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7 

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: 

BRADLEY RICKER, an individual,

 Plaintiff, 

v. 

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

PERIPHERAL VASCULAR INC., a 

corporation, and DOES 1 through 100, 

inclusive, 

 Defendants.

Case No. CV-16-00130-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 Bradley Ricker (“Plaintiff”) as follows: 

INTRODUCTORY ALLEGATIONS

1. Defendants admit that Plaintiff has brought this civil action for damages but 

deny that Plaintiff has suffered any personal injuries caused by Defendants, deny that 

Defendants are liable to Plaintiff, and deny that Plaintiff is entitled to any damages from 

Defendants. Defendants deny any remaining allegations contained in Paragraph 1 of 

Plaintiff’s Complaint. 

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

manufactured, including filters under the trademarks G2®, G2®X, G2® Express, EclipseTM, 

MeridianTM, and DenaliTM 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 trademarks G2®, G2®X, G2® Express, EclipseTM, 

MeridianTM, and DenaliTM Filter Systems. The allegations contained in Paragraph 2 of 

Plaintiff’s Complaint referencing the Recovery® Cone contain no factual allegations directed 

at Defendants and, therefore, require no response. To the extent a response is required, those 

allegations are denied. Defendants deny any remaining allegations contained in Paragraph 2 

of Plaintiff’s Complaint. 

3. Defendants admit that Plaintiff has brought this civil action for damages but 

deny that Plaintiff has suffered any personal injuries caused by Defendants, deny that 

Defendants are liable to Plaintiff, and deny that Plaintiff is entitled to any damages from 

Defendants. Defendants deny any remaining allegations contained in Paragraph 3 of 

Plaintiff’s Complaint. 

4. Defendants deny the allegations contained in Paragraph 4 of Plaintiff’s 

Complaint. 

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5. Defendants deny the allegations contained in Paragraph 5 of Plaintiff’s 

Complaint. 

6. Defendants deny that any of its inferior vena cava filter products are 

unreasonably dangerous or defective in any manner. Defendants admit that Bard owns a 

facility where vena cava filters are manufactured, including filters under the trademarks G2®, 

G2®X, G2® Express, EclipseTM, MeridianTM, and DenaliTM 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 trademarks G2®, 

G2®X, G2® Express, EclipseTM, MeridianTM, and DenaliTM Filter Systems. Defendants deny 

any remaining allegations contained in Paragraph 6 of Plaintiff’s Complaint. 

7. Defendants deny the allegations contained in Paragraph 7 of Plaintiff’s 

Complaint. 

PARTIES

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

to the truth of the allegations contained in Paragraph 8 of Plaintiff’s Complaint and, therefore, 

deny them. 

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

Bard is a New Jersey Corporation. Defendants admit that Bard owns a facility where vena 

cava filters are manufactured, including filters under the trademarks G2®, G2®X, G2® 

Express, EclipseTM, MeridianTM, and DenaliTM Filter Systems. Defendants further admit that 

Bard is authorized to do business, and does business, in the Commonwealth of Pennsylvania. 

Defendants deny any remaining allegations contained in Paragraph 9 of Plaintiff’s Complaint. 

10. Defendants admit that BPV is an Arizona Corporation. Defendants admit that 

BPV is a wholly owned subsidiary of Bard. 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 trademarks G2®, G2®X, G2® Express, EclipseTM, 

MeridianTM, and DenaliTM Filter Systems. Defendants admit that BPV is authorized to do 

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business, and does business, in the Commonwealth of Pennsylvania. Defendants deny any 

remaining allegations contained in Paragraph 10 of Plaintiff’s Complaint. 

11. Paragraph 11 of Plaintiff’s Complaint contains no factual allegations directed at 

Defendants and, therefore, requires no response. To the extent a response is required, 

Defendants deny those allegations. 

12. Paragraph 12 of Plaintiff’s Complaint contains no factual allegations directed at 

Defendants and, therefore, requires no response. To the extent a response is required, 

Defendants deny those allegations. 

JURISDICTION AND VENUE

13. Regarding Paragraph 13 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 Middle District of Pennsylvania. 

14. Regarding Paragraph 14 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 Middle District of Pennsylvania. 

GENERAL FACTUAL ALLEGATIONS

15. 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 or the identity of manufacturers of inferior vena cava filters. 

