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`DOCKET # UWY-CV19-6051392-S
`
`TRACEY A. KING, JOSEPH KING
`
`Plaintiff,
`
` v.
`
`JOHNSON & JOHNSON, ET AL.
`
`Defendants.
`
`
`
`: SUPERIOR COURT
`:
`
`:
`J.D. OF WATERBURY
`:
`
`: COMPLEX LITIGATION DOCKET
`:
`
`:
`
`:
`
`: APRIL 23, 2021
`
`DEFENDANT ETHICON, INC.’S
`ANSWER AND SECOND AMENDED SPECIAL DEFENSES
`
`Pursuant to this court’s order of March 24, 2021, Defendant Ethicon, Inc. hereby submits it
`
`Answer and Second Amended Special Defenses to the Amended Complaint, dated July 6,
`
`2020 (“Amended Complaint”) of Plaintiffs Tracey King and Joseph King (“Plaintiffs”), as follows.
`
`Any allegation not specifically admitted is deemed denied.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of the
`
`allegations contained in the first unnumbered paragraph of the Amended Complaint, and, therefore
`
`Ethicon denies those allegations.
`
`Ethicon admits that Johnson & Johnson is a business corporation organized under the laws of
`
`the State of New Jersey with its principal place of business at One Johnson & Johnson Plaza in New
`
`Brunswick, New Jersey. Ethicon admits further that Johnson & Johnson is a holding company that
`
`does not manufacture, market, distribute, sell or design any products or services. Ethicon further
`
`admits that Johnson & Johnson’s website speaks for itself. Ethicon denies the remaining allegations
`
`contained in the second unnumbered paragraph of the Amended Complaint.
`
`Ethicon admits that Ethicon, Inc. is a business corporation organized under the laws of the
`
`State of New Jersey with its principal place of business at Route 22 West, Somerville, New Jersey
`
`08876, and that it is a wholly owned subsidiary of Johnson & Johnson. Ethicon denies the remaining
`
`allegations contained in the third unnumbered paragraph of the Amended Complaint.
`
`

`

`Ethicon admits that Ethicon Women’s Health and Urology (“EWH&U”) is an internal division
`
`of Ethicon, Inc. Ethicon further states that EWH&U is a non-juridical entity that is incapable of suing
`
`or being sued in its own name. Ethicon denies the remaining allegations contained in the fourth
`
`unnumbered paragraph of the Amended Complaint.
`
`Ethicon admits that Gynecare was a former internal division of Ethicon, Inc. that is now known
`
`as EWH&U. Ethicon further states that Gynecare is a non-juridical entity that is incapable of suing
`
`or being sued in its own name. Ethicon denies the remaining allegations contained in the fifth
`
`unnumbered paragraph of the Amended Complaint.
`
`The allegations of the sixth unnumbered paragraph of the Amended Complaint are not directed
`
`to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon lacks
`
`knowledge or information sufficient to form a belief as to the truth of the allegations contained in the
`
`sixth unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`The allegations of the seventh unnumbered paragraph of the Amended Complaint are not
`
`directed to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in the seventh unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`The allegations of the eighth unnumbered paragraph of the Amended Complaint are not
`
`directed to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in the eighth unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`
`
`2
`
`

`

`The allegations of the ninth unnumbered paragraph of the Amended Complaint are not directed
`
`to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon lacks
`
`knowledge or information sufficient to form a belief as to the truth of the allegations contained in the
`
`ninth unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`The allegations of the tenth unnumbered paragraph of the Amended Complaint are not directed
`
`to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon lacks
`
`knowledge or information sufficient to form a belief as to the truth of the allegations contained in the
`
`tenth unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`The allegations of the eleventh unnumbered paragraph of the Amended Complaint are not
`
`directed to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in the eleventh unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`The allegations of the twelfth unnumbered paragraph of the Amended Complaint are not
`
`directed to Ethicon and, therefore, require no response. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in the twelfth unnumbered paragraph of the Amended Complaint and, therefore, Ethicon denies those
`
`allegations.
`
`
`
`3
`
`

