STATE 0F RHODE ISLAND SUPERIOR COURT PROVIDENCE, SC

IN RE: DA VOL / CR. BARD HERNIA MESH

MESHMULTI—CASE MANAGEMENT : Coordination N0. 20 1 7-02

This Document Relates to: ALL CASES

MASTER LONG FORM COMPLAINT AND JURY DEMAND

Plaintiffs, by and through the undersigned lead counsel, bring this Master Long Form Complaint as an administrative device to set forth potential claims individual Plaintiffs may assert against Defendants in this litigation. Individual Plaintiffs Will incorporate this Master Long Form Complaint by reference in their Short Form Complaints.

PARTIES, JURISDICTION & VENUE

PLAINTIFFS

1. Plaintiffs include men and women Who had one or more ofDefendants’ hernia mesh
products listed in Paragraphs 19 and 20 of this Master Long Form Complaint (hereinafter “Master
Complaint”) inserted in their bodies to treat hernia(s).

2. Plaintiffs also include their spouses, as well as others With standing to file claims
arising from Defendants’ hernia mesh products described herein.

DEFENDANTS

3. Defendant DAVOL INC. (hereinafter “DAVOL”) is a wholly owned subsidiary of Defendant C.R. BARD, INC. DAVOL is a corporation that is incorporated under the laws of the State of Delaware, With its principal place of business in Warwick, Rhode Island. DAVOL is a citizen of Rhode Island.

4. DAVOL is a medical device company involved in the research, development, testing, manufacture, production, marketing, promotion and/or sale of products in key surgical specialties, including hernia repair, hemostasis, orthopedics, and laparoscopy. According to its website, DAVOL is the “the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants.”

5. Defendant C. R. BARD INC. (hereinafter “BARD”) is a corporation that is incorporated under the laws of the State of New Jersey. It is the corporate parent/stockholder of DAVOL. BARD is a citizen of New Jersey, but, at all times relevant, did substantial and continuous business in the State of Rhode Island.

6. BARD participates in the manufacture and distribution of its hernia mesh products. It also manufactures and supplies DAVOL With material that forms component parts of the hernia mesh products. BARD touts itself as “the market leader in comprehensive soft tissue reconstruction, delivering a growing line of mesh prosthetics, biologic implants and fixation systems to complement innovative techniques for inguinal, ventral and other hernia repair procedures.” Both directly and/or through the actions of Defendant DAVOL, BARD has at all pertinent times been responsible for the research, development, testing, manufacture, production, marketing, advertising, promotion, distribution and/or sale of its hernia mesh products worldwide.

7. Defendants DAVOL and BARD (hereinafter “Defendants”) are individually, jointly and severally liable to Plaintiffs for damages resulting from the Defendants’ design, manufacture, marketing, packaging, labeling, distribution, sale and placement 0f its defective
mesh products at issue in the instant suit, effectuated directly and indirectly through their respective agents, servants, employees and/or owners, all acting within the course and scope of their representative agencies, services, employments and/or ownership.

8. At all times relevant herein, the 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 their hernia mesh devices. As a result of the coordinated activities of all Defendants named above, Plaintiffs were implanted With defective hernia mesh products.

9. Defendants are vicariously liable for the acts and/or omissions of their employees and/or agents Who were at all times relevant hereto acting on behalf of Defendants and within the scope of their employment or agency with Defendants.

10. BARD is also liable for any acts and/or omissions by or through DAVOL because it is merely the alter ego or an instrumentality of Bard.

11. Publicly available information, published by DAVOL and BARD, indicates that BARD considers DAVOL to be a division of BARD.4 Indeed, DAVOL’S website directs consumers to contact customer service Via a BARD email address.5 Furthermore, employees of
these corporations consider BARD and DAVOL to be one in the same. Finally, the hernia mesh products at issue in this case are advertised and sold on the BARD website the product brochures bare the BARD logo, and BARD claims to own the trademarks associated with the product names.

12. BARD, directly and/or through the actions of their DAVOL division, is and/or has, at all pertinent times, been responsible for the research, development, testing, manufacture, production, packaging, labeling, marketing, promotion, distribution, and/or sale of hernia mesh products.

13. DAVOL acts as an agent for BARD as it is merely a business conduit of BARD. Therefore, BARD is vicariously liable for the acts and/or omissions of its employees and/or agents at DAVOL Who were at all times relevant hereto acting on behalf of BARD and Within the scope of their employment or agency With BARD.

14. At all times relevant herein, Defendants were directly or indirectly 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 their hernia mesh
devices. As a result of the coordinated activities of Defendants named above, Plaintiffs were implanted with defective hernia mesh products.

VENUE AND JURISDICTION

15. This Court has personal jurisdiction over the issues and the parties to this cause of action. DAVOL is a resident of the State ofRhode Island, Who designed, manufactured, marketed, and/or sold the product in Rhode Island. DAVOL’S principal place of business is the State of
Rhode Island. BARD owns and operates DAVOL, and exercises control over the DAVOL division that designed, manufactured, marketed, and/or sold the product in Rhode Island. DAVOL acts as an agent of BARD.

