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WILENTZ, GOLDMAN & SPITZER, P.A.
Joshua S. Kincannon, Esquire
NJ Attorney ID No.: 034052000
90 Woodbridge Center Drive, Suite 900
Woodbridge, New Jersey 07095
(732)-855-6141
(732)-726-6541 (Fax)
Jkincannon@wilentz.com
FLEMING, NOLEN & JEZ, L.L.P.
Kelsey L. Stokes, Esq. (Pro Hac Vice)
Texas Bar No. 24083912
kelsey_stokes@fleming-law.com
David Hobbs (Pro Hac Vice forthcoming)
Texas Bar No. 24074420
Utah Bar No. 17490
david_hobbs@fleming-law.com
2800 Post Oak Blvd. Suite 4000
Houston, Texas 77056-6109
Telephone (713) 621-7944
Fax (713) 621-9638
Attorneys for Plaintiff Theresa Peterson
IN RE PROCEED MESH LITIGATION
(Proceed Surgical Mesh and Proceed Ventral Patch
SUPERIOR COURT OF NEW JERSEY
Hernia Mesh) LAW DIVISION-ATLANTIC COUNTY
Case No. 630
THERESA PETERSON, Master Case No. ATL-L-794-19
Plaintiff, CIVIL ACTION
v.
JOHNSON & JOHNSON and
ETHICON, INC., COMPLAINT
JURY TRIAL DEMANDED
Defendants.
Plaintiff Theresa Peterson, by and through his counsel, hereby sues JOHNSON &
JOHNSON (“J&J”), a New Jersey corporation; and ETHICON, INC. (“Ethicon”), a New Jersey
corporation (collectively “Defendants”).
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NATURE OF THE ACTION
1. This is an action for strict products liability, failure to warn, and defective design,
brought by Plaintiff Theresa Peterson for injuries arising out of the Proceed Ventral Patch
(“Proceed” or “Ethicon Multi-Layered Hernia Mesh”).
2. Defendants manufactured and supplied to doctors a nine-layer hernia mesh patch
known as the Proceed Ventral Patch.
3. The Proceed Ventral Patch created an unreasonable risk of harm to Plaintiff Theresa
Peterson.
4. The unreasonable risk of pain, dense adhesion formation, bowel complications,
mesh shrinkage, hernia recurrence, seroma and fistula formation, and infection whether from a
prolonged and pronounced inflammatory response caused by the nine layers, degradation of
polymers due to exposure to gamma irradiation, non-conforming subcomponents, or some other
mechanism renders the Ethicon Multi-Layered Hernia Mesh a defective product.
5. The selection and implantation of the Ethicon Multi-Layered Hernia Mesh by
Plaintiff’s surgeon was a result of the misinformation, marketing, sales, promotion and direction
by Ethicon.
JURISDICTION & VENUE
6. This is a lawsuit over defective hernia mesh designed, marketed, manufactured,
promoted, and sold within New Jersey and the United States by Defendant Ethicon and its parent
company J&J.
7. Theresa Peterson currently resides in Holiday, Florida and is a citizen and resident
of Florida. Plaintiff underwent hernia repair surgery on or about May 27, 2020, at Advent Health
North Pinellas in Tarpon Springs, Florida. At that time, the Ethicon Multi-Layered Hernia Mesh
product that Defendants manufactured, designed, distributed, and warranted by Defendants was
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implanted into Plaintiff. Theresa Peterson’s surgeon, medical staff, and other healthcare providers
met or exceeded the standard of care applicable to the hernia surgery.
8. Defendant J&J is a corporation incorporated in New Jersey, and according to its
website, the world’s largest and most diverse medical device and diagnostics company, with its
principal place of business located at One Johnson & Johnson Plaza, New Brunswick, New Jersey.
9. Defendant J&J organizes its subsidiary businesses into individual Business Units
to coordinate the development, manufacture, testing, marketing promotion, training, distribution
and sale of its products, including its hernia repair mesh 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.” J&J charged
the Ethicon Franchise with the design, development, promotion, marketing, testing, training,
distribution and sale of the Proceed Ventral Patch, the hernia repair mesh product 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 comprising the Ethicon Franchise
are thus controlled by Defendant J&J and include Ethicon, Inc.
10. Defendant Ethicon is a wholly owned subsidiary of Defendant J&J. Defendant
Ethicon is a corporation incorporated in the State of New Jersey with its principal place of business
in Somerville, New Jersey. Defendants conduct business in every county in New Jersey.
11. Defendant Ethicon is a medical device company involved in the research,
development, testing, manufacture, production, marketing, promotion and/or sale of medical
devices including Ethicon Multi-Layered Hernia Mesh.
12. J&J, directly and/or through the actions of Ethicon, has at all pertinent times been
responsible for the research, development, testing, manufacture, production, marketing,
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promotion, distribution and/or sale of Ethicon Multi-Layered Hernia Mesh.
13. At all relevant times, Defendants either directly, or through their agents, apparent
agents, servants or employees sold, distributed, and marketed the defective Ethicon Multi-Layered
Hernia Mesh in the State of New Jersey. Defendants derive substantial revenue from hernia mesh
products used or implanted in the State of New Jersey. As such, Defendants expected or should
have expected that their business activities could or would subject them to legal action in the State
of New Jersey.
14. Defendants were also involved in the business of monitoring and reporting adverse
events concerning the Ethicon Multi-Layered Hernia Mesh, and having a role in the decision
process and any response related to these adverse events.
15. The Ethicon Multi-Layered Hernia Mesh Defendants are subject to jurisdiction
within the State of New Jersey and this Court because:
a. Defendants are engaged in substantial and not isolated business activity within
the State of New Jersey, Middlesex County.
b. Defendants’ hernia mesh products, including the subject Proceed Ventral Patch,
were designed, manufactured, and placed into the stream of commerce in the
State of New Jersey by Defendants.
c. Defendants maintain an office or agency within the State of New Jersey.
d. Upon information and belief, at all relevant times, Defendants committed
tortious acts within the State of New Jersey out of which these causes of action
arise.
16. At all material times, Defendants developed, manufactured, advertised, promoted,
marketed, sold, and/or distributed the defective Ethicon Multi-Layered Hernia Mesh throughout
the United States, including within the State of Florida and specifically to Plaintiff’s implanting
physician or their practice group, or to the hospital where the Ethicon Multi-Layered Hernia Mesh
was implanted.
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17. Plaintiff has reviewed potential legal claims and causes of action against
Defendants and has chosen to only pursue state-law claims. Any reference to any federal agency,
regulation, or rule is stated solely as background information and does not raise a federal question.
Defendants J&J and Ethicon are both New Jersey corporations and both maintained their principal
place of business in New Jersey. Accordingly, this Court may rightfully exercise jurisdiction, and
venue is proper.
18. Defendants designed, manufactured, fabricated, marketed, packaged, advertised,
and sold the Ethicon Multi-Layered Hernia Mesh throughout the world, including in Middlesex
County, State of New Jersey.
19. Defendants knowingly market to, and derive income from, patients in the State of
New Jersey from the sale of Ethicon Multi-Layered Hernia Mesh.
20. This is an action for damages in excess of Fifteen Thousand Dollars ($15,000.00),
exclusive of interest and costs.
PROCEED HISTORY
21. Defendants were the designers, manufacturers, marketers, distributors and
suppliers of the Ethicon Proceed Ventral Patch at all material times.
22. Defendants warranted the Ethicon Multi-Layered Hernia Mesh and placed the
device into the United States stream of commerce.
23. Defendants knew that the oxidized regenerated cellulose layer of the Ethicon Multi-
Layered Hernia Mesh was ineffective at preventing adhesion formation to the underlying
polypropylene of the Proceed before Defendants set out to design the Proceed Ventral Patch in
2006, and even before Defendants set out to design the Proceed Surgical Mesh predicate device in
2003.
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24. Before 2003, Defendants were aware that the Oxidized Regenerated Cellulose
utilized in the Ethicon Multi-Layered Hernia Mesh had pores which were too large to prevent
adhesion formation.
25. Before 2003, Defendants were aware that increased adhesion formation would
result in increased mesh shrinkage.
26. Before 2003, Defendants were aware that utilizing Oxidized Regenerated Cellulose
in their mesh products would result in dense adhesions in the presence of blood or fibrinous
exudate.
27. Before 2003, Defendants were aware that polypropylene elicits a chronic, life-long
inflammatory response that is accompanied by exudation of fibrinogen.
28. Before 2003, Defendants were aware that any exposure to gamma radiation would
weaken and embrittle the polypropylene of the Ethicon Multi-Layered Hernia Mesh.
29. Before 2006, Defendants were aware that adding Vicryl and other additional layers
to the Proceed Surgical Mesh to create the Proceed Ventral Patch, would increase the intensity and
duration of inflammation and foreign body response (FBR), thus increasing fibrinous exudate.
30. Before placing the Ethicon Multi-Layered Hernia Mesh on the market, Defendants
were required to mitigate risks of the product, including any element of design or sterilization
which could render the device ineffective, weaken the structural integrity of the device, or increase
or prolong inflammation once the device is implanted that would result in an increase in adhesion
formation, mesh shrinkage, pain, bowel complications, hernia recurrence, and/or the need for early
surgical revision in patients-consumers.
31. Defendants designed, manufactured, and marketed the Ethicon Multi-Layered
Hernia Mesh, despite long-standing knowledge that the materials utilized in the Proceed would
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cause dense adhesions, chronic pain, mesh shrinkage, bowel obstructions, and early hernia
recurrence.
32. Defendants sterilized the Ethicon Multi-Layered Hernia Mesh with gamma
radiation, despite long-standing knowledge that polypropylene will degrade and embrittle if
exposed to any amount of gamma radiation.
