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James R. Condo (#005867) 

Amanda Sheridan (#005867) 

SNELL & WILMER L.L.P. 

One Arizona Center 

400 E. Van Buren 

Phoenix, AZ 85004-2204 

Telephone: (602) 382-6000 

JCondo@swlaw.com 

ASheridan@swlaw.com 

Richard B. North, Jr. (admitted pro hac vice) 

Georgia Bar No. 545599 

Matthew B. Lerner (admitted pro hac vice) 

Georgia Bar No. 446986 

NELSON MULLINS RILEY & SCARBOROUGH, LLP 

Atlantic Station 

201 17th Street, NW, Suite 1700 

Atlanta, GA 30363 

Telephone: (404) 322-6000 

Richard.North@nelsonmullins.com 

Matthew.Lerner@nelsonmullins.com 

Attorneys for Defendants 

C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc.

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: Bard IVC Filters Products Liability 

Litigation 

MDL NO. 15-02641-PHX-DGC

This Document Relates to: 

ALEXANDRA WILLMARTH, an 

individual, 

 Plaintiff, 

v. 

C. R. BARD, INC., a corporation, and 

BARD PERIPHERAL VASCULAR INC., 

a corporation, and DOES 1 through 100, 

inclusive 

 Defendants.

Case No. CV-16-00445-PHX-DGC 

DEFENDANTS C. R. BARD, INC. AND 

BARD PERIPHERAL VASCULAR, 

INC.’S ANSWER AND AFFIRMATIVE 

DEFENSES AND DEMAND FOR 

TRIAL BY JURY 

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Defendants C. R. Bard, Inc. (“Bard”) and Bard Peripheral Vascular, Inc. (“BPV”) 

(Bard and BPV are collectively “Defendants”) answer the Complaint (“Plaintiff’s 

Complaint”) of Plaintiff Alexandra Willmarth (“Plaintiff”) as follows: 

INTRODUCTORY ALLEGATIONS

1. Defendants are without knowledge or information sufficient to form a belief as 

to the truth of the allegations contained in Paragraph 1 of Plaintiff’s Complaint and, and, on 

that basis, deny them. 

2. Defendants deny that Bard is a Delaware Corporation. Defendants admit that 

Bard is a New Jersey Corporation and that Bard is authorized to do business, and does 

business, in the State of Wisconsin. Defendants admit that Bard owns a facility where vena 

cava filters are manufactured, including filters under the trademark EclipseTM Filter Systems. 

Defendants deny any remaining allegations contained in Paragraph 2 of Plaintiff’s Complaint. 

3. Defendants admit that BPV is a foreign Corporation and that BPV is authorized 

to do business, and does business, in the State of Wisconsin. Defendants further admit that 

BPV designs, sells, markets, and distributes inferior vena cava filters and that BPV has 

designed, sold, marketed, and distributed filters under the trademark EclipseTM Filter 

Systems. Defendants further admit that BPV is a wholly owned subsidiary of Bard. 

Defendants deny any remaining allegations contained in Paragraph 3 of Plaintiff’s Complaint. 

4. The allegations of Paragraph 4 of Plaintiff’s Complaint are not directed at 

Defendants and, therefore, require no response. However, to the extent Paragraph 4 purports 

to cast liability either directly or indirectly upon Defendants, said Paragraph is expressly 

denied. 

5. The allegations of Paragraph 5 of Plaintiff’s Complaint are not directed at 

Defendants and, therefore, require no response. However, to the extent Paragraph 5 purports 

to cast liability either directly or indirectly upon Defendants, said Paragraph is expressly 

denied. 

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JURISDICTION AND VENUE

6. Regarding Paragraph 6 of Plaintiff’s Complaint, Defendants do not contest that 

the injuries and damages alleged within Plaintiff’s Complaint exceed the jurisdictional limit 

of this Court. However, Defendants deny that they are liable to Plaintiff for any amount 

whatsoever and deny that Plaintiff has suffered any damages whatsoever. Defendants do not 

dispute that, based on the facts as alleged by Plaintiff, which have not been, and could not 

have been confirmed by Defendants, jurisdiction appears to be proper in the United States 

District Court for the Western District of Wisconsin. 

7. Regarding Paragraph 7 of Plaintiff’s Complaint, Defendants do not dispute that, 

based on the facts as alleged by Plaintiff, which have not been and could not have been 

confirmed by Defendants, venue appears to be proper in the United States District Court for 

the Western District of Wisconsin. 

GENERAL FACTUAL ALLEGATIONS

8. Defendants incorporate by reference their responses to Paragraphs 1-7 of 

Plaintiff’s Complaint as if fully set forth herein. 

9. Defendants deny the allegations contained in Paragraph 9 of Plaintiff’s 

Complaint. 

10. Defendants deny the allegations contained in Paragraph 10 of Plaintiff’s 

Complaint. 

11. Defendants deny the allegations contained in Paragraph 11 of Plaintiff’s 

Complaint. 

12. Defendants deny the allegations contained in Paragraph 12 of Plaintiff’s 

Complaint. 

13. Defendants deny the allegations contained in Paragraph 13 of Plaintiff’s 

Complaint. 

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

truth of the allegation regarding the time frame when inferior vena cava filters were first 

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introduced on the market or the identity of manufacturers of inferior vena cava filters. 

Defendants deny any remaining allegations of Paragraph 14 of Plaintiff’s Complaint. 

15. Defendants admit that inferior vena cava filters are intended to prevent injury or 

death resulting from venous thrombosis and pulmonary embolism. Defendants further admit 

that inferior vena cava filters may be designed for permanent placement, temporary 

placement, or both. Defendants deny any remaining allegations of Paragraph 15 of Plaintiff’s 

Complaint. 

16. Defendants admit that the inferior vena cava is a large vein that receives blood 

from the lower regions of the body and delivers it to the right atrium of the heart. Defendants 

further admit that deep vein thrombosis and pulmonary emboli present dangerous risks to 

human health, including sometimes death. Defendants deny any remaining allegations of 

Paragraph 16 of Plaintiff’s Complaint. 