`

`RESPONSE TO “FIRST COUNT: (Product Liability Claim v. Johnson & Johnson; Ethicon,
`Inc., Ethicon Women’s Health and Urology, A Division of Ethicon, Inc.; Gynecare, A Division
`of Ethicon, Inc.)”1
`
`Response to “A. JOHNSON & JOHNSON DEFENDANTS”
`
`1.
`
`Paragraph 1 of the First Count of the Amended Complaint is not directed to Ethicon
`
`and, therefore, does not require a response by Ethicon. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in paragraph 1 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations.
`
`2.
`
`Ethicon admits only that in 1998, Ethicon, Inc. received FDA clearance through the
`
`510(k) process to market and sell TVT for uses consistent with its packaging and labeling, and that
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`the ProteGen Sling was identified as a predicate product in Ethicon’s 510(k) application for TVT.
`
`Ethicon denies the remaining allegations contained in paragraph 2 of the First Count of the Amended
`
`Complaint.
`
`3.
`
`Paragraph 3 of the First Count of the Amended Complaint is not directed to Ethicon
`
`and, therefore, does not require a response by Ethicon. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in paragraph 3 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations.
`
`4.
`
`Ethicon admits only that Ethicon, Inc. marketed and sold Gynemesh for uses consistent
`
`with its packaging and labeling. Johnson & Johnson does not market or sell any product. Ethicon
`
`denies the remaining allegations contained in paragraph 4 of the First Count of the Amended
`
`Complaint.
`
`
`1 The repetition of the Amended Complaint’s subheadings in the Answer is done solely for
`organizational purposes and is not an admission as to their truth.
`4
`
`
`

`

`5.
`
`Ethicon admits only that Ethicon, Inc. has manufactured, marketed, and sold Prolene
`
`Mesh for uses consistent with its packaging and labeling. Johnson & Johnson does not manufacture,
`
`market, or sell any product. Ethicon denies the remaining allegations contained in paragraph 5 of the
`
`First Count of the Amended Complaint.
`
`6.
`
`Ethicon admits only that Ethicon, Inc. marketed and sold Prolift for uses consistent
`
`with its packaging and labeling. Johnson & Johnson does not market or sell any product. Ethicon
`
`denies the remaining allegations contained in paragraph 6 of the First Count of the Amended
`
`Complaint.
`
`7.
`
`Ethicon admits only that Ethicon, Inc. marketed and sold Prolift +M for uses consistent
`
`with its packaging and labeling. Johnson & Johnson does not market or sell any product. Ethicon
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`denies the remaining allegations contained in paragraph 7 of the First Count of the Amended
`
`Complaint.
`
`8.
`
`Ethicon admits that Ethicon, Inc. has marketed and sold TVT, TVT-O, and TVT-S for
`
`uses consistent with their packaging and labeling. Johnson & Johnson does not market or sell any
`
`products. Ethicon denies the remaining allegations contained in paragraph 8 of the First Count of the
`
`Amended Complaint.
`
`9.
`
`Ethicon admits that Ethicon, Inc. has manufactured, marketed and sold certain of its
`
`pelvic mesh products, including but not limited to Prolene Mesh, Gynemesh, Prolift, Prolift +M, and
`
`TVT, for uses consistent with their packaging and labeling. Johnson & Johnson does not manufacture,
`
`market or sell any products. Ethicon denies the remaining allegations contained in paragraph 9 of the
`
`First Count of the Amended Complaint.2
`
`
`2 Ethicon objects to and denies that the definition of “Products Liability Defendants’ Pelvic Mesh
`Products” contained in Plaintiffs’ Amended Complaint should include any products other than
`Ethicon, Inc.’s pelvic mesh products. Therefore, Ethicon will respond to any such allegation
`contained in Plaintiffs’ Amended Complaint that references either “Products Liability Defendants’
`5
`
`
`

