Preview
ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 1 of 54 Trans ID: LCV20223784378
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)
SUPERIOR COURT OF NEW JERSEY
LENA BRYANT, LAW DIVISION - ATLANTIC COUNTY
DOCKET NO. ATL-L-002600-22
Plaintiff,
v. CIVIL ACTION
JOHNSON & JOHNSON and ETHICON, ANSWER TO COMPLAINT, SEPARATE
INC., DEFENSES, AND JURY DEMAND OF
DEFENDANT ETHICON, INC.
Defendants.
Defendant Ethicon, Inc. (“Ethicon”), by and through its
attorneys, responds to Plaintiff’s Complaint and Jury Demand
(“Complaint”) as follows.
RESPONSE TO “NATURE OF THE ACTION” 1
1. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
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 the remaining allegations contained in Paragraph 1 of
Plaintiff’s Complaint.
2. Ethicon admits only that it manufactured and supplied
Proceed Ventral Patch for uses consistent with the packaging and
labeling. Johnson & Johnson does not manufacture or supply any
product. Ethicon denies the remaining allegations contained in
Paragraph 2 of Plaintiff’s Complaint.
3. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 3 of
Plaintiff’s Complaint.
4. Ethicon denies the allegations contained in Paragraph 4
of Plaintiff’s Complaint.
5. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it marketed, sold and promoted Proceed Ventral
Patch for uses consistent with the packaging and labeling. Johnson
& Johnson does not market, sell or promote any product. Ethicon
denies the remaining allegations contained in Paragraph 5 of
Plaintiff’s Complaint.
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RESPONSE TO “JURISDICTION & VENUE”
6. Ethicon denies the allegations contained in Paragraph 6
of Plaintiff’s Complaint.
7. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that Ethicon, Inc. manufactured, designed, and
distributed Proceed Ventral Patch 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 manufacture, design, distribute, or warrant any product.
Ethicon is without sufficient knowledge or information so as to
form a belief as to the truth of the remaining allegations
contained in Paragraph 7 of Plaintiff’s Complaint; therefore,
Ethicon denies those allegations.
8. Ethicon admits that Johnson & Johnson is a New Jersey
corporation with its principal place of business located at One
Johnson & Johnson Plaza, New Brunswick, New Jersey. Ethicon admits
further that Johnson & Johnson’s website speaks for itself. Ethicon
denies the remaining allegations contained in Paragraph 8 of
Plaintiff’s Complaint.
9. With respect to the allegations contained in Paragraph
9 of the Complaint, Johnson & Johnson is a holding company for
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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. Ethicon admits that it designed, developed,
manufactured, tested, marketed, promoted, distributed, and sold
certain hernia mesh products for uses consistent with the packaging
and labeling. Ethicon 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. Ethicon denies the remaining allegations contained in
Paragraph 9 of Plaintiff’s Complaint and all allegations
inconsistent with the foregoing.
10. Ethicon admits that it is a New Jersey corporation with
its principal place of business in New Jersey and it is a wholly
owned subsidiary of Johnson & Johnson. Ethicon admits that certain
hernia mesh products, including but not limited to Proceed Ventral
Patch, have been available for purchase in the State of New Jersey.
Ethicon denies the remaining allegations contained in Paragraph 10
of Plaintiff’s Complaint.
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11. Ethicon admits only that it researched, developed,
tested, manufactured, produced, marketed, promoted, and/or sold
certain hernia mesh products, including but not limited to Proceed
Ventral Patch for uses consistent with the packaging and labeling.
Johnson & Johnson does not research, develop, test, manufacture,
produce, market, promote, or sell any product. Ethicon denies the
remaining allegations contained in Paragraph 11 of Plaintiff’s
Complaint.
12. Ethicon admits only that it researched, developed,
tested, manufactured, produced, marketed, promoted, distributed,
and/or sold Proceed Ventral Patch for uses consistent with the
packaging and labeling. Johnson & Johnson does not research,
develop, test, manufacture, produce, market, promote, distribute,
or sell any product. Ethicon denies the remaining allegations
contained in Paragraph 12 of Plaintiff’s Complaint.
13. Ethicon admits only that its Proceed Ventral Patch has
been available for purchase in the State of New Jersey. Ethicon
denies the remaining allegations contained in Paragraph 13 of
Plaintiff’s Complaint.
14. Ethicon admits that it has certain duties imposed on it
by law, but denies that it has breached any duties. Ethicon denies
the remaining allegations contained in Paragraph 14 of Plaintiff’s
Complaint as phrased.
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15. Paragraph 15 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon admits that it designed and
manufactured certain hernia mesh products, including but not
limited to Proceed Ventral Patch, and that they have been available
for purchase in the State of New Jersey. Johnson & Johnson does
not design or manufacture any product. Ethicon admits further that
it and Johnson & Johnson’s principal places of business are located
in New Jersey. Ethicon denies the remaining allegations contained
in Paragraph 15 of Plaintiff’s Complaint, including subparts (a.)
– (d.).
16. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 16 of
Plaintiff’s Complaint.
17. The first two sentences of Paragraph 17 of Plaintiff’s
Complaint make no allegations against Ethicon and require no
response by Ethicon. To the extent a response is required, Ethicon
is without sufficient knowledge or information so as to form a
belief as to the truth of those allegations in Paragraph 17 of
Plaintiff’s Complaint; therefore, Ethicon denies those
allegations. As to the third and fourth sentences of Paragraph 17
of Plaintiff’s Complaint, Ethicon admits only that it and Johnson
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& Johnson are New Jersey corporations with their principal places
of business located in New Jersey. Ethicon is without sufficient
knowledge or information so as to form a belief as to the truth of
the remaining allegations contained in Paragraph 17 of Plaintiff’s
Complaint; therefore, Ethicon denies those factual allegations and
legal conclusions.
18. Ethicon admits only that it designed, manufactured,
marketed, and sold Proceed Ventral Patch for uses consistent with
the packaging and labeling, and that Proceed Ventral Patch 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. Ethicon denies the remaining
allegations contained in Paragraph 18 of Plaintiff’s Complaint.
19. Ethicon admits only that it marketed Proceed Ventral
Patch 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. Ethicon denies the
remaining allegations contained in Paragraph 19 of Plaintiff’s
Complaint.
20. Paragraph 20 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon is without sufficient
knowledge or information so as to form a belief as to the truth of
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the allegations contained in Paragraph 20 of Plaintiff’s
Complaint; therefore, Ethicon denies those allegations.
RESPONSE TO “PROCEED HISTORY”
21. Ethicon admits that it designed, manufactured,
marketed, distributed, and supplied Proceed Ventral Patch for uses
consistent with the packaging and labeling. Johnson & Johnson does
not design, manufacture, market, distribute, or supply any
product. Ethicon denies the remaining allegations contained in
Paragraph 21 of Plaintiff’s Complaint.
22. Ethicon admits only that Proceed Ventral Patch has been
available for purchase in the State of New Jersey. Ethicon denies
the remaining allegations contained in Paragraph 22 of Plaintiff’s
Complaint.
