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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 1 of 17
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`Christopher B. Dolan, Esq. (SBN 165358)
`Lourdes DeArmas, Esq. (SBN 210167)
`Allison L. Stone, Esq. (SBN 274607)
`Taylor French, Esq. (SBN 317880)
`DOLAN LAW FIRM, PC
`1438 Market Street
`San Francisco, California 94102
`Telephone: (415) 421-2800
`Facsimile: (415) 421-2830
`Attorneys for Plaintiffs,
`DAWNWILLIAMS and DANIEL WILLIAMS
`
`
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
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`Plaintiffs,
`
`DAWN WILLIAMS and DANIEL
`WILLIAMS,
`
`
`
`v.
`
`
`ETHICON WOMEN’S HEALTH AND
`UROLOGY, a Division of ETHICON, INC;
`GYNECARE, a Division of ETHICON,
`INC; ETHICON, INC; and JOHNSON &
`JOHNSON,
`
`
`
`
`
`
`Defendants.
`
`CASE NO.:
`
`COMPLAINT FOR DAMAGES AND DEMAND
`FOR JURY TRIAL
`
` 1. Strict Liability – Failure to Warn
` 2. Strict Liability – Manufacturing Defect
` 3. Negligence
` 4. Negligent Misrepresentation
` 5. Loss of Consortium
`
`
`
`
`
`All allegations in this Complaint are based upon information and belief except for those
`allegations which pertain to the Plaintiff named herein and her counsel. Each allegation in this
`Complaint either has evidentiary support or is likely to have evidentiary support after reasonable
`opportunity for further investigation and discovery. Plaintiff, for her causes of action against these
`Defendants, alleges as follows:
`///
`
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`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 2 of 17
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`NATURE OF CASE
`Plaintiff Dawn Williams and her husband, Plaintiff Daniel Williams, by their
`1.
`undersigned counsel, brings this Complaint against Ethicon Women’s Health and Urology, A
`Division Of Ethicon, Inc., Gynecare, A Division Of Ethicon, Inc., Ethicon, Inc., and Johnson &
`Johnson (collectively referred to herein as “Defendants”) related to the design, manufacture,
`marketing, distribution and sale of Defendants’ GYNECARE TVT™ Sling Retropubic System
`(“Retropubic Sling”) implanted in Plaintiff Dawn Williams. This action is for compensatory,
`equitable, injunctive, and declaratory relief. Plaintiff makes the following allegations based upon
`her individual personal knowledge as to her own acts, and upon information and belief, as well
`as upon her attorneys’ investigative efforts as to Defendants’ actions and misconduct and
`alleges as follows.
`
`JURISDICTION AND VENUE
`This Court has jurisdiction over this civil action pursuant to 28 U.S.C. §1332(a)
`2.
`inasmuch as the amount in controversy exceeds $75,000 and the Plaintiff is a citizen of a
`different state than the Defendants.
`3.
`Venue is proper under 28 U.S.C. §1391, inasmuch as a substantial part of the
`events or omissions giving rise to the claim occurred in this district.
`4.
`Defendants are subject to in personam jurisdiction in the U.S. District Court for the
`Northern District of California because Defendants placed a defective product in the stream of
`commerce, including in California, and that product caused personal injuries to Plaintiff while
`she resided in the State of California.
`
`5.
`
`6.
`
`PLAINTIFFS
`Plaintiff Dawn Williams is, and was, at all relevant times mentioned herein:
`a.
`A resident of the city of West Sacramento, State of California; and,
`b.
`Injured by Defendants’ conduct in the city of Fremont, State of California.
`Plaintiff Daniel Williams is, and was, at all relevant times mentioned herein:
`a.
`A resident of the city of West Sacramento, State of California; and,
`b.
`Injured by Defendants’ conduct in the city of Fremont, State of California.
`2
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`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`DEFENDANTS
`Plaintiffs are informed and believe, and based upon that information and belief
`7.
