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UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF OHIO 

IN RE: DAVOL, INC./C.R. BARD, 

INC., POLYPROPYLENE HERNIA 

MESH PRODUCTS LIABILITY 

LITIGATION 

Case No. 2:18-md-2846 

CHIEF JUDGE EDMUND A. SARGUS, JR. 

Magistrate Judge Kimberly A. Jolson 

This document relates to: 

ALL CASES 

ANSWER AND DEFENSES OF 

DEFENDANTS DAVOL INC. AND C. R. BARD, INC. TO 

MASTER LONG FORM COMPLAINT 

Defendants Davol Inc. and C. R. Bard, Inc., (“Defendants”) by and through counsel, 

answer the Master Long Form Complaint (the “Master Complaint”) as follows: 

I. PARTIES 

PLAINTIFFS 

1. Paragraph 1 of the Master Complaint contains allegations regarding parties other 

than Defendants to which no response is required. To the extent that a response is required, 

Defendants lack sufficient knowledge or information to form a belief as to the truth of the 

allegations in Paragraph 1 of the Master Complaint and therefore deny the same. 

2. Paragraph 2 of the Master Complaint contains allegations regarding parties other 

than Defendants to which no response is required. To the extent that a response is required, 

Defendants lack sufficient knowledge or information to form a belief as to the truth of the 

allegations in Paragraph 2 of the Master Complaint and therefore deny the same. 

DEFENDANTS 

3. Davol Inc. (“Davol”) admits that it is a subsidiary of C. R. Bard, Inc. (“Bard”). 

Davol also admits that it is incorporated in Delaware with its principal place of business in 

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Rhode Island. Davol admits that it focuses its business on products in key surgical specialties, 

including hernia repair, hemostasis, orthopedics, and laparoscopy. Davol further admits that it 

conducts, at certain times, design, limited manufacturing, marketing, and sale of its products. 

Davol does not know what is meant by “research,” “development,” “testing,” “production,” and 

“promotion” beyond the meanings of design, manufacturing, marketing, and sale, which have 

been addressed above. Davol denies the remaining allegations as phrased. 

4. Davol denies Paragraph 4 of the Master Complaint as phrased. Davol further 

states that at certain timed it conduced limited manufacturing of some of its hernia repair 

products in Rhode Island. 

5. Davol admits that it has communicated with the FDA related to its hernia repair 

products and that some of those communications may have come from Rhode Island. 

6. Davol admits that its marketing efforts are managed from its principal place of 

business in Rhode Island. 

7. C. R. Bard, Inc. (“Bard”) admits that it is organized under the laws of the State of 

New Jersey and that Davol is its subsidiary. Bard is a multinational developer, manufacturer and 

marketer of medical devices in vascular, urology, oncology and surgical specialty areas. Bard 

denies the remaining allegations, as phrased. 

8. The allegations in Paragraph 8 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 8 of the Master Complaint. 

9. The allegations in Paragraph 9 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 9 of the Master Complaint. 

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10. The allegations in Paragraph 10 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 10 of the Master Complaint. 

11. The allegations in Paragraph 11 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 11 of the Master Complaint. 

II. JURISDICTION AND VENUE 

12. Defendants admit this court has subject matter jurisdiction. 

13. Defendants do not know what is meant by “the federal judicial jurisdiction” and 

therefore cannot properly respond. Bard denies that this Court has personal jurisdiction over it 

based on the allegations in the Master Complaint. The specific jurisdiction analysis for Davol 

and Bard would depend on the allegations and state of residence of each Plaintiff identified in the 

Short Form Complaint for each case. As to the remaining allegations in Paragraph 13 of the 

Master Complaint, they are conclusions of law and no answer is required, but to the extent an 

answer is required, Defendants deny the same. 

14. Defendants do not know what is meant by “the federal judicial jurisdiction” and 

therefore cannot properly respond. A venue analysis would depend on information contained in 

each Short Form Complaint for each case. As to the remaining allegations in Paragraph 14 of the 

Master Complaint, they are conclusions of law and no answer is required, but to the extent an 

answer is required, Defendants deny the same. 

III. FACTS COMMON TO ALL COUNTS 

“DAVOL/BARD HERNIA MESH DEVICES” 

15. Defendants admit that at various times either Bard or Davol designed, distributed, 

manufactured, and sold the 3DMaxTM Light Mesh, 3DMaxTM Mesh, Bard® Mesh Dart, Bard® 

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Mesh (formally known as Marlex), ComposixTM Mesh, ComposixTM E/X Mesh, Composix® 

Kugel® Hernia Patch, ComposixTM L/P Mesh, Kugel® Hernia Patch, Modified Kugel® Hernia 

Patch, PerFixTM Plug, PerFixTM Light Plug, SpermaTexTM Mesh, VentralightTM ST Mesh, 

VentralexTM Hernia Patch, VentralexTM ST Hernia Patch, VentrioTM Hernia Patch, VentrioTM ST 

Hernia Patch, and VisilexTM Mesh. Davol admits that at various times it distributed, 

manufactured, and sold, the SeprameshTM IP Composite. The description of each product from 

its marketing materials speaks for itself. Defendants deny the remaining allegations in Paragraph 

15 of the Master Complaint. 

16. Defendants admit that United States Food and Drug Administration (“FDA”), 

through Section 510(k) of the Food, Drug and Cosmetic Act, cleared the 3DMaxTM Light Mesh, 

3DMaxTM Mesh, Bard® Mesh Dart, ComposixTM Mesh, ComposixTM E/X Mesh, Composix® 

Kugel® Hernia Patch, ComposixTM L/P Mesh, Kugel® Hernia Patch, Modified Kugel® Hernia 

Patch, PerFixTM Plug, PerFixTM Light Plug, SpermaTexTM Mesh, VentralightTM ST Mesh, 

VentralexTM Hernia Patch, VentralexTM ST Hernia Patch, VentrioTM Hernia Patch, VentrioTM ST 

Hernia Patch, VisilexTM Mesh, and SeprameshTM IP Composite for use by prescribing physicians 

in accordance with their accompanying labeling information. As to Bard® Mesh, Defendants 

deny the allegations as phrased. Bard® Mesh was legally marketed in the United States before 

May 28, 1976, and thus is a pre-amendment device. The 510(k) process speaks for itself. 

