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`DOCKET NO.: FBT-CV25-6150553-S ) SUPERIOR COURT
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`SUSAN CLARK, )
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`Plaintiff, ) JUDICIAL DISTRICT OF BRIDGEPORT
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`v. )
` ) AT BRIDGEPORT
`COOPERSURGICAL, INC., THE )
`COOPER COMPANIES, INC., FEMCARE, )
`LTD. -UK SUBSIDIARY OF UTAH )
`MEDICAL PRODUCTS, INC., and UTAH )
`MEDICAL PRODUCTS, INC., )
` )
`Defendants. ) OCTOBER 03, 2025
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`SECOND AMENDED COMPLAINT
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`Plaintiff Susan Clark files this Second Amended Complaint for causes of action against
`Defendants CooperSurgical, Inc. (the "Defendants"), all jointly and severally, as the companies
`and/or successors in interest to the companies that designed, developed, manufactured, tested,
`labeled, packaged, distributed, marketed and/or sold the Filshie Clip medical product that was
`implanted into Plaintiff and alleges as follows:
`INTRODUCTION
`1. Plaintiff was surgically implanted with a contraceptive tubal occlusion device
`known as a “Filshie Clip.” The Filshie Clip is intended to act as a permanent female birth control
`device by occluding, or causing a blockage, in the fallopian tube that prevents an ovum from
`descending from the ovary into the uterus.
`2. Although the system was intended to prevent fertilization and cause long- term
`sterilization, neither Plaintiff nor her healthcare providers were warned that the Filshie Clip
`product was defective and negligently designed and manufactured. As a result of being surgically
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`implanted with Defendants' unreasonably dangerous and defective Filshie Clip product, Plaintiff
`has suffered, and continues to suffer, debilitating injuries, as described further herein. Plaintiff
`brings this suit for damages related to those injuries.
`PARTIES
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`3. Plaintiff Susan Clark is, and was at all times relevant to this suit, a citizen and
`resident of California.
`4. Defendant CooperSurgical, Inc. ("CooperSurgical") is a Delaware corporation with
`its principal place of business at 95 Corporate Drive in Trumbull, Fairfield County, Connecticut
`and is a subsidiary of Defendant Cooper Companies, Inc. CooperSurgical may be served with
`process by serving its registered agent or the person in charge at CooperSurgical, Inc., 95 Corporate
`Drive, Trumbull, Connecticut 06611.
`JURISDICTION AND VENUE
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`5. This Court has jurisdiction over the subject matter of this action and the parties.
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`6. This Court has specific jurisdiction over Defendants because they purposefully
`availed themselves of the privilege of conducting business in the State of Connecticut and
`established minimum contacts sufficient to confer jurisdiction over Defendants, and the
`assumption of jurisdiction over Defendants will not offend traditional notions of fair play and
`substantial justice and is consistent with constitutional requirements of due process.
`7. Defendant CooperSurgical is subject to the jurisdiction of this Court because it has
`its principal place of business in the State of Connecticut and has transacted business and
`committed acts directly relating to matters complained of herein within the State of Connecticut.
`8. At all times relevant to this action, Defendants engaged, either directly or indirectly,
`in the business of designing, developing, marketing, promoting, distributing, and selling Filshie
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`Clip products within Connecticut, with a reasonable expectation that the products would be used
`or consumed in Connecticut, and thus regularly solicited or transacted business in this state.
`9. At all times relevant to this action, Defendants were engaged in substantial business
`activities including disseminating inaccurate, false, and misleading information about Filshie Clips
`to health care professionals in Connecticut, with a reasonable expectation that such information
`would be used and relied upon by health care professionals in this state.
`10. There is no federal jurisdiction over this matter because Plaintiff asserts claims
`against a forum defendant. Defendant CooperSurgical maintains its principal place of business in
`Connecticut. Defendants are therefore precluded from removing this civil action. 28 U.S.C. §
`1441(b)(2) (''A civil action ... may not be removed if any of the parties properly joined and served
`as defendants is a citizen of the State in which such action is brought.").
`FACTUAL BACKGROUND
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`The Filshie Clip Product
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`11. Filshie Clips are part of the "Filshie Clip system" for laparoscopic tubal ligation.
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`This system involves applying a titanium clip with a silicone rubber lining around each of the
`fallopian tubes.
`12. The Filshie Clip exerts continued pressure on the fallopian tube, which causes
`avascularization (cutting off the blood supply) for the 3 to 5mm area it encompasses. The silicone
`continues to apply pressure to the tube even after necrosis starts and the fallopian tube decreases
`in size. Ideally, fibrosis then occurs, and the clip is periotonealized.
