(Below you will find a hernia mesh victim’s lawsuit against Johnson and Johnson and Ethicon alleging that Physiomesh hernia mesh is defective. This lawsuit was filed on 03/24/17 in United States District Court, Middle District of Florida, Tampa Division. In pertinent part the Plaintiff / victim alleged that “Plaintiff was forced to undergo multiple revision surgeries due to complications from Defendant’s defective hernia mesh, eventually resulting in a surgery to remove the mesh.”
The hernia mesh law firm representing the victim asserted that: “Defendants’ Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design and/or manufacture of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; 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.”)
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UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
DIANA JANE PICOLLA,
JOHNSON & JOHNSON and
Civil Action No.:
JURY TRIAL DEMANDED
Comes now Plaintiff, Diana Jane Picolla (“Plaintiff”), by and through undersigned counsel,
and brings this action against Defendants Ethicon, Inc. and Johnson & Johnson (hereinafter
“Defendants”), and alleges as follows:
1. Plaintiff is, and was, at all relevant times, a citizen and resident of Florida and the
2. Defendant Johnson & Johnson (“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. J&J has as its citizenship the State of New Jersey.
3. Defendant J&J organizes its subsidiary businesses into individual Business Units
to coordinate the development, manufacture, testing, marketing promotion, training, distribution
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and sale of its products, including but not limited to 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.”
The Ethicon Franchise was charged by J&J with the design, development, promotion, marketing,
testing, training, distribution and sale of the hernia repair mesh products at issue in this case. The
Company Group Chairman and Worldwide Franchise Chairman for the Ethicon Franchise, Gary
Pruden, is employed by J&J. The companies which comprise the Ethicon Franchise are thus
controlled by J&J and include, but are not limited to, Ethicon Inc.
4. Defendant Ethicon, Inc. (“Ethicon”) is a wholly owned subsidiary of Defendant
Johnson & Johnson. Defendant Ethicon is a corporation incorporated in the State of New Jersey
with its principal place of business in Somerville, New Jersey. Ethicon is authorized and registered
to transact business within the State of Florida. Ethicon has as its citizenship the State of New
5. Ethicon is a medical device company involved in the research, development,
testing, manufacture, production, marketing, promotion and/or sale of medical devices
including Physiomesh (hereinafter may be referred to as the “product”).
6. 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,
promotion, distribution and/or sale of Physiomesh.
7. Defendants are individually, jointly and severally liable to Plaintiff for damages
suffered by Plaintiff arising from the Defendants’ design, manufacture, marketing, labeling,
distribution, sale and placement of its defective mesh products at issue in the instant action,
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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. Defendants are vicariously liable for the acts and/or omissions of its 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.
Jurisdiction and Venue
9. This Court has subject-matter jurisdiction over this action pursuant to 28 U.S.C. §
1332(a) based on complete diversity of citizenship between Plaintiff and all Defendants. The
amount in controversy exceeds $75,000.
10. This Court has personal jurisdiction over each of the Defendants pursuant to the
Florida Long-Arm Statute, § 48.193. Defendants transact business within the State of Florida, and
Defendants committed tortious acts and omissions in Florida. Defendants’ tortious acts and
omissions caused injury to Plaintiff in the State of Florida. Defendants have purposefully engaged
in the business of developing, manufacturing, publishing information, marketing, distributing,
promoting and/or selling, either directly or indirectly, through third parties, as successor in interest,
or other related entities, medical devices including Physiomesh in Florida, for which they derived
significant and regular income. The Defendants reasonably expected that that their defective mesh
products, including Physiomesh, would be sold and implanted in Florida.
11. Venue is proper in this Court pursuant to 28 U.S.C. § 1391(b)(2).
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Facts Common To All Counts
12. On or about December 16, 2010, Plaintiff had 15 x 20 cm Physiomesh Composite
mesh, implanted laparoscopically to repair an incisional hernia.
13. Defendants manufactured, sold, and/or distributed the Physiomesh device to
Plaintiff, through her doctors, to be used for treatment of hernia repair.
14. Plaintiff was forced to undergo multiple revision surgeries due to complications
from Defendant’s defective hernia mesh, eventually resulting in a surgery to remove the mesh.
15. Plaintiff has suffered and will continue to suffer physical pain and mental anguish.
Defendants were responsible for the research, design, development, testing, manufacture,
production, marketing, promotion, distribution and sale of Physiomesh, including providing the
warnings and instructions concerning the product.