23. Ethicon denies the allegations contained in Paragraph
23 of Plaintiff’s Complaint.
24. Ethicon denies the allegations contained in Paragraph
24 of Plaintiff’s Complaint.
25. Ethicon denies the allegations contained in Paragraph
25 of Plaintiff’s Complaint.
26. Ethicon denies the allegations contained in Paragraph
26 of Plaintiff’s Complaint.
27. Ethicon denies the allegations contained in Paragraph
27 of Plaintiff’s Complaint.
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28. Ethicon denies the allegations contained in Paragraph
28 of Plaintiff’s Complaint.
29. Ethicon admits only that it has certain duties imposed
on it by law, but denies that it breached any duty. Ethicon denies
the remaining allegations contained in Paragraph 29 of Plaintiff’s
Complaint as phrased.
30. Ethicon denies the allegations contained in Paragraph
30 of Plaintiff’s Complaint.
31. Ethicon denies the allegations contained in Paragraph
31 of Plaintiff’s Complaint.
32. Ethicon denies the allegations, including the bulleted
subparts, contained in Paragraph 32 of Plaintiff’s Complaint as
phrased.
33. Ethicon denies the allegations contained in Paragraph
33 of Plaintiff’s Complaint.
34. Ethicon denies the allegations contained in Paragraph
34 of Plaintiff’s Complaint.
35. Ethicon denies the allegations contained in Paragraph
35 of Plaintiff’s Complaint.
36. Ethicon denies the allegations contained in Paragraph
36 of Plaintiff’s Complaint.
37. Ethicon denies the allegations contained in Paragraph
37 of Plaintiff’s Complaint.
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38. Ethicon denies the allegations contained in Paragraph
38 of Plaintiff’s Complaint.
39. Ethicon admits only that its Proceed Ventral Patch
contains polypropylene and that it is a non-absorbable material.
Ethicon denies the remaining allegations contained in Paragraph 39
of Plaintiff’s Complaint as phrased.
40. Ethicon admits that it designed, manufactured,
promoted, sold, and/or marketed Proceed Ventral Patch for uses
consistent with the packaging and labeling. Johnson & Johnson does
not design, manufacture, promote, sell, or market any product.
Ethicon admits further that the Proceed Ventral Patch Instructions
for Use speaks for itself. Ethicon denies the remaining allegations
contained in Paragraph 40 of Plaintiff’s Complaint.
41. Ethicon denies the allegations contained in Paragraph
41 of Plaintiff’s Complaint.
42. Ethicon denies the allegations contained in Paragraph
42 of Plaintiff’s Complaint.
43. Ethicon admits only that it marketed Proceed Ventral
Patch for uses consistent with the packaging and labeling. Johnson
& Johnson does not market any product. Ethicon denies the remaining
allegations contained in Paragraph 43 of Plaintiff’s Complaint.
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RESPONSE TO “FAILURE TO WARN PHYSICIANS OF THE DANGERS
ASSOCIATED WITH ETHICON MULTI-LAYERED HERNIA MESH”
44. Ethicon admits only that it marketed Proceed Ventral
Patch for uses consistent with the packaging and labeling. Johnson
& Johnson does not market any product. Ethicon denies the remaining
allegations contained in Paragraph 44 of Plaintiff’s Complaint.
45. Ethicon admits only that it sold Proceed Ventral Patch
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. Ethicon
denies the remaining allegations contained in Paragraph 45 of
Plaintiff’s Complaint.
46. Ethicon denies the allegations contained in Paragraph
46 of Plaintiff’s Complaint.
47. Ethicon admits only that the Proceed Ventral Patch
Instructions for Use speaks for itself. Ethicon denies the
remaining allegations contained in Paragraph 47 of Plaintiff’s
Complaint.
48. Ethicon admits only that the Proceed Ventral Patch
Instructions for Use speaks for itself. Ethicon denies the
remaining allegations contained in Paragraph 48 of Plaintiff’s
Complaint.
49. Ethicon admits only that the Proceed Ventral Patch
Instructions for Use speaks for itself. Ethicon denies the
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remaining allegations contained in Paragraph 49 of Plaintiff’s
Complaint.
50. Ethicon admits only that the Proceed Ventral Patch
Instructions for Use speaks for itself. Ethicon denies the
remaining allegations contained in Paragraph 50 of Plaintiff’s
Complaint.
51. Ethicon denies the allegations contained in Paragraph
51 of Plaintiff’s Complaint.
52. Ethicon denies the allegations contained in Paragraph
52 of Plaintiff’s Complaint.
53. Ethicon admits only that it tested and marketed Proceed
Ventral Patch for uses consistent with the packaging and labeling.
Johnson & Johnson does not test or market any product. Ethicon
denies the remaining allegations contained in Paragraph 53 of
Plaintiff’s Complaint.
54. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it tested Proceed Ventral Patch for uses
consistent with the packaging and labeling. Johnson & Johnson does
not test any product. Ethicon denies the remaining allegations
contained in Paragraph 54 of Plaintiff’s Complaint.
55. Ethicon denies the allegations contained in Paragraph
55 of Plaintiff’s Complaint.
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56. Ethicon admits that it promoted Proceed Ventral Patch
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. Ethicon
denies the remaining allegations contained in Paragraph 56 of
Plaintiff’s Complaint.
57. Ethicon denies the allegations contained in Paragraph
57 of Plaintiff’s Complaint.
58. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 58 of
Plaintiff’s Complaint.
59. Ethicon admits that it marketed Proceed Ventral Patch
for uses consistent with the packaging and labeling. Johnson &
Johnson does not market any product. Ethicon admits that its
Proceed Ventral Patch is safe and effective for uses consistent
with the packaging and labeling. Ethicon denies the remaining
allegations contained in Paragraph 59 of Plaintiff’s Complaint.
60. Ethicon denies the allegations contained in Paragraph
60 of Plaintiff’s Complaint.
RESPONSE TO “USE OF THE PRODUCT”
61. Ethicon denies the allegations contained in the first
sentence of Paragraph 61 of Plaintiff’s Complaint. Ethicon lacks
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sufficient knowledge or information to know whether Plaintiff Lena
Bryant was treated with any of its products; therefore, Ethicon
denies that allegation. Ethicon is without sufficient knowledge or
information so as to form a belief as to the truth of the remaining
allegations contained in Paragraph 61 of Plaintiff’s Complaint;
therefore, Ethicon denies those allegations.
62. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 62,
including subparts (a.) - (e.), of Plaintiff’s Complaint.
63. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 63 of
Plaintiff’s Complaint.
64. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 64 of
Plaintiff’s Complaint.
65. Ethicon denies the allegations contained in Paragraph
65 of Plaintiff’s Complaint.
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RESPONSE TO “THE FDA’S 510(k) CLEARANCE PROCESS”
66. Paragraph 66 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon lacks sufficient
knowledge or information so as to form a belief as to the truth of
the allegations contained in Paragraph 66 of Plaintiff’s
Complaint; therefore, Ethicon denies those allegations as phrased.
