Preview
ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 1 of 48 Trans ID: LCV20223939248
Kelly S. Crawford – NJ Attorney ID #029141993
RIKER DANZIG LLP
Headquarters Plaza
One Speedwell Avenue
Morristown, NJ 07962-1981
(973) 538-0800
Attorneys for Defendants
Ethicon, Inc. and Johnson & Johnson
IN RE PROCEED MESH LITIGATION MCL CASE NO. 630
(PROCEED SURGICAL MESH AND PROCEED MASTER DOCKET NO.: ATL-L-794-19
VENTRAL PATCH HERNIA MESH)
JULIE HALL, SUPERIOR COURT OF NEW JERSEY
LAW DIVISION - ATLANTIC COUNTY
DOCKET NO. ATL-L-002607-22
Plaintiff,
v. CIVIL ACTION
JOHNSON & JOHNSON; and ETHICON, ANSWER TO COMPLAINT, SEPARATE
INC., DEFENSES, AND JURY DEMAND OF
DEFENDANT JOHNSON & JOHNSON
Defendants.
Defendant Johnson & Johnson, by and through its attorneys,
responds to Plaintiff’s Complaint and Jury Demand (“Complaint”) as
follows.
RESPONSE TO “NATURE OF THE ACTION” 1
1. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
1 The repetition of the Complaint’s subheadings in the Answer is
done solely for organizational purposes and is not an admission as
to their truth.
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denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 1 of Plaintiff’s Complaint.
2. Johnson & Johnson admits only that Ethicon, Inc.
manufactured and supplied Proceed Surgical Mesh for uses
consistent with the packaging and labeling. Johnson & Johnson does
not manufacture or supply any product. Johnson & Johnson denies
the remaining allegations contained in Paragraph 2 of Plaintiff’s
Complaint.
3. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 3 of Plaintiff’s Complaint.
4. Johnson & Johnson denies the allegations contained in
Paragraph 4 of Plaintiff’s Complaint.
5. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. marketed and promoted Proceed Surgical Mesh for uses
consistent with the packaging and labeling. Johnson & Johnson does
not market or promote any product. Johnson & Johnson denies the
remaining allegations contained in Paragraph 5 of Plaintiff’s
Complaint.
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RESPONSE TO “JURISDICTION & VENUE”
6. Johnson & Johnson denies the allegations contained in
Paragraph 6 of Plaintiff’s Complaint.
7. Johnson & Johnson is without sufficient knowledge or
information so as to form a belief as to the truth of the
allegations contained in Paragraph 7 of Plaintiff’s Complaint;
therefore, Johnson & Johnson denies those allegations.
8. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. manufactured, designed, and distributed Proceed Surgical Mesh
for uses consistent with the packaging and labeling. Johnson &
Johnson does not manufacture, design, distribute, or warrant any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 8 of Plaintiff’s Complaint.
9. Johnson & Johnson admits that it is a New Jersey
corporation with its principal place of business located at One
Johnson & Johnson Plaza, New Brunswick, New Jersey. Johnson &
Johnson admits further that its website speaks for itself. Johnson
& Johnson denies the remaining allegations contained in Paragraph
9 of Plaintiff’s Complaint.
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10. With respect to the allegations contained in Paragraph
10 of the Complaint, Johnson & Johnson is a holding company for
companies with a primary focus of providing products and services
related to human health and well-being. Each of these subsidiary
companies operates independently of Johnson & Johnson. Johnson &
Johnson’s subsidiaries are organized in three business segments:
Consumer, Pharmaceutical, and Medical Devices. The companies
within these segments are financially and operationally
independent. Johnson & Johnson admits that Ethicon, Inc. designed,
developed, manufactured, tested, marketed, promoted, distributed,
and sold certain hernia mesh products for uses consistent with the
packaging and labeling. Johnson & Johnson further admits that in
2009, Mr. Gary Pruden became Company Group Chairman of Ethicon. In
2012, he was named Worldwide Chairman, Global Surgery Group, and
in 2015, Worldwide Chairman, Medical Devices. Mr. Pruden retired
effective June 1, 2017. Johnson & Johnson denies the remaining
allegations contained in Paragraph 10 of Plaintiff’s Complaint and
all allegations inconsistent with the foregoing.
11. Johnson & Johnson admits that Ethicon, Inc. is a New
Jersey corporation with its principal place of business in New
Jersey, and it is a wholly owned subsidiary of Johnson & Johnson.
Johnson & Johnson admits that certain hernia mesh products,
including but not limited to Proceed Surgical Mesh, have been
available for purchase in the State of New Jersey. Johnson &
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Johnson denies the remaining allegations contained in Paragraph 11
of Plaintiff’s Complaint.
12. Johnson & Johnson admits only that Ethicon, Inc.
researched, developed, tested, manufactured, produced, marketed,
promoted, and/or sold certain hernia mesh products, including but
not limited to Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not research,
develop, test, manufacture, produce, market, promote, or sell any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 12 of Plaintiff’s Complaint.
13. Johnson & Johnson admits only that Ethicon, Inc.
researched, developed, tested, manufactured, produced, marketed,
promoted, distributed, and/or sold Proceed Surgical Mesh for uses
consistent with the packaging and labeling. Johnson & Johnson does
not research, develop, test, manufacture, produce, market,
promote, distribute, or sell any product. Johnson & Johnson denies
the remaining allegations contained in Paragraph 13 of Plaintiff’s
Complaint.
14. Johnson & Johnson admits only that Ethicon, Inc.’s
Proceed Surgical Mesh has been available for purchase in the State
of New Jersey. Johnson & Johnson denies the remaining allegations
contained in Paragraph 14 of Plaintiff’s Complaint.
15. Johnson & Johnson admits that Ethicon, Inc. has certain
duties imposed on it by law, but denies that Ethicon, Inc. breached
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any duties. Johnson & Johnson denies the remaining allegations
contained in Paragraph 15 of Plaintiff’s Complaint as phrased.
16. Paragraph 16 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson admits that
Ethicon, Inc. designed and manufactured certain hernia mesh
products, including but not limited to Proceed Surgical Mesh, and
that they have been available for purchase in the State of New
Jersey. Johnson & Johnson does not design or manufacture any
product. Johnson & Johnson admits further that its and Ethicon,
Inc.’s principal places of business are located in New Jersey.
Johnson & Johnson denies the remaining allegations contained in
Paragraph 16 of Plaintiff’s Complaint, including subparts (a.) –
(d.).
17. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 17 of Plaintiff’s Complaint.
18. The first two sentences of Paragraph 18 of Plaintiff’s
Complaint make no allegations against Johnson & Johnson and require
no response by Johnson & Johnson. To the extent a response is
required, Johnson & Johnson is without sufficient knowledge or
information so as to form a belief as to the truth of those
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allegations in Paragraph 18 of Plaintiff’s Complaint; therefore,
Johnson & Johnson denies those allegations. As to the third and
fourth sentences of Paragraph 18 of Plaintiff’s Complaint, Johnson
& Johnson admits only that it and Ethicon, Inc. are New Jersey
corporations with their principal places of business located in
New Jersey. Johnson & Johnson is without sufficient knowledge or
information so as to form a belief as to the truth of the remaining
allegations contained in Paragraph 18 of Plaintiff’s Complaint;
therefore, Johnson & Johnson denies those factual allegations and
legal conclusions.