17. Defendants admit that inferior vena cava filters are intended to prevent injury or 

death resulting from venous thrombosis and pulmonary embolism. Defendants further admit 

that inferior vena cava filters may also be used to treat patients who are at a high risk for 

developing deep vein thrombosis and pulmonary embolism. The remaining allegations 

contained in Paragraph 17 of Plaintiff’s Complaint are conclusions of law, to which no 

response is required. To the extent a response is required, Defendants deny those allegations. 

18. Defendants deny the allegations contained in Paragraph 18 of Plaintiff’s 

Complaint. 

19. Defendants admit that patients at a high risk for developing deep vein 

thrombosis and pulmonary embolism are frequently treated with anticoagulation therapy, 

including but not limited to the medications listed in Paragraph 19 of Plaintiff’s Complaint. 

Defendants further admit that inferior vena cava filters may also be used to treat patients who 

are at a high risk for developing deep vein thrombosis and pulmonary embolism. Defendants 

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

allegations contained in Paragraph 19 of Plaintiff’s Complaint and, on that basis, deny them. 

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

truth of the allegation regarding the time frame when inferior vena cava filters were first 

introduced on the market. Defendants also lack knowledge or information sufficient to form a 

belief as to the truth of the allegation regarding the time frame when optional or retrievable 

filters came to be marketed or the other allegations regarding optional or retrievable filters 

marketed by other manufacturers. Defendants deny any remaining allegations contained in 

Paragraph 20 of Plaintiff’s Complaint. 

21. Defendants admit that Bard has distributed the Simon Nitinol Filter in the 

United States since at least 1992. Defendants admit that, as part of their continuing efforts to 

constantly evaluate the medical devices they sell, in conjunction with the ever-changing stateof-the-art, they are continually striving to improve the life-saving performance of those 

devices. The Recovery® Filter was developed in furtherance of those efforts. Defendants 

further admit that the Recovery® Filter was cleared by the FDA for optional use as a 

retrievable inferior vena cava filter. Defendants deny any remaining allegations contained in 

Paragraph 21 of Plaintiff’s Complaint. 

22. Defendants deny the allegations contained in Paragraph 22 of Plaintiff’s 

Complaint. 

23. Defendants deny the allegations contained in Paragraph 23 of Plaintiff’s 

Complaint. 

24. Defendants deny the allegations contained in Paragraph 24 of Plaintiff’s 

Complaint. 

25. Defendants admit that the Recovery® Filter was cleared by the FDA for 

permanent placement on November 27, 2002, pursuant to an application submitted under 

Section 510(k) of the Food, Drug and Cosmetic Act. The allegations contained in Footnote 1 

regarding the 510(k) process are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. Defendants deny any 

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remaining allegations contained in Paragraph 25 of Plaintiff’s Complaint, including any 

additional allegations in Footnote 1. 

26. Defendants admit that the Recovery® Filter was cleared by the FDA for 

retrievable placement on July 25, 2003, pursuant to applications submitted under 

Section 510(k) of the Food, Drug and Cosmetic Act. Defendants deny any remaining 

allegations contained in Paragraph 26 of Plaintiff’s Complaint. 

27. Defendants deny the allegations contained in Paragraph 27 of Plaintiff’s 

Complaint. 

28. Defendants deny the allegations contained in Paragraph 28 of Plaintiff’s 

Complaint. 

29. Defendants deny the allegations contained in Paragraph 29 of Plaintiff’s 

Complaint. 

30. Defendants admit that the Recovery® Filter consists of twelve, shape-memory 

Nitinol wires emanating from a central Nitinol sleeve. Defendants further admit that the 

twelve wires form two levels of filtration for emboli: the legs provide the lower level of 

filtration, and the arms provide the upper level of filtration. Defendants deny any remaining 

allegations contained in Paragraph 30 of Plaintiff’s Complaint. 

31. Defendants admit that the Recovery® Filter was designed to be inserted 

endovascularly. Defendants further admit that the Recovery® Filter is designed to be 

delivered via an introducer sheath, which is included in the delivery system for the device. 

Defendants deny any remaining allegations of Paragraph 31 of Plaintiff’s Complaint. 

32. Defendants admit that, as part of their continuing efforts to constantly evaluate 

the medical devices they sell, in conjunction with the ever-changing state-of-the-art, they are 

continually striving to improve the life-saving performance of those devices. The Recovery® 

Filter was developed in furtherance of those efforts. Defendants deny the remaining 

allegations contained in Paragraph 32 of Plaintiff’s Complaint, including all sub-parts thereof. 

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33. Defendants deny the allegations contained in Paragraph 33 of Plaintiff’s 

Complaint. 

34. Defendants deny the allegations contained in Paragraph 34 of Plaintiff’s 

Complaint. 

35. Defendants deny the allegations contained in Paragraph 35 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

36. Defendants deny the allegations contained in Paragraph 36 of Plaintiff’s 

Complaint. 

37. Defendants deny the allegations contained in Paragraph 37 of Plaintiff’s 

Complaint. 

38. Defendants deny the allegations contained in Paragraph 38 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

39. Defendants deny the allegations contained in Paragraph 39 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

40. Defendants deny the allegations contained in Paragraph 40 of Plaintiff’s 

Complaint. 

41. Defendants deny the allegations contained in Paragraph 41 of Plaintiff’s 

Complaint. By way of further response, Defendants admit that there are various welldocumented complications that may occur as a result of the fracture, perforation, and/or 

migration of any inferior vena cava filter. Defendants further admit that it is well documented 

that many instances of filter fracture and/or migration result in no complications whatsoever 

but, rather, are completely asymptomatic. Bard further states that there are incidents related to 

the occurrence of known complications associated with every manufacturer of inferior vena 

cava filters. Defendants deny the remaining allegations of Paragraph 41 of Plaintiff’s 

Complaint. 

