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IN THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA 

CHARLESTON DIVISION 

MDL No. 2327 

In Re Ethicon Inc., Pelvic Repair System Products Liability Litigation 

______________________________________________________________________________ 

FIRST AMENDED MASTER LONG FORM COMPLAINT AND JURY DEMAND

 Plaintiffs, by and through counsel, bring this First Amended Master Long Form 

Complaint (“First Amended Master Complaint”) as an administrative device to set forth potential 

claims individual Plaintiffs may assert against Defendants in this litigation. By operation of the 

Order of this Court, all allegations pled herein are deemed pled in any previously filed Complaint 

and any Short-Form Complaint hereafter filed. Accordingly, Plaintiffs allege as follows: 

I. PARTIES

A. Plaintiffs

1. Plaintiffs include women who had one or more of Defendants’ Pelvic 

Mesh Products (defined below) inserted in their bodies to treat medical conditions, primarily 

pelvic organ prolapse and stress urinary incontinence. 

2. Plaintiffs also include the spouses and intimate partners of the aforesaid 

women, as well as others with standing to file claims arising from Defendants’ Products. 

B. Defendants

3. Defendant, Johnson & Johnson (“J&J”) 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. Johnson & Johnson organizes its subsidiary businesses into individual Business Units to 

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coordinate the development, manufacture, testing, marketing promotion, training, distribution 

and sale of its’ pelvic floor repair products. Within J&J there are three sectors, medical devices 

and diagnostics, pharmaceutical, and consumer. Within the medical devices and diagnostic 

sector are “Business Units” including the “Ethicon Franchise.” The Ethicon Franchise was 

charged by J&J with the design, development, promotion, marketing, testing, training, 

distribution and sale of the pelvic floor repair products at issue in this case. The Company Group 

Chairman and Worldwide Franchise Chairman for the Ethicon Franchise, Gary Pruden, is 

employed by J&J. The companies which comprise the Ethicon Franchise are thus controlled by 

J&J and include, but are not limited to, Ethicon Inc., Ethicon LLC, Ethicon LTD. 

4. Defendant, Ethicon, Inc., is a wholly owned subsidiary of Defendant 

Johnson & Johnson located in Somerville, New Jersey. 

5. Defendant, Ethicon, LLC, is a wholly owned subsidiary of Johnson & 

Johnson Medical, Inc., located in San Lorenzo, Puerto Rico. Ethicon LLC was charged by J&J 

with the manufacture of Ethicon Inc.’s pelvic floor repair products. 

6. Defendants, JOHN DOES 1-20 (fictitious names), are entities and/or 

persons who are liable to Plaintiffs, but who have not yet been identified despite reasonable due 

diligence on the part of Plaintiffs. 

7. At all times relevant herein, Defendants were engaged in the business of 

placing medical devices into the stream of commerce by designing, manufacturing, testing, 

training, marketing, promoting, packaging, labeling, and/or selling such devices, including the 

Prolene Mesh/Prolene Soft Mesh, Gynemesh, Gynemesh PS, TVT, TVT-Obturator (TVT-O), 

TVT-SECUR (TVT-S), TVT Exact, TVT Abbrevo, Prolift, Prolift +M, Prosima and other pelvic 

mesh products unknown at the present (hereinafter collectively referred to as “Pelvic Mesh 

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Products” or the “Products”). Defendants manufacture, market, advertise, promote and sell 

Pelvic Mesh Products worldwide. As a result of the coordinated activities of all Defendants 

named above, Plaintiff was implanted with a defective pelvic floor repair product. 

8. Defendants had a legal duty to insure the safety and effectiveness of their 

pelvic mesh products by conducting adequate and well controlled studies on their products prior 

to marketing. Defendants deliberately chose to manipulate the only studies that were conducted 

on their products and by so doing provided doctors and patients with false and misleading 

information about the safety and effectiveness of their pelvic mesh products. Furthermore, 

Defendants made a conscious decision to forego performing studies and creating registries that 

would have provided doctors and patients in the United States with accurate information 

regarding the lack of proof of the safety and effectiveness of their pelvic mesh products. 

II. JURISDICTION AND VENUE

9. Federal subject matter jurisdiction in the constituent actions is based upon 

28 U.S.C. § 1332(a), in that in each of the constituent actions there is complete diversity among 

Plaintiffs and Defendants and the amount in controversy exceeds $75,000. 

10. Defendants have significant contacts with the federal judicial district 

identified in the Short Form Complaint such that they are subject to the personal jurisdiction of 

the court in said district. 

11. A substantial part of the events and omissions giving rise to Plaintiffs’ 

causes of action occurred in the federal judicial district identified in the Short Form Complaint. 

Pursuant to 28 U.S.C. § 1391(a), venue is proper in said district. 

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III.DEFENDANTS’ PELVIC MESH PRODUCTS

12. 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, 

primarily pelvic organ prolapse and stress urinary incontinence. All references to Gynemesh 

include all variations of or names used for Gynemesh, including but not limited to Gynemesh PS. 

13. 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 to Prolene 

Mesh include all variations of Prolene Mesh, including but not limited to Prolene Soft Mesh. 

14. On or about January l, 2005, without seeking FDA clearance, the 

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 ProliftSystem was and is offered as an anterior, posterior, or total repair 

system, and all references to the Prolift and/or Prolift System include by reference all variations. 

15. On or about May, 2008, the 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 to the Prolift+M 

and/or Prolift +M System include by reference all variations. 

16. On 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 

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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 include by reference all 

variations. 

17. The 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), TVT Exact and TVT Abbrevo. All references to TVT include by reference all 

variations. 

18. As stated above, the products known as Prolene Mesh, Gynemesh, Prolift, 

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 herein as Defendants’ “Pelvic Mesh Products” or the “Products”. 

19. Defendants’ Pelvic Mesh Products were designed, patented, manufactured, 

labeled, marketed, sold and distributed by the Defendants, at all times relevant herein. 

IV.FACTUAL BACKGROUND 

20. Surgical mesh products have been used to repair abdominal hernias since 

the 1950s. In the 1970s, gynecologists began using surgical mesh products designed for hernia 

repair for abdominal repair to surgically repair prolapsed organs. In the 1990s, gynecologists 

began using this surgical mesh for the surgical treatment of pelvic organ prolapse (“POP”) and 

stress urinary incontinence (“SUI”). Manufacturers, including Defendants, began to modify the 

mesh used in hernia repair to be used as products specifically intended to correct POP an SUI. 

Today, defendants sell pelvic mesh “kits” which can include not only the surgical mesh, but also 

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tissue fixation anchors and insertion tools. The Products manufactured by Defendants are 

considered Class II medical devices. 

21. Defendants’ Pelvic Mesh Products are targeted for women who suffer 

from pelvic organ prolapse and stress urinary incontinence as a result of the weakening or 

damage caused to the walls of the vagina. These products are specifically promoted to physicians 

and patients as an innovative, minimally invasive procedure with minimal local tissue reactions, 

minimal tissue trauma and minimal pain while correcting vaginal prolapse, stress urinary 

incontinence, pelvic organ prolapse and/or rectocele. 

22. Moreover, these Pelvic Mesh Products contain polypropylene mesh. 

Despite claims that this material is inert, the scientific evidence shows that this mesh material is 

biologically incompatible with human tissue and promotes an immune response in a large subset 

of the population receiving Defendants’ Pelvic Mesh Products. This immune response promotes 

degradation of the polypropylene mesh, as well as the pelvic tissue, and can contribute to the 

formation of severe adverse reactions to the mesh. 

23. At various times, Defendants sought and obtained Food and Drug 

Administration (“FDA”) clearance to market the Pelvic Mesh Products under Section 510(k) of 

the Medical Device Amendment. Section 510(k) allows marketing of medical devices if the 

device is deemed substantially equivalent to other legally marketed predicate devices marketed 

prior to May 28, 1976. This clearance process did not require Defendants to prove the safety or 

efficacy of the Pelvic Mesh Products and, thus, a formal review of the safety and efficacy of the 

Pelvic Mesh Products was never conducted with regard to the Products. In the case of the Prolift 

product, Defendants marketed and sold the product for human implantation for over two years 

without the necessary clearance under Section 510(k) 

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24. Defendants’ Pelvic Mesh Products have been and continue to be marketed 

to the medical community and directly to patients as safe, effective, reliable, medical devices; 

implanted by safe and effective, minimally invasive surgical techniques for the treatment of 

medical conditions, primarily vaginal vault prolapse, stress urinary incontinence, pelvic organ 

prolapse and/or rectocele, and as safer and more effective as compared to the traditional products 

and procedures for treatment, and other competing Pelvic Mesh Products. 

25. The Defendants have marketed and sold the Pelvic Mesh Products to the 

medical community at large and directly to patients through carefully planned, multifaceted 

marketing campaigns and strategies. These campaigns and strategies include, but are not limited 

to, aggressive marketing to health care providers at medical conferences, hospitals, private 

offices, and include the provision of valuable cash and non-cash benefits to health care providers. 

Defendants also utilized documents, patient brochures, and websites, offering exaggerated and 

misleading expectations as to the safety and utility of the Pelvic Mesh Products. Defendants’ 

further engaged in direct-to-consumer marketing specifically designed to drive consumers to 

seek out these products for implantation into their bodies. 

26. At all times relevant to this action, Defendants intentionally, recklessly 

and/or negligently concealed, suppressed, omitted, and misrepresented the risks, dangers, 

defects, and disadvantages of the Pelvic Mesh Products and advertised, promoted, marketed, sold 

and distributed the Pelvic Mesh Products as a safe medical device when, in fact, Defendants 

knew that the Pelvic Mesh Products were not safe for their intended purposes and that the Pelvic 

Mesh Products would cause, and did cause, serious medical problems, and in some patients, 

catastrophic and permanent injuries. 

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27. For example, Defendants described in its Patient Brochures, Instructions 

for Use, and other marketing materials, that the known complications for its Pelvic Mesh 

Products were consistent with any surgical procedure of an implantable medical device and 

described such occurrences as “rare” and “small” when in fact Defendants knew or should have 

known that the complications were not “rare nor small” but common, permanent, and 

debilitating. 

28. Contrary to Defendants’ representations and marketing to the medical 

community and to the patients themselves, the Defendants’ Pelvic Mesh Products have high 

malfunction, 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 the Plaintiffs, making them defective 

under the law. The Products’ defects include, but are not limited to, the following: 

a. the use of polypropylene material in the mesh itself and the immune 

reaction that results, causing adverse reactions and injuries; 

b. in the case of the Prolift + M, the use of polypropylene in combination 

with monocryl, a partially dissolvable mesh that increases the immune 

reaction and inflammatory response; 

c. the design of the Pelvic Mesh Products to be inserted transvaginally into 

an area of the body with high levels of bacteria, yeast, and fungus that 

adhere to the mesh causing immune reactions and subsequent tissue 

breakdown and adverse reactions and injuries; 

d. the procedure itself, which is a part of the Pelvic Mesh Products, requires 

to the physician to insert the device “blindly,” resulting in nerve damage 

and damage to other internal organs; 

e. biomechanical issues with the design of the mesh that create strong 

amounts of friction between the mesh and the underlying tissue that 

subsequently cause that tissue to degrade resulting in injury; 

f. the lack of porosity in the mesh resulting in the formation of a scar plate 

that prohibits tissue in-growth, resulting in mesh contraction, nerve 

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damage, pain, and erosion of the mesh into other organs, and failure of the 

device; 

g. the use and design of anchors in the Pelvic Mesh Products which when 

placed correctly are likely to pass through and injure major nerve routes in 

the pelvic region; 

h. degradation of the mesh itself over time which causes the internal tissue to 

degrade resulting in injury; 

i. particle loss and or “shedding” of the mesh both during implantation and 

following implantation that results in additional undesirable complications 

including an increased inflammatory response and a migration of those 

particles resulting in injury. 

j. the welding and heating of the mesh itself during production which creates 

a toxic substance that contributes to the degradation of the mesh and host 

tissue alike; 

k. the design of trocars, as devices to insert the Pelvic Mesh Products into the 

vagina, are defective because the device requires tissue penetration in 

nerve rich environments which results frequently in the destruction of 

nerve endings causing pain and other injuries; 

l. the propensity of the mesh for “creep”, or to gradually elongate and 

deform when subject to prolonged tension inside the body; 

m. the propensity of the mesh to contract, retract, and/or shrink inside the 

body; 

n. the inelasticity of the mesh, causing them to be improperly matted to the 

delicate and sensitive areas of the vagina and pelvis where they are 

implanted, and causing pain upon normal daily activities that involve 

movement in the pelvic region (e.g., intercourse, defecation, walking); and 

o. the creation of a non-anatomic condition in the pelvis leading to chronic 

pain and functional disabilities when the mesh is implanting according to 

the manufacturer’s instructions. 

29. Upon information and belief, the Defendants have consistently 

underreported and withheld information about the propensity of Defendants’ Pelvic Mesh 

Products to fail and cause injury and complications, and have misrepresented the efficacy and 

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safety of the Pelvic Mesh Products, through various means and media, actively and intentionally 

misleading the FDA, the medical community, patients, and the public at large. 

30. Defendants have further deliberately chosen to forego the conduct of 

studies and registries to avoid reporting obligations that would be mandated under the federal 

regulations upon receipt of adverse event information. 

31. Despite the chronic underreporting of adverse events associated with the 

Defendants’ Pelvic Mesh Products, the underreporting of events associated with similarly 

designed competitor products, and Defendants’ deliberately avoiding the conduct of studies and 

registries to avoid the reporting of adverse events, eventually enough complaints were recorded 

for the FDA to issue a public health notification regarding the dangers of these devices. 

32. On October 20, 2008, the Food and Drug Administration (“FDA”) issued 

a Public Health Notification that described over 1,000 complaints (otherwise known as “adverse 

events”) that had been reported over a three-year period relating to Pelvic Mesh Products. 

Although the FDA notice did not identify the transvaginal mesh manufacturers by name, a 

review of the FDA’s MAUDE database indicates that the Defendants are one of the 

manufacturers of the Pelvic Mesh Products that are the subject of the notification. 

33. On July 13, 2011, the FDA issued a Safety Communication:” UPDATE on 

Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic 

Organ Prolapse." Therein, the FDA advised that it had conducted an updated analysis of adverse 

events reported to the FDA and complications reported in the scientific literature and concluded 

that surgical mesh used in transvaginal repair of Pelvic Organ Prolapse was an area of 

"continuing serious concern." (emphasis added) The FDA concluded that serious complications 

associated with surgical mesh for transvaginal repair of Pelvic Organ Prolapse, were “not rare.” 

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These serious complications include, but are not limited to neuromuscular problems, vaginal 

scarring/shrinkage and emotional problems. Many of the serious complications required medical 

and surgical treatment and hospitalization. 

34. The FDA concluded in its Safety Communication that it was not clear that 

transvaginal repair of Pelvic Organ Prolapse with mesh or repair of SUI with mesh kits are more 

effective than traditional non mesh repair of pelvic organ prolapse. Further, the FDA conducted a 

systematic review of the published scientific literature from 1996-2011 and concluded that based 

thereon, that transvaginal pelvic organ prolapse repair with mesh "does not improve symptomatic 

results or quality of life over traditional non mesh repair." The FDA concluded that "a mesh 

procedure may put the patient at risk for requiring additional surgery or for the development of 

new complications. Removal of the mesh due to mesh complications may involve multiple 

surgeries and significantly impair the patient's quality of life. Complete removal of mesh may not 

be possible." 

35. The information contained in the FDA's Public Health Notification of 

October 2008 and the FDA Safety Communication of July 13 2011, was known or knowable to 

Defendants and was not disclosed in oral or written communications, direct to consumer 

advertising in the form of patient brochures, instructions for use, or labeling. 

36. In fact, at the time Defendants began marketing each of its Pelvic Mesh 

Products, Defendants were aware that its Pelvic Mesh Products were associated with each and 

every one of the adverse events communicated by the FDA in its July 13, 2011 Safety 

Communication. 

37. In a December 2011 Joint Committee Opinion, the American College of 

Obstetricians and Gynecologists (“ACOG”) and the American Urogynecologic Society 

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(“AUGS”) also identified physical and mechanical changes to the mesh inside the body as a 

serious complication associated with vaginal mesh, stating: 

There are increasing reports of vaginal pain associated with changes that can 

occur with mesh (contraction, retraction, or shrinkage) that result in taut 

sections of mesh . . . Some of these women will require surgical intervention 

to correct the condition, and some of the pain appears to be intractable. 

38. Defendants knew or should have known about the Products’ risks and 

complications identified in the FDA Safety Communication and the ACOG/AUGS Joint 

Committee Opinion. 

39. Defendants also knew or should have known that: (1) some of the 

predicate products for the Pelvic Mesh Products had high failure and complication rates, 

resulting in the recall of some of these predicate devices (including a medical device known as 

Protogen device); (2) that there were and are differences between the Defendants’ Pelvic Mesh 

Products and some or all of the predicate products, rendering them unsuitable for designation as 

predicate products; (3) that significant differences exist and existed between the Pelvic Mesh 

Products and their predecessor and predicate products, such that the disclosures to the FDA were 

and are incomplete and misleading; and (4) that the Pelvic Mesh Products were and are causing 

numerous patients severe injuries and complications. 

40. The Defendants suppressed this information and failed to accurately and 

completely disseminate or share this and other critical information with the FDA, health care 

providers, and the patients. As a result, the Defendants actively and intentionally misled and 

continue to mislead the public, including the medical community, health care providers and 

patients, into believing that the Pelvic Mesh Products and the procedures for implantation were 

and are safe and effective, leading to the prescription for and implantation of the Pelvic Mesh 

Products into Plaintiff. 

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41. Defendants’ Pelvic Mesh Products are also defective due to Defendants’ 

failure to adequately warn or instruct the female Plaintiffs named in the Short Form Complaint 

and/or her health care providers of risks and complications including, but not limited to, the 

following: 

a. the Products’ propensities to contract, retract, and/or shrink inside the 

body; 

b. the Products’ propensities for degradation, fragmentation and/or creep; 

c. the Products’ inelasticity preventing proper mating with the pelvic floor 

and vaginal region; 

d. the Products’ lack of porosity in preventing proper mating with the pelvic 

floor and vaginal region. 

e. the rate and manner of mesh erosion or extrusion; 

f. the risk of chronic inflammation resulting from the Products; 

g. the risk of chronic infections resulting from the Products; 

h. the risk of permanent vaginal or pelvic scarring as a result of the Products; 

i. the risk of permanent vaginal shorting as a result of the Products; 

j. the risk of recurrent, intractable pelvic pain and other pain resulting from 

the Products; 

k. the need for corrective or revision surgery to adjust or remove the 

Products; 

l. the severity of complications that could arise as a result of implantation of 

the Products; 

m. the hazards associated with the Products; 

n. the Products’ defects described herein; 

o. treatment of pelvic organ prolapse and stress urinary incontinence with the 

Products is no more effective than feasible available alternatives; 

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p. treatment of pelvic organ prolapse and stress urinary incontinence with the 

Products exposes patients to greater risk than feasible available 

alternatives; 

q. treatment of pelvic organ prolapse and stress urinary incontinence with the 

Products makes future surgical repair more difficult than feasible available 

alternatives; 

r. use of the Products puts the patient at greater risk of requiring additional 

surgery than feasible available alternatives; 

s. removal of the Products due to complications may involve multiple 

surgeries and may significantly impair the patient’s quality of life; and 

t. complete removal of the Products may not be possible and may not result 

in complete resolution of the complications, including pain; and 

u. the fact that neither pelvic organ prolapse, nor stress urinary incontinence, 

are life threatening conditions, and that other options, including nonsurgical options, were available and superior alternatives to the use of the 

Products. 

42. Defendants also failed to perform or rely on proper and adequate testing 

and research in order to determine and evaluate the risks and benefits of their Pelvic Mesh 

Products. 

43. Defendants failed to design and establish a safe, effective procedure for 

removal of the Pelvic Mesh Products. Therefore, in the event of a failure, injury, or 

complications, it is impossible to easily and safely remove the Pelvic Mesh Products. 

44. Feasible and suitable alternative designs as well as suitable alternative 

procedures and instruments for implantation have existed at all times relevant as compared to the 

Defendants’ Pelvic Mesh Products. 

45. The Pelvic Mesh Products were at all times utilized and implanted in a 

manner foreseeable to the Defendants, as Defendants generated the instructions for use, created 

the procedures for implanting the devices, and trained the implanting physicians. 

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46. Furthermore, the Defendants 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 Products, and 

also leading to the dissemination of inadequate and misleading information to patients, including 

Plaintiff. 

47. The Pelvic Mesh Products implanted into the Plaintiffs 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 the Defendants. 

48. Plaintiffs and Plaintiffs’ physicians foreseeably used and implanted the 

Pelvic Mesh Products, and did not misuse or alter the Pelvic Mesh Product in an unforeseeable 

manner. 

49. The injuries, conditions, and complications suffered by women who have 

been implanted with Defendants’ Pelvic Mesh Products include, but are not limited to, mesh 

erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, 

dyspareunia (pain during sexual intercourse), inability to engage in sexual relations, urinary 

problems, inability to void, blood loss, neuropathic and other acute and chronic nerve damage 

and pain, pudendal nerve damage, shortening of the vagina, pelvic floor damage, chronic pelvic 

pain, urinary and fecal incontinence, prolapse of organs, and in many cases the women have been 

forced to undergo intensive medical treatment, including but not limited to, operations to locate 

and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the 

use of pain control and other medications, injections into various areas of the pelvis, spine, and 

the vagina, and operations to remove portions of the female genitalia. 

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50. The medical and scientific literature studying the effects of polypropylene 

pelvic mesh, like Defendants’ Pelvic Mesh Products, have examined each of these injuries, 

conditions, and complications and determined that they are in fact casually related to the mesh 

itself and do not often implicate errors related to the implantation of the devices. 

51. Defendants misrepresented to the medical and healthcare community, 

Plaintiffs, the FDA, and the public that the Pelvic Mesh Products had been tested and were found 

to be safe and effective for the purposes of treating incontinence and/or prolapse. 

52. In the case of the Prolift device, Defendants misrepresented to the 

Plaintiffs, to the Plaintiffs’ physicians, and to the medical community at large, that such product 

had been properly cleared for marketing by the FDA when in fact no such clearance had been 

sought or obtained. 

