Ex. F at p. 11, ¶ 27. 67. In the context of FDA regulation, monographs represent published standards by which the use of one or more substances are automatically authorized. After the FDA approves a monograph, the products that meet the labeling standards and the active ingredients under the monograph are approved for sale. See Ex. Q at p. 173; Ex. M. 68. The USP monograph on talc contains detailed provisions regarding the identification, labeling, microbial limits, and purity of talc, including specifications as to the microscopic levels for testing talc for the presence or absence of various contaminants, including asbestos. See Ex. L. 69. The USP specifies certain “methods to determine the absence of asbestos” in talc, including the microscopic ranges of detection to be used. See Ex. L at p. 3921. 70. A Certificate of Analysis is an authenticated document that is generally issued by a company’s regulatory or quality assurance department that ascertains that a product has met its predetermined product release specification(s) and quality. See Ex. G at p. 2, ¶10; Ex. F at p. 12, ¶ 34. B. Insight and Caldesene 71. Caldesene is for the treatment and prevention of diaper rash to protect against minor 11 11 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 skin irritation. See Ex. G at p. 2, ¶ 7. 72. Insight acquired the Caldesene brand as of January 2001. See Ex. G at p. 2, ¶ 7. 73. Insight had no manufacturing facility and has never manufactured Caldesene talcum powder or any other product. See Ex. G at p. 2, ¶ 8. 74. Insight has never mined, milled or processed raw talc or talc ore. See Ex. G at p. 2, ¶ 8. 75. Insight had a written agreement with Pharma Tech Industries, Inc. (“Pharma Tech”), a company which provides manufacturing and packaging services. See Ex. G at p. 2, ¶ 8. 76. Pharma Tech has at all times been the manufacturer of the Caldesene talcum powder marketed and sold by Insight. See Ex. G at p. 2, ¶ 8. 77. The written material specifications for the talc that has been used in the manufacture of Caldesene has, at all times since Insight acquired the brand, required the use of U.S. Pharmacopeia (USP) grade talc, which meets the highest quality, purity and compliance standards. See Ex. G at p. 2, ¶ 9.; Ex. B to the Boyko Aff. 78. To the best of my knowledge and understanding, USP talc does not contain asbestos. See Ex. G at p. 2, ¶ 10; Ex. C to the Boyko Aff. 79. Caldesene is classified as an OTC drug that is regulated by the FDA and sold pursuant to an FDA monograph. See Ex. M; Ex. Q at p. 173. 80. At all relevant times, the Caldesene talcum powder marketed and sold by Insight was manufactured and labeled in compliance with the FDA’s 1990 monograph for diaper rash drug products, which has since been deemed a final order. See Ex. G at p. 2, ¶ 8; 86 Federal Register 52474; 21 U.S.C. § 355h(b)(8). 81. The supplier of the talc used by Pharma Tech to manufacture Caldesene from 2001 to 2014 was Barretts Minerals, located in Dillon, Montana. See Ex. G at pp. 2, ¶¶ 9-10, Exs. B & C 12 12 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 to the Boyko Aff. 82. Barretts Minerals has sourced its talc from mines in Southwest Montana, specifically, the Regal, Treasure and State mines. See Ex. F at p. 2, ¶ 9. 83. Talc mined in the southwest part of Montana is generally high purity talc that does not contain asbestos, has been widely recognized by governmental agencies (including NIOSH, USEPA and IARC) for being asbestos-free, and they have an extensive history confirming these conclusions. See Ex. F at pp. 6-9, ¶¶ 22-26. 84. Sean Fitzgerald, a geologist and microscopist, who has frequently been retained as an expert witness on behalf of plaintiffs in asbestos/talc litigation, has testified that if he were to advise a talc company where to find cosmetic talc, he would direct them to southwestern Montana, where the mines at issue in this case are located. See Ex. K at pp. 257-58. 