67. Paragraph 67 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon lacks sufficient
knowledge or information so as to form a belief as to the truth of
the allegations contained in Paragraph 67 of Plaintiff’s
Complaint; therefore, Ethicon denies those allegations as phrased.
68. Paragraph 68 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon lacks sufficient
knowledge or information so as to form a belief as to the truth of
the allegations contained in Paragraph 68 of Plaintiff’s
Complaint; therefore, Ethicon denies those allegations as phrased.
69. Paragraph 69 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon lacks sufficient
knowledge or information so as to form a belief as to the truth of
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the allegations contained in Paragraph 69 of Plaintiff’s
Complaint; therefore, Ethicon denies those allegations as phrased.
70. Paragraph 70 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon 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, Ethicon denies those allegations as phrased.
71. Paragraph 71 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon 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, Ethicon denies those allegations as phrased.
72. Paragraph 72 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon 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, Ethicon denies those allegations.
73. Ethicon admits only that the FDA cleared Proceed Ventral
Patch under the 510(k) Premarket Notification. Ethicon denies the
remaining allegations contained in Paragraph 73 of Plaintiff’s
Complaint as phrased.
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74. Paragraph 74 of Plaintiff’s Complaint makes no
allegation against Ethicon and requires no response by Ethicon. To
the extent a response is required, Ethicon admits only that any
document published by the FDA speaks for itself. Ethicon denies
the remaining allegations contained in Paragraph 74 of Plaintiff’s
Complaint.
75. Ethicon admits that the FDA cleared Proceed Ventral
Patch under the 510(k) Premarket Notification. Ethicon admits
further that it marketed Proceed Ventral Patch for uses consistent
with the packaging and labeling. Johnson & Johnson does not market
any product. Ethicon denies the remaining allegations contained in
Paragraph 75 of Plaintiff’s Complaint.
76. Ethicon admits that it marketed Proceed Ventral Patch
for uses consistent with the packaging and labeling. Johnson &
Johnson does not market any product. Ethicon admits further that
the Proceed Ventral Patch Instructions for Use speaks for itself.
Ethicon denies the remaining allegations contained in Paragraph 76
of Plaintiff’s Complaint.
RESPONSE TO “ESTOPPEL FROM PLEADING AND TOLLING OF
APPLICABLE STATUTES OF LIMITATIONS”
77. In response to the first sentence of Paragraph 77 of
Plaintiff’s Complaint, Ethicon incorporates by reference its
responses to each and every allegation contained in Plaintiff’s
Complaint. The second sentence of Paragraph 77 of Plaintiff’s
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Complaint states a legal conclusion and requires no response by
Ethicon. To the extent a response is required, Ethicon denies
the factual allegations and legal conclusions contained in
Paragraph 77 of Plaintiff’s Complaint.
78. Paragraph 78 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the factual allegations and
legal conclusions contained in Paragraph 78 of Plaintiff’s
Complaint.
79. Paragraph 79 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the factual allegations and
legal conclusions contained in Paragraph 79 of Plaintiff’s
Complaint.
80. Paragraph 80 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the allegations contained in
Paragraph 80 of Plaintiff’s Complaint.
81. Paragraph 81 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the factual allegations and
legal conclusion contained in Paragraph 81 of Plaintiff’s
Complaint.
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82. Ethicon denies the allegations contained in Paragraph
82 of Plaintiff’s Complaint.
83. Ethicon denies the allegations contained in Paragraph
83 of Plaintiff’s Complaint.
84. Ethicon denies the allegations contained in Paragraph
84 of Plaintiff’s Complaint.
85. Ethicon denies the allegations contained in Paragraph
85 of Plaintiff’s Complaint.
86. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 86 of
Plaintiff’s Complaint.
87. Ethicon is without sufficient knowledge or information
so as to form a belief as to the truth of the allegations contained
in Paragraph 87 of Plaintiff’s Complaint; therefore, Ethicon
denies those allegations.
88. Ethicon is without sufficient knowledge or information
so as to form a belief as to the truth of the allegations contained
in Paragraph 88 of Plaintiff’s Complaint; therefore, Ethicon
denies those allegations.
89. Ethicon denies the allegations contained in Paragraph
89 of Plaintiff’s Complaint.
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90. Ethicon is without sufficient knowledge or information
so as to form a belief as to the truth of the allegations contained
in Paragraph 90 of Plaintiff’s Complaint; therefore, Ethicon
denies those allegations.
RESPONSE TO “CAUSES OF ACTION PURSUANT TO NEW JERSEY LAW”
RESPONSE TO “COUNT I: PRODUCTS LIABILITY ACT – STRICT PRODUCTS
LIABILITY – DEFECTIVE DESIGN (N.J.S.A. 2A:58C-1, et seq.)”
91. Ethicon incorporates by reference its responses to each
and every allegation contained in Plaintiff’s Complaint.
92. Ethicon admits that it has certain duties imposed on it
by law, but denies that it breached any duty. Ethicon admits that
it manufactured, distributed, marketed, promoted, and sold Proceed
Ventral Patch for uses consistent with the packaging and labeling.
Johnson & Johnson does not manufacture, distribute, market,
promote, or sell any product. Ethicon denies the remaining
allegations contained in Paragraph 92 of Plaintiff’s Complaint.
93. Ethicon admits that it designed, manufactured,
marketed, distributed, and sold Proceed Ventral Patch for uses
consistent with the packaging and labeling. Johnson & Johnson does
not design, manufacture, market, distribute, or sell any product.
Ethicon denies the remaining allegations contained in Paragraph 93
of Plaintiff’s Complaint.
94. Ethicon admits that it manufactured, sold, distributed,
supplied, and/or promoted Proceed Ventral Patch for uses
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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. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 94 of
Plaintiff’s Complaint.
95. Ethicon denies the allegations, including the bulleted
subparts, contained in Paragraph 95 of Plaintiff’s Complaint.
96. Ethicon denies the allegations contained in Paragraph
96 of Plaintiff’s Complaint.
97. Ethicon admits that it designed, manufactured,
marketed, and sold Proceed Ventral Patch 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. Ethicon
lacks sufficient knowledge or information to know whether
Plaintiff Lena Bryant was treated with any of its products;
therefore, Ethicon denies that allegation. Ethicon denies the
remaining allegations contained in Paragraph 97 of Plaintiff’s
Complaint.
98. Ethicon denies the allegations contained in Paragraph
98 of Plaintiff’s Complaint.
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99. Ethicon denies the allegations contained in Paragraph
99 of Plaintiff’s Complaint.
100. Ethicon denies that Plaintiff is entitled to any
recovery or any form of relief whatsoever from Ethicon. Ethicon
denies the remaining allegations contained in Paragraph 100 of
Plaintiff’s Complaint.
101. Paragraph 101 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the factual allegations and
legal conclusions contained in Paragraph 101 of Plaintiff’s
Complaint. Ethicon denies the remaining allegations contained in
Paragraph 101 of Plaintiff’s Complaint.
In response to the unnumbered “WHEREFORE” paragraph following
Paragraph 101 of Plaintiff’s Complaint, Ethicon denies that
Plaintiff is entitled to any recovery or any form of relief
whatsoever from Ethicon. Ethicon denies any remaining allegations
contained in this paragraph.