Defendants deny any remaining allegations of Paragraph 15 of Plaintiff’s Complaint. 

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

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

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

placement, or both. Defendants deny any remaining allegations of Paragraph 16 of Plaintiff’s 

Complaint. 

17. 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 17 of Plaintiff’s Complaint. 

18. 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 18 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 18 of Plaintiff’s Complaint and, on that basis, deny them. 

19. Defendants lack knowledge or information 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 doctors’ use of permanent filters. 

Defendants deny any remaining allegations contained in Paragraph 19 of Plaintiff’s 

Complaint. 

20. Defendants deny the allegations contained in Paragraph 20 of Plaintiff’s 

Complaint. 

21. Defendants deny the allegations contained in Paragraph 21 of Plaintiff’s 

Complaint. 

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

truth of the allegations regarding the medical community’s concerns regarding the desirability 

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of a retrievable filter. Defendants deny any remaining allegations of Paragraph 22 of 

Plaintiff’s Complaint. 

23. Defendants lack knowledge or information sufficient to admit or deny the 

allegations regarding the intent of any other manufacturers in developing inferior vena cava 

filter products. Defendants deny any remaining allegations of Paragraph 23 of Plaintiff’s 

Complaint. 

24. 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 24 of Plaintiff’s Complaint. 

25. Defendants deny the allegations contained in Paragraph 25 of Plaintiff’s 

Complaint. 

26. Defendants deny the 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, including all sub-parts thereof. 

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

Complaint. 

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

United States since at least 1992. Defendants further admit that the Simon Nitinol Filter is 

designed for permanent placement. Defendants deny any remaining allegations contained in 

Paragraph 30 of Plaintiff’s Complaint. 

31. 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® 

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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 31 of Plaintiff’s 

Complaint. 

32. Defendants deny the allegations contained in Paragraph 32 of Plaintiff’s 

Complaint. 

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, as stated. 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. Defendants deny any remaining 

allegations contained in Paragraph 34 of Plaintiff’s Complaint. 

35. The allegations contained in Paragraph 35 of Plaintiff’s Complaint 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. The remaining allegations contained 

in Paragraph 35 are not directed at Defendants and, therefore, require no response. To the 

extent a response is required, Defendants deny those allegations. 

36. The allegations contained in Paragraph 36 are not directed at Defendants and, 

therefore, require no response. To the extent a response is required, Defendants deny those 

allegations. 

37. The allegations contained in Paragraph 37 of Plaintiff’s Complaint 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. 

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

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

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

allegations contained in Paragraph 38 of Plaintiff’s Complaint. 

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

Complaint. 

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

Complaint. 

41. 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 41 of Plaintiff’s Complaint. 

42. 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 42 of Plaintiff’s Complaint. 

43. 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 43 of Plaintiff’s Complaint. 

44. Defendants admit that a nickel-titanium alloy named Nitinol is used in the 

manufacture of the Recovery® Filter. Defendants admit that Nitinol contains shape memory. 

Defendants deny any remaining allegations contained in Paragraph 44 of Plaintiff’s 

Complaint. 

45. Defendants admit that a nickel-titanium alloy named Nitinol is used in the 

manufacture of the Recovery® Filter. Defendants admit that Nitinol contains shape memory. 

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Defendants deny any remaining allegations contained in Paragraph 45 of Plaintiff’s 

Complaint. 

46. 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 46 of Plaintiff’s Complaint. 

47. 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 47 of Plaintiff’s Complaint. 

48. The allegations contained in Paragraph 48 of Plaintiff’s Complaint are 

conclusions of law, requiring no response. To the extent a response is required, 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, as stated. 

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. 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 

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

cava filters. 

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

Complaint. 

54. Defendants deny the allegations contained in Paragraph 54 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. 

55. Defendants admit that the MAUDE database is a publicly available database 

that houses certain data regarding adverse events with medical devices. By way of further 

response, Defendants state that information available in the public domain, including the 

FDA MAUDE database, is not a comprehensive analysis of all instances of such 

complications. 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 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 G2® Filter 

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

contained in Paragraph 58 of Plaintiff’s Complaint, including all sub-parts thereof. 

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59. 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 59 of Plaintiff’s Complaint. 

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

Complaint. 

61. Defendants deny the allegations contained in Paragraph 61 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. 

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. 

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

Complaint. 