16. Among the intended purposes for which Defendants designed, manufactured and
sold Physiomesh was used by surgeons for hernia repair surgeries, the purpose for which the
Physiomesh was implanted in Plaintiff.
17. Defendants represented to Plaintiff and Plaintiff’s physicians that Physiomesh was
a safe and effective product for hernia repair.
18. Defendants’ Physiomesh was defectively designed and/or manufactured, was not
reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any
potential benefits associated with the design. As a result of the defective design and/or manufacture
of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh
components including: chronic pain; recurrence of hernia; foreign body response; rejection;
infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of
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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.
19. Physiomesh has a unique design incorporating five (5) distinct layers: two layers of
polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film
(“PDS”), which in turn coat a polypropylene mesh. This design is not used in any other hernia
repair product sold in the United States. The multi-layer coating was represented and promoted
by the Defendants to prevent or minimize adhesion and inflammation and to facilitate
incorporation of the mesh into the body, but it did not. Instead, the multi-layer coating prevented
adequate incorporation of the mesh into the body and caused or contributed to an intense
inflammatory and chronic foreign body response resulting in an adverse tissue reaction including
migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic
tissue and improper healing.
20. When affixed to the body’s tissue, the impermeable multi-layer coating of the
Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause
infection, abscess formation and other complications.
21. The multi-layer coating provides a breeding ground for bacteria in which the
bacteria cannot be eliminated by the body’s immune response, which allows infection to
22. The multi-layer coating of Defendants’ Physiomesh is cytotoxic, immunogenic,
and not biocompatible, which causes or contributes to complications such as delayed wound
healing, inflammation, foreign body response, rejection, infection, and other complications.
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23. Defendants knew or should have known of the cytotoxic and immunogenic
properties of the multi-layer coating of the Physiomesh prior to introducing it into the stream of
24. When the multi-layer coating of the Physiomesh is disrupted and/or degrades, the
“naked” polypropylene mesh is exposed to the adjoining tissue and viscera, and can become
adhered to organs, and cause damage to organs, and potentiate fistula formation.
25. These manufacturing and design defects associated with the Physiomesh were
directly and proximately related to the injuries suffered by Plaintiff Diana Jane Picolla.
26. Neither Plaintiff Diana Jane Picolla nor her implanting physician were adequately
warned or informed by Defendants of the defective and dangerous nature of Physiomesh.
Moreover, neither Plaintiff Diana Jane Picolla nor her implanting physician were adequately
warned or informed by Defendants of the risks associated with the Physiomesh or the frequency,
severity, or duration of such risks.
27. The Physiomesh implanted in Plaintiff failed to reasonably perform as intended.
The mesh caused serious injury and had to be surgically removed via invasive surgery, and
necessitated additional invasive surgery to repair the hernia that the Physiomesh was initially
implanted to treat.
28. Plaintiff Diana Jane Picolla’s severe adverse reaction, and the necessity for two
surgical revisions of the Physiomesh, 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, and the frequency, severity and duration of such risks. Plaintiff
Diana Jane Picolla has suffered, and will continue to suffer, both physical injury and pain and
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mental anguish, permanent and severe scarring and disfigurement, lost wages and earning capacity,
and has incurred substantial medical bills and other expenses, resulting from the defective and
dangerous condition of the product and from Defendants’ defective and inadequate warnings about
the risks associated with the product.
29. In May of 2016, Defendants issued an “Urgent: Field Safety Notice” relating to its
Physiomesh Flexible Composite Mesh, the same product implanted in Plaintiff, and sent such
notification to hospitals and medical providers in various countries worldwide. In this safety
notice, Defendants advise these providers of “a voluntary product recall”, citing two international
device registries which reported data reflecting recurrence/reoperation rates after laproscopic
placement as being higher than that observed from a data set relating to patient outcomes after
being implanted with other mesh. However, in the United States, Defendants failed to issue a
nationwide recall, opting instead to simply remove the product from shelves and cease further sales
within the United States.
Strict Product Liability: Defective Design
30. At the time the Physiomesh that was implanted in Plaintiff Diana Jane Picolla’s
body, the product was defectively designed. As described above, 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 against such dangers, and failed to provide adequate
warnings and instructions concerning these risks.
31. Defendants expected and intended the Physiomesh product to reach users such as
Plaintiff in the condition in which the product was sold.