33. The Ethicon Proceed Ventral Patch is made of the following, starting with the
component placed closest to the bowel of the patient-consumer:
Oxidized Regenerated Cellulose (ORC) barrier layer
Polydioxanone (PDS) film layer
Large pore polypropylene (Prolene soft mesh)
PDS film layer
PDS reinforcing element
PDS ring
PDS film layer
Vicryl
PDS film layer
34. Polypropylene hernia meshes are traditionally sterilized with ethylene oxide.
35. The ORC layer of the Ethicon Multi-Layered Hernia Mesh will react and degrade
in the presence of ethylene oxide.
36. Defendants sterilize the Ethicon Multi-Layered Hernia Mesh with gamma
radiation.
37. Gamma radiation degrades, weakens, and embrittles the polypropylene base of the
Ethicon Multi-Layered Hernia Mesh.
38. Decades before the release of the Ethicon Multi-Layered Hernia Mesh, Defendants
were aware that polypropylene degrades, weakens, and embrittles when exposed to gamma
irradiation.1
1
U.S. Patent No. 3,943,933 (Issued Mar. 16, 1976).
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39. The embrittled polypropylene of the Ethicon Multi-Layered Hernia Mesh increases
its propensity to tear away from the securing devices, such as sutures or tacks.
40. The polypropylene base is the only permanent, non-resorbable portion of the
Ethicon Multi-Layered Hernia Mesh.
41. Defendants designed, manufactured, promoted, sold and/or marketed the Ethicon
Multi-Layered Hernia Mesh to be utilized in anyone with a soft tissue defect, including, but not
limited to: “infants, children, pregnant women, or women planning pregnancies…”2
42. For decades, the medical community had concerns about severe complications if
polypropylene was placed too close to the bowel or other underlying organs, due to the formation
of dense adhesions to the polypropylene.
43. Defendants were aware that the ORC layer in the Ethicon Multi-Layered Hernia
Mesh was ineffective at preventing adhesion formation to polypropylene over a decade before
Defendants brought the Ethicon Multi-Layered Hernia Mesh to market.3
44. Despite significant evidence to the contrary, Defendants marketed the Ethicon
Multi-Layered Hernia Mesh and its ORC layer as a tissue-separating barrier that would prevent
adhesion formation from the underlying polypropylene to any nearby organs.
45. The following studies have investigated complications associated with the Ethicon
Multi-Layered Hernia Mesh:
a. In 2006, a study out of The Netherlands evaluating the use of new
prosthetic meshes for ventral hernia repair was published in Surgical
Endoscopy. Proceed showed significantly less incorporation… Proceed
composite has a smooth surface designed to prevent adhesion
formation. However, it is less smooth than other composite meshes with
antiadhesive barriers. Furthermore, the barrier applied is oxidized
cellulose, which may not prevent mesh adhesions as effectively as
2
Proceed Ventral Patch Instructions for Use, RMC 8550915, Status 9/08.
3
Robert J. Fitzgibbons, Jr., M.D. et al., A Laparoscopic Intraperitoneal Onlay Mesh Technique for the Repair of an
Indirect Inguinal Hernia, 219-2 ANNALS OF SURGERY 114 (1994).
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anticipated or as reported previously.
Burger, J.W. et al, Evaluation of New Prosthetic Meshes for Ventral Hernia
Repair. Surg Endosc. 20:1320 – 1325 (2006). DOI: 10.1007/s00464-005-
0706-4.
b. In 2009, a study out of The Netherlands on adhesions prevention
during hernia mesh repair was published in the Annals of Biomedical
Engineering. The uncoated Prolene meshes were found to invoke a
moderate inflammatory response in their immediate vicinity,
characterized by the presence of active macrophages. A stronger
inflammatory response was observed with the Proceed meshes,
presumably due to ongoing phagocytosis of the oxidizing regenerated
cellulose and polydioxanone coating… Most remarkable were
adhesions with Proceed. Although adhesion scores were the lowest at
day 7, they increased by day 30 and exceeded adhesion scores of
NVP/BMA-coated Prolene mesh and Prolene.
Emans, P. et al, Polypropylene Meshes to Prevent Abdominal Herniation.
Can Stable Coatings Prevent Adhesions in the Long Term? Annals of
Biomedical Engineering. 37(2):410 – 418 (2009). DOI: 10.1007/s10439-
008-9608-7.
c. In 2009, a study out of Saint Louis, Missouri measuring adhesions
and mesh contraction was published by Surgical Innovation. The data was
previously presented at the American Hernia Society, Third International
Hernia Congress on June 9, 2006. The highest degrees of mesh
contraction occurred with DualMesh and Proceed… Proceed exhibited
the greatest surface area of adhesion coverage and the highest-grade
adhesions.
Pierce, R. et al, 120-Day Comparative Analysis of Adhesion Grade and
Quantity, Mesh Contraction, and Tissue Response to a Novel Omega-3
Fatty Acid Bioabsorbable Barrier Macroporous Mesh After Intraperitoneal
Placement. Surg Innov. (2009). DOI: 10.1177/1553350608330479.
d. In 2010, a study out of Saint Louis, Missouri on adhesion related
complications associated with intraperitoneal mesh was published in
Surgical Endoscopy. Nevertheless, there appears to be some
differentiation in the adhesion characteristics of the absorbable-
barrier-coated meshes… We noticed a similar increase in the adhesion
tenacity score of PROCEED in a preclinical study of intraperitoneal
placement f absorbable-barrier-coated meshes in a rabbit model.
Jenkins, E. et al, Prospective Evaluation of Adhesion Characteristics to
Intraperitoneal Mesh and Adhesiolysis-Related Complications During
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Laparoscopic Re-Exploration After Prior Ventral Hernia Repair. Surg
Endosc. 24:3002 – 3007. DOI: 10.1007/s00464-010-1076-0.
e. In 2010, a study out of Belgium on the lack of convincing data in
medical literature regarding to use of intraperitoneal hernia mesh was
published in The World Journal of Hernia and Abdominal Wall Surgery.
The content of the paper was presented during the 32nd International
Congress of the European Hernia Society, in Istanbul, on October 6-8, 2010.
After release of the omental adhesions, we found the [Proceed] mesh to
have shrunk and folded up, to a dimension of approximately 3.0 cm in
diameter. This means a shrinkage from a circle of diameter 6.4 cm
(surface: 3.14 x 3.22 = 32.2 cm2) to a “circle” of diameter 3.0 cm
(surface: 3.14 x 1.52 = 7.1 cm2), equivalent to a mesh surface shrinkage
of 77.9%... There is a complete lack of convincing data on these mesh
devices in the medical literature.
Muysoms, F.E. et al, Complications of Mesh Devices for Intraperitoneal
Umbilical Hernia Repair: A Word of Caution. Journal of Hernia. 15:463-
468 (2011). DOI: 10.1007/s10029-010-0692-x.
f. In 2012, a study out of Saint Louis, Missouri on the effectiveness of
barrier hernia mesh was published in Surgical Endoscopy. This study also
demonstrated increased adhesion formation for all of the barrier mesh
prostheses between 7 and 30 days, which the authors attributed to
increased inflammation related to the degradation and resorption of
the barrier layer components, which were ongoing between 7 and 30
days. This effect was most pronounced in PROCEED Surgical Mesh
materials, which again highlights the influence that the chemistry of the
particular barrier components may have over the inflammatory
response and subsequent adhesion formation.
Deeken, C. et al, A Review of the Composition, Characteristics, and
Effectiveness of Barrier Mesh Prostheses Utilized for Laparoscopic Ventral
Hernia Repair. Surg Endosc. 26:566-575 (2012). DOI: 10.1007/s00464-
011-1899-3.
g. In 2014, a study out of Belgium on the Proceed Ventral Patch (PVP)
was published in The World Journal of Hernia and Abdominal Wall
Surgery. Polypropylene meshes, like the PVP, have demonstrated an in
vivo centripetal shrinkage percentage of up to 77% in some patients.
This finding of mesh contraction was confirmed in those patients. This
finding of mesh contraction was confirmed in those patients that were
re-operated for recurrence in 21% of the patients where the radiologist
was able to visualize the mesh. The overlap obtained with a mesh of 6.4
cm in diameter is in sufficient with hernias larger than 2 cm. Therefore,
we recommend not to use PVP in hernias of 2cm or more.
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Bontinck, J. et al, Single Centre Observational Study to Evaluate the Safety
and Efficacy of the Proceed Ventral Patch to Repair Small Ventral Hernias.
Journal of Hernia. 18:671 – 680 (2014). DOI: 10.1007/s10029-013-1140-5.
h. In 2015, a study out of Belgium on the Proceed (PP/ORC) was
published in The World Journal of Hernia and Abdominal Wall Surgery. In
our opinion, there are several factors contributing to the extensive FBR
and shrinkage/mesh contraction of the PP/ORC device. First, the
composition of the PP/ORC device out of nine different layers will lead
to a more extensive FBR. Second, absorption of 8 of these 9 layers will
create a severe inflammatory reaction as, e.g.. shown with vicryl mesh
absorption, also being one of the components of the PP/ORC device. A
third possible explanation is delamination of the device.
Reynvoet, E. et al, Intraperitoneal Mesh Devices for Small Midline
Hernias: Mesh Behavior in a Porcine Model. Journal of Hernia. 19:955 –
963 (2015). DOI: 10.1007/s10029-015-1368-3.
i. In 2016, a study out of Bosnia and Herzegovina was published by
The Royal Belgian Society for Surgery. The extent of [adhesion] site
involvement after 28 days was statistically significantly greater in the
Proceed group.
Delibegovic, S. et al, Formation of Adhesions After Intraperitoneal
Applications of TiMesh: Experimental Study on a Rodent Model. The Royal
Belgian Society for Surgery. (2016). DOI
10.1080/00015458.2016.1179513
j. In 2016, a study out of Germany on the adhesion prevention efficacy
of Proceed (PCM) was published in International Journal of Medical
Sciences. PCM does not provide significant adhesion prevention.