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

Complaint. 

67. Defendants deny the allegations contained in Paragraph 67 of Plaintiff’s 

Complaint. 

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68. Defendants deny the allegations contained in Paragraph 68 of Plaintiff’s 

Complaint. 

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

Complaint. 

70. Defendants admit that there are various well-documented 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 any remaining allegations contained in Paragraph 70 of Plaintiff’s Complaint. 

71. Defendants deny the allegations contained in Paragraph 71 of Plaintiff’s 

Complaint. 

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

Complaint, including all sub-parts thereof. 

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

Complaint, including all sub-parts thereof. 

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

Complaint. 

75. Defendants deny the allegations contained in Paragraph 75 of Plaintiff’s 

Complaint. 

76. Defendants deny the allegations contained in Paragraph 76 of Plaintiff’s 

Complaint. 

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

Complaint, including all sub-parts thereof. 

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

Complaint. 

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

Complaint. 

80. Defendants deny the 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. 

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 deny the allegations contained in Paragraph 85 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

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

Complaint, including all sub-parts thereof. 

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

Complaint. 

88. Defendants admit that the EclipseTM Filter, which 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, was electropolished. Defendants deny 

the remaining allegations contained in Paragraph 88 of Plaintiff’s Complaint, including all 

sub-parts thereof. 

89. Defendants admit that the MeridianTM Filter 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 2011. Defendants deny the remaining allegations 

contained in Paragraph 89 of Plaintiff’s Complaint, including all sub-parts thereof. 

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90. Defendants admit that the DenaliTM Filter 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 2013 and that the DenaliTM Filter contained penetration 

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

Complaint, including all sub-parts thereof. 

91. Defendants admit 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. 

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. 

100. Defendants deny the allegations contained in Paragraph 100 of Plaintiff’s 

Complaint. 

101. Defendants deny the allegations contained in Paragraph 101 of Plaintiff’s 

Complaint. 

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102. Defendants deny the allegations contained in Paragraph 102 of Plaintiff’s 

Complaint. 

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

and Drug Administration in 2005 for permanent use pursuant to an application submitted 

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

allegations contained in Paragraph 103 of Plaintiff’s Complaint. 

104. Defendants admit that the FDA initially declined to clear the G2® Filter. 

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

Complaint. 

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

Complaint. 

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

and Drug Administration in 2005 for permanent 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 subsequently cleared for retrievable use in 2008. Defendants deny the 

remaining allegations contained in Paragraph 108 of Plaintiff’s Complaint, including any 

allegations contained in Footnotes 1 and 2. 

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, as stated. 

111. Defendants deny the allegations contained in Paragraph 111 of Plaintiff’s 

Complaint. 

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112. Defendants deny the allegations contained in Paragraph 112 of Plaintiff’s 

Complaint. 

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 admit that there are various well-documented 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. Defendants further state that there are incidents related to the occurrence of 

known complications associated with every manufacturer of inferior vena cava filters. 

Defendants deny any remaining allegations contained in Paragraph 120 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

121. Defendants admit that there are various well-documented complications that 

may occur as the result of the fracture of any inferior vena cava filter. Defendants state that 

there are incidents related to the occurrence of known complications associated with every 

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manufacturer of inferior vena cava filters. By way of further response, Defendants state that 

information available in the public domain, including the FDA MAUDE database, is not a 

comprehensive analysis of all instances of such complications. Defendants deny the 

remaining 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. By way of further response, Defendants state that information available in the 

public domain, including the FDA MAUDE database, is not a comprehensive analysis of all 

instances of such complications. 

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

Complaint. 

125. Defendants deny the allegations contained in Paragraph 125 of Plaintiff’s 

Complaint. 

126. 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 126 of Plaintiff’s Complaint. 

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

Complaint. 

128. Defendants deny that the G2® Filter, G2®X, or G2® Express Filters are 

unreasonably dangerous or defective in any manner. 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 EclipseTM Filter was developed in furtherance of those 

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efforts. Defendants deny any remaining allegations contained in Paragraph 128 of Plaintiff’s 

Complaint. 

129. 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, which was 

electropolished, was developed in furtherance of those efforts. Defendants deny any 

remaining 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. 

133. Defendants deny the allegations contained in Paragraph 133 of Plaintiff’s 

Complaint. 