53. These representations were made by Defendants with the intent of 

inducing the medical community, Plaintiff, and the public, to recommend, prescribe, dispense, 

and purchase the Pelvic Mesh Products for use as a means of treatment for stress urinary 

incontinence and/or prolapse, all of which evinced an indifference to the health, safety, and 

welfare of Plaintiff. 

54. Defendants failed to undertake their duties to properly know the qualities 

of their Pelvic Mesh Products and in representations to Plaintiffs and/or to Plaintiffs’ healthcare 

providers, and concealed and intentionally omitted the following material information: 

a. That the Pelvic Mesh Products were not as safe as other products and 

procedures available to treat incontinence and/or prolapse; 

b. That the Pelvic Mesh Products were not as effective as other products and 

procedures available to treat incontinence and/or prolapsed; 

c. That the risk of adverse events with the Pelvic Mesh Products was higher 

than with other products and procedures available to treat incontinence 

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and/or prolapse; 

d. That the risk of adverse events with the Pelvic Mesh Products were not 

adequately tested and were known by Defendants; 

e. That the limited clinical testing revealed the Pelvic Mesh Products had a 

higher risk of adverse effects, in addition to, and above and beyond those 

associated with other products and procedures available to treat 

incontinence and/or prolapse; 

f. That Defendants failed to follow up on the adverse results from clinical 

studies and buried and/or misrepresented those findings; 

g. That Defendants were aware of dangers in the Pelvic Mesh Products in 

addition to and above and beyond those associated with other products and 

procedures available to treat incontinence and/or prolapse; 

h. That the Pelvic Mesh Products were dangerous and caused adverse side 

effects, including but not limited to higher incidence of erosion and 

failure, at a much more significant rate than other products and procedures 

available to treat incontinence and/or prolapse; 

i. That patients needed to be monitored more regularly than usual while 

using the Pelvic Mesh Products and that in the event the Pelvic Mesh 

Products needed to be removed that the procedures to remove them had a 

very high failure rate and/or needed to be performed repeatedly; Thus: 

j. That the Pelvic Mesh Products were manufactured negligently; 

k. That the Pelvic Mesh Products were manufactured defectively; and 

l. That the Pelvic Mesh Products were designed negligently, and designed 

defectively. 

55. Defendants were under a duty to disclose to Plaintiffs and Plaintiffs’ 

physicians, the defective nature of the Pelvic Mesh Products, including, but not limited to, the 

heightened risks of erosion, failure and permanent injury. 

56. Defendants had sole access to material facts concerning the defective 

nature of the Pelvic Mesh Products and their propensity to cause serious and dangerous side 

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effects and hence, cause dangerous injuries and damage to persons who used the Pelvic Mesh 

Products. 

57. Defendants’ concealment and omissions of material fact concerning the 

safety of the Pelvic Mesh Products were made to cause the Plaintiffs, the Plaintiffs’ physicians 

and healthcare providers to purchase, prescribe, and/or dispense the Pelvic Mesh Products; 

and/or to mislead Plaintiffs and Plaintiffs’ physicians into reliance and cause Plaintiffs to have 

the Pelvic Mesh Products implanted into their bodies. 

58. At the time these representations were made by Defendants, and at the 

time Plaintiffs used the Pelvic Mesh Products, Plaintiffs were unaware of the falsehood of these 

representations, and reasonably believed them to be true. 

59. Defendants knew and had reason to know that the Pelvic Mesh Products 

could and would cause severe and grievous personal injury to the users of the Pelvic Mesh 

Products, and that they were inherently dangerous in a manner that exceeded any purported, 

inaccurate, or otherwise downplayed warnings. 

60. In reliance upon these false representations, Plaintiffs were induced to, and 

did use the Pelvic Mesh Products, thereby sustaining severe and permanent personal injuries and 

damages. Defendants knew or had reason to know that Plaintiffs and Plaintiffs’ physicians and 

other healthcare providers had no way to determine the truth behind Defendants’ concealment 

and omissions, and that these included material omissions of facts surrounding the use of the 

Pelvic Mesh Products, as described in detail herein. 

61. As a result of Defendants’ research and testing or lack thereof, Defendants 

distributed false information, including but not limited to assuring Plaintiffs, the public, and 

Plaintiffs’ healthcare providers and physicians, that the Pelvic Mesh Products were safe for use 

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as a means of providing relief from stress urinary incontinence and/or prolapse and were as safe 

or safer than other products and/or procedures available and on the market. Further, Defendants 

misrepresented to the Plaintiffs and to the Plaintiffs’ physicians that the Pelvic Mesh Products 

were more effective than other means of treatment for these conditions for which they were 

implanted. As a result of Defendants’ research and testing, or lack thereof, Defendants 

intentionally omitted, concealed and suppressed certain results of testing and research to 

healthcare professionals, Plaintiffs, and the public at large. 

62. Defendants had a duty when disseminating information to the public to 

disseminate truthful information and a parallel duty not to deceive the public, Plaintiffs, 

Plaintiffs’ healthcare providers, and the FDA. 

63. The information distributed to the public, the medical community, the 

FDA, and Plaintiffs by Defendants included, but was not limited to, reports, press releases, 

advertising campaigns, television commercials, print advertisements, billboards and other 

commercial media containing material representations, which were false and misleading, and 

contained omissions and concealment of the truth about the dangers of the use of the Pelvic 

Mesh Products. 

64. Defendants intentionally made material misrepresentations to the medical 

community and public, including Plaintiffs, regarding the safety of the Pelvic Mesh Products 

specifically, that the Pelvic Mesh Products did not have dangerous and/or serious adverse health 

safety concerns, and that the Pelvic Mesh Products were as safe as other means of treating 

vaginal vault prolapse, stress urinary incontinence, pelvic organ prolapse or rectocele. 

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65. Defendants intentionally failed to inform the public, including Plaintiffs, 

of the high failure rate including erosion, the difficulty of removing the mesh, and the risk of 

permanent injury. 

66. Defendants chose to over-promote the safety, efficacy and benefits of the 

Pelvic Mesh Products instead. 

67. Defendants’ intent and purpose in making these misrepresentations was to 

deceive the public, the medical community, and Plaintiffs; to gain the confidence of the public, 

the medical community, and Plaintiffs; to falsely assure them of the quality and fitness for use of 

the Pelvic Mesh Products; and induce Plaintiffs, the public and the medical community to 

request, recommend, prescribe, dispense, purchase, and continue to use the Pelvic Mesh 

Products. 

68. Upon information and belief, Defendants made claims and representations 

in its documents submitted to the FDA and its reports to the public and to healthcare 

professionals and in advertisements that the Pelvic Mesh Products did not present serious health 

risks. 

69. These representations, and others made by Defendants, were false when 

made and/or were made with the pretense of actual knowledge when such knowledge did not 

actually exist, and were made recklessly and without regard to the true facts. 

70. These representations, and others made by Defendants, were made with 

the intention of deceiving Plaintiffs, Plaintiffs’ healthcare professionals and other members of 

the healthcare community, and were made in order to induce Plaintiffs, and Plaintiffs’ healthcare 

professionals, to rely on misrepresentations, and caused Plaintiffs to purchase, rely, use, and 

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request the Pelvic Mesh Products, and caused her healthcare professionals to dispense, 

recommend, or prescribe the Pelvic Mesh Products. 

71. Defendants recklessly and/or intentionally falsely represented the 

dangerous and serious health and safety concerns inherent in the use of the Pelvic Mesh Products 

to the public at large, for the purpose of influencing the sales of Pelvic Mesh Products known to 

be dangerous and defective, and/or not as safe as other alternatives. Defendants utilized direct-toconsumer advertising to market, promote, and advertise the Pelvic Mesh Products. 

72. At the time the representations were made, Plaintiffs and Plaintiffs’ 

healthcare providers did not know the truth about the dangers and serious health and/or safety 

risks inherent in the use of the Pelvic Mesh Products. Plaintiffs did not discover the true facts 

about the dangers and serious health and/or safety risks, nor did Plaintiffs discover the false 

representations of Defendants, nor would Plaintiffs with reasonable diligence have discovered 

the true facts or Defendants’ misrepresentations. 

73. Had Plaintiffs known the true facts about the dangers and serious health 

and/or safety risks of the Pelvic Mesh Products, or in the case of the Prolift System, that the 

Defendants had not sought nor obtained FDA clearance for the product, Plaintiffs would not 

have purchased, used, or relied on Defendants’ Pelvic Mesh Products. 

74. At all times relevant herein, the Pelvic Mesh Products were widely 

advertised and promoted by the Defendants as a safe and effective treatment for vaginal vault 

prolapse, stress urinary incontinence, pelvic organ prolapse or rectocele. Defendants minimized 

the risks posed to rectocele and vaginal prolapse patients with implantation of the Pelvic Mesh 

Products. 

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75. At all times relevant to this action, Defendants knew that the Pelvic Mesh 

Products were not safe for the patients for whom they were prescribed and implanted, because 

the mesh eroded and otherwise malfunctioned, and therefore failed to operate in a safe and 

continuous manner, causing injuries including, but not limited to, erosion, extrusion, infection, 

sepsis, chronic foreign body invasion, dense adhesions and worsening dyspareunia. Removal of 

eroded or infected mesh brings a high rate of life-threatening complications including permanent 

disfigurement and hemorrhage. Removal can require multiple surgical interventions in the 

operating theater for complete removal and results in scarring on fragile compromised pelvic 

tissue and muscles. 

76. Defendants failed to design and establish a safe, effective procedure for 

removal of the Products, or to determine if a safe, effective procedure for removal of the 

Products exists. 

77. At all relevant times herein, Defendants continued to promote Pelvic Mesh 

Products as safe and effective even when no clinical trials had been done supporting long or 

short term efficacy. 

78. In doing so the Defendants concealed the known risks and failed to warn 

of known or scientifically knowable dangers and risks associated with the Pelvic Mesh Products 

for treatment of vaginal vault prolapse, stress urinary incontinence, pelvic organ prolapse or 

rectocele. 

79. At all relevant times herein, Defendants failed to provide sufficient 

warnings and instructions that would have put Plaintiffs and the general public on notice of the 

dangers and adverse effects caused by implantation of the Pelvic Mesh Products system 

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including, but not limited to, mesh erosion, dense adhesions, worsening dyspareunia, chronic 

pain, infection, sepsis, permanent disfigurement and multiple surgeries for mesh removal. 

80. The Pelvic Mesh Products as designed, manufactured, distributed sold 

and/or supplied by Defendants were defective as marketed due to inadequate warnings, 

instructions, labeling and/or inadequate testing in the presence of Defendants’ knowledge of lack 

of pelvic health safety. 

81. At all times herein mentioned, the employees, agents, officers and/or 

directors of the Defendants named herein participated in, authorized and/or directed the 

production and promotion of the aforementioned Pelvic Mesh Products when they knew of the 

hazards and dangerous propensities of said Pelvic Mesh Products, and thereby actively 

participated in the tortuous conduct that resulted in the injuries suffered by Plaintiffs. 

V. FRAUDULENT CONCEALMENT

82. Defendants’ failure to document or follow up on the known defects in its 

product, and concealment of known defects, constitutes fraudulent concealment that equitably 

tolls applicable statutes of limitation. 

83. Defendants are estopped from relying on the statute of limitations defense 

because Defendants actively concealed the defects, suppressing reports, failing to follow through 

on FDA notification requirements, and failing to disclose known defects to physicians. Instead of 

revealing the defects, Defendants continued to represent its Pelvic Mesh Products as safe for 

their intended use. 