`allege, that Defendant Ethicon Women’s Health and Urology is a division of Ethicon, Inc., located
`at 555 US-22, Somerville, New Jersey.
`8.
`Plaintiffs are informed and believe, and based upon that information and belief
`allege, that Defendant Gynecare is a division of Ethicon, Inc., located at 555 US-22, Somerville,
`New Jersey.
`Plaintiffs are informed and believe, and based upon that information and belief
`9.
`allege, that Defendant Ethicon, Inc. is a wholly owned subsidiary of Defendant Johnson &
`Johnson, located at 555 US-22, Somerville, New Jersey.
`10.
`Plaintiffs are informed and believe, and based upon that information and belief
`allege, that Defendant, Johnson & Johnson is a corporation and, according to its website, the
`world’s largest and most diverse medical device and diagnostics company, with its worldwide
`headquarters located at One Johnson & Johnson Plaza, New Brunswick, New Jersey.
`(Collectively, Defendants Ethicon, Inc., Ethicon Women’s Health and Urology of Ethicon, Inc.,
`Gynecare, and Johnson & Johnson are hereinafter referred to as “Defendants.”)
`11.
`The true names and capacities, whether individual, corporate, partnership,
`associate, or otherwise of Defendant DOES 1 through 10, inclusive are unknown to Plaintiff who
`therefore sues these Defendants by such fictitious names. Plaintiff will seek leave to amend this
`complaint to allege Defendant DOES 1 through 10 true names and capacities when they are
`ascertained.
`Plaintiffs are informed and believe, and based upon that information and belief
`12.
`allege, that each Defendant named in this Complaint, including DOES 1 through 10, inclusive,
`is responsible in some manner for one or more of the events and happenings, and proximately
`caused the injuries and damages, hereinafter alleged.
`13.
`Plaintiffs are informed and believe, and based upon that information and belief
`allege, that each Defendant named in this Complaint, including DOES 1 through 10, inclusive,
`are, and at all times mentioned herein were, the agent, servant, and/or employee of each of the
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`3
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`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`other Defendants, and that each Defendant was acting within the course and scope of his, her,
`or its authority as the agent, servant, and/or employee of each of the other Defendants.
`Consequently, each Defendant is jointly and severally liable to Plaintiff for the damages
`sustained as a proximate result of their conduct.
`14.
`Plaintiffs are informed and believe, and based upon that information and belief
`allege, that each Defendant named in this Complaint, including DOES 1 through 10, inclusive,
`are, and at all times mentioned herein were working jointly and in concert with one another to
`further their business of developing, designing, licensing, distributing, selling, marketing,
`advertising, and delivering, and introducing into interstate commerce within the United States
`transvaginal mesh products, specifically The Retropubic Sling Single Incision Sling System. At
`all times relevant hereto, each of the Defendants were the representatives, agents, employees,
`co-conspirators, servants, employees, partners, joint-venturers, franchisees, or alter egos of the
`other and was acting within the scope of this respective authority by virtue of those
`interrelationships.
`15.
`Plaintiffs are informed and believe, and based upon that information and belief
`allege, that each Defendant named in this Complaint, including DOES 1 through 10, inclusive,
`are, and at all times mentioned herein were individuals, sometimes referred to as detail persons,
`who provided instruction and guidance to Plaintiff Dawn Williams ’s physicians on how to market,
`sell and in the method and/or manner to perform surgery utilizing Defendant’s mesh products in
`conjunction with care and treatment provided to her.
`FACTUAL BACKGROUND
`16. Defendants Ethicon, Inc., Ethicon Women’s Health and Urology of Ethicon, Inc.,
`Gynecare, and Johnson & Johnson (Collectively hereinafter referred to as “Defendants”)
`developed, designed, licensed, advertised, delivered, manufactured, packaged, labeled,
`marketed, sold, and distributed Retropubic Sling which was implanted in Plaintiff Dawn Williams
`(“Mrs. Williams”).