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`13. Defendants' disposable delivery system consists of an applicator that is inserted into
`the woman's body so that the Filshie Clip can be snapped onto the fallopian tube.
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`1 Versage, Jessica L. M.D., Ed: Isaacs, Christine M.D., Laparoscopic Tubal Ligation Technique, Updated: 7/26/2021,
`https://emedicine.medscape.com/article/1848429-technigue#c3.
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`14. Femcare, the manufacturer of the Filshie Clip, obtained Conditional Premarket
`Approval (PMA) by the Food and Drug Administration (FDA). Defendants' failure to conform
`with the FDA requirements prescribed in the PMA and their violations of relevant state and federal
`law form the basis of this lawsuit.
`15. Class III medical devices are those that either "present a potential unreasonable risk
`of illness or injury or are for a use in supporting or sustaining human life or for a use which is of
`substantial importance in preventing impairment of human health." 21 U.S.C. § 360(c)(1)(c).
`16. Because Filshie Clips are classified as a Class III medical device, the FDA
`evaluated Filshie Clips' safety and effectiveness prior to granting the product Conditional PMA in
`1996.
`17. At that time, the FDA authorized its commercial distribution. Such approval was
`contingent upon the FDA's finding that there was "a reasonable assurance" of the device's safety
`and effectiveness. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
`18. However, the PMA imposed certain conditions on Femcare's sale of the product,
`including certain labeling requirements and restrictions on false or misleading advertising.
`19. The Medical Device Amendments of 1976, 21 U.S.C. § 360(c), et seq. (“MDA”)),
`expressly preempt certain state law requirements, stating that:
`Except as provided in subsection (b) of this section, no State or political subdivision
`of a State may establish or continue in effect with respect to a device intended for
`human use any requirement –
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`(1) which is different from, or in addition to, any requirement applicable under
`this chapter to the device, and
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`(2) which relates to the safety or effectiveness of the device or to any other
`matter included in a requirement applicable to the device under this chapter.
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`21 U.S.C. § 360k(a).
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`20. In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the United States Supreme Court
`set forth a two-step analysis for dete1mining whether a claim is expressly preempted pursuant to
`the statute. Id. at 321-22.
`21. First, the court must ascertain whether the federal government has established
`requirements applicable to the medical device at issue. Id . at 321. The Supreme Court concluded
`that any Class III device that receives premarket approval, which is specific to individual devices,
`satisfies this first prong of the§ 360k(a) test.
`22. Second, the court must determine whether the state common law claims relate to
`safety and effectiveness and impose requirements that are "different from, or in addition to" those
`imposed by federal law. Id. at 321-22 (quoting 21 U.S.C. § 360k(a)(l)).
`23. Here, the express preemption provision "does not prevent a State from providing a
`damages remedy for claims premised on a violation of FDA regulations; the state duties in such a
`case 'parallel,' rather than add to, federal requirements." Id. at 330.
`Plaintiff's Claims are Not Preempted by Federal Law Because They Do Not Impose Additional
`Requirements on Defendants
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`24. Personal injury claims caused by a medical device were not swept away on the day
`the MDA was enacted in 1976, nor does the PMA process establish that a medical device
`manufacturer and/or distributor are entirely immune from liability.
`25. Section 360k(a) does not preempt state -law claims against a medical device
`manufacturer based on duties that parallel federal requirements because such claims do not impose
`requirements that are "different from, or in addition to" those imposed by federal law.
`26. State tort law provides a right of action to a person who is injured when a device
`manufacturer's noncompliance with federal reporting standards results in a failure to warn of the
`risks of using a device and causes injury to a patient.
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`27. Defendants singularly and in combination designed, manufactured, sold, and
`distributed Filshie Clips and related equipment utilized in Plaintiffs tubal ligations.
`28. For years, Defendants intentionally manufactured, sold, and distributed Filshie
`Clips to the public as a quick, easy, and simple form of sterilization. Defendants told women they
`could use Filshie Clips to effectively prevent pregnancy while the product was in place and that
`the product was safe. Defendants' representations were false.
`29. Created by Marcus Filshie in the late 1970s, more than 12 million women
`worldwide have undergone tubal ligation with the Filshie Clip method.