16. A substantial part of the events and omissions giving rise t0 Plaintiffs’ causes of
actions occurred in Rhode Island. Through these actions, Defendants have significant contacts
with this jurisdiction such that requiring their appearance does not offend traditional notions of
fair play and substantial justice.
17. Further, Defendants have and continue t0 conduct substantial business in this State,
including designing, manufacturing, marketing, and distributing hernia mesh products in this State.
They further receive substantial compensation and profits from sales of hernia mesh products in
and from this State.
18. This Court has subject matter jurisdiction over the issues and the parties to this
cause of action. Plaintiffs bring this complaint solely under state law and not under federal law
and specifically not under the United States Constitution, or any of its amendments. Plaintiffs
believe and allege that causes of action exist under the hereinafter set out state law claims for the
conduct complained of herein.
FACTUAL BACKGROUND
19. Defendants’ Bard Mesh, Composite Prosthesis (also known as Composix),
Composix E/X Mesh, Composix Kugel Hernia Patch, Kugel Hernia Patch, Marlex Mesh, Modified
Kugel Hernia Patch, PerFix Plug, SpermaTex, Ventralex Hernia Patch, Ventralex ST Hernia Patch,
Ventrio Hernia Patch, Ventrio ST Hernia Patch, Visilex Mesh, and 3DMaX Mesh were designed,
patented, manufactured, packaged, labeled, marketed, and sold and distributed by Defendants.
20. Defendants’ Sepramesh IP Composite was, at all relevant times, manufactured,
packaged, labeled, marketed, and sold and distributed by Defendants.
21. The products listed in paragraphs 19 and 20 (hereinafter “the products,” “the Hernia
Mesh products” or “Defendants’ Hernia Mesh products”) were designed and/or manufactured
primarily for the purpose of treating hernias. These products share common design elements and
common defects. Moreover, the products in paragraph 19 were cleared for sale in the U.S. after
Defendants made assertions to the Food and Drug Administration of “Substantial Equivalence”
under Section 5 10(k) of the Food, Drug and Cosmetic Act; this clearance process does not require
the applicant to prove safety or efficacy.
22. Sepramesh IP was also cleared for sale in the U.S. under Section 5 10(k) ofthe Food,
Drug and Cosmetic Act.
23. Defendants were responsible for the research, design, development, testing,
manufacture, production, marketing, packaging, promotion, distribution and sale of their Products,
as well as providing the warnings and the instructions concerning their Products.
24. Among the intended purposes for which Defendants designed, and/or
manufactured, marketed, and sold their Products was for use by surgeons for hernia repair
surgeries—the purpose for which the Product was implanted in the Plaintiff named in the Short
Form Complaint.
25. Defendants’ Hernia Mesh Products are designed, intended, and utilized for
permanent implantation in the human body.
26. Defendants represented t0 Plaintiffs and Plaintiffs’ physicians that their Products
were safe and effective products for hernia repair and for permanent implantation in humans.
27. Defendants failed to perform and/or rely 0n adequate testing and research in order
to determine and evaluate the risks and benefits of their Products.
28. Defendants’ Hernia Mesh Products are defectively designed and/or manufactured,
are not reasonably safe for their intended use in hernia repair, and the risks of the design outweigh
any potential benefits associated with the design. As a result of the defective design and/or
manufacture of their Products, there was an unreasonable risk of severe adverse reactions to the
mesh or mesh components, including, but not limited to: chronic pain; recurrence ofhernia; foreign
body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration;
scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation;
adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma
formation; nerve damage; tissue damage and/or death; and other complications.
29. The Defendants’ Hernia Mesh Products are manufactured from polypropylene that
is unsuitable. Defendants’ Polypropylene contains about 15 additional compounds that are leached
from the polypropylene and are toxic to tissue, which enhances the inflammatory reaction and the
intensity of fibrosis.
30. Mesh is not inert. It flakes and fissures and this leads to degradation and the release
of toxic compounds. This enhances the inflammatory and fibrotic reactions.
3 1. The polypropylene material used in the Defendant’s Hernia Mesh Products is
unreasonably susceptible to in ViVO oxidative degradation, Which causes or exacerbates excessive
inflammation and adverse foreign body reaction, leading to excessive shrinkage, scarification, pain
and mesh deformation.
32. The FDA defines “degradation” as a “device problem” t0 Which the FDA assigns a
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specific “device problem code. “Degradation” is defined as an “[i]ssue associated With a
deleterious change in the chemical structure, physical properties, or appearance in the materials
that are used in device construction?”
33. Heat begins the degradation process. At room temperature, which is approximately
70 F, there is Virtually no reaction. However, the effect is exponential at elevated temperatures.
The typical body temperature of a human being is 98.6 °F.
34. Degradation 0f polypropylene causes two phenomena: (1) a greatly increased
surface area, thus providing larger areas for bacterial adherence and more elution of toxic
compounds from the polypropylene, and (2) freed polypropylene, thus creating additional eluding
of toxins. Both phenomena increase the in Vivo inflammatory reaction and intensity of fibrosis.
35. The greatly increased surface area also promotes wicking of fluids and bacteria,
acting as a “bacterial super highway,” which provides a safe haven for bacteria.
36. Upon information and belief, Defendants’ numerous suppliers of various forms of
polypropylene cautioned all users in their United States Material Safety Data Sheet (hereinafter
“MSDS”) that the polypropylene was not to be used for medical applications involving permanent
implantation in the human body or permanent contact With internal body fluids or tissues.
37. Defendants knew or should have known of the unreasonably dangerous and
defective nature of their polypropylene prior to introducing it into the stream of commerce.
38. Additional design defects of Defendants’ Hernia Mesh Products include:
9See
https://www.fda.gov/MedicalDeVices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseE
vents/ManufacturerEvaluationCodes/ucm270416.htm (last Visited Nov. 9, 20 1 7).
1° See https://www.fda.gov/MedicalDeVices/ucml34761 .htm (last Visited Nov. 9, 2017).
a) Mesh Weight: Mesh weight is an important factor in mesh
biocompatibility. Defendants knew or should have known prior to designing and/or
manufacturing, marketing and distributing Bard Mesh, Composite Prosthesis (also
known as Composix), Composix E/X Mesh, Composix Kugel Hernia Patch, Kugel
Hernia Patch, Marlex Mesh, Modified Kugel Hernia Patch, PerFiX Plug, Sepramesh
Composite IP, SpermaTex, Ventralex Hernia Patch, Ventralex ST Hernia Patch,
Visilex Mesh, and the 3DMaX Mesh that heavyweight mesh is responsible for an
undesirable foreign body reaction and fibrotic bridging, both of which lead to
excessive shrinkage, contracture, scarification, and mesh banding. More than 85%
of Defendants’ Hernia Mesh Products are made out of heavyweight mesh.
b) Pore Size: Mesh porosity is important for tissue ingrowth, With 10W
porosity decreasing tissue incorporation. Defendants knew or should have known
prior to designing and/or manufacturing, marketing and distributing Bard Mesh,
Composite Prosthesis (also known as Composix), Composix E/X Mesh, Composix
Kugel Hernia Patch, Kugel Hernia Patch, Marlex Mesh, Modified Kugel Hernia
Patch, PerFiX Plug, Sepramesh Composite IP, SpermaTex, Ventralex Hernia Patch,
Ventralex ST Hernia Patch, Visilex Mesh, the 3DMax Mesh that the smaller the
pore size, the greater the risk of fibrotic bridging, Which leads to greater
inflammation, excessive shrinkage, contracture, scarification, and mesh banding.
Pore size should be at least 3mm. Fibrotic bridging is often observed in mesh
variants with pore sizes of <3mm. More than 87% of Defendants’ Hernia Mesh
Products have a pore size of <1mm.
c) Sepra Technology (“ST”): Sepra Technology is polypropylene co-knitted
using polypropylene and polyglycolic acid (“PGA”). The PGA is coated With a
bioresorbable coating composed of sodium hyaluronate (“HA”),
carboxymethlcellulose (“CMC”), and polyethylene glycol (“PEG”). Upon in Vivo
placement of a mesh with the ST coating, the coated side of the mesh is implanted
facing the viscera or other internal organs. Defendants advertise the ST coating to
prevent adhesions to underlying organs during the “critical healing process,” and
to dissolve and secrete from the body Within 30 days, thereby reducing the amount
of foreign material remaining in the body. Defendants knew 0r should have known
prior to designing and/or manufacturing, marketing and distributing Sepramesh IP
Composite Mesh, Ventralex ST Hernia Patch, and the Ventrio ST Hernia Patch that
the Sepra Technology does not prevent adhesions, the coating dissolves too quickly
once implanted, and the coating scrapes/flakes off easily before and during implant,
dangerously exposing uncoated polypropylene to underlying organs. Such
exposure can cause incarceration of organs, and, among other things, can result in
severe infections, abscess(es), and/or fistula formation
d) Composite Meshes: Composite meshes have one or more 1ayer(s) of
polypropylene mesh on one side, and an expanded polytetrafluoroethylene
(“ePTFE”) layer on the other side. The layers are either heat bonded or stitched
together with polytetrafluoroethylene (“PTFE”) monofilament. Upon in Vivo
implant, the ePTFE is intended to face the viscera or other internal organs.