`

`10.
`
`Ethicon admits only that Ethicon, Inc. designed, manufactured, tested, marketed,
`
`promoted, and/or sold Prolene Mesh/Prolene Soft Mesh, Gynemesh, Gynemesh PS, TVT, TVT-
`
`Obturator (TVT-O), TVT-SECUR (TVT-S), TVT Exact, TVT Abbrevo, Prolift, Prolift +M, and
`
`Prosima for uses consistent with their packing and labeling. Johnson & Johnson does not design,
`
`manufacture, test, train, market, promote, package, label, sell or resell any product. As to any
`
`allegations contained in paragraph 10 of the First Count of the Amended Complaint that are directed
`
`towards Danbury Hospital and/or AMS/Astora and/or AMS/Astora’s product(s) allegedly at issue in
`
`this case, no response is required from Ethicon as to those allegations; to the extent a response is
`
`required to any such allegations, Ethicon would deny any such allegations directed towards Danbury
`
`Hospital and/or Physician Defendants and/or Physicians for Women’s Health, LLC and/or Women’s
`
`Health Connecticut, Inc. and/or Westwood Women’s Health and/or the AMS Defendants and the
`
`AMS Defendants’ product(s) allegedly at issue in this case for lack of knowledge. Ethicon denies the
`
`remaining allegations contained in paragraph 10 of the First Count of the Amended Complaint.
`
`11.
`
`Ethicon admits only that Ethicon, Inc. has manufactured, marketed and sold certain of
`
`its pelvic mesh products, including but not limited to Prolene Mesh, Prolene Soft Mesh, Gynemesh,
`
`Gynemesh PS, TVT, TVT-Obturator (TVT-O), TVT-Secur (TVT-S), TVT Exact, TVT Abbrevo,
`
`Prolift, Prolift +M, and Prosima, for uses consistent with their packaging and labeling. Johnson &
`
`Johnson does not manufacture, market or sell any product. Ethicon denies the remaining allegations
`
`contained in paragraph 11 of the First Count of the Amended Complaint.
`
`12.
`
`Ethicon admits only that Ethicon, Inc. has manufactured, marketed and sold certain of
`
`its pelvic mesh products, including but not limited to Prolene Mesh, Gynemesh, Prolift, Prolift +M,
`
`and TVT, for uses consistent with their packaging and labeling. Johnson & Johnson does not
`
`
`Pelvic Mesh Products,” “Defendants’ Pelvic Mesh Products,” “Pelvic Mesh Products,” and/or
`“Products” as if the term(s) include(s) such product(s) manufactured by Ethicon, Inc. only.
`6
`
`
`

`

`manufacture, market or sell any product. Ethicon objects to and denies that the definition of “pelvic
`
`mesh products” contained in Plaintiffs’ Amended Complaint should include any products other than
`
`Ethicon, Inc.’s pelvic mesh products. Therefore, Ethicon will respond to any such allegation
`
`contained in Plaintiff’s Amended Complaint that references either “Defendants’ Pelvic Mesh
`
`Products,” “Pelvic Mesh Products,” and/or “Products” as if the term(s) include(s) such product(s)
`
`manufactured by Ethicon, Inc. only. Ethicon denies the remaining allegations contained in paragraph
`
`12 of the First Count of the Amended Complaint.
`
`13.
`
`The allegations of paragraph 13 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and, therefore, do not require a response by Ethicon. To the extent a response is
`
`required, Ethicon lacks knowledge or information sufficient to form a belief as to the truth of the
`
`allegations contained in paragraph 13 of the First Count of the Amended Complaint and, therefore,
`
`Ethicon denies those allegations.
`
`14.
`
`The allegations of paragraph 14 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and state a legal conclusion, and, therefore, do not require a response by Ethicon.
`
`To the extent a response is required, Ethicon lacks knowledge or information sufficient to form a
`
`belief as to the truth of the allegations contained in paragraph 14 of the First Count of the Amended
`
`Complaint and, therefore, Ethicon denies those allegations.
`
`15.
`
`The allegations of paragraph 15 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and state a legal conclusion and, therefore, do not require a response by Ethicon.
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`To the extent a response is required, Ethicon lacks knowledge or information sufficient to form a
`
`belief as to the truth of the allegations contained in paragraph 24 of the First Count of the Amended
`
`Complaint and, therefore, Ethicon denies those allegations.
`
`16.
`
`The allegations of paragraph 16 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and, therefore, do not require a response by Ethicon. To the extent a response is
`
`
`
`7
`
`