`17.
`In or about October 2002, Defendants began to manufacture, market, and sell a
`product known as Gynemesh for the treatment of medical conditions in the female pelvis,
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`primarily pelvic organ prolapse and stress urinary incontinence. All references herein to
`Gynemesh include all variations of or names used for Gynemesh, including but not limited to
`Gynemesh PS.
`18. Gynemesh was derived from a product known as Prolene Mesh, which was used
`in the treatment of medical conditions in the female pelvis, primarily pelvic organ prolapse and
`stress urinary incontinence. Prolene Mesh was derived from Defendants’ Prolene mesh hernia
`product and was and is utilized in the treatment of medical conditions in the female pelvis,
`primarily pelvic organ prolapse and stress urinary incontinence. All references herein to Prolene
`Mesh include all variations of Prolene Mesh, including but not limited to Prolene Soft Mesh.
`19. On or about January l, 2005, without seeking clearance from the United States
`Food and Drug Administration (FDA), Defendants began to market and sell a product known as
`the Prolift System, for the treatment of medical conditions in the female pelvis, primarily pelvic
`organ prolapse and stress urinary incontinence. The Prolift System was and is offered as an
`anterior, posterior, or total repair system, and all references herein to the Prolift and/or Prolift
`System include by reference all variations thereof.
`20.
`In or about May 2008, Defendants began to market and sell a product known as
`Prolift+M System, for the treatment of medical conditions in the female pelvis, primarily pelvic
`organ prolapse and stress urinary incontinence. The Prolift+M System was and is offered as an
`anterior, posterior, or total repair system, and all references herein to the Prolift+M and/or Prolift
`+M System include by reference all variations thereof.
`21.
`In or about March 2010, Defendants began to market and sell a product known as
`Prosima System, for the treatment of medical conditions in the female pelvis, primarily pelvic
`organ prolapse and stress urinary incontinence. The Prosima was and is offered as an anterior,
`posterior, or total repair system, and all references to Prosima herein include by reference all
`variations thereof.
`22. Defendants market and sell a product known as TVT for the treatment of stress
`urinary incontinence in females. The TVT has been and is offered in multiple and significant
`variations including, but not limited to, the TVT, TVT-Obturator (TVT-O), TVTSECUR (TVT-S),
`
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`TVT Exact and TVT Abbrevo. All references to TVT herein include by reference all variations
`thereof.
`As stated above, the products known as Prolene Mesh, Gynemesh, Prolift,
`23.
`Prosima, Prolift+M, and TVT, as well as any as yet unidentified pelvic mesh products designed
`and sold for similar purposes, inclusive of the instruments and procedures for implantation, are
`collectively referenced to herein as Defendants’ “Pelvic Mesh Products” or the “Products.”
`24. Defendants’ Pelvic Mesh Products were designed, patented, manufactured,
`labeled, marketed, sold, and distributed by Defendants at all times relevant herein.
`25. Defendants did so knowing and intending that the Pelvic Mesh Products would be
`surgically implanted into women.
`26. On or about November 8, 2002, Plaintiff was implanted with one or more of
`Defendants’ Pelvic Mesh Products—a surgical repair mesh packaged as the Gynecare TVT-
`Obturator—during a surgical procedure conducted by her surgeon, Michael Goland, M.D., at
`Freemont Medical Center.
`27. Defendants’ Pelvic Mesh Products were implanted in Plaintiff to treat her pelvic
`floor prolapse and/or stress urinary incontinence, the uses for which Defendants manufactured,
`marketed, and/or sold them.
`28.
`As a result of having the Pelvic Mesh Products implanted in her, Plaintiff has
`sustained permanent injury, is seeking necessary corrective surgery, and has experienced, and
`will continue to experience, significant mental and physical pain and suffering, financial, or
`economic loss, including without limitation obligations for medical services and expenses.
`29.