Defendants knew or should have known prior t0 designing and/or manufacturing,
marketing and distributing the Composite Prosthesis (also known as Composix),
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Composix E/X Patch, Composix Kugel Hernia Patch, Modified Kugel Hernia
Patch, Ventralex Hernia Patch, and the Ventrio Hernia Patch that the polypropylene
and ePTFE shrink and contract at different rates, which causes deformation of the
mesh, such as buckling, folding, crumpling and/or balling-up; thus, causing the
polypropylene side of the mesh to come in contact with underlying tissue and
organs. Such exposure can cause incarceration of organs, and, among other things,
can result in severe infections, erosion, abscess(es), and/or fistula formation.
e) Polyethylene Terephthalate (“PET”) Memory Recoil Ring: The PET
ring is a plastic ring(s) sewn between two layers of polypropylene, and in some
products, those layers of polypropylene are also sewn to a layer of ePTFE. In
advertisement and function, the ring(s) only purpose is to facilitate initial placement
of the mesh by the surgeon, by causing the mesh patch to spring open and lay flat
While the surgeon sutures or tacks the mesh patch into place. The ring(s) has no
purpose thereafter, but remains indefinitely. Defendants knew 0r should have
known prior to designing and/or manufacturing, marketing and distributing the
Composix Kugel Hernia Patch, Kugel Hernia Patch, Modified Kugel Patch and the
Ventralex Patch that the PET Memory Recoil Ring(s) posed a number 0f risks
because the ring(s) was insufficient to Withstand assembly/deployment and bodily
forces, such as mesh and/or mesh/wound shrinkage, tissue ingrowth, other
mechanical forces acting on the ring, or of plane positioning and repositioning of
the patch (noting that the surface t0 Which it is attached is not actually flat even
initially), and initial lack of flatness of the ring plane. Inconceivably, despite the
problems associated with the PET ring(s), Defendants recalled only some of the
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Composix Kugel patch lots, leaving several Composix Kugel lots on the market,
along with all of the Modified Kugel, Kugel and Ventralex patches. Even more
reprehensibly, Defendants in or around December 2013 secretly recalled the PET
ring in the Ventralex Patch and Modified Kugel Patch by replacing the PET ring
with the PDO ring, which is a ring that is absorbable, and further, at an unknown
date, secretly recalled the Kugel Hernia Patch altogether. According to their
website, the Defendants no longer manufacture, market, and distribute the Kugel
Hernia Patch The assembly/deployment and bodily forces 0n the ring can lead t0
deformation and buckling of the patch, and/or a ring(s) break, causing an array of
problems including, but not limited to, adhesions, erosion, bowel perforation,
fistula formation, and even death.
f) SorbaFlex Memory Technology Polydioxanone (“PDO”) Ring:
Following massive complications as a result of the PET ring, Defendants designed
and manufactured an absorbable ring to replace the PET ring. The PDO ring is
meant to facilitate initial placement of the mesh by the surgeon, by causing the
mesh patch to spring open and lay flat while the surgeon sutures or tacks the mesh
patch into place, and then fully absorbs, according to Defendants, within 6 to 8
months. Mirroring the old design, the PDO ring(s) is sewn between the layers of
polypropylene and those layers are then sewn to a layer of ePTFE or Sepramesh 1P.
Defendants knew or should have known prior to designing and/or manufacturing,
marketing and distributing the Ventrio Hernia Patch, Ventrio ST Hernia Patch,
Ventralex Hernia Patch and the Ventralex ST Hernia Patch that the PDO Memory
Ring was insufficient Withstand assembly/deployment and bodily forces, such as
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39.
mesh and/or mesh/wound shrinkage, tissue ingrowth, other mechanical forces
acting on the ring, or of plane positioning and repositioning of the patch (noting
that the surface to which it is attached is not actually flat even initially), and initial
lack of flatness of the ring plane. The assembly/deployment and bodily forces on
the ring can lead to deformation and buckling of the patch, and/or a ring(s) break,
causing an array of problems including, but not limited to, adhesions, erosion,
bowel perforation, fistula formation, and even death.
A11 of the Defendants’ Hernia Mesh Products contain one or more of the above
design defects. Specifically:
a. Bard Mesh: Bard mesh is constructed of a single layer of small pore, heavy weight,
unsuitable polypropylene.
Composite Prosthesis: Composite Prosthesis, also known as Composix, is a
constructed of a double layer of small pore, heavy weight, unsuitable polypropylene,
that is heat bonded to a single layer of ePTFE.
Composix E/X Mesh: Composix E/X Mesh is constructed of a single layer of small
pore, heavy weight, unsuitable polypropylene, that is stitched to a layer 0f ePTFE
using polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge 0f
the mesh is heat sealed to the ePTFE layer.
Composix Kugel Hernia Patch: The Composix Kugel Hernia Patch is constructed of
two layers of small pore, heavy weight, unsuitable polypropylene that is stitched to a
layer of ePTFE with one or two PET ring(s) sewn in between. Class 1 Device Recalls
ofthis patch were required in 2005, 2006, and 2007 due to the defective and dangerous
nature 0f this product. The FDA classified all 0f the recalls as Class 1 Device Recalls.
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This means that the FDA found there is a reasonable chance that the patches could
cause serious health problems or death.
e. Kugel Hernia Patch: The Kugel Hernia Patch is constructed of two layers of small
pore, heavy weight, unsuitable polypropylene with a PET ring sewn between them.
At an unknown date, Defendants secretly recalled the Kugel Hernia Patch altogether.
According to their website, the Defendants no longer manufacture, market, and
distribute the Kugel Hernia Patch.
f. Marlex Mesh: Marlex Mesh is constructed of a single layer of small pore, heavy
weight, unsuitable polypropylene.
g. Modified Kugel Hernia Patch: The Modified Kugel Patch is constructed of a layer of
small pore, heavyweight, unsuitable polypropylene that includes a PET ring, and
additional layers of the above-noted mesh, Which act as a positioning pocket and a
positioning strap, along with a separate flat, pre-shaped onlay piece of small pore,
heavyweight, unsuitable polypropylene mesh.
h. PerFix Plug: The PerFix plug is a pre-formed, three-dimensional device constructed
of a fluted outer layer of small pore, heavyweight, unsuitable polypropylene mesh and
multiple inner layers of that same mesh attached at the tip, with an additional separate
flat, pre—shaped onlay piece of small pore, heavyweight, unsuitable polypropylene
mesh. This excessive amount 0f foreign material has been flagged in the World
Guidelines for Groin Hernia Management as having a high incidence of erosion and a
lifetime risk of migration.“
11 The HemiaSurge Group, World Guidelines for Groin Hernia Management, at 5, available at
https://www.europeanhemiasociety.eu/sites/www.europeanherniasociety.eu/files/medias/PDF/HemiaSurgeGuidelin
esStatementsRecomendations.pdf (last Visited Nov. 9, 2017).
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i. Sepramesh Composite 1P: Sepramesh Composite IP is constructed 0f small pore
heavyweight, unsuitable polypropylene mesh co-knitted with polyglycolic acid
(“PGA”), With a bioresorbable coating 0n one side composed of sodium hyaluronate
(“HA”), carboxymethlcellulose (“CMC”), and polyethylene glycol. Sepramesh
Composite IP is the Sepra Technology.
SpermaTex: SpermaTeX is thumbnail in shape and constructed of small pore,
heavyweight, unsuitable polypropylene mesh, with a patch of ePTFE stitched to one
side of the mesh at the rounded corner.
Ventralex Hernia Patch: The Ventralex Hernia patch used to be constructed of two
layers of small pore, heavy weight, unsuitable polypropylene mesh that included a
PET ring between those layers, and both of those layers and ring are stitched t0 a layer
of ePTFE using polytetrafluoroethylene (PTFE) monofilament thread. The peripheral
edge of the mesh was heat sealed to the ePTFE layer. In or around December 2013,
Defendants initiated a remedial measure by manufacturing the Ventralex Hernia Patch
With a PDO absorbable ring encased in a small pore, heavyweight, unsuitable
polypropylene tube, instead of the PET ring.
Ventralex ST Hernia Patch: The Ventralex ST Hernia Patch is constructed of one layer
of small pore, heavy weight, unsuitable polypropylene mesh and one layer of
Sepramesh Composite IP, that includes a PDO ring encased within a small pore, heavy
weight, unsuitable polypropylene mesh tube that is sewn between the two layers.
Ventrio Hernia Patch: The Ventrio Hernia patch is constructed of one layer of large
pore, lightweight mesh and one layer 0f small pore, heavy weight, unsuitable
polypropylene mesh, and there is a PDO ring encased within a small pore, heavy
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weight, unsuitable polypropylene mesh tube that is sewn between the two layers, and
both of those layers and ring are stitched to a layer of ePTFE using
polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge of the
mesh was heat sealed to the ePTFE layer.
n. Ventrio ST Hernia Patch: The Ventrio ST Hernia Patch is constructed of one layer of
small pore, heavy weight, unsuitable polypropylene mesh and one layer of Sepramesh
Composite IP, that includes a PDO ring within a small pore, heavy weight, unsuitable
polypropylene mesh tube that is sewn between the two layers.
o. Visilex Mesh: is constructed of a single layer of small pore, heavy weight, unsuitable
polypropylene With one selvage edge.
p. 3DMax Mesh: 3DMax is a three-dimensional anatomically shaped pre-formed small
pore, heavyweight, unsuitable polypropylene mesh.
40. Defendants failed to adequately test all of the above design features in animals and