RESPONSE TO “COUNT II: PRODUCTS LIABILITY ACT – STRICT PRODUCTS
LIABILITY – FAILURE TO WARN (N.J.S.A. 2A:58C-1, et seq.)”
102. Ethicon incorporates by reference its responses to each
and every allegation contained in Plaintiff’s Complaint.
103. Ethicon admits that it researched, developed, designed,
tested, manufactured, distributed, marketed, promoted, and sold
Proceed Ventral Patch for uses consistent with the packaging and
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labeling. Johnson & Johnson does not research, develop, design,
test, manufacture, inspect, label, distribute, market, promote, or
sell any product. Ethicon lacks sufficient knowledge or
information to know whether Plaintiff Lena Bryant was treated with
any of its products; therefore, Ethicon denies that allegation.
Ethicon admits further that it has certain duties imposed on it by
law but denies that it breached any duty. Ethicon denies the
remaining allegations contained in Paragraph 103 of Plaintiff’s
Complaint.
104. Ethicon admits only that it distributed and sold Proceed
Ventral Patch for uses consistent with the packaging and labeling.
Johnson & Johnson does not distribute or sell any product. Ethicon
denies the remaining allegations contained in Paragraph 104 of
Plaintiff’s Complaint.
105. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it manufactured and sold Proceed Ventral Patch
for uses consistent with the packaging and labeling. Johnson &
Johnson does not manufacture or sell any product. Ethicon denies
the remaining allegations contained in Paragraph 105 of
Plaintiff’s Complaint.
106. Ethicon denies the allegations contained in Paragraph
106 of Plaintiff’s Complaint.
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107. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 107 of
Plaintiff’s Complaint.
108. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it sold Proceed Ventral Patch for uses consistent
with the packaging and labeling. Johnson & Johnson does not sell
any product. Ethicon denies the remaining allegations contained in
Paragraph 108 of Plaintiff’s Complaint.
109. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 109 of
Plaintiff’s Complaint.
110. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 110 of
Plaintiff’s Complaint.
111. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
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products; therefore, Ethicon denies that allegation. Ethicon
admits that its Proceed Ventral Patch is safe and effective for
uses consistent with the packaging and labeling. Ethicon denies
the remaining allegations contained in Paragraph 111 of
Plaintiff’s Complaint.
112. Ethicon admits that its Proceed Ventral Patch is safe
and effective for uses consistent with the packaging and labeling.
Ethicon denies the remaining allegations contained in Paragraph
112 of Plaintiff’s Complaint.
113. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it researched, developed, designed, tested,
manufactured, distributed, marketed, promoted, and sold Proceed
Ventral Patch 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. Ethicon denies the remaining allegations contained in
Paragraph 113 of Plaintiff’s Complaint.
114. Ethicon admits only that it researched, developed,
designed, tested, manufactured, distributed, marketed, promoted,
and sold Proceed Ventral Patch for uses consistent with the
packaging and labeling. Johnson & Johnson does not research,
develop, design, test, manufacture, inspect, label, distribute,
25
ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 26 of 54 Trans ID: LCV20223784378
market, promote, or sell any product. Ethicon denies the remaining
allegations contained in Paragraph 114 of Plaintiff’s Complaint.
115. Ethicon denies the allegations contained in Paragraph
115 of Plaintiff’s Complaint.
116. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it sold Proceed Ventral Patch for uses consistent
with the packaging and labeling. Johnson & Johnson does not sell
any product. Ethicon denies the remaining allegations contained in
Paragraph 116 of Plaintiff’s Complaint.
117. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 117 of
Plaintiff’s Complaint.
118. Ethicon denies the allegations contained in Paragraph
118 of Plaintiff’s Complaint.
119. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 119 of
Plaintiff’s Complaint.
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120. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 120 of
Plaintiff’s Complaint.
121. Ethicon denies the allegations contained in Paragraph
121 of Plaintiff’s Complaint.
122. Paragraph 122 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the factual allegations and
legal conclusions contained in Paragraph 122 of Plaintiff’s
Complaint.
In response to the unnumbered “WHEREFORE” paragraph following
Paragraph 122 of Plaintiff’s Complaint, Ethicon denies that
Plaintiff is entitled to any recovery or any form of relief
whatsoever from Ethicon. Ethicon denies any remaining allegations
contained in this paragraph.
RESPONSE TO “COUNT III: PRODUCTS LIABILITY ACT – STRICT PRODUCTS
LIABILITY – MANUFACTURING DEFECT (N.J.S.A. 2A:58C-1, et seq.)”
123. Ethicon incorporates by reference its responses to each
and every allegation contained in Plaintiff’s Complaint.
124. Ethicon admits only that it designed, developed,
manufactured, tested, promoted, marketed, distributed and sold
Proceed Ventral Patch for uses consistent with the packaging and
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labeling. Johnson & Johnson does not design, develop, manufacture,
test, package, advertise, promote, market, distribute, label, or
sell any product. Ethicon denies the remaining allegations
contained in Paragraph 124 of Plaintiff’s Complaint.
125. Ethicon admits only that it manufactured and marketed
Proceed Ventral Patch for uses consistent with the packaging and
labeling. Johnson & Johnson does not manufacture or market any
product. Ethicon admits that its Proceed Ventral Patch is safe and
effective for uses consistent with the packaging and labeling.
Ethicon denies the remaining allegations contained in Paragraph
125 of Plaintiff’s Complaint.
126. Ethicon denies the allegations contained in Paragraph
126 of Plaintiff’s Complaint.
127. Paragraph 127 of Plaintiff’s Complaint states a legal
conclusion and requires no response by Ethicon. To the extent a
response is required, Ethicon denies the factual allegations and
legal conclusions contained in Paragraph 127 of Plaintiff’s
Complaint.
In response to the unnumbered “WHEREFORE” paragraph following
Paragraph 127 of Plaintiff’s Complaint, Ethicon denies that
Plaintiff is entitled to any recovery or any form of relief
whatsoever from Ethicon. Ethicon denies any remaining allegations
contained in this paragraph.
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RESPONSE TO “COUNT IV: BREACH OF IMPLIED WARRANTY”
128. Ethicon incorporates by reference its responses to each
and every allegation contained in Plaintiff’s Complaint.
129. Ethicon admits that it designed, manufactured,
produced, tested, marketed, sold, promoted, and distributed
Proceed Ventral Patch 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. Ethicon lacks
sufficient knowledge or information to know whether Plaintiff Lena
Bryant was treated with any of its products; therefore, Ethicon
denies that allegation. Ethicon denies the remaining allegations
contained in Paragraph 129 of Plaintiff’s Complaint.
130. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it sold Proceed Ventral Patch for uses consistent
with the packaging and labeling. Johnson & Johnson does not sell
any product. Ethicon denies the remaining allegations contained in
Paragraph 130 of Plaintiff’s Complaint.
131. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
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denies the remaining allegations contained in Paragraph 131 of
Plaintiff’s Complaint.
132. Ethicon admits that its Proceed Ventral Patch is safe
and effective for uses consistent with the packaging and labeling.