`30. As stated above, the Filshie Clip works by exerting continued pressure on the
`fallopian tube, causing avascularization for the 3mm to 5 mm area it encompasses. The silicone
`sustains this pressure even after necrosis starts and the fallopian tube decreases in size. Fibrosis
`then occurs, and the clip is peritonealized. The clips are placed perpendicular to the isthmic portion
`of the tube so that it completely encompasses the tube, and the lower edge of the jaw can be seen
`in the mesosalpinx.2
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`2 Medical drawing of Filshie Clips being applied in a laparoscopic and c-section procedure provided by
`CooperSurgical in their surgical products catalog.
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`31. The Filshie Clip System was manufactured and promoted prior to 1996 in Europe
`and elsewhere. In 1996, the Filshie Clip System received PMA from the FDA, after information
`was submitted regarding, among other things, the safety and efficacy of the system.
`32. Subsequently, the Filshie Clip System was marketed and sold throughout the United
`States, including the State of Washington/California and Connecticut.
`33. It is of the utmost importance that women know all risks associated with a particular
`type of birth control given that a woman's choice of birth control can have long-term consequences
`on her health.
`34. Filshie Clips pose significant health risk, and the product has subjected untold
`thousands of women to significant injuries. These injuries stem from the simple fact that Filshie
`Clips have a propensity to migrate after being placed on the fallopian tubes. Migration of the clips
`following a normal application is estimated to occur over 25% of the time. The pathophysiology is
`related to the speed at which peritoneal-like tissue forms over the clip anchoring it to the fallopian
`tube.3
`35. The migration of the clip often requires surgical intervention to remove the Filshie
`Clips from the woman's body. Defendants neither warned nor adequately informed Plaintiff nor
`her healthcare providers how frequently these migrations occur or the severity and pe1manency of
`the potential injuries even though Defendants had received adverse reports and knew or should
`have known Filshie Clips had a significant propensity to migrate.
`36. Women and their doctors depend on Defendants, the manufacturers and distributors
`of products like Filshie Clips, to be forthcoming about the safety and risks of Filshie Clips. This
`reliance on Defendants was warranted here. The regulatory scheme that governs Filshie Clips is
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`3 G. Marcus Filshie, Female sterilization: medico legal aspects, Reviews in Gynaecological Practice; Vol. I Summer
`2001.
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`premised on a system whereby the manufacturer is responsible for reporting relevant safety
`information to the public.
`37. The onus is on the manufacturer to come forward with any safety risks because the
`public and the U.S. Food and Drug Administration ("FDA") would otherwise have no insight of
`adverse events.
`38. Plaintiff has suffered as a result of Defendants' failure to report adverse events
`involving the Filshie Clip. That failure violated requirements imposed by the FDA.
`39. As shown below in the excerpt from the Defendants' PMA application, during the
`premarket approval process, it was reported to the FDA that the Filshie Clip System had a
`migration incidence of .13%:
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`40. However, the risk of clip migration was significantly higher and continued to
`increase from year to year since the initial PMA. Despite these increases, Defendants failed to
`address the Filshie Clips safety issues, even though adverse event reports did or should have alerted
`them to a product defect causing the device to cause injuries.
`41. Rather than inform of the risks, CooperSurgical tout the benefits of the Filshie Clip
`version of the bilateral tubal ligation procedure over other available procedures. As noted in the
`press release regarding the Femcare, Ltd. purchase, the Filshie Clip System was claimed to be
`"safer than electrocautery and the newer hysteroscopic devices" without mention Defendants
`had a duty to act as reasonable manufacturers and
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`distributors of medical devices. They had a duty to continually monitor their product, including,
`but not limited to, its design, manufacturing, performance, safety profile, and labeling. They had
`a duty to continually test their product and ensure it was safe and would perform as intended. Yet
`Defendants breached their duties, and as a result, Plaintiff was injured.
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`42. The knowledge Defendants had regarding the migration issues involved with the
`Filshie Clip Systems not only triggers responsibility under Washington/California and/or
`Connecticut law for product liability, it also imposes parallel duties on Defendants pursuant to the
`Food, Drug, and Cosmetic Act (FDCA) to accurately report and update the FDA of the same. These
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`duties, both under Washington/California and/or Connecticut product liability law and the FDCA,
`are substantially similar. Washington/California and/or Connecticut product liability law does not
`impose a higher standard than the FDCA.
`43. If Defendants had timely disclosed the propensity and severity of risks associated
`with use of the Filshie Clips, Plaintiff’s injuries could have been avoided. Instead, Defendants did
`nothing, and for that, Plaintiff here seeks redress both to compensate them for her losses and to
`strongly deter future, similar misconduct.