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32. The implantation of Physiomesh in Plaintiff’s body was medically reasonable, and
was a type of use that Defendants intended and foresaw when it designed, manufactured and sold
33. The risks of the Physiomesh significantly outweigh any benefits that Defendants
contend could be associated with the product. The multi-layer coating, which is not used in any
other hernia mesh product sold in the United States, prevents tissue from incorporating into the
mesh, leading to encapsulation, deformation, scarification and contraction, migration, erosion and
rejection. The impermeable multi-layer coating leads to seroma formation, and provides a breeding
ground for infection, and protects bacteria from being eliminated by the body’s natural immune
34. The multi-layer coating of the Physiomesh, which was marketed, promoted and
intended as a barrier against adhesion to the internal organs, was only temporary; it was expected
and intended to degrade over time inside the body. Thus, this coating prevented tissue ingrowth
in the short term, and degraded in the long-term, eventually leaving the “naked” polypropylene
mesh exposed to the internal viscera and tissues. The degradation of this multi-layer coating
caused or exacerbated an intense inflammatory and foreign body reaction. Once exposed to the
viscera, the polypropylene mesh will inevitably adhere to the viscera, initiating a cascade of
adverse consequences. Any purported beneficial purpose of the multi-layer coating (to prevent
adhesion to the internal viscera and organs) was non-existent; the product provided no benefit
while substantially increasing the risks to the patient.
35. The polypropylene mesh within the defective multi-layer coating of the
Physiomesh was in itself dangerous and defective, particularly when used in the manner intended
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by Defendants in the Physiomesh. When implanted adjacent to the intestines and other internal
organs, as Defendants intended for Physiomesh, polypropylene mesh is unreasonably susceptible
to adhesion, bowel perforation or erosion, fistula formation and bowel strangulation or hernia
incarceration, and other injuries.
36. The appropriate treatment for complications associated with Physiomesh involves
additional invasive surgery to remove the mesh from the body, thus eliminating any purported
benefit that the mesh was intended to provide to the patient.
37. Physiomesh was designed and intended for intraperitoneal implantation, which
involved the product being implanted in contact with the intestines and/or other internal organs,
which unnecessarily increased the risks of adhesion, erosion, fistula formation, and other injuries.
38. At the time the Physiomesh was implanted in Plaintiff, there were safer feasible
alternative designs for hernia mesh products that would have prevented the injuries he suffered.
39. The Physiomesh product cost significantly more than competitive products because
of its unique multi-layer coating, even though the multi-layer coating provided no benefit to
consumers, and increased the risks to patients implanted with these devices.
40. The Physiomesh implanted in Plaintiff failed to reasonably perform as intended,
and had to be surgically removed necessitating further invasive surgery to repair the very issue
that the product was intended to repair, and thus provided no benefit to him.
41. As a direct and proximate result of the defective and unreasonably dangerous
condition of the product, Plaintiff suffered injuries and damages as summarized herein.
Strict Product Liability: Failure to Warn
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42. At the time the Physiomesh that was implanted in Plaintiff’s body, the warnings
and instructions provided by Defendants for the Physiomesh were inadequate and defective. As
described above, 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
concerning these risks.
43. Defendants expected and intended the Physiomesh product to reach users such as
Plaintiff in the condition in which the product was sold.
44. Plaintiff and her physicians were unaware of the defects and dangers of
Physiomesh, and were unaware of the frequency, severity and duration of the defects and risks
associated with the Physiomesh.
45. The Defendants’ Instructions for Use provided with the Physiomesh expressly
understates and misstates the risks known to be associated specifically with the Physiomesh by
stating that “Potential adverse reactions are those typically associated with surgically implantable
materials.” No other surgical mesh sold in the United States – and no other “surgically implantable
material” – suffers the same serious design flaws as Physiomesh. No other device or material
contains the dangerous and defective multi-layer coating, which itself causes or increases the risks
of numerous complications, including prevention of incorporation, increased risk of seroma
formation, immunologic response, increased risk for infection, and increased inflammatory
reaction and foreign body response. Defendants provided no warning to physicians about the risks
or increased risks specifically associated with the unique design of the Physiomesh.
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46. The Defendants’ Instructions for Use for the Physiomesh failed to adequately warn
Plaintiff’s physicians of numerous risks which Defendants knew or should have known were
associated with the Physiomesh, including the risks of the product’s inhibition of tissue
incorporation, pain, immunologic response, dehiscence, encapsulation, rejection, migration,
scarification, shrinkage/contraction, adhesion to internal organs and viscera, erosion through
adjacent tissue and viscera, bowel obstruction, failure of repair/hernia recurrence, or hernia
incarceration or strangulation.