42. Defendants deny the allegations contained in Paragraph 42 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

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43. Defendants deny the allegations contained in Paragraph 43 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

44. Defendants deny the allegations contained in Paragraph 44 of Plaintiff’s 

Complaint. 

45. Defendants deny the allegations contained in Paragraph 45 of Plaintiff’s 

Complaint. 

46. Defendants deny the allegations contained in Paragraph 46 of Plaintiff’s 

Complaint as stated. Defendants state that, as part of their continuing efforts to constantly 

evaluate the medical devices they sell, in conjunction with the ever-changing state-of-the-art, 

they are continually striving to improve the life-saving performance of those devices. 

Defendants deny any remaining allegations contained in Paragraph 46 of Plaintiff’s 

Complaint. 

47. Defendants deny the allegations contained in Paragraph 47 of Plaintiff’s 

Complaint. 

48. Defendants deny the allegations contained in Paragraph 48 of Plaintiff’s 

Complaint. 

49. Defendants deny the allegations contained in Paragraph 49 of Plaintiff’s 

Complaint. 

50. Defendants deny the allegations contained in Paragraph 50 of Plaintiff’s 

Complaint. 

51. Defendants deny the allegations contained in Paragraph 51 of Plaintiff’s 

Complaint. 

52. Defendants deny the allegations contained in Paragraph 52 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

53. Defendants deny the allegations contained in Paragraph 53 of Plaintiff’s 

Complaint. Defendants deny that the Recovery® Filter is unreasonably dangerous or 

defective in any manner. By way of further answer, Defendants state that, as part of their 

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continuing efforts to constantly evaluate the medical devices they sell, in conjunction with the 

ever-changing state-of-the-art, they are continually striving to improve the life-saving 

performance of those devices. The G2® Filter was developed in furtherance of those efforts. 

Defendants deny any remaining allegations contained in Paragraph 53 of Plaintiff’s 

Complaint. 

54. Defendants admit the G2® Filter System was cleared by the United States Food 

and Drug Administration pursuant to an application submitted under Section 510(k) of the 

Food, Drug and Cosmetic Act in 2005. Defendants deny any remaining allegations contained 

in Paragraph 54 of Plaintiff’s Complaint. 

55. Defendants admit the G2® Filter System was cleared by the United States Food 

and Drug Administration for both permanent and retrievable use pursuant to an application 

submitted under Section 510(k) of the Food, Drug and Cosmetic Act. Defendants further 

admit that the G2® Filter was originally cleared by the FDA for permanent use and was 

subsequently cleared in 2008 by the FDA for optional use as a retrievable inferior vena cava 

filter. Defendants deny any remaining allegations contained in Paragraph 55 of Plaintiff’s 

Complaint. 

56. Defendants deny the allegations contained in Paragraph 56 of Plaintiff’s 

Complaint. 

57. Defendants deny the allegations contained in Paragraph 57 of Plaintiff’s 

Complaint. 

58. Defendants deny the allegations contained in Paragraph 58 of Plaintiff’s 

Complaint. 

59. Defendants deny the allegations contained in Paragraph 59 of Plaintiff’s 

Complaint. 

60. Defendants deny the allegations contained in Paragraph 60 of Plaintiff’s 

Complaint. 

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61. Defendants deny the allegations contained in Paragraph 61 of Plaintiff’s 

Complaint. 

62. Defendants deny the allegations contained in Paragraph 62 of Plaintiff’s 

Complaint. 

63. Defendants deny the allegations contained in Paragraph 63 of Plaintiff’s 

Complaint. 

64. Defendants deny the allegations contained in Paragraph 64 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

65. Defendants deny the allegations contained in Paragraph 65 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

66. Defendants deny the allegations contained in Paragraph 66 of Plaintiff’s 

Complaint. 

67. Defendants admit the G2® Express Filter System was cleared by the United 

States Food and Drug Administration pursuant to an application submitted under 

Section 510(k) of the Food, Drug and Cosmetic Act in 2008. Defendants further admit that 

the G2® Express Filter is similar to the G2® Filter, but includes a snare on the sheath of the 

filter to enhance retrievability. Defendants deny any remaining allegations contained in 

Paragraph 67 of Plaintiff’s Complaint. 

68. Defendants deny that the G2® Filter is unreasonably dangerous or defective in 

any manner. Defendants admit that the EclipseTM Filter System was cleared by the United 

States Food and Drug Administration pursuant to an application submitted under 

Section 510(k) of the Food, Drug and Cosmetic Act in 2010. Defendants further admit that, as 

part of their continuing efforts to constantly evaluate the medical devices they sell, in 

conjunction with the ever-changing state-of-the-art, they are continually striving to improve 

the life-saving performance of those devices. The EclipseTM Filter was developed in 

furtherance of those efforts. Defendants deny any remaining allegations contained in 

Paragraph 68 of Plaintiff’s Complaint. 

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69. Defendants deny the allegations contained in Paragraph 69 of Plaintiff’s 

Complaint. 

70. Defendants deny the allegations contained in Paragraph 70 of Plaintiff’s 

Complaint, as stated. Defendants deny that the G2® Filter is unreasonably dangerous or 

defective in any manner. By way of further response, Defendants admit that, as part of their 

continuing efforts to constantly evaluate the medical devices they sell, in conjunction with the 

ever-changing state-of-the-art, they are continually striving to improve the life-saving 

performance of those devices. In this regard, and pursuant to an application submitted under 

Section 510(k) of the Food, Drug and Cosmetic Act, BPV received FDA clearance on 

August 24, 2011, for the MeridianTM Filter. Defendants deny the remaining allegations of 

Paragraph 70 of Plaintiff’s Complaint. 

71. Defendants admit that, as part of their continuing efforts to constantly evaluate 

the medical devices they sell, in conjunction with the ever-changing state-of-the-art, they are 

continually striving to improve the life-saving performance of those devices. The MeridianTM 

Filter was developed in furtherance of those efforts. Defendants deny any remaining 

allegations of Paragraph 71 of Plaintiff’s Complaint. 

72. Defendants deny the allegations contained in Paragraph 72 of Plaintiff’s 

Complaint. 

73. Defendants deny the allegations contained in Paragraph 73 of Plaintiff’s 

Complaint. 

74. Defendants deny the allegations contained in Paragraph 74 of Plaintiff’s 

Complaint. 

75. Defendants deny that the G2® or MeridianTM Filter Systems were unreasonably 

dangerous or defective in any manner. Defendants admit that, as part of their continuing 

efforts to constantly evaluate the medical devices they sell, and in conjunction with the everchanging state-of-the-art, they are continually striving to improve the life-saving performance 

of those devices. The DenaliTM Filter was developed in furtherance of those efforts. 

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Defendants further admit that the DenaliTM Filter was cleared by the FDA for permanent 

placement on May 15, 2013, pursuant to an application submitted under Section 510(k) of the 

Food, Drug and Cosmetic Act. Defendants deny any remaining allegations contained in 

Paragraph 75 of Plaintiff’s Complaint. 

76. Defendants deny that the G2® or G2® Express Filter Systems were 

unreasonably dangerous or defective in any manner. Defendants admit that, as part of their 

continuing efforts to constantly evaluate the medical devices they sell, and in conjunction 

with the ever-changing state-of-the-art, they are continually striving to improve the lifesaving performance of those devices. The DenaliTM Filter was developed in furtherance of 

those efforts. Defendants deny any remaining allegations contained in Paragraph 76 of 

Plaintiff’s Complaint. 

77. Defendants deny the allegations contained in Paragraph 77 of Plaintiff’s 

Complaint. 

78. Defendants deny the allegations contained in Paragraph 78 of Plaintiff’s 

Complaint. 

79. Defendants deny the allegations contained in Paragraph 79 of Plaintiff’s 

Complaint. 

80. Defendants admit that the Recovery® Cone Removal System was designed to 

assist physicians with the removal of inferior vena cava filters. Defendants also admit that the 

Recovery® Cone was marketed to physicians as the preferred mechanism for retrieval of 

Bard’s inferior vena cava filters. Defendants deny any remaining allegations contained in 

Paragraph 80 of Plaintiff’s Complaint. 

81. Defendants deny the allegations contained in Paragraph 81 of Plaintiff’s 

Complaint. 

82. Defendants deny the allegations contained in Paragraph 82 of Plaintiff’s 

Complaint. 

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83. Defendants deny the allegations contained in Paragraph 83 of Plaintiff’s 

Complaint. 

84. Defendants deny the allegations contained in Paragraph 84 of Plaintiff’s 

Complaint. 

85. Defendants admit that Bard received a warning letter from the FDA’s Los 

Angeles District Office dated July 13, 2015. Defendants deny the remaining allegations of 

Paragraph 85 of the Complaint as stated. 

86. Defendants deny the allegations contained in Paragraph 86 of Plaintiff’s 

Complaint. 

87. Defendants deny the allegations contained in Paragraph 87 of Plaintiff’s 

Complaint. 

88. Defendants deny the allegations contained in Paragraph 88 of Plaintiff’s 

Complaint. 

89. Defendants deny the allegations contained in Paragraph 89 of Plaintiff’s 

Complaint. 

90. Defendants deny the allegations contained in Paragraph 90 of Plaintiff’s 

Complaint. 

91. Defendants deny the allegations contained in Paragraph 91 of Plaintiff’s 

Complaint. 

92. Defendants deny the allegations contained in Paragraph 92 of Plaintiff’s 

Complaint. 

93. Defendants deny the allegations contained in Paragraph 93 of Plaintiff’s 

Complaint. 

94. Defendants deny the allegations contained in Paragraph 94 of Plaintiff’s 

Complaint. 

95. Defendants deny the allegations contained in Paragraph 95 of Plaintiff’s 

Complaint. 

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96. Defendants deny the allegations contained in Paragraph 96 of Plaintiff’s 

Complaint. 

97. Defendants deny the allegations contained in Paragraph 97 of Plaintiff’s 

Complaint. 

98. Defendants deny the allegations contained in Paragraph 98 of Plaintiff’s 

Complaint. 

99. Defendants deny the allegations contained in Paragraph 99 of Plaintiff’s 

Complaint. 

FIRST CAUSE OF ACTION

NEGLIGENCE

100. Defendants incorporate by reference their responses to Paragraphs 1-99 of 

Plaintiff’s Complaint as if fully set forth herein. 

101. Defendants admit that Bard owns a facility where vena cava filters are 

manufactured, including under the trademark EclipseTM Filter Systems. Defendants further 

admit that BPV designs, sells, markets, and distributes inferior vena cava filters and that BPV 

has designed, sold, marketed, and distributed filters under the trademark EclipseTM Filter 

Systems. Defendants deny any remaining allegations contained in Paragraph 101 of the 

Complaint. 

102. Defendants are without knowledge or information sufficient to form a belief as 

to the truth of the allegations regarding the trade name of any inferior vena cava filter 

implanted in Plaintiff and, on that basis, deny them. Defendants deny any remaining 

allegations of Paragraph 102 of the Complaint. 

103. The allegations contained in Paragraph 103 regarding Defendants’ duty are 

legal conclusions of law, and no answer is required. To the extent a response is required, 

Defendants deny the allegations. Defendants deny any remaining allegations contained in 

Paragraph 103 of the Complaint. 

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104. Defendants deny the allegations contained in Paragraph 104 of Plaintiff’s 

Complaint. 

105. Defendants deny the allegations contained in Paragraph 105 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

106. Defendants deny the allegations contained in Paragraph 106 of Plaintiff’s 

Complaint. 

107. Defendants deny the allegations contained in Paragraph 107 of Plaintiff’s 

Complaint. 

108. Defendants deny the allegations contained in Paragraph 108 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

109. Defendants deny the allegations contained in Paragraph 109 of Plaintiff’s 

Complaint. 

110. Defendants deny the allegations contained in Paragraph 110 of Plaintiff’s 

Complaint. 

SECOND CAUSE OF ACTION

STRICT LIABILITY – FAILURE TO WARN

111. Defendants incorporate by reference their responses to Paragraphs 1-110 of 

Plaintiff’s Complaint as if fully set forth herein. 

112. Defendants are without knowledge or information sufficient to form a belief as 

to the truth of the allegations regarding the trade name of any inferior vena cava filter 

implanted in Plaintiff and, on that basis, deny them. By way of further response, Defendants 

admit that Bard owns a facility where vena cava filters are manufactured, including under the 

trademark Recovery® Filter Systems. Defendants further admit that BPV designs, sells, 

markets, and distributes inferior vena cava filters and that BPV has designed, sold, marketed, 

and distributed filters under the trademark Recovery® Filter Systems. Defendants deny any 

remaining allegations contained in Paragraph 112 of Plaintiff’s Complaint. 

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113. Defendants deny the allegations contained in Paragraph 113 of Plaintiff’s 

Complaint. 

114. Defendants deny the allegations contained in Paragraph 114 of Plaintiff’s 

Complaint. 

115. Defendants deny the allegations contained in Paragraph 115 of Plaintiff’s 

Complaint. 

116. Defendants deny the allegations contained in Paragraph 116 of Plaintiff’s 

Complaint. 

117. Defendants deny the allegations contained in Paragraph 117 of Plaintiff’s 

Complaint. 

118. Defendants deny the allegations contained in Paragraph 118 of Plaintiff’s 

Complaint. 

119. Defendants deny the allegations contained in Paragraph 119 of Plaintiff’s 

Complaint. 

120. Defendants deny the allegations contained in Paragraph 120 of Plaintiff’s 

Complaint. 

121. Defendants deny the allegations contained in Paragraph 121 of Plaintiff’s 

Complaint. 

122. Defendants deny the allegations contained in Paragraph 122 of Plaintiff’s 

Complaint. 

123. Defendants deny the allegations contained in Paragraph 123 of Plaintiff’s 

Complaint. 

124. Defendants deny the allegations contained in Paragraph 124 of Plaintiff’s 

Complaint. 

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THIRD CAUSE OF ACTION

STRICT LIABILITY – DESIGN DEFECT

125. Defendants incorporate by reference their responses to Paragraphs 1-124 of 

Plaintiff’s Complaint as if fully set forth herein. 

126. Defendants are without knowledge or information sufficient to form a belief as 

to the truth of the allegations regarding the trade name of any inferior vena cava filter 

implanted in Plaintiff and, on that basis, deny them. By way of further response, Defendants 

admit that Bard owns a facility where vena cava filters are manufactured, including under the 

trademarks Recovery® Filter Systems. Defendants further admit that BPV designs, sells, 

markets, and distributes inferior vena cava filters and that BPV has designed, sold, marketed, 

and distributed inferior vena cava filters under the trademark Recovery® Filter Systems. 

Defendants deny any remaining allegations contained in Paragraph 126 of Plaintiff’s 

Complaint. 

127. Defendants deny the allegations contained in Paragraph 127 of Plaintiff’s 

Complaint. 

128. Defendants deny the allegations contained in Paragraph 128 of Plaintiff’s 

Complaint. 

129. Defendants deny the allegations contained in Paragraph 129 of Plaintiff’s 

Complaint. 

130. Defendants deny the allegations contained in Paragraph 130 of Plaintiff’s 

Complaint. 

131. Defendants deny the allegations contained in Paragraph 131 of Plaintiff’s 

Complaint. 

132. Defendants deny the allegations contained in Paragraph 132 of Plaintiff’s 

Complaint. 

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FOURTH CAUSE OF ACTION

STRICT LIABILITY – MANUFACTURING DEFECT

133. Defendants incorporate by reference their responses to Paragraphs 1-132 of 

Plaintiff’s Complaint as if fully set forth herein. 

134. Defendants deny that their inferior vena cava filters are unreasonably dangerous 

or defective in any manner. Defendants are without knowledge or information sufficient to 

form a belief as to the truth of the allegations regarding the trade name of any inferior vena 

cava filter implanted in Plaintiff and, on that basis, deny them. By way of further response, 

Defendants admit that Bard owns a facility where vena cava filters are manufactured, 

including under the trademarks Recovery® Filter Systems. Defendants further admit that 

BPV designs, sells, markets, and distributes inferior vena cava filters and that BPV has 

designed, sold, marketed, and distributed inferior vena cava filters under the trademark 

Recovery® Filter Systems. Defendants deny any remaining allegations contained in 

Paragraph 134 of Plaintiff’s Complaint. 

135. Defendants deny the allegations contained in Paragraph 135 of Plaintiff’s 

Complaint. 

136. Defendants deny the allegations contained in Paragraph 136 of Plaintiff’s 

Complaint. 

137. Defendants deny the allegations contained in Paragraph 137 of Plaintiff’s 

Complaint. 

FIFTH CAUSE OF ACTION

BREACH OF EXPRESS WARRANTY

138. Defendants incorporate by reference their responses to Paragraphs 1-137 of 

Plaintiff’s Complaint as if fully set forth herein. 

139. Defendants deny the allegations contained in Paragraph 139 of Plaintiff’s 

Complaint. 

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140. Defendants deny the allegations contained in Paragraph 140 of Plaintiff’s 

Complaint. 

141. Defendants deny the allegations contained in Paragraph 141 of Plaintiff’s 

Complaint. 

142. Defendants deny the allegations contained in Paragraph 142 of Plaintiff’s 

Complaint. 

143. Defendants deny the allegations contained in Paragraph 143 of Plaintiff’s 

Complaint. 

144. Defendants deny the allegations contained in Paragraph 144 of Plaintiff’s 

Complaint. 

145. Defendants deny the allegations contained in Paragraph 145 of Plaintiff’s 

Complaint. 

146. Defendants deny the allegations contained in Paragraph 146 of Plaintiff’s 

Complaint. 

SIXTH CAUSE OF ACTION

BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS

147. Defendants incorporate by reference their responses to Paragraphs 1-146 of 

Plaintiff’s Complaint as if fully set forth herein. 

148. Defendants admit that Bard owns a facility where vena cava filters are 

manufactured, including under the trademarks Recovery® Filter Systems. Defendants further 

admit that BPV designs, sells, markets, and distributes inferior vena cava filters and that BPV 

has designed, sold, marketed, and distributed filters under the trademark Recovery® Filter 

Systems. Defendants deny the remaining allegations contained in Paragraph 148 of Plaintiff’s 

Complaint. 

149. Defendants deny the allegations contained in Paragraph 149 of Plaintiff’s 

Complaint. 

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150. Defendants deny the allegations contained in Paragraph 150 of Plaintiff’s 

Complaint. 

151. Defendants deny the allegations contained in Paragraph 151 of Plaintiff’s 

Complaint. 

152. Defendants deny the allegations contained in Paragraph 152 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

153. Defendants deny the allegations contained in Paragraph 153 of Plaintiff’s 

Complaint. 

154. Defendants deny the allegations contained in Paragraph 154 of Plaintiff’s 

Complaint. 

155. Defendants deny the allegations contained in Paragraph 155 of Plaintiff’s 

Complaint. 

156. Defendants deny the allegations contained in Paragraph 156 of Plaintiff’s 

Complaint. 

SEVENTH CAUSE OF ACTION

NEGLIGENT MISREPRESENTATION

157. Defendants incorporate by reference their responses to Paragraphs 1-156 of 

Plaintiff’s Complaint as if fully set forth herein. 

158. Defendants deny the allegations contained in Paragraph 158 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

159. Defendants deny the allegations contained in Paragraph 159 of Plaintiff’s 

Complaint. 

160. Defendants deny the allegations contained in Paragraph 160 of Plaintiff’s 

Complaint. 

161. Defendants deny the allegations contained in Paragraph 161 of Plaintiff’s 

Complaint. 

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162. Defendants deny the allegations contained in Paragraph 162 of Plaintiff’s 

Complaint. 

163. Defendants deny the allegations contained in Paragraph 163 of Plaintiff’s 

Complaint. 

164. Defendants deny the allegations contained in Paragraph 164 of Plaintiff’s 

Complaint. 

165. Defendants deny the allegations contained in Paragraph 165 of Plaintiff’s 

Complaint. 

166. Defendants deny the allegations contained in Paragraph 166 of Plaintiff’s 

Complaint. 

PUNITIVE DAMAGES ALLEGATIONS

167. Defendants incorporate by reference their responses to Paragraphs 1-166 of 

Plaintiff’s Complaint as if fully set forth herein. 

168. Defendants deny the allegations contained in Paragraph 168 of Plaintiff’s 

Complaint. 

169. Defendants deny the allegations contained in Paragraph 169 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

170. Defendants deny the allegations contained in Paragraph 170 of Plaintiff’s 

Complaint. 

171. Defendants deny the allegations contained in Paragraph 171 of Plaintiff’s 

Complaint. 

PRAYER FOR RELIEF

Furthermore, responding to the unnumbered Paragraphs, including sub-parts, 

following the heading “PRAYER FOR RELIEF” and beginning “WHEREFORE,” 

Defendants deny the allegations contained in such Paragraphs and all sub-parts thereof. 

Defendants further deny each and every allegation not specifically admitted herein. 

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DEFENSES

Defendants allege as affirmative defenses the following: 

1. Plaintiff’s Complaint filed herein fails to state a claim or claims upon which 

relief can be granted under Rule 12 of the Federal Rules of Civil Procedure. 

2. The sole proximate cause of Plaintiff’s damages, if any were sustained, was the 

negligence of a person or persons or entity for whose acts or omissions Defendants were and 

are in no way liable. 

3. Plaintiff’s claims are barred, in whole or in part, by the applicable statutes of 

limitations and/or statute of repose. 

4. If Plaintiff has been damaged, which Defendants deny, any recovery by 

Plaintiff is barred to the extent Plaintiff voluntarily exposed herself to a known risk and/or 

failed to mitigate her alleged damages. To the extent Plaintiff has failed to mitigate her 

alleged damages, any recovery shall not include alleged damages that could have been 

avoided by reasonable care and diligence. 

5. If Plaintiff has been damaged, which Defendants deny, such damages were 

caused by the negligence or fault of Plaintiff. 

6. If Plaintiff has been damaged, which Defendants deny, such damages were 

caused by the negligence or fault of persons and/or entities for whose conduct Defendants are 

not legally responsible. 

7. The conduct of Defendants and the subject product at all times conformed to 

the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 301, et seq., and other pertinent 

federal statutes and regulations. Accordingly, Plaintiff’s claims are barred, in whole or in 

part, under the doctrine of federal preemption, and granting the relief requested would 

impermissibly infringe upon and conflict with federal laws, regulations, and policies in 

violation of the Supremacy Clause of the United States Constitution. 

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8. If Plaintiff has been damaged, which Defendants deny, such damages were 

caused by unforeseeable, independent, intervening, and/or superseding events for which 

Defendants are not legally responsible. 

9. There was no defect in the product at issue with the result that Plaintiff is not 

entitled to recover against Defendants in this cause. 

10. If there were any defect in the products – and Defendants deny that there were 

any defects – nevertheless, there was no causal connection between any alleged defect and 

the product on the one hand and any damage to Plaintiff on the other with the result that 

Plaintiff is not entitled to recover against Defendants in this cause. 

11. Plaintiff’s injuries, losses or damages, if any, were caused by or contributed to 

by other persons or entities that are severally liable for all or part of Plaintiff’s alleged 

injuries, losses or damages. If Defendants are held liable to Plaintiff, which liability is 

specifically denied, Defendants are entitled to contribution, set-off, and/or indemnification, 

either in whole or in part, from all persons or entities whose negligence or fault proximately 

caused or contributed to cause Plaintiff’s alleged damages. 

