Case 2:21-cv-00730-LF-GBW Document 1-2 Filed 08/04/21 Page 1 of 32
`
`Service of Process
`Transmittal
`07/07/2021
`CT Log Number 539862505
`
`Carol Purcell
`Endo Pharmaceuticals Inc.
`1400 Atwater Dr
`Malvern, PA 19355-8701
`
`Process Served in Delaware
`
`Endo Pharmaceuticals Holdings Inc.  (Former Name)  (Domestic State: DE)
`Endo Health Solutions Inc. (True Name)
`
`TO:
`
`RE:
`
`FOR:
`
`ENCLOSED ARE COPIES OF LEGAL PROCESS RECEIVED BY THE STATUTORY AGENT OF THE ABOVE COMPANY AS FOLLOWS:
`
`TITLE OF ACTION:
`
`Susan Ellen Candelaria, Pltf. vs. American Medical Systems, Inc., et al., Dfts. // To:
`Endo Pharmaceuticals Holdings, Inc., etc.
`Name discrepancy noted.
`
`DOCUMENT(S) SERVED:
`
`Summons, Return, Complaint
`
`COURT/AGENCY:
`
`Chaves County, Fifth Judicial District Court, NM
`Case # D504CV202100455
`
`NATURE OF ACTION:
`
`Product Liability Litigation - Personal Injury - AMS Monarc Hammock
`
`ON WHOM PROCESS WAS SERVED:
`
`The Corporation Trust Company, Wilmington, DE
`
`DATE AND HOUR OF SERVICE:
`
`By Process Server on 07/07/2021 at 15:23
`
`JURISDICTION SERVED :
`
`Delaware
`
`APPEARANCE OR ANSWER DUE:
`
`No later than 30 days from the date you are served with this Summons
`
`ATTORNEY(S) / SENDER(S):
`
`Rachel E. Montes
`MONTES LAW GROUP, PC
`1121 Kinwest Parkway, Suite 100
`Irving, TX 75063
`214/522-9401
`
`ACTION ITEMS:
`
`CT has retained the current log, Retain Date: 07/08/2021, Expected Purge Date:
`07/13/2021
`
`Image SOP
`
`Email Notification,  Jobina Jones-McDonnell  jones.jobina@endo.com
`
`Email Notification,  Helen Howlett  howlett.helen@endo.com
`
`Email Notification,  Gary Cennerazzo  gary.cennerazzo@parpharm.com
`
`Email Notification,  Carolyn Hazard  hazard.carrie@endo.com
`
`Email Notification,  Par Notice Dept  Par.noticeDept@parpharm.com
`
`Email Notification,  Carol Purcell  Purcell.Carol@endo.com
`
`Email Notification,  Sandra DiIorio  DiIorio.Sandra@endo.com
`
` EXHIBIT B
`
`Page 1 of  2 / KA
`
`

`

`Case 2:21-cv-00730-LF-GBW Document 1-2 Filed 08/04/21 Page 2 of 32
`
`Service of Process
`Transmittal
`07/07/2021
`CT Log Number 539862505
`
`Carol Purcell
`Endo Pharmaceuticals Inc.
`1400 Atwater Dr
`Malvern, PA 19355-8701
`
`Process Served in Delaware
`
`Endo Pharmaceuticals Holdings Inc.  (Former Name)  (Domestic State: DE)
`Endo Health Solutions Inc. (True Name)
`
`TO:
`
`RE:
`
`FOR:
`
`Email Notification,  Julianne Decker  julianne.decker@parpharm.com
`
`Email Notification,  Bethann Miles  miles.bethann@endo.com
`
`Email Notification,  Jacqueline Gorbey  gorbey.jacqueline@endo.com
`
`Email Notification,  Stephanie Chadick  chadick.stephanie@endo.com
`
`Email Notification,  Lance Arnott  sopverification@wolterskluwer.com
`
`REGISTERED AGENT ADDRESS:
`
`The Corporation Trust Company
`1209 Orange Street
`Wilmington, DE 19801
`866-401-8252
`EastTeam2@wolterskluwer.com
`The information contained in this Transmittal is provided by CT for quick reference only. It does not constitute a legal opinion, and should not otherwise be
`relied on, as to the nature of action, the amount of damages, the answer date, or any other information contained in the included documents. The recipient(s)
`of this form is responsible for reviewing and interpreting the included documents and taking appropriate action, including consulting with its legal and other
`advisors as necessary. CT disclaims all liability for the information contained in this form, including for any omissions or inaccuracies that may be contained
`therein.
`
`Page 2 of  2 / KA
`
`

`

`a Wolters Kluwer
`
`PROCESS SERVER DELIVERY DETAILS
`
`Date:
`
`Wed, Jul 7, 2021
`
`Server Name:
`
`Kevin Dunn
`
`Entity Served
`
`Case Number
`
`J urisdiction
`
`ENDO PHARMACEUTICALS HOLDINGS INC
`
`504-CV-2021-00455
`
`DE
`
`111
`
`

`

`SUMMONS
`
`Case Number: D-504-CV-2021-00455
`
`Judge: Dustin K. Hunter
`
`Defendant Name:
`Endo Pharmaceuticals Holdings, Inc.
`Address:
`100 Endo Boulevard
`Chadds Ford, Pennsylvania 19317
`
`FIFTH JUDICIAL DISTRICT COURT
`Chaves, County, New Mexico
`., ,
`Court Address: 400 N. Virginia
`Roswell, NM 88201
`Court Telephone Number.:
`
`Plaintiff(s): Susan Ellen Candelaria
`v.
`Defendant(s): American Medical
`Systems, Inc. and American Medical
`System Holdings, Inc, Endo
`Pharmaceuticals, Inc., Endo
`Pharmaceuticals Holdings, Inc., Endo
`Health Solutions Inc.
`
`TO THE ABOVE NAMED DEFENDANT(S): Take notice that
`
`A lawsuit has been filed against you. A copy of the lawsuit is attached. The Court
`1.
`issued this Summons.
`You must respond to this lawsuit in writing. You must file your written response
`2.
`with the Court no later than thirty (30) days from the date you are served with this Summons.
`(The date you are considered served with the Summons is determined by Rule 1-004 NMRA)
`The Court's address is listed above.
`3.
`You must file (in person or by mail) your written response with the Court. When
`you file your response, you must give or mail a copy to the person who signed the lawsuit.
`If you do not respond in writing, the Court may enter judgment against you as
`4.
`requested in the lawsuit.
`You are entitled to a jury trial in most types of lawsuits. To ask for a jury trial, you
`5.
`must request one in writing and pay a jury fee.
`If you need an interpreter, you must ask for one in writing.
`6.
`You may wish to consult a lawyer. You may contact the State Bar of New Mexico
`7.
`for help finding a lawyer at www.nmbar.org; 1-800-876-6227; or 1-505-797-6066.
` , New Mexico, this 6 day of July
`Dated at Roswell
`
`20 421.
`
`Katie Espinoza
`CLERK OF COURT
`
`By: &RAk-,3 CC\ VcA.A,Acks---
`Deputy
`
`/s/ Rachel Montes
`Rachel E. Montes
`SBOT 45005925
`Rachel@MontesLawGroup.com
`1 121 Kinwest Parkway, Suite 100
`Irving, Texas 75063
`Dallas 214/522-9401
`Fax 214/522-9428
`
`SUMMONS IS ISSUED PURSUANT TO RULE 1-004 NMRA OF THE NEW MEXICO
`RULES OF CIVIL PROCEDURE FOR DISTRICT COURTS.
`
`

`

`RETURN'
`
`STATE OF NEW MEXICO
`
`COUNTY OF
`
`)ss
`
`I, being duly sworn, on oath, state that I am over the age of eighteen (18) years and not a party to
`this lawsuit, and that I served this summons in
`county on the
`day of
` , by delivering a copy of this summons, with a copy of complaint
`attached, in the following manner:
`
`(check one box and fill in appropriate blanks)
`
`(used when defendant accepts a copy of
`[] to the defendant
`summons and complaint or refuses to accept the summons and complaint)
`
`[] to the defendant by [mail] [courier service] as provided by Rule 1-004 NMRA (used
`when service is by mail or commercial courier service).
`
`After attempting to serve the summons and complaint on the defendant by personal service or by
`mail or commercial courier service, by delivering a copy of this summons, with a copy of
`complaint attached, in the following manner:
`
`[] to , a person over fifteen (15) years of age and residing at
`the usual place of abode of defendant
`, (used when the defendant is not
`presently at place of abode) and by mailing by first class mail to the defendant at
`
` (insert defendant's last known mailing address) a copy of the summons
`and complaint.
`
`[] to , the person apparently in charge at the actual place of
`business or employment of the defendant and by mailing by first class mail to the defendant at
`
` (insert defendant's business address) and by mailing the summons
`and complaint by first class mail to the defendant at
`(insert defendant's
`last known mailing address).
`
`[ ] to
`
`, an agent authorized to receive service of process for
`
`

`

`defendant
`
`[] to , [parent] [guardian] [custodian] [conservator] [guardian ad
`(used when defendant is a minor or an
`litem] of defendant
`incompetent person).
`
`(name of person),
`[] to
`(title of person authorized to receive service. Use this alternative when the defendant is a
`corporation or an association subject to a suit under a common name, a land grant board of
`trustees, the State of New Mexico or any political subdivision).
`
`Fees:
`
`Signature of person making service
`
`Title (if any)
`
`Subscribed and sworn to before me this
`
`day of
`
`2
`
`Judge, notary or other officer
`authorized to administer oaths
`
`Official title
`
`USE NOTE
`
`Unless otherwise ordered by the court, this return is not to be filed with the court
`1.
`prior to service of the summons and complaint on the defendant.
`If service is made by the sheriff or a deputy sheriff of a New Mexico county, the
`2.
`signature of the sheriff or deputy sheriff need not be notarized.
`
`[Adopted effective August 1, 1988; as amended by Supreme Court Order 05-8300-01, effective
`March 1, 2005; by Supreme Court Order 07-8300-16, effective August 1, 2007; by Supreme
`Court Order No. 12-8300-026, effective for all cases filed or pending on or after January 7, 2013;
`as amended by Supreme Court Order No. 13-8300-022, effective for all cases pending or filed on
`or after December 31, 2013; as amended by Supreme Court Order No. 14-8300-017, effective for
`all cases pending or filed on or after December 31, 2014.]
`
`

`

`FILED
`5th JUDICIAL DISTRICT COURT
`Chaves County
`7/2/2021 2:33 PM
`KATIE ESPINOZA
`CLERK OF THE COURT
`Haley Norris
`
`NO.
`
`0-504-CV-2021-00455
`
`Case assigned to Hunter, Dustin K.
`
`STATE OF NEW MEXICO
`COUNTY OF CRAVES
`FIFTH JUDICIAL DISTRICT
`
`SUSAN ELLEN CANDELARIA
`
`VS.
`
`AMERICAN MEDICAL SYSTEMS,
`INC., AMERICAN MEDICAL
`SYSTEM HOLDINGS, INC., ENDO
`PHARMACEUTICALS, INC., and
`ENDO PHARMACEUTICALS
`HOLDINGS, INC. A.K.A. EDNO
`HEALTH SOLUTIONS, INC.
`
`Defendants.
`
`PLAINTIFF'S COMPLAINT FOR PERSONAL INJURY
`
`Plaintiff, Susan Ellen Candelaria, by and through the undersigned counsel, files this
`
`Complaint against Defendants, American Medical Systems, Inc. and American Medical System
`
`Holdings, Inc., and alleges as follows:
`
`PLAINTIFF
`
`1.
`
`Plaintiff Susan Ellen Candelaria ("Plaintiff"), at all times relevant to this action is a citizen
`
`of and resides in and continues to reside in Roswell, New Mexico, which is located in Chaves
`
`County, New Mexico. Plaintiff was injured as a result of having a transvaginal mesh manufactured
`
`by American Medical Systems, Inc. implanted into her vaginal area and therefore seeks damages
`
`for pain and suffering, ascertainable economic losses, attorneys' fees, reimbursement of the cost
`
`of the mesh, reimbursement for all past health and medical care costs related to the implantation
`
`of the American Medical Systems Monarc Subfascial Hammock ("ANIS Monarc Hammock"), and
`
`subsequent revision/removal surgery.
`
`1
`
`

`

`DEFENDANTS
`
`2.
`
`American Medical Systems, Inc. ("AMS") is a wholly owned subsidiary of Defendant
`-
`American Medical Systems Holdings, Inc. Defendant AMS is a wholly owned subsidiary of the
`
`Defendant Endo Pharmaceuticals, Inc., Endo Pharmaceuticals Holdings, Inc., and Endo Health
`
`Solutions, Inc., and is a Delaware Corporation and may be served pursuant to 10 Del. C. §3111 by
`
`serving its registered agent, Corporation Trust Company, at 1209 N. Orange Street, Wilmington,
`
`Delaware 19801.
`
`3.
`
`Defendant American Medical Systems, Holdings, Inc., ("AMS HOLDINGS") is a
`
`Delaware corporation and may be served pursuant to 10 Del. C. §3111 by serving its registered
`
`agent, Corporation Trust Company, at 1209 N. Orange Street, Wilmington, Delaware 19801 and
`
`is the parent of wholly owned subsidiary AMS.
`
`4.
`
`Defendant Endo Pharmaceuticals, Inc. (ENDO) is a Pennsylvania corporation, with its
`
`principal place of business at 100 Endo Boulevard, Chadds Ford, Pennsylvania 19317.
`
`5.
`
`Defendant Endo Pharmaceuticals Holdings, Inc. (ENDO HOLDINGS) was a Delaware
`
`corporation with its principal place of business at 100 Endo Boulevard, Chadds Ford, Pennsylvania
`
`19317. ENDO HOLDINGS was the parent of wholly owned subsidiary ENDO. On May 23, 2012,
`
`ENDO HOLDINGS changed its name to Endo Health Solutions, Inc.
`
`6.
`
`Defendants 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 AMS and AMS HOLDINGS.
`
`7.
`
`Defendant ENDO HEALTH SOLUTIONS has aggregated four operating businesses into
`
`one enterprise including AMS and AMS HOLDINGS.
`
`

`

`8.
`
`At all relevant times, defendant ENDO merged with AMS 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. ENDO and AMS shall be referred to hereinafter
`
`collectively as "Defendants."
`
`9.
`
`At all relevant times material to this action, Defendants have designed, patented,
`
`manufactured, labeled, marketed, sold, and distributed a line of pelvic mesh products, including
`
`the ANIS Monarc Hammock implanted in Plaintiff. These products were designed primarily for
`
`the purpose of treating stress urinary incontinence and pelvic organ prolapse. These products share
`
`common design elements and common defects. Moreover, each of these products, including the
`
`ANIS Monarc Hammock, were cleared for sale in the U.S. after the Defendants 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.
`
`JURISDICTION AND VENUE
`
`10.
`
`At all relevant times, Defendants transacted, solicited, and conducted business in Chaves
`
`County, in the State of New Mexico, and derived substantial revenue from such business.
`
`1 1.
`
`At all relevant times, Defendants expected or should have expected that its acts would have
`
`consequences within the United States of America and the State of New Mexico.
`
`12.
`
`Venue is proper in Chaves County, New Mexico, because Plaintiff is a resident of Chaves
`
`County and Plaintiff's cause of action originated in Chaves County.'
`
`' "All civil actions commenced in the district courts shall be brought and shall be commenced in counties as follows and not otherwise:
`A. First, except as provided in Subsection F of this section relating to foreign corporations, all transitory actions shall be brought in the county
`where either the plaintiff or defendant, or any one of them in case there is more than one of either, resides; or second; in the bounty Where the
`contract sued on was made or is to be performed or where the cause of action originated or indebtedness sued on was incurred; or third, in any
`county in which the defendant or either of them maybe found in the judicial district where the defendant resides." N.M. Stat Ann. §
`
`3
`
`

`

`13.
`
`This Court has general jurisdiction over this lawsuit, because Article VI of the Constitution
`
`of the State of New Mexico gives district courts original jurisdiction in all matters and causes.2
`
`14.
`
`The Court has personal jurisdiction over Defendants because Defendants committed a
`
`tortious act within the State of New Mexico.3
`
`1 5.
`
`Defendants marketed, advertised, and distributed their Pelvic Mesh Products in the State
`
`of New Mexico. The Court has personal jurisdiction over Defendants because Defendants
`
`transacted business within the State of New Mexico.4
`
`FACTUAL BACKGROUND
`
`16.
`
`Plaintiff Susan Ellen Candelaria was diagnosed with stress urinary incontinence in 2016.
`
`Her physician, Dr. Donald Wenner, III recommended implantation of the AMS Monarc Hammock
`
`as the appropriate course of treatment to remedy Plaintiffs stress urinary incontinence. Dr. Wenner
`
`surgically implanted the AMS Monarc Hammock into Plaintiff's vaginal area on March 18, 2016,
`
`at Lovelace Regional Hospital at Roswell, located in Roswell, New Mexico. Shortly after the
`
`procedure, Plaintiff began suffering from incomplete bladder emptying, urinary retention, intra-
`
`abdominal and pelvic swelling, and urinary tract infections.
`
`17.
`
`On July 2, 2018, Dr. Wenner performed revision surgery on Plaintiff to remove the AMS
`
`Monarc Hammock from Plaintiff's vaginal area. Dr. Wenner noted that Plaintiff had intraurethral
`
`erosion of synthetic mesh. Plaintiff suffered through the pain of this additional surgery and had to
`
`assume the risk of complications associated with general anesthesia surgery.
`
`2 The district court shall have original jurisdiction in all matters and causes not excepted in this constitution, and such jurisdiction of special cases
`and proceedings as provided by law, and appellate jurisdiction of cases originating in inferior courts and tribunals in their respective districts as
`provided by law, and supervisory control over the same. N.M. Const. art. VI, § 13.
`3 A. Any person, whether or not a citizen or resident of this state, who in person or through an agent does any of the acts enumerated in this
`subsection thereby submits himself or his personal representative to the jurisdiction of the courts of this state as to any cause of action arising
`from:
`(1) the transaction of any business within this state;
`(2) the operation of a motor vehicle upon the highways of this state;
`(3) the commission of a tortious act within this state;
`(4) the contracting to insure any person, property or risk located within this state at the time of contracting; N.M. Stat. Ann. § 38-1-16.
`4 Id.
`
`4
`
`

`

`18.
`
`Defendants'AMS Monarc Hammock contains monoffiament polypropylene mesh and/or
`
`polypropylene.
`
`19.
`
`Despite Defendants' claims that polypropylene is inert, the scientific evidence shows that
`
`this material as implanted in Plaintiff in the AMS Monarc Hammock is biologically incompatible
`
`with human tissue and promotes a negative immune response in a large subset of the population
`
`implanted with Defendants' Pelvic Mesh Products, including the AMS Monarc Hammock
`
`implanted in Plaintiff. This negative response promotes inflammation of the pelvic tissue and can
`
`contribute to the formation of severe adverse reactions to the mesh. Furthermore, Defendants'
`
`AMS Monarc Hammock causes hyper-inflammatory responses leading to problems, including
`
`chronic pain and fibrotic reactions. Defendants' AMS Monarc Hammock disintegrates after
`
`implantation in the female pelvis. This product causes adverse tissue reaction and is causally
`
`related to infection. When mesh is inserted in the female body according to the manufacturers'
`
`instructions, it creates a non-anatomic condition in the pelvis leading to chronic pain and functional
`
`disabilities.
`
`20.
`
`Defendants sought and obtained FDA clearance to market the AMS Monarc Hammock
`
`under Section 510(k) of the Medical Device Amendment to the Food, Drug and Cosmetics Act.
`
`Section 510(k) provides for marketing of a medical device is the device is deemed "substantially
`
`equivalent" to other predicate devices marketed prior to May 28, 1976. No formal review for safety
`
`or efficacy is required, and no formal review for safety or efficacy was ever conducted with regard
`
`to the Products, including the AMS Monarc Hammock.
`
`21.
`
`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.
`
`5
`
`

`

`22.
`
`Although the FDA notice did not identify the transvaginal mesh manufacturers by name, a
`
`review of the FDA's MAUDE database indicates that the Defendants are the manufacturers of the
`
`products noted in the notification. In 2008, the FDA described the complications associated with
`
`pelvic mesh products as "rare."
`
`23.
`
`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"
`
`(emphasis in the original).
`
`24.
`
`The FDA Safety Communication also stated, "Mesh contraction (shrinkage) is a previously
`
`unidentified risk of transvaginal POP repair with mesh that has been reported in 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." (emphasis in
`
`original).
`
`25.
`
`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.
`
`26.
`
`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."
`
`27.
`
`In July 2011 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."
`
`

`

`28.
`
`The FDA White Paper 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." (Emphasis in
`
`original).
`
`29.
`
`The FDA White Paper further stated that "these products are associated with serious
`
`adverse events. . . Compounding the concerns regarding adverse events are performance data that
`
`fail to demonstrate improved clinical benefit over traditional non-mesh repair."
`
`30. In its White Paper, the FDA advises doctors to, inter alia, "Necognize that in most cases,
`
`POP can be treated successfully without mesh thus avoiding the risk of mesh-related
`
`complications."
`
`31. 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."
`
`32. At the time Defendants began marketing each of its Pelvic Mesh Products, including
`
`specifically the product at issue in this case—the AMS Monarc Hammock—Defendants were
`
`aware that its Pelvic Mesh Products were associated with each and every one of the adverse events
`
`communicated by the FDA in its July 13, 2011 Safety Communication.
`
`33. The information contained in the FDA's Public Health Notification of October 2008 and
`
`the FDA Safety Communication of July 13, 2011, was known or knowable to Defendants and was
`
`not disclosed in oral or written communications, direct to consumer advertising in the form of
`
`patient brochures, instructions of use or labeling.
`
`7
`
`

`

`34. In a December 2011 Joint Committee Opinion, the American College of Obstetricians and
`
`Gynecologists ("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:
`
`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.
`
`35. 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."
`
`36. The injuries sustained by the female Plaintiff as will be more fully set forth in the
`
`Plaintiffs Fact Sheet to be served in this civil action are consistent with the complications
`
`identified in the ACOG/AUGS Joint Committee Opinion.
`
`37. Defendants knew or should have known about the Products' risks and complications
`
`identified in the FDA Safety Communication and the ACOG/AUGS Joint Committee Opinion.
`
`38. Defendants knew or should have known that the AMS Monarc Hammock unreasonably
`
`exposed patients to the risk of serious harm while conferring no benefit over available feasible
`
`alternatives that do not involve the same risks.
`
`39. The scientific evidence shows that the material from which Defendants' AMS Monarc
`
`Hammock are made is biologically incompatible with human tissue and promotes a negative
`
`immune response in a large subset of the population implanted with the Product, including the
`
`Plaintiff.
`
`40. This negative response promotes inflammation of the pelvic tissue and contributes to the
`
`formation of severe adverse reactions to the mesh, such as those experienced by the Plaintiff.
`
`8
`
`

`

`41. The FDA defines both "degradation" and "fragmentation" as "device problems" to which
`
`the FDA assigns a specific "device problem 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 AMS Monarc Hammock
`
`are unreasonably susceptible to degradation and fragmentation inside the body.
`
`42. The AMS Monarc Hammock is unreasonably susceptible to shrinkage and contraction
`
`inside the body.
`
`43.
`
`The AMS Monarc Hammock is unreasonably susceptible to "creep" or the gradual
`
`elongation and deformation when subject to prolonged tension inside the body.
`
`44.
`
`The AMS Monarc Hammock has been and continues to be marketed to the medical
`
`community and to patients as a safe, effective, reliable, medical device, implanted by safe,
`
`effective, and 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.
`
`45. Defendants omitted the risks, dangers, defects, and disadvantages of the AMS Monarc
`
`Hammock, and advertised, promoted, marketed, sold and distributed them as safe medical devices
`
`when Defendants knew or should have known that the AMS Monarc Hammock was, and is not
`
`safe for its intended purposes, and that the Products would cause, and did cause, serious medical
`
`problems, and in some patients, including the Plaintiff, catastrophic injuries.
`
`46. Contrary to Defendants' representations and marketing to the medical community and to
`
`the patients themselves, the AMS Monarc Hammock has high rates of failure, injury, and
`
`complications, fail to perform as intended, require frequent and often debilitating re-operations,
`
`9
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`

`

`and have-caused severe and irreversible injuries, conditions, and damage to a significant number
`
`of women, including the Plaintiff, making them defective under the law.
`
`47. The specific nature of the AMS Monarc Hammock defects includes, but is not limited to,
`
`the following:
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`the use of polypropylene material in the Monarc Hammock and the immune
`reactions that result from such material, causes adverse reactions and injuries;
`
`the design of the AMS Monarc Hammock 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 AMS Monarc Hammock, including, but
`not limited to, their propensity 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 AMS Monarc Hammock, which, when
`placed in the women, are likely to pass through contaminated spaces and that can
`injure major nerve routes in the pelvic region;
`
`the propensity of the AMS Monarc Hammock for "creep," or to gradually elongate
`and deform when subject to prolonged tension inside the body;
`
`the inelasticity of the AMS Monarc Hammock, causing it to be improperly mated to
`the delicate and sensitive areas of the vagina and pelvis where it is implanted,
`causing pain upon normal daily activities that involve movement in the pelvic region
`(e.g., intercourse, defecation, walking); and
`
`the propensity of the AMS Monarc Hammock for degradation or fragmentation over
`time, which causes a chronic inflammatory and fibrotic reaction, resulting in
`continuing injury over time;
`
`the hyper-inflammatory responses to polypropylene leading to problems including
`chronic pain and fibrotic reaction;
`
`the adverse tissue reactions caused by the polypropylene in the AMS Monarc
`Hammock, which are causally related to infection, as the polypropylene is a foreign
`material;
`
`the creation of a non-anatomic condition in the pelvis leading to chronic pain and
`functional disabilities when the mesh is implanted according to the manufacturers'
`instructions;
`
`k.
`
`the procedure itself, which is part of Defendants' AMS Monarc Hammock, requires
`the physician to insert the device "blindly" resulting in nerve damage and damage
`to other internal organs;
`
`10
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`

`

`1.
`
`the design of trocars, part of Defendants' AMS Monarc Hammock, used to insert
`the Pelvic Mesh Products into the vagina, are defective because the device requires
`tissue penetration in nerve rich environments which results frequently in the
`destruction of nerve endings causing pain and other injuries.
`
`48.
`
`The AMS Monarc Hammock is also defective due to Defendants' failure to adequately
`
`warn or instruct the Plaintiff and/or her health care providers of subjects including, but not limited
`
`to, the following.
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`h.
`
`i.
`
`k.
`
`1.
`
`m.
`
`n.
`
`o.
`
`P.
`
`(71.
`
`the AMS Monarc Hammock propensity to contract, retract, and/or shrink inside the
`body;
`
`the AMS Monarc Hammock propensity for degradation, fragmentation and/or creep;
`
`the AMS Monarc Hammock inelasticity preventing proper mating with the pelvic
`floor and vaginal region;
`
`the rate and manner of mesh erosion or extrusion;
`
`the risk of chronic inflammation resulting from the AMS Monarc Hammock;
`
`the risk of chronic infections resulting from the AMS Monarc Hammock;
`
`the risk of permanent vaginal or pelvic scarring as a result of the AMS Monarc
`Hammock;
`
`the risk of permanent vaginal shortening resulting from the AMS Monarc
`Hammock;
`
`the risk of recurrent, intractable pelvic pain and other pain resulting from the AMS
`Monarc Hammock;
`
`the need for corrective or revision surgery to adjust or remove the AMS Monarc
`Hammock;
`
`the severity of complications that could arise as a result of implantation of the AMS
`Monarc Hammock;
`
`the hazards associated with the AMS Monarc Hammock;
`
`the AMS Monarc Hammock defects described herein;
`
`treatment of stress urinary incontinence with the Monarc Hammock is no more
`effective than feasible available alternatives;
`
`treatment of stress urinary incontinence with the AMS Monarc Hammock exposes
`patients to greater risk than feasible available alternatives;
`
`treatment of stress urinary incontinence with the AMS Monarc Hammock makes
`future surgical repair more difficult than feasible available alternatives;
`
`use of the AMS Monarc Hammock puts the patient at greater risk of requiring
`
`11
`
`

`

`additional surgery than feasible available alternatives;
`
`r.
`
`s.
`
`removal of the AMS Monarc Hammock due to complications may involve multiple
`surgeries and may significantly impair the patient's quality of life; and
`
`complete removal of the AMS Monarc Hammock may not be possible and may not
`result in complete resolution of the complications, including pain.
`
`49. Defendants have underreported information about the propensity of the AMS Monarc
`
`Hammock to fail and cause injury and complications and have made unfounded representations
`
`regarding the efficacy and safety of the AMS Monarc Hammock through various means and
`
`media. Defendants have also underreported information about the injuries caused by the use of
`
`the implantation kits and surgical technique instructions that accompany their pelvic meshes.
`
`50. Defendants failed to perform proper and adequate testing and research in order to
`
`determine and evaluate the risks and benefits of the AMS Monarc Hammock.
`
`51. Defendants failed to design and establish a safe, effective procedure for removal of the
`
`AMS Monarc Hammock, or to determine if a safe, effective procedure for removal of the AMS
`
`Monarc Hammock exists.
`
`52. Feasible and suitable alternatives to the AMS Monarc Hammock existed at all times
`
`relevant that do not present the same frequency or severity of risks associated with the AMS
`
`Monarc Hammock.
`
`53. The AMS Monarc Hammock were at all times utilized and implanted in a manner
`
`foreseeable to Defendants, as Defendants generated the instructions for use, created the
`
`procedures for implanting them, provided the surgical kits for implantation, and provided training
`
`for the implanting physician.
`
`54. Defendants provided incomplete and insufficient training and information to physicians
`
`regarding the use of the AMS Monar