134. Defendants admit that, 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 134 of Plaintiff’s Complaint. 

135. Defendants admit that, 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 135 of Plaintiff’s Complaint. 

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

Complaint. 

137. 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 further admit that the 

MeridianTM Filter is constructed of Nitinol. Defendants deny any remaining allegations 

contained in Paragraph 137 of Plaintiff’s Complaint. 

138. 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 further admit that the 

MeridianTM Filter was electropolished and contained a caudal anchoring system. Defendants 

deny any remaining allegations contained in Paragraph 138 of Plaintiff’s Complaint. 

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

Complaint. 

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

Complaint. 

141. 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 life-saving performance of those devices. The 

DenaliTM Filter was developed in furtherance of those efforts. 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 141 of Plaintiff’s 

Complaint. 

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

Complaint, as stated. By way of further answer, Defendants 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. 

143. 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 further admit that the 

MeridianTM Filter is made of Nitinol, is electropolished, and contains a caudal anchoring 

system and penetration limiters. Defendants deny any remaining allegations contained in 

Paragraph 143 of Plaintiff’s Complaint. 

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

Complaint. By way of further answer, 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. 

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. 

147. Defendants deny the allegations contained in Paragraph 147 of Plaintiff’s 

Complaint. 

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

Complaint. 

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

Complaint. 

150. Defendants incorporate by reference their responses to Paragraphs 1-149 of 

Plaintiff’s Complaint as if fully set forth herein. 

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. 

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. 

157. Defendants deny the allegations contained in Paragraph 157 of Plaintiff’s 

Complaint. 

FIRST CAUSE OF ACTION

STRICT LIABILITY MANUFACTURING DEFECT

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

Plaintiff’s Complaint as if fully set forth herein. 

159. Defendants lack information or knowledge 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, therefore, deny them. Defendants admit that Bard owns a facility where vena 

cava filters are manufactured. Defendants further admit that BPV designs, sells, markets, and 

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distributes inferior vena cava filters. Defendants deny any remaining 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. 

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

Complaint. 

SECOND CAUSE OF ACTION

STRICT LIABILITY INFORMATION DEFECT

163. Defendants incorporate by reference their responses to Paragraphs 1-162 of 

Plaintiff’s Complaint as if fully set forth herein. 

164. Defendants lack information or knowledge 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, therefore, deny them. Defendants admit that Bard owns a facility where vena 

cava filters are manufactured. Defendants further admit that BPV designs, sells, markets, and 

distributes inferior vena cava filters. Defendants deny any remaining allegations contained in 

Paragraph 164 of Plaintiff’s Complaint. 

165. Defendants lack information or knowledge 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, therefore, deny them. Defendants admit that Bard owns a facility where vena 

cava filters are manufactured. Defendants further admit that BPV designs, sells, markets, and 

distributes inferior vena cava filters. Defendants deny any remaining allegations contained in 

Paragraph 165 of Plaintiff’s Complaint. 

166. Defendants admit that there are various well-documented 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 

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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 any remaining allegations contained in Paragraph 166 of Plaintiff’s Complaint. 

167. Defendants deny the allegations contained in Paragraph 167 of Plaintiff’s 

Complaint. 

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. 

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. 

172. Defendants deny the allegations contained in Paragraph 172 of Plaintiff’s 

Complaint. 

173. Defendants deny the allegations contained in Paragraph 173 of Plaintiff’s 

Complaint. 

THIRD CAUSE OF ACTION

STRICT LIABILITY DESIGN DEFECT

174. Defendants incorporate by reference their responses to Paragraphs 1-173 of 

Plaintiff’s Complaint as if fully set forth herein. 

175. Defendants lack information or knowledge 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, therefore, deny them. Defendants admit that Bard owns a facility where vena 

cava filters are manufactured. Defendants further admit that BPV designs, sells, markets, and 

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distributes inferior vena cava filters. Defendants deny any remaining allegations contained in 

Paragraph 175 of Plaintiff’s Complaint. 

176. Defendants deny the allegations contained in Paragraph 176 of Plaintiff’s 

Complaint. 

177. Defendants deny the allegations contained in Paragraph 177 of Plaintiff’s 

Complaint. 

178. Defendants deny the allegations contained in Paragraph 178 of Plaintiff’s 

Complaint. 