Ethicon denies the remaining allegations contained in Paragraph
132 of Plaintiff’s Complaint.
133. Ethicon denies the allegations contained in Paragraph
133 of Plaintiff’s Complaint.
In response to the unnumbered “WHEREFORE” paragraph following
Paragraph 133 of Plaintiff’s Complaint, Ethicon denies that
Plaintiff is entitled to any recovery or any form of relief
whatsoever from Ethicon. Ethicon denies any remaining allegations
contained in this paragraph.
RESPONSE TO “COUNT V: BREACH OF EXPRESS WARRANTY”
134. Ethicon incorporates by reference its responses to each
and every allegation contained in Plaintiff’s Complaint.
135. Ethicon admits that it manufactured, distributed,
promoted, and sold Proceed Ventral Patch for uses consistent with
the packaging and labeling. Johnson & Johnson does not manufacture,
distribute, promote, or sell any product. Ethicon denies the
remaining allegations contained in Paragraph 135 of Plaintiff’s
Complaint.
136. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
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products; therefore, Ethicon denies that allegation. Ethicon
admits that it sold Proceed Ventral Patch 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. Ethicon denies the remaining
allegations contained in Paragraph 136 of Plaintiff’s Complaint.
137. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
denies the remaining allegations contained in Paragraph 137 of
Plaintiff’s Complaint.
138. Ethicon denies the allegations contained in Paragraph
138 of Plaintiff’s Complaint.
139. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it manufactured and sold Proceed Ventral Patch
for uses consistent with the packaging and labeling. Johnson &
Johnson does not manufacture or sell any product. Ethicon denies
the remaining allegations contained in Paragraph 139 of
Plaintiff’s Complaint.
140. Ethicon denies the allegations, including the bulleted
subparts, contained in Paragraph 140 of Plaintiff’s Complaint.
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141. Ethicon lacks sufficient knowledge or information to
know whether Plaintiff Lena Bryant was treated with any of its
products; therefore, Ethicon denies that allegation. Ethicon
admits only that it promoted and marketed Proceed Ventral Patch
for uses consistent with the packaging and labeling. Johnson &
Johnson does not promote or market any product. Ethicon denies the
remaining allegations contained in Paragraph 141 of Plaintiff’s
Complaint.
142. Ethicon admits that its Proceed Ventral Patch is safe
and effective for uses consistent with the packaging and labeling.
Ethicon denies the remaining allegations contained in Paragraph
142 of Plaintiff’s Complaint.
143. Ethicon denies the allegations contained in Paragraph
143 of Plaintiff’s Complaint.
144. Ethicon admits that its Proceed Ventral Patch is safe
and e
Preview
ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 1 of 54 Trans ID: LCV20223784378 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) SUPERIOR COURT OF NEW JERSEY LENA BRYANT, LAW DIVISION - ATLANTIC COUNTY DOCKET NO. ATL-L-002600-22 Plaintiff, v. CIVIL ACTION JOHNSON & JOHNSON and ETHICON, ANSWER TO COMPLAINT, SEPARATE INC., DEFENSES, AND JURY DEMAND OF DEFENDANT ETHICON, INC. Defendants. Defendant Ethicon, Inc. (“Ethicon”), by and through its attorneys, responds to Plaintiff’s Complaint and Jury Demand (“Complaint”) as follows. RESPONSE TO “NATURE OF THE ACTION” 1 1. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon 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. ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 2 of 54 Trans ID: LCV20223784378 denies the remaining allegations contained in Paragraph 1 of Plaintiff’s Complaint. 2. Ethicon admits only that it manufactured and supplied Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or supply any product. Ethicon denies the remaining allegations contained in Paragraph 2 of Plaintiff’s Complaint. 3. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 3 of Plaintiff’s Complaint. 4. Ethicon denies the allegations contained in Paragraph 4 of Plaintiff’s Complaint. 5. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it marketed, sold and promoted Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not market, sell or promote any product. Ethicon denies the remaining allegations contained in Paragraph 5 of Plaintiff’s Complaint. 2 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 3 of 54 Trans ID: LCV20223784378 RESPONSE TO “JURISDICTION & VENUE” 6. Ethicon denies the allegations contained in Paragraph 6 of Plaintiff’s Complaint. 7. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that Ethicon, Inc. manufactured, designed, and distributed Proceed Ventral Patch 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 manufacture, design, distribute, or warrant any product. Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of the remaining allegations contained in Paragraph 7 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. 8. Ethicon admits that Johnson & Johnson is a New Jersey corporation with its principal place of business located at One Johnson & Johnson Plaza, New Brunswick, New Jersey. Ethicon admits further that Johnson & Johnson’s website speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 8 of Plaintiff’s Complaint. 9. With respect to the allegations contained in Paragraph 9 of the Complaint, Johnson & Johnson is a holding company for 3 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 4 of 54 Trans ID: LCV20223784378 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. Ethicon admits that it designed, developed, manufactured, tested, marketed, promoted, distributed, and sold certain hernia mesh products for uses consistent with the packaging and labeling. Ethicon 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. Ethicon denies the remaining allegations contained in Paragraph 9 of Plaintiff’s Complaint and all allegations inconsistent with the foregoing. 10. Ethicon admits that it is a New Jersey corporation with its principal place of business in New Jersey and it is a wholly owned subsidiary of Johnson & Johnson. Ethicon admits that certain hernia mesh products, including but not limited to Proceed Ventral Patch, have been available for purchase in the State of New Jersey. Ethicon denies the remaining allegations contained in Paragraph 10 of Plaintiff’s Complaint. 4 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 5 of 54 Trans ID: LCV20223784378 11. Ethicon admits only that it researched, developed, tested, manufactured, produced, marketed, promoted, and/or sold certain hernia mesh products, including but not limited to Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, test, manufacture, produce, market, promote, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 11 of Plaintiff’s Complaint. 12. Ethicon admits only that it researched, developed, tested, manufactured, produced, marketed, promoted, distributed, and/or sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, test, manufacture, produce, market, promote, distribute, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 12 of Plaintiff’s Complaint. 13. Ethicon admits only that its Proceed Ventral Patch has been available for purchase in the State of New Jersey. Ethicon denies the remaining allegations contained in Paragraph 13 of Plaintiff’s Complaint. 14. Ethicon admits that it has certain duties imposed on it by law, but denies that it has breached any duties. Ethicon denies the remaining allegations contained in Paragraph 14 of Plaintiff’s Complaint as phrased. 5 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 6 of 54 Trans ID: LCV20223784378 15. Paragraph 15 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon admits that it designed and manufactured certain hernia mesh products, including but not limited to Proceed Ventral Patch, and that they have been available for purchase in the State of New Jersey. Johnson & Johnson does not design or manufacture any product. Ethicon admits further that it and Johnson & Johnson’s principal places of business are located in New Jersey. Ethicon denies the remaining allegations contained in Paragraph 15 of Plaintiff’s Complaint, including subparts (a.) – (d.). 16. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 16 of Plaintiff’s Complaint. 17. The first two sentences of Paragraph 17 of Plaintiff’s Complaint make no allegations against Ethicon and require no response by Ethicon. To the extent a response is required, Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of those allegations in Paragraph 17 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. As to the third and fourth sentences of Paragraph 17 of Plaintiff’s Complaint, Ethicon admits only that it and Johnson 6 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 7 of 54 Trans ID: LCV20223784378 & Johnson are New Jersey corporations with their principal places of business located in New Jersey. Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of the remaining allegations contained in Paragraph 17 of Plaintiff’s Complaint; therefore, Ethicon denies those factual allegations and legal conclusions. 18. Ethicon admits only that it designed, manufactured, marketed, and sold Proceed Ventral Patch for uses consistent with the packaging and labeling, and that Proceed Ventral Patch 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. Ethicon denies the remaining allegations contained in Paragraph 18 of Plaintiff’s Complaint. 19. Ethicon admits only that it marketed Proceed Ventral Patch 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. Ethicon denies the remaining allegations contained in Paragraph 19 of Plaintiff’s Complaint. 20. Paragraph 20 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of 7 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 8 of 54 Trans ID: LCV20223784378 the allegations contained in Paragraph 20 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. RESPONSE TO “PROCEED HISTORY” 21. Ethicon admits that it designed, manufactured, marketed, distributed, and supplied Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, market, distribute, or supply any product. Ethicon denies the remaining allegations contained in Paragraph 21 of Plaintiff’s Complaint. 22. Ethicon admits only that Proceed Ventral Patch has been available for purchase in the State of New Jersey. Ethicon denies the remaining allegations contained in Paragraph 22 of Plaintiff’s Complaint. 23. Ethicon denies the allegations contained in Paragraph 23 of Plaintiff’s Complaint. 24. Ethicon denies the allegations contained in Paragraph 24 of Plaintiff’s Complaint. 25. Ethicon denies the allegations contained in Paragraph 25 of Plaintiff’s Complaint. 26. Ethicon denies the allegations contained in Paragraph 26 of Plaintiff’s Complaint. 27. Ethicon denies the allegations contained in Paragraph 27 of Plaintiff’s Complaint. 8 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 9 of 54 Trans ID: LCV20223784378 28. Ethicon denies the allegations contained in Paragraph 28 of Plaintiff’s Complaint. 29. Ethicon admits only that it has certain duties imposed on it by law, but denies that it breached any duty. Ethicon denies the remaining allegations contained in Paragraph 29 of Plaintiff’s Complaint as phrased. 30. Ethicon denies the allegations contained in Paragraph 30 of Plaintiff’s Complaint. 31. Ethicon denies the allegations contained in Paragraph 31 of Plaintiff’s Complaint. 32. Ethicon denies the allegations, including the bulleted subparts, contained in Paragraph 32 of Plaintiff’s Complaint as phrased. 33. Ethicon denies the allegations contained in Paragraph 33 of Plaintiff’s Complaint. 34. Ethicon denies the allegations contained in Paragraph 34 of Plaintiff’s Complaint. 35. Ethicon denies the allegations contained in Paragraph 35 of Plaintiff’s Complaint. 36. Ethicon denies the allegations contained in Paragraph 36 of Plaintiff’s Complaint. 37. Ethicon denies the allegations contained in Paragraph 37 of Plaintiff’s Complaint. 9 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 10 of 54 Trans ID: LCV20223784378 38. Ethicon denies the allegations contained in Paragraph 38 of Plaintiff’s Complaint. 39. Ethicon admits only that its Proceed Ventral Patch contains polypropylene and that it is a non-absorbable material. Ethicon denies the remaining allegations contained in Paragraph 39 of Plaintiff’s Complaint as phrased. 40. Ethicon admits that it designed, manufactured, promoted, sold, and/or marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, promote, sell, or market any product. Ethicon admits further that the Proceed Ventral Patch Instructions for Use speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 40 of Plaintiff’s Complaint. 41. Ethicon denies the allegations contained in Paragraph 41 of Plaintiff’s Complaint. 42. Ethicon denies the allegations contained in Paragraph 42 of Plaintiff’s Complaint. 43. Ethicon admits only that it marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Ethicon denies the remaining allegations contained in Paragraph 43 of Plaintiff’s Complaint. 10 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 11 of 54 Trans ID: LCV20223784378 RESPONSE TO “FAILURE TO WARN PHYSICIANS OF THE DANGERS ASSOCIATED WITH ETHICON MULTI-LAYERED HERNIA MESH” 44. Ethicon admits only that it marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Ethicon denies the remaining allegations contained in Paragraph 44 of Plaintiff’s Complaint. 45. Ethicon admits only that it sold Proceed Ventral Patch 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. Ethicon denies the remaining allegations contained in Paragraph 45 of Plaintiff’s Complaint. 46. Ethicon denies the allegations contained in Paragraph 46 of Plaintiff’s Complaint. 47. Ethicon admits only that the Proceed Ventral Patch Instructions for Use speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 47 of Plaintiff’s Complaint. 48. Ethicon admits only that the Proceed Ventral Patch Instructions for Use speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 48 of Plaintiff’s Complaint. 49. Ethicon admits only that the Proceed Ventral Patch Instructions for Use speaks for itself. Ethicon denies the 11 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 12 of 54 Trans ID: LCV20223784378 remaining allegations contained in Paragraph 49 of Plaintiff’s Complaint. 50. Ethicon admits only that the Proceed Ventral Patch Instructions for Use speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 50 of Plaintiff’s Complaint. 51. Ethicon denies the allegations contained in Paragraph 51 of Plaintiff’s Complaint. 52. Ethicon denies the allegations contained in Paragraph 52 of Plaintiff’s Complaint. 53. Ethicon admits only that it tested and marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not test or market any product. Ethicon denies the remaining allegations contained in Paragraph 53 of Plaintiff’s Complaint. 54. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it tested Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not test any product. Ethicon denies the remaining allegations contained in Paragraph 54 of Plaintiff’s Complaint. 55. Ethicon denies the allegations contained in Paragraph 55 of Plaintiff’s Complaint. 12 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 13 of 54 Trans ID: LCV20223784378 56. Ethicon admits that it promoted Proceed Ventral Patch 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. Ethicon denies the remaining allegations contained in Paragraph 56 of Plaintiff’s Complaint. 57. Ethicon denies the allegations contained in Paragraph 57 of Plaintiff’s Complaint. 58. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 58 of Plaintiff’s Complaint. 59. Ethicon admits that it marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Ethicon admits that its Proceed Ventral Patch is safe and effective for uses consistent with the packaging and labeling. Ethicon denies the remaining allegations contained in Paragraph 59 of Plaintiff’s Complaint. 60. Ethicon denies the allegations contained in Paragraph 60 of Plaintiff’s Complaint. RESPONSE TO “USE OF THE PRODUCT” 61. Ethicon denies the allegations contained in the first sentence of Paragraph 61 of Plaintiff’s Complaint. Ethicon lacks 13 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 14 of 54 Trans ID: LCV20223784378 sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of the remaining allegations contained in Paragraph 61 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. 62. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 62, including subparts (a.) - (e.), of Plaintiff’s Complaint. 63. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 63 of Plaintiff’s Complaint. 64. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 64 of Plaintiff’s Complaint. 65. Ethicon denies the allegations contained in Paragraph 65 of Plaintiff’s Complaint. 14 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 15 of 54 Trans ID: LCV20223784378 RESPONSE TO “THE FDA’S 510(k) CLEARANCE PROCESS” 66. Paragraph 66 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 66 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations as phrased. 