`44. Defendants had a duty under federal4 and Connecticut law to be truthful about the
`safety of the Filshie Clip device. This duty applied to their voluntary statements, representations,
`and warranties, including all advertising and promotional materials. The Uniform Food, Drug, and
`Cosmetic Act
`5 incorporates much of the language of the federal Food, Drug, and Cosmetic Act
`and sets forth state standards which parallel federal device safety standards, including prohibiting
`the sale in intrastate commerce of any food, drug, device or cosmetic that is adulterated or
`misbranded
`6 and the dissemination of any false advertisement. 7 An advertisement of a device
`“shall be deemed to be false, if it is false or misleading in any particular.”8A device is misbranded
`under Connecticut law “if its labeling is false or misleading in any particular.” 9 To this end,
`Defendants breaches included the following acts or omissions:
`• Downplaying, omitting, or misrepresenting the dangers and prevalence of
`Filshie Clip breakage and/or migration to Plaintiff or Plaintiff’s physicians;
`• Concealing the true risks of Filshie Clips by failing to report complications
`and injuries associated with them;
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`4 For example, under 21 U.S.C. § 360e(c)(2)(A)(x) and 21 C.F.R. § 820 et. seq., including 21 C.F.R. § 820.1(a)(l), 21
`C.F.R. § 820.5, 21 C.F.R. § 820.20(a) (“Management with executive responsibility shall ensure that the quality policy
`is understood, implemented, and maintained at all levels of the organization”).
`5Conn Gen. Stat. § 91, et. seq.
`6 Conn Gen. Stat. § 21a-93(1).
`7 Conn Gen. Stat. § 21a-93(5).
`8 Conn. Gen. Stat. § 21a-113.
`9 Conn. Gen. Stat. § 21a-106(a).
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`• Failing to timely notify Plaintiff or Plaintiff’s physicians on a continuous
`basis of information they acquired about known or knowable risks of the
`Filshie Clips;
`• Failing to ensure that the information given to Plaintiff or Plaintiff’s
`physicians was accurate, complete, and not misleading;
`• Deliberately creating a false impression about the safety and efficacy of the
`Filshie Clips;
`• Misrepresenting the efficacy and safety of the Filshie Clips;
`• Misrepresenting that that the Filshie Clips had a low migration rate when,
`in fact, the opposite was true;
`• Misrepresenting that Filshie Clip migration, should it occur, was low
`severity and not likely to cause significant injury to the patient;
`• Misrepresenting that Filshie Clips were of merchantable quality;
`• Misrepresenting that Filshie Clips would function as intended when
`necessary.
`45. Defendants, as experts in medical device safety, knew that federal regulations
`known as Design Control Standards “set forth requirements that are intended to “ensure that
`finished devices will be safe and effective and otherwise in compliance with the [Food, Drug, and
`Cosmetic Act].” 21 C.F.R. § 820.1(a)(l). Defendants had a legal obligation to “establish and
`maintain a quality system that is appropriate for the specific medical device(s) designed or
`manufactured, and that meets the requirements of” part 820, 21 C.F.R. § 820.5, and its executives
`had a duty to ensure that these standards are complied with. 21 C.F.R. § 820.20(a). Defendants
`also had ongoing postmarket obligations to track its devices through the entirety of the product
`lifecycle. Defendants violated its standard of care and wrongfully distributed the Filshie Clips the
`following ways:
`• Failing to establish and maintain appropriate reliability assurance testing to
`validate the Filshie Clip’s design after marketing and distributing such
`device;
`• Ignoring or discounting the existence of numerous adverse events and
`complaints, such as revision surgeries, which it knew or should have known
`were not being accurately reported to the FDA;
`• Failing to adequately communicate adverse events involving Filshie Clips
`to the FDA when it did report them, and improperly attempting to attribute
`the adverse events to other causes;
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`• Failing to adequately analyze Filshie Clip -related adverse events, failures,
`and revision surgeries to determine why they were occurring and how they
`could be prevented.
`46. Defendants negligently failed to comply with the Design Control Standards found
`in 21 C.F.R. § 820.30. Defendants further failed to implement reasonable pre -market and post -
`market risk controls or health hazard evaluations, and they failed to adequately i nvestigate
`complaints, failed to report complaints, and failed to maintain complaint files as required by 21
`C.F.R. § 820.198. A reasonable company would have a robust complaint monitoring system that
`would carefully analyze every single complaint or adverse event and obtain the maximum amount
`of information possible about each one, as required by 21 C.F.R. § 820.198 and ISO 14971 (Int’l
`Org. for Standardization, ISO 4971:2007 Medical Devices —Application of Risk Management to
`Medical Devices (2007)), but Defendants ignored and willfully violated these standards and laws.