19. Johnson & Johnson admits only that Ethicon, Inc.
designed, manufactured, marketed, and sold Proceed Surgical Mesh
for uses consistent with the packaging and labeling, and that
Proceed Surgical Mesh has been available for purchase in the State
of New Jersey. Johnson & Johnson does not design, manufacture,
fabricate, market, package, advertise, or sell any product.
Johnson & Johnson denies the remaining allegations contained in
Paragraph 19 of Plaintiff’s Complaint.
20. Johnson & Johnson admits only that Ethicon, Inc.
marketed Proceed Surgical Mesh for uses consistent with the
packaging and labeling, and that it has been available for purchase
in the State of New Jersey. Johnson & Johnson does not market any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 20 of Plaintiff’s Complaint.
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21. Paragraph 21 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson is without sufficient knowledge or information so as to
form a belief as to the truth of the allegations contained in
Paragraph 21 of Plaintiff’s Complaint; therefore, Johnson &
Johnson denies those allegations.
RESPONSE TO “PROCEED HISTORY”
22. Johnson & Johnson admits that Ethicon, Inc. designed,
manufactured, marketed, distributed, and supplied Proceed Surgical
Mesh for uses consistent with the packaging and labeling. Johnson
& Johnson does not design, manufacture, market, distribute, or
supply any product. Johnson & Johnson denies the remaining
allegations contained in Paragraph 22 of Plaintiff’s Complaint.
23. Johnson & Johnson admits only that Proceed Surgical Mesh
has been available for purchase in the State of New Jersey. Johnson
& Johnson denies the remaining allegations contained in Paragraph
23 of Plaintiff’s Complaint.
24. Johnson & Johnson denies the allegations contained in
Paragraph 24 of Plaintiff’s Complaint.
25. Johnson & Johnson denies the allegations contained in
Paragraph 25 of Plaintiff’s Complaint.
26. Johnson & Johnson denies the allegations contained in
Paragraph 26 of Plaintiff’s Complaint.
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27. Johnson & Johnson denies the allegations contained in
Paragraph 27 of Plaintiff’s Complaint.
28. Johnson & Johnson denies the allegations contained in
Paragraph 28 of Plaintiff’s Complaint.
29. Johnson & Johnson denies the allegations contained in
Paragraph 29 of Plaintiff’s Complaint.
30. Johnson & Johnson admits only that Ethicon, Inc. has
certain duties imposed on it by law, but denies that Ethicon, Inc.
breached any duty. Johnson & Johnson denies the remaining
allegations contained in Paragraph 30 of Plaintiff’s Complaint as
phrased.
31. Johnson & Johnson denies the allegations contained in
Paragraph 31 of Plaintiff’s Complaint.
32. Johnson & Johnson denies the allegations contained in
Paragraph 32 of Plaintiff’s Complaint.
33. Johnson & Johnson denies the allegations, including the
bulleted subparts, contained in Paragraph 33 of Plaintiff’s
Complaint as phrased.
34. Johnson & Johnson denies the allegations contained in
Paragraph 34 of Plaintiff’s Complaint.
35. Johnson & Johnson denies the allegations contained in
Paragraph 35 of Plaintiff’s Complaint.
36. Johnson & Johnson denies the allegations contained in
Paragraph 36 of Plaintiff’s Complaint.
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37. Johnson & Johnson denies the allegations contained in
Paragraph 37 of Plaintiff’s Complaint.
38. Johnson & Johnson denies the allegations contained in
Paragraph 38 of Plaintiff’s Complaint.
39. Johnson & Johnson denies the allegations contained in
Paragraph 39 of Plaintiff’s Complaint.
40. Johnson & Johnson admits only that Ethicon, Inc.’s
Proceed Surgical Mesh contains polypropylene and that it is a non-
absorbable material. Johnson & Johnson denies the remaining
allegations contained in Paragraph 40 of Plaintiff’s Complaint as
phrased.
41. Johnson & Johnson admits that Ethicon, Inc. designed,
manufactured, promoted, sold, and/or marketed Proceed Surgical
Mesh for uses consistent with the packaging and labeling. Johnson
& Johnson does not design, manufacture, promote, sell, or market
any product. Johnson & Johnson also admits that the Proceed
Surgical Mesh Instructions for Use speaks for itself. Johnson &
Johnson denies the remaining allegations contained in Paragraph 41
of Plaintiff’s Complaint.
42. Johnson & Johnson denies the allegations contained in
Paragraph 42 of Plaintiff’s Complaint.
43. Johnson & Johnson denies the allegations contained in
Paragraph 43 of Plaintiff’s Complaint.
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44. Johnson & Johnson admits only that Ethicon, Inc.
marketed Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not market any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 44 of Plaintiff’s Complaint.
RESPONSE TO “FAILURE TO WARN PHYSICIANS OF THE DANGERS
ASSOCIATED WITH PROCEED”
45. Johnson & Johnson admits only that Ethicon, Inc.
marketed Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not market any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 45 of Plaintiff’s Complaint.
46. Johnson & Johnson admits only that Ethicon, Inc. sold
Proceed Surgical Mesh for uses consistent with the packaging and
labeling, and that it is safe and effective for uses consistent
with the packaging and labeling. Johnson & Johnson does not sell
any product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 46 of Plaintiff’s Complaint.
47. Johnson & Johnson denies the allegations contained in
Paragraph 47 of Plaintiff’s Complaint.
48. Johnson & Johnson admits only that the Proceed Surgical
Mesh Instructions for Use speaks for itself. Johnson & Johnson
denies the remaining allegations contained in Paragraph 48 of
Plaintiff’s Complaint.
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49. Johnson & Johnson admits only that the Proceed Surgical
Mesh Instructions for Use speaks for itself. Johnson & Johnson
denies the remaining allegations contained in Paragraph 49 of
Plaintiff’s Complaint.
50. Johnson & Johnson admits only that the Proceed Surgical
Mesh Instructions for Use speaks for itself. Johnson & Johnson
denies the remaining allegations contained in Paragraph 50 of
Plaintiff’s Complaint.
51. Johnson & Johnson admits only that the Proceed Surgical
Mesh Instructions for Use speaks for itself. Johnson & Johnson
denies the remaining allegations contained in Paragraph 51 of
Plaintiff’s Complaint.
52. Johnson & Johnson denies the allegations contained in
Paragraph 52 of Plaintiff’s Complaint.
53. Johnson & Johnson denies the allegations contained in
Paragraph 53 of Plaintiff’s Complaint.
54. Johnson & Johnson admits only that Ethicon, Inc. tested
and marketed Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not test or market
any product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 54 of Plaintiff’s Complaint.
55. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
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denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. tested Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not test any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 55 of Plaintiff’s Complaint.
56. Johnson & Johnson denies the allegations contained in
Paragraph 56 of Plaintiff’s Complaint.
57. Johnson & Johnson admits that Ethicon, Inc. promoted
Proceed Surgical Mesh for uses consistent with the packaging and
labeling, and that it is safe and effective for uses consistent
with the packaging and labeling. Johnson & Johnson does not promote
any product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 57 of Plaintiff’s Complaint.
58. Johnson & Johnson denies the allegations contained in
Paragraph 58 of Plaintiff’s Complaint.
59. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 59 of Plaintiff’s Complaint.
60. Johnson & Johnson admits that Ethicon, Inc. marketed
Proceed Surgical Mesh for uses consistent with the packaging and
labeling. Johnson & Johnson does not market any product. Johnson
& Johnson admits that Ethicon, Inc.’s Proceed Surgical Mesh is
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safe and effective for uses consistent with the packaging and
labeling. Johnson & Johnson denies the remaining allegations
contained in Paragraph 60 of Plaintiff’s Complaint.
61. Johnson & Johnson denies the allegations contained in
Paragraph 61 of Plaintiff’s Complaint.
RESPONSE TO “USE OF THE PRODUCT”
62. Johnson & Johnson denies the allegations contained in
the first sentence of Paragraph 62 of Plaintiff’s Complaint.
Johnson & Johnson lacks sufficient knowledge or information to
know whether Plaintiff Julie Hall was treated with any of Ethicon,
Inc.’s products; therefore, Johnson & Johnson denies that
allegation. Johnson & Johnson is without sufficient knowledge or
information so as to form a belief as to the truth of the remaining
allegations contained in Paragraph 62 of Plaintiff’s Complaint;
therefore, Johnson & Johnson denies those allegations.
63. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 63, including subparts (a.) -
(d.), of Plaintiff’s Complaint.
64. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
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denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 64 of Plaintiff’s Complaint.
65. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 65 of Plaintiff’s Complaint.
66. Paragraph 66 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson lacks sufficient
knowledge or information to know whether Plaintiff Julie Hall was
treated with any of Ethicon, Inc.’s products; therefore, Johnson
& Johnson denies that allegation. Johnson & Johnson is without
sufficient knowledge or information so as to form a belief as to
the truth of the remaining allegations contained in Paragraph 66
of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations.
67. Paragraph 67 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
allegations and legal conclusion contained in Paragraph 67 of
Plaintiff’s Complaint.
68. Johnson & Johnson denies the allegations contained in
Paragraph 68 of Plaintiff’s Complaint.
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RESPONSE TO “THE FDA’S 510(k) CLEARANCE PROCESS”
69. Paragraph 69 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
69 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations as phrased.
70. Paragraph 70 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
70 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations as phrased.
71. Paragraph 71 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
71 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations as phrased.
72. Paragraph 72 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
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Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
72 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations as phrased.
73. Paragraph 73 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
73 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations as phrased.
74. Paragraph 74 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
74 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations.
75. Paragraph 75 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson lacks sufficient knowledge or information so as to form
a belief as to the truth of the allegations contained in Paragraph
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75 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies
those allegations.
76. Johnson & Johnson admits only that the FDA cleared
Proceed Surgical Mesh under the 510(k) Premarket Notification.
Johnson & Johnson denies the remaining allegations contained in
Paragraph 76 of Plaintiff’s Complaint as phrased.
77. Paragraph 77 of Plaintiff’s Complaint makes no
allegation against Johnson & Johnson and requires no response by
Johnson & Johnson. To the extent a response is required, Johnson
& Johnson admits only that any document published by the FDA speaks
for itself. Johnson & Johnson denies the remaining allegations
contained in Paragraph 77 of Plaintiff’s Complaint.
78. Johnson & Johnson admits that the FDA cleared Proceed
Surgical Mesh under the 510(k) Premarket Notification. Johnson &
Johnson admits further that Ethicon, Inc. marketed Proceed
Surgical Mesh for uses consistent with the packaging and labeling.
Johnson & Johnson does not market any product. Johnson & Johnson
denies the remaining allegations contained in Paragraph 78 of
Plaintiff’s Complaint.
79. Johnson & Johnson admits that Ethicon, Inc. marketed
Proceed Surgical Mesh for uses consistent with the packaging and
labeling. Johnson & Johnson does not market any product. Johnson
& Johnson also admits that the Proceed Surgical Mesh Instructions
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for Use speaks for itself. Johnson & Johnson denies the remaining
allegations contained in Paragraph 79 of Plaintiff’s Complaint.
RESPONSE TO “CAUSES OF ACTION”
RESPONSE TO “COUNT I: STRICT PRODUCTS LIABILITY – DEFECTIVE
DESIGN UNDER NEW JERSEY PRODUCT LIABILITY ACT (NJ PLA)”
80. Johnson & Johnson incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint.
81. Johnson & Johnson admits that Ethicon, Inc. has certain
duties imposed on it by law, but denies that Ethicon, Inc. breached
any duty. Johnson & Johnson admits that Ethicon, Inc. manufactured,
distributed, marketed, promoted, and sold Proceed Surgical Mesh
for uses consistent with the packaging and labeling. Johnson &
Johnson does not manufacture, distribute, market, promote, or sell
any product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 81 of Plaintiff’s Complaint.
82. Johnson & Johnson admits that Ethicon, Inc. designed,
manufactured, marketed, distributed, and sold Proceed Surgical
Mesh for uses consistent with the packaging and labeling. Johnson
& Johnson does not design, manufacture, market, distribute, or
sell any product. Johnson & Johnson denies the remaining
allegations contained in Paragraph 82 of Plaintiff’s Complaint.
83. Johnson & Johnson admits that Ethicon, Inc.
manufactured, sold, distributed, supplied, and/or promoted Proceed
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Surgical Mesh for uses consistent with the packaging and labeling,
and that it has been available for purchase in the State of New
Jersey. Johnson & Johnson does not manufacture, sell, distribute,
supply, or sell any product. Johnson & Johnson lacks sufficient
knowledge or information to know whether Plaintiff Julie Hall was
treated with any of Ethicon, Inc.’s products; therefore, Johnson
& Johnson denies that allegation. Johnson & Johnson denies the
remaining allegations contained in Paragraph 83 of Plaintiff’s
Complaint.
84. Johnson & Johnson denies the allegations, including the
bulleted subparts, contained in Paragraph 84 of Plaintiff’s
Complaint.
85. Johnson & Johnson denies the allegations contained in
Paragraph 85 of Plaintiff’s Complaint.
86. Johnson & Johnson admits that Ethicon, Inc. designed,
manufactured, marketed, and sold Proceed Surgical Mesh for uses
consistent with the packaging and labeling, and that it is safe
and effective for uses consistent with the packaging and labeling.