Defendants deny that “no formal review for safety or efficacy was ever conducted for the Hernia 

Mesh Devices” and that “[t]he 510(k) process is not a formal review for safety or efficacy.” 

“POLYPROPYLENE IN HERNIA MESH DEVICES: DEFECTS & RISKS” 

17. Defendants admit that the products identified in the Master Complaint contain in 

part polypropylene. Defendants deny the remaining allegations in Paragraph 17 of the Master 

Complaint. 

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18. The MSDS sheets referred to in Paragraph 18 of the Master Complaint speak for 

themselves. To the extent material allegations are alleged, Defendants deny those allegations. 

19. Defendants deny the allegations in Paragraph 19 of the Master Complaint. 

20. Defendants deny the allegations in Paragraph 20 of the Master Complaint, 

including subparts (a) through (m). 

21. Defendants deny the allegations in Paragraph 21 of the Master Complaint. 

22. Defendants deny the allegations in Paragraph 22 of the Master Complaint. 

23. Defendants deny the allegations in Paragraph 23 of the Master Complaint. 

24. Defendants deny the allegations in Paragraph 24 of the Master Complaint. 

“DEFENDANTS’ ACTS & OMISSIONS REGARDING THEIR DEFECTIVE DEVICES” 

25. Defendants admit that at various times either Bard or Davol designed, distributed, 

manufactured, and sold the 3DMaxTM Light Mesh, 3DMaxTM Mesh, Bard® Mesh Dart, Bard® 

Mesh (formally known as Marlex), ComposixTM Mesh, ComposixTM E/X Mesh, Composix® 

Kugel® Hernia Patch, ComposixTM L/P Mesh, Kugel® Hernia Patch, Modified Kugel® Hernia 

Patch, PerFixTM Plug, PerFixTM Light Plug, SpermaTexTM Mesh, VentralightTM ST Mesh, 

VentralexTM Hernia Patch, VentralexTM ST Hernia Patch, VentrioTM Hernia Patch, VentrioTM ST 

Hernia Patch, and VisilexTM Mesh for use by prescribing physicians in accordance with their 

instruction for use. Davol admits that at various times it distributed, manufactured, and sold, the 

SeprameshTM IP Composite for use by prescribing physicians in accordance with their instruction 

for use. Defendants do not know what is meant by “producing,” “testing,” “studying,” 

“inspection,” “labeling,” “marketing,” “advertising,” and “promoting,” besides what is admitted 

above. Defendants deny the remaining allegations in Paragraph 25 of the Master Complaint. 

26. Defendants deny the allegations in Paragraph 26 of the Master Complaint. 

27. Defendants deny the allegations in Paragraph 27 of the Master Complaint. 

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28. Defendants deny the allegations in Paragraph 28 of the Master Complaint. 

29. Defendants deny the allegations in Paragraph 29 of the Master Complaint. 

30. Defendants deny the allegations in Paragraph 30 of the Master Complaint. 

31. Defendants deny the allegations in Paragraph 31 of the Master Complaint. 

32. Defendants deny the allegations in Paragraph 32 of the Master Complaint. 

33. Defendants deny the allegations in Paragraph 33 of the Master Complaint. 

34. Defendants deny the allegations in Paragraph 34 of the Master Complaint. 

35. Defendants deny the allegations in Paragraph 35 of the Master Complaint. 

36. Defendants deny the allegations in Paragraph 36 of the Master Complaint. 

37. Defendants deny the allegations in Paragraph 37 of the Master Complaint. 

38. Defendants deny the allegations in Paragraph 38 of the Master Complaint. 

39. Defendants deny the allegations in Paragraph 39 of the Master Complaint. 

40. Defendants deny the allegations in Paragraph 40 of the Master Complaint, 

including subparts (a) through (p) 

41. Defendants admit that instructions for use are provided with the 3DMaxTM Light 

Mesh, 3DMaxTM Mesh, Bard® Mesh Dart, Bard® Mesh (formally known as Marlex), 

ComposixTM Mesh, ComposixTM E/X Mesh, Composix® Kugel® Hernia Patch, ComposixTM

L/P Mesh, Kugel® Hernia Patch, Modified Kugel® Hernia Patch, PerFixTM Plug, PerFixTM

Light Plug, SpermaTexTM Mesh, VentralightTM ST Mesh, VentralexTM Hernia Patch, VentralexTM

ST Hernia Patch, VentrioTM Hernia Patch, VentrioTM ST Hernia Patch, VisilexTM Mesh, and 

SeprameshTM IP Composite. Defendants lack sufficient knowledge or information to form a 

belief as to the truth of the allegation that “[t]he Hernia Mesh Devices were at all times utilized 

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and implanted in a manner foreseeable to Defendants.” Defendants deny the remaining 

allegations in Paragraph 41 of the Master Complaint. 

42. Defendants lack sufficient knowledge or information to form a belief as to the 

truth of the allegations in Paragraph 42 of the Master Complaint and therefore deny the same. 

43. Defendants lack sufficient knowledge or information to form a belief as to the 

truth of the allegations in Paragraph 43 of the Master Complaint and therefore deny the same. 

“ADDITIONAL DEFECTS: CERTAIN HERNIA MESH DEVICES” 

44. Defendants deny the allegations in Paragraph 44 of the Master Complaint. 

45. Defendants deny the allegations in Paragraph 45 of the Master Complaint. 

46. Defendants admit that hernia products with “ST” contain Sepra® Technology. 

Defendants also admit that SeprameshTM IP Composite contains Sepra® Technology. 

Defendants deny the remaining allegations in Paragraph 46 of the Master Complaint. 