67. Paragraph 67 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 67 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations as phrased. 68. Paragraph 68 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 68 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations as phrased. 69. Paragraph 69 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks sufficient knowledge or information so as to form a belief as to the truth of 15 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 16 of 54 Trans ID: LCV20223784378 the allegations contained in Paragraph 69 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations as phrased. 70. Paragraph 70 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon 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, Ethicon denies those allegations as phrased. 71. Paragraph 71 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon 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, Ethicon denies those allegations as phrased. 72. Paragraph 72 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon 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, Ethicon denies those allegations. 73. Ethicon admits only that the FDA cleared Proceed Ventral Patch under the 510(k) Premarket Notification. Ethicon denies the remaining allegations contained in Paragraph 73 of Plaintiff’s Complaint as phrased. 16 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 17 of 54 Trans ID: LCV20223784378 74. Paragraph 74 of Plaintiff’s Complaint makes no allegation against Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon admits only that any document published by the FDA speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 74 of Plaintiff’s Complaint. 75. Ethicon admits that the FDA cleared Proceed Ventral Patch under the 510(k) Premarket Notification. Ethicon admits further that it marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Ethicon denies the remaining allegations contained in Paragraph 75 of Plaintiff’s Complaint. 76. Ethicon admits that it marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not market any product. Ethicon admits further that the Proceed Ventral Patch Instructions for Use speaks for itself. Ethicon denies the remaining allegations contained in Paragraph 76 of Plaintiff’s Complaint. RESPONSE TO “ESTOPPEL FROM PLEADING AND TOLLING OF APPLICABLE STATUTES OF LIMITATIONS” 77. In response to the first sentence of Paragraph 77 of Plaintiff’s Complaint, Ethicon incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. The second sentence of Paragraph 77 of Plaintiff’s 17 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 18 of 54 Trans ID: LCV20223784378 Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusions contained in Paragraph 77 of Plaintiff’s Complaint. 78. Paragraph 78 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusions contained in Paragraph 78 of Plaintiff’s Complaint. 79. Paragraph 79 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusions contained in Paragraph 79 of Plaintiff’s Complaint. 80. Paragraph 80 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the allegations contained in Paragraph 80 of Plaintiff’s Complaint. 81. Paragraph 81 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusion contained in Paragraph 81 of Plaintiff’s Complaint. 18 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 19 of 54 Trans ID: LCV20223784378 82. Ethicon denies the allegations contained in Paragraph 82 of Plaintiff’s Complaint. 83. Ethicon denies the allegations contained in Paragraph 83 of Plaintiff’s Complaint. 84. Ethicon denies the allegations contained in Paragraph 84 of Plaintiff’s Complaint. 85. Ethicon denies the allegations contained in Paragraph 85 of Plaintiff’s Complaint. 86. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 86 of Plaintiff’s Complaint. 87. Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 87 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. 88. Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 88 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. 89. Ethicon denies the allegations contained in Paragraph 89 of Plaintiff’s Complaint. 19 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 20 of 54 Trans ID: LCV20223784378 90. Ethicon is without sufficient knowledge or information so as to form a belief as to the truth of the allegations contained in Paragraph 90 of Plaintiff’s Complaint; therefore, Ethicon denies those allegations. RESPONSE TO “CAUSES OF ACTION PURSUANT TO NEW JERSEY LAW” RESPONSE TO “COUNT I: PRODUCTS LIABILITY ACT – STRICT PRODUCTS LIABILITY – DEFECTIVE DESIGN (N.J.S.A. 2A:58C-1, et seq.)” 91. Ethicon incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 92. Ethicon admits that it has certain duties imposed on it by law, but denies that it breached any duty. Ethicon admits that it manufactured, distributed, marketed, promoted, and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture, distribute, market, promote, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 92 of Plaintiff’s Complaint. 93. Ethicon admits that it designed, manufactured, marketed, distributed, and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not design, manufacture, market, distribute, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 93 of Plaintiff’s Complaint. 94. Ethicon admits that it manufactured, sold, distributed, supplied, and/or promoted Proceed Ventral Patch for uses 20 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 21 of 54 Trans ID: LCV20223784378 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. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 94 of Plaintiff’s Complaint. 95. Ethicon denies the allegations, including the bulleted subparts, contained in Paragraph 95 of Plaintiff’s Complaint. 96. Ethicon denies the allegations contained in Paragraph 96 of Plaintiff’s Complaint. 97. Ethicon admits that it designed, manufactured, marketed, and sold Proceed Ventral Patch 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. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 97 of Plaintiff’s Complaint. 98. Ethicon denies the allegations contained in Paragraph 98 of Plaintiff’s Complaint. 21 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 22 of 54 Trans ID: LCV20223784378 99. Ethicon denies the allegations contained in Paragraph 99 of Plaintiff’s Complaint. 100. Ethicon denies that Plaintiff is entitled to any recovery or any form of relief whatsoever from Ethicon. Ethicon denies the remaining allegations contained in Paragraph 100 of Plaintiff’s Complaint. 101. Paragraph 101 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusions contained in Paragraph 101 of Plaintiff’s Complaint. Ethicon denies the remaining allegations contained in Paragraph 101 of Plaintiff’s Complaint. In response to the unnumbered “WHEREFORE” paragraph following Paragraph 101 of Plaintiff’s Complaint, Ethicon denies that Plaintiff is entitled to any recovery or any form of relief whatsoever from Ethicon. Ethicon denies any remaining allegations contained in this paragraph. RESPONSE TO “COUNT II: PRODUCTS LIABILITY ACT – STRICT PRODUCTS LIABILITY – FAILURE TO WARN (N.J.S.A. 2A:58C-1, et seq.)” 102. Ethicon incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 103. Ethicon admits that it researched, developed, designed, tested, manufactured, distributed, marketed, promoted, and sold Proceed Ventral Patch for uses consistent with the packaging and 22 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 23 of 54 Trans ID: LCV20223784378 labeling. Johnson & Johnson does not research, develop, design, test, manufacture, inspect, label, distribute, market, promote, or sell any product. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits further that it has certain duties imposed on it by law but denies that it breached any duty. Ethicon denies the remaining allegations contained in Paragraph 103 of Plaintiff’s Complaint. 104. Ethicon admits only that it distributed and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not distribute or sell any product. Ethicon denies the remaining allegations contained in Paragraph 104 of Plaintiff’s Complaint. 105. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it manufactured and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or sell any product. Ethicon denies the remaining allegations contained in Paragraph 105 of Plaintiff’s Complaint. 106. Ethicon denies the allegations contained in Paragraph 106 of Plaintiff’s Complaint. 