Johnson & Johnson does not design, manufacture, market, or sell
any product. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 86 of Plaintiff’s Complaint.
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87. Johnson & Johnson denies the allegations contained in
Paragraph 87 of Plaintiff’s Complaint.
88. Johnson & Johnson denies the allegations contained in
Paragraph 88 of Plaintiff’s Complaint.
89. Johnson & Johnson denies that Plaintiff is entitled to
any recovery or any form of relief whatsoever from Johnson &
Johnson. Johnson & Johnson denies the remaining allegations
contained in Paragraph 89 of Plaintiff’s Complaint.
90. Paragraph 90 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
allegations and legal conclusions contained in Paragraph 90 of
Plaintiff’s Complaint.
RESPONSE TO “COUNT II: STRICT PRODUCTS LIABILITY - FAILURE TO
WARN UNDER NJ PLA”
91. Johnson & Johnson incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint.
92. Johnson & Johnson admits that Ethicon, Inc. researched,
developed, designed, tested, manufactured, distributed, marketed,
promoted, and sold Proceed Surgical Mesh for uses consistent with
the packaging and labeling. Johnson & Johnson does not research,
develop, design, test, manufacture, inspect, label, distribute,
market, promote, or sell any product. Johnson & Johnson lacks
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sufficient knowledge or information to know whether Plaintiff
Julie Hall was treated with any of Ethicon, Inc.’s products;
therefore, Johnson & Johnson denies that allegation. Johnson &
Johnson admits further that Ethicon, Inc. has certain duties
imposed on it by law but denies that Ethicon, Inc. breached any
duty. Johnson & Johnson denies the remaining allegations contained
in Paragraph 92 of Plaintiff’s Complaint.
93. Johnson & Johnson admits only that Ethicon, Inc.
distributed and sold Proceed Surgical Mesh for uses consistent
with the packaging and labeling. Johnson & Johnson does not
distribute or sell any product. Johnson & Johnson denies the
remaining allegations contained in Paragraph 93 of Plaintiff’s
Complaint.
94. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. manufactured and sold Proceed Surgical Mesh for uses
consistent with the packaging and labeling. Johnson & Johnson does
not manufacture or sell any product. Johnson & Johnson denies the
remaining allegations contained in Paragraph 94 of Plaintiff’s
Complaint.
95. Johnson & Johnson denies the allegations contained in
Paragraph 95 of Plaintiff’s Complaint.
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96. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 96 of Plaintiff’s Complaint.
97. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. sold Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not sell any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 97 of Plaintiff’s Complaint.
98. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 98 of Plaintiff’s Complaint.
99. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 99 of Plaintiff’s Complaint.
23
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100. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits that Ethicon,
Inc.’s Proceed Surgical Mesh is safe and effective for uses
consistent with the packaging and labeling. Johnson & Johnson
denies the remaining allegations contained in Paragraph 100 of
Plaintiff’s Complaint.
101. Johnson & Johnson admits that Ethicon, Inc.’s Proceed
Surgical Mesh is safe and effective for uses consistent with the
packaging and labeling. Johnson & Johnson denies the remaining
allegations contained in Paragraph 101 of Plaintiff’s Complaint.
102. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. researched, developed, designed, tested, manufactured,
distributed, marketed, promoted, and sold Proceed Surgical Mesh
for uses consistent with the packaging and labeling. Johnson &
Johnson does not research, develop, design, test, manufacture,
inspect, label, distribute, market, promote, or sell any product.
Johnson & Johnson denies the remaining allegations contained in
Paragraph 102 of Plaintiff’s Complaint.
24
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103. Johnson & Johnson admits only that Ethicon, Inc.
researched, developed, designed, tested, manufactured,
distributed, marketed, promoted, and sold Proceed Surgical Mesh
for uses consistent with the packaging and labeling. Johnson &
Johnson does not research, develop, design, test, manufacture,
inspect, label, distribute, market, promote, or sell any product.
Johnson & Johnson denies the remaining allegations contained in
Paragraph 103 of Plaintiff’s Complaint.
104. Johnson & Johnson denies the allegations contained in
Paragraph 104 of Plaintiff’s Complaint.
105. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. sold Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not sell any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 105 of Plaintiff’s Complaint.
106. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 106 of Plaintiff’s Complaint.
25
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107. Johnson & Johnson denies the allegations contained in
Paragraph 107 of Plaintiff’s Complaint.
108. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 108 of Plaintiff’s Complaint.
109. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 109 of Plaintiff’s Complaint.
110. Johnson & Johnson denies the allegations contained in
Paragraph 110 of Plaintiff’s Complaint.
111. Paragraph 111 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
allegations and legal conclusions contained in Paragraph 111 of
Plaintiff’s Complaint.
RESPONSE TO “COUNT III: STRICT PRODUCTS LIABILITY –
MANUFACTURING DEFECT UNDER NJ PLA”
112. Johnson & Johnson incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint.
26
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113. Johnson & Johnson admits only that Ethicon, Inc.
designed, developed, manufactured, tested, promoted, marketed,
distributed and sold Proceed Surgical Mesh for uses consistent
with the packaging and labeling. Johnson & Johnson does not design,
develop, manufacture, test, package, advertise, promote, market,
distribute, label, or sell any product. Johnson & Johnson denies
the remaining allegations contained in Paragraph 113 of
Plaintiff’s Complaint.
114. Johnson & Johnson admits only that Ethicon, Inc.
manufactured and marketed Proceed Surgical Mesh for uses
consistent with the packaging and labeling. Johnson & Johnson does
not manufacture or market any product. Johnson & Johnson admits
that Ethicon, Inc.’s Proceed Surgical Mesh is safe and effective
for uses consistent with the packaging and labeling. Johnson &
Johnson denies the remaining allegations contained in Paragraph
114 of Plaintiff’s Complaint.
115. Johnson & Johnson denies the allegations contained in
Paragraph 115 of Plaintiff’s Complaint.
116. Paragraph 116 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
allegations and legal conclusions contained in Paragraph 116 of
Plaintiff’s Complaint.
27
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RESPONSE TO “COUNT IV: NEGLIGENCE - PURSUANT TO NEW JERSEY
COMMON LAW AND NJ PLA”
117. Johnson & Johnson incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint.
118. Johnson & Johnson admits that Ethicon, Inc. has certain
duties imposed on it by law, but denies that Ethicon, Inc. breached
any duty. Johnson & Johnson admits that Ethicon, Inc. designed,
tested, manufactured, marketed, and distributed Proceed Surgical
Mesh for uses consistent with the packaging and labeling. Johnson
& Johnson does not design, test, inspect, manufacture, package,
label, market, distribute, promote, or sell any product. Johnson
& Johnson denies the remaining allegations contained in Paragraph
118 of Plaintiff’s Complaint.
119. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 119 of Plaintiff’s Complaint.
120. Johnson & Johnson denies the allegations contained in
Paragraph 120 of Plaintiff’s Complaint.