`

`required, Ethicon lacks knowledge or information sufficient to form a belief as to the truth of the
`
`allegations contained in paragraph 16 of the First Count of the Amended Complaint and, therefore,
`
`Ethicon denies those allegations.
`
`17.
`
`The allegations of paragraph 17 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and state a legal conclusion and, therefore, do not require a response by Ethicon.
`
`To the extent a response is required, Ethicon lacks knowledge or information sufficient to form a
`
`belief as to the truth of the allegations contained in paragraph 17 of the First Count of the Amended
`
`Complaint and, therefore, Ethicon denies those allegations.
`
`18.
`
`The allegations of paragraph 18 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and, therefore, do not require a response by Ethicon by Ethicon. To the extent a
`
`response is required, Ethicon lacks knowledge or information sufficient to form a belief as to the truth
`
`of the allegations contained in paragraph 18 of the First Count of the Amended Complaint and,
`
`therefore, Ethicon denies those allegations.
`
`19.
`
`The allegations of paragraph 19 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and, therefore, do not require a response by Ethicon. To the extent a response is
`
`required, Ethicon lacks knowledge or information sufficient to form a belief as to the truth of the
`
`allegations contained in paragraph 19 of the First Count of the Amended Complaint and, therefore,
`
`Ethicon denies those allegations.
`
`20.
`
`The allegations of paragraph 20 of the First Count of the Amended Complaint are not
`
`directed to Ethicon and state a legal conclusion, and, therefore, do not require a response by Ethicon.
`
`To the extent a response is required, Ethicon lacks knowledge or information sufficient to form a
`
`belief as to the truth of the allegations contained in paragraph 20 of the First Count of the Amended
`
`Complaint and, therefore, Ethicon denies those allegations.
`
`
`
`8
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`

`

`Response to “FACTUAL BACKGROUND”
`
`
`
`21.
`
`The first two sentences in Paragraph 21 of the First Count of the Amended Complaint
`
`make no allegations against Ethicon and require no response by Ethicon. With respect to the third,
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`fourth, fifth, and sixth sentences in paragraph 21 of the Amended Complaint, Ethicon admits only that
`
`Ethicon, Inc. has manufactured, marketed, and sold certain products classified as Class II devices for
`
`uses consistent with their packaging and labeling. Johnson & Johnson does not manufacture or sell
`
`any product. Ethicon denies the remaining allegations contained in Paragraph 21 of the First Count of
`
`the Amended Complaint.
`
`22. With respect to the first sentence of paragraph 22 of the First Count of the Amended
`
`Complaint, Ethicon admits that certain of Ethicon, Inc.’s pelvic mesh products have been cleared by
`
`the FDA under the 510(k) Premarket Notification. The second sentence of paragraph 22 of the First
`
`Count of the Amended Complaint makes no allegation against Ethicon and requires no response by
`
`Ethicon. Johnson & Johnson does not market or sell any product. Ethicon admits further that it
`
`complied with the mandates of the Food and Drug Administration (“FDA”) and that the FDA
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`regulations referenced in paragraph 22 of the First Count of the Amended Complaint speak for
`
`themselves. Ethicon denies any remaining allegations contained in Paragraph 22 of the First Count of
`
`the Amended Complaint.
`
`23.
`
`Paragraph 23 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks
`
`sufficient knowledge or information so as to form a belief as to the truth of the allegations contained
`
`in paragraph 23 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations.
`
`24.
`
`Ethicon admits only that Ethicon, Inc. has designed, manufactured, marketed, sold, and
`
`distributed certain pelvic mesh products for uses consistent with their packaging and labeling.
`
`
`
`9
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`

`

`Johnson & Johnson does not design, patent, manufacture, label, market, sell, or distribute any product.
`
`Ethicon denies the remaining allegations contained in paragraph 24 of the First Count of the Amended
`
`Complaint.
`
`25.
`
`Ethicon admits only that certain of Ethicon, Inc.’s products contain polypropylene
`
`mesh. Ethicon denies the remaining allegations contained in paragraph 25 of the First Count of the
`
`Amended Complaint.
`
`26.
`
`27.
`
`28.
`
`Denied.
`
`Denied.
`
`Ethicon admits that Ethicon, Inc. has marketed certain of its pelvic mesh products for
`
`uses consistent with their packaging and labeling, and that they are safe and effective for uses
`
`consistent with their packaging and labeling. Johnson & Johnson does not market any product.
`
`Ethicon denies the remaining allegations contained in paragraph 28 of the First Count of the Amended
`
`Complaint.
`
`29.
`
`Ethicon denies the allegations contained in paragraph 29 of the First Count of the
`
`Amended Complaint as directed to it.
`
`30.
`
`31.
`
`32.
`
`33.
`
`34.
`
`35.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Ethicon states that the FDA Public Health Notification referenced in paragraph 35 of
`
`the First Count of the Amended Complaint speaks for itself. Ethicon denies the remaining allegations
`
`contained in paragraph 35 of the First Count of the Amended Complaint.
`
`
`
`10
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`

`

`36.
`
`Paragraph 36 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks
`
`sufficient knowledge or information so as to form a belief as to the truth of the allegations contained
`
`in paragraph 36 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations
`
`37.
`
`38.
`
`Denied.
`
`Paragraph 38 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the July 13, 2011 FDA Safety Communication speaks for itself. Ethicon denies the remaining
`
`allegations contained in paragraph 38 of the First Count of the Amended Complaint.
`
`39.
`
`Paragraph 39 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the July 13, 2011 FDA Safety Communication speaks for itself. Ethicon denies the remaining
`
`allegations contained in paragraph 39 of the First Count of the Amended Complaint.
`
`40.
`
`Paragraph 40 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the July 13, 2011 FDA Safety Communication speaks for itself. Ethicon denies the remaining
`
`allegations contained in paragraph 40 of the First Count of the Amended Complaint.
`
`41.
`
`Paragraph 41 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the FDA Publication titled “Urogynecologic Surgical Mesh: Update on the Safety and
`
`Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” speaks for itself. Ethicon denies
`
`the remaining allegations contained in paragraph 41 of the First Count of the Amended Complaint.
`
`
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`11
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`

`

`42.
`
`Paragraph 42 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the FDA Publication titled “Urogynecologic Surgical Mesh: Update on the Safety and
`
`Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” speaks for itself. Ethicon denies
`
`the remaining allegations contained in paragraph 42 of the First Count of the Amended Complaint.
`
`43.
`
`Paragraph 43 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the FDA Publication titled “Urogynecologic Surgical Mesh: Update on the Safety and
`
`Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” speaks for itself. Ethicon denies
`
`the remaining allegations contained in paragraph 43 of the First Count of the Amended Complaint.
`
`44.
`
`45.
`
`Denied.
`
`Paragraph 45 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent that a response is required, Ethicon admits
`
`only that the December 2011 Joint Committee Opinion of the American College of Obstetricians and
`
`Gynecologists (“ACOG”) and the American Urogynecologic Society (“AUGS”) speaks for itself.
`
`Ethicon denes the remaining allegations contained in paragraph 45 of Amended Complaint.
`
`46.
`
`47.
`
`Denied.
`
`Paragraph 47 of the First Count of the Amended Complaint makes no allegation against
`
`Ethicon and requires no response by Ethicon. To the extent a response is required, Ethicon lacks
`
`sufficient knowledge or information so as to form a belief as to the truth of the allegations contained
`
`in paragraph 47 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations.
`
`48.
`
`49.
`
`Denied.
`
`Denied.
`
`
`
`12
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`

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`50.
`
`51.
`
`52.
`
`53.
`
`54.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations contained in paragraph 54 of the First Count of the Amended Complaint; therefore,
`
`Ethicon denies those allegations.
`
`55.
`
`56.
`
`Denied.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations contained in paragraph 56 of the First Count of the Amended Complaint; therefore,
`
`Ethicon denies those allegations.
`
`Denied.
`
`Denied.
`
`Denied, including subparts (a) – (p) of paragraph 59 of the First Count of the Amended
`
`57.
`
`58.
`
`59.
`
`Complaint.
`
`60.
`
`Denied, including subparts (a) – (s) of paragraph 60 of the First Count of the Amended
`
`Complaint.
`
`61.
`
`62.
`
`Denied.
`
`Paragraph 62 of the First Count of the Amended Complaint is not directed to Ethicon
`
`and, therefore, does not require a response by Ethicon. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in paragraph 62 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations.
`
`
`
`13
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`