12. Plaintiff’s claims are barred to the extent that the injuries alleged in the 

Plaintiff’s Complaint were caused by the abuse, misuse, abnormal use, or use of the product 

at issue in a manner not intended by Defendants and over which Defendants had no control. 

13. Plaintiff’s claims are barred to the extent that the injuries alleged in the 

Plaintiff’s Complaint were caused by a substantial change in the product after leaving the 

possession, custody, and control of Defendants. 

14. Plaintiff’s breach of warranty claims are barred because: (1) Defendants did not 

make any warranties, express or implied, to Plaintiff; (2) there was a lack of privity between 

Defendants and Plaintiff; and (3) notice of an alleged breach was not given to the seller or 

Defendants. 

15. Plaintiff’s claims for breach of implied warranty must fail because the product 

was not used for its ordinary purpose. 

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16. Defendants neither had nor breached any alleged duty to warn with respect to 

the product, with the result that Plaintiff is not entitled to recover in this cause. 

17. Plaintiff’s claims are barred by Defendants’ dissemination of legally adequate 

warnings and instructions to learned intermediaries. 

18. At all relevant times, herein, Plaintiff’s physicians were in the position of 

sophisticated purchasers, fully knowledgeable and informed with respect to the risks and 

benefits of the subject product. 

19. If Plaintiff has been damaged, which Defendants deny, the actions of persons or 

entities for whose conduct Defendants are not legally responsible and the independent 

knowledge of these persons or entities of the risks inherent in the use of the product and other 

independent causes, constitute an intervening and superseding cause of Plaintiff’s alleged 

damages. 

20. To the extent that injuries and damages sustained by Plaintiff, as alleged in 

Plaintiff’s Complaint, were caused directly, solely, and proximately by sensitivities, medical 

conditions, and idiosyncrasies peculiar to Plaintiff not found in the general public, they were 

unknown, unknowable, or not reasonably foreseeable to Defendants. 

21. Defendants believe, and upon that ground allege, that Plaintiff was advised of 

the risks associated with the matters alleged in Plaintiff’s Complaint and knowingly and 

voluntarily assumed them. Pursuant to the doctrine of assumption of the risk, informed 

consent, release, waiver, or comparative fault, this conduct bars in whole or in part the 

damages that Plaintiff seeks to recover herein. 

22. At all relevant times during which the device at issue was designed, developed, 

manufactured, and sold, the device was reasonably safe and reasonably fit for its intended 

use, was not defective or unreasonably dangerous, and was accompanied by proper warnings, 

information, and instructions, all pursuant to generally recognized prevailing industry 

standards and state-of-the-art in existence at the time. 

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23. Plaintiff’s claims are barred because Plaintiff suffered no injury or damages as a 

result of the alleged conduct and do not have any right, standing, or competency to maintain 

claims for damages or other relief. 

24. Plaintiff’s claims are barred, in whole or in part, by the doctrines of waiver, 

estoppel, and/or laches. 

25. If Plaintiff suffered any damages or injuries, which is denied, Defendants state 

that Plaintiff’s recovery is barred, in whole or in part, or subject to reduction, under the 

doctrines of contributory and/or comparative negligence. 

26. In the further alternative, and only in the event that it is determined that 

Plaintiff is entitled to recover against Defendants, recovery should be reduced in proportion to 

the degree or percentage of negligence, fault or exposure to products attributable to Plaintiff, 

any other defendants, third-party defendants, or other persons, including any party immune 

because bankruptcy renders them immune from further litigation, as well as any party, codefendant, or non-parties with whom Plaintiff has settled or may settle in the future. 

27. Should Defendants be held liable to Plaintiff, which liability is specifically 

denied, Defendants would be entitled to a setoff for the total of all amounts paid to Plaintiff 

from all collateral sources. 

28. Plaintiff’s claims may be barred, in whole or in part, from seeking recovery 

against Defendants pursuant to the doctrines of res judicata, collateral estoppel, release of 

claims, and the prohibition on double recovery for the same injury. 

29. The injuries and damages allegedly sustained by Plaintiff may be due to the 

operation of nature or idiosyncratic reaction(s) and/or pre-existing condition(s) in Plaintiff 

over which Defendants had no control. 

30. The conduct of Defendants and all activities with respect to the subject product 

have been and are under the supervision of the Federal Food and Drug Administration 

(“FDA”). Accordingly, this action, including any claims for monetary and/or injunctive relief, 

is barred by the doctrine of primary jurisdiction and exhaustion of administrative remedies. 

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31. Defendants assert any and all defenses, claims, credits, offsets, or remedies 

provided by the Restatements (Second and Third) of Torts and reserve the right to amend 

their Answer to file such further pleadings as are necessary to preserve and assert such 

defenses, claims, credits, offsets, or remedies. 

32. The device at issue complied with any applicable product safety statute or 

administrative regulation, and therefore Plaintiff’s defective design and warnings-based 

claims are barred under the Restatement (Third) of Torts: Products Liability § 4, et seq. and 

comments thereto. 

33. Plaintiff cannot show that any reasonable alternative design would have 

rendered the inferior vena cava filter device as alleged in Plaintiff’s Complaint to be safer 

overall under the Restatement (Third) of Product Liability § 2, cmt. f, nor could Defendants 

have known of any alternative design that may be identified by Plaintiff. 

34. The device at issue was not sold in a defective condition unreasonably 

dangerous to the user or consumer, and therefore Plaintiff’s claims are barred under the 

Restatement (Second) of Torts: Products Liability § 402A and comments thereto, and 

comparable provisions of the Restatement (Third) of Torts (Products Liability). 

35. At all relevant times during which the device at issue was designed, developed, 

manufactured, and sold, the device was reasonably safe and reasonably fit for its intended 

use, was not defective or unreasonably dangerous, and was accompanied by proper warnings, 

information, and instructions, all pursuant to generally recognized prevailing industry 

standards and state-of-the-art in existence at the time. 

36. Defendants specifically plead all affirmative defenses under the Uniform 

Commercial Code (“UCC”) now existing or which may arise in the future, including those 

defenses provided by UCC §§ 2-607 and 2-709. 

37. Plaintiff’s alleged damages, if any, should be apportioned among all parties at 

fault, and any non-parties at fault, pursuant to the Uniform Contribution Among Tortfeasors 

Act. 

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38. No act or omission of Defendants was malicious, willful, wanton, reckless, or 

grossly negligent, and, therefore, any award of punitive damages is barred. 

39. To the extent the claims asserted in Plaintiff’s Complaint are based on a theory 

providing for liability without proof of defect and proof of causation, the claims violate 

Defendants’ rights under the Constitution of the United States and analogous provisions of 

the Wisconsin Constitution. 

40. To the extent Plaintiff seeks punitive damages, Defendants specifically 

incorporate by reference any and all standards of limitations regarding the determination 

and/or enforceability of punitive damages awards that arose in the decisions of BMW of 

No. America v. Gore, 517 U.S. 559 (1996); Cooper Industries, Inc. v. Leatherman Tool 

Group, Inc., 532 U.S. 424 (2001); State Farm Mut. Auto Ins. Co. v. Campbell, 123 S. Ct. 

1513 (2003); and Exxon Shipping Co. v. Baker, No. 07-219, 2008 U.S. LEXIS 5263 (U.S. 

June 25, 2008) and their progeny as well as other similar cases under both federal and state 

law. 

41. Any of Plaintiff’s claims for punitive or exemplary damages violate, and are 

therefore barred by, the Fourth, Fifth, Sixth, Eighth and Fourteenth Amendments to the 

Constitution of the United States of America, and similar provisions of the Wisconsin 

Constitution, on grounds including the following: 

(a) it is a violation of the Due Process and Equal Protection Clauses of the 

Fourteenth Amendment of the United States Constitution to impose punitive 

damages, which are penal in nature, against a civil defendant upon the plaintiffs 

satisfying a burden of proof which is less than the “beyond a reasonable doubt” 

burden of proof required in criminal cases; 

(b) the procedures pursuant to which punitive damages are awarded may result in 

the award of joint and several judgments against multiple defendants for 

different alleged acts of wrongdoing, which infringes upon the Due Process and 

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Equal Protection Clauses of the Fourteenth Amendment of the United States 

Constitution; 

(c) the procedures to which punitive damages are awarded fail to provide a 

reasonable limit on the amount of the award against Defendants, which thereby 

violates the Due Process Clause of the Fourteenth Amendment of the United 

States Constitution; 

(d) the procedures pursuant to which punitive damages are awarded fail to provide 

specific standards for the amount of the award of punitive damages which 

thereby violates the Due Process Clause of the Fourteenth Amendment of the 

United States Constitution; 

(e) the procedures pursuant to which punitive damages are awarded result in the 

imposition of different penalties for the same or similar acts, and thus violate 

the Equal Protection Clause of the Fourteenth Amendment of the United States 

Constitution; 

(f) the procedures pursuant to which punitive damages are awarded permit the 

imposition of punitive damages in excess of the maximum criminal fine for the 

same or similar conduct, which thereby infringes upon the Due Process Clause 

of the Fifth and Fourteenth Amendments and the Equal Protection Clause of the 

Fourteenth Amendment of the United States Constitution; 

(g) the procedures pursuant to which punitive damages are awarded permit the 

imposition of excessive fines in violation of the Eighth Amendment of the 

United States Constitution; 

(h) the award of punitive damages to the plaintiff in this action would constitute a 

deprivation of property without due process of law; and 

(i) the procedures pursuant to which punitive damages are awarded permit the 

imposition of an excessive fine and penalty. 

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42. Defendants expressly reserve the right to raise as an affirmative defense that 

Plaintiff has failed to join all parties necessary for a just adjudication of this action, should 

discovery reveal the existence of facts to support such defense. 

43. Defendants reserve the right to raise such other affirmative defenses as may be 

available or apparent during discovery or as may be raised or asserted by other defendants in 

this case. Defendants have not knowingly or intentionally waived any applicable affirmative 

defense. If it appears that any affirmative defense is or may be applicable after Defendants 

have had the opportunity to conduct reasonable discovery in this matter, Defendants will 

assert such affirmative defense in accordance with the Federal Rules of Civil Procedure. 

REQUEST FOR JURY TRIAL

Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. demand a trial by jury 

on all issues appropriate for jury determination. 

WHEREFORE, Defendants aver that Plaintiff is not entitled to the relief demanded in 

the Plaintiff’s Complaint, and these Defendants, having fully answered, pray that this action 

against them be dismissed and that they be awarded their costs in defending this action and 

that they be granted such other and further relief as the Court deems just and appropriate. 

This 23rd day of February, 2016. 

s/Richard B. North, Jr. 

Richard B. North, Jr. 

Georgia Bar No. 545599 

Matthew B. Lerner 

Georgia Bar No. 446986 

NELSON MULLINS RILEY & SCARBOROUGH, LLP 

Atlantic Station 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

PH: (404) 322-6000 

FX: (404) 322-6050 

Richard.North@nelsonmullins.com 

(Continued on Following Page) 

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James R. Condo (#005867) 

Amanda Sheridan (#005867) 

SNELL & WILMER L.L.P. 

One Arizona Center 

400 E. Van Buren 

Phoenix, AZ 85004-2204 

PH: (602) 382-6000 

JCondo@swlaw.com 

ASheridan@swlaw.com 

Attorney for Defendants C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc. 

 

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CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on February 23, 2016, I electronically filed the foregoing

with the Clerk of the Court by using the CM/ECF system which will send notification of such 

filing to all counsel of record. 

s/Richard B. North, Jr. 

Richard B. North, Jr. 

Georgia Bar No. 545599 

NELSON MULLINS RILEY & SCARBOROUGH, LLP 

Atlantic Station 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

PH: (404) 322-6000 

FX: (404) 322-6050 

Richard.North@nelsonmullins.com 

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