121. Paragraph 121 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
28
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allegations and legal conclusions contained in Paragraph 121 of
Plaintiff’s Complaint.
122. Paragraph 122 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
allegations and legal conclusions contained in Paragraph 122 of
Plaintiff’s Complaint.
RESPONSE TO “COUNT V: BREACH OF IMPLIED WARRANTY UNDER NJ PLA”
123. Johnson & Johnson incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint.
124. Johnson & Johnson admits that Ethicon, Inc. designed,
manufactured, produced, tested, marketed, sold, promoted, and
distributed Proceed Surgical Mesh for uses consistent with the
packaging and labeling, and that it is safe and effective for uses
consistent with the packaging and labeling. Johnson & Johnson does
not design, manufacture, produce, test, study, inspect, label,
market, advertise, sell, promote, or distribute any product.
Johnson & Johnson lacks sufficient knowledge or information to
know whether Plaintiff Julie Hall was treated with any of Ethicon,
Inc.’s products; therefore, Johnson & Johnson denies that
allegation. Johnson & Johnson denies the remaining allegations
contained in Paragraph 124 of Plaintiff’s Complaint.
29
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125. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits only that Ethicon,
Inc. sold Proceed Surgical Mesh for uses consistent with the
packaging and labeling. Johnson & Johnson does not sell any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 125 of Plaintiff’s Complaint.
126. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson denies the remaining
allegations contained in Paragraph 126 of Plaintiff’s Complaint.
127. Johnson & Johnson admits that Ethicon, Inc.’s Proceed
Surgical Mesh is safe and effective for uses consistent with the
packaging and labeling. Johnson & Johnson denies the remaining
allegations contained in Paragraph 127 of Plaintiff’s Complaint.
128. Johnson & Johnson denies the allegations contained in
Paragraph 128 of Plaintiff’s Complaint.
129. Paragraph 129 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Johnson & Johnson. To the
extent a response is required, Johnson & Johnson denies the factual
allegations and legal conclusions contained in Paragraph 129 of
Plaintiff’s Complaint.
30
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RESPONSE TO “COUNT VI: BREACH OF EXPRESS WARRANTY UNDER NJ PLA”
130. Johnson & Johnson incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint.
131. Johnson & Johnson admits that Ethicon, Inc.
manufactured, distributed, promoted, and sold Proceed Surgical
Mesh for uses consistent with the packaging and labeling. Johnson
& Johnson does not manufacture, distribute, promote, or sell any
product. Johnson & Johnson denies the remaining allegations
contained in Paragraph 131 of Plaintiff’s Complaint.
132. Johnson & Johnson lacks sufficient knowledge or
information to know whether Plaintiff Julie Hall was treated with
any of Ethicon, Inc.’s products; therefore, Johnson & Johnson
denies that allegation. Johnson & Johnson admits that Ethicon,
Inc. sold Proceed Surgical Mesh for uses consistent with the
packaging and labeling, and that it is safe and effective for uses
consistent with the packaging and labeling. Johnson & John
Preview
ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 1 of 48 Trans ID: LCV20223939248 Kelly S. Crawford – NJ Attorney ID #029141993 RIKER DANZIG LLP Headquarters Plaza One Speedwell Avenue Morristown, NJ 07962-1981 (973) 538-0800 Attorneys for Defendants Ethicon, Inc. and Johnson & Johnson IN RE PROCEED MESH LITIGATION MCL CASE NO. 630 (PROCEED SURGICAL MESH AND PROCEED MASTER DOCKET NO.: ATL-L-794-19 VENTRAL PATCH HERNIA MESH) JULIE HALL, SUPERIOR COURT OF NEW JERSEY LAW DIVISION - ATLANTIC COUNTY DOCKET NO. ATL-L-002607-22 Plaintiff, v. CIVIL ACTION JOHNSON & JOHNSON; and ETHICON, ANSWER TO COMPLAINT, SEPARATE INC., DEFENSES, AND JURY DEMAND OF DEFENDANT JOHNSON & JOHNSON Defendants. Defendant Johnson & Johnson, by and through its attorneys, responds to Plaintiff’s Complaint and Jury Demand (“Complaint”) as follows. RESPONSE TO “NATURE OF THE ACTION” 1 1. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson 1 The repetition of the Complaint’s subheadings in the Answer is done solely for organizational purposes and is not an admission as to their truth. 1 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 2 of 48 Trans ID: LCV20223939248 denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 1 of Plaintiff’s Complaint. 2. Johnson & Johnson admits only that Ethicon, Inc. manufactured and supplied Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or supply any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 2 of Plaintiff’s Complaint. 3. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 3 of Plaintiff’s Complaint. 4. Johnson & Johnson denies the allegations contained in Paragraph 4 of Plaintiff’s Complaint. 5. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. marketed and promoted Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not market or promote any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 5 of Plaintiff’s Complaint. 2 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 3 of 48 Trans ID: LCV20223939248 RESPONSE TO “JURISDICTION & VENUE” 6. Johnson & Johnson denies the allegations contained in Paragraph 6 of Plaintiff’s Complaint. 7. Johnson & Johnson is without sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 7 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. 8. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. manufactured, designed, and distributed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture, design, distribute, or warrant any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 8 of Plaintiff’s Complaint. 9. Johnson & Johnson admits that it is a New Jersey corporation with its principal place of business located at One Johnson & Johnson Plaza, New Brunswick, New Jersey. Johnson & Johnson admits further that its website speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 9 of Plaintiff’s Complaint. 3 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 4 of 48 Trans ID: LCV20223939248 10. With respect to the allegations contained in Paragraph 10 of the Complaint, Johnson & Johnson is a holding company for companies with a primary focus of providing products and services related to human health and well-being. Each of these subsidiary companies operates independently of Johnson & Johnson. Johnson & Johnson’s subsidiaries are organized in three business segments: Consumer, Pharmaceutical, and Medical Devices. The companies within these segments are financially and operationally independent. Johnson & Johnson admits that Ethicon, Inc. designed, developed, manufactured, tested, marketed, promoted, distributed, and sold certain hernia mesh products for uses consistent with the packaging and labeling. Johnson & Johnson further admits that in 2009, Mr. Gary Pruden became Company Group Chairman of Ethicon. In 2012, he was named Worldwide Chairman, Global Surgery Group, and in 2015, Worldwide Chairman, Medical Devices. Mr. Pruden retired effective June 1, 2017. Johnson & Johnson denies the remaining allegations contained in Paragraph 10 of Plaintiff’s Complaint and all allegations inconsistent with the foregoing. 11. Johnson & Johnson admits that Ethicon, Inc. is a New Jersey corporation with its principal place of business in New Jersey, and it is a wholly owned subsidiary of Johnson & Johnson. Johnson & Johnson admits that certain hernia mesh products, including but not limited to Proceed Surgical Mesh, have been available for purchase in the State of New Jersey. Johnson & 4 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 5 of 48 Trans ID: LCV20223939248 Johnson denies the remaining allegations contained in Paragraph 11 of Plaintiff’s Complaint. 12. Johnson & Johnson admits only that Ethicon, Inc. researched, developed, tested, manufactured, produced, marketed, promoted, and/or sold certain hernia mesh products, including but not limited to Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, test, manufacture, produce, market, promote, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 12 of Plaintiff’s Complaint. 13. Johnson & Johnson admits only that Ethicon, Inc. researched, developed, tested, manufactured, produced, marketed, promoted, distributed, and/or sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, test, manufacture, produce, market, promote, distribute, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 13 of Plaintiff’s Complaint. 14. Johnson & Johnson admits only that Ethicon, Inc.’s Proceed Surgical Mesh has been available for purchase in the State of New Jersey. Johnson & Johnson denies the remaining allegations contained in Paragraph 14 of Plaintiff’s Complaint. 15. Johnson & Johnson admits that Ethicon, Inc. has certain duties imposed on it by law, but denies that Ethicon, Inc. breached 5 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 6 of 48 Trans ID: LCV20223939248 any duties. Johnson & Johnson denies the remaining allegations contained in Paragraph 15 of Plaintiff’s Complaint as phrased. 16. Paragraph 16 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson admits that Ethicon, Inc. designed and manufactured certain hernia mesh products, including but not limited to Proceed Surgical Mesh, and that they have been available for purchase in the State of New Jersey. Johnson & Johnson does not design or manufacture any product. Johnson & Johnson admits further that its and Ethicon, Inc.’s principal places of business are located in New Jersey. Johnson & Johnson denies the remaining allegations contained in Paragraph 16 of Plaintiff’s Complaint, including subparts (a.) – (d.). 17. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 17 of Plaintiff’s Complaint. 18. The first two sentences of Paragraph 18 of Plaintiff’s Complaint make no allegations against Johnson & Johnson and require no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson is without sufficient knowledge or information so as to form a belief as to the truth of those 6 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 7 of 48 Trans ID: LCV20223939248 allegations in Paragraph 18 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. As to the third and fourth sentences of Paragraph 18 of Plaintiff’s Complaint, Johnson & Johnson admits only that it and Ethicon, Inc. are New Jersey corporations with their principal places of business located in New Jersey. Johnson & Johnson is without sufficient knowledge or information so as to form a belief as to the truth of the remaining allegations contained in Paragraph 18 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those factual allegations and legal conclusions. 19. Johnson & Johnson admits only that Ethicon, Inc. designed, manufactured, marketed, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that Proceed Surgical Mesh has been available for purchase in the State of New Jersey. Johnson & Johnson does not design, manufacture, fabricate, market, package, advertise, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 19 of Plaintiff’s Complaint. 20. Johnson & Johnson admits only that Ethicon, Inc. marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that it has been available for purchase in the State of New Jersey. Johnson & Johnson does not market any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 20 of Plaintiff’s Complaint. 7 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 8 of 48 Trans ID: LCV20223939248 21. Paragraph 21 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson is without sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 21 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. RESPONSE TO “PROCEED HISTORY” 22. Johnson & Johnson admits that Ethicon, Inc. designed, manufactured, marketed, distributed, and supplied Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, market, distribute, or supply any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 22 of Plaintiff’s Complaint. 23. Johnson & Johnson admits only that Proceed Surgical Mesh has been available for purchase in the State of New Jersey. Johnson & Johnson denies the remaining allegations contained in Paragraph 23 of Plaintiff’s Complaint. 24. Johnson & Johnson denies the allegations contained in Paragraph 24 of Plaintiff’s Complaint. 25. Johnson & Johnson denies the allegations contained in Paragraph 25 of Plaintiff’s Complaint. 26. Johnson & Johnson denies the allegations contained in Paragraph 26 of Plaintiff’s Complaint. 8 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 9 of 48 Trans ID: LCV20223939248 27. Johnson & Johnson denies the allegations contained in Paragraph 27 of Plaintiff’s Complaint. 28. Johnson & Johnson denies the allegations contained in Paragraph 28 of Plaintiff’s Complaint. 29. Johnson & Johnson denies the allegations contained in Paragraph 29 of Plaintiff’s Complaint. 30. Johnson & Johnson admits only that Ethicon, Inc. has certain duties imposed on it by law, but denies that Ethicon, Inc. breached any duty. Johnson & Johnson denies the remaining allegations contained in Paragraph 30 of Plaintiff’s Complaint as phrased. 31. Johnson & Johnson denies the allegations contained in Paragraph 31 of Plaintiff’s Complaint. 32. Johnson & Johnson denies the allegations contained in Paragraph 32 of Plaintiff’s Complaint. 33. Johnson & Johnson denies the allegations, including the bulleted subparts, contained in Paragraph 33 of Plaintiff’s Complaint as phrased. 34. Johnson & Johnson denies the allegations contained in Paragraph 34 of Plaintiff’s Complaint. 35. Johnson & Johnson denies the allegations contained in Paragraph 35 of Plaintiff’s Complaint. 36. Johnson & Johnson denies the allegations contained in Paragraph 36 of Plaintiff’s Complaint. 9 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 10 of 48 Trans ID: LCV20223939248 37. Johnson & Johnson denies the allegations contained in Paragraph 37 of Plaintiff’s Complaint. 38. Johnson & Johnson denies the allegations contained in Paragraph 38 of Plaintiff’s Complaint. 39. Johnson & Johnson denies the allegations contained in Paragraph 39 of Plaintiff’s Complaint. 40. Johnson & Johnson admits only that Ethicon, Inc.’s Proceed Surgical Mesh contains polypropylene and that it is a non- absorbable material. Johnson & Johnson denies the remaining allegations contained in Paragraph 40 of Plaintiff’s Complaint as phrased. 41. Johnson & Johnson admits that Ethicon, Inc. designed, manufactured, promoted, sold, and/or marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, promote, sell, or market any product. Johnson & Johnson also admits that the Proceed Surgical Mesh Instructions for Use speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 41 of Plaintiff’s Complaint. 42. Johnson & Johnson denies the allegations contained in Paragraph 42 of Plaintiff’s Complaint. 43. Johnson & Johnson denies the allegations contained in Paragraph 43 of Plaintiff’s Complaint. 10 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 11 of 48 Trans ID: LCV20223939248 44. Johnson & Johnson admits only that Ethicon, Inc. marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 44 of Plaintiff’s Complaint. RESPONSE TO “FAILURE TO WARN PHYSICIANS OF THE DANGERS ASSOCIATED WITH PROCEED” 45. Johnson & Johnson admits only that Ethicon, Inc. marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 45 of Plaintiff’s Complaint. 46. Johnson & Johnson admits only that Ethicon, Inc. sold Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that it is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 46 of Plaintiff’s Complaint. 47. Johnson & Johnson denies the allegations contained in Paragraph 47 of Plaintiff’s Complaint. 48. Johnson & Johnson admits only that the Proceed Surgical Mesh Instructions for Use speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 48 of Plaintiff’s Complaint. 11 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 12 of 48 Trans ID: LCV20223939248 49. Johnson & Johnson admits only that the Proceed Surgical Mesh Instructions for Use speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 49 of Plaintiff’s Complaint. 50. Johnson & Johnson admits only that the Proceed Surgical Mesh Instructions for Use speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 50 of Plaintiff’s Complaint. 51. Johnson & Johnson admits only that the Proceed Surgical Mesh Instructions for Use speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 51 of Plaintiff’s Complaint. 52. Johnson & Johnson denies the allegations contained in Paragraph 52 of Plaintiff’s Complaint. 53. Johnson & Johnson denies the allegations contained in Paragraph 53 of Plaintiff’s Complaint. 54. Johnson & Johnson admits only that Ethicon, Inc. tested and marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not test or market any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 54 of Plaintiff’s Complaint. 55. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson 12 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 13 of 48 Trans ID: LCV20223939248 denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. tested Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not test any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 55 of Plaintiff’s Complaint. 56. Johnson & Johnson denies the allegations contained in Paragraph 56 of Plaintiff’s Complaint. 57. Johnson & Johnson admits that Ethicon, Inc. promoted Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that it is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson does not promote any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 57 of Plaintiff’s Complaint. 58. Johnson & Johnson denies the allegations contained in Paragraph 58 of Plaintiff’s Complaint. 59. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 59 of Plaintiff’s Complaint. 60. Johnson & Johnson admits that Ethicon, Inc. marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Johnson & Johnson admits that Ethicon, Inc.’s Proceed Surgical Mesh is 13 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 14 of 48 Trans ID: LCV20223939248 safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson denies the remaining allegations contained in Paragraph 60 of Plaintiff’s Complaint. 61. Johnson & Johnson denies the allegations contained in Paragraph 61 of Plaintiff’s Complaint. RESPONSE TO “USE OF THE PRODUCT” 62. Johnson & Johnson denies the allegations contained in the first sentence of Paragraph 62 of Plaintiff’s Complaint. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson is without sufficient knowledge or information so as to form a belief as to the truth of the remaining allegations contained in Paragraph 62 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. 63. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 63, including subparts (a.) - (d.), of Plaintiff’s Complaint. 64. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson 14 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 15 of 48 Trans ID: LCV20223939248 denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 64 of Plaintiff’s Complaint. 65. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 65 of Plaintiff’s Complaint. 66. Paragraph 66 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson is without sufficient knowledge or information so as to form a belief as to the truth of the remaining allegations contained in Paragraph 66 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. 67. Paragraph 67 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual allegations and legal conclusion contained in Paragraph 67 of Plaintiff’s Complaint. 68. Johnson & Johnson denies the allegations contained in Paragraph 68 of Plaintiff’s Complaint. 15 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 16 of 48 Trans ID: LCV20223939248 RESPONSE TO “THE FDA’S 510(k) CLEARANCE PROCESS” 69. Paragraph 69 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 69 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations as phrased. 70. Paragraph 70 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 70 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations as phrased. 71. Paragraph 71 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 71 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations as phrased. 72. Paragraph 72 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by 16 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 17 of 48 Trans ID: LCV20223939248 Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 72 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations as phrased. 73. Paragraph 73 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 73 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations as phrased. 74. Paragraph 74 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 74 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. 75. Paragraph 75 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 17 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 18 of 48 Trans ID: LCV20223939248 75 of Plaintiff’s Complaint; therefore, Johnson & Johnson denies those allegations. 76. Johnson & Johnson admits only that the FDA cleared Proceed Surgical Mesh under the 510(k) Premarket Notification. Johnson & Johnson denies the remaining allegations contained in Paragraph 76 of Plaintiff’s Complaint as phrased. 77. Paragraph 77 of Plaintiff’s Complaint makes no allegation against Johnson & Johnson and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson admits only that any document published by the FDA speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 77 of Plaintiff’s Complaint. 78. Johnson & Johnson admits that the FDA cleared Proceed Surgical Mesh under the 510(k) Premarket Notification. Johnson & Johnson admits further that Ethicon, Inc. marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 78 of Plaintiff’s Complaint. 79. Johnson & Johnson admits that Ethicon, Inc. marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Johnson & Johnson also admits that the Proceed Surgical Mesh Instructions 18 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 19 of 48 Trans ID: LCV20223939248 for Use speaks for itself. Johnson & Johnson denies the remaining allegations contained in Paragraph 79 of Plaintiff’s Complaint. RESPONSE TO “CAUSES OF ACTION” RESPONSE TO “COUNT I: STRICT PRODUCTS LIABILITY – DEFECTIVE DESIGN UNDER NEW JERSEY PRODUCT LIABILITY ACT (NJ PLA)” 80. Johnson & Johnson incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 81. Johnson & Johnson admits that Ethicon, Inc. has certain duties imposed on it by law, but denies that Ethicon, Inc. breached any duty. Johnson & Johnson admits that Ethicon, Inc. manufactured, distributed, marketed, promoted, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture, distribute, market, promote, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 81 of Plaintiff’s Complaint. 82. Johnson & Johnson admits that Ethicon, Inc. designed, manufactured, marketed, distributed, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, market, distribute, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 82 of Plaintiff’s Complaint. 83. Johnson & Johnson admits that Ethicon, Inc. manufactured, sold, distributed, supplied, and/or promoted Proceed 19 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 20 of 48 Trans ID: LCV20223939248 Surgical Mesh for uses consistent with the packaging and labeling, and that it has been available for purchase in the State of New Jersey. Johnson & Johnson does not manufacture, sell, distribute, supply, or sell any product. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 83 of Plaintiff’s Complaint. 84. Johnson & Johnson denies the allegations, including the bulleted subparts, contained in Paragraph 84 of Plaintiff’s Complaint. 85. Johnson & Johnson denies the allegations contained in Paragraph 85 of Plaintiff’s Complaint. 86. Johnson & Johnson admits that Ethicon, Inc. designed, manufactured, marketed, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that it is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, market, or sell any product. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 86 of Plaintiff’s Complaint. 20 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 21 of 48 Trans ID: LCV20223939248 87. Johnson & Johnson denies the allegations contained in Paragraph 87 of Plaintiff’s Complaint. 88. Johnson & Johnson denies the allegations contained in Paragraph 88 of Plaintiff’s Complaint. 89. Johnson & Johnson denies that Plaintiff is entitled to any recovery or any form of relief whatsoever from Johnson & Johnson. Johnson & Johnson denies the remaining allegations contained in Paragraph 89 of Plaintiff’s Complaint. 90. Paragraph 90 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual allegations and legal conclusions contained in Paragraph 90 of Plaintiff’s Complaint. RESPONSE TO “COUNT II: STRICT PRODUCTS LIABILITY - FAILURE TO WARN UNDER NJ PLA” 91. Johnson & Johnson incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 92. Johnson & Johnson admits that Ethicon, Inc. researched, developed, designed, tested, manufactured, distributed, marketed, promoted, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, design, test, manufacture, inspect, label, distribute, market, promote, or sell any product. Johnson & Johnson lacks 21 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 22 of 48 Trans ID: LCV20223939248 sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits further that Ethicon, Inc. has certain duties imposed on it by law but denies that Ethicon, Inc. breached any duty. Johnson & Johnson denies the remaining allegations contained in Paragraph 92 of Plaintiff’s Complaint. 