84. Defendants are and were under a continuing duty to disclose the true 

character, quality, and nature of risks and dangers associated with their Pelvic Mesh Products. 

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Because of Defendants’ concealment of the true character, quality and nature of their Pelvic 

Mesh Products, Defendants are estopped from relying on any statute of limitations defense. 

85. Defendants furthered this fraudulent concealment through a continued and 

systematic failure to disclose information to Plaintiffs, physicians and the public. 

86. Defendants’ acts before, during and/or after the act causing Plaintiffs’ 

injury prevented Plaintiffs from discovering the injury or cause thereof. 

87. Defendants’ conduct, as described in the preceding paragraphs, amounts to 

conduct purposely committed, which Defendants must have realized was dangerous, heedless 

and reckless, without regard to the consequences or the rights and safety of Plaintiffs.

88. Defendants’ conduct, as described in the preceding paragraphs, also 

amounts to a continuing tort, and continues up through and including the date of the filing of 

Plaintiffs’ Complaint.

VI.CAUSES OF ACTION 

COUNT I: NEGLIGENCE 

89. Paragraphs 1-88 of the First Amended Master Complaint are hereby 

incorporated by reference as if fully set forth herein. 

90. Defendants had a duty to individuals, including Plaintiffs, to exercise 

reasonable and ordinary care in the manufacture, design, labeling, packaging, testing, instruction, 

warning, selling, marketing, distribution, and training related to its Pelvic Mesh Products. 

91. Defendants breached their duty of care and were negligent as described 

herein in the design, manufacture, labeling, warning, instruction, training, selling, marketing, and 

distribution of the Pelvic Mesh Products in one or more of the following respects: 

a. Failing to design the Products so as to avoid an unreasonable risk of harm 

to women in whom the Products were implanted, including Plaintiffs; 

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b. Failing to manufacture the Products so as to avoid an unreasonable risk of 

harm to women in whom the Products were implanted, including 

Plaintiffs; 

c. Failing to use reasonable care in the testing of the Products so as to avoid 

an unreasonable risk of harm to women in whom the Products were 

implanted, including Plaintiffs; 

d. Failing to use reasonable care in inspecting the Products so as to avoid 

unreasonable risk of harm to women in whom the Products were 

implanted, including Plaintiffs; 

e. Failing to use reasonable care in training its employees and health care 

providers related to the use of the Products so as to avoid unreasonable 

risk of harm to women in whom the Products were implanted, including 

Plaintiffs; 

f. Failing to use reasonable care in instructing and/or warning health care 

providers, the FDA and the public as set forth herein of risks associated 

with the Products, so as to avoid unreasonable risk of harm to women in 

whom the Products were implanted, including Plaintiffs; 

g. Failing to use reasonable care in marketing and promoting the Products, so 

as to avoid unreasonable risk of harm to women in whom the Products 

were implanted, including Plaintiffs; 

h. In negligently and carelessly promoting the use of the Pelvic Mesh 

Products to physicians who had not received sufficient training to master 

the techniques necessary for implantation of the device into the Plaintiffs; 

i. Otherwise negligently or carelessly designing, manufacturing, marketing, 

distributing, warning, labeling studying, testing or selling the Pelvic Mesh 

Products, and; 

j. In the case of the Prolift System, failing to use reasonable care in seeking 

and obtaining FDA clearance prior to marketing and selling the device for 

implantation into the human body. 

92. Failed to conduct post-market vigilance, or surveillance, by: 

a. Monitoring or acting on findings in the scientific and medical literature; 

and 

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b. Monitoring or investigating and evaluating reports in the FDA adverse 

event databases for their potential significance for defendants’ Pelvic 

Mesh Products. 

93. Failed to comply with manufacturer requirements of the Medical Device 

Reporting (MDR) Regulations, specifically: 

a. Failed to report MDRs (Medical Device [adverse event] Reports); and 

b. Failed to investigate reports of serious adverse events. 

94. As a direct and proximate result of Defendants’ negligence, Plaintiffs have 

been injured, often catastrophically, sustained severe and permanent pain, suffering, disability, 

impairment, loss of enjoyment of life, loss of care, comfort, and consortium, economic loss and 

damages including, but not limited to medical expenses, lost income, other damages, and/or 

death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT II 

STRICT LIABILITY – MANUFACTURING DEFECT 

95. Paragraphs 1-94 of the First Amended Master Complaint are hereby 

incorporated by reference as if fully set forth herein. 

96. The Pelvic Mesh Product implanted in Plaintiffs was not reasonably safe 

for its intended use and was defective with respect to its manufacture, as described herein, in that 

Defendants deviated materially from their design and manufacturing specifications and/or such 

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design and manufacture posed an unreasonable risk of harm to Plaintiffs in whom the Pelvic 

Mesh Products were implanted. 

97. The Defendants’ Pelvic Mesh Products are inherently dangerous and 

defective, unfit and unsafe for their intended and reasonably foreseeable uses, and do not meet or 

perform to the expectations of patients and their health care providers. 

98. The Pelvic Mesh Products create risks to the health and safety of the 

patients that are far more significant and devastating than the risks posed by other products and 

procedures available to treat the corresponding medical conditions, and which far outweigh the 

utility of the Pelvic Mesh Products. 

99. Defendants have intentionally and recklessly manufactured, the Pelvic 

Mesh Products with wanton and willful disregard for the rights and health of the Plaintiffs and 

others, and with malice, placing their economic interests above the health and safety of the 

Plaintiffs and others. 

100. As a direct and proximate result of the Defendants’ defective manufacture 

of the Pelvic Mesh Products, Plaintiffs have been injured, often catastrophically, sustained severe 

and permanent pain, suffering, disability, impairment, loss of enjoyment of life, loss of care, 

comfort, and consortium, economic loss and damages including, but not limited to medical 

expenses, lost income, other damages, and/or death. 

101. The Defendants are strictly liable in tort to the Plaintiffs for their wrongful 

conduct. 

WHEREFORE, Plaintiffs demand judgment against Defendants of compensatory 

damages, punitive damages, interest, attorneys’ fees, costs of suit, and such further relief as the 

Court deems equitable and just. 

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COUNT III 

STRICT LIABILITY – FAILURE TO WARN 

102. Paragraphs 1-101 of the First Amended Master Complaint are hereby 

incorporated by reference as if fully set forth herein. 

103. The Defendants failed to properly and adequately warn and instruct the 

Plaintiffs and their health care providers as to the proper candidates, and the safest and most 

effective methods of implantation and use of the Defendants’ Pelvic Mesh Products. 

104. The Defendants failed to properly and adequately warn and instruct the 

Plaintiffs and their health care providers as to the risks and benefits of the Defendants’ Pelvic 

Mesh Products, given the Plaintiffs’ conditions and need for information. 

105. The Defendants failed to properly and adequately warn and instruct the 

Plaintiffs and their health care providers with regard to the inadequate research and testing of the 

Pelvic Mesh Products, and the complete lack of a safe, effective procedure for removal of the 

Pelvic Mesh Products. 

106. In addition, the Pelvic Mesh Products were defective due to the lack of 

necessary and appropriate warnings regarding, but not limited to, the following: 

a. the Products’ propensities to contract, retract, and/or shrink inside the 

body; 

b. the Products’ propensities for degradation, fragmentation, disintegration 

and/or creep; 

c. the Products’ inelasticity preventing proper mating with the pelvic floor 

and vaginal region; 

d. the rate and manner of mesh erosion or extrusion; 

e. the risk of chronic inflammation resulting from the Products; 

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f. the risk of chronic infections resulting from the Products; 

g. the risk of permanent vaginal or pelvic scarring as a result of the Products; 

h. the risk of recurrent, intractable pelvic pain and other pain resulting from 

the Products; 

i. the need for corrective or revision surgery to adjust or remove the 

Products; 

j. the severity of complications that could arise as a result of implantation of 

the Products; 

k. the hazards associated with the Products; 

l. the Products’ defects described herein; 

m. treatment of pelvic organ prolapse and stress urinary incontinence with the 

Products is no more effective than feasible available alternatives; 

n. treatment of pelvic organ prolapse and stress urinary incontinence with the 

Products exposes patients to greater risk than feasible available 

alternatives; 

o. treatment of pelvic organ prolapse and stress urinary incontinence with the 

Products makes future surgical repair more difficult than feasible available 

alternatives; 

p. use of the Products puts the patient at greater risk of requiring additional 

surgery than feasible available alternatives; 

q. removal of the Products due to complications may involve multiple 

surgeries and may significantly impair the patient’s quality of life; and 

r. complete removal of the Products may not be possible and may not result 

in complete resolution of the complications, including pain. 

107. The Defendants intentionally, recklessly, and maliciously misrepresented 

the safety, risks, and benefits of the Defendants’ Pelvic Mesh Products, understating the risks 

and exaggerating the benefits in order to advance their own financial interests, with wanton and 

willful disregard for the rights and health of the Plaintiffs. 

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108. As a direct and proximate result of the Pelvic Mesh Products’ 

aforementioned defects, Plaintiffs have been injured, often catastrophically, sustained severe and 

permanent pain, suffering, disability, impairment, loss of enjoyment of life, loss of care, comfort, 

and consortium, economic loss and damages including, but not limited to medical expenses, lost 

income, other damages, and/or death. 

109. The Defendants are strictly liable in tort to the Plaintiffs for their wrongful 

conduct. 

WHEREFORE, Plaintiffs demand judgment against Defendants of compensatory 

damages, punitive damages, interest, attorneys’ fees, costs of suit, and such further relief as the 

Court deems equitable and just. 

COUNT IV 

STRICT LIABILITY – DEFECTIVE PRODUCT 

110. Paragraphs 1-109 of the First Amended Master Complaint are hereby 

incorporated by reference as if fully set forth herein. At the time of Plaintiffs’’ injuries, the 

Defendants’ Pelvic Mesh Products were defective and unreasonably dangerous to foreseeable 

consumers, patients, and users, including Plaintiffs, and the warnings labels, and instructions 

were deficient. 

111. The Defendants’ Pelvic Mesh Products are inherently dangerous and 

defective, unfit and unsafe for their intended and reasonably foreseeable uses, and do not meet or 

perform to the expectations of patients and their health care providers. 

112. Plaintiffs from Alaska, Arizona, California, District of Columbia, Florida, 

Hawaii, Illinois, Iowa, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New 

Hampshire, Minnesota, New Mexico, New York, North Dakota, Oklahoma, Oregon, Rhode 

Island, Utah, Vermont, Washington, D.C., West Virginia, Wisconsin, Wyoming and such other 

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states where the common law, the Restatement of Torts (Second) and/or the Restatement of Torts 

(Third) are adopted, bring strict product liability claims under the common law, Section 402A of 

the Restatement of Torts (Second), and/or Restatement of Torts (Third)) against Defendants. 

113. Plaintiffs from jurisdictions that provide a statutory cause of action for 

strict liability assert each of these claims against Defendants. 

114. As a proximate result of the Defendants’ design, manufacture, marketing, 

sale, and distribution of the Pelvic Mesh Products, Plaintiffs have been injured, often 

catastrophically, and sustained severe and permanent pain, suffering, disability, impairment, loss 

of enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT V

 STRICT LIABILITY – DESIGN DEFECT

115. Plaintiffs incorporate by reference paragraphs 1-114 of this First Amended 

Master Complaint as if fully set forth herein. 