47. Defendants failed to adequately train or warn Plaintiff or her physicians about the
necessity for invasive surgical intervention in the event of complications, or how to properly treat
such complications when they occurred.
48. Defendants failed to adequately warn Plaintiff or her physicians that the necessary
surgical removal of the Physiomesh in the event of complications would leave the hernia
unrepaired, and would necessitate further medical treatment to attempt to repair the same hernia
that the failed Physiomesh was intended to treat.
49. Defendants represented to physicians, including Plaintiff’s physician, that the
multi-layer coating would prevent or reduce adhesion, and expressly intended for the Physiomesh
to be implanted in contact with the intestines and internal organs and marketed and promoted the
product for said purpose. Defendants failed to warn physicians that the multi-layer coating
prevented tissue ingrowth, which is the desired biologic response to an implantable mesh device.
Defendants failed to warn physicians that the multi-layer coating was only temporary and therefore
at best would provide only a temporary adhesion barrier, and when the coating inevitably
degraded, the exposed polypropylene would become adhered to the organs or tissue.
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50. With respect to the complications that were listed in the Defendants’ warnings,
Defendants provided no information or warning regarding the frequency, severity and duration of
those complications, even though the complications associated with Physiomesh were more
frequent, more severe and lasted longer than those with safer feasible alternative hernia repair
51. If Plaintiff and/or her physicians had been properly warned of the defects and
dangers of Physiomesh, and of the frequency, severity and duration of the risks associated with
the Physiomesh, Plaintiff would not have consented to allow the Physiomesh to be implanted in
her body, and Plaintiff physicians would not have implanted the Physiomesh in Plaintiff.
52. As a direct and proximate result of the inadequate and defective warnings and
instructions, Plaintiff suffered injuries and damages as summarized herein.
53. Defendants had a duty to use reasonable care in designing, testing, inspecting,
manufacturing, packaging, labeling, marketing, distributing, and preparing written instructions and
warnings for Physiomesh, but failed to do so.
54. Defendants knew, or in the exercise of reasonable care should have known, that
Physiomesh was defectively and unreasonably designed and/or manufactured, and was
unreasonably dangerous and likely to injure patients in whom Physiomesh was implanted.
Defendants knew or should have known that Plaintiff and her physicians were unaware of the
dangers and defects inherent in the Physiomesh.
55. As a direct and proximate result of Defendants’ negligence in designing, testing,
inspecting, manufacturing, packaging, labeling, marketing, distributing, and preparing written
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instructions and warnings for Physiomesh, Plaintiff suffered injuries and damages as summarized
56. Defendants continued to manufacture and sell Physiomesh after obtaining
knowledge and information that the product was defective and unreasonably unsafe. Defendants
were aware of the probable consequences of implantation of the dangerous and defective
Physiomesh, including the risk of failure and serious injury, such as suffered by Plaintiff Diana
Jane Picolla. Defendants willfully and deliberately failed to avoid those consequences, and in
doing so, Defendants acted with conscious indifference, indifference to, and/or flagrant disregard
of, the safety of those persons who might foreseeably have been harmed by the Physiomesh
product, including Plaintiff, justifying the imposition of punitive damages.
WHEREFORE, as a result of the acts and omissions and conduct of Defendants set forth
herein, Plaintiff Diana Jane Picolla is entitled to recover for her personal injuries; past, present,
and future medical and related expenses; past, present, and future lost wages; past, present and
future loss of earning capacity; and past, present and future mental and physical pain and suffering;
and Plaintiff is entitled to punitive damages in an amount sufficient to punish, penalize and deter
Defendants from such conduct.
Plaintiff demands trial by jury, judgment against Defendants, jointly and severally, for
compensatory and punitive damages in an amount not less than $75,000, as well as costs, attorney
fees, interest, or any other relief, monetary or equitable, to which she is entitled.
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AYLSTOCK, WITKIN, KREIS & OVERHOLTZ, PLLC
By: /s/Douglass A. Kreis
Douglass A. Kreis
Florida Bar No. 129704
Daniel J. Thornburgh
Florida Bar No. 42661
Nathan C. Bess
Florida Bar No. 51945
17 East Main Street, Suite 200
Pensacola, FL 32502
Todd Matthews (Pro Hac Vice application pending)
Gori Julian & Associates, P.C.
156 North Main Street
Edwardsville, IL 62025
Attorneys for Plaintiff