Winny, M. et al, Adhesions Prevention Efficacy of Composite Meshes
Parietex, Proceed, and 4DryField PH Covered Polypropylene Meshes in
an IPOM Rat Model. Int. J. Med. Sci. 13:936 – 941 (2016). DOI:
10.7150/ijms.16215.
k. In 2017, a Proceed (PVP) randomized controlled trial out of The
Netherlands was published in the World Journal of Surgery. At this point,
PVP device usage shows an easier and faster operating procedure.
Nevertheless, this advantage is outweighed by the significantly higher
incidence of early re-operations due to early complications.
Ponten, J.E. et al, Mesh Versus Patch Repair for Epigastric and Umbilical
Hernia (MORPHEUS Trial); One-Year Results of a Randomized Controlled
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Trial. World J. Surg. (2017). DOI: 10.1007/s00268-017-4297-8.
l. In 2017, a study out of Brazil was published on adhesions and
collagen formation following mesh implantation. The study follow-up
time, 90 days, was established because there were no articles in the
literature with prolonged follow-up… What we can formulate is that
absorption of the regenerated oxidized cellulose exposes the
polypropylene layer to the abdominal visceral content and that this
consequently led to the adhesions found… The adhesion formation is a
complex process and is basically started by the tissue injury process
which breaks down the balance between coagulation and fibrinolysis.
Fibrin deposition results in a matrix where the fibroblasts produce
extracellular matrix. The end process generates various degrees of
adhesion… In the present study, type III collagen was expressed more
in the coated group and based on the result of the research this could
increase hernia formation.
Rossi, L. et al, Peritoneal Adhesions Type I, III and Total Collagen on
Polypropylene and Coated Polypropylene Meshes: Experimental Study in
Rats. ABCD Arq Bras Cir Dig 30(2):77 – 82 (2017). DOI: 10.1590/0102-
6720201700020001.
FAILURE TO WARN PHYSICIANS OF THE DANGERS ASSOCIATED
WITH ETHICON MULTI-LAYERED HERNIA MESH
46. Defendants marketed the Ethicon Multi-Layered Hernia Mesh to general surgeons,
hospitals, and group purchasing organizations (GPOs), rather than end-user patients.
47. Defendants had the ability to inform surgeons, hospitals, or GPOs of developing
problems or defects in its devices through e-mail, letter, recalls, warnings in product inserts, and/or
through its product representatives, who work directly with surgeons.
48. The nine layers of the Ethicon Multi-Layered Hernia Mesh increase the intensity
and duration of the inflammatory response. That response in turn increases dense adhesion
formation from underlying organs to the Ethicon Proceed, resulting in bowel complications, mesh
contracture, hernia recurrence, increased foreign body reaction, chronic severe pain, and more.
49. Defendants downplayed the intensity of the inflammatory reaction caused by Vicryl
by stating in the Ethicon Proceed Instructions for Use (IFU) that the Vicryl elicits “only a mild
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tissue reaction during absorption.”
50. Defendants state in the Proceed IFU that “The PROLENE Soft Mesh components
are constructed of knitted filaments of extruded polypropylene, identical in composition to that
used in PROLENE Polypropylene Suture, Nonabsorbable Surgical Suture, U.S.P.” This statement
is false, or at the very least misleading, as the Proceed undergoes gamma irradiation that changes
the composition of the polypropylene.
51. Defendants also state in the Proceed IFU that the polypropylene material “when
used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in
clinical use. The PROLENE Soft Mesh affords excellent strength, durability and surgical
adaptability, with a porous structure to enable mesh incorporation into surrounding tissues.” This
statement is false, or at the very least misleading, as Defendants are aware that the Ethicon Proceed
is reactive and does not retain its strength. Furthermore, Defendants are aware of reports that the
small polypropylene sutures do elicit a small reaction, and increasing amounts of polypropylene
greatly increase such reaction. The very reason the Defendants added the ORC layer to the Prolene
Soft Mesh was to protect organs from reacting with the polypropylene of the Prolene Soft Mesh.
52. The Proceed IFU has a section for contraindications, which lists “None known.”
53. The Proceed IFU has a section for adverse reactions, which lists “Potential adverse
reactions are those typically associated with surgically implantable materials…” The
polypropylene base of the Ethicon Proceed carries many potential adverse reactions, such as a life-
long inflammatory response that other surgically implantable materials do not present.
Additionally, the multiple layers of the Ethicon Multi-Layered Hernia Mesh further increase the
inflammatory response and rate of infection, adhesion formation, chronic pain, seroma formation,
fistula formation, hematomas, mesh contracture, hernia recurrence, mesh migration, bowel
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complications, foreign body response, extrusion, and other additional injuries.
54. The Proceed IFU notes that “Selected mesh size should allow for adequate overlap
of the fascial defect on all sides.” The IFU never defines what constitutes “adequate overlap.”
Defendants are aware that the Proceed shrinks over time, with reports of the Proceed shrinking as
much as 77%.
55. Defendants failed to warn that the Ethicon Multi-Layered Hernia Mesh will elicit a
fibrinous exudate.
56. Defendants failed to warn that the Ethicon Multi-Layered Hernia Mesh creates a
solid barrier preventing the body from adequately clearing or transporting fluid, which results in
seroma formation, potentiating infections and fistula formation.
57. Defendants never performed any clinical trials and/or studies before marketing the
Ethicon Multi-Layered Hernia Mesh.
58. Defendants did not fully and/or adequately test the configuration of its new, multi-
layered hernia mesh patch design with ORC, polypropylene, Vicryl, and six layers of PDS, that
was implanted into Plaintiff.
59. Although the United States does not have a complete and accurate database to track
problems with hernia mesh implants, controlled studies have investigated the problems with the
Ethicon Multi-Layered Hernia Mesh.
60. A single center study was conducted in Belgium, where three surgeons implanted
only the Ethicon Proceed in 101 patients between April 2009 and December 2011. The Ethicon
Proceed was able to be visualized by ultrasound in 47 patients. Of those 47 patients, 10 were noted
to have mesh contraction. The Ethicon Proceed “was removed during the operation in four patients
and important centripetal contraction of the mesh, diminishing the surface area, was observed in
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all cases.” The authors concluded the Proceed has “demonstrated an in vivo centripetal shrinkage
percentage of up to 77% in some patients. This finding of mesh contraction was confirmed in those
patients that were reoperated for recurrence and in 21% of the patients where the radiologist was
able to visualize the mesh. The overlap obtained with a mesh of 6.4cm in diameter was insufficient
with hernias larger than 2 cm. Therefore, we recommend not to use PVP (Proceed Ventral Patch)
in hernias of 2 cm or more.” The authors go on to note that their study is likely underpowered as
“Most recurrences after ventral hernia repair occur within 2 years after the operation. Since our
study had a mean follow-up of 16 months, it is likely that a longer follow-up would yield a higher
recurrence rate.”4
61. In 2015, another study in Belgium confirmed “massive shrinkage” with the Ethicon
Proceed. The authors concluded that “This can however not be considered the ideal indication for
a mesh device repair with a suggested mesh overlap of at least 5 cm for incisional hernias.”5
62. Defendants continue to market the Ethicon Multi-Layered Hernia Mesh without
warning of the massive mesh shrinkage or the necessary overlap to prevent early hernia recurrence
due to mesh shrinkage.
63. Reassurances of device safety were made through direct promotional contact by
Defendants’ sales representatives and distributors, through word-of-mouth from Defendants’
physician/technical consultants, and/or through industry-targeted promotional materials.
64. Despite these reassurances, the defective design and manufacture of the Ethicon
Multi-Layered Hernia Mesh continued to elicit severe and chronic inflammatory responses,
resulting in adhesion formation, bowel injuries, mesh contracture, pain, hernia recurrence,
4
J. Bontinck, Single Centre Observational Study to Evaluate the Safety and Efficacy of the Proceed Ventral Patch to
Repair Small Ventral Hernias, 18 Hernia 671, Clinical.Trials.gov: NCT01307696 (2013).
5
E. Reynvoet, Intraperitoneal Mesh Devices for Small Midline Hernias: Mesh Behavior in a Porcine Model, 19 Hernia
955 (2015).
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infections, seromas, fistulas, erosion, extrusion, and additional complications.
65. Defendants were aware that the ORC layer was ineffective in preventing adhesions
to the polypropylene; gamma irradiation would weaken the polypropylene; and the nine-layer
mesh would contract massively over time. Nonetheless, Defendants employed the design in the
Ethicon Proceed Ventral Patch in reckless disregard for the safety of patients, including Plaintiff.
66. Moreover, despite direct knowledge of significant adverse events reported by
patients and physicians, as well as awareness of failures that have been reported in literature and
published clinical trials, Defendants have continued to market the Ethicon Multi-Layered Hernia
Mesh as being safe and effective for hernia repair.
67. From the time Defendants first began selling the Ethicon Multi-Layered Hernia
Mesh in the United States through today, product labeling and the product information failed to
contain adequate information, instructions, and warnings concerning the following: implantation
of the Proceed, specifically its propensity to massively shrink, the increased in duration and
intensity of inflammation, and the elevated rate of adhesions, bowel complications, chronic pain,
hernia recurrence, seroma formation, hematoma formation, fistula formation, erosion, extrusion,
infection, and other injuries occurring at a higher rate than other surgically implanted devices.
USE OF THE PRODUCT
68. A defectively designed, manufactured and marketed Ethicon Multi-Layered Hernia
Mesh left the hands of Defendants in its defective condition, and was delivered into the stream of
commerce. Dr. Jared Conte Frattini implanted the Proceed Surgical Mesh to repair a ventral hernia
on or about May 27, 2020, at Advent Health North Pinellas in Tarpon Springs, Florida. Plaintiff
was implanted with a Proceed Surgical Mesh, Model No. PCDH1.
69. As a direct and proximate result of Defendants’ defective design, manufacture,
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marketing, distribution, and/or sale of the Ethicon Multi-Layered Hernia Mesh, and their placing
of their defective product into the stream of commerce, Plaintiff has been injured and damaged as
follows:
a. Theresa Peterson underwent repair of the Ethicon Proceed Surgical Mesh at
Advent Health North Pinellas in Tarpon Springs, Florida by Dr. Jared Conte Frattini
due to adhesions and hernia recurrence.
b. On or about November 3, 2020, Theresa Peterson underwent partial
removal of the Ethicon Proceed Ventral Patch at Advent Health North Pinellas in
Tarpon Springs, Florida by Dr. Jared Conte Frattini due to adhesions, abdominal
pain, and hernia recurrence.
c. Plaintiff experienced and/or continues to experience the need for additional
surgery, severe pain, inflammation, and/or other injuries which have impaired
Plaintiff’s activities of daily living.
d. Plaintiff continues to suffer complications as a result of his implantation
with the Ethicon Multi-Layered Hernia Mesh.
e. Plaintiff is at a higher risk of severe complications during an abdominal
surgery, to the extent that future abdominal operations might not be feasible.
70. The mechanism of failure in Plaintiff’s device was a mechanism of failure that
Defendants had marketed and warranted would not occur because of the Ethicon Multi-Layered
Hernia Mesh design and composition. It was also the same failure mechanism that the medical and
scientific community had been studying and documenting since the 1990s, i.e., ORC was
ineffective at preventing adhesions to polypropylene, and polypropylene contracts when dense
adhesions form to it.
71. Moreover, the symptoms and findings associated with Ethicon Multi-Layered
Hernia Mesh product failures that have been reported in the literature are identical to those Plaintiff
suffered.
72. As a direct and proximate result of Defendants’ defective design, manufacturing,
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marketing, distribution, sale and warnings of the Ethicon Multi-Layered Hernia Mesh, Plaintiff
has suffered and continues to suffer injuries and damages, including, but not limited to: past,
present and future physical and mental pain and suffering; physical disability; past, present, and
future medical, hospital, rehabilitative, and pharmaceutical expenses; and other related damages.
THE FDA’S 510(k) CLEARANCE PROCESS
73. The 510(k) clearance process refers to Section 510(k) of the Medical Device
Amendments of 1976 MDA of the Federal Food, Drug and Cosmetic Act. Under this process,
device manufacturers are only required to notify the FDA at least 90 days before they market a
device claimed to be “substantially equivalent” to a device the FDA had approved for sale before
1976, when the MDA was enacted.
74. No clinical testing is required under this process.
75. Subsequent amendments to the MDA allowed for 510(k) clearance of products
deemed “substantially equivalent” to post-MDA, 510(k)-cleared devices.
76. Through this domino effect, devices deemed “substantially equivalent” to devices
previously deemed “substantially equivalent” to devices approved for sale by the FDA before 1976
could be sold to patients in a matter of 90 days without any clinical testing.
77. Clearance for sale under the 510(k) process does not equate to FDA approval of the
cleared device.
78. In 2012, at the request of the FDA, the National Institute of Health (NIH) conducted
a thorough review of the 510(k) process, coming to the following major conclusion:
The 510(k) clearance process is not intended to evaluate the
safety and effectiveness of medical devices with some exceptions.
The 510(k) process cannot be transformed into a pre-market
evaluation of safety and effectiveness so long as the standard for
clearance is substantial equivalence to any previously cleared
device.
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79. The NIH explained, “The assessment of substantial equivalence does not require
an independent demonstration that the new device provides a ‘reasonable assurance of safety and
effectiveness.’” Further, the NIH even pointed out that the classification of predicate devices
approved for sale prior to the 1976 MDA “did not include any evaluation of the safety and
effectiveness of individual medical devices . . .Thus it is common for devices to be cleared through
the 510(k) program by being found substantially equivalent to devices that were never individually
evaluated for safety and effectiveness, either through the original device classification program or
through the 510(k) process.”
80. Defendants cleared the Ethicon Proceed Ventral Patch, and its related components,
under the 510(k) Premarket Notification. Under Section 510(k) of the Federal Food, Drug and
Cosmetic Act, a medical device does not have to go through the rigors of a clinical study to gain
approval by the FDA. Instead, the device was supposed to demonstrate substantial equivalence to
a predicate medical device.
81. On June 18, 2002, the Food and Drug Administration issued a document titled
“Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery;
Guidance for Industry.” The 26 page document starts by explaining:
FDA has determined that the resorbable adhesion barrier is a
significant risk device as defined in 21 CFR 812.3(m)(4). The
resorbable adhesion barrier is a class III device which is subject
to premarket approval in accordance with section 515 of the
Federal Food, Drug, and Cosmetics (FD&C) Act.
82. The first Proceed Surgical Mesh did not undergo premarket approval, but instead
received 510(k) clearance on or about September 17, 2003. The only predicate device listed on the
510(k) application is the Prolene Soft Polypropylene Mesh, a non-barrier hernia mesh. Defendants
did not claim that the Proceed Surgical Mesh was a resorbable adhesion barrier in their 510(k)
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application. However, after 510(k) clearance, Defendants marketed the Proceed Surgical Mesh as
a resorbable adhesion barrier.
83. Defendants applied for 510(k) clearance for the Proceed Surgical Mesh again in
May of 2006. The only predicate device listed on the 510(k) application is the prior Proceed
Surgical Mesh. In this 510(k) application, Defendants did not claim the intended use of the Proceed
was a resorbable adhesion barrier; however, in the device description Defendants note that the
“ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from
underlying tissue and organ surfaces during the wound-healing period to minimize tissue
attachment to the mesh.” Defendants continued to market the Proceed Surgical Mesh as a
resorbable adhesion barrier.
84. Defendants applied for 510(k) clearance for the Proceed Ventral Patch in December
of 2006. Defendants do not mention in the 510(k) application for the Proceed Ventral Patch that
the mesh is intended to act as a resorbable adhesion barrier. After 510(k) clearance, Defendants
marketed and continue to market the Proceed Ventral Patch as a resorbable adhesion barrier. Even
the Ethicon Proceed IFU notes “The ORC side of the patch provides a bioresorbable layer that
physically separates the polypropylene mesh from underlying tissue and organ surfaces while
minimizing tissue attachment to the polypropylene mesh during the critical wound healing period.”
CAUSES OF ACTION PURSUANT TO NEW JERSEY LAW
COUNT I: PRODUCTS LIABILITY ACT – STRICT PRODUCTS LIABILITY –
DEFECTIVE DESIGN (N.J.S.A. 2A:58C-1, et seq.)
85. Plaintiff incorporates by reference the allegations in all prior paragraphs and further
alleges as follows:
86. Defendants had a duty to design and manufacture, distribute, market, promote and
sell, the Ethicon Multi-Layered Hernia Mesh so that it was neither defective nor unreasonably
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dangerous when put to the use for which it was designed, manufactured, distributed, marketed and
sold.
87. In and before 2003, Defendants were engaged in the business of designing,
manufacturing, marketing, distributing and selling hernia mesh implants, and did design,
manufacture, distribute, market and sell the Ethicon Multi-Layered Hernia Mesh.
88. Defendants expected the Ethicon Multi-Layered Hernia Mesh Devices they were
manufacturing, selling, distributing, supplying, and/or promoting to reach, and they did in fact
reach, implanting physicians and consumers in the State of New Jersey and the United States,
including Plaintiff and Plaintiff’s implanting physician, without substantial change in their
condition.
89. At the time the Ethicon Multi-Layered Hernia Mesh left Defendants’ possession
and the time the Ethicon Multi-Layered Hernia Mesh entered the stream of commerce in the State
of New Jersey, it was in an unreasonably dangerous or defective condition. These defects include
the following:
the Ethicon Multi-Layered Hernia Mesh was not reasonably safe as intended to
be used;
the Ethicon Multi-Layered Hernia Mesh had an inadequate design for the
purpose of hernia repair;
the Ethicon Multi-Layered Hernia Mesh contained unreasonably dangerous
design defects, including a large pore ORC layer that is ineffective at preventing
adhesion formation to the underlying polypropylene;
the Ethicon Multi-Layered Hernia Mesh is unreasonably dangerous, due to the
degraded state of the polypropylene utilized, which has been exposed to gamma
radiation;
the Ethicon Multi-Layered Hernia Mesh contained unreasonably dangerous
design defects, utilizing multiple layers, which increase and prolong the
inflammatory response;
the Ethicon Multi-Layered Hernia Mesh was not appropriately or adequately
tested before distribution; and
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the Ethicon Multi-Layered Hernia Mesh had an unreasonably high propensity
for adhesion formation, mesh contracture, hernia recurrence, chronic pain,
bowel complications, seroma formation, fistula formation, hematoma
formation, infection, erosion, and extrusion.
90. At the time of Defendants’ initial design, manufacture, marketing, and sale of the
Ethicon Multi-Layered Hernia Mesh, a feasible, safer alternative design was known and available,
including, but not limited to, a flat, non-coated, single-layer mesh placed away from the bowel.
91. At the time subsequent to Defendants’ initial design and manufacture and
marketing and sale of the Ethicon Multi-Layered Hernia Mesh, including before Plaintiff’s hernia
surgery, Defendants had the ability to eliminate the unsafe character of the Ethicon Multi-Layered
Hernia Mesh without impairing its usefulness.
92. Had the Defendants properly and adequately tested the Ethicon Multi-Layered
Hernia Mesh, they would have discovered the following: the ORC layer was ineffective at
preventing adhesion formation to the polypropylene; the multiple layers would increase and
prolong the inflammatory response; the mesh experiences significant contraction over time;
recurrence rates are unacceptably high; the polypropylene was too weak; and the defects result in
bowel obstructions, seromas, fistulas, infections, erosion, extrusion, and a pronounced foreign
body response, among other complications.
93. The Ethicon Multi-Layered Hernia Mesh, manufactured, supplied, distributed,
marketed, promoted and sold by Defendants, was
Preview
ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 1 of 33 Trans ID: LCV20223420504 WILENTZ, GOLDMAN & SPITZER, P.A. Joshua S. Kincannon, Esquire NJ Attorney ID No.: 034052000 90 Woodbridge Center Drive, Suite 900 Woodbridge, New Jersey 07095 (732)-855-6141 (732)-726-6541 (Fax) Jkincannon@wilentz.com FLEMING, NOLEN & JEZ, L.L.P. Kelsey L. Stokes, Esq. (Pro Hac Vice) Texas Bar No. 24083912 kelsey_stokes@fleming-law.com David Hobbs (Pro Hac Vice forthcoming) Texas Bar No. 24074420 Utah Bar No. 17490 david_hobbs@fleming-law.com 2800 Post Oak Blvd. Suite 4000 Houston, Texas 77056-6109 Telephone (713) 621-7944 Fax (713) 621-9638 Attorneys for Plaintiff Theresa Peterson IN RE PROCEED MESH LITIGATION (Proceed Surgical Mesh and Proceed Ventral Patch SUPERIOR COURT OF NEW JERSEY Hernia Mesh) LAW DIVISION-ATLANTIC COUNTY Case No. 630 THERESA PETERSON, Master Case No. ATL-L-794-19 Plaintiff, CIVIL ACTION v. JOHNSON & JOHNSON and ETHICON, INC., COMPLAINT JURY TRIAL DEMANDED Defendants. Plaintiff Theresa Peterson, by and through his counsel, hereby sues JOHNSON & JOHNSON (“J&J”), a New Jersey corporation; and ETHICON, INC. (“Ethicon”), a New Jersey corporation (collectively “Defendants”). #13399270.1 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 2 of 33 Trans ID: LCV20223420504 NATURE OF THE ACTION 1. This is an action for strict products liability, failure to warn, and defective design, brought by Plaintiff Theresa Peterson for injuries arising out of the Proceed Ventral Patch (“Proceed” or “Ethicon Multi-Layered Hernia Mesh”). 2. Defendants manufactured and supplied to doctors a nine-layer hernia mesh patch known as the Proceed Ventral Patch. 3. The Proceed Ventral Patch created an unreasonable risk of harm to Plaintiff Theresa Peterson. 4. The unreasonable risk of pain, dense adhesion formation, bowel complications, mesh shrinkage, hernia recurrence, seroma and fistula formation, and infection whether from a prolonged and pronounced inflammatory response caused by the nine layers, degradation of polymers due to exposure to gamma irradiation, non-conforming subcomponents, or some other mechanism renders the Ethicon Multi-Layered Hernia Mesh a defective product. 5. The selection and implantation of the Ethicon Multi-Layered Hernia Mesh by Plaintiff’s surgeon was a result of the misinformation, marketing, sales, promotion and direction by Ethicon. JURISDICTION & VENUE 6. This is a lawsuit over defective hernia mesh designed, marketed, manufactured, promoted, and sold within New Jersey and the United States by Defendant Ethicon and its parent company J&J. 7. Theresa Peterson currently resides in Holiday, Florida and is a citizen and resident of Florida. Plaintiff underwent hernia repair surgery on or about May 27, 2020, at Advent Health North Pinellas in Tarpon Springs, Florida. At that time, the Ethicon Multi-Layered Hernia Mesh product that Defendants manufactured, designed, distributed, and warranted by Defendants was 2 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 3 of 33 Trans ID: LCV20223420504 implanted into Plaintiff. Theresa Peterson’s surgeon, medical staff, and other healthcare providers met or exceeded the standard of care applicable to the hernia surgery. 8. Defendant J&J is a corporation incorporated in New Jersey, and according to its website, the world’s largest and most diverse medical device and diagnostics company, with its principal place of business located at One Johnson & Johnson Plaza, New Brunswick, New Jersey. 9. Defendant J&J organizes its subsidiary businesses into individual Business Units to coordinate the development, manufacture, testing, marketing promotion, training, distribution and sale of its products, including its hernia repair mesh 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.” J&J charged the Ethicon Franchise with the design, development, promotion, marketing, testing, training, distribution and sale of the Proceed Ventral Patch, the hernia repair mesh product 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 comprising the Ethicon Franchise are thus controlled by Defendant J&J and include Ethicon, Inc. 10. Defendant Ethicon is a wholly owned subsidiary of Defendant J&J. Defendant Ethicon is a corporation incorporated in the State of New Jersey with its principal place of business in Somerville, New Jersey. Defendants conduct business in every county in New Jersey. 11. Defendant Ethicon is a medical device company involved in the research, development, testing, manufacture, production, marketing, promotion and/or sale of medical devices including Ethicon Multi-Layered Hernia Mesh. 12. J&J, directly and/or through the actions of Ethicon, has at all pertinent times been responsible for the research, development, testing, manufacture, production, marketing, 3 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 4 of 33 Trans ID: LCV20223420504 promotion, distribution and/or sale of Ethicon Multi-Layered Hernia Mesh. 13. At all relevant times, Defendants either directly, or through their agents, apparent agents, servants or employees sold, distributed, and marketed the defective Ethicon Multi-Layered Hernia Mesh in the State of New Jersey. Defendants derive substantial revenue from hernia mesh products used or implanted in the State of New Jersey. As such, Defendants expected or should have expected that their business activities could or would subject them to legal action in the State of New Jersey. 14. Defendants were also involved in the business of monitoring and reporting adverse events concerning the Ethicon Multi-Layered Hernia Mesh, and having a role in the decision process and any response related to these adverse events. 15. The Ethicon Multi-Layered Hernia Mesh Defendants are subject to jurisdiction within the State of New Jersey and this Court because: a. Defendants are engaged in substantial and not isolated business activity within the State of New Jersey, Middlesex County. b. Defendants’ hernia mesh products, including the subject Proceed Ventral Patch, were designed, manufactured, and placed into the stream of commerce in the State of New Jersey by Defendants. c. Defendants maintain an office or agency within the State of New Jersey. d. Upon information and belief, at all relevant times, Defendants committed tortious acts within the State of New Jersey out of which these causes of action arise. 16. At all material times, Defendants developed, manufactured, advertised, promoted, marketed, sold, and/or distributed the defective Ethicon Multi-Layered Hernia Mesh throughout the United States, including within the State of Florida and specifically to Plaintiff’s implanting physician or their practice group, or to the hospital where the Ethicon Multi-Layered Hernia Mesh was implanted. 4 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 5 of 33 Trans ID: LCV20223420504 17. Plaintiff has reviewed potential legal claims and causes of action against Defendants and has chosen to only pursue state-law claims. Any reference to any federal agency, regulation, or rule is stated solely as background information and does not raise a federal question. Defendants J&J and Ethicon are both New Jersey corporations and both maintained their principal place of business in New Jersey. Accordingly, this Court may rightfully exercise jurisdiction, and venue is proper. 18. Defendants designed, manufactured, fabricated, marketed, packaged, advertised, and sold the Ethicon Multi-Layered Hernia Mesh throughout the world, including in Middlesex County, State of New Jersey. 19. Defendants knowingly market to, and derive income from, patients in the State of New Jersey from the sale of Ethicon Multi-Layered Hernia Mesh. 20. This is an action for damages in excess of Fifteen Thousand Dollars ($15,000.00), exclusive of interest and costs. PROCEED HISTORY 21. Defendants were the designers, manufacturers, marketers, distributors and suppliers of the Ethicon Proceed Ventral Patch at all material times. 22. Defendants warranted the Ethicon Multi-Layered Hernia Mesh and placed the device into the United States stream of commerce. 23. Defendants knew that the oxidized regenerated cellulose layer of the Ethicon Multi- Layered Hernia Mesh was ineffective at preventing adhesion formation to the underlying polypropylene of the Proceed before Defendants set out to design the Proceed Ventral Patch in 2006, and even before Defendants set out to design the Proceed Surgical Mesh predicate device in 2003. 5 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 6 of 33 Trans ID: LCV20223420504 24. Before 2003, Defendants were aware that the Oxidized Regenerated Cellulose utilized in the Ethicon Multi-Layered Hernia Mesh had pores which were too large to prevent adhesion formation. 25. Before 2003, Defendants were aware that increased adhesion formation would result in increased mesh shrinkage. 26. Before 2003, Defendants were aware that utilizing Oxidized Regenerated Cellulose in their mesh products would result in dense adhesions in the presence of blood or fibrinous exudate. 27. Before 2003, Defendants were aware that polypropylene elicits a chronic, life-long inflammatory response that is accompanied by exudation of fibrinogen. 28. Before 2003, Defendants were aware that any exposure to gamma radiation would weaken and embrittle the polypropylene of the Ethicon Multi-Layered Hernia Mesh. 29. Before 2006, Defendants were aware that adding Vicryl and other additional layers to the Proceed Surgical Mesh to create the Proceed Ventral Patch, would increase the intensity and duration of inflammation and foreign body response (FBR), thus increasing fibrinous exudate. 30. Before placing the Ethicon Multi-Layered Hernia Mesh on the market, Defendants were required to mitigate risks of the product, including any element of design or sterilization which could render the device ineffective, weaken the structural integrity of the device, or increase or prolong inflammation once the device is implanted that would result in an increase in adhesion formation, mesh shrinkage, pain, bowel complications, hernia recurrence, and/or the need for early surgical revision in patients-consumers. 31. Defendants designed, manufactured, and marketed the Ethicon Multi-Layered Hernia Mesh, despite long-standing knowledge that the materials utilized in the Proceed would 6 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 7 of 33 Trans ID: LCV20223420504 cause dense adhesions, chronic pain, mesh shrinkage, bowel obstructions, and early hernia recurrence. 32. Defendants sterilized the Ethicon Multi-Layered Hernia Mesh with gamma radiation, despite long-standing knowledge that polypropylene will degrade and embrittle if exposed to any amount of gamma radiation. 