“‘ST DEVICES’: ADDED DEFECTS & RISKS” 

47. Defendants deny the allegations in Paragraph 47 of the Master Complaint. 

48. Defendants deny the allegations in Paragraph 48 of the Master Complaint. 

49. Defendants deny the allegations in Paragraph 49 of the Master Complaint. 

50. Defendants deny the allegations in Paragraph 50 of the Master Complaint, 

including all subparts 

51. Defendants deny the allegations in Paragraph 51 of the Master Complaint. 

52. Defendants deny the allegations in Paragraph 52 of the Master Complaint. 

53. Defendants deny the allegations in Paragraph 53 of the Master Complaint. 

54. Defendants deny the allegations in Paragraph 54 of the Master Complaint. 

“DEFENDANTS’’ ACTS & OMISSIONS REGARDING ‘ST DEVICES’” 

55. Defendants deny the allegations in Paragraph 55 of the Master Complaint. 

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56. Defendants deny the allegations in Paragraph 56 of the Master Complaint. 

57. Defendants deny the allegations in Paragraph 57 of the Master Complaint. 

58. Defendants deny the allegations in Paragraph 58 of the Master Complaint. 

59. Defendants deny the allegations in Paragraph 59 of the Master Complaint. 

60. Defendants deny the allegations in Paragraph 60 of the Master Complaint. 

“‘ePTFE DEVICES’”: ADDED DEFECTS & RISKS” 

61. Defendants deny the allegations in Paragraph 61 of the Master Complaint. 

62. Defendants deny the allegations in Paragraph 62 of the Master Complaint. 

63. Defendants deny the allegations in Paragraph 63 of the Master Complaint. 

64. Defendants deny the allegations in Paragraph 64 of the Master Complaint. 

65. Defendants deny the allegations in Paragraph 65 of the Master Complaint. 

66. Defendants deny the allegations in Paragraph 66 of the Master Complaint. 

67. Defendants deny the allegations in Paragraph 67 of the Master Complaint. 

68. Defendants deny the allegations in Paragraph 68 of the Master Complaint. 

69. Defendants deny the allegations in Paragraph 69 of the Master Complaint. 

70. Defendants deny the allegations in Paragraph 70 of the Master Complaint. 

71. Defendants deny the allegations in Paragraph 71 of the Master Complaint. 

“DEFENDANTS’ ACTS & OMISSIONS REGARDING “‘ePTFE DEVICES’” 

72. Defendants deny the allegations in Paragraph 72 of the Master Complaint, 

including subparts (a) through (h). 

73. Defendants deny the allegations in Paragraph 73 of the Master Complaint. 

74. Defendants deny the allegations in Paragraph 74 of the Master Complaint, as 

phrased. 

75. Defendants deny the allegations in Paragraph 75 of the Master Complaint. 

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76. Defendants deny the allegations in Paragraph 76 of the Master Complaint. 

77. Defendants deny the allegations in Paragraph 77 of the Master Complaint. 

78. Defendants deny the allegations in Paragraph 78 of the Master Complaint. 

79. Defendants deny the allegations in Paragraph 79 of the Master Complaint. 

80. Defendants deny the allegations in Paragraph 80 of the Master Complaint. 

81. Defendants deny the allegations in Paragraph 81 of the Master Complaint. 

82. Defendants deny the allegations in Paragraph 82 of the Master Complaint. 

83. The October 6, 2002, complaint referred to in Paragraph 83 of the Master 

Complaint speaks for itself. 

84. The April 14, 2003, email referred to in Paragraph 84 of the Master Complaint 

speaks for itself. To the extent any material allegations are alleged, those are denied. 

85. The January 2002, survey referred to in Paragraph 85 of the Master Complaint 

speaks for itself. To the extent any material allegations are alleged, those are denied. 

86. David Paolo’s testimony referred to in Paragraph 86 of the Master Complaint 

speaks for itself. To the extent any material allegations are alleged, those are denied. 

87. Stephen Clarke’s testimony referred to in Paragraph 87 of the Master Complaint 

speaks for itself. To the extent any material allegations are alleged, those are denied. 

88. Jim Keegan’s testimony referred to in Paragraph 88 of the Master Complaint 

speaks for itself. To the extent any material allegations are alleged, those are denied. 

89. The January 7, 2002, patent application referred to in Paragraph 89 of the Master 

Complaint speaks for itself. 

90. Thomas Swanson’s testimony referred to in Paragraph 90 of the Master 

Complaint speaks for itself. To the extent any material allegations are alleged, those are denied. 

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91. The DaVinci studies referred to in Paragraph 91 of the Master Complaint speak 

for themselves. To the extent any material allegations are alleged, those are denied. 

92. The FDA’s 2006 Establishment Inspection Report referred to in Paragraph 92 of 

the Master Complaint speaks for itself. To the extent any material allegations are alleged, those 

are denied. 

93. Defendants deny the allegations in Paragraph 93 of the Master Complaint. 

94. The FDA’s 2006 Establishment Inspection Report referred to in Paragraph 94 of 

the Master Complaint speaks for itself. To the extent any material allegations are alleged, those 

are denied. 

95. Defendants deny the allegations in Paragraph 95 of the Master Complaint. 

96. Defendants deny the allegations in Paragraph 96 of the Master Complaint. 

97. The FDA’s definition of a Class 1 recall speaks for itself. 

98. Defendants admit that certain sizes of the Composix Kugel Hernia Patches were 

voluntarily recalled due to the memory recoil ring being broken by physicians who were 

aggressively bending and manipulating the patches during implantation, including folding the 

patches inappropriately along the short axis. Defendants deny the remaining allegations in 

Paragraph 98 of the Master Complaint. 

99. The FDA’s 2006 Establishment Inspection Report referred to in Paragraph 99 of 

the Master Complaint speaks for itself. To the extent any material allegations are alleged, those 

are denied. 