`At all times relevant to this matter, Defendants have marketed their Pelvic Mesh
`Products to the medical community and/or medical device manufacturers and to patients and
`consumers as safe, effective, reliable, medical devices that can be implanted by safe and
`effective, minimally invasive surgical techniques for the treatment of medical conditions, primarily
`pelvic organ prolapse and stress urinary incontinence, and as safer and more effective when
`compared to the traditional products and procedures for treatment and other competing pelvic
`mesh products.
`
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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 6 of 17
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`30. Defendants have marketed and sold their Pelvic Mesh Products to medical device
`manufacturers, the medical community at large, and patients through carefully planned,
`multifaceted marketing campaigns and strategies. These campaigns and strategies include
`without limitation direct-to-consumer advertising; aggressive marketing to healthcare providers
`at medical conferences, hospitals, private offices; and/or the provision of valuable consideration
`and benefits to healthcare providers. Defendants also utilized documents, brochures, websites,
`and/or telephone information lines in offering exaggerated and misleading expectations as to the
`safety and utility of the products.
`31. Contrary to Defendants’ representations and marketing to the medical community
`and to the patients themselves, Defendants’ Pelvic Mesh Products have high failure, injury, and
`complication rates; fail to perform as intended; require frequent and often debilitating re-
`operations; and have caused severe and irreversible injuries, conditions, and damage to a
`significant number of women, including Plaintiff. A study published in the official publication of
`the American College of Obstetricians and Gynecologists based on a multi-center randomized
`controlled trial in August 2010concluded that there is a high vaginal mesh erosion (exposure of
`the mesh outside of the surgery site) rate (15.6%) with the Prolift, one of the Pelvic Mesh
`Products, “with no difference in overall objective and subjective cure rates. This study questions
`the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.” Iglesia CB,
`Sokol AI, Sokol ER, et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet
`Gynecol. 2010;116(2 Pt 1):293-303.
`32. Upon information and belief, Defendants have consistently underreported and
`withheld information about the propensity of their Pelvic Mesh Products to fail and to cause injury
`and complications, have misrepresented the efficacy and safety of their Pelvic Mesh Products
`through various means and media, and have actively and intentionally misled the FDA, the
`medical community, patients, and the public at large.
`33. Defendants have known, continue to know, and at all times had reason to know
`that their Pelvic Mesh Products were and are causing numerous patients severe injuries and
`complications like those suffered by Plaintiff and that their disclosures to the FDA were and are
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`incomplete and misleading. Defendants suppressed this information and failed to accurately and
`completely disseminate or share this and other critical information with the FDA, healthcare
`providers, and patients. As a result, Defendants actively and intentionally misled and continue
`to mislead the public, including the medical community, healthcare providers, and patients, into
`believing that their Pelvic Mesh Products were and are safe and effective, which led to the
`prescribing and implantation of one or more of the Pelvic Mesh Products into Plaintiff.
`34. Defendants individually and/or jointly failed to perform or rely on proper and
`adequate testing and research in order to determine and evaluate the risks and benefits of the
`Pelvic Mesh Products.
`35.
`Knowing the significant risk that the Pelvic Mesh Products would fail and/or imperil
`the health and welfare of the women in which they were implanted, Defendants failed to design
`the Pelvic Mesh Products in order to establish a safe, effective procedure for the removal of the
`Pelvic Mesh Products, rendering it impossible to safely or easily remove the Pelvic Mesh
`Products.
`Feasible and suitable alternative designs and products, as compared to
`36.
`Defendants’ Pelvic Mesh Products as well as suitable alternative procedures and instruments
`for implantation and treatment of stress urinary incontinence, pelvic organ prolapse, and other
`similar conditions, have existed at all times relevant.
`37.
`The Pelvic Mesh Products were at all times utilized and implanted in a manner
`foreseeable to Defendants.
`38. Defendants have at all times provided incomplete, insufficient, and misleading
`training and information to physicians, in order to increase the number of physicians utilizing the
`Pelvic Mesh Products, and thus increase the sales of the Pelvic Mesh Product. This has also
`led to the dissemination of inadequate and misleading information to doctors and patients,
`including Plaintiff.
`39.
`The Pelvic Mesh Products implanted into Plaintiff were in the same or substantially
`similar condition as they were when they left the possession of Defendants, and in the condition
`directed by and expected by Defendants.
`
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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 8 of 17
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`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`The injuries, conditions, and complications suffered by Plaintiff due to the Pelvic
`40.
`Mesh Products include without limitation dyspareunia, spastic pelvic floor syndrome, pudendal
`neuralgia, pelvic pain, groin pain, vaginal pain, inner thigh pain, and recurrent urinary
`incontinence.
`41. Despite knowledge of these catastrophic injuries, conditions, and complications
`caused by the Pelvic Mesh Products, Defendants manufactured, marketed, and sold the Pelvic
`Mesh Products while failing to adequately warn, label, instruct, and disseminate information with
`regard to the Pelvic Mesh Products, both prior to and after the marketing and sale of the Pelvic
`Mesh Products.
`42. On or about January 3, 2012, the FDA ordered Defendants to conduct randomized,
`controlled clinical testing of the Pelvic Mesh Products or be ordered to cease their manufacture,
`marketing, and sale.
`43. On or about June 5, 2012, Defendants announced that they were withdrawing
`some and/or all of the Pelvic Mesh Products from the market and, as a result, would not be
`conducting the randomized, controlled clinical testing ordered by the FDA.
`44.
`As of the date of the filing of this Complaint, Defendants have not begun or
`completed any of the randomized, controlled clinical testing ordered by the FDA.
`FIRST CAUSE OF ACTION
`STRICT LIABILITY – FAILURE TO WARN
`(By Plaintiff Dawn Williams Against All Defendants)
`Plaintiff repeats, re-alleges and incorporates by reference each and all of the
`45.
`allegations contained in paragraphs 1 through 44, inclusive, of this complaint, and by this
`reference incorporate the same into this cause of action herein.
`46. Defendants manufactured, sold and/or distributed the Product to Mrs. Williams to
`be used for the treatment of SUI and/or POP.
`47. Defendants manufacturing process and the raw materials used for their Product
`resulted in product defects.
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`At all times mentioned herein, the Product was and is dangerous and presented a
`48.
`substantial danger to patients who were implanted with the Product, and these risks and dangers
`were known or knowable at the time of distribution and implantation in the Mrs. Williams.
`Ordinary consumers would not have recognized the potential risks and dangers the Product
`posed to pelvic reconstruction patients because its uses were specifically promoted to improve
`the health of such patients. The Product was used in a way reasonably foreseeable to Defendant
`by Mrs. Williams. Defendant failed to provide warnings of such risks and dangers to Mrs.
`Williams as described herein.
`49. Mrs. Williams would not have consented to use the Retropubic Sling had
`Defendants given adequate warnings to Mrs. Williams and Plaintiff’s implanting physicians.
`50.
`As a result of the implantation of the Product, Mrs. Williams suffered debilitating
`injuries including, but not limited to, pudendal neuralgia, obturator neuralgia, complex regional
`pain syndrome, pelvic floor tension myalgia, dyspareunia, recurrent urinary tract infection,
`permanent disfigurement, hip adductor myalgia, anorectal pain, erosion, bowel and bladder
`dysfunction, loss of mobility, and the need for additional surgery and therapeutic treatments.
`51.
`At all times herein mentioned the Product was used in its original condition and as
`intended by Defendants and in a manner foreseeable to Defendants.
`52.
`As a result of the defective condition of the Product, namely the lack of sufficient
`warnings, Mrs. Williams has suffered the economic and non-economic losses in an amount to
`be proven at the time of trial.
`53.