116. The Pelvic Mesh Product implanted in Plaintiffs was not reasonably safe 

for its intended use and was defective as described herein with respect to its design. As 

previously stated, the Products’ design defects include, but are not limited to: 

a. the use of polypropylene material and/or collagen material in the 

Products and the immune reaction that results from such material, 

causing adverse reactions and injuries; 

b. the design of the Products to be inserted into and through an area of 

the body with high levels of bacteria that adhere to the mesh causing 

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immune reactions and subsequent tissue breakdown and adverse 

reactions and injuries; 

c. biomechanical issues with the design of the Products, including, but 

not limited to, the propensity of the Products to contract or shrink 

inside the body, that in turn cause surrounding tissue to be inflamed, 

become fibrotic, and contract, resulting in injury; 

d. the use and design of arms and anchors in the Products, which, when 

placed in the women, are likely to pass through contaminated spaces 

and injure major nerve routes in the pelvic region; 

e. the propensity of the Products for “creep,” or to gradually elongate and 

deform when subject to prolonged tension inside the body; 

f. the inelasticity of the Products, causing them to be improperly mated 

to the delicate and sensitive areas of the pelvis where they are 

implanted, and causing pain upon normal daily activities that involve 

movement in the pelvis (e.g., intercourse, defecation); 

g. the propensity of the Products for degradation or fragmentation over 

time, which causes a chronic inflammatory and fibrotic reaction, and 

results in continuing injury over time; 

h. the propensity of the Products for particle loss or “shedding”, which 

causes a chronic inflammatory response and fibrotic reaction, and 

results in continuing injury over time; the lack of porosity of the 

Products, which leads to fibrotic bridging and results in continuing 

injury over time; and 

i. the creation of a non-anatomic condition in the pelvis leading to 

chronic pain and functional disabilities when the mesh is implanting 

according to the manufacturers' instructions. 

117. As a direct and proximate result of the Product’s aforementioned defects 

as described herein, Plaintiffs experienced significant mental and physical pain and suffering, 

have sustained permanent injury, have undergone medical treatment and will likely undergo 

future medical treatment and procedures, has suffered financial or economic loss, including, but 

not limited to, obligations for medical services and expenses, lost income, other damages, and 

death. 

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118. Defendants are strictly liable to Plaintiffs for designing a defective 

product. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT VI 

COMMON LAW FRAUD

119. Plaintiffs incorporate by reference paragraphs 1-118 of this First Amended 

Master Complaint as if fully set forth herein. 

120. Defendants falsely and fraudulently represented and continue to represent 

to the medical and healthcare community, Plaintiffs, and the public that the Pelvic Mesh 

Products had been tested and were found to be safe and effective. 

121. The representations made by Defendants were, in fact, false. When 

Defendants made their representations, Defendants knew and/or had reason to know that those 

representations were false, and Defendants willfully, wantonly, and recklessly disregarded the 

inaccuracies in their representations and the dangers and health risks to users of the Pelvic Mesh 

Products. 

122. These representations were made by Defendants with the intent of 

defrauding and deceiving the medical community, Plaintiffs, and the public, and also inducing 

the medical community, Plaintiffs, and the public, to recommend, prescribe, dispense, and 

purchase the Pelvic Mesh Products for use as a means of treatment for stress urinary 

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incontinence and/or prolapse, all of which evinced a callous, reckless, willful, and depraved 

indifference to the health, safety, and welfare of Plaintiffs. 

123. In representations to Plaintiffs and/or to Plaintiffs’ healthcare providers, 

Defendants fraudulently concealed and intentionally or recklessly omitted the following material 

information: 

a) That the Defendants’ Pelvic Mesh Products were not as safe as other 

products and procedures available to treat incontinence and/or 

prolapse; 

b) That the Defendants’ Pelvic Mesh Products were more effective than 

other products and procedures available to treat incontinence and/or 

prolapse; 

c) That the risk of adverse events with the Defendants’ Pelvic Mesh 

Products was higher than with other products and procedures available 

to treat incontinence and/or prolapse; 

d) The Defendants’ Pelvic Mesh Products were not adequately tested; 

e) That the limited clinical testing revealed the Defendants’ Pelvic Mesh 

Products had a higher risk of adverse effects, in addition to, and above 

and beyond those associated with other products and procedures 

available to treat incontinence and/or prolapse; 

f) That Defendants deliberately failed to follow up on the adverse results 

from clinical studies and formal and informal reports from physicians 

and other healthcare providers and buried and/or misrepresented those 

findings; 

g) That Defendants deliberately chose to forego studies that might reveal 

the true rate of adverse events or otherwise necessitate the need to 

reveal information as to adverse events to the Plaintiff, the medical 

community, or the regulatory authorities; 

h) That Defendants were aware of dangers in the Defendants’ Pelvic 

Mesh Products in addition to and above and beyond those associated 

with other products and procedures available to treat incontinence 

and/or prolapse; 

i) That the Defendants’ Pelvic Mesh Products were defective, and that 

they caused dangerous and adverse side effects, including but not 

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limited to higher incidence of erosion and failure, at a much more 

significant rate than other products and procedures available to treat 

incontinence and/or prolapse; 

j) That patients needed to be monitored more regularly than usual while 

using the Defendants’ Pelvic Mesh Products and that in the event the 

products needed to be removed that the procedures to remove them 

had a very high failure rate and/or needed to be performed repeatedly; 

k) That the Defendants’ Pelvic Mesh Products were manufactured 

negligently; 

l) That the Defendants’ Pelvic Mesh Products were manufactured 

defectively; 

m) That the Defendants’ Pelvic Mesh Products were designed negligently, 

and designed defectively; and 

n) In the case of the Prolift System, that the Defendants’ had not sought 

nor obtained FDA clearance at the time it began marketing and selling 

the product. 

124. Defendants were under a duty to disclose to Plaintiffs and their physicians, 

the defective nature of the Defendants’ Pelvic Mesh Products, including, but not limited to, the 

heightened risks of erosion, failure, and permanent injury. 

125. Defendants had sole access to material facts concerning the defective 

nature of the products and their propensity to cause serious and dangerous side effects and hence, 

cause dangerous injuries and damage to persons who used the Defendants’ Pelvic Mesh 

Products. 

126. Defendants’ concealment and omissions of material fact concerning the 

safety of the Products were made purposefully, willfully, wantonly, and/or recklessly to mislead, 

to cause Plaintiffs’ physicians and healthcare providers to purchase, prescribe, and/or dispense 

the Pelvic Mesh Products; and/or to mislead Plaintiffs into reliance and cause Plaintiffs to use the 

Defendants’ Pelvic Mesh Products. 

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127. At the time these representations were made by Defendants, and at the 

time Plaintiffs used the Pelvic Mesh Products, Plaintiffs were unaware of the falsehood of these 

representations, and reasonably believed them to be true. 

128. Defendants knew and had reason to know that the Defendants’ Pelvic 

Mesh Products could and would cause severe and grievous personal injury to the users of the 

Defendants’ Pelvic Mesh Products, and that they were inherently dangerous in a manner that 

exceeded any purported, inaccurate, or otherwise downplayed warnings. 

129. In reliance upon these false representations, Plaintiffs were induced to, and 

did use the Pelvic Mesh Products, thereby sustaining severe and permanent personal injuries and 

damages. Defendants knew or had reason to know that Plaintiffs and their physicians and other 

healthcare providers had no way to determine the truth behind Defendants’ concealment and 

omissions, and that these included material omissions of facts surrounding the use of the 

Defendants’ Pelvic Mesh Products, as described in detail herein. 

130. Plaintiffs reasonably relied on revealed facts which foreseeably and 

purposefully suppressed and concealed facts that were critical to understanding the real dangers 

inherent in the use of the Defendants’ Pelvic Mesh Products. 

131. Having knowledge based upon Defendants’ research and testing, or lack 

thereof, Defendants blatantly and intentionally distributed false information, including but not 

limited to assuring Plaintiffs, the public, and Plaintiffs’ healthcare providers and physicians, that 

the Defendants’ Pelvic Mesh Products were safe for use as a means of providing relief from 

stress urinary incontinence and/or prolapse and were as safe or safer than other products and/or 

procedures available and on the market. As a result of Defendants’ research and testing, or lack 

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thereof, Defendants intentionally omitted, concealed and suppressed certain results of testing and 

research to healthcare professionals, Plaintiffs, and the public at large. 

132. Defendants had a duty when disseminating information to the public to 

disseminate truthful information; and a parallel duty not to deceive the public, Plaintiffs, 

Plaintiffs’ healthcare providers, and the United States Food and Drug Administration (“FDA”). 

133. The information distributed to the public, the medical community, the 

FDA, and Plaintiffs, by Defendants included, but was not limited to websites, information 

presented at medical and professional meetings, information disseminated by sales 

representatives to physicians and other medical care providers, reports, press releases, 

advertising campaigns, television commercials, print advertisements, billboards and other 

commercial media containing material representations, which were false and misleading, and 

contained omissions and concealment of the truth about the dangers of the use of the Defendants’ 

Pelvic Mesh Products. 

134. Defendants intentionally made material misrepresentations to the medical 

community and public, including Plaintiffs, regarding the safety of the Defendants’ Pelvic Mesh 

Products specifically that the Products did not have dangerous and/or serious adverse health 

safety concerns, and that the Defendants’ Pelvic Mesh Products were as safe or safer than other 

means of treating stress urinary incontinence and/or prolapse. 

135. Defendants intentionally failed to inform the public, including Plaintiffs, 

of the high failure rate including erosion, the difficulty or impossibility of removing the mesh, 

and the risk of permanent injury. 

136. Defendants chose to over-promote the purported safety, efficacy and 

benefits of the Defendants’ Pelvic Mesh Products instead. 

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137. Defendants’ intent and purpose in making these misrepresentations was to 

deceive and defraud the public, the medical community, and Plaintiffs; to gain the confidence of 

the public, the medical community, and Plaintiffs; to falsely assure them of the quality and 

fitness for use of the Products; and induce Plaintiffs, the public and the medical community to 

request, recommend, prescribe, dispense, purchase, and continue to use the Defendants’ Pelvic 

Mesh Products. 

138. Defendants made claims and representations in its documents submitted to 

the FDA and its reports to the public and to healthcare professionals and in advertisements that 

the Defendants’ Pelvic Mesh Products had innovative beneficial properties and did not present 

serious health risks. 

139. These representations, and others made by Defendants, were false when 

made and/or were made with the pretense of actual knowledge when such knowledge did not 

actually exist, and were made recklessly and without regard to the true facts. 

140. These representations, and others made by Defendants, were made with 

the intention of deceiving and defrauding Plaintiffs, Plaintiffs’ healthcare professionals and other 

members of the healthcare community, and were made in order to induce Plaintiffs, and their 

respective healthcare professionals, to rely on misrepresentations, and caused Plaintiffs to 

purchase, rely, use, and request the Defendants’ Pelvic Mesh Products and their healthcare 

professionals to dispense, recommend, or prescribe the Defendants’ Pelvic Mesh Products. 

141. Defendants recklessly and/or intentionally falsely represented the 

dangerous and serious health and safety concerns inherent in the use of the Defendants’ Pelvic 

Mesh Products to the public at large, for the purpose of influencing the sales of products known 

to be dangerous and defective, and/or not as safe as other alternatives. 

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142. Defendants willfully and intentionally failed to disclose the truth, failed to 

disclose material facts and made false representations, for the purpose of deceiving and lulling 

Plaintiffs, as well as their healthcare professionals, into a false sense of security, so that Plaintiffs 

and their healthcare providers would rely on Defendants’ representations, and Plaintiffs would 

request and purchase the Defendants’ Pelvic Mesh Products, and that their healthcare providers 

would dispense, prescribe, and recommend the Defendants’ Pelvic Mesh Products. 

143. Defendants utilized direct-to-consumer advertising to market, promote, 

and advertise the Defendants’ Pelvic Mesh Products. 

144. At the time the representations were made, Plaintiffs and their healthcare 

providers did not know the truth about the dangers and serious health and/or safety risks inherent 

in the use of the Defendants’ Pelvic Mesh Products. Plaintiffs did not discover the true facts 

about the dangers and serious health and/or safety risks, nor did Plaintiffs discover the false 

representations of Defendants, nor would Plaintiffs with reasonable diligence have discovered 

the true facts or Defendant’s misrepresentations. 

145. Had Plaintiffs known the true facts about the dangers and serious health 

and/or safety risks of the Defendants’ Pelvic Mesh Products, Plaintiffs would not have 

purchased, used, or relied on Defendants’ Pelvic Mesh Products. 

146. Defendants’ wrongful conduct constitutes fraud and deceit, and was 

committed and perpetrated willfully, wantonly, and/or purposefully on Plaintiffs. 

147. As a direct and proximate result of Defendants’ conduct, Plaintiffs 

experienced significant mental and physical pain and suffering, have sustained permanent injury, 

have undergone medical treatment and will likely undergo future medical treatment and 

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procedures, have suffered financial or economic loss, including, but not limited to, obligations 

for medical services and expenses, lost income, other damages, and death.

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT VII 

FRAUDULENT CONCEALMENT 

148. Plaintiffs incorporate by reference paragraphs 1-147 of this First Amended 

Master Complaint as if fully set forth herein. 

149. Plaintiffs from Alabama, Arizona, California, Colorado, Delaware, 

Georgia, Illinois, Iowa, Kansas, Maine, Maryland, Michigan, Mississippi, Missouri, Nebraska, 

New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, 

Vermont, West Virginia and Wisconsin and any other states that recognize such a cause of action 

bring this fraudulent concealment claim under the common law. 

150. Throughout the relevant time period, Defendants knew that their Pelvic 

Mesh Products were defective and unreasonably unsafe for their intended purpose. 

151. Defendants fraudulently concealed from and/or failed to disclose to or 

warn Plaintiffs, their physicians and the medical community that their Pelvic Mesh Products 

were defective, unsafe, and unfit for the purposes intended, and that they were not of 

merchantable quality. 

152. Defendants were under a duty to Plaintiffs to disclose and warn of the 

defective nature of the Products because: 

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a) Defendants were in a superior position to know the true quality, safety and 

efficacy of the Defendants’ Pelvic Mesh Products; 

b) Defendants knowingly made false claims about the safety and quality of 

the Defendants’ Pelvic Mesh Products in the documents and marketing 

materials Defendants provided to the FDA, physicians, and the general 

public; and 

c) Defendants fraudulently and affirmatively concealed the defective nature 

of the Defendants’ Pelvic Mesh Products from Plaintiffs. 

153. The facts concealed and/or not disclosed by Defendants to Plaintiffs were 

material facts that a reasonable person would have considered to be important in deciding 

whether or not to purchase and/or use the Defendants’ Pelvic Mesh Products. 

154. Defendants intentionally concealed and/or failed to disclose the true 

defective nature of the Products so that Plaintiffs would request and purchase the Defendants’ 

Pelvic Mesh Products, and that her healthcare providers would dispense, prescribe, and 

recommend the Defendants’ Pelvic Mesh Products, and Plaintiffs justifiably acted or relied upon, 

to her detriment, the concealed and/or non-disclosed facts as evidenced by her purchase of the 

Defendants’ Pelvic Mesh Products. 

155. Defendants, by concealment or other action, intentionally prevented 

Plaintiffs and Plaintiffs’ physicians and other healthcare providers from acquiring material 

information regarding the lack of safety and effectiveness of the Defendants’ Pelvic Mesh 

Products, and are subject to the same liability to Plaintiffs for Plaintiffs’ pecuniary losses, as 

though Defendants had stated the non-existence of such material information regarding the 

Defendants’ Pelvic Mesh Products’ lack of safety and effectiveness and dangers and defects, and 

as though Defendants had affirmatively stated the non-existence of such matters that Plaintiffs 

were thus prevented from discovering the truth. Defendants therefore have liability for 

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fraudulent concealment under all applicable law, including, inter alia, Restatement (Second) of 

Torts § 550 (1977). 

156. As a proximate result of the Defendants’ conduct, Plaintiffs have been 

injured, and sustained severe and permanent pain, suffering, disability, impairment, loss of 

enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT VIII 

CONSTRUCTIVE FRAUD 

157. Plaintiffs incorporate by reference paragraphs 1-156 of this First Amended 

Master Complaint as if fully set forth herein. 

158. Defendants are in a unique position of knowledge concerning the quality, 

safety and efficacy of the Defendants’ Pelvic Mesh Products, which knowledge is not possessed 

by Plaintiffs or their physicians, and Defendants thereby hold a position of superiority over 

Plaintiffs and their physicians. 

159. Despite their unique and superior knowledge regarding the defective 

nature of the Defendants’ Pelvic Mesh Products, Defendants continue to suppress, conceal, omit, 

and/or misrepresent information to Plaintiffs, the medical community, and/or the FDA, 

concerning the severity of risks and the dangers inherent in the intended use of the Defendants’ 

Pelvic Mesh Products, as compared to other products and forms of treatment. 

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160. For example, scientists in the recent study published in Obstetrics & 

Gynecology, August, 2010, found that the complication rate was so high that the clinical trial was 

halted early. 

161. Defendants have concealed and suppressed material information, 

including limited clinical testing, that would reveal that the Defendants’ Pelvic Mesh Products 

had a higher risk of adverse effects, in addition to, and exceeding those associated with 

alternative procedures and available devices. Instead, Defendants have misrepresented the safety 

and efficacy of the Products. 

162. Upon information and belief, Defendants’ misrepresentations are designed 

to induce physicians and Plaintiffs to prescribe, dispense, recommend and/or purchase the 

Defendants’ Pelvic Mesh Products. Plaintiffs and the medical community have relied upon 

Defendants’ representations. 

163. Defendants took unconscionable advantage of their dominant position of 

knowledge with regard to Plaintiffs and their medical providers and engaged in constructive 

fraud in their relationship with Plaintiffs and their medical providers. Plaintiffs reasonably relied 

on Defendants’ representations. 

164. As a proximate result of the Defendants’ conduct, Plaintiffs have been 

injured, and sustained severe and permanent pain, suffering, disability, impairment, loss of 

enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

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WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT IX 

NEGLIGENT MISREPRESENTATION 

165. Plaintiffs incorporate by reference paragraphs 1-164 of this First Amended 

Master Complaint as if fully set forth herein. Defendants had a duty to accurately and truthfully 

represent to the medical and healthcare community, Plaintiffs, and the public, that the Pelvic 

Mesh Products had not been adequately tested and found to be safe and effective for the 

treatment of incontinence and prolapse. The representations made by Defendants, in fact, were 

false. 

166. Defendants failed to exercise ordinary care in the representations 

concerning the Pelvic Mesh Products while they were involved in their manufacture, sale, 

testing, quality assurance, quality control, and distribution in interstate commerce, because 

Defendants negligently misrepresented the Pelvic Mesh Products’ high risk of unreasonable, 

dangerous, adverse side effects. 

167. Defendants breached their duty in representing that the Defendants’ Pelvic 

Mesh Products have no serious side effects different from older generations of similar products 

and/or procedures to Plaintiffs, Plaintiffs’ physicians, and the medical and healthcare 

community. 

168. As a foreseeable, direct and proximate result of the negligent 

misrepresentation of Defendants as set forth herein, Defendants knew, and had reason to know, 

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that the Pelvic Mesh Products had been insufficiently tested, or had not been tested at all, and 

that they lacked adequate and accurate warnings, and that they created a high risk, and/or higher 

than acceptable risk, and/or higher than reported and represented risk, of adverse side effects, 

including, erosion, pain and suffering, surgery to remove the products, and other severe and 

personal injuries, which are permanent and lasting in nature. 

169. As a direct and proximate result of the Defendants’ conduct, Plaintiffs 

have been injured, and sustained severe and permanent pain, suffering, disability, impairment, 

loss of enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT X 

NEGLIGENT INFLICTION OF EMOTIONAL DISTRESS 

170. Plaintiffs incorporate by reference paragraphs 1-169 of this First Amended 

Master Complaint as if fully set forth herein. 

171. Defendants carelessly and negligently manufactured, designed, developed, 

tested, labeled, marketed and sold the Defendants’ Pelvic Mesh Products to Plaintiffs, carelessly 

and negligently concealing the harmful effects of the Defendants’ Pelvic Mesh Products from 

Plaintiffs, and carelessly and negligently misrepresented the quality, safety and efficacy of the 

products. 

172. Plaintiffs were directly impacted by Defendants’ carelessness and 

negligence, in that Plaintiffs have sustained and will continue to sustain emotional distress, 

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severe physical injuries and/or death, economic losses, and other damages as a direct result of the 

decision to purchase the Pelvic Mesh Products sold and distributed by Defendants. 

173. As a direct and proximate result of the Defendants’ conduct, Plaintiffs 

have been injured, and sustained severe and permanent pain, suffering, disability, impairment, 

loss of enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT XI 

BREACH OF EXPRESS WARRANTY 

174. Plaintiffs incorporate by reference paragraphs 1-173 of this First Amended 

Master Complaint as if fully set forth herein. 

175. At all relevant and material times, Defendants manufactured, distributed, 

advertised, promoted, and sold the Defendants’ Pelvic Mesh Products. 

176. At all relevant times, Defendants intended that the Defendants’ Pelvic 

Mesh Products be used in the manner that Plaintiffs in fact used them and Defendants expressly 

warranted that each product was safe and fit for use by consumers, that each product was of 

merchantable quality, that their side effects were minimal and comparable to other pelvic mesh 

products, and that they were adequately tested and fit for their intended use. 

177. At all relevant times, Defendants were aware that consumers, including 

Plaintiffs, would use the Pelvic Mesh Products; which is to say that Plaintiffs were foreseeable 

users of the Defendants’ Pelvic Mesh Products. 

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178. Plaintiffs and/ or their implanting physicians were at all relevant times in 

privity with Defendants. 

179. The Defendants’ Pelvic Mesh Products were expected to reach and did in 

fact reach consumers, including Plaintiffs and their implanting physicians, without substantial 

change in the condition in which it was manufactured and sold by Defendants. 

180. Defendants breached various express warranties with respect to the Pelvic 

Mesh Products including the following particulars: 

a) Defendants represented to Plaintiffs and their physicians and healthcare 

providers through its labeling, advertising, marketing materials, detail 

persons, seminar presentations, publications, notice letters, and regulatory 

submissions that the Defendants’ Pelvic Mesh Products were safe and 

fraudulently withheld and concealed information about the substantial 

risks of serious injury and/or death associated with using the Pelvic Mesh 

Products; 

b) Defendants represented to Plaintiffs and their physicians and healthcare 

providers that the Defendants’ Pelvic Mesh Products were as safe, and/or 

safer than other alternative procedures and devices, that complications are 

rare, and fraudulently concealed information, which demonstrated that the 

Products were not safer than alternatives available on the market and that 

complications were not, in fact, rare; and 

c) Defendants represented to Plaintiffs and their physicians and healthcare 

providers that the Defendants’ Pelvic Mesh Products were more 

efficacious than other alternative medications and fraudulently concealed 

information, regarding the true efficacy of the products. 

181. In reliance upon Defendants’ express warranties, Plaintiffs were implanted 

with the Defendants’ Pelvic Mesh Products as prescribed and directed, and therefore, in the 

foreseeable manner normally intended, recommended, promoted, and marketed by Defendants. 

182. At the time of making such express warranties, Defendants knew or 

should have known that the Defendants’ Pelvic Mesh Products do not conform to these express 

representations because the Defendants’ Pelvic Mesh Products were not safe and had numerous 

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serious side effects, many of which are common and Defendants did not accurately warn about, 

thus making the Defendants’ Pelvic Mesh Products unreasonably unsafe for their intended 

purpose. 

183. Members of the medical community, including physicians and other 

healthcare professionals, as well as Plaintiffs and the Public relied upon the representations and 

warranties of Defendants in connection with the use recommendation, description, and/or 

dispensing of the Defendants’ Pelvic Mesh Products. 

184. Defendants breached their express warranties to Plaintiffs in that the 

Defendants’ Pelvic Mesh Products were not of merchantable quality, safe and fit for their 

intended uses, nor were they adequately tested. 

185. Defendants’ breaches constitute violations of common law principles and 

the statutory provisions of the Plaintiffs’ respective states. 

186. As a direct and proximate result of the Defendants’ conduct, Plaintiffs 

have been injured, and sustained severe and permanent pain, suffering, disability, impairment, 

loss of enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT XII 

BREACH OF IMPLIED WARRANTY 

187. Plaintiffs incorporate by reference paragraphs 1-186 of this First Amended 

Master Complaint as if fully set forth herein. 

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188. At all relevant and material times, Defendants manufactured, distributed, 

advertised, promoted, and sold the Defendants’ Pelvic Mesh Products. 

189. At all relevant times, Defendants intended that the Defendants’ Pelvic 

Mesh Products be implanted for the purposes and in the manner those Plaintiffs or Plaintiffs’ 

implanting physicians in fact used they and Defendants impliedly warranted each product to be 

of merchantable quality, safe and fit for such use, even though they were not adequately tested. 

190. Defendants were aware that consumers, including Plaintiffs or Plaintiffs’ 

physicians, would implant the Defendants’ Pelvic Mesh Products in the manner directed by the 

instructions for use; which is to say that Plaintiffs or Plaintiffs’ Decedents were foreseeable users 

of the Defendants’ Pelvic Mesh Products. 

191. Plaintiffs and/or their physicians were at all relevant times in privity with 

Defendants. 

192. The Defendants’ Pelvic Mesh Products were expected to reach and did in 

fact reach consumers, including Plaintiffs or Plaintiffs’ physicians, without substantial change in 

the condition in which they were manufactured and sold by Defendants. 

193. Defendants breached various implied warranties with respect to the 

Defendants’ Pelvic Mesh Products, including, but not limited to, the following particulars: 

a) Defendants represented through their labeling, advertising, marketing 

materials, detail persons, seminar presentations, publications, notice 

letters, and regulatory submissions that the Defendants’ Pelvic Mesh 

Products were safe and fraudulently withheld and concealed 

information about the substantial risks of serious injury and/or death 

associated with using the Pelvic Mesh Products; 

b) Defendants represented that the Defendants’ Pelvic Mesh Products 

were safe, and/or safer than other alternative devices or procedures and 

that complications were rare, and fraudulently concealed information, 

which demonstrated that the Defendants’ Pelvic Mesh Products were 

not as safe or safer than alternatives available on the market; and 

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c) Defendants represented that the Defendants’ Pelvic Mesh Products 

were more efficacious than alternative pelvic mesh products and 

procedures and fraudulently concealed information, regarding the true 

efficacy of the Defendants’ Pelvic Mesh Products. 

194. In reliance upon Defendants’ implied warranty, Plaintiffs used the Pelvic 

Mesh Products as prescribed and in the foreseeable manner normally intended, recommended, 

promoted, and marketed by Defendants. 

195. Defendants breached their implied warranty to Plaintiffs in that the 

Defendants’ Pelvic Mesh Products were not of merchantable quality, safe and fit for their 

intended use, or adequately tested, in violation of Common Law principles and the statutory 

provisions of the Plaintiffs’ respective states. 

196. As a direct and proximate result of the Defendants’ conduct, Plaintiffs 

have been injured, and sustained severe and permanent pain, suffering, disability, impairment, 

loss of enjoyment of life, loss of care, comfort, and consortium, economic damages, and death. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

punitive damages, together with interest, costs of suit, attorneys’ fees, and such further relief as 

the Court deems equitable and just. 

COUNT XIII 

VIOLATION OF CONSUMER PROTECTION LAWS 

197. Plaintiffs incorporate by reference paragraphs 1-196 of this First Amended 

Master Complaint as if fully set forth herein. 

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198. Plaintiffs purchased and used the Defendants’ Pelvic Mesh Products 

primarily for personal use and thereby suffered ascertainable losses as a result of Defendants’ 

actions in violation of the consumer protection laws. 

199. Had Defendants not engaged in the deceptive conduct described herein, 

Plaintiffs would not have purchased and/or paid for the Defendants’ Pelvic Mesh Products, and 

would not have incurred related medical costs and injury. 

200. Defendants engaged in wrongful conduct while at the same time 

obtaining, under false pretenses, moneys from Plaintiffs for the Pelvic Mesh Products that would 

not have been paid had Defendants not engaged in unfair and deceptive conduct. 

201. Unfair methods of competition or deceptive acts or practices that were 

proscribed by law, including the following: 

a) Representing that goods or services have characteristics, ingredients, 

uses benefits or quantities that they do not have; 

b) Advertising goods or services with the intent not to sell them as 

advertised; and, 

c) Engaging in fraudulent or deceptive conduct that creates a likelihood 

of confusion or misunderstanding. 

202. Plaintiffs were injured by the cumulative and indivisible nature of 

Defendants’ conduct. The cumulative effect of Defendants’ conduct directed at patients, 

physicians and consumers was to create demand for and sell the Defendants’ Pelvic Mesh 

Products. Each aspect of Defendants’ conduct combined to artificially create sales of the 

Defendants’ Pelvic Mesh Products. 

203. Defendants have a statutory duty to refrain from unfair or deceptive acts or 

trade practices in the design, labeling, development, manufacture, promotion, and sale of the 

Defendants’ Pelvic Mesh Products. 

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204. Had Defendants not engaged in the deceptive conduct described above, 

Plaintiffs would not have purchased and/or paid for the Products, and would not have incurred 

related medical costs. 

205. Defendants’ deceptive, unconscionable, or fraudulent representations and 

material omissions to patients, physicians and consumers, including Plaintiffs, constituted unfair 

and deceptive acts and trade practices in violation of the state consumer protection statutes listed 

below. 

206. Defendants’ actions, as complained of herein, constitute unfair 

competition or unfair, unconscionable, deceptive or fraudulent acts, or trade practices in 

violation of state consumer protection statutes, as listed below. 

207. Defendants have engaged in unfair competition or unfair or deceptive acts 

or trade practices or have made false representations in violation of the statutory provisions of 

the Plaintiffs’ respective states. 

208. Under the applicable statutes to protect consumers against unfair, 

deceptive, fraudulent and unconscionable trade and business practices and false advertising, 

Defendants are the suppliers, manufacturers, advertisers, and sellers, who are subject to liability 

under such legislation for unfair, deceptive, fraudulent and unconscionable consumer sales 

practices. 

209. Defendants violated the statutes that were enacted in these states to protect 

consumers against unfair, deceptive, fraudulent and unconscionable trade and business practices 

and false advertising, by knowingly and falsely representing that the Defendants’ Pelvic Mesh 

Products were fit to be used for the purpose for which they were intended, when in fact they 

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were defective and dangerous, and by other acts alleged herein. These representations were 

made in marketing and promotional materials. 

210. The actions and omissions of Defendants alleged herein are uncured or 

incurable deceptive acts under the statutes enacted in the states to protect consumers against 

unfair, deceptive, fraudulent and unconscionable trade and business practices and false 

advertising. 

211. Defendants had actual knowledge of the defective and dangerous 

condition of the Defendants’ Pelvic Mesh Products and failed to take any action to cure such 

defective and dangerous conditions. 

212. Plaintiffs and the medical community relied upon Defendants’ 

misrepresentations and omissions in determining which product and/or procedure to undergo 

and/or perform (if any). 

213. Defendants’ deceptive, unconscionable or fraudulent representations and 

material omissions to patients, physicians and consumers, constituted unfair and deceptive acts 

and practices. 

214. By reason of the unlawful acts engaged in by Defendants, and as a direct 

and proximate result thereof, Plaintiffs have suffered ascertainable losses and damages. 

215. As a direct and proximate result of Defendants’ violations of the states’ 

consumer protection laws, Plaintiffs have sustained economic losses, injuries and other damages 

and are entitled to statutory and compensatory damages in an amount to be proven at trial. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests restitution and disgorgement of 

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profits, together with interest, cost of suit, attorneys’ fees, and all such other and further relief as 

this Court deems just and proper. 

COUNT XIV 

GROSS NEGLIGENCE 

216. Plaintiffs incorporate by reference paragraphs 1-215 of this First Amended 

Master Complaint as if fully set forth herein. 

217. The wrongs done by Defendants were aggravated by the kind of malice, 

fraud, and grossly negligent disregard for the rights of others, the public, and Plaintiffs for which 

the law would allow, and which Plaintiffs will seek at the appropriate time under governing law 

for the imposition of exemplary damages, in that Defendants’ conduct, including the failure to 

comply with applicable Federal standards: was specifically intended to cause substantial injury to 

Plaintiffs; or when viewed objectively from Defendants’ standpoint at the time of the conduct, 

involved an extreme degree of risk, considering the probability and magnitude of the potential 

harm to others, and Defendants were actually, subjectively aware of the risk involved, but 

nevertheless proceeded with conscious indifference to the rights, safety, or welfare of others; or 

included a material representation that was false, with Defendants, knowing that it was false or 

with reckless disregard as to its truth and as a positive assertion, with the intent that the 

representation is acted on by Plaintiffs. 

218. Plaintiffs relied on the representation and suffered injury as a proximate 

result of this reliance. 

219. Plaintiffs therefore will seek to assert claims for exemplary damages at the 

appropriate time under governing law in an amount within the jurisdictional limits of the Court. 

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220. Plaintiffs also allege that the acts and omissions of named Defendants, 

whether taken singularly or in combination with others, constitute gross negligence that 

proximately caused the injuries to Plaintiffs. In that regard, Plaintiffs will seek exemplary 

damages in an amount that would punish Defendants for their conduct and which would deter 

other manufacturers from engaging in such misconduct in the future. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

together with interest, costs of suit, attorneys’ fees, and such further relief as the Court deems 

equitable and just. 