33. The Ethicon Proceed Ventral Patch is made of the following, starting with the component placed closest to the bowel of the patient-consumer: Oxidized Regenerated Cellulose (ORC) barrier layer Polydioxanone (PDS) film layer Large pore polypropylene (Prolene soft mesh) PDS film layer PDS reinforcing element PDS ring PDS film layer Vicryl PDS film layer 34. Polypropylene hernia meshes are traditionally sterilized with ethylene oxide. 35. The ORC layer of the Ethicon Multi-Layered Hernia Mesh will react and degrade in the presence of ethylene oxide. 36. Defendants sterilize the Ethicon Multi-Layered Hernia Mesh with gamma radiation. 37. Gamma radiation degrades, weakens, and embrittles the polypropylene base of the Ethicon Multi-Layered Hernia Mesh. 38. Decades before the release of the Ethicon Multi-Layered Hernia Mesh, Defendants were aware that polypropylene degrades, weakens, and embrittles when exposed to gamma irradiation.1 1 U.S. Patent No. 3,943,933 (Issued Mar. 16, 1976). 7 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 8 of 33 Trans ID: LCV20223420504 39. The embrittled polypropylene of the Ethicon Multi-Layered Hernia Mesh increases its propensity to tear away from the securing devices, such as sutures or tacks. 40. The polypropylene base is the only permanent, non-resorbable portion of the Ethicon Multi-Layered Hernia Mesh. 41. Defendants designed, manufactured, promoted, sold and/or marketed the Ethicon Multi-Layered Hernia Mesh to be utilized in anyone with a soft tissue defect, including, but not limited to: “infants, children, pregnant women, or women planning pregnancies…”2 42. For decades, the medical community had concerns about severe complications if polypropylene was placed too close to the bowel or other underlying organs, due to the formation of dense adhesions to the polypropylene. 43. Defendants were aware that the ORC layer in the Ethicon Multi-Layered Hernia Mesh was ineffective at preventing adhesion formation to polypropylene over a decade before Defendants brought the Ethicon Multi-Layered Hernia Mesh to market.3 44. Despite significant evidence to the contrary, Defendants marketed the Ethicon Multi-Layered Hernia Mesh and its ORC layer as a tissue-separating barrier that would prevent adhesion formation from the underlying polypropylene to any nearby organs. 45. The following studies have investigated complications associated with the Ethicon Multi-Layered Hernia Mesh: a. In 2006, a study out of The Netherlands evaluating the use of new prosthetic meshes for ventral hernia repair was published in Surgical Endoscopy. Proceed showed significantly less incorporation… Proceed composite has a smooth surface designed to prevent adhesion formation. However, it is less smooth than other composite meshes with antiadhesive barriers. Furthermore, the barrier applied is oxidized cellulose, which may not prevent mesh adhesions as effectively as 2 Proceed Ventral Patch Instructions for Use, RMC 8550915, Status 9/08. 3 Robert J. Fitzgibbons, Jr., M.D. et al., A Laparoscopic Intraperitoneal Onlay Mesh Technique for the Repair of an Indirect Inguinal Hernia, 219-2 ANNALS OF SURGERY 114 (1994). 8 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 9 of 33 Trans ID: LCV20223420504 anticipated or as reported previously. Burger, J.W. et al, Evaluation of New Prosthetic Meshes for Ventral Hernia Repair. Surg Endosc. 20:1320 – 1325 (2006). DOI: 10.1007/s00464-005- 0706-4. b. In 2009, a study out of The Netherlands on adhesions prevention during hernia mesh repair was published in the Annals of Biomedical Engineering. The uncoated Prolene meshes were found to invoke a moderate inflammatory response in their immediate vicinity, characterized by the presence of active macrophages. A stronger inflammatory response was observed with the Proceed meshes, presumably due to ongoing phagocytosis of the oxidizing regenerated cellulose and polydioxanone coating… Most remarkable were adhesions with Proceed. Although adhesion scores were the lowest at day 7, they increased by day 30 and exceeded adhesion scores of NVP/BMA-coated Prolene mesh and Prolene. Emans, P. et al, Polypropylene Meshes to Prevent Abdominal Herniation. Can Stable Coatings Prevent Adhesions in the Long Term? Annals of Biomedical Engineering. 37(2):410 – 418 (2009). DOI: 10.1007/s10439- 008-9608-7. c. In 2009, a study out of Saint Louis, Missouri measuring adhesions and mesh contraction was published by Surgical Innovation. The data was previously presented at the American Hernia Society, Third International Hernia Congress on June 9, 2006. The highest degrees of mesh contraction occurred with DualMesh and Proceed… Proceed exhibited the greatest surface area of adhesion coverage and the highest-grade adhesions. Pierce, R. et al, 120-Day Comparative Analysis of Adhesion Grade and Quantity, Mesh Contraction, and Tissue Response to a Novel Omega-3 Fatty Acid Bioabsorbable Barrier Macroporous Mesh After Intraperitoneal Placement. Surg Innov. (2009). DOI: 10.1177/1553350608330479. d. In 2010, a study out of Saint Louis, Missouri on adhesion related complications associated with intraperitoneal mesh was published in Surgical Endoscopy. Nevertheless, there appears to be some differentiation in the adhesion characteristics of the absorbable- barrier-coated meshes… We noticed a similar increase in the adhesion tenacity score of PROCEED in a preclinical study of intraperitoneal placement f absorbable-barrier-coated meshes in a rabbit model. Jenkins, E. et al, Prospective Evaluation of Adhesion Characteristics to Intraperitoneal Mesh and Adhesiolysis-Related Complications During 9 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 10 of 33 Trans ID: LCV20223420504 Laparoscopic Re-Exploration After Prior Ventral Hernia Repair. Surg Endosc. 24:3002 – 3007. DOI: 10.1007/s00464-010-1076-0. e. In 2010, a study out of Belgium on the lack of convincing data in medical literature regarding to use of intraperitoneal hernia mesh was published in The World Journal of Hernia and Abdominal Wall Surgery. The content of the paper was presented during the 32nd International Congress of the European Hernia Society, in Istanbul, on October 6-8, 2010. After release of the omental adhesions, we found the [Proceed] mesh to have shrunk and folded up, to a dimension of approximately 3.0 cm in diameter. This means a shrinkage from a circle of diameter 6.4 cm (surface: 3.14 x 3.22 = 32.2 cm2) to a “circle” of diameter 3.0 cm (surface: 3.14 x 1.52 = 7.1 cm2), equivalent to a mesh surface shrinkage of 77.9%... There is a complete lack of convincing data on these mesh devices in the medical literature. Muysoms, F.E. et al, Complications of Mesh Devices for Intraperitoneal Umbilical Hernia Repair: A Word of Caution. Journal of Hernia. 15:463- 468 (2011). DOI: 10.1007/s10029-010-0692-x. f. In 2012, a study out of Saint Louis, Missouri on the effectiveness of barrier hernia mesh was published in Surgical Endoscopy. This study also demonstrated increased adhesion formation for all of the barrier mesh prostheses between 7 and 30 days, which the authors attributed to increased inflammation related to the degradation and resorption of the barrier layer components, which were ongoing between 7 and 30 days. This effect was most pronounced in PROCEED Surgical Mesh materials, which again highlights the influence that the chemistry of the particular barrier components may have over the inflammatory response and subsequent adhesion formation. Deeken, C. et al, A Review of the Composition, Characteristics, and Effectiveness of Barrier Mesh Prostheses Utilized for Laparoscopic Ventral Hernia Repair. Surg Endosc. 26:566-575 (2012). DOI: 10.1007/s00464- 011-1899-3. g. In 2014, a study out of Belgium on the Proceed Ventral Patch (PVP) was published in The World Journal of Hernia and Abdominal Wall Surgery. Polypropylene meshes, like the PVP, have demonstrated an in vivo centripetal shrinkage percentage of up to 77% in some patients. This finding of mesh contraction was confirmed in those patients. This finding of mesh contraction was confirmed in those patients that were re-operated for recurrence in 21% of the patients where the radiologist was able to visualize the mesh. The overlap obtained with a mesh of 6.4 cm in diameter is in sufficient with hernias larger than 2 cm. Therefore, we recommend not to use PVP in hernias of 2cm or more. 10 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 11 of 33 Trans ID: LCV20223420504 Bontinck, J. et al, Single Centre Observational Study to Evaluate the Safety and Efficacy of the Proceed Ventral Patch to Repair Small Ventral Hernias. Journal of Hernia. 18:671 – 680 (2014). DOI: 10.1007/s10029-013-1140-5. h. In 2015, a study out of Belgium on the Proceed (PP/ORC) was published in The World Journal of Hernia and Abdominal Wall Surgery. In our opinion, there are several factors contributing to the extensive FBR and shrinkage/mesh contraction of the PP/ORC device. First, the composition of the PP/ORC device out of nine different layers will lead to a more extensive FBR. Second, absorption of 8 of these 9 layers will create a severe inflammatory reaction as, e.g.. shown with vicryl mesh absorption, also being one of the components of the PP/ORC device. A third possible explanation is delamination of the device. Reynvoet, E. et al, Intraperitoneal Mesh Devices for Small Midline Hernias: Mesh Behavior in a Porcine Model. Journal of Hernia. 19:955 – 963 (2015). DOI: 10.1007/s10029-015-1368-3. i. In 2016, a study out of Bosnia and Herzegovina was published by The Royal Belgian Society for Surgery. The extent of [adhesion] site involvement after 28 days was statistically significantly greater in the Proceed group. Delibegovic, S. et al, Formation of Adhesions After Intraperitoneal Applications of TiMesh: Experimental Study on a Rodent Model. The Royal Belgian Society for Surgery. (2016). DOI 10.1080/00015458.2016.1179513 j. In 2016, a study out of Germany on the adhesion prevention efficacy of Proceed (PCM) was published in International Journal of Medical Sciences. PCM does not provide significant adhesion prevention. Winny, M. et al, Adhesions Prevention Efficacy of Composite Meshes Parietex, Proceed, and 4DryField PH Covered Polypropylene Meshes in an IPOM Rat Model. Int. J. Med. Sci. 13:936 – 941 (2016). DOI: 10.7150/ijms.16215. k. In 2017, a Proceed (PVP) randomized controlled trial out of The Netherlands was published in the World Journal of Surgery. At this point, PVP device usage shows an easier and faster operating procedure. Nevertheless, this advantage is outweighed by the significantly higher incidence of early re-operations due to early complications. Ponten, J.E. et al, Mesh Versus Patch Repair for Epigastric and Umbilical Hernia (MORPHEUS Trial); One-Year Results of a Randomized Controlled 11 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 12 of 33 Trans ID: LCV20223420504 Trial. World J. Surg. (2017). DOI: 10.1007/s00268-017-4297-8. l. In 2017, a study out of Brazil was published on adhesions and collagen formation following mesh implantation. The study follow-up time, 90 days, was established because there were no articles in the literature with prolonged follow-up… What we can formulate is that absorption of the regenerated oxidized cellulose exposes the polypropylene layer to the abdominal visceral content and that this consequently led to the adhesions found… The adhesion formation is a complex process and is basically started by the tissue injury process which breaks down the balance between coagulation and fibrinolysis. Fibrin deposition results in a matrix where the fibroblasts produce extracellular matrix. The end process generates various degrees of adhesion… In the present study, type III collagen was expressed more in the coated group and based on the result of the research this could increase hernia formation. Rossi, L. et al, Peritoneal Adhesions Type I, III and Total Collagen on Polypropylene and Coated Polypropylene Meshes: Experimental Study in Rats. ABCD Arq Bras Cir Dig 30(2):77 – 82 (2017). DOI: 10.1590/0102- 6720201700020001. FAILURE TO WARN PHYSICIANS OF THE DANGERS ASSOCIATED WITH ETHICON MULTI-LAYERED HERNIA MESH 46. Defendants marketed the Ethicon Multi-Layered Hernia Mesh to general surgeons, hospitals, and group purchasing organizations (GPOs), rather than end-user patients. 47. Defendants had the ability to inform surgeons, hospitals, or GPOs of developing problems or defects in its devices through e-mail, letter, recalls, warnings in product inserts, and/or through its product representatives, who work directly with surgeons. 48. The nine layers of the Ethicon Multi-Layered Hernia Mesh increase the intensity and duration of the inflammatory response. That response in turn increases dense adhesion formation from underlying organs to the Ethicon Proceed, resulting in bowel complications, mesh contracture, hernia recurrence, increased foreign body reaction, chronic severe pain, and more. 49. Defendants downplayed the intensity of the inflammatory reaction caused by Vicryl by stating in the Ethicon Proceed Instructions for Use (IFU) that the Vicryl elicits “only a mild 12 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 13 of 33 Trans ID: LCV20223420504 tissue reaction during absorption.” 50. Defendants state in the Proceed IFU that “The PROLENE Soft Mesh components are constructed of knitted filaments of extruded polypropylene, identical in composition to that used in PROLENE Polypropylene Suture, Nonabsorbable Surgical Suture, U.S.P.” This statement is false, or at the very least misleading, as the Proceed undergoes gamma irradiation that changes the composition of the polypropylene. 51. Defendants also state in the Proceed IFU that the polypropylene material “when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. The PROLENE Soft Mesh affords excellent strength, durability and surgical adaptability, with a porous structure to enable mesh incorporation into surrounding tissues.” This statement is false, or at the very least misleading, as Defendants are aware that the Ethicon Proceed is reactive and does not retain its strength. Furthermore, Defendants are aware of reports that the small polypropylene sutures do elicit a small reaction, and increasing amounts of polypropylene greatly increase such reaction. The very reason the Defendants added the ORC layer to the Prolene Soft Mesh was to protect organs from reacting with the polypropylene of the Prolene Soft Mesh. 52. The Proceed IFU has a section for contraindications, which lists “None known.” 53. The Proceed IFU has a section for adverse reactions, which lists “Potential adverse reactions are those typically associated with surgically implantable materials…” The polypropylene base of the Ethicon Proceed carries many potential adverse reactions, such as a life- long inflammatory response that other surgically implantable materials do not present. Additionally, the multiple layers of the Ethicon Multi-Layered Hernia Mesh further increase the inflammatory response and rate of infection, adhesion formation, chronic pain, seroma formation, fistula formation, hematomas, mesh contracture, hernia recurrence, mesh migration, bowel 13 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 14 of 33 Trans ID: LCV20223420504 complications, foreign body response, extrusion, and other additional injuries. 54. The Proceed IFU notes that “Selected mesh size should allow for adequate overlap of the fascial defect on all sides.” The IFU never defines what constitutes “adequate overlap.” Defendants are aware that the Proceed shrinks over time, with reports of the Proceed shrinking as much as 77%. 55. Defendants failed to warn that the Ethicon Multi-Layered Hernia Mesh will elicit a fibrinous exudate. 56. Defendants failed to warn that the Ethicon Multi-Layered Hernia Mesh creates a solid barrier preventing the body from adequately clearing or transporting fluid, which results in seroma formation, potentiating infections and fistula formation. 57. Defendants never performed any clinical trials and/or studies before marketing the Ethicon Multi-Layered Hernia Mesh. 58. Defendants did not fully and/or adequately test the configuration of its new, multi- layered hernia mesh patch design with ORC, polypropylene, Vicryl, and six layers of PDS, that was implanted into Plaintiff. 59. Although the United States does not have a complete and accurate database to track problems with hernia mesh implants, controlled studies have investigated the problems with the Ethicon Multi-Layered Hernia Mesh. 60. A single center study was conducted in Belgium, where three surgeons implanted only the Ethicon Proceed in 101 patients between April 2009 and December 2011. The Ethicon Proceed was able to be visualized by ultrasound in 47 patients. Of those 47 patients, 10 were noted to have mesh contraction. The Ethicon Proceed “was removed during the operation in four patients and important centripetal contraction of the mesh, diminishing the surface area, was observed in 14 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 15 of 33 Trans ID: LCV20223420504 all cases.” The authors concluded the Proceed has “demonstrated an in vivo centripetal shrinkage percentage of up to 77% in some patients. This finding of mesh contraction was confirmed in those patients that were reoperated for recurrence and in 21% of the patients where the radiologist was able to visualize the mesh. The overlap obtained with a mesh of 6.4cm in diameter was insufficient with hernias larger than 2 cm. Therefore, we recommend not to use PVP (Proceed Ventral Patch) in hernias of 2 cm or more.” The authors go on to note that their study is likely underpowered as “Most recurrences after ventral hernia repair occur within 2 years after the operation. Since our study had a mean follow-up of 16 months, it is likely that a longer follow-up would yield a higher recurrence rate.”4 61. In 2015, another study in Belgium confirmed “massive shrinkage” with the Ethicon Proceed. The authors concluded that “This can however not be considered the ideal indication for a mesh device repair with a suggested mesh overlap of at least 5 cm for incisional hernias.”5 62. Defendants continue to market the Ethicon Multi-Layered Hernia Mesh without warning of the massive mesh shrinkage or the necessary overlap to prevent early hernia recurrence due to mesh shrinkage. 63. Reassurances of device safety were made through direct promotional contact by Defendants’ sales representatives and distributors, through word-of-mouth from Defendants’ physician/technical consultants, and/or through industry-targeted promotional materials. 64. Despite these reassurances, the defective design and manufacture of the Ethicon Multi-Layered Hernia Mesh continued to elicit severe and chronic inflammatory responses, resulting in adhesion formation, bowel injuries, mesh contracture, pain, hernia recurrence, 4 J. Bontinck, Single Centre Observational Study to Evaluate the Safety and Efficacy of the Proceed Ventral Patch to Repair Small Ventral Hernias, 18 Hernia 671, Clinical.Trials.gov: NCT01307696 (2013). 5 E. Reynvoet, Intraperitoneal Mesh Devices for Small Midline Hernias: Mesh Behavior in a Porcine Model, 19 Hernia 955 (2015). 15 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 16 of 33 Trans ID: LCV20223420504 infections, seromas, fistulas, erosion, extrusion, and additional complications. 65. Defendants were aware that the ORC layer was ineffective in preventing adhesions to the polypropylene; gamma irradiation would weaken the polypropylene; and the nine-layer mesh would contract massively over time. Nonetheless, Defendants employed the design in the Ethicon Proceed Ventral Patch in reckless disregard for the safety of patients, including Plaintiff. 66. Moreover, despite direct knowledge of significant adverse events reported by patients and physicians, as well as awareness of failures that have been reported in literature and published clinical trials, Defendants have continued to market the Ethicon Multi-Layered Hernia Mesh as being safe and effective for hernia repair. 67. From the time Defendants first began selling the Ethicon Multi-Layered Hernia Mesh in the United States through today, product labeling and the product information failed to contain adequate information, instructions, and warnings concerning the following: implantation of the Proceed, specifically its propensity to massively shrink, the increased in duration and intensity of inflammation, and the elevated rate of adhesions, bowel complications, chronic pain, hernia recurrence, seroma formation, hematoma formation, fistula formation, erosion, extrusion, infection, and other injuries occurring at a higher rate than other surgically implanted devices. USE OF THE PRODUCT 68. A defectively designed, manufactured and marketed Ethicon Multi-Layered Hernia Mesh left the hands of Defendants in its defective condition, and was delivered into the stream of commerce. Dr. Jared Conte Frattini implanted the Proceed Surgical Mesh to repair a ventral hernia on or about May 27, 2020, at Advent Health North Pinellas in Tarpon Springs, Florida. Plaintiff was implanted with a Proceed Surgical Mesh, Model No. PCDH1. 