179. Defendants deny the allegations contained in Paragraph 179 of Plaintiff’s 

Complaint. 

180. Defendants deny the allegations contained in Paragraph 180 of Plaintiff’s 

Complaint. 

181. Defendants deny the allegations contained in Paragraph 181 of Plaintiff’s 

Complaint. 

182. Defendants deny the allegations contained in Paragraph 182 of Plaintiff’s 

Complaint. 

183. Defendants deny the allegations contained in Paragraph 183 of Plaintiff’s 

Complaint. 

FOURTH CAUSE OF ACTION

NEGLIGENCE – DESIGN

184. Defendants incorporate by reference their responses to Paragraphs 1-183 of 

Plaintiff’s Complaint as if fully set forth herein. 

185. Defendants deny the allegations contained in Paragraph 185 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

186. Defendants deny the allegations contained in Paragraph 186 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

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187. The allegations contained in Paragraph 187 of Plaintiff’s Complaint regarding 

Defendants’ legal duties are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. 

188. Defendants deny the allegations contained in Paragraph 188 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

189. Defendants deny the allegations contained in Paragraph 189 of Plaintiff’s 

Complaint. 

FIFTH CAUSE OF ACTION

NEGLIGENCE – MANUFACTURE

190. Defendants incorporate by reference their responses to Paragraphs 1-189 of 

Plaintiff’s Complaint as if fully set forth herein. 

191. The allegations contained in Paragraph 191 of Plaintiff’s Complaint regarding 

Defendants’ legal duties are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. 

192. Defendants deny the allegations contained in Paragraph 192 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

193. Defendants deny the allegations contained in Paragraph 193 of Plaintiff’s 

Complaint. 

SIXTH CAUSE OF ACTION

NEGLIGENCE – FAILURE TO RECALL/RETROFIT

194. Defendants incorporate by reference their responses to Paragraphs 1-193 of 

Plaintiff’s Complaint as if fully set forth herein. 

195. The allegations contained in Paragraph 195 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. 

196. Defendants deny the allegations contained in Paragraph 196 of Plaintiff’s 

Complaint. 

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197. Defendants deny the allegations contained in Paragraph 197 of Plaintiff’s 

Complaint. 

198. Defendants deny the allegations contained in Paragraph 198 of Plaintiff’s 

Complaint. 

199. The allegations contained in Paragraph 199 of Plaintiff’s Complaint regarding 

Defendants’ legal duties are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. 

200. Defendants deny the allegations contained in Paragraph 200 of Plaintiff’s 

Complaint. 

201. Defendants deny the allegations contained in Paragraph 201 of Plaintiff’s 

Complaint. 

SEVENTH CAUSE OF ACTION

NEGLIGENCE – FAILURE TO WARN

202. Defendants incorporate by reference their responses to Paragraphs 1-201 of 

Plaintiff’s Complaint as if fully set forth herein. 

203. Defendants deny the allegations contained in Paragraph 203 of Plaintiff’s 

Complaint. 

204. Defendants deny the allegations contained in Paragraph 204 of Plaintiff’s 

Complaint. 

205. Defendants deny the allegations contained in Paragraph 205 of Plaintiff’s 

Complaint. 

206. Defendants deny the allegations contained in Paragraph 206 of Plaintiff’s 

Complaint. 

207. The allegations contained in Paragraph 207 of Plaintiff’s Complaint regarding 

Defendants’ legal duties are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. 

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208. Defendants deny the allegations contained in Paragraph 208 of Plaintiff’s 

Complaint. 

209. Defendants deny the allegations contained in Paragraph 209 of Plaintiff’s 

Complaint. 

EIGHTH CAUSE OF ACTION

NEGLIGENT MISREPRESENTATION

210. Defendants incorporate by reference their responses to Paragraphs 1-209 of 

Plaintiff’s Complaint as if fully set forth herein. 

211. Defendants deny the allegations contained in Paragraph 211 of Plaintiff’s 

Complaint. 

212. Defendants deny the allegations contained in Paragraph 212 of Plaintiff’s 

Complaint. 

213. The allegations contained in Paragraph 213 of Plaintiff’s Complaint regarding 

Defendants’ legal duties are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. 

214. Defendants deny the allegations contained in Paragraph 214 of Plaintiff’s 

Complaint. 

215. Defendants deny the allegations contained in Paragraph 215 of Plaintiff’s 

Complaint. 