23 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 24 of 54 Trans ID: LCV20223784378 107. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 107 of Plaintiff’s Complaint. 108. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Ethicon denies the remaining allegations contained in Paragraph 108 of Plaintiff’s Complaint. 109. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 109 of Plaintiff’s Complaint. 110. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 110 of Plaintiff’s Complaint. 111. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its 24 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 25 of 54 Trans ID: LCV20223784378 products; therefore, Ethicon denies that allegation. Ethicon admits that its Proceed Ventral Patch is safe and effective for uses consistent with the packaging and labeling. Ethicon denies the remaining allegations contained in Paragraph 111 of Plaintiff’s Complaint. 112. Ethicon admits that its Proceed Ventral Patch is safe and effective for uses consistent with the packaging and labeling. Ethicon denies the remaining allegations contained in Paragraph 112 of Plaintiff’s Complaint. 113. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it researched, developed, designed, tested, manufactured, distributed, marketed, promoted, and sold Proceed Ventral Patch 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. Ethicon denies the remaining allegations contained in Paragraph 113 of Plaintiff’s Complaint. 114. Ethicon admits only that it researched, developed, designed, tested, manufactured, distributed, marketed, promoted, and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not research, develop, design, test, manufacture, inspect, label, distribute, 25 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 26 of 54 Trans ID: LCV20223784378 market, promote, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 114 of Plaintiff’s Complaint. 115. Ethicon denies the allegations contained in Paragraph 115 of Plaintiff’s Complaint. 116. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Ethicon denies the remaining allegations contained in Paragraph 116 of Plaintiff’s Complaint. 117. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 117 of Plaintiff’s Complaint. 118. Ethicon denies the allegations contained in Paragraph 118 of Plaintiff’s Complaint. 119. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 119 of Plaintiff’s Complaint. 26 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 27 of 54 Trans ID: LCV20223784378 120. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 120 of Plaintiff’s Complaint. 121. Ethicon denies the allegations contained in Paragraph 121 of Plaintiff’s Complaint. 122. Paragraph 122 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusions contained in Paragraph 122 of Plaintiff’s Complaint. In response to the unnumbered “WHEREFORE” paragraph following Paragraph 122 of Plaintiff’s Complaint, Ethicon denies that Plaintiff is entitled to any recovery or any form of relief whatsoever from Ethicon. Ethicon denies any remaining allegations contained in this paragraph. RESPONSE TO “COUNT III: PRODUCTS LIABILITY ACT – STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT (N.J.S.A. 2A:58C-1, et seq.)” 123. Ethicon incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 124. Ethicon admits only that it designed, developed, manufactured, tested, promoted, marketed, distributed and sold Proceed Ventral Patch for uses consistent with the packaging and 27 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 28 of 54 Trans ID: LCV20223784378 labeling. Johnson & Johnson does not design, develop, manufacture, test, package, advertise, promote, market, distribute, label, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 124 of Plaintiff’s Complaint. 125. Ethicon admits only that it manufactured and marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or market any product. Ethicon admits that its Proceed Ventral Patch is safe and effective for uses consistent with the packaging and labeling. Ethicon denies the remaining allegations contained in Paragraph 125 of Plaintiff’s Complaint. 126. Ethicon denies the allegations contained in Paragraph 126 of Plaintiff’s Complaint. 127. Paragraph 127 of Plaintiff’s Complaint states a legal conclusion and requires no response by Ethicon. To the extent a response is required, Ethicon denies the factual allegations and legal conclusions contained in Paragraph 127 of Plaintiff’s Complaint. In response to the unnumbered “WHEREFORE” paragraph following Paragraph 127 of Plaintiff’s Complaint, Ethicon denies that Plaintiff is entitled to any recovery or any form of relief whatsoever from Ethicon. Ethicon denies any remaining allegations contained in this paragraph. 28 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 29 of 54 Trans ID: LCV20223784378 RESPONSE TO “COUNT IV: BREACH OF IMPLIED WARRANTY” 128. Ethicon incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 129. Ethicon admits that it designed, manufactured, produced, tested, marketed, sold, promoted, and distributed Proceed Ventral Patch 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. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 129 of Plaintiff’s Complaint. 130. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not sell any product. Ethicon denies the remaining allegations contained in Paragraph 130 of Plaintiff’s Complaint. 131. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon 29 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 30 of 54 Trans ID: LCV20223784378 denies the remaining allegations contained in Paragraph 131 of Plaintiff’s Complaint. 132. Ethicon admits that its Proceed Ventral Patch is safe and effective for uses consistent with the packaging and labeling. Ethicon denies the remaining allegations contained in Paragraph 132 of Plaintiff’s Complaint. 133. Ethicon denies the allegations contained in Paragraph 133 of Plaintiff’s Complaint. In response to the unnumbered “WHEREFORE” paragraph following Paragraph 133 of Plaintiff’s Complaint, Ethicon denies that Plaintiff is entitled to any recovery or any form of relief whatsoever from Ethicon. Ethicon denies any remaining allegations contained in this paragraph. RESPONSE TO “COUNT V: BREACH OF EXPRESS WARRANTY” 134. Ethicon incorporates by reference its responses to each and every allegation contained in Plaintiff’s Complaint. 135. Ethicon admits that it manufactured, distributed, promoted, and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture, distribute, promote, or sell any product. Ethicon denies the remaining allegations contained in Paragraph 135 of Plaintiff’s Complaint. 136. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its 30 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 31 of 54 Trans ID: LCV20223784378 products; therefore, Ethicon denies that allegation. Ethicon admits that it sold Proceed Ventral Patch 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. Ethicon denies the remaining allegations contained in Paragraph 136 of Plaintiff’s Complaint. 137. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon denies the remaining allegations contained in Paragraph 137 of Plaintiff’s Complaint. 138. Ethicon denies the allegations contained in Paragraph 138 of Plaintiff’s Complaint. 139. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it manufactured and sold Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not manufacture or sell any product. Ethicon denies the remaining allegations contained in Paragraph 139 of Plaintiff’s Complaint. 140. Ethicon denies the allegations, including the bulleted subparts, contained in Paragraph 140 of Plaintiff’s Complaint. 31 ATL-L-002600-22 10/28/2022 2:05:37 PM Pg 32 of 54 Trans ID: LCV20223784378 141. Ethicon lacks sufficient knowledge or information to know whether Plaintiff Lena Bryant was treated with any of its products; therefore, Ethicon denies that allegation. Ethicon admits only that it promoted and marketed Proceed Ventral Patch for uses consistent with the packaging and labeling. Johnson & Johnson does not promote or market any product. Ethicon denies the remaining allegations contained in Paragraph 141 of Plaintiff’s Complaint. 142. Ethicon admits that its Proceed Ventral Patch is safe and effective for uses consistent with the packaging and labeling. Ethicon denies the remaining allegations contained in Paragraph 142 of Plaintiff’s Complaint. 143. Ethicon denies the allegations contained in Paragraph 143 of Plaintiff’s Complaint. 144. Ethicon admits that its Proceed Ventral Patch is safe and e