COUNT XV

UNJUST ENRICHMENT

221. Plaintiffs incorporate by reference paragraphs 1-220 of this First Amended 

Master Complaint as if fully set forth herein. Defendants are and at all times relevant were the 

manufacturers, sellers, and/or suppliers of the Defendants’ Pelvic Mesh Products. 

222. Plaintiffs paid for the Defendants’ Pelvic Mesh Products for the purpose 

of treatment of stress urinary incontinence and/ or pelvic organ prolapse or other similar 

conditions. 

223. Defendants have accepted payment by Plaintiffs and others on Plaintiffs’ 

behalf for the purchase of the Defendants’ Pelvic Mesh Products. 

224. Plaintiffs have not received the safe and effective medical devices for 

which they paid. 

225. It would be inequitable for Defendants to keep this money since Plaintiffs 

did not in fact receive a safe and effective medical device as represented by Defendants 

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WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

together with interest, costs of suit, attorneys’ fees, and such further relief as the Court deems 

equitable and just. 

COUNT XVI

LOSS OF CONSORTIUM 

226. Plaintiffs incorporate by reference paragraphs 1-225 of this First Amended 

Master Complaint as if fully set forth herein. 

227. At all relevant times hereto, Plaintiffs had spouses (hereafter referred to as 

“Spouse Plaintiffs”) and/or family members (hereafter referred to as “Family Member 

Plaintiffs”) who have suffered injuries and losses as a result of the Pelvic Mesh Products and 

Plaintiffs’ injuries. 

228. For the reasons set forth herein, Spouse Plaintiffs and/or Family Member 

Plaintiffs have necessarily paid and have become liable to pay for medical aid, treatment, 

monitoring, medications, and other expenditures and will necessarily incur further expenses of a 

similar nature in the future as a proximate result of Defendants’ misconduct. 

229. For the reasons set forth herein, Spouse Plaintiffs and/or Family Member 

Plaintiffs have suffered and will continue to suffer the loss of their loved one’s support, 

companionship, services, society, love and affection. 

230. For all Spouse Plaintiffs, Plaintiffs allege that their marital relationship 

was impaired and depreciated, and the marital association between husband and wife has been 

altered. 

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231. Spouse Plaintiffs and/or Family Member Plaintiffs have suffered great 

emotional pain and mental anguish. 

232. As a direct and proximate result of Defendants’ wrongful conduct, Spouse 

Plaintiffs, Family Member Plaintiffs, and/or intimate partners of the aforesaid women, have 

sustained and will continue to sustain severe physical injuries, severe emotional distress, 

economic losses and other damages for which they are entitled to compensatory and equitable 

damages and declaratory relief in an amount to be proven at trial. Defendants are liable to 

Spouse Plaintiffs, Family Member Plaintiffs, and intimate partners jointly and severally for all 

general, special and equitable relief to which Spouse Plaintiffs, Family Member Plaintiffs, and 

intimate partners are entitled by law. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

together with interest, costs of suit, attorneys’ fees, and such further relief as the Court deems 

equitable and just. 

COUNT XVII 

PUNITIVE DAMAGES 

233. Plaintiffs incorporate by reference paragraphs 1-232 of this First Amended 

Master Complaint as if fully set forth herein. 

234. Defendants sold their Products to Plaintiffs’ healthcare providers and other 

healthcare providers throughout the United States without doing adequate testing to ensure that 

the Products were reasonably safe for implantation in the female pelvic area. 

235. Defendants sold the Products to Plaintiffs’ health care providers and other 

health care providers throughout the United States in spite of their knowledge that their Products 

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can shrink, disintegrate and/or degrade inside the body, and cause the other problems heretofore 

set forth in this First Amended Master Complaint, thereby causing severe and debilitating 

injuries suffered by the Plaintiffs. 

236. At all times relevant hereto, Defendants knew or should have known that 

the Defendants’ Pelvic Mesh Products were inherently dangerous with respect to the risks of 

erosion, failure, pain and suffering, loss of life’s enjoyment, remedial surgeries and treatments in 

an effort to cure the conditions proximately related to the use of the product, as well as other 

severe and personal injuries which are permanent and lasting in nature. 

237. At all times material hereto, Defendants attempted to misrepresent and did 

misrepresent facts concerning the safety of the Defendants’ Pelvic Mesh Products. 

238. Defendants’ misrepresentations included knowingly withholding material 

information from the medical community and the public, including Plaintiffs, concerning the 

safety and efficacy of the Defendants’ Pelvic Mesh Products. 

239. At all times material hereto, Defendants knew and intentionally and/or 

recklessly disregarded the fact that the Defendants’ Pelvic Mesh Products cause debilitating and 

potentially lethal side effects with greater frequency than safer alternative methods products 

and/or procedures and/or treatment. 

240. At all times material hereto, Defendants knew and intentionally and/or 

recklessly disregarded the fact that the Defendants’ Pelvic Mesh Products cause debilitating and 

potentially lethal side effects with greater frequency than safer alternative products and/or 

methods of treatment and recklessly failed to advise healthcare providers, the public and the 

FDA of same. 

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241. At all times material hereto, Defendants intentionally misstated and 

misrepresented data and continue to misrepresent data so as to minimize the true and accurate 

risk of injuries and complications caused by the Defendants’ Pelvic Mesh Products. 

242. Notwithstanding the foregoing, Defendants continue to aggressively 

market the Defendants’ Pelvic Mesh Products to consumers, without disclosing the true risk of 

side effects and complications. 

243. Defendants knew of the Defendants’ Pelvic Mesh Products defective and 

unreasonably dangerous nature, but continued to manufacture, produce, assemble, market, 

distribute, and sell the Defendants’ Pelvic Mesh Products so as to maximize sales and profits at 

the expense of the health and safety of the Public, including Plaintiffs, in conscious and/or 

reckless disregard of the foreseeable harm caused by the Defendants’ Pelvic Mesh Products. 

244. Defendants continue to intentionally conceal and/or recklessly and/or 

grossly negligently fail to disclose to the public, including Plaintiffs, the serious side effects of 

the Defendants’ Pelvic Mesh Products in order to ensure continued and increased sales. 

245. Defendants’ intentionally, reckless and/or grossly negligent failure to 

disclose information deprived Plaintiffs of necessary information to enable them to weigh the 

true risks of using the Defendants’ Pelvic Mesh Products against their benefits. 

246. As a direct and proximate result of the foregoing acts and omissions, 

Plaintiffs have required and will require health care and services, and have incurred medical, 

health care, incidental, and related expenses. Plaintiffs are informed and believe and further 

allege that Plaintiffs will in the future be required to obtain further medical care and/or hospital 

care and medical services. 

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247. Defendants have engaged in conduct entitling Plaintiffs to an award of 

punitive damages pursuant Common Law principles and the statutory provisions of the 

Plaintiffs’ respective states. 

248. Defendants’ conduct as described herein shows willful misconduct, 

malice, fraud, wantonness, oppression, or that entire want of care which raises the presumption 

of conscious indifference to consequences, thereby justifying an award of punitive damages. 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly, severally and in the alternative, and requests compensatory damages, 

together with interest, costs of suit, attorneys’ fees, punitive damages, and such further relief as 

the Court deems equitable and just. 

COUNT XVIII: DISCOVERY RULE AND TOLLING 

249. Plaintiffs incorporate by reference paragraphs 1-248 of this First Amended 

Master Complaint as if fully set forth herein. 

250. Plaintiffs assert all applicable state statutory and common law rights and 

theories related to the tolling or extension of any applicable statute of limitations, including 

equitable tolling, class action tolling, delayed discovery, discovery rule, and fraudulent 

concealment. 

251. Plaintiffs plead that the discovery rule should be applied to toll the running 

of the statute of limitations until Plaintiffs knew, or through the exercise of reasonable care and 

diligence should have known, of facts indicating that Plaintiffs had been injured, the cause of the 

injury, and the tortious nature of the wrongdoing that caused the injury. 

252. Despite diligent investigation by Plaintiffs into the cause of their injuries, 

including consultations with Plaintiffs’ medical providers, the nature of Plaintiffs’ injuries and 

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damages, and their relationship to the Products was not discovered, and through reasonable care 

and due diligence could not have been discovered, until a date within the applicable statute of 

limitations for filing Plaintiffs’ claims. Therefore, under appropriate application of the discovery 

rule, Plaintiffs’ suit was filed well within the applicable statutory limitations period. 

253. The running of the statute of limitations in this cause is tolled due to 

equitable tolling. Defendant(s) are estopped from asserting a statute of limitations defense due to 

Defendants’ fraudulent concealment, through affirmative misrepresentations and omissions, from 

Plaintiffs and Plaintiffs’ physicians of the true risks associated with the Products. As a result of 

Defendants’ fraudulent concealment, Plaintiffs and Plaintiffs’ physicians were unaware, and 

could not have known or have learned through reasonable diligence that Plaintiffs had been 

exposed to the risks alleged herein and that those risks were the direct and proximate result of the 

wrongful acts and omissions of the Defendant(s). 

V. PRAYER FOR RELIEF 

WHEREFORE, Plaintiffs demand judgment against Defendants, and each of them, 

individually, jointly and severally and requests compensatory damages, together with interest, 

cost of suit, attorneys’ fees, and all such other relief as the Court deems just and proper as well 

as: 

1. Compensatory damages to Plaintiffs for past, present, and future damages, 

including, but not limited to, pain and suffering for severe and permanent 

personal injuries sustained by Plaintiffs, health and medical care costs, 

together with interest and costs as provided by law; 

2. Restitution and disgorgement of profits; 

3. Reasonable attorneys’ fees; 

4. The costs of these proceedings; 

5. All ascertainable economic damages; 

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6. Punitive damages; 

7. Survival damages (if applicable); 

8. Wrongful death damages (if applicable); and 

9. Such other and further relief as this Court deems just and proper. 

Dated: August 31, 2012 

Respectfully submitted,

/s/ D. Renee Baggett 

D. RENEE BAGGETT 

Aylstock, Witkin, Kreis and Overholtz, PLC 

17 E. Main Street, Suite 200 

Pensacola, FL 32563 

850-202-1010 

850-916-7449 

Rbaggett@awkolaw.com

/s/ Thomas P. Cartmell 

THOMAS P. CARTMELL 

Wagstaff & Cartmell LLP 

4740 Grand Avenue, Suite 300 

Kansas City, MO 64112 

816-701-1102 

Fax 816-531-2372 

tcartmell@wcllp.com

http://www.wagstaffcartmell.com/

Plaintiffs’ Co-Lead Counsel 

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DEMAND FOR JURY TRIAL 

Plaintiffs hereby demand a trial by jury as to all issues. 

Dated: August 31, 2012 

Respectfully submitted,

/s/ D. Renee Baggett 

D. RENEE BAGGETT 

Aylstock, Witkin, Kreis and Overholtz, PLC 

17 E. Main Street, Suite 200 

Pensacola, FL 32563 

850-202-1010 

850-916-7449 

Rbaggett@awkolaw.com

/s/ Thomas P. Cartmell 

THOMAS P. CARTMELL 

Wagstaff & Cartmell LLP 

4740 Grand Avenue, Suite 300 

Kansas City, MO 64112 

816-701-1102 

Fax 816-531-2372 

tcartmell@wcllp.com

Plaintiffs’ Co-Lead Counsel 

 

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