85. The Certificates of Analysis for the USP talc used by Pharma Tech in the manufacture of Caldesene for Insight confirm that the talc does not contain asbestos. See Ex. G at p. 2, ¶10; Ex. F at p. 11, ¶ 34. 86. The Caldesene sold, supplied or distributed by Insight was free of asbestos. See Ex. G at p. 2, ¶ 10. 87. In other words, no samples of Caldesene talcum powder tested in the 1973 FDA- commissioned study were found to contain asbestos. See id. C. Plaintiff, Patsy Young’s, Use of Caldesene 88. With respect to the instant action, Plaintiff does not allege exposure from applying Caldesene talcum powder directly to her own body. See Ex. B at p. 439. 89. Instead, Plaintiff’s alleged exposure it related to the application of Caldesene talcum powder to her mother and grandmother. See Ex. B at pp. 438-39. 90. Plaintiff has no receipts reflecting the purchase of any Caldesene talcum powder. See 13 13 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 Ex. B at pp. 469-70. 91. Plaintiff does not possess any of the actual containers of Caldesene talcum powder that she allegedly applied to her mother or grandmother and/or which was applied to her mother or grandmother in her presence. See Ex. B at pp. 464, 476-79. 92. Plaintiff has no personal knowledge that any of the Caldesene talcum powder that she used contained asbestos. See Ex. B at pp. 481-82. 93. Plaintiff, nor anyone on Plaintiff’s behalf, ever had any of the bottles of Caldesene she used tested for asbestos. See Ex. B at pp. 481-82. 94. The Plaintiff’s Answers to Interrogatories allege exposure to asbestos containing products, including Caldesene; however, the Interrogatory responses do not provide any evidence that the Caldesene talcum powder Plaintiff encountered actually contained asbestos. See generally Ex. A. 95. Plaintiff has not produced in discovery any documents which support the allegation that Caldesene talcum powder sold, supplied or distributed by Insight contained asbestos. 96. No treating doctor has advised Plaintiff that her alleged mesothelioma was caused by her alleged exposure to Caldesene talcum powder. See Ex. B at pp. 583-84. 14 14 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 WHEREFORE, for the reasons set forth in the accompanying memorandum of law, it is respectfully requested that this Court enter an Order granting Insight’s motion for summary judgment, pursuant to Civil Practice Law and Rules Rule 3212, dismissing the Plaintiff’s Complaint, including all cross-claims, asserted against Insight in their entirety; or in the alternative Insight’s motion for summary judgment seeks dismissal, at a minimum of the claim for punitive damages, together with such other and further relief as this Court shall deem just and proper. Dated: Buffalo, New York _____________________________________ March 3, 2023 Robert J. Mullins, II, Esq. BENNETT SCHECHTER ARCURI & WILL, LLC Attorneys for Defendant INSIGHT PHARMACEUTICALS, LLC 701 Seneca Street, Suite 609 Buffalo, New York 14210 (716) 242-8100 TO: John P. Comerford, Esq. LIPSITZ PONTERIO & COMERFORD, LLC Attorneys for Plaintiff Office and P.O. Address 424 Main Street, Suite 1500 Buffalo, New York 14202 (716) 849-0701 Sean Kerley, Esq. SIMON GREENSTONE PANATIER, P.C. Attorneys for Plaintiff 1201 Elm Street, Suite 3400 Dallas, Texas 75270 (214) 276-7680 cc: All Known Remaining Defense Counsel of Record 15 15 of 16 FILED: ERIE COUNTY CLERK 03/03/2023 02:30 PM INDEX NO. 815818/2020 NYSCEF DOC. NO. 88 RECEIVED NYSCEF: 03/03/2023 CERTIFICATION I, Robert J. Mullins, II, Esq., certify that the attorney affirmation submitted in support of the motion for summary judgement on behalf of Defendant, Insight Pharmaceuticals LLC, complies with the word count limit pursuant to Section 202.8-b of the Uniform Civil Rules for the Supreme Court and County Court. WORD COUNT: 4,193 words (excluding caption, signature block, and certification) 16 16 of 16