`47. Defendants were in a superior position to know the true quality, safety, and efficacy
`of their products. For years, Defendants made voluntary statements outside the labeling and
`directly to surgeons that Filshie Clips were safe. Defendants knew, and continue to know, that their
`disclosures to the public (including statements made outside the labeling) and to the Plaintiffs were
`and are incomplete and misleading.
`48. At the time the Filshie Clips left Defendants’ control, they were unreasonably
`dangerous due to Defendants’ non-compliance with the Food Drug and Cosmetic Act and related
`regulations, in one or more of the following ways:
`• Defendants failed to establish and maintain appropriate reliability assurance
`testing to validate the safety of the Filshie Clips after its entry into the
`marketplace, in violation of 21 C.F.R. 820.30 (g);
`• Defendants failed to establish and maintain procedures for implementing
`corrective and preventative action in response to, inter alia, complaints
`regarding the Filshie Clips and other quality problems associated with
`Filshie Clips, in violation of 21 C.F.R. 820.100;
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`• Defendants failed to appropriately respond to adverse incident reports and
`complaints that strongly indicated that Filshie Clips were Malfunctioning
`[as defined in 21 C.F.R. 803.3], or otherwise not responding to their Design
`Objective Intents, in violation of 21 C.F.R. 820.198;
`• Defendants failed to conduct complete device investigations on returned
`Filshie Clips in violation of 21 C.F.R. 820.198;
`• Defendants continued to place the Filshie Clips into the stream of interstate
`commerce when they knew, or should have known, that Filshie Clips were
`Malfunctioning (as defined in 21 C.F.R. 803.3) or otherwise not responding
`to their Design Objective Intents, in violation of 21 C.F.R. 820.198; and/or
`• Defendants failed to accurately establish the in vivo life expectancy, in
`violation of 21 C.F.R. 820.306.
`Facts Specific to Plaintiff
`49. On or around January 13, 2013, Plaintiff Susan Clark was implanted by Cathy J.
`Jang. MD with Filshie Clips that were designed, manufactured, marketed and distributed by
`Defendants at Woodland Memorial Hospital, located at 1325 Cottonwood Street, Woodland, CA
`93695, for the purpose of permanent birth control. Neither Plaintiff nor her healthcare providers
`were warned that the Filshie Clips were defective and negligently designed and manufactured, as
`discussed further herein.
`50. The Filshie Clips implanted in Plaintiff were in the same or substantially similar
`condition as it was when it left Defendants’ possession, and in the condition directed by and
`expected by Defendants.
`51. Upon information and belief, Plaintiff's treating physician(s) implanted the Filshie
`Clips properly and appropriately.
`52. On or around July 26, 2023, Plaintiff underwent an additional procedure related to
`the Filshie Clips at Providence St. Peter Hospital by Robert M. Ore, MD. Plaintiff had previously
`been implanted with Filshie Clips, but the clips were not identified at the time her fallopian tubes
`were removed.
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`53. Neither Plaintiff nor her healthcare providers were warned that Filshie Clips were
`unreasonably dangerous, even when used exactly as intended according to Defendants. To the
`contrary, Defendants promoted, marketed, and sold the Filshie Clip product implanted in Plaintiff
`(and thousands of women like Plaintiff) to healthcare providers as a safe alternative to other
`procedures that did not incorporate the Defendants' products.
`54. Had Defendants properly disclosed the risks associated with the Filshie Clip
`product, Plaintiff would not have agreed to treatment with the device. On information and belief,
`had Plaintiff's implanting physician been adequately and properly warned, he would have advised
`Plaintiff of the risks as part of her informed consent discussion and/or would have recommended
`a different treatment or no treatment at all.
`55. As a direct and proximate result of having Filshie Clips implanted in her, Plaintiff
`has experienced significant mental and physical pain and suffering, has sustained injuries which
`include or more likely than not may include any of the following: abdomina l and pelvic pain,
`difficult and painful bowel movements, pain in and around her uterus, stabbing pains in her
`abdomen and legs, and pain during intercourse. Plaintiff will likely undergo medical treatment and
`procedures, has suffered financial or economic loss, including, but not limited to, obligations for
`medical services and expenses, and/or lost income, and other damages. Plaