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Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 1 of 94 PageID #: 1

FILED

2013 Feb-14 PM 03:32
U.S. DISTRICT COURT
N.D. OF ALABAMA

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ALABAMA

HUNTSVILLE DIVISION

JANICE FLANNAGAN and JEFFREY
FLANNAGAN

Plaintiffs,


vs.

AMERICAN MEDICAL SYSTEMS, INC.,
AMERICAN MEDICAL SYSTEMS
HOLDINGS, INC., ENDO
PHARMACEUTICALS, INC., ENDO
PHARMACEUTICALS HOLDINGS, INC.,
ENDO HEALTH SOLUTIONS, INC.,
COOK BIOTECH, INC., COOK MEDICAL,
INC., COOK, INC., and COOK GROUP,
INC.


Defendants.


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COMPLAINT AND JURY DEMAND


Civil Action No.








COMPLAINT AND DEMAND FOR JURY TRIAL

COMES NOW Plaintiffs, JANICE FLANNAGAN AND JEFFREY FLANNAGAN,

bring this Complaint against Defendants American Medical Systems, Inc., American Medical

Systems Holdings, Inc., Endo Pharmaceuticals, Inc., Endo Pharmaceuticals Holdings, Inc. and

Endo Health Solutions Inc. (hereinafter jointly referred to as AMS) as well as Cook Biotech,

Inc., Cook Medical, Inc., Cook, Inc. and Cook Group, Inc. (hereinafter jointly referred to as

Cook) as follows:

NATURE OF CASE

1.

This is an action for damages suffered by JANICE FLANNAGAN AND

JEFFREY FLANNAGAN (“Plaintiff”), as a direct and proximate result of Cook and AMS’s

wrongful conduct in connection with the development, design, manufacture, marketing,

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 2 of 94 PageID #: 2

distribution and selling of Cook and AMS’s Pelvic Mesh Products1 inserted in Plaintiff JANICE

FLANNAGAN’S body to treat medical conditions, primarily pelvic organ prolapse and/or stress

urinary incontinence.

PARTIES

2.

Plaintiffs are citizens of the State of Alabama, County of Limestone, and the City

of Elkmont.

3.

Defendant American Medical Systems, Inc. is a for profit corporation organized

and existing under the laws of Delaware with its corporate headquarters in Minnesota. American

Medical Systems, Inc. may be served through its registered agent at American Medical Systems,

Inc., 3070 Orchard Drive, San Jose, California 95134; its president Anthony P. Bihl, III at 10700

Bren Road West, Minnetonka, Minnesota 55343; or the Delaware Registered Agent for Service,

Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington,

Delaware 19801. Defendant American Medical Systems, Inc. is a wholly owned subsidiary of

defendant American Medical Systems Holdings Inc. Defendant American Medical Systems, Inc.

is a wholly owned subsidiary of defendant Endo Pharmaceuticals, Inc., Endo Pharmaceuticals

Holdings, Inc. and Endo Health Solutions Inc. At all times material hereto, American Medical

Systems, Inc. did business in Alabama

4.

Defendant American Medical Systems Holdings, Inc. (AMS Holdings) is a

Delaware corporation and may be served pursuant to 10 Del. C. Section 3111 by serving its

registered agent, Corporation Trust Company at 1209 N. Orange Street, Wilmington, Delaware

1 The term Pelvic Mesh Products includes Cook and AMS’s mesh, hammock and sling products
used to treat pelvic organ prolapse and/or stress urinary incontinence. The term Pelvic Mesh
Products also specifically includes the AMS products implanted into Plaintiff, which include
AMS Perigee System and Monarc Sling, and the Cook products implanted into Plaintiff, which
include the Surgisis Biodesign Tension-Free Urethral Sling (hereinafter “Products”).

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 3 of 94 PageID #: 3

19801 and is the parent of wholly-owned subsidiary American Medical Systems, Inc. At all

times material hereto, American Medical Systems Holdings, Inc. did business in Alabama

5.

Defendant Endo Pharmaceutical, Inc. (Endo) is a Pennsylvania corporation, with

its principal place of business at 100 Endo Boulevard, Chadds Ford, Pennsylvania 19317. At all

times material hereto, Endo Pharmaceutical, Inc. did business in Alabama

6.

Defendant Endo Pharmaceuticals Holdings, Inc. (Endo Holdings) is a for profit

corporation organized and existing under the laws of Delaware with its corporate headquarters in

Pennsylvania. On June 20, 2011, AMS became a wholly owned subsidiary of Endo

Pharmaceuticals Holdings, Inc. Endo Pharmaceuticals Holdings, Inc. may be served through its

registered agent at Endo Pharmaceuticals Holdings, Inc. 100 Endo Boulevard, Chadds Ford,

Pennsylvania 19317; or the Delaware Registered Agent for Service, Corporation Trust Company,

Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801. On May 23,

2012, Endo Holdings changed its name to Endo Health Solutions, Inc. At all times material

hereto, Endo Pharmaceuticals Holdings, Inc. did business in Alabama

7.

Defendant Endo Health Solutions, Inc. (Endo Health Solutions) is a Delaware

corporation with its principal place of business at 100 Endo Boulevard, Chadds Ford,

Pennsylvania 19317 and is the parent of American Medical Systems, Inc. and AMS Holdings.

At all times material hereto, Endo Health Solutions, Inc. did business in Alabama

8.

Defendant Endo Health Solutions has aggregated four operating businesses into

one enterprise including American Medical Systems, Inc. and AMS Holdings.

9.

At all relevant times, defendant Endo merged with American Medical Systems,

Inc. and as part of that acquisition, purchased and assumed all liability relating to legal claims

arising from the implantation of defective synthetic pelvic mesh systems.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 4 of 94 PageID #: 4

10.

Defendant Cook Biotech, Inc. is a corporation organized under the laws of

Indiana, with a principal place of business at 1425 Innovation Place, West Lafayette, Indiana

47906. Defendant Cook Biotech Inc. alleges as follows: it was created to develop and

manufacture biomaterials from natural tissue sources for use in medical products. The company

conducts research, development and manufacturing operations in a state-of-the-art facility. Cook

Biotech operates its own processing and production line where natural tissues are transformed

into acellular biomaterials. In cooperation with university researchers, Cook Biotech has

developed a line of products that can remodel native tissues using a biomaterial made from

porcine small intestinal submucosa (SIS). Several FDA-cleared products using this technology

to dress wounds or to surgically repair soft tissues are currently available from Cook and its

distributors. Numerous potential medical applications for products made from SIS and other

nature tissues are under development. See http://www.cookmedical.com/profile.do?id=profile

biotech. All acts and omissions of Cook Biotech, Inc. as described herein were done by its

agents, servants, employees and/or owners, acting in the course and scope of their respective

agencies, services, employments and/or ownership. At all times material hereto, Cook

Biotech, Inc. did business in Alabama.

11.

Defendant Cook Medical, Inc. is a corporation organized under the laws of

Indiana, with a principal place of business at 1025 W. Acuff Road, Bloomington, Indiana 47402-

4195. Defendant Cook Medical Incorporated alleges as follows: it was established to offer a

synchronized service for the efficient purchase and distribution of all Cook medical devices.

With particular focus on lowering supply chain costs, the company coordinates price file access,

purchase orders, ship points and accounts payable. All acts and omissions of Cook Medical,

Inc. as described herein were done by its agents, servants, employees and/or owners, acting

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 5 of 94 PageID #: 5

in the course and scope of their respective agencies, services, employments and/or

ownership. At all times material hereto, Cook Medical, Inc. did business in Alabama.

12.

Defendant Cook, Inc. is a corporation organized under the laws of Indiana, with a

principal place of business at 750 Daniels Way, P.O. Box 489, Bloomington, Indiana 47402.

Defendant Cook Incorporated alleges as follows: it is also on the forefront of developing next

generation technologies that advance combination drug/device and biologic/device design

concepts. All acts and omissions of Cook, Inc. as described herein were done by its agents,

servants, employees and/or owners, acting in the course and scope of their respective

agencies, services, employments and/or ownership. At all times material hereto, Cook, Inc.

did business in Alabama.

13.

Defendant Cook Group, Inc. is a corporation organized under the laws of Indiana,

with a principal place of business at 750 N. Daniels Way, Bloomington, Indiana 47404-9120.

Defendant Cook Group Incorporated alleges as follows: it was founded to help manage financial,

legal and regulatory issues that emerged as the Cook companies expanded in the United States

and abroad. All acts and omissions of Cook Group, Inc. as described herein were done by its

agents, servants, employees and/or owners, acting in the course and scope of their respective

agencies, services, employments and/or ownership. At all times material hereto, Cook

Group, Inc. did business in Alabama.

14.

Defendants Cook Biotech, Inc. and Cook Medical, Inc. are subsidiaries of Cook,

Inc. Cook Group, Inc. is the parent company and did the following through its subsidiaries

named herein: designed; secured clearance for sale; manufactured; labeled; marketed;

distributed; sold; benefited financially from the sale; and placed into the stream of

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 6 of 94 PageID #: 6

commerce the products implanted in Plaintiff JANICE FLANNAGAN. The Cook

Defendants, as such, are individually, jointly and severally liable to Plaintiffs.

15.

Upon information and belief, and upon review of the Cook Defendants’ own

combined website, Plaintiffs assert that the following Cook Defendants' participated in placing

the product implanted in Plaintiff JANICE FLANNAGAN into the stream of commerce causing

her injuries: Cook Group, Inc. is the parent and nerve center of the Cook operations which,

through its subsidiaries designed, tested, sought regulatory clearance, marketed, advertised,

labeled, distributed and sold the subject medical device; Defendant Cook Incorporated

participated in the development of the subject medical device; Defendant Cook Biotech, Inc.

developed, with the aid of other co-Defendants, manufactured, sought regulatory clearance,

marketed, advertised, labeled, distributed and sold the subject medical device; and Defendant

Cook Medical, Inc. was the central and key agent in the distribution of Plaintiff's medical device.

16.

All acts and omissions of each Cook Defendant as described herein were done by

its agents, servants, employees and/or owners, acting in the course and scope of their respective

agencies, services, employments and/or ownership.

17.

The Cook Defendants share many of the same officers, directors and

operations; and maintain ownership in the assets and/or liabilities relating to the design,

manufacture, marketing, distribution and sale of the medical device line at issue in this

litigation and shall be referenced collectively hereinafter as “Cook”.

JURISDICTION AND VENUE

18.

This Court has jurisdiction pursuant to 28 U.S.C. § 1332(a) because Plaintiffs and

Defendants American Medical Systems, Inc., AMS Holdings, Endo, Endo Holdings, Endo

Health Solutions, Cook Biotech, Inc., Cook Medical, Inc., Cook, Inc. and Cook Group, Inc.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 7 of 94 PageID #: 7

(hereinafter Cook and AMS shall be jointly referred to as Defendants) are citizens of different

States and the amount in controversy exceeds $75,000 exclusive of interest and costs.

19.

Venue in this action properly lies in this judicial district pursuant to 28 U.S.C.

§ 1391(a), as this is the judicial district where a substantial number of the events, actions or

omissions giving rise to Plaintiffs’ claims occurred. At all times material hereto, AMS and Cook

were for profit corporations authorized to and doing substantial business in this district.

20.

At all times material hereto, Cook developed, designed, manufactured, labeled,

packaged, distributed, marketed, supplied, advertised, sold and otherwise engaged in all activities

that are part and parcel of the sale and distribution of the Pelvic Mesh Products at issue in this

matter. By said activities, Cook’s Pelvic Mesh Products are placed into the stream of commerce

throughout the United States, including within the State of Alabama.

21.

At all times material hereto, AMS developed, designed, manufactured, labeled,

packaged, distributed, marketed, supplied, advertised, sold and otherwise engaged in all activities

that are part and parcel of the sale and distribution of the Pelvic Mesh Products at issue in this

matter. By said activities, AMS’ Pelvic Mesh Products are placed into the stream of commerce

throughout the United States, including within the State of Alabama.

22.

At all times material to this action, Cook and AMS both designed, patented,

manufactured, labeled, marketed, sold and distributed a line of pelvic mesh products. The

products by Cook and the products by AMS were both designed primarily for the purposes of

treating stress urinary incontinence and pelvic organ prolapse. The Cook and AMS products

share common design elements and common defects. Moreover, Cook’s product at issue in this

case was cleared for sale in the U.S. after Cook made assertions to the Food and Drug

Administration of “Substantial Equivalence” under Section 510(k) of the Food, Drug and

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 8 of 94 PageID #: 8

Cosmetic Act; this clearance process does not require the applicant to prove safety or efficacy.

Likewise, AMS’ product at issue in this case was cleared for sale in the U.S. after AMS made

assertions to the Food and Drug Administration of “Substantial Equivalence” under Section

510(k) of the Food, Drug and Cosmetic Act; this clearance process does not require the applicant

to prove safety or efficacy.

23.

Defendants are subject to personal jurisdiction in this district as Defendants

systematically and continually conduct business in this district, and both Cook and AMS conduct

business throughout the United States, including in Alabama.

PELVIC ORGAN PROLAPSE PRODUCTS BACKGROUND

FACTUAL ALLEGATIONS

24.

AMS develops, designs, manufactures, labels, packages, distributes, markets,

supplies, advertises, sells and otherwise engages in all activities that are part and parcel of the

sale and distribution Pelvic Mesh Product medical devices for the treatment of medical

conditions in the female pelvis, primarily pelvic organ prolapse and stress urinary incontinence.

25.

AMS’ and Cook’s Pelvic Mesh Products were derived from polypropylene mesh

hernia products, and were and are utilized in the treatment of medical conditions in the female

pelvis, primarily pelvic organ prolapse and stress urinary incontinence.

26.

AMS’ Pelvic Mesh Product at issue in this litigation contains polypropylene mesh

and/or collagen. Despite claims that polypropylene is inert, the scientific evidence shows that

this material as implanted in the female pelvic is biologically incompatible with human tissue

and promotes a negative immune response in a large subset of the population implanted with

AMS’ Pelvic Mesh Products. This negative response promotes inflammation of the pelvic tissue

and can contribute to the formation of severe adverse reactions to the mesh.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 9 of 94 PageID #: 9

27.

AMS’ biologic mesh products, made mainly of collagen, and Cook’s biologic

products, Surgisis Biodesign Tension-Free Urethral Sling, are likewise biologically incompatible

with human tissue and promote a negative immune response in a large subset of the population

implanted with AMS and Cook’s biologic mesh products. These biologic products cause hyper-

inflammatory response leading to problems including chronic pain and fibrotic reaction. AMS

and Cook’s biologic products disintegrate after implantation in the female pelvic. The AMS and

Cook biologic products cause adverse tissue reactions, and are causally related to infection, as

the biologic material is a foreign material derived from animal tissue. Animal tissue is harsh

upon the female pelvic tissue. It hardens in the body. When AMS and Cook’s mesh is inserted

in the female body according to the manufacturer’s instructions, it creates a non-anatomic

condition in the pelvis leading to chronic pain and functional disabilities.

28.

Defendants AMS and Cook both develop, design, manufacture, label, package,

distribute, market, supply, advertise, sell and otherwise engage in all activities that are part and

parcel of the sale and distribution medical devices, including medical devices implanted to treat

certain women, like Plaintiff, for pelvic organ prolapse and stress urinary incontinence

(hereinafter “Products”). The Pelvic Mesh Products specifically implanted into Plaintiff

JANICE FLANNAGAN as well as any as yet unidentified pelvic mesh products designed and

sold for similar purposes, inclusive of the instruments and procedures for implantation, are

collectively referenced herein as Defendants’ Pelvic Mesh Products or the Pelvic Mesh Products.

29.

As to Cook, in or about 1999, Cook began to market and sell products for the

treatment of medical conditions in the female pelvis, primarily pelvic organ prolapse and stress

urinary incontinence.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 10 of 94 PageID #: 10

30.

Specifically, Cook Group, Incorporated, by and through its subsidiary, Cook

Biotech, Inc., sought and secured 510K clearance on the following medical devices indicated

and/or sold for the repair or restoration of stress urinary incontinence: Surgisis Biodesign

Urethral Sling on September 23, 1999 and Surgisis Biodesign Tension-Free Urethral Sling on

April 9, 2002. Cook Biotech, Inc. sought and secured 510K clearance on the following medical

devices indicated and/or sold for the repair or restoration of pelvic floor repair: Surgisis

Biodesign Anterior Pelvic Floor Graft; Surgisis Biodesign Posterior Pelvic Floor Graft; and

Surgisis Biodesign Vaginal Erosion Repair Graft on September 23, 1999.

31.

Cook’s products were derived largely from hernia mesh products, and were and

are utilized in the treatment of medical conditions in the female pelvis, primarily pelvic organ

prolapse and stress urinary incontinence.

32.

Cook’s Pelvic Mesh Products were designed, patented, manufactured, labeled,

marketed, and sold and distributed by Cook, at all times relevant herein.

33.

Cook makes the following assertions regarding its products:

Surgisis Biodesign is not a new- graft or mesh, but a whole new
category in the evolution of tissue repair. A breakthrough
technology, it incorporates the best attributes of a biologic graft—
resistant to infection and complete remodeling—with the added
benefits of moderate price, ease of use and widespread availability.
Surgisis Biodesign offers you a new level of assurance and, most
important, contributes to an improved quality of life for your
patient.

See http://www.cookmedical.com/bioNew/bio overview.html.


34.

Cook further asserts the following about their Biodesign products: “And unlike

synthetic mesh, nothing is left permanently in the body to cause problems down the road.”

See http://www.cookbiodesign.com/for-patients/conditions/fistula/faqs.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 11 of 94 PageID #: 11

35.

On August 20, 2011, Cook issued a communication to the FDA in advance of the

September 2011 Advisory Committee Hearings regarding the investigation into the risks

associated with mesh for stress urinary incontinence and pelvic floor repair and/or pelvic floor

prolapse. In its communication, Cook assert regarding its non-cross linked biologic matrix that:

“[a]ny inflammation is localized in regions where small remnants of the synthetic suture

used to affix the graft remain.”

36.

Contrary to Cook’s assertions that its products are resistant to infection; result in

complete remodeling, are limited in inflammatory response to area where synthetic sutures

are/were utilized during surgery and will not cause any problem down the road, the following

non-inclusive literature suggests otherwise:

In November of 2005, results from a study were published in the
International Journal of Obstetrics & Gynecology relating to the
comparison of the host response, architectural integration and
tensile strength of polypropylene to porcine small intestine
submucosa-derived implants including Defendants SIS products.
Implants from the SIS group showed a short term increase in
thickness in the first 14 days. Formation of adhesions was
significantly more extensive in the SIS group at 90 days.
Tensile strength increased over time in both groups but was
significantly lower in the SIS group. Implants in the SIS group
showed inflammatory response.





Konstantinovic ML., Lagae P., Zheng F., Verbeken EK., De Ridder D., Deprest JA. (2005).
Comparison of Host Response to Polypropylene and Non-Cross-Linked Porcine Small Intestine
Serosal-Derived Collagen Implants in a Rat Model. BJOG: An International Journal of
Obstetrics & Gynecology, 112(11),1554-1560.

In October of 2008, results from a study were published in the
Archives of Gastroenterology relating to the comparison of the
repair of induced abdominal wall defects with Defendants' Surgisis
mesh and Covidien, Inc.'s Parietex. Both meshes induced skin
erosions. There were peritoneal adhesions to the surface of both
types of meshes after 30 and 60 days. Meshes' shrinking
correspond to 1/3 of the original size and Parietex caused less
inflammatory process at the histologic evaluation.


Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 12 of 94 PageID #: 12

Baroncello JB., Czeczko NG., Malafaia O., Ribas-Filho JM., Nassif PA., Dietz AU. (2008). The
Repair of Abdominal Defects in Rabbits with Parietex and Surgisis Meshes Abdominal wall.
Arquivos de Gastroenterologia, 45(4), 323-9.

In November of 2008, results from a study were published in
Urology relating to reports of intense local inflammatory reactions
in patients undergoing pubovaginal sling or tape using a small
intestinal submucosa graft. After implantation of 16 standard
pubovaginal sling or tension-free tape procedures for stress
urinary incontinence, using the Cook 4-ply Stratasis or 8-ply
Stratasis-TF system, 5 (31.3%) had intense suprapubic pain
after surgery. One patient had induration of the mons pubis
that required surgical drainage. One patient had vaginal
inflammation, with expulsion of graft material. Other patients
had intense rectus sheath inflammation, as confirmed on
computed tomography. This study confirmed previous case
reports of inflammatory complications of small intestinal
submucosa leading to that institution's cessation of use of
Defendants' products.






John TT., Aggarwal N., Singla AK., Santucci RA. (2008). Intense Inflammatory Reaction with
Porcine Small Intestine Submucosa Pubovaginal Sling or Tape for Stress Urinary Incontinence.
Urology, 72(5), 1036-9.


In January of 2009, results from a study were published in the
Journal of Biomedical Materials Research Part B relating to the
evaluation of Defendants' Surgisis Gold to other materials
including C.R. Bard, Inc.'s Permacol; Ethicon's Prolene mesh and
Life Cell's Alloderm in the context of human mesothelial cells.
The results of the study indicate that Surgisis Gold was
inferior in aiding in the growth and fibrinolytic activity of
human mesothelial cells than other products.


Wilshaw SP., Burke D., Fisher J., Ingham E. (2009). Investigation of the Antiadhesive Properties
of Human Mesothelial Cells Cultured in Vitro on Implantable Surgical Materials. Journal of
Biomedical Materials Research Part D: Applied Biomaterials, 88(1), 49-60.

In October of 2011, results from a study were published in the
Archives of Gastroenterology relating to the comparison of
different biologic materials regarding relative implant integration,
shrinkage, and foreign body reaction. Relating to Defendants'
Surgisis, the integration of its product was insufficient and
could detached easily from the underlying tissue; the
penetration of fibroblasts and vessels was limited; foreign body
reaction was pronounced, leading to persistent granulomatous
inflammation; and shrinkage was excessive in comparison to

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 13 of 94 PageID #: 13

all other products. Other products yielded sufficient anti-
adhesion and elicited no foreign body reaction.

Petter-Puchner AH., Fortelny RH., Silic K, Brand J., Gruber-Blum S., Redl H. (2011). Biologic
Hernia Implants in Experimental Intraperitoneal Onlay Mesh Plasty Repair: The Impact of
Proprietary Collagen Processing Methods and Fibrin Sealant Application on Tissue Integration.
Surg Endosc, 25(10), 3245-52.







De Castro Brás LE., Shurey, S., Sibbons, PD. (2012). Evaluation of Crosslinked and Non-
Crosslinked Biologic Prostheses for Abdominal Hernia Repair. Hernia, 16(1), 77-89.


two non-crosslinked meshes and

In February of 2012, results from a study were published in Hernia
relating to the comparison of different biologic meshes including
Defendants' Surgisis Gold regarding the relative performance and
efficacy as between
two
Major complications seen with
crosslinked prostheses.
Defendants' product included: that it appeared to be wrinkled
and folded by excessive shrinkage, eliciting severe adhesions
and a pronounced local inflammation, characterized by foreign
body giant cells. The multilayer design was preserved but
disintegrated by transversal movement of layers against each
other.


In September of 2012, results from a study were published in
Biomaterials relating to the clinical performance of biomaterials in
the context of comparing leukocyte activation by commercially
available biologic surgical materials and define
the extent
manufacturing variables influence down-stream response. The
data demonstrated Defendants' Surgisis Biodesign which was
implanted in Plaintiff showed excessive leukocyte activation
and was significantly more pro-inflammatory as compared to
the other products analyzed. High degrees of leukocyte
activation
compliance,
accelerated degeneration and graft rejection.

to poor material/patient

lead

Bryan N., Ashwin H., Smart N., Bayon Y., Scarborough N., Hunt JA. (2012). The Innate
Oxygen Dependant Immune Pathway as a Sensitive Parameter to Predict the Performance of
Biological Graft Materials. Biomaterials, 33(27), 6380-92.


37.

Plaintiff JANICE FLANNAGAN was implanted with AMS’ and Cook’s Pelvic

Mesh Products developed, designed, manufactured, marketed, packaged, labeled, distributed,

supplied, advertised, sold and placed in the stream of commerce by Defendants. Due to

defective design, defective manufacturing, defective marketing, failure to warn and negligence

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 14 of 94 PageID #: 14

by Defendants AMS and Cook, the Products have caused Plaintiff JANICE FLANNAGAN

severe and permanent bodily injuries and significant mental and physical pain and suffering, as

well as economic losses.

38.

Defendants’ Pelvic Mesh Products, including the Pelvic Mesh Products

specifically used for Plaintiff JANICE FLANNAGAN, have been and continue to be marketed to

the medical community and to patients as safe, effective, reliable medical devices implanted by

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

conditions, primarily pelvic organ prolapse and stress urinary incontinence. Defendants market

the Pelvic Mesh Products, including the Products specifically used for Plaintiff JANICE

FLANNAGAN, as safer and more effective when compared to 1) the traditional products and

procedures for treatment of pelvic organ prolapse and stress urinary incontinence and 2) other

competing pelvic mesh and sling products.

39.

Defendants made public statements in the form of written product descriptions,

product labels, promotional materials, marketing materials and other materials that asserted that

implanting the Pelvic Mesh Products in patients was safe and would not cause harm to patients,

like Plaintiff JANICE FLANNAGAN. Defendants have also marketed and sold its Pelvic Mesh

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

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

to direct to consumer advertising, aggressive marketing to healthcare providers at medical

conferences, hospitals, private offices and include the provision of valuable consideration and

benefits to healthcare providers. Also utilized are documents, brochures, websites, telephone

information lines, and training offering exaggerated and misleading expectations as to the safety

and utility of the Defendants’ Pelvic Mesh Products.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 15 of 94 PageID #: 15

40.

Contrary to Defendants’ representations and marketing to the medical community

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

complication rates, fail to perform as intended, require frequent and often debilitating re-

operations, and have caused severe and irreversible injuries, conditions, and damage to Plaintiff

JANICE FLANNAGAN. These defects include, but are not limited to:

a.

b.

c.

d.

e.

f.

g.

h.

i.

The material is not inert and therefore reacts to human tissues and/or other
naturally occurring human bodily contents adversely affecting patient
health.

The mesh material harbors infections that adversely affect human tissues
and patient heath.

The Pelvic Mesh Products migrate from the location of their implantation,
adversely affecting tissues and patient health.

The mesh material abrades tissues adversely affecting patient health.

The Pelvic Mesh Products regularly fail to perform the purpose of their
implantation such that the patient requires removal of the device and
repeated treatment and surgery.

Due to their various defects, the Pelvic Mesh Products regularly cause
significant injury to patients such that the Pelvic Mesh Products must be
removed, resulting in additional surgery.

The Pelvic Mesh Products become embedded in human tissue over time
such that if it needs to be removed due to its various defects, the removal
causes damage to the organs and tissues, adversely affecting patient
health.

The Pelvic Mesh Products are defective in shape, composition, weight,
physical, chemical and mechanical properties and are inappropriately
engineered for use in the female pelvis.

The Pelvic Mesh Products erode into other pelvic organs, tissue, muscle,
nerves, and bone adversely affecting tissues and patient health.

41.

Because of their numerous defects, the Pelvic Mesh Products create an



unreasonable risk of injury and other adverse health consequences for patients, including, but not

necessarily limited to, mesh erosion, extrusion/protrusion, chronic pain, mesh contraction,

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 16 of 94 PageID #: 16

infection, abscesses, fistulae, inflammation, scar tissue, organ perforation, dyspareunia, bleeding,

neuropathy, and other acute and chronic nerve damage and pain, pudendal nerve damage, vaginal

scarring, vaginal shrinkage, pelvic floor damage, pelvic pain, urinary and fecal problems,

prolapse of organs, and in many cases forcing the need for intensive medical treatment, including

but not limited to operations to locate and remove mesh, operations to attempt to repair pelvic

organs, tissue and nerve damage, the use of pain control and other medications, injections into

various areas of the pelvis, spine, and the vagina, and operations to remove portions of the

female genitalia, and injuries to the woman’s intimate partner.

42.

Defendants made, participated in and/or contributed to filings with the Food and

Drug Administration in conjunction with the clearance process and other filing requirements for

Defendants’ Pelvic Mesh Products.

43.

Upon information and belief, Defendants sent to the FDA a 510(k) submission for

its Pelvic Mesh Products.

44.

Upon information and belief, Defendants were in control of designing,

assembling, manufacturing, marketing, testing, distributing, packaging, labeling, processing,

supplying, marketing, advertising, promoting, selling and issuing of product warnings and

related information with respect to its Pelvic Mesh Products.

45.

Defendants have consistently underreported and withheld information about the

propensity of its Pelvic Mesh Products to fail and cause injury and complications, and have

misrepresented the efficacy and safety of the Products, through various means and media,

actively and intentionally misleading the FDA, the medical community, patients and the public at

large.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 17 of 94 PageID #: 17

46.

Defendants have known and continue to know that its disclosures to the FDA

were and are incomplete and misleading; and that its Pelvic Mesh Products were and are causing

numerous patients severe injuries and complications. Defendants suppressed this information,

and failed to accurately and completely disseminate or share this and other critical information

with the FDA, healthcare providers, or the patients. As a result, Defendants actively and

intentionally misled and continue to mislead the public, including the medical community,

healthcare providers and patients, into believing that its Pelvic Mesh Products were and are safe

and effective, and would not cause harm to patients. These statements were made with the intent

that medical professionals and members of the public would rely upon them, with the intent that

members of the public would pay for the Pelvic Mesh Products and that the Pelvic Mesh

Products would be implanted in patients. When Defendants made these statements, Defendants

knew or should have known that the statements were inaccurate.

47.

Defendants have at all times provided incomplete, insufficient, and misleading

training and information to physicians, in order to increase the number of physicians utilizing the

Defendants’ Pelvic Mesh Products, and thus increase the sales of the Pelvic Mesh Products, and

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

Plaintiff.

48.

Defendants were at all times material hereto subject to the laws of the United

States of America, including provisions relating to the FDA, and the rules and regulations

thereof, in conjunction with the clearance process, labeling and other marketing activities that

pertain to its Pelvic Mesh Products.

49.

Defendants failed to perform or rely on proper and adequate testing and research

in order to determine the safety and effectiveness of its Pelvic Mesh Products.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 18 of 94 PageID #: 18

50.

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

of its Pelvic Mesh Products; therefore, in the event of a failure, injury, or complication it is

impossible to easily and safely remove Defendants’ Pelvic Mesh Products.

51.

Feasible and suitable alternative designs as well as suitable alternative procedures

and instruments for implantation and treatment of stress urinary incontinence, pelvic organ

prolapse, and similar other conditions have existed at all times relevant as compared to

Defendants’ Pelvic Mesh Products.

52.

Defendants’ Pelvic Mesh Products were at all times utilized and implanted in a

manner foreseeable to Defendants.

53.

The Pelvic Mesh Products implanted into Plaintiff JANICE FLANNAGAN were

in the same or substantially similar condition as they were when they left the possession of

Defendants, and in the condition directed by Defendants.

54.

The injuries, conditions and complications suffered due to Defendants’ Pelvic

Mesh Products include but are not limited to mesh erosion, extrusion/protrusion, chronic pain,

mesh contraction, infection, abscesses, fistulae, inflammation, scar tissue, organ perforation,

dyspareunia, bleeding, neuropathy, and other acute and chronic nerve damage and pain, pudendal

nerve damage, vaginal scarring, vaginal shrinkage, pelvic floor damage, pelvic pain, urinary and

fecal problems, prolapse of organs, and in many cases forcing the need for intensive medical

treatment, including but not limited to operations to locate and remove mesh, operations to

attempt to repair pelvic organs, tissue and nerve damage, the use of pain control and other

medications, injections into various areas of the pelvis, spine, and the vagina, and operations to

remove portions of the female genitalia, and injuries to the woman’s intimate partner.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 19 of 94 PageID #: 19

55.

Despite Defendants’ knowledge of these catastrophic injuries, conditions, and

complications caused by their Pelvic Mesh Products, Defendants have, and continue to

manufacture, market and sell the Pelvic Mesh Products, while continuing to fail to adequately

warn, label, instruct, and disseminate information with regard to Defendants’ Pelvic Mesh

Products, both prior to and after the marketing and sale of the Pelvic Mesh Products.

56.

Prior to the time that the Pelvic Mesh Products were implanted into Plaintiff

JANICE FLANNAGAN, Defendants were aware of numerous defects in the Pelvic Mesh

Products, including, but not limited to, the defects and unreasonable risks identified above.

Based thereon, Defendants knew or should have known that the Pelvic Mesh Products caused an

unreasonably high rate of complications, such as mesh erosion, extrusion/protrusion, chronic

pain, mesh contraction, infection, abscesses, fistulae, inflammation, scar tissue, organ

perforation, dyspareunia, bleeding, neuropathy, and other acute and chronic nerve damage and

pain, pudendal nerve damage, vaginal scarring, vaginal shrinkage, pelvic floor damage, pelvic

pain, urinary and fecal problems, and prolapse of organs in women implanted with the Pelvic

Mesh Products. Despite being aware of the numerous defects and unreasonable risks in its

products, Defendants developed, designed, manufactured, labeled, packaged, distributed,

marketed, supplied, advertised, sold and otherwise engaged in all activities that are part and

parcel of the sale and distribution of the Pelvic Mesh Products with the intent that it would be

implanted in patients. Defendants were aware that implanting the Pelvic Mesh Products in

patients was likely to cause injury and harm to the patients into whom the Pelvic Mesh Products

were implanted. Alternatively, Defendants failed to exercise reasonable care in determining the

risks and potential adverse consequences of implanting the Products into patients.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 20 of 94 PageID #: 20

57.

Even though Defendants have known or should have known that the Pelvic Mesh

Products created a foreseeable, unreasonable risk of harm to those women into whom they were

implanted, Defendants continued to market the Pelvic Mesh Products in the United States.

Defendants have sold thousands of Pelvic Mesh Products in the United States alone.

58.

Defendants have failed to provide adequate warning or information about the

risks that the Pelvic Mesh Products cause an unreasonably high rate of complications, including

mesh erosion, extrusion/protrusion, chronic pain, mesh contraction, infection, abscesses, fistulae,

inflammation, scar tissue, organ perforation, dyspareunia, bleeding, neuropathy, and other acute

and chronic nerve damage and pain, pudendal nerve damage, vaginal scarring, vaginal shrinkage,

pelvic floor damage, pelvic pain, urinary and fecal problems, and prolapse of organs to

physicians who implanted the Pelvic Mesh Products, or to women implanted with the Pelvic

Mesh Products.

59.

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

Health Notification that described over 1,000 reports of complications (otherwise known as

“adverse events”) that had been reported over a three year period relating to pelvic mesh

products. These complications included reports against AMS and Cook. Although the FDA

notice did not identify the transvaginal mesh manufacturers by name, a review of the FDA’s

MAUDE database indicates that Cook and AMS are two of the manufacturers of the products

that are the subject of the notification. In 2008, the FDA described the complications associated

with pelvic mesh products as “rare.”

60.

On July 13, 2011, the FDA issued a Safety Communication wherein the FDA

stated that “serious complications associated with surgical mesh for transvaginal repair of POP

are not rare.”

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 21 of 94 PageID #: 21

61.

The FDA Safety Communication also stated, “Mesh contraction (shrinkage) is a

previously unidentified risk of transvaginal POP repair with mesh that has been reported to the

published scientific literature and in adverse event reports to the FDA. . . . Reports in the

literature associate mesh contraction with vaginal shortening, vaginal tightening, and vaginal

pain.”

62.

The FDA Safety Communication further indicated that the benefits of using

transvaginal mesh products instead of other feasible alternatives did not outweigh the associated

risks.

63.

Specifically, the FDA Safety Communication stated: “it is not clear that

transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all

patients with POP and it may expose patients to greater risk.”

64.

Contemporaneously with the Safety Communication, the FDA released a

publication titled “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of

Transvaginal Placement for Pelvic Organ Prolapse” (the “White Paper”). In the White Paper, the

FDA noted that the published, peer-reviewed literature demonstrates that “[p]atients who

undergo POP repair with mesh are subject to mesh-related complications that are not

experienced by patients who undergo traditional surgery without mesh.”

65.

The FDA summarized its findings from its review of the adverse event reports

and applicable literature stating that it “has not seen conclusive evidence that using

transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional

POP repair that does not use mesh, and it may expose patients to greater risk.”

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 22 of 94 PageID #: 22

66.

In its White Paper, the FDA advises doctors to, inter alia, “[r]ecognize that in

most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related

complications.”

67.

The FDA concludes its White Paper by stating that it “has identified serious

safety and effectiveness concerns over the use of surgical mesh for the transvaginal repair of

pelvic organ prolapse.”

68.

At the time AMS and Cook began marketing their Pelvic Mesh Products, both

Cook and AMS were aware that their respective Pelvic Mesh Products were associated with each

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

Communication.

69.

The information contained in the FDA’s Public Health Notification of October

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

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

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

70.

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

Obstetricians and Gynecologist (“ACOG”) and

the American Urogynecologic Society

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

serious complication associated with vaginal mesh, stating that with regard to both AMS and

Cook’s Pelvic Mesh Products:

There are increasing reports of vaginal pain associated with
changes that can occur with mesh (contraction, retraction, or
shrinkage) that result in taut sections of mesh. . . . Some of these
women will require surgical intervention to correct the condition,
and some of the pain appears to be intractable.



Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 23 of 94 PageID #: 23

The ACOG/AUGS Joint Committee Opinion also recommended, among other things, that

“[p]elvic organ prolapse vaginal mesh repair should be reserved for high-risk individuals in

whom the benefit of mesh placement may justify the risk.”

71.

The injuries of the female Plaintiff as will be more fully set forth in the Plaintiff’s

Profile Sheet and Fact Sheet to be served in this civil action are reported in the FDA Safety

Communication and in the ACOG/AUGS Joint Committee Opinion.

72.

Cook knew or should have known about the Pelvic Mesh Products’ risks and

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

Committee Opinion.

73.

AMS knew or should have known about the Pelvic Mesh Products’ risks and

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

Committee Opinion.

74.

Cook knew or should have known that their Pelvic Mesh Products unreasonably

exposed patients to the risk of serious harm while conferring no benefit over available feasible

alternatives that do not involve the same risks.

75.

AMS knew or should have known that their Pelvic Mesh Products unreasonably

exposed patients to the risk of serious harm while conferring no benefit over available feasible

alternatives that do not involve the same risks.

76.

The scientific evidence shows that the material from which Cook’s Pelvic Mesh

Products are made is biologically incompatible with human tissue and promotes a negative

immune response in a large subset of the population implanted with the Pelvic Mesh Products,

including JANICE FLANNAGAN.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 24 of 94 PageID #: 24

77.

The scientific evidence shows that the material from which AMS’ Pelvic Mesh

Products are made is biologically incompatible with human tissue and promotes a negative

immune response in a large subset of the population implanted with the Pelvic Mesh Products,

including JANICE FLANNAGAN.

78.

This negative response, from Cook’s Pelvic Mesh Products as well as AMS’

Pelvic Mesh Products, promotes inflammation of the pelvic tissue and contributes to the

formation of severe adverse reactions to the mesh, such as those experienced by JANICE

FLANNAGAN.

79.

The FDA defines both “degradation” and “fragmentation” as “device problems”

to which the FDA assigns a specific “device problems code.” “Material fragmentation” is

defined as an “[i]ssue associated with small pieces of the device breaking off unexpectedly” and

“degraded” as an “[i]ssue associated with a deleterious change in the chemical structure, physical

properties, or appearance in the materials that are used in device construction.” The Cook Pelvic

Mesh Products were unreasonably susceptible to degradation and fragmentation inside the body.

The AMS Pelvic Mesh Products were unreasonably susceptible to degradation and fragmentation

inside the body.

80.

The Cook Pelvic Mesh Products were unreasonably susceptible to shrinkage and

contraction inside the body. The AMS Pelvic Mesh Products were unreasonably susceptible to

shrinkage and contraction inside the body.

81.

The Cook Pelvic Mesh Products were unreasonably susceptible to “creep” or the

gradual elongation and deformation when subjected to prolonged tension inside the body. The

AMS Pelvic Mesh Products were unreasonably susceptible to “creep” or the gradual elongation

and deformation when subjected to prolonged tension inside the body.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 25 of 94 PageID #: 25

82.

The Cook Pelvic Mesh Products have been and continue to be marketed to the

medical community and patients to be safe, effective, reliable, medical devices, implanted by

safe and effective, minimally invasive surgical techniques, and as safer and more effective as

compared to available feasible alternative treatments of pelvic organ prolapse and stress urinary

incontinence, and other competing products.

83.

The AMS Pelvic Mesh Products have been and continue to be marketed to the

medical community and patients to be safe, effective, reliable, medical devices, implanted by

safe and effective, minimally invasive surgical techniques, and as safer and more effective as

compared to available feasible alternative treatments of pelvic organ prolapse and stress urinary

incontinence, and other competing products.

84.

Defendant Cook omitted the risks, dangers, defects and disadvantages of their

Pelvic Mesh Products, and advertised, promoted, marketed, sold and distributed their Pelvic

Mesh Products as safe medical devices when Defendant Cook knew or should have known that

the Pelvic Mesh Products were not safe for other intended purposes, and that the Pelvic Mesh

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

JANICE FLANNAGAN, catastrophic injuries.

85.

Defendant AMS omitted the risks, dangers, defects and disadvantages of their

Pelvic Mesh Products, and advertised, promoted, marketed, sold and distributed their Pelvic

Mesh Products as safe medical devices when Defendant AMS knew or should have known that

the Pelvic Mesh Products were not safe for other intended purposes, and that the Pelvic Mesh

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

JANICE FLANNAGAN, catastrophic injuries.

Case 2:13-cv-14231 Document 1 Filed 02/14/13 Page 26 of 94 PageID #: 26

86.

Contrary to Cook and AMS’ representations and marketing to the medical

community and to patients themselves, Cook and AMS’ Pelvic Mesh Products have high rates of

failure, injury and complications, fail to perform as intended, require frequent and often

debilitating re-operations, and have caused severe and irreversible injuries, conditions and

damage to a significant number of women, including JANICE FLANNAGAN, making them

defective under the law.

87.

The specific nature of the Cook and AMS Pelvic Mesh Products’ defects include,

but is not limited to, the following:

a.

b.

c.

d.

e.

f.

AMS’ use of polypropylene as well as AMS and Cook’s use of collagen
material and animal products in the Pelvic Mesh Products and the immune
reactions that result from such material, cause adverse reactions and
injuries;

the design of the polypropylene, collagen and animal product Pelvic Mesh
Products to be inserted transvaginally, into and through an area of the
body with high levels of bacteria that can adhere to the mesh causing
immune reactions and subsequent tissue breakdown and adverse reactions
and injuries;

biomechanical issues with the design of the Cook and AMS Pelvic Mesh
Products, including, but not limited to, the propensity of the Pelvic Mesh
Products to contract or shrink inside the body, that in turn cause
surrounding tissue to be inflamed, become fibrotic, and contract, resulting
in injury;

the use and design of arms and anchors in the Pelvic Mesh Products,
which, wh