humans, both before and after their Products entered the stream of commerce.
41. Feasible and suitable alternative procedures and instruments to the Defendants’
Hernia Mesh Products, as well as suitable alternative designs for implantation and treatment of
hernias and soft tissue repair have existed at all relevant times.
42. Defendants failed to design and establish a safe, effective procedure for removal of
their Products; thus, in the event of a failure, injury, or other complication, it is difficult to safely
remove the Defendants’ Hernia Mesh Products.
43. Defendants had sole access to material facts concerning the defective nature oftheir
Products and their propensity to cause serious and dangerous side effects.
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44. Upon information and belief, Defendants adjusted the threshold for reporting and
recalling their Products due to non-conformities and adverse event reports, resulting in a large
number of injurious events, deemed by Defendants to be acceptable, to go unreported.
45 . Indeed, a 2006 FDA inspection of Defendants’ facilities resulted in a 483 citing that
there are inconsistencies in the way Defendants record data for tracking and trending complaint
and Medical Device Reporting information.
46. Upon information and belief, Defendants misled physicians about potential adverse
events and attempted to convince physicians of alternative causes other than their Products.
47. Defendants “stealth recalled” or cannibalized some of their Products that were
experiencing high levels of adverse events by simply halting production of certain products
Without notifying consumers or physicians of the recall or high levels 0f adverse events, and
simultaneously conducting aggressive and substantial marketing of new/other products.
48. Upon information and belief, Defendants manipulated altered, skewed, slanted,
misrepresented, and/or falsified pre-clinical and/or clinical studies to bolster the perceived
performance of their Products and/or diminish adverse events.
49. Upon information and belief, Defendants paid doctors, surgeons, physicians, and/or
clinicians to promote their Products, but did not readily disclose this information.
50. Defendants marketed and sold their Products to the medical community at large
and patients through carefully planned, multifaceted marketing campaigns and strategies. These
campaigns and strategies include, but are not limited to, aggressive marketing t0 healthcare
providers at medical conferences, hospitals, and private offices, as well as the provision ofvaluable
benefits to healthcare providers. Defendants further utilized documents, patients, brochures, and
websites.
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5 1. Defendants have, at all times relevant hereto, provided incomplete, insufficient, and
misleading training and information to physicians, in order to increase the number of physicians
utilizing their Products, thereby increasing sales. Further, Defendants’ failure to truthfully and
fully disclose complete information of the frequency, severity, and pennanency of the
complications associated with its Products prevented doctors, including Plaintiffs’ doctors, from
being a true learned intermediary. This has led to the dissemination of inadequate and misleading
information to patients, including Plaintiffs.
52. Upon information and belief, Defendants have been notified about the Widespread
catastrophic complications associated With their Products by leading hernia repair specialists,
surgeons, hospitals, patients, internal consultants, and/or employees. Reprehensibly, however,
only 1 out of the 16 Products named in this complaint has been formally recalled from the market.
Defendants have misrepresented the efficacy and safety of their Products, through various means
and media, actively and intentionally misleading the medical community, patients, and the public
at large.
53. Defendants’ Hernia Mesh Products have been and continue to be marketed to the
medical community and to patients as safe, effective, reliable medical devices, implanted by safe
and effective surgical techniques for the treatment of hernias and soft tissue repair, and as safer 0r
more effective as compared to the traditional products and procedures, including competing hernia
mesh products.
54. In reliance on Defendants’ representation, Plaintiffs’ physicians were induced to,
and did use, Defendants’ Hernia Mesh Products.
55. Defendants’ Hernia Mesh Products were, at all times, utilized and implanted in a
manner foreseeable and/or intended by Defendants.
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56. The Product implanted into each of the Plaintiffs was in the same or substantially
similar condition as When it left Defendants’ possession, and/or in the condition directed by and
expected by Defendants.
57. As a direct and proximate result of having the Product implanted, Plaintiffs have
been severely and permanently injured.
58. The manufacturing and design defects associated with the Products were directly
and proximately related to the injuries suffered by the Plaintiff named in the Short Form
Complaint.
59. Neither Plaintiffs nor their implanting physicians were adequately warned or
informed by Defendants of the defective and dangerous nature of Defendants’ Hernia Mesh
Products, including the risks specifically associated With Defendants’ polypropylene, the mesh
weight and pore size of their Products, Sepra Technology, Composite Mesh products, PET ring,
and/or PDO ring. Moreover, neither Plaintiffs nor their implanting physicians were adequately
warned or informed by Defendants of the risks associated With the Products.
60. The Product implanted in the Plaintiff named in the Short Form Complaint failed
to reasonably perform as intended. The mesh caused serious and permanent injuries, resulting in
the need for additional treatment, including additional corrective surgery or surgeries.
61. Plaintiffs’ severe adverse reactions, and the necessity for additional treatment,
directly and proximately resulted from the defective and dangerous condition of the product and
Defendants’ defective and inadequate warnings about the risks associated With the product.
62. Plaintiffs have suffered, and Will continue to suffer, both physical injury and pain
and mental anguish, permanent and severe injury, including scarring and disfigurement, lost wages
and earning capacity, and have incurred substantial medical bills and other expenses, resulting
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from the defective and dangerous condition of the product and from Defendants’ defective and
inadequate warnings about the risks associated with the product.
63. The Plaintiff named in the Short Form Complaint, in the existence of due diligence
could not have reasonably discovered the Defendants’ wrongful conduct and the cause of his/her
injuries, including, but not limited to, the defective design and/or manufacturing of the Product
until a date Within the applicable statute of limitations.
COUNT I
Negligence
64. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
65. At all relevant times, Defendants had a duty to individuals, including the Plaintiff
named in the Short Form Complaint, t0 exercise reasonable and ordinary care in the
manufacturing, designing, testing, packaging, labeling, instructions, warnings, sale, marketing,
distributing, training, and preparing written instructions for the hernia mesh products, as well as in
the training of physicians t0 implant the Hernia Mesh products and/or to properly treat
complications associated with the Hernia Mesh products.
66. Defendants further owed a duty to Plaintiffs t0 adequately warn them of the risks
associated with the Hernia Mesh products, including but not limited to, the risks of degradation,
infection, excessive and chronic inflammation, inadequate or failure of incorporation/ingrowth,
contracture, shrinkage, breakage, buckling, folding, adhesions, recurrence, migration, excessive
scarification, erosion, abscess, fistula fonnation, nerve damage, tissue damage, fibrotic bridging,
mesh banding, chronic pain, and other complications associated with the Hernia Mesh products
and the resulting harm it would cause patients.
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67. Defendants knew, or in the exercise of reasonable care should have known, that the
Hernia Mesh products were of such a nature that they were not properly manufactured, tested,
inspected packaged, labeled, distributed, marketed, examined, sold, supplied, prepared, and/or
provided with the proper warnings, and were defective, unreasonably dangerous, and likely to
injure patients in whom the Hernia Mesh products were implanted. Defendants knew or should
have known that Plaintiff and Plaintiffs’ physicians were unaware of the dangers and defects
inhering in the Hernia Mesh Products.
68. Defendants so negligently and carelessly designed, manufactured, tested or failed
to test, inspected or failed to inspect, packaged, labeled, distributed, recommended, displayed,
sold, examined or failed to examine, and supplied the Hernia Mesh products that they were
unreasonably dangerous and unsafe for the use and purpose for which they were intended.
69. Defendants were aware of the probable consequences of the Hernia Mesh products
and knew or should have known that they would cause serious injury. In spite of this, Defendants
failed to disclose the known or knowable risks associated with the Hernia Mesh products. By
willfully and deliberately failing to avoid the probable consequences, Defendants acted in
conscious disregard of the Plaintiff’s safety.
70. 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 Hernia Mesh products.
71. Defendants breached their duty of care by:
a) Failing to design the Hernia Mesh products s0 as to avoid an unreasonable
risk ofharm to the patients in Whom the products were implanted, including
Plaintiffs;
21
b)
d)
g)
Failing to manufacture the Hernia Mesh products so as to avoid an
unreasonable risk of harm to the patients in whom the products were
implanted, including Plaintiffs;
Failing to use reasonable care in the testing of the Hernia Mesh products so
as to avoid an unreasonable risk of harm to the patients in whom the
products were implanted, including Plaintiffs;
Failing to use reasonable care in inspecting the Hernia Mesh products so as
to avoid an unreasonable risk of haIm to the patients in Whom the products
were implanted, including Plaintiffs;
Withholding adverse infomation regarding the Hernia Mesh products that
was Within their knowledge, including, but not limited t0 the unsuitability
of the polypropylene for human implantation and the risks posed by
Composite meshes, the PET or PDO rings and/or Sepramesh Technology
used in their products, thereby preventing Plaintiffs and their physicians
from understanding the true risks associated With the Hernia Mesh products;
Failing to adequately instruct, train, or warn physicians regarding the use of
the Hernia Mesh products and the true risks associated with the products,
including the frequency, severity and duration of such risks, and the
appropriate treatment for complications associated with the Hernia Mesh
products.
Failing to comply with state and federal regulations concerning the study,
testing, design, development, manufacture, inspection, production,
22
h)
advertisement, marketing, promotion, distribution and/or sale of the Hernia
Mesh products.
Otherwise negligently or carelessly designing, manufacturing, marketing,
labeling, packaging, and/or selling the Hernia Mesh products.
72. The reasons that Defendants’ negligence caused the Hernia Mesh products t0 be
unreasonably dangerous and defective include those described hereinabove and hereafter, which
include but are not limited to:
a)
b)
d)
The polypropylene material used in the Hernia Mesh products is not suitable
for permanent human implantation and/or is unreasonably susceptible t0 in
Vivo oxidative degradation, which causes or exacerbates an excessive and
chronic inflammatory response, scarification, shrinkage and deformation of
the mesh.
Defendants ignored the warnings provided by their polypropylene supplier
that the material provided was not safe for human implantation.
The heavyweight mesh unreasonably increases the risk of an undesirable
foreign body reaction, fibrotic bridging, excessive shrinkage, contracture
and scarification.
The small pore size unreasonably increases the risk of fibrotic bridging,
greater inflammation, excessive shrinkage, contracture, and scarification.
By utilizing two materials that shrink and contract at different rates,
composite meshes unreasonably increase the risk of deformation 0f the
mesh, which can lead to exposing the polypropylene side 0f the mesh t0
internal organs and result in severe complications.
23
f)
g)
h)
j)
k)
The polypropylene mesh used is insufficient in strength to withstand the
internal forces of the abdomen after implantation, making it susceptible to
rupture and/or deformation.
The PET ring has no purpose following implantation and carries an
increased risk of breaking and/or causing the mesh to buckle due to its
inability to withstand inter-abdominal forces.
Defendants knew that the PET ring was susceptible to breaking or buckling,
causing the ring to pierce internal organs and/or the polypropylene side t0
come into contact With intestines and/or other internal organs, Which can
result in severe complications. Inexcusably, Defendants publicly recalled
only 1 out of their 4 products that contained PET ring(s).
When implanted intraperitoneally, Which involves the abdomen being
inflated and then deflated, and the product being implanted in contact With
the intestines and/or other internal organs, the Hernia Mesh products’
design unnecessarily increased the risks of mesh deformation, adhesion,
erosion, fistula formation, and other injuries.
The Sepra Technology fails to prevent adhesions and instead dissolves too
quickly, leaving the uncoated polypropylene exposed to internal organs,
Which makes the products unreasonably susceptible to adhesion, bowel
perforation 0r erosion, fistula formation, bowel strangulation, hernia
incarceration, and other injuries.
The appropriate treatment for complications associated With Defendants’
Hernia Mesh products involves an additional invasive surgery to remove
24
the mesh and repair the damage caused; thus eliminating any purported
benefit that the product was intended to provide the patient.
73. Defendants also negligently failed to warn or instruct Plaintiffs or their physicians
regarding the reasonably foreseeable risks and defects associated with the Hernia Mesh products,
including those described hereinabove and hereafter, which include, but are not limited to:
a)
b)
d)
Defendants failed to adequately warn Plaintiffs or their physicians that the
polypropylene used in their products was not suited for permanent
implantation in humans.
Defendants failed to adequately warn Plaintiffs or their physicians that their
polypropylene supplier advised that the material provided was not safe for
human implantation
Defendants failed to adequately warn Plaintiffs or their physicians that the
polypropylene used in their products is unreasonably susceptible to in ViVO
oxidative degradation, which causes or exacerbates an excessive and
chronic inflammatory response, scarification, shrinkage and deformation of
the mesh.
Defendants failed to adequately warn Plaintiffs or their physicians that their
composite meshes carry a high risk of deformation, which can lead to the
polypropylene side of the mesh being exposed to organs.
Defendants failed t0 adequately warn Plaintiffs or their physicians that the
Sepra Technology scrapes off and/or dissolves too quickly, leaving the
naked polypropylene exposed to organs.
25
g)
h)
j)
k)
1)
Defendants failed to adequately warn Plaintiffs or their physicians that the
ringed devices had a propensity to break or buckle.
Defendants failed to adequately warn Plaintiffs or their physicians that the
polypropylene mesh had a propensity to fracture, curl, roll, and deform.
Defendants failed to adequately warn Plaintiffs or their physicians of the
propensity of the Hernia Mesh products to shrink or contract within the
body.
Defendants failed to adequately warn Plaintiffs or their physicians of the
risk of chronic inflammation associated With the Hernia Mesh products.
Defendants failed to adequately warn Plaintiffs or their physicians of the
need for corrective surgery to adjust, remove, or revise the Hernia Mesh
products.
Defendants failed to adequately warn Plaintiffs or their physicians of the
frequency, severity, and duration of complications and risks associated with
the Hernia Mesh products.
Defendants failed to adequately warn plaintiffs or their physicians of the
defects described herein.
m) Defendants failed to adequately warn Plaintiffs or their physicians that the
n)
Hernia Mesh products exposes patients to more risks and different risks than
those associated with safer, feasible alternative products.
Defendants failed t0 adequately warn Plaintiffs or their physicians that the
risks associated with the Hernia Mesh products are more frequent, severe,
26
p)
q)
t)
longer lasting, and more difficult to treat than those associated With safer
feasible alternative products.
Defendants failed to adequately warn Plaintiffs or their physicians that the
Hernia Mesh products are no more effective than feasible, available
alternatives.
Defendants failed to adequately warn Plaintiffs or their physicians that the
Hernia Mesh products put patients at a greater risk of requiring additional
surgery than feasible, available alternatives.
Defendants failed to adequately warn Plaintiffs or their physicians that use
of the Hernia Mesh products makes any future abdominal surgery on the
patient much more complex and dangerous than feasible, available
alternatives.
Defendants failed to adequately warn Plaintiffs or their physicians of the
inability to safely remove the Hernia Mesh products after injury, which
increases the risk of future injuries.
Defendants failed to adequately warn Plaintiffs or their physicians that
When the Sepra Technology coating is disrupted and/or degrades, the
“naked” polypropylene mesh may result in adherence t0 organs, damage t0
organs and may potentiate fistula formation.
Defendants failed t0 adequately warn Plaintiffs or their physicians that
removal of the Hernia Mesh products due to complications may
significantly impair the patients’ quality of life and may not result in
complete resolution of their injuries.
27
74. Defendants knew 0r should have known that its failure to exercise ordinary care in
the manufacture, design, packaging, labeling, warnings, instructions, sale, marketing, distribution,
and training ofphysicians to implant the Hernia Mesh products and/or treat resulting complications
would cause foreseeable harm, injuries, and damages to individuals implanted with the products,
including the Plaintiffs.
75. As a direct and proximate result of Defendants’ negligence, Plaintiffs have been
injured, sustained severe and permanent physical and mental 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.
COUNT II
Strict Liabilitv: Defective Design
76. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
77. Defendants are strictly liable to Plaintiff for the defective design ofthe Hernia Mesh
products, Which resulted in Plaintiffs’ injuries and damages.
78. Defendants designed, manufactured, marketed, assembled, distributed, conveyed,
and/or sold the products for hernia repair surgery.
79. The Hernia Mesh products were defectively designed when supplied, sold,
distributed, and/or otherwise placed into the stream of commerce.
80. At the time the Hernia Mesh product was implanted in the Plaintiff named in the
Short Form Complaint, the product was defectively designed. As described herein, there was an
unreasonable risk that the product would not perform safely and effectively for the purposes for
28
which it was intended, Defendants failed to design against such dangers and failed t0 provide
adequate warnings and instructions concerning these risks.
81. Defendants expected and intended the Hernia Mesh products to reach users, such
as the Plaintiff named in the Short Form Complaint, in the condition in which the product was
sold.
82. At all times relevant, the Hernia Mesh products were substantially in the same
condition as when they left the possession of Defendants.
83. The implantation 0f the Hernia Mesh product in the Plaintiff named in the Short
Form Complaint was medically reasonable, and was a use that Defendants intended and foresaw
When it was designed, manufactured, and/or sold the product.
84. As designed, Defendants’ Hernia Mesh products are unreasonably dangerous and
unsafe for their intended use, presenting an unreasonable risk of harm to Plaintiffs.
85. Defendants Hernia Mesh products did not perform safely as an ordinary patient,
like the Plaintiff named in the Short Form Complaint, would expect.
86. The reasons that Defendants’ Hernia Mesh products are unsafe for their intended
use and defective include those defects described hereinabove and hereafter, including but not
limited to:
a) The polypropylene material used in the Hernia Mesh products is not suitable
for permanent human implantation and/or is unreasonably susceptible to in
Vivo oxidative degradation, which causes or exacerbates an excessive and
chronic inflammatory response, scarification, shrinkage and deformation 0f
the mesh.
29
b)
d)
g)
h)
Defendants ignored the warnings provided by their polypropylene supplier
that the material provided was not safe for human implantation.
The heavyweight mesh unreasonably increases the risk of an undesirable
foreign body reaction, fibrotic bridging, excessive shrinkage, contracture
and scarification.
The small pore size unreasonably increases the risk of fibrotic bridging,
greater inflammation, excessive shrinkage, contracture, and scarification.
By utilizing two materials that shrink and contract at different rates,
composite meshes unreasonably increase the risk of deformation of the
mesh, Which can lead to exposing the polypropylene side 0f the mesh to
internal organs and result in severe complications.
The polypropylene mesh used is insufficient in strength t0 Withstand the
internal forces 0f the abdomen after implantation, making it susceptible to
rupture and/or deformation.
The PET ring has no purpose following implantation and carries an
increased risk of the mesh buckling or breaking due to its inability to
Withstand inter-abdominal forces.
Defendants knew that the PET ring was susceptible t0 breaking or buckling,
causing the ring(s) to pierce internal organs and/or the polypropylene side
to come into contact With intestines and/or other internal organs, which can
result in severe complications. In spite of this, Defendants publicly recalled
only 1 of their 4 products containing a PET ring(s).
30
i) When implanted intraperitoneally, which involves the abdomen being
inflated and then deflated, and the product being implanted in contact with
the intestines and/or other internal organs, the Hernia Mesh products’
design unnecessarily increased the risks of mesh deformation, adhesion,
erosion, fistula formation, and other injuries.
j) The Sepra Technology fails to prevent adhesions and instead dissolves too
quickly, leaving the uncoated polypropylene exposed to internal organs,
Which makes the products unreasonably susceptible to adhesions, bowel
perforation or erosion, fistula formation, bowel strangulation, hernia
incarceration, and other injuries.
k) The appropriate treatment for complications associated With Defendants’
Hernia Mesh products involves an additional invasive surgery to remove
the mesh and repair the damage caused; thus eliminating any purported
benefit that the product was intended to provide the patient.
87. Defendants failed to adequately warn the end user about these risks and the dangers
of the Hernia Mesh products.
88. As a direct and proximate result of the defective and unreasonably dangerous
condition of the products, Plaintiffs have been injured, sustained severe and permanent physical
and mental 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.
31
COUNT III
Strict Liabilitv: Manufacturing Defect
89. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
90. At the time the Hernia Mesh products were implanted in Plaintiffs, the products
were defective with respect to the manufacture, as described herein, in that Defendants deviated
materially from their design and manufacturing specifications and/or such design and manufacture
posed an unreasonable risk 0f harm t0 Plaintiffs.
91. As a direct and proximate result 0f the defective manufacture, the Hernia Mesh
products are unreasonably dangerous and defective, unfit and unsafe for their intended and
reasonably foreseeable uses, and do not meet or perform t0 the expectations 0f patients and their
healthcare providers.
92. The manufacturing defects associated with the Hernia Mesh products were not
known, knowable, or readily visible t0 Plaintiffs’ physicians or to Plaintiffs, nor were they
discoverable upon any reasonable examination by Plaintiffs’ physicians or Plaintiffs.
93. The Hernia Mesh products were used and implanted in the very manner in which
they were intended to be used and in accordance with the instructions for use and specifications
provided by Defendants.
94. The Hernia Mesh products implanted in Plaintiffs were different from the intended
design and failed to perform as safely as products manufactured in accordance with the intended
design would have performed.
95. The defective manufacture of the Hernia Mesh product was a proximate cause of
the injuries and damages suffered by the Plaintiff(s) named in the Short Form Complaint.
96. Defendants are strictly liable in tort to Plaintiffs for their wrongful conduct.
32
97. As a direct and proximate result of the defective and unreasonably dangerous
condition of the products, Plaintiffs have been injured, sustained severe and permanent physical
and mental 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.
COUNT IV
Failure t0 Warn
98. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
99. Defendants designed, manufactured, marketed, and sold the Hernia Mesh products
for hernia repair surgeries.
100. In performing Plaintiffs’ hernia repair surgery, the surgeon used and implanted one
of Defendants’ Hernia Mesh products.
101. At the time the Plaintiff named in the Short Form Complaint had her implant
surgery, the Hernia Mesh product was in the same condition as when it was manufactured,
distributed, and sold.
102. At the time the Defendants’ Hernia Mesh products were implanted in Plaintiffs’
bodies, they were defective and unreasonably dangerous when put t0 their intended and reasonably
anticipated use. As described herein there was an unreasonable risk that the product would not
perform safely and effectively for the purposes for which it was intended, and Defendants failed
to design and/or manufacture against such dangers and failed to provide adequate warnings and
instructions regarding those risks.
103. Further, Defendants Hernia Mesh products were not accompanied by proper
warning regarding the significant adverse consequences associated.
33
104. Defendants failed to provide warnings, labels, 0r instructions of the dangerous
propensities that were known or scientifically knowable at the time of distribution. The reasonably
foreseeable use of the products involved significant dangers not readily obvious to the ordinary
user. Defendant failed to warn of the known or knowable injuries associated With the Hernia
Mesh products, including but not limited to:
a)
b)
d)
Defendants failed to adequately warn Plaintiffs or their physicians that the
polypropylene used in their products was not suited for permanent
implantation in humans.
Defendants failed to adequately warn Plaintiffs 0r their physicians that their
polypropylene supplier advised that the material provided was not safe for
human implantation.
Defendants failed to adequately warn Plaintiffs or their physicians that the
polypropylene used in their products is unreasonably susceptible to in Vivo
oxidative degradation, which causes or exacerbates an excessive and
chronic inflammatory response, scarification, shrinkage and deformation 0f
the mesh.
Defendants failed to adequately warn Plaintiffs or their physicians that their
composite meshes carry a high risk of deformation, which can lead to the
polypropylene side of the mesh being exposed to organs.
Defendants failed t0 adequately warn Plaintiffs or their physicians that the
Sepra Technology scrapes off and/or dissolves too quickly, leaving the
naked polypropylene exposed to organs.
34
g)
h)
j)
k)
1)
Defendants failed to adequately warn Plaintiffs or their physicians that the
ringed devices had a propensity to break or buckle, causing the ring(s) to
pierce internal organs and/or polypropylene to come in contact with bowel
or other internal organs.
Defendants failed to adequately warn Plaintiffs or their physicians that the
polypropylene mesh had a propensity to fracture, curl, roll, and deform.
Defendants failed to adequately warn Plaintiffs or their physicians of the
propensity of the Hernia Mesh products to shrink or contract within the
body.
Defendants failed to adequately warn Plaintiffs or their physicians of the
risk of chronic inflammation associated With the Hernia Mesh products.
Defendants failed to adequately warn Plaintiffs or their physicians of the
need for corrective surgery to adjust, remove, or revise the Hernia Mesh
products.
Defendants failed to adequately warn Plaintiffs or their physicians of the
frequency, severity, and duration of complications and risks associated With
the Hernia Mesh products.
Defendants failed to adequately warn plaintiffs or their physicians of the
defects described herein.
m) Defendants failed t0 adequately warn Plaintiffs 0r their physicians that the
Hernia Mesh products exposes patients t0 more risks and different risks than
those associated with safer, feasible alternative products.
35
p)
q)
t)
Defendants failed to adequately warn Plaintiffs or their physicians that the
risks associated with the Hernia Mesh products are more frequent, severe,
longer lasting, and more difficult to treat than those associated with safer
feasible alternative products.
Defendants failed to adequately warn Plaintiffs or their physicians that the
Hernia Mesh products are no more effective than feasible, available
alternatives.
Defendants failed to adequately warn Plaintiffs or their physicians that the
Hernia Mesh products put patients at a greater risk of requiring additional
surgery than feasible, available alternatives.
Defendants failed to adequately warn Plaintiffs or their physicians that use
of the Hernia Mesh products makes any future abdominal surgery on the
patient much more complex and dangerous than feasible, available
alternatives.
Defendants failed to adequately warn Plaintiffs or their physicians of the
inability to safely remove the Hernia Mesh products after injury, which
increases the risk of future injuries.
Defendants failed to adequately warn Plaintiffs or their physicians that
When the Sepra Technology coating is disrupted and/or degrades, the
“naked” polypropylene mesh may result in adherence t0 organs, damage t0
organs and may potentiate fistula formation.
Defendants failed t0 adequately warn Plaintiffs or their physicians that
removal of the Hernia Mesh products due to complications may
36
significantly impair the patients’ quality of life and may not result in
complete resolution of their injuries.
u) Defendants failed to adequately warn Plaintiffs or their physicians that the
necessary surgical removal of the Hernia Mesh products would leave the
hernia unrepaired, and would necessitate further medical treatment.
105. Defendants failed to properly and adequately warn and instruct the Plaintiffs and
their health care providers as t0 the risks of the Hernia Mesh products, given the Plaintiffs’
conditions and need for information.
106. Defendants failed to properly and adequately warn and instruct the Plaintiffs and
their healthcare providers with regard to the inadequate research and testing of the Hernia Mesh
products, and the complete lack of a safe, effective procedure for removal.
107. Defendants expected and intended the Hernia Mesh products to reach users such as
Plaintiffs in the condition in which they were sold.
108. At the time of the implant surgery, Plaintiffs and their physicians were unaware of
the defects and dangerous propensities of the Hernia Mesh products, and were unaware of the
frequency, severity, and duration of these risks.
109. If Plaintiffs and/or their physicians had been properly warned of the defects and
dangers of Defendants’ Hernia Mesh products, and of the frequency, severity, and duration of the
risks, Plaintiffs would not have consented t0 allow implantation and Plaintiffs’ physicians would
not have performed the implantation.
110. As a direct and proximate result of the inadequate warnings and instructions,
Plaintiffs have been injured, sustained severe and permanent physical and mental pain, suffering,
disability, impairment, loss of enjoyment of life, loss 0f care, comfort and consortium, economic
37
loss, and damages, including, but not limited to, medical expenses, lost income, other damages,
and/or death.
111. Defendants are equitably estopped from asserting a learned intermediary defense
due t0 Defendants’ fraudulent concealment, through affirmative misrepresentations and omissions,
from Plaintiffs and Plaintiffs’ physicians of the risks and defects associated with the Hernia Mesh
products. Defendants affirmatively withheld and/or misrepresented facts concerning the safety of
the Hernia Mesh products, including but not limited to adverse data and information regarding the
risks of the products. As a result of Defendants’ misrepresentations and 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/or omissions of Defendants.
COUNT V
Consumer Protection
112. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
113. Defendants have a duty t0 refrain from unfair 0r deceptive acts in the design,
labeling, development, manufacture, promotion, and sale of the Hernia Mesh products.
114. Plaintiffs purchased and used Defendants’ Hernia Mesh products for person use
and thereby suffered ascertainable losses as a result of Defendants’ actions in violation of the
consumer protection laws.
115. Had Defendants properly advised patients, physicians, and medical facilities of the
defects and risks, including the frequency, severity, and duration of the risks, Plaintiffs would not
have purchased and/or paid for the Hernia Mesh products, would not have consented to allow the
38
Hernia Mesh products to be implanted in their bodies and would not have incurred related medical
costs and injury.
116. Defendants engaged in wrongful conduct while at the same time obtaining, under
false pretenses, moneys from Plaintiffs for the hernia Mesh devices that would not have been paid
had Defendants not engaged in unfair and/or deceptive acts.
117. Defendants’ engaged in deceptive, unconscionable, fraudulent representations and
material omissions to patients, physicians, and consumers—like Plaintiffs—in their labeling,
promotion, marketing, and sale of the products.
118. Defendants knowingly and falsely represented that the Hernia Mesh products were
fit to be used for the purpose for which the products were intended—when, in fact, they were
defective and dangerous.
119. 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 Hernia Mesh products. Each aspect of
Defendants’ conduct combined t0 artificially create sales of the products.
120. Defendants had actual knowledge of the defective and dangerous condition of the
Hernia Mesh products and failed to take any action to cure such condition.
121. Defendants’ practices were likely to, and did, mislead consumers and induce them
to purchase the products.
122. Plaintiffs, Plaintiffs’ treating physicians, and the medical community relied upon
Defendants’ misrepresentations and omissions in determining t0 use the Hernia Mesh products or
in allowing the products to be implanted.
39
123. As a direct and proximate result of Defendants’ unfair and/or deceptive acts,
Plaintiffs have been injured, sustained severe and permanent physical and mental pain, suffering,
disability, impainnent, 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.
COUNT VI
Breach 0f Implied Warrantv
124. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
125. Defendants sold the Hernia Mesh products that were implanted in Plaintiffs.
Defendants impliedly warranted t0 Plaintiffs and their healthcare providers that the products were
0f merchantable quality and safe for the use for which it was intended.
126. Defendants knew or reasonably should have known, at the time of sale, that the
Hernia Mesh products were intended to be used for the purpose 0f surgical implantation into the
human body for hernia repair.
127. Plaintiffs and their healthcare providers reasonably relied 0n Defendants’
judgment, indications, and statements that the Hernia Mesh products were fit for such use. In
reliance 0n Defendants’ statements, Defendants’ Hernia Mesh products were implanted in
Plaintiffs.
128. When the Hernia Mesh products were distributed into the stream of commerce and
sold by Defendants, they were unsafe for their intended use, and not of merchantable quality, as
warranted by Defendants, in that they had dangerous propensities when used as intended and
implanted into a patient’s body.
40
129. As a result of Defendants’ conduct, Plaintiffs suffered injuries and damages, and
Defendants are liable for breaching the implied warranty.
COUNT VII
Egligent Infliction of Emotional Distress
130. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
13 1. As described herein, Defendants engaged in negligent conduct in in failing to
adequately design and construct effective and safe Hernia Mesh products, in failing to warn 0f its
dangerous propensities, and in studying, designing, developing, testing, inspecting, manufacturing,
advertising, marketing, promoting, labeling, distributing, and/or selling the Hernia Mesh products.
132. As a direct and proximate result of Defendants’ negligence, Plaintiffs have suffered
severe emotional distress, as well as economic loss, and damages, including, but not limited t0,
medical expenses, lost income, and other damages.
COUNT VIII
Intentional Infliction 0f Emotional Distress
133. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
134. As described herein, Defendants engaged in extreme, outrageous, intentional,
willful, and reckless conduct in in failing to adequately design and construct effective and safe
Hernia Mesh products, in failing to warn of its dangerous propensities, and in studying, designing,
developing, testing, inspecting, manufacturing, advertising, marketing, promoting, labeling,
distributing, and/or selling the Hernia Mesh products.
41
135. As a direct and proximate result of Defendants’ conduct, Plaintiffs have suffered
severe emotional distress, as well as economic loss, and damages, including, but not limited to,
medical expenses, lost income, and other damages.
COUNT IX
Fraud
136. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
137. Defendants designed, manufactured, marketed, and sold the Hernia Mesh products
for hernia repair surgeries.
138. At the time 0f the design, manufacture, and sale of the Hernia Mesh products and,
more specifically, at the time Plaintiffs received the products, they were defective and
unreasonably dangerous for their intended and reasonably anticipated use.
139. Defendants were aware of the dangerous and defective condition of the products
and intentionally concealed this information from Plaintiffs, Plaintiffs’ physicians, the FDA, and
the general public. These significant dangers, including, but not limited to, the warning that the
material was not suited for permanent human implantation, were not readily obvious t0 the
ordinary user of the products, even after a post-surgical complication had arisen.
140. Defendants fraudulently represented t0 Plaintiffs, Plaintiffs’ physicians, and the
general public that the Hernia Mesh products were safe and effective permanent implants, even
though they were fully aware of the dangerous and defective nature of the products, which could
(and would) cause injuries such as those suffered by Plaintiffs.
141. Plaintiffs and Plaintiffs’ physicians relied upon the fraudulent misrepresentations
and concealments of Defendants in allowing the defective Hernia Mesh products to be implanted.
42
142. As a medical device manufacturer, Defendants have an affirmative continuing duty
t0 warn the public, including Plaintiffs and Plaintiffs’ physicians, regarding the increased risks and
dangers it knew, learned, or should have known about associated with its medical devices.
143. Instead of conveying increased risks and dangers it knew, learned about, or should
have known to Plaintiffs and Plaintiffs’ Physicians, Defendants concealed the increased risks and
dangers by “stealth recalling” or cannibalizing certain Products that were experiencing high levels
of adverse events by halting production without notifying consumers or physicians of the recall or
high levels of adverse events, and simultaneously conducted aggressive and substantial marketing
of neW/other products.
144. As a direct and proximate result of Defendants’ fraudulent misrepresentation and
concealments, Plaintiffs have been injured, sustained severe and permanent physical and mental
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.
COUNT X
Punitive Damages
145. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
146. Defendants sold their products t0 healthcare providers throughout the United States
without doing adequate testing to ensure that the products were reasonably safe for implantation.
147. Defendants sold their products to healthcare providers throughout the United States
in spite 0f their knowledge that the products pose risks of degradation, excessive and chronic
inflammation, inadequate or complete failure to incorporate in tissue, migration, infection, erosion,
abscess, fistula formation, never damage, excessive scarification, contracture, shrinkage, breakage,
43
separation, tearing, and other problems, thereby causing severe and debilitating injuries to
Plaintiffs.
148. Defendants ignored reports from patients and healthcare providers throughout the
United States and elsewhere of the products’ failures t0 perform as intended, Which lead t0 the
severe and debilitating injuries suffered by Plaintiffs. Rather than doing adequate testing to rule
out the products’ design or the processes by Which the products are manufactured as the cause of
these injuries, Defendants chose to continue marketing the products as safe and effective.
149. Defendants knew the products were unreasonably dangerous in light of their risks
of failure resulting in 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 products.
150. Defendants Withheld material information from the medical community and the
public in general, including Plaintiffs, regarding the safety and efficacy of the products.
15 1. Defendants knew and recklessly disregarded the fact that the products caused
debilitating and potentially life-altering complications with greater frequency than feasible
alternative methods and/or products.
152. Defendants misstated and misrepresented data so as to minimize the perceived risk
of injuries caused by the products.
153. Notwithstanding the foregoing, Defendants continue to aggressively market the
products, Without disclosing the true risks associated With them.
154. Defendants knew of the products’ defective and unreasonably dangerous nature,
but continued to manufacture, market, distribute, and sell the products so as to maximize sales and
profits at the expense 0f the health and safety of the public, including the Plaintiff.
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155. Defendants continue to conceal and/or fail to disclose to the public, including the
Plaintiffs, the serious complications associated with the use of the products to ensure continued
and increased sales.
156. Defendants’ conduct in continuing t0 market, sell, and distribute the Hernia Mesh
products after obtaining knowledge that the products were failing and not performing as
represented and intended, showed complete indifference to and/or a conscious disregard for the
safety of others, justifying an award of additional damages for aggravating circumstances in such
a sum Which Will serve to deter Defendants and others from similar conduct in the future.
157. 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 aware of punitive damages.
COUNT XI
Unjust Enrichment
158. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
159. Defendants are and, at all relevant times, were manufacturers, sellers, and/or
suppliers of the Hernia Mesh products.
160. Plaintiffs paid for Defendants’ Hernia Mesh products for the purpose of medical
treatment.
161. Defendants have accepted payment by Plaintiffs and others 0n Plaintiffs’ behalf for
the purchase of Defendants’ Hernia Mesh products.
162. Plaintiffs have not received the safe and effective medical devices for which they
paid.
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163. It would be inequitable for Defendants to keep the moneys paid because Plaintiffs
did not, in fact, receive a safe and effective medical device, as represented by Defendants.
COUNT XII
Loss 0f Consortium
164. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
165. As a direct and proximate result of Defendants’ conduct as detailed above,
Plaintiff’s spouse, as specified in the Short Form Complaint, has suffered and Will continue t0
suffer the loss of their loved one’s support, companionship, services, society, love, and affection.
166. The marital association between the husband and wife has been altered, impaired,
and depreciated.
167. Plaintiff’s spouse has suffered great emotional pain and mental anguish.
168. Plaintiff’s spouse has sustained and Will continue t0 sustain several physical and
mental injuries, severe emotional distress, economic losses, and other damages for Which they are
entitled t0 compensatory damages.
COUNT XIII:
Discoverv Rule, Equitable TollinglEstoppel
169. Plaintiffs re-allege and incorporate by reference each and every paragraph set forth
in this Master Complaint as though fully set forth herein.
170. Plaintiffs assert all applicable statutory and common law rights and theories related
to the tolling or extension of any applicable statute of limitations, including equitable tolling,
delayed discovery, discovery rule, and/or fraudulent concealment.
171. The discovery rule applies t0 toll the running 0f the statute of limitations until
Plaintiffs knew, or through the exercise of reasonable care and diligence should have known, 0f
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facts that Plaintiffs had been injured, the cause of the injury, and the tortious nature of the
wrongdoing that caused the injury.
172. The nature of Plaintiffs’ injuries, damages, or their causal relationship t0
Defendants conduct 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.
173. The running of the statute of limitations is tolled due to equitable tolling.
Defendants are estopped from relying on any statutes of limitation or repose by Virtue of their acts
of fraudulent concealment, through affirmative misrepresentations and omissions, from Plaintiffs
and Plaintiffs’ physicians of the risks and defects associated With the Hernia Mesh products,
including the severity, duration, and frequency of risks and complications. Defendants
affirmatively Withheld and/or misrepresented facts concerning the safety of Defendants Hernia
Mesh products, including, but not limited to, the dangers associated With the PET rings and
composite products. As a result of Defendants’ misrepresentations and concealment, Plaintiffs
and Plaintiff’s 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/or omissions of the Defendant(s).
174. Given the Defendants’ affirmative actions of concealment by failing to disclose this
known but non-public information about the defects — information over Which the Defendants had
exclusive control—and because Plaintiffs could not reasonably have known that Defendants
Hernia Mesh Products were and are defective, Defendants are estopped from relying on any
statutes of limitations 0r repose that might otherwise be applicable to the claims asserted herein.
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PRAYER FOR RELIEF
Wherefore, Plaintiffs respectfully request judgment in their favor against Defendants, and
each of them, individually, jointly and severally, and Plaintiffs request compensatory damages, in
a sum to confer jurisdiction upon this Court, together with interest on that amount at the legal rate
from the date ofjudgment until paid, costs of suit, attorneys’ fees, and all such other relief as this
Court deems just and proper, as well as:
1. Compensatory damages to Plaintiffs for past, present, and future damages, including
but not limited to, mental and physical pain and suffering for severe and permanent
personal injuries sustained by Plaintiffs, health and medical care costs, lost wages, 0r
income, and loss of earning capacity, together with interest and costs as provided by law;
2. Restitution and disgorgement 0f profits;
3. Punitive damages;
4. Reasonable attorneys’ fees;
5. The costs of these proceedings;
6. A11 ascertainable economic 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.
DEMAND FOR JURY TRIAL
Plaintiffs hereby demand a trial by jury on all issues so triable.
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Respectfully submitted,
/s Donald Migliori
Donald A. Migliori (#4936)
Jonathan D. Orent (#7408)
MOTLEY RICE LLC
55 Cedar Street, Suite 100
Providence, RI 02903
401-457-7700
401-457-7708 Fax
Plaintiffs

Liaison Counsel
Henry G. Garrard, III.
James B. Matthews
Blasingame, Burch, Garrard, Ashley, P.C.
440 College Ave Suite 320
Athens, GA 30601
(706) 584-2794
(706) 353-0673 Fax
Plaintifi’s ’Lead Counsel
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