100. Defendants admit that in March 2006 Davol expanded the recall to Composix 

Kugel models 202 and 204 manufactured before January 2004 and model 209 manufactured 

before March 2006. 

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101. Defendants admit that in January 2007 Davol expanded the recall and/or 

withdrew lots of large patches manufactured between January 2004 and September 2005. 

Defendants deny the remaining allegations in Paragraph 101 of the Master Complaint. 

102. The April 24, 2007, FDA “Warning Letter” referred to in Paragraph 102 of the 

Master Complaint speaks for itself. To the extent any material allegations are alleged, those are 

denied. 

103. The BioAssist report referred to in Paragraph 103 of the Master Complaint speaks 

for itself. To the extent any material allegations are alleged, those are denied. 

104. Defendants deny the allegations in Paragraph 104 of the Master Complaint. 

105. Defendants deny the allegations in Paragraph 105 of the Master Complaint. 

DISCOVERY RULE; STATUTORY OR EQUITABLE TOLLING; ESTOPPEL 

106. The allegations in Paragraph 106 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 106 of the Master Complaint. 

107. The allegations in Paragraph 107 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 107 of the Master Complaint. 

108. The allegations in Paragraph 108 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 108 of the Master Complaint. 

109. The allegations in Paragraph 109 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 109 of the Master Complaint. 

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110. The allegations in Paragraph 110 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 110 of the Master Complaint. 

IV. COUNTS 

COUNT I 

STRICT PRODUCT LIABILITY: DEFECTIVE DESIGN 

111. In response to Paragraph 111 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

112. The allegations in Paragraph 112 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 112 of the Master Complaint. 

113. The allegations in Paragraph 113 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 113 of the Master Complaint. 

114. The allegations in Paragraph 114 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 114 of the Master Complaint. 

115. The allegations in Paragraph 115 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 115 of the Master Complaint. 

116. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 116 of the Master Complaint and therefore deny the same. 

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117. The allegations in Paragraph 117 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 117 of the Master Complaint. 

118. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 118 of the Master Complaint and therefore deny the same. 

119. The allegations in Paragraph 119 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 119 of the Master Complaint. 

120. The allegations in Paragraph 120 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 120 of the Master Complaint. 

121. The allegations in Paragraph 121 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 121 of the Master Complaint. 

122. The allegations in Paragraph 122 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 122 of the Master Complaint. 

123. The allegations in Paragraph 123 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 123 of the Master Complaint. 

124. The allegations in Paragraph 124 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 124 of the Master Complaint. 

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125. The allegations in Paragraph 125 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 125 of the Master Complaint. 

COUNT II 

STRICT PRODUCT LIABILITY: FAILURE TO WARN 

126. In response to Paragraph 126 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

127. Davol admits that it manufactured and distributed the 3DMaxTM Light Mesh, 

3DMaxTM Mesh, Bard® Mesh Dart, Bard® Mesh (formally known as Marlex), ComposixTM

Mesh, ComposixTM E/X Mesh, Composix® Kugel® Hernia Patch, ComposixTM L/P Mesh, 

Kugel® Hernia Patch, Modified Kugel® Hernia Patch, PerFixTM Plug, PerFixTM Light Plug, 

SpermaTexTM Mesh, VentralightTM ST Mesh, VentralexTM Hernia Patch, VentralexTM ST Hernia 

Patch, VentrioTM Hernia Patch, VentrioTM ST Hernia Patch, and VisilexTM Mesh for use by 

prescribing physicians in accordance with its accompanying labeling information. Davol admits 

that at various times it conducted limited manufacturing of, and distributed the SeprameshTM IP 

Composite. Bard denies the remaining allegations in Paragraph 127 of the Master Complaint. 

128. The allegations in Paragraph 128 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 128 of the Master Complaint. 

129. The allegations in Paragraph 129 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 129 of the Master Complaint. 

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130. The allegations in Paragraph 130 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 130 of the Master Complaint. 

131. The allegations in Paragraph 131 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 131 of the Master Complaint. 

132. The allegations in Paragraph 132 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 132 of the Master Complaint. 

133. The allegations in Paragraph 133 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 133 of the Master Complaint. 

134. The allegations in Paragraph 134 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 134 of the Master Complaint. 

135. The allegations in Paragraph 135 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 135 of the Master Complaint. 

136. The allegations in Paragraph 136 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 136 of the Master Complaint. 

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137. The allegations in Paragraph 137 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 137 of the Master Complaint. 

138. The allegations in Paragraph 138 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 138 of the Master Complaint. 

139. The allegations in Paragraph 139 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 139 of the Master Complaint. 

140. The allegations in Paragraph 140 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 140 of the Master Complaint. 

141. The allegations in Paragraph 141 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 141 of the Master Complaint. 

142. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 142 of the Master Complaint and therefore deny the same. 

143. The allegations in Paragraph 143 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 143 of the Master Complaint. 

144. The allegations in Paragraph 144 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 144 of the Master Complaint. 

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145. The allegations in Paragraph 145 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 145 of the Master Complaint. 

146. The allegations in Paragraph 146 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 146 of the Master Complaint. 

147. The allegations in Paragraph 147 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 147 of the Master Complaint. 

COUNT III 

STRICT PRODUCT LIABILITY: MANUFACTURING DEFECT 

148. In response to Paragraph 148 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

149. The allegations in Paragraph 149 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 149 of the Master Complaint. 

150. The allegations in Paragraph 150 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 150 of the Master Complaint. 

151. The allegations in Paragraph 151 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 151 of the Master Complaint. 

152. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 152 of the Master Complaint and therefore deny the same. 

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153. The allegations in Paragraph 153 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 153 of the Master Complaint. 

154. The allegations in Paragraph 154 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 154 of the Master Complaint. 

155. The allegations in Paragraph 155 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 155 of the Master Complaint. 

156. The allegations in Paragraph 156 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 156 of the Master Complaint. 

157. The allegations in Paragraph 157 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 157 of the Master Complaint. 

158. The allegations in Paragraph 158 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 158 of the Master Complaint. 

COUNT IV 

NEGLIGENCE 

159. In response to Paragraph 159 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

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160. The allegations in Paragraph 160 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 160 of the Master Complaint. 

161. The allegations in Paragraph 161 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 161 of the Master Complaint. 

162. The allegations in Paragraph 162 of the Master Complaint, including subparts (a) 

through (w) are conclusions of law, and no answer is required. To the extent an answer is 

required, Defendants deny the allegations in Paragraph 162 of the Master Complaint, including 

subparts (a) through (w). 

163. The allegations in Paragraph 163 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 163 of the Master Complaint. 

164. The allegations in Paragraph 164 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 164 of the Master Complaint. 

165. The allegations in Paragraph 165 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 165 of the Master Complaint. 

166. The allegations in Paragraph 166 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 166 of the Master Complaint. 

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167. The allegations in Paragraph 167 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 167 of the Master Complaint. 

168. The allegations in Paragraph 168 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 168 of the Master Complaint. 

169. The allegations in Paragraph 169 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 169 of the Master Complaint. 

170. The allegations in Paragraph 170 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 170 of the Master Complaint. 

COUNT V 

NEGLIGENCE PER SE 

171. In response to Paragraph 171 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

172. The allegations in Paragraph 172 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 172 of the Master Complaint. 

173. The allegations in Paragraph 173 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 173 of the Master Complaint. 

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174. The allegations in Paragraph 174 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 174 of the Master Complaint. 

175. The allegations in Paragraph 175 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 175 of the Master Complaint. 

176. The allegations in Paragraph 176 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 176 of the Master Complaint. 

177. The allegations in Paragraph 177 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 177 of the Master Complaint. 

178. The allegations in Paragraph 178 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 178 of the Master Complaint. 

COUNT VI 

GROSS NEGLIGENCE 

179. In response to Paragraph 179 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

180. The allegations in Paragraph 180 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 180 of the Master Complaint. 

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181. The allegations in Paragraph 181 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 181 of the Master Complaint. 

182. The allegations in Paragraph 182 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 182 of the Master Complaint. 

183. The allegations in Paragraph 183 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 183 of the Master Complaint. 

184. The allegations in Paragraph 184 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 184 of the Master Complaint. 

COUNT VII 

STATE CONSUMER PROTECTION LAWS 

185. In response to Paragraph 185 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

186. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 186 of the Master Complaint or those allegations are 

conclusions of law, and no answer is required. To the extent an answer is required, Defendants 

deny the allegations in Paragraph 186 of the Master Complaint. 

187. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 187 of the Master Complaint and therefore deny the same. 

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188. The allegations in Paragraph 188 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 188 of the Master Complaint. 

189. The allegations in Paragraph 189 of the Master Complaint, including subparts (a) 

through (c) are conclusions of law, and no answer is required. To the extent an answer is 

required, Defendants deny the allegations in Paragraph 189 of the Master Complaint, including 

subparts (a) through (c). 

190. The allegations in Paragraph 190 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 190 of the Master Complaint. 

191. The allegations in Paragraph 191 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 191 of the Master Complaint. 

192. The allegations in Paragraph 192 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 192 of the Master Complaint. 

193. The allegations in Paragraph 193 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 193 of the Master Complaint. 

194. The allegations in Paragraph 194 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 194 of the Master Complaint. 

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195. The allegations in Paragraph 195 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 195 of the Master Complaint. 

196. The allegations in Paragraph 196 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 196 of the Master Complaint. 

197. The allegations in Paragraph 197 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 197 of the Master Complaint. 

198. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 198 of the Master Complaint and therefore deny the same. 

199. The allegations in Paragraph 199 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 199 of the Master Complaint. 

200. The allegations in Paragraph 200 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 200 of the Master Complaint. 

COUNT VIII 

BREACH OF IMPLIED WARRANTY 

201. In response to Paragraph 201 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

202. Defendants admit that either Bard or Davol sold the 3DMaxTM Light Mesh, 

3DMaxTM Mesh, Bard® Mesh Dart, Bard® Mesh (formally known as Marlex), ComposixTM

Mesh, ComposixTM E/X Mesh, Composix® Kugel® Hernia Patch, ComposixTM L/P Mesh, 

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Kugel® Hernia Patch, Modified Kugel® Hernia Patch, PerFixTM Plug, PerFixTM Light Plug, 

SpermaTexTM Mesh, VentralightTM ST Mesh, VentralexTM Hernia Patch, VentralexTM ST Hernia 

Patch, VentrioTM Hernia Patch, VentrioTM ST Hernia Patch, and VisilexTM Mesh for use by 

prescribing physicians in accordance with its accompanying labeling information. Davol admits 

that at various times it sold the SeprameshTM IP Composite for use by prescribing physicians in 

accordance with its accompanying labeling information. Defendants deny the remaining 

allegations in Paragraph 202 of the Master Complaint. 

203. The allegations in Paragraph 203 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 203 of the Master Complaint. 

204. The allegations in Paragraph 204 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 204 of the Master Complaint. 

205. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 205 of the Master Complaint and therefore deny the same. 

206. The allegations in Paragraph 206 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 206 of the Master Complaint. 

207. The allegations in Paragraph 207 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 207 of the Master Complaint. 

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208. The allegations in Paragraph 208 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 208 of the Master Complaint. 

COUNT IX 

BREACH OF EXPRESS WARRANTY 

209. In response to Paragraph 209 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

210. The allegations in Paragraph 210 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 210 of the Master Complaint. 

211. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 211 of the Master Complaint and therefore deny the same. 

212. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 212 of the Master Complaint and therefore deny the same. 

213. The allegations in Paragraph 213 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 213 of the Master Complaint. 

214. The allegations in Paragraph 214 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 214 of the Master Complaint. 

215. The allegations in Paragraph 215 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 215 of the Master Complaint. 

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COUNT X 

NEGLIGENT INFLICTION OF EMOTIONAL DISTRESS 

216. In response to Paragraph 216 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

217. The allegations in Paragraph 217 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 217 of the Master Complaint. 

218. The allegations in Paragraph 218 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 218 of the Master Complaint. 

219. The allegations in Paragraph 219 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 219 of the Master Complaint. 

220. The allegations in Paragraph 220 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 220 of the Master Complaint. 

COUNT XI 

INTENTIONAL INFLICTION OF EMOTIONAL DISTRESS 

221. In response to Paragraph 221 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

222. The allegations in Paragraph 222 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 222 of the Master Complaint. 

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223. The allegations in Paragraph 223 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 223 of the Master Complaint. 

224. The allegations in Paragraph 224 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 224 of the Master Complaint. 

COUNT XII 

NEGLIGENT MISREPRESENTATION 

225. In response to Paragraph 225 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

226. The allegations in Paragraph 226 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 226 of the Master Complaint. 

227. The allegations in Paragraph 227 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 227 of the Master Complaint. 

228. The allegations in Paragraph 228 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 228 of the Master Complaint. 

229. The allegations in Paragraph 229 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 229 of the Master Complaint. 

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230. The allegations in Paragraph 230 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 230 of the Master Complaint. 

231. The allegations in Paragraph 231 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 231 of the Master Complaint. 

232. The allegations in Paragraph 232 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 232 of the Master Complaint. 

233. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 233 of the Master Complaint and therefore deny the same. 

234. The allegations in Paragraph 234 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 234 of the Master Complaint. 

235. The allegations in Paragraph 235 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 235 of the Master Complaint. 

COUNT XIII 

FRAUD AND FRAUDULENT MISREPRESENTATION 

236. In response to Paragraph 236 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

237. Defendants admit that at various times either Bard or Davol designed, 

manufactured, marketed, and sold the 3DMaxTM Light Mesh, 3DMaxTM Mesh, Bard® Mesh 

Dart, Bard® Mesh (formally known as Marlex), ComposixTM Mesh, ComposixTM E/X Mesh, 

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Composix® Kugel® Hernia Patch, ComposixTM L/P Mesh, Kugel® Hernia Patch, Modified 

Kugel® Hernia Patch, PerFixTM Plug, PerFixTM Light Plug, SpermaTexTM Mesh, VentralightTM

ST Mesh, VentralexTM Hernia Patch, VentralexTM ST Hernia Patch, VentrioTM Hernia Patch, 

VentrioTM ST Hernia Patch, and VisilexTM Mesh for use by prescribing physicians in accordance 

with its accompanying labeling information. Davol admits that at various times it manufactured, 

marketed, and sold the SeprameshTM IP Composite for use by prescribing physicians in 

accordance with its accompanying labeling information. Defendants deny that the warnings for 

these products were inadequate. 

238. The allegations in Paragraph 238 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 238 of the Master Complaint. 

239. The allegations in Paragraph 239 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 239 of the Master Complaint. 

240. The allegations in Paragraph 240 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 240 of the Master Complaint. 

241. The allegations in Paragraph 241 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 241 of the Master Complaint. 

242. The allegations in Paragraph 242 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 242 of the Master Complaint. 

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243. The allegations in Paragraph 243 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 243 of the Master Complaint. 

244. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 244 of the Master Complaint and therefore deny the same. 

245. The allegations in Paragraph 245 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 245 of the Master Complaint. 

246. The allegations in Paragraph 246 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 246 of the Master Complaint. 

247. The allegations in Paragraph 247 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 247 of the Master Complaint. 

COUNT XIV 

FRAUDULENT CONCEALMENT 

248. In response to Paragraph 248 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

249. The allegations in Paragraph 249 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 249 of the Master Complaint. 

250. The allegations in Paragraph 250 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 250 of the Master Complaint. 

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251. The allegations in Paragraph 251 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 251 of the Master Complaint. 

252. The allegations in Paragraph 252 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 252 of the Master Complaint. 

253. The allegations in Paragraph 253 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 253 of the Master Complaint. 

254. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 254 of the Master Complaint and therefore deny the same. 

255. The allegations in Paragraph 255 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 255 of the Master Complaint. 

256. The allegations in Paragraph 256 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 256 of the Master Complaint. 

257. The allegations in Paragraph 257 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 257 of the Master Complaint. 

258. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 258 of the Master Complaint and therefore deny the same. 

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259. The allegations in Paragraph 259 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 259 of the Master Complaint. 

260. The allegations in Paragraph 260 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 260 of the Master Complaint. 

261. The allegations in Paragraph 261 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 261 of the Master Complaint. 

262. The allegations in Paragraph 262 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 262 of the Master Complaint. 

263. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 263 of the Master Complaint and therefore deny the same. 

264. The allegations in Paragraph 264 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 264 of the Master Complaint. 

265. The allegations in Paragraph 265 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 265 of the Master Complaint. 

266. Defendants lack knowledge or information sufficient to form a belief as to the 

truth of the allegations in Paragraph 266 of the Master Complaint and therefore deny the same. 

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267. The allegations in Paragraph 267 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 267 of the Master Complaint. 

268. The allegations in Paragraph 268 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 268 of the Master Complaint. 

269. The allegations in Paragraph 269 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 269 of the Master Complaint. 

270. The allegations in Paragraph 270 of the Master Complaint are conclusions of law, 

and no answer is required. To the extent an answer is required, Defendants deny the allegations 

in Paragraph 270 of the Master Complaint. 

COUNT XV 

WRONGFUL DEATH 

271. In response to Paragraph 271 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

272. The allegations in Paragraph 272 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 272 of the Master Complaint. 

273. The allegations in Paragraph 273 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 273 of the Master Complaint. 

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274. The allegations in Paragraph 274 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 274 of the Master Complaint. 

275. The allegations in Paragraph 275 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 275 of the Master Complaint. 

COUNT XVI 

LOSS OF CONSORTIUM 

276. In response to Paragraph 276 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

277. The allegations in Paragraph 277 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 277 of the Master Complaint. 

278. The allegations in Paragraph 278 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 278 of the Master Complaint. 

279. The allegations in Paragraph 279 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 279 of the Master Complaint. 

280. The allegations in Paragraph 280 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 280 of the Master Complaint. 

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281. The allegations in Paragraph 281 of the Master Complaint are conclusions of law, 

tied to the filing of a Short Form Complaint, and no answer is required. To the extent an answer 

is required, Defendants deny the allegations in Paragraph 281 of the Master Complaint. 

COUNT XVII 

PUNITIVE DAMAGES 

282. In response to Paragraph 282 of the Master Complaint, Defendants incorporate by 

reference their responses in all preceding paragraphs. 

283. Defendants deny the allegations in Paragraph 283 of the Master Complaint. 

284. Defendants deny the allegations in Paragraph 284 of the Master Complaint. 

285. Defendants deny the allegations in Paragraph 285 of the Master Complaint. 

286. Defendants deny the allegations in Paragraph 286 of the Master Complaint. 

287. Defendants deny the allegations in Paragraph 287 of the Master Complaint. 

288. Defendants deny the allegations in Paragraph 288 of the Master Complaint. 

289. Defendants deny the allegations in Paragraph 289 of the Master Complaint. 

290. Defendants deny the allegations in Paragraph 290 of the Master Complaint. 

291. Defendants deny the allegations in Paragraph 291 of the Master Complaint. 

SEPARATE DEFENSES 

1. The Master Complaint, in whole or part, fails to state a claim or cause of action 

against Defendants upon which relief can be granted. 

2. The doctrines contained in Restatement (Second) of Torts § 402A, Comment k, 

bar Plaintiff’s claims against Defendants in whole or in part. 

3. The doctrines contained in Restatement (Third) of Torts, Product Liability §§ 4 

and 6, bar Plaintiff’s claims against Defendants in whole or in part. 

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4. The doctrine of spoliation and the failure to properly preserve evidence necessary 

to the determination of the alleged claims bar Plaintiff’s claims against Defendants in whole or in 

part. 

5. The doctrine of forum non conveniens applies to this case. 

6. Plaintiff’s claims against Bard fail for lack of personal jurisdiction for any 

Plaintiff whose state of residency is outside of New Jersey. 

7. Plaintiff’s claims against Davol fail for lack of personal jurisdiction for any 

Plaintiff whose state of residency is outside of Rhode Island. 

8. Defendants reserve all rights under Lexecon Inc. v. Milberg Weiss Bershad Hynes 

& Lerach, 523 U.S. 26 (1998). 

9. Applicable statutes of limitations, statute of repose, and the doctrine of laches bar 

Plaintiff’s claims in whole or in part. 

10. Plaintiff’s, or Plaintiff’s agents’, including Plaintiff’s physicians’, misuse or 

abnormal use of the product or failure to follow instructions bar Plaintiffs’ claims in whole or in 

part. 

11. If Plaintiff used a product sold by Defendants, then Plaintiff’s claims are barred, 

in whole or in part, because Plaintiff assumed the risks disclosed by the product labeling, by the 

prescribing physicians, or by other persons or entities. 

12. Any alleged negligent or culpable conduct of Defendants, none being admitted, 

was so insubstantial as to be insufficient to be a proximate or substantial contributing cause of 

Plaintiff’s alleged injuries. 

13. If Plaintiff sustained any damages or injuries, which is denied, then such damages 

and injuries were caused or contributed to by the acts, omissions or fault of Plaintiff, including 

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contributory negligence, contributory fault, comparative fault, assumption of the risk, or failure 

to mitigate damages. 

14. If Plaintiff used a product sold by Defendants, Plaintiff used the product for offlabel purposes, which bars the Plaintiff’s claims. 

15. The learned intermediary doctrine bars Plaintiff’s claims. 

16. Plaintiff’s claims are barred, in whole or in part, because the products at issue 

were designed, manufactured, marketed and labeled with proper warnings, information, cautions 

and instructions, in accordance with the state of the art and the state of scientific and 

technological knowledge. 

17. Plaintiff’s claims are barred, in whole or in part, because the products at issue 

were not defective or unreasonably dangerous in that they complied with, at all relevant times, 

all applicable government safety standards. 

18. Plaintiff’s claims are preempted, in whole or in part, by applicable federal law. 

19. Plaintiff’s claims are barred, in whole or in part, because Plaintiff’s injuries, if 

any, were the result of conduct of Plaintiffs, independent third parties, and/or events that were 

extraordinary under the circumstances, not foreseeable in the normal course of events, and/or 

independent, intervening and superseding causes of the alleged injuries, including but not limited 

to Plaintiffs’ pre-existing medical conditions. 

20. If Plaintiff suffered injuries or damages as alleged, which is denied, such injuries 

or damages resulted from acts or omissions of persons or entities for which Defendants are 

neither liable nor responsible or resulted from diseases and/or causes that are not related or 

connected with any product sold, distributed, or manufactured by Defendants. Such acts or 

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omissions on the part of other persons or entities, such diseases and/or such causes constitute an 

independent, intervening and sole proximate cause of Plaintiff’s alleged injury or damages. 

21. Defendants state that if Plaintiff sustained any damages or injuries, which is 

specifically denied, such damages or injuries were caused by the acts, omissions or fault of 

Plaintiff or others, for whose conduct these Defendants are not responsible; accordingly, they are 

entitled to an assessment of the relative degree of fault for all such persons and entities. 

22. Plaintiff’s claims are barred, in whole or in part, because Plaintiff’s alleged 

injuries, if caused by Defendants’ product(s), which is denied, were the result of Plaintiff’s own 

idiosyncratic reactions. 

23. Plaintiff failed to mitigate damages, which limits Plaintiff’s recovery, if any, in 

whole or in part. 

24. Defendants have no legal relationship or privity with Plaintiff and owe no duty to 

Plaintiff by which liability could be attributed to it. 

25. Defendants made no warranties of any kind, express or implied, or any 

representations of any nature whatsoever to Plaintiff. If any such warranties were made, whether 

express or implied, which Defendants specifically deny, then Plaintiff failed to give notice of any 

breach thereof. Moreover, Defendants effectively and fully disclaimed any warranty, express or 

implied, in the sale of any product for which they are responsible in this matter. 

26. Plaintiff’s claims are barred in whole or in part by Plaintiff’s own comparative 

negligence. 

27. Plaintiff’s recovery, if any, shall be reduced by those payments that Plaintiff 

received from collateral sources. 

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28. If Plaintiff has been injured or damaged, no injury or damages being admitted, 

such injuries were not caused by Defendants’ product. 

29. At the time the product(s) at issue left the custody and control of Defendants, 

there was no defect in said product(s) that either caused or contributed to any injuries or damages 

that Plaintiff may have suffered, if any. 

30. At the time Plaintiff’s received the product(s), Defendants did not design, 

manufacture, or sell the product(s). 

31. Plaintiff fails to allege facts to state a cause of action against Defendants to 

support a claim for negligent infliction of emotional distress. 

32. Plaintiff fails to allege facts to state a cause of action against Defendants to 

support a claim for intentional infliction of emotional distress. 

33. Plaintiff fails to allege facts to state a cause of action against Defendants to 

support a claim for breach of implied warranty. 

34. To the extent Plaintiff is required to plead his claims with sufficient particularity 

to satisfy the requirements of Federal Rule of Civil Procedure 9, Plaintiff has failed to do so and 

Plaintiff’s claims must be dismissed. Plaintiff has not pled the fraud claim with particularity as 

required by Federal Rule of Civil Procedure 9 and that claim must be dismissed. 

35. The applicable state and federal law, including State Farm Mutual Auto. Ins. Co. 

v. Campbell, 538 U.S. 408 (2003), bars Plaintiff’s alleged claims for punitive or exemplary 

damages. Permitting recovery of punitive or exemplary damages in this case would violate 

Defendants’ rights as reserved by the Fifth, Seventh, Eighth, and Fourteenth Amendments to the 

United States Constitution, and related provisions of the United States Constitution, as well as 

the due process guarantees embodied in state constitutions. 

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36. To the extent that the applicable state law permits the jury and Courts to measure 

punitive or exemplary damages by the net worth or financial status of Defendants and imposes 

greater punishment on defendants with greater net worth, such an award would be 

unconstitutional because it permits arbitrary punishment, allows bias and prejudice to infect the 

verdict, and allows dissimilar treatment of similarly situated defendants, all in violation of the 

due process and equal protection provisions of the Fourteenth Amendment to the United States 

Constitution, the Commerce Clause of the United States Constitution, and the similar provisions 

in state constitutions. 

37. To the extent Plaintiff’s Master Complaint seeks punitive damages, such claims 

are barred because Plaintiff has failed to allege conduct warranting the imposition of punitive 

damages under the applicable state law and/or other applicable laws. 

38. To the extent Plaintiff’s Master Complaint seeks punitive damages, applicable 

federal law preempts any such claim, in whole or in part. 

39. Depending on the specific theory advanced by any given plaintiff at trial, such 

claims may be impliedly preempted. 

40. Plaintiff’s claims are, in whole or in part, subject to adjudication under the laws of 

states or jurisdictions other than Ohio. 

41. Defendants hereby give notice that state law applicable to the claims of each 

Plaintiff on a case by case basis may provide additional defenses, which Defendants reserve their 

right to amend this Master Answer or Short Form Adoption By Reference Answer To Plaintiffs’ 

Short Form Adoption By Reference Complaint to assert such defenses. 

42. Defendants hereby give notice that state law applicable to an individual Plaintiff’s 

case may not recognize a claim asserted in the Master Complaint or provide a defense to it. 

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43. Defendants hereby give notice that they intend to rely upon such other defenses as 

may become available or apparent during the course of discovery and thus reserve their right to 

amend this Master Answer or Short Form Adoption By Reference Answer To Plaintiffs’ Short 

Form Adoption By Reference Complaint to assert such defenses. 

WHEREFORE, Defendants Davol Inc. and C. R. Bard, Inc. demand judgment in their 

favor and against Plaintiffs, dismissing Plaintiffs’ Master Complaint with prejudice, together 

with the costs of suit and such other relief as the Court deems equitable and just. 

JURY TRIAL DEMAND 

PLEASE TAKE NOTICE that answering Defendants hereby demand a trial by jury as to 

all issues. 

January 2, 2019 Respectfully submitted, 

/s/ William D. Kloss, Jr. 

William D. Kloss, Jr. 

Henrique A. Geigel 

Arryn K. Miner 

Vorys Sater Seymour and Pease 

52 East Gay Street 

Columbus, OH 43215 

(614) 464-6360 

wdklossjr@vorys.com 

hageigel@vorys.com 

akminer@vorys.com 

Liaison Counsel for Defendants C. R. Bard, 

Inc. and Davol Inc. 

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Michael K. Brown 

REED SMITH LLP 

355 South Grand Avenue 

Suite 2900 

Los Angeles, CA 90071-1514 

(213) 457-8000 

mkbrown@reedsmith.com 

Eric L. Alexander 

REED SMITH, LLP 

1301 K Street, NW 

Suite 1000 – East Tower 

Washington, DC 20005 

(202) 414-9200 

ealexander@reedsmith.com 

Lead Counsel for Defendants C. R. Bard, 

Inc. and Davol Inc. 

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CERTIFICATE OF SERVICE 

I hereby certify that on January 2, 2019, I electronically filed the foregoing with the Clerk 

of the Court by using the CM/ECF system, which will send a notice of this electronic filing to all 

counsel of record. 

/s/ William D. Kloss, Jr. 

Liaison Counsel for Defendants C. R. Bard, 

Inc. and Davol Inc. 

1/02/2019 31950758 

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