`

`63.
`
` Paragraph 63 of the First Count of the Amended Complaint is not directed to Ethicon
`
`and, therefore, does not require a response by Ethicon. To the extent a response is required, Ethicon
`
`lacks knowledge or information sufficient to form a belief as to the truth of the allegations contained
`
`in paragraph 63 of the First Count of the Amended Complaint; therefore, Ethicon denies those
`
`allegations.
`
`64.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations contained in paragraph 64 of the First Count of the Amended Complaint; therefore,
`
`Ethicon denies those allegations.
`
`65.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations contained in paragraph 65 of the First Count of the Amended Complaint; therefore,
`
`Ethicon denies those allegations.
`
`66.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations contained in paragraph 66 of the First Count of the Amended Complaint; therefore,
`
`Ethicon denies those allegations.
`
`67.
`
`Ethicon denies the allegations contained in paragraph 67 of the First Count of the
`
`Amended Complaint as directed to it.
`
`68.
`
`Ethicon denies the allegations contained in paragraph 68 of the First Count of the
`
`Amended Complaint as directed to it.
`
`69.
`
`Ethicon denies that Plaintiffs’ alleged injuries were caused by Ethicon, Inc.’s products.
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of the allegations
`
`contained in paragraph 69 of the First Count of the Amended Complaint, and, therefore, denies those
`
`allegations, including as to all subparts. Ethicon denies that Plaintiffs are entitled to any relief from
`
`Ethicon.
`
`70.
`
`Denied.
`
`
`
`14
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`

`

`71.
`
`Ethicon admits only that Ethicon, Inc. sold Prolene Mesh, Gynemesh, Prolift, Prolift
`
`+M, and TVT for uses consistent with the packaging and labeling, and that certain of Ethicon, Inc.’s
`
`pelvic mesh products have been available for purchase in the State of Connecticut. Johnson & Johnson
`
`does not sell any product. Ethicon denies the remaining allegations contained in paragraph 71 of the
`
`First Count of the Amended Complaint.
`
`72.
`
`Ethicon admits only that Ethicon, Inc. sold Prolene Mesh, Gynemesh, Prolift, Prolift
`
`+M, and TVT for uses consistent with the packaging and labeling, and that certain of Ethicon, Inc.’s
`
`pelvic mesh products have been available for purchase in the State of Connecticut. Johnson & Johnson
`
`does not sell any product. Ethicon denies the remaining allegations contained in paragraph 72 of the
`
`First Count of the Amended Complaint.
`
`73.
`
`Ethicon admits only that Ethicon, Inc. has certain duties imposed on it by law and
`
`denies that Ethicon, Inc. breached any such duties. Ethicon denies the remaining allegations in
`
`paragraph 73 of the First Count of the Amended Complaint.
`
`74.
`
`Ethicon admits only that Ethicon, Inc. has certain duties imposed on it by law and
`
`denies that Ethicon, Inc. breached any such duties. Ethicon denies the remaining allegations in
`
`paragraph 74 of the First Count of the Amended Complaint.
`
`75.
`
`76.
`
`Denied.
`
`Ethicon denies the allegations contained in paragraph 76 of the First Count of the
`
`Amended Complaint as directed to it.
`
`77.
`
`Ethicon denies the allegations contained in paragraph 77 of the First Count of the
`
`Amended Complaint as directed to it.
`
`78.
`
`79.
`
`80.
`
`Denied.
`
`Denied.
`
`Denied.
`
`
`
`15
`
`