93. Johnson & Johnson admits only that Ethicon, Inc. distributed and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not distribute or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 93 of Plaintiff’s Complaint. 94. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. manufactured and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 94 of Plaintiff’s Complaint. 95. Johnson & Johnson denies the allegations contained in Paragraph 95 of Plaintiff’s Complaint. 22 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 23 of 48 Trans ID: LCV20223939248 96. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 96 of Plaintiff’s Complaint. 97. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 97 of Plaintiff’s Complaint. 98. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 98 of Plaintiff’s Complaint. 99. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 99 of Plaintiff’s Complaint. 23 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 24 of 48 Trans ID: LCV20223939248 100. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits that Ethicon, Inc.’s Proceed Surgical Mesh is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson denies the remaining allegations contained in Paragraph 100 of Plaintiff’s Complaint. 101. Johnson & Johnson admits that Ethicon, Inc.’s Proceed Surgical Mesh is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson denies the remaining allegations contained in Paragraph 101 of Plaintiff’s Complaint. 102. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. researched, developed, designed, tested, manufactured, distributed, marketed, promoted, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, design, test, manufacture, inspect, label, distribute, market, promote, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 102 of Plaintiff’s Complaint. 24 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 25 of 48 Trans ID: LCV20223939248 103. Johnson & Johnson admits only that Ethicon, Inc. researched, developed, designed, tested, manufactured, distributed, marketed, promoted, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, design, test, manufacture, inspect, label, distribute, market, promote, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 103 of Plaintiff’s Complaint. 104. Johnson & Johnson denies the allegations contained in Paragraph 104 of Plaintiff’s Complaint. 105. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 105 of Plaintiff’s Complaint. 106. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 106 of Plaintiff’s Complaint. 25 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 26 of 48 Trans ID: LCV20223939248 107. Johnson & Johnson denies the allegations contained in Paragraph 107 of Plaintiff’s Complaint. 108. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 108 of Plaintiff’s Complaint. 109. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 109 of Plaintiff’s Complaint. 110. Johnson & Johnson denies the allegations contained in Paragraph 110 of Plaintiff’s Complaint. 111. Paragraph 111 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual allegations and legal conclusions contained in Paragraph 111 of Plaintiff’s Complaint. RESPONSE TO “COUNT III: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT UNDER NJ PLA” 112. Johnson & Johnson incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 26 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 27 of 48 Trans ID: LCV20223939248 113. Johnson & Johnson admits only that Ethicon, Inc. designed, developed, manufactured, tested, promoted, marketed, distributed and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not design, develop, manufacture, test, package, advertise, promote, market, distribute, label, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 113 of Plaintiff’s Complaint. 114. Johnson & Johnson admits only that Ethicon, Inc. manufactured and marketed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or market any product. Johnson & Johnson admits that Ethicon, Inc.’s Proceed Surgical Mesh is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson denies the remaining allegations contained in Paragraph 114 of Plaintiff’s Complaint. 115. Johnson & Johnson denies the allegations contained in Paragraph 115 of Plaintiff’s Complaint. 116. Paragraph 116 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual allegations and legal conclusions contained in Paragraph 116 of Plaintiff’s Complaint. 27 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 28 of 48 Trans ID: LCV20223939248 RESPONSE TO “COUNT IV: NEGLIGENCE - PURSUANT TO NEW JERSEY COMMON LAW AND NJ PLA” 117. Johnson & Johnson incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 118. Johnson & Johnson admits that Ethicon, Inc. has certain duties imposed on it by law, but denies that Ethicon, Inc. breached any duty. Johnson & Johnson admits that Ethicon, Inc. designed, tested, manufactured, marketed, and distributed Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not design, test, inspect, manufacture, package, label, market, distribute, promote, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 118 of Plaintiff’s Complaint. 119. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 119 of Plaintiff’s Complaint. 120. Johnson & Johnson denies the allegations contained in Paragraph 120 of Plaintiff’s Complaint. 121. Paragraph 121 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual 28 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 29 of 48 Trans ID: LCV20223939248 allegations and legal conclusions contained in Paragraph 121 of Plaintiff’s Complaint. 122. Paragraph 122 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual allegations and legal conclusions contained in Paragraph 122 of Plaintiff’s Complaint. RESPONSE TO “COUNT V: BREACH OF IMPLIED WARRANTY UNDER NJ PLA” 123. Johnson & Johnson incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 124. Johnson & Johnson admits that Ethicon, Inc. designed, manufactured, produced, tested, marketed, sold, promoted, and distributed Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that it is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, produce, test, study, inspect, label, market, advertise, sell, promote, or distribute any product. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 124 of Plaintiff’s Complaint. 29 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 30 of 48 Trans ID: LCV20223939248 125. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits only that Ethicon, Inc. sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 125 of Plaintiff’s Complaint. 126. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson denies the remaining allegations contained in Paragraph 126 of Plaintiff’s Complaint. 127. Johnson & Johnson admits that Ethicon, Inc.’s Proceed Surgical Mesh is safe and effective for uses consistent with the packaging and labeling. Johnson & Johnson denies the remaining allegations contained in Paragraph 127 of Plaintiff’s Complaint. 128. Johnson & Johnson denies the allegations contained in Paragraph 128 of Plaintiff’s Complaint. 129. Paragraph 129 of Plaintiff’s Complaint states a legal conclusion and requires no response by Johnson & Johnson. To the extent a response is required, Johnson & Johnson denies the factual allegations and legal conclusions contained in Paragraph 129 of Plaintiff’s Complaint. 30 ATL-L-002607-22 11/14/2022 4:46:10 PM Pg 31 of 48 Trans ID: LCV20223939248 RESPONSE TO “COUNT VI: BREACH OF EXPRESS WARRANTY UNDER NJ PLA” 130. Johnson & Johnson incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 131. Johnson & Johnson admits that Ethicon, Inc. manufactured, distributed, promoted, and sold Proceed Surgical Mesh for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture, distribute, promote, or sell any product. Johnson & Johnson denies the remaining allegations contained in Paragraph 131 of Plaintiff’s Complaint. 132. Johnson & Johnson lacks sufficient knowledge or information to know whether Plaintiff Julie Hall was treated with any of Ethicon, Inc.’s products; therefore, Johnson & Johnson denies that allegation. Johnson & Johnson admits that Ethicon, Inc. sold Proceed Surgical Mesh for uses consistent with the packaging and labeling, and that it is safe and effective for uses consistent with the packaging and labeling. Johnson & John