69. As a direct and proximate result of Defendants’ defective design, manufacture, 16 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 17 of 33 Trans ID: LCV20223420504 marketing, distribution, and/or sale of the Ethicon Multi-Layered Hernia Mesh, and their placing of their defective product into the stream of commerce, Plaintiff has been injured and damaged as follows: a. Theresa Peterson underwent repair of the Ethicon Proceed Surgical Mesh at Advent Health North Pinellas in Tarpon Springs, Florida by Dr. Jared Conte Frattini due to adhesions and hernia recurrence. b. On or about November 3, 2020, Theresa Peterson underwent partial removal of the Ethicon Proceed Ventral Patch at Advent Health North Pinellas in Tarpon Springs, Florida by Dr. Jared Conte Frattini due to adhesions, abdominal pain, and hernia recurrence. c. Plaintiff experienced and/or continues to experience the need for additional surgery, severe pain, inflammation, and/or other injuries which have impaired Plaintiff’s activities of daily living. d. Plaintiff continues to suffer complications as a result of his implantation with the Ethicon Multi-Layered Hernia Mesh. e. Plaintiff is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible. 70. The mechanism of failure in Plaintiff’s device was a mechanism of failure that Defendants had marketed and warranted would not occur because of the Ethicon Multi-Layered Hernia Mesh design and composition. It was also the same failure mechanism that the medical and scientific community had been studying and documenting since the 1990s, i.e., ORC was ineffective at preventing adhesions to polypropylene, and polypropylene contracts when dense adhesions form to it. 71. Moreover, the symptoms and findings associated with Ethicon Multi-Layered Hernia Mesh product failures that have been reported in the literature are identical to those Plaintiff suffered. 72. As a direct and proximate result of Defendants’ defective design, manufacturing, 17 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 18 of 33 Trans ID: LCV20223420504 marketing, distribution, sale and warnings of the Ethicon Multi-Layered Hernia Mesh, Plaintiff has suffered and continues to suffer injuries and damages, including, but not limited to: past, present and future physical and mental pain and suffering; physical disability; past, present, and future medical, hospital, rehabilitative, and pharmaceutical expenses; and other related damages. THE FDA’S 510(k) CLEARANCE PROCESS 73. The 510(k) clearance process refers to Section 510(k) of the Medical Device Amendments of 1976 MDA of the Federal Food, Drug and Cosmetic Act. Under this process, device manufacturers are only required to notify the FDA at least 90 days before they market a device claimed to be “substantially equivalent” to a device the FDA had approved for sale before 1976, when the MDA was enacted. 74. No clinical testing is required under this process. 75. Subsequent amendments to the MDA allowed for 510(k) clearance of products deemed “substantially equivalent” to post-MDA, 510(k)-cleared devices. 76. Through this domino effect, devices deemed “substantially equivalent” to devices previously deemed “substantially equivalent” to devices approved for sale by the FDA before 1976 could be sold to patients in a matter of 90 days without any clinical testing. 77. Clearance for sale under the 510(k) process does not equate to FDA approval of the cleared device. 78. In 2012, at the request of the FDA, the National Institute of Health (NIH) conducted a thorough review of the 510(k) process, coming to the following major conclusion: The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a pre-market evaluation of safety and effectiveness so long as the standard for clearance is substantial equivalence to any previously cleared device. 18 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 19 of 33 Trans ID: LCV20223420504 79. The NIH explained, “The assessment of substantial equivalence does not require an independent demonstration that the new device provides a ‘reasonable assurance of safety and effectiveness.’” Further, the NIH even pointed out that the classification of predicate devices approved for sale prior to the 1976 MDA “did not include any evaluation of the safety and effectiveness of individual medical devices . . .Thus it is common for devices to be cleared through the 510(k) program by being found substantially equivalent to devices that were never individually evaluated for safety and effectiveness, either through the original device classification program or through the 510(k) process.” 80. Defendants cleared the Ethicon Proceed Ventral Patch, and its related components, under the 510(k) Premarket Notification. Under Section 510(k) of the Federal Food, Drug and Cosmetic Act, a medical device does not have to go through the rigors of a clinical study to gain approval by the FDA. Instead, the device was supposed to demonstrate substantial equivalence to a predicate medical device. 81. On June 18, 2002, the Food and Drug Administration issued a document titled “Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry.” The 26 page document starts by explaining: FDA has determined that the resorbable adhesion barrier is a significant risk device as defined in 21 CFR 812.3(m)(4). The resorbable adhesion barrier is a class III device which is subject to premarket approval in accordance with section 515 of the Federal Food, Drug, and Cosmetics (FD&C) Act. 82. The first Proceed Surgical Mesh did not undergo premarket approval, but instead received 510(k) clearance on or about September 17, 2003. The only predicate device listed on the 510(k) application is the Prolene Soft Polypropylene Mesh, a non-barrier hernia mesh. Defendants did not claim that the Proceed Surgical Mesh was a resorbable adhesion barrier in their 510(k) 19 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 20 of 33 Trans ID: LCV20223420504 application. However, after 510(k) clearance, Defendants marketed the Proceed Surgical Mesh as a resorbable adhesion barrier. 83. Defendants applied for 510(k) clearance for the Proceed Surgical Mesh again in May of 2006. The only predicate device listed on the 510(k) application is the prior Proceed Surgical Mesh. In this 510(k) application, Defendants did not claim the intended use of the Proceed was a resorbable adhesion barrier; however, in the device description Defendants note that the “ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh.” Defendants continued to market the Proceed Surgical Mesh as a resorbable adhesion barrier. 84. Defendants applied for 510(k) clearance for the Proceed Ventral Patch in December of 2006. Defendants do not mention in the 510(k) application for the Proceed Ventral Patch that the mesh is intended to act as a resorbable adhesion barrier. After 510(k) clearance, Defendants marketed and continue to market the Proceed Ventral Patch as a resorbable adhesion barrier. Even the Ethicon Proceed IFU notes “The ORC side of the patch provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces while minimizing tissue attachment to the polypropylene mesh during the critical wound healing period.” CAUSES OF ACTION PURSUANT TO NEW JERSEY LAW COUNT I: PRODUCTS LIABILITY ACT – STRICT PRODUCTS LIABILITY – DEFECTIVE DESIGN (N.J.S.A. 2A:58C-1, et seq.) 85. Plaintiff incorporates by reference the allegations in all prior paragraphs and further alleges as follows: 86. Defendants had a duty to design and manufacture, distribute, market, promote and sell, the Ethicon Multi-Layered Hernia Mesh so that it was neither defective nor unreasonably 20 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 21 of 33 Trans ID: LCV20223420504 dangerous when put to the use for which it was designed, manufactured, distributed, marketed and sold. 87. In and before 2003, Defendants were engaged in the business of designing, manufacturing, marketing, distributing and selling hernia mesh implants, and did design, manufacture, distribute, market and sell the Ethicon Multi-Layered Hernia Mesh. 88. Defendants expected the Ethicon Multi-Layered Hernia Mesh Devices they were manufacturing, selling, distributing, supplying, and/or promoting to reach, and they did in fact reach, implanting physicians and consumers in the State of New Jersey and the United States, including Plaintiff and Plaintiff’s implanting physician, without substantial change in their condition. 89. At the time the Ethicon Multi-Layered Hernia Mesh left Defendants’ possession and the time the Ethicon Multi-Layered Hernia Mesh entered the stream of commerce in the State of New Jersey, it was in an unreasonably dangerous or defective condition. These defects include the following: the Ethicon Multi-Layered Hernia Mesh was not reasonably safe as intended to be used; the Ethicon Multi-Layered Hernia Mesh had an inadequate design for the purpose of hernia repair; the Ethicon Multi-Layered Hernia Mesh contained unreasonably dangerous design defects, including a large pore ORC layer that is ineffective at preventing adhesion formation to the underlying polypropylene; the Ethicon Multi-Layered Hernia Mesh is unreasonably dangerous, due to the degraded state of the polypropylene utilized, which has been exposed to gamma radiation; the Ethicon Multi-Layered Hernia Mesh contained unreasonably dangerous design defects, utilizing multiple layers, which increase and prolong the inflammatory response; the Ethicon Multi-Layered Hernia Mesh was not appropriately or adequately tested before distribution; and 21 ATL-L-002605-22 09/23/2022 10:15:26 AM Pg 22 of 33 Trans ID: LCV20223420504 the Ethicon Multi-Layered Hernia Mesh had an unreasonably high propensity for adhesion formation, mesh contracture, hernia recurrence, chronic pain, bowel complications, seroma formation, fistula formation, hematoma formation, infection, erosion, and extrusion. 90. At the time of Defendants’ initial design, manufacture, marketing, and sale of the Ethicon Multi-Layered Hernia Mesh, a feasible, safer alternative design was known and available, including, but not limited to, a flat, non-coated, single-layer mesh placed away from the bowel. 91. At the time subsequent to Defendants’ initial design and manufacture and marketing and sale of the Ethicon Multi-Layered Hernia Mesh, including before Plaintiff’s hernia surgery, Defendants had the ability to eliminate the unsafe character of the Ethicon Multi-Layered Hernia Mesh without impairing its usefulness. 92. Had the Defendants properly and adequately tested the Ethicon Multi-Layered Hernia Mesh, they would have discovered the following: the ORC layer was ineffective at preventing adhesion formation to the polypropylene; the multiple layers would increase and prolong the inflammatory response; the mesh experiences significant contraction over time; recurrence rates are unacceptably high; the polypropylene was too weak; and the defects result in bowel obstructions, seromas, fistulas, infections, erosion, extrusion, and a pronounced foreign body response, among other complications. 93. The Ethicon Multi-Layered Hernia Mesh, manufactured, supplied, distributed, marketed, promoted and sold by Defendants, was