`

`81.
`
`Denied, including sub-parts (a) – (f) of paragraph 81 of the First Count of the Amended
`
`Complaint.
`
`82.
`
`83.
`
`Denied.
`
`Ethicon admits only that Ethicon, Inc.’s products are safe, fit, and of merchantable
`
`quality for uses consistent with their packaging and labeling. Ethicon denies the remaining allegations
`
`contained in paragraph 83 of the First Count of the Amended Complaint.
`
`84.
`
`85.
`
`86.
`
`Denied.
`
`Denied.
`
`Ethicon admits only that Ethicon, Inc.’s products are safe, fit and of merchantable
`
`quality for uses consistent with their packaging and labeling. Ethicon denies the remaining allegations
`
`contained in paragraph 86 of the First Count of the Amended Complaint.
`
`87.
`
`88.
`
`89.
`
`Complaint.
`
`90.
`
`91.
`
`Complaint.
`
`92.
`
`93.
`
`Denied.
`
`Denied.
`
`Denied, including subparts (a) – (f) of paragraph 89 of the First Count of the Amended
`
`Denied.
`
`Denied, including subparts (a) – (f) of paragraph 91 of the First Count of the Amended
`
`Denied.
`
`Ethicon admits only that Ethicon, Inc. has sold certain of its pelvic mesh products for
`
`uses consistent with their packaging and labeling. Johnson & Johnson does not sell any product.
`
`Ethicon lacks sufficient knowledge or information to know whether Plaintiff was treated with any of
`
`Ethicon, Inc.’s products; therefore, Ethicon denies that allegation. Ethicon denies the remaining
`
`allegations contained in paragraph 93 of the First Count of the Amended Complaint.
`
`
`
`16
`
`

`

`94.
`
`Ethicon admits only that Ethicon, Inc.’s products are safe, fit and of merchantable
`
`quality for uses consistent with their packaging and labeling. Ethicon denies the remaining allegations
`
`contained in paragraph 94 of the First Count of the Amended Complaint
`
`95.
`
`96.
`
`97.
`
`98.
`
`99.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`100. Denied.
`
`101. Ethicon denies the allegations contained in paragraph 101 of the First Count of the
`
`Amended Complaint as directed to it.
`
`Response to “SECOND COUNT: (CUPTA v. Johnson & Johnson; Ethicon, Inc.; Ethicon
`Women’s Health and Urology, A Division of Ethicon, Inc.; Gynecare, A Division of Ethicon,
`Inc.)”
`
`
`
`1-101. Ethicon incorporates its responses to every allegation contained in paragraphs 1-101
`
`of the First Count of the Amended Complaint by reference as if expressly set forth herein.
`
`102. Denied.
`
`103. Denied.
`
`104. Denied.
`
`105. Denied.
`
`106. Denied.
`
`107. Ethicon lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations contained in paragraph 107 of the Second Count of the Amended Complaint and,
`
`therefore, Ethicon denies those allegations.
`
`
`
`
`
`
`
`17
`
`

`

`Response to “THIRD COUNT: (Lack of Informed Consent v. Mark R. Preston, M.D., and
`Physicians for Women’s Health, LLC a/k/a Women’s Health Connecticut, Inc., d/b/a Westwood
`Women’s Health, Westwood Women’s Health (“Physician Defendants”))
`
`1-11.
`
`In response to the allegations contained in paragraphs 1 through 11 of the Third Count
`
`of the Amended Complaint, Ethicon incorporates its responses to paragraphs 1 through 11 of the First
`
`Count of the Amended Complaint by reference as if expressly set forth herein.
`
`12.
`
`The allegations of paragraph 12 of the Third Count of the Amended Complaint are not
`
`directed to Ethicon and, therefore, do not require a response. To the extent a response is required,
`
`Ethicon lacks knowledge or information sufficient to form a belief as to the truth of the allegations
`
`contained in paragraph 12 of the Third Count of the Amended Complaint and, therefore, Ethicon
`
`denies those allegations.
`
`13.
`
`Ethicon admits only that in 1998, Ethicon, Inc. received FDA clearance through the
`
`510(k) process to market and sell TVT for uses consistent with its packaging and labeling, and that
`
`the ProteGen Sling was identified as a predicate product in Ethicon, Inc.’s 510(k) application for TVT.
`
`Ethicon denies the remaining allegations contained in paragraph 13 of the Third Count of the
`
`Amended Complaint.
`
`14.
`
`Paragraph 14 of the Third Count of the Amended Complaint is not directed to Ethicon
`
`and, therefore, does not require a response by Ethicon. To the extent a response is required, Ethicon
`
`lac