216. Defendants deny the allegations contained in Paragraph 216 of Plaintiff’s 

Complaint. 

217. Defendants deny the allegations contained in Paragraph 217 of Plaintiff’s 

Complaint. 

218. The allegations contained in Paragraph 218 of Plaintiff’s Complaint regarding 

Defendants’ legal duties are conclusions of law, to which no response is required. To the 

extent a response is required, Defendants deny those allegations. 

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219. Defendants deny the allegations contained in Paragraph 219 of Plaintiff’s 

Complaint. 

220. Defendants deny the allegations contained in Paragraph 220 of Plaintiff’s 

Complaint. 

NINTH CAUSE OF ACTION

NEGLIGENCE PER SE

221. Defendants incorporate by reference their responses to Paragraphs 1-220 of 

Plaintiff’s Complaint as if fully set forth herein. 

222. The allegations contained in Paragraph 222 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. 

223. Defendants deny the allegations contained in Paragraph 223 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

224. The allegations contained in Paragraph 224 of Plaintiff’s Complaint are not 

directed at Defendants and, therefore, require no response. To the extent a response is 

required, Defendants deny those allegations. 

225. The allegations contained in Paragraph 225 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. 

226. Defendants deny the allegations contained in Paragraph 226 of Plaintiff’s 

Complaint. 

TENTH CAUSE OF ACTION

BREACH OF EXPRESS WARRANTY

227. Defendants incorporate by reference their responses to Paragraphs 1-226 of 

Plaintiff’s Complaint as if fully set forth herein. 

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

to the truth of the allegations contained in Paragraph 228 of Plaintiff’s Complaint and, 

therefore, deny those allegations. 

229. The allegations contained in Paragraph 229 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. 

230. Defendants deny the allegations contained in Paragraph 230 of Plaintiff’s 

Complaint. 

231. Defendants deny the allegations contained in Paragraph 231 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

232. Defendants deny the allegations contained in Paragraph 232 of Plaintiff’s 

Complaint. 

ELEVENTH CAUSE OF ACTION

BREACH OF IMPLIED WARRANTY

233. Defendants incorporate by reference their responses to Paragraphs 1-232 of 

Plaintiff’s Complaint as if fully set forth herein. 

234. Defendants deny the allegations contained in Paragraph 234 of Plaintiff’s 

Complaint. 

235. Defendants deny the allegations contained in Paragraph 235 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

236. Defendants deny the allegations contained in Paragraph 236 of Plaintiff’s 

Complaint. 

TWELFTH CAUSE OF ACTION

FRAUDULENT MISREPRESENTATION

237. Defendants incorporate by reference their responses to Paragraphs 1-236 of 

Plaintiff’s Complaint as if fully set forth herein. 

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238. Defendants deny the allegations contained in Paragraph 238 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

239. Defendants deny the allegations contained in Paragraph 239 of Plaintiff’s 

Complaint, as stated. 

240. Defendants deny the allegations contained in Paragraph 240 of Plaintiff’s 

Complaint. 

241. Defendants deny the allegations contained in Paragraph 241 of Plaintiff’s 

Complaint. 

242. Defendants deny the allegations contained in Paragraph 242 of Plaintiff’s 

Complaint. 

243. Defendants deny the allegations contained in Paragraph 243 of Plaintiff’s 

Complaint. 

244. Defendants deny the allegations contained in Paragraph 244 of Plaintiff’s 

Complaint. 

245. Defendants deny the allegations contained in Paragraph 245 of Plaintiff’s 

Complaint. 

246. Defendants deny the allegations contained in Paragraph 246 of Plaintiff’s 

Complaint. 

247. Defendants deny the allegations contained in Paragraph 247 of Plaintiff’s 

Complaint. 

248. Defendants deny the allegations contained in Paragraph 248 of Plaintiff’s 

Complaint. 

249. Defendants deny the allegations contained in Paragraph 249 of Plaintiff’s 

Complaint. 

250. Defendants deny the allegations contained in Paragraph 250 of Plaintiff’s 

Complaint. 

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251. Defendants deny the allegations contained in Paragraph 251 of Plaintiff’s 

Complaint. 

THIRTEENTH CAUSE OF ACTION

FRAUDULENT CONCEALMENT

252. Defendants incorporate by reference their responses to Paragraphs 1-251 of 

Plaintiff’s Complaint as if fully set forth herein. 

253. Defendants deny the allegations contained in Paragraph 253 of Plaintiff’s 

Complaint. 

254. Defendants deny the allegations contained in Paragraph 254 of Plaintiff’s 

Complaint, including all sub-parts thereof. 

255. Defendants deny the allegations contained in Paragraph 255 of Plaintiff’s 

Complaint. 

256. Defendants deny the allegations contained in Paragraph 256 of Plaintiff’s 

Complaint. 

257. Defendants deny the allegations contained in Paragraph 257 of Plaintiff’s 

Complaint. 

258. Defendants deny the allegations contained in Paragraph 258 of Plaintiff’s 

Complaint. 

FOURTEENTH CAUSE OF ACTION

VIOLATION OF APPLICABLE STATE LAW PROHIBITING

CONSUMER FRAUD AND UNFAIR DECEPTIVE TRADE PRACTICES

259. Defendants incorporate by reference their responses to Paragraphs 1-258 of 

Plaintiff’s Complaint as if fully set forth herein. 

260. The allegations contained in Paragraph 260 regarding Defendants’ legal duties 

are conclusions of law, to which no response is required. To the extent a response is required, 

Defendants deny those allegations. 

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261. Defendants deny the allegations contained in Paragraph 261 of Plaintiff’s 

Complaint. 

262. Defendants deny the allegations contained in Paragraph 262 of Plaintiff’s 

Complaint. 

263. Defendants deny the allegations contained in Paragraph 263 of Plaintiff’s 

Complaint. 

264. Defendants deny the allegations contained in Paragraph 264 of Plaintiff’s 

Complaint. 

265. Defendants deny the allegations contained in Paragraph 265 of Plaintiff’s 

Complaint. 

266. Defendants deny the allegations contained in Paragraph 266 of Plaintiff’s 

Complaint. 

267. Defendants deny the allegations contained in Paragraph 267 of Plaintiff’s 

Complaint. 

268. Defendants deny the allegations contained in Paragraph 268 of Plaintiff’s 

Complaint. 

269. Defendants deny the allegations contained in Paragraph 269 of Plaintiff’s 

Complaint. 

270. Defendants deny the allegations contained in Paragraph 270 of Plaintiff’s 

Complaint. 

271. Defendants deny the allegations contained in Paragraph 271 of Plaintiff’s 

Complaint. 

PUNITIVE DAMAGES ALLEGATIONS

272. Defendants incorporate by reference their responses to Paragraphs 1-271 of 

Plaintiff’s Complaint as if fully set forth herein. 

273. Defendants deny the allegations contained in Paragraph 273 of Plaintiff’s 

Complaint. 

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274. Defendants deny the allegations contained in Paragraph 274 of Plaintiff’s 

Complaint. 

275. Defendants deny the allegations contained in Paragraph 275 of Plaintiff’s 

Complaint. 

276. Defendants deny the allegations contained in Paragraph 276 of Plaintiff’s 

Complaint. 

277. Defendants deny the allegations contained in Paragraph 277 of Plaintiff’s 

Complaint. 

278. Defendants deny the allegations contained in Paragraph 278 of Plaintiff’s 

Complaint. 

279. Defendants deny the allegations contained in Paragraph 279 of Plaintiff’s 

Complaint. 

280. Defendants deny the allegations contained in Paragraph 280 of Plaintiff’s 

Complaint. 

281. Defendants deny the allegations contained in Paragraph 281 of Plaintiff’s 

Complaint. 

282. Defendants deny the allegations contained in Paragraph 282 of Plaintiff’s 

Complaint. 

PRAYER FOR RELIEF

Furthermore, responding to the unnumbered Paragraph, including sub-parts, following 

the heading “PRAYER FOR RELIEF” and beginning “WHEREFORE,” Defendants deny the 

allegations contained in such Paragraph and all sub-parts thereof. 

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

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. 

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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 himself to a known risk and/or 

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

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. 

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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. 

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. 

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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. 

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. 

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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. 

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. 

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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 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. 

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 

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

the Pennsylvania 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 Pennsylvania 

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 

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 

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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. 

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 

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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 25th 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 

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 25, 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 

Case 2:15-md-02641-DGC Document 885 Filed 02/25/16 Page 42 of 42