`In doing the acts herein, the Defendants acted with oppression and/or fraud and/or
`malice demonstrating a conscious disregard for the rights and safety of the Mrs. Williams and
`others. Said wrongful conduct was done with advance knowledge and or authorization and/or
`was ratified by an officer, director and/or managing agent of the Defendants and warrants the
`imposition of an award of punitive damages.
`54.
`As a proximate result of the Defendants' design, manufacture, labeling, marketing,
`sale, and distribution of the Product, Plaintiff was injured catastrophically, and sustained severe
`
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`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`and permanent pain, suffering, disability, impairment, loss of enjoyment of life, loss of care,
`comfort, and consortium, and economic damages.
`SECOND CAUSE OF ACTION
`STRICT LIABILITY – MANUFACTURING DEFECT
`(By Plaintiff Dawn Williams Against All Defendants)
` Plaintiff repeats, re-alleges and incorporates by reference each and all of the
`55.
`allegations contained in paragraphs 1 through 54, inclusive, of this complaint, and by this
`reference incorporate the same into this cause of action herein.
`56.
`At all times herein mentioned, Defendants Product was prescribed and used as
`intended by Defendants and in a manner reasonably foreseeable to them. The Retropubic Sling
`sling was defective at the time of its manufacture, development, production, testing, inspection,
`endorsement, prescription, sale and distribution, and at the time it left the possession of the
`Defendants, in that, and not by way of limitation, the product differed from Defendants intended
`result and intended design and specifications, and from other ostensibly identical units of the
`same product line.
`57.
`As a proximate and legal result of the defective condition of the Product, Mrs.
`Williams was caused to suffer and will continue to suffer economic and non-economic losses in
`an amount to be proven at the time of trial.
`58.
`In doing the acts herein, the Defendants acted with oppression and/or fraud and/or
`malice demonstrating a conscious disregard for the rights and safety of the Mrs. Williams and
`others. Said wrongful conduct was done with advance knowledge and or authorization and/or
`was ratified by an officer, director and/or managing agent of the Defendants and warrants the
`imposition of an award of punitive damages.
`59.
`As a proximate result of the Defendants' design, manufacture, labeling, marketing,
`sale, and distribution of the Product, Plaintiff was injured catastrophically, an sustained severe
`and permanent pain, suffering, disability, impairment, loss of enjoyment of life, loss of care,
`comfort, and consortium, and economic damages.
`//
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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 12 of 17
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`THIRD CAUSE OF ACTION
`NEGLIGENCE
`(By Plaintiff Dawn Williams Against All Defendants)
`Plaintiff repeats, re-alleges and incorporates by reference each and all of the
`60.
`allegations contained in paragraphs 1 through 59, inclusive, of this complaint, and by this
`reference incorporate the same into this cause of action herein.
`61.
`At all times herein mentioned, Defendants, were engaged in the business of
`researching, manufacturing, licensing, fabricating, designing, labeling, distributing, supplying,
`promoting, selling, marketing, warranting, packaging and advertising the Product and/or
`directing Physicians and Surgeons how to use and implant the Product.
`62. Defendants owed to Mrs. Williams and the public a duty to act reasonably and to
`exercise ordinary care in pursuit of the activities mentioned above, and Defendants breached
`said duty of care.
`63.
`At all times relevant hereto, Defendants owed to Mrs. Williams and the public a
`duty to act reasonably and to exercise ordinary care with respect to the safe, legal, and proper
`manufacture, license, design, formulation, distribution, production, processing, assembly,
`testing, inspection, research, marketing, labeling, packaging, preparation for use, instruction and
`direction on implantation, use, issuance of warnings with respect to promotion, advertising, sale,
`and safety monitoring of the Product, and to adequately test and warn of the risk and dangers
`of the Product, both before and after sale.
`64.
`Additionally, Defendants owed to Mrs. Williams and the public a duty to provide
`accurate, reliable, and completely truthful information regarding the safety and any dangerous
`propensities of the Product manufactured, used, distributed, and/or supplied by them and to
`provide accurate, reliable, and completely truthful information regarding the failure of the Product
`to perform as intended or as an ordinary consumer would expect.
`65.
`At all times relevant hereto, Defendants breached the aforementioned duties in
`that it negligently and carelessly manufactured, fabricated, designed, licensed, produced,
`compounded, assembled, inspected or failed to inspect, tested or failed to test, warned or failed
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`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 13 of 17
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`13
`COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`to warn of the health hazards, labeled, distributed, handled, used, supplied, sold, marketed,
`warranted, packaged, promoted, advertised, instructed on the manner and method of
`implantation and surgery, the Product in that said Product caused, directly and proximately, the
`injuries of Mrs. Williams through failure of the Product to perform as intended or as an ordinary
`consumer would expect.
`66. Defendants' manufacturing process and the raw materials used for the Retropubic
`Sling sling resulted in product defects.
`67.
`The acts of Defendants constitute violations of the duty of ordinary care and skill
`owed by Defendants to Mrs. Williams and/or her physicians.
`68.
`Plaintiff used, handled, or was implanted with Defendants’ Product referred herein
`in a manner that was intended and reasonably foreseeable by Defendants.
`69.
`As the direct and proximate result of Defendants’ breach of its aforementioned
`duties with respect to the Retropubic Sling, Mrs. Williams suffered the economic and non-
`economic losses in an amount to be proven at the time of trial.
`70.
`In doing the acts herein, the Defendants acted with oppression and/or fraud and/or
`malice demonstrating a conscious disregard for the rights and safety of the Plaintiff and others.
`Said wrongful conduct was done with advance knowledge and or authorization and/or was
`ratified by an officer, director and/or managing agent of the Defendants and warrants the
`imposition of an award of punitive damages.
`71.
`As a proximate result of the oppression and/or fraud and/or malice demonstrating
`a conscious disregard for the rights and safety of the Plaintiff and other, Plaintiff was injured
`catastrophically, an sustained severe and permanent pain, suffering, disability, impairment, loss
`of enjoyment of life, loss of care, comfort, and consortium, and economic damages.
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`Case 3:21-cv-04285 Document 1 Filed 06/04/21 Page 14 of 17
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`FOURTH CAUSE OF ACTION
`NEGLIGENT MISREPRESENTATION
`(By Plaintiff Dawn Williams Against All Defendants)
`Plaintiff repeats, re-alleges and incorporates by reference each of the for each and
`72.
`all of the allegations contained in paragraphs 1 through 71, inclusive, of this complaint, and by
`this reference incorporate the same into this cause of action herein.
`73. Defendants from the time that the Retropubic Sling was first tested, studied,
`researched, first manufactured, marketed and distributed, and up to the present, made false
`representations concerning the product and its related procedures, as previously set forth herein,
`to the Mrs. Williams , her prescribing physicians and healthcare providers, the medical, scientific,
`pharmaceutical and healthcare communities, and the public in general, including, but not limited
`to, the misrepresentation that the Product was inert, safe, fit, and effective, permanent, would
`not cause inflammatory responses or infections, would not migrate and would not result in
`neuropathic and other acute and chronic nerve damage and pain for the treatment of pelvic
`organ prolapse and/or stress urinary incontinence.
`74.
`At all times relevant hereto, Defendants conducted a sales and marketing
`campaign to promote the sale of the Product and willfully deceived Mrs. Williams, her prescribing
`physicians and healthcare providers, the medical, scientific, pharmaceutical and healthcare
`communities, and the public in general as to the health risks and consequences of the use of
`the Product including but not limited to making the false representations outlined in Paragraph
`149.
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`75. Defendants made the foregoing misrepresentations without any reasonable
`ground for believing them to be true. These misrepresentations were made directly by
`Defendants, their sales wholesalers, distributors representatives, detail persons and other
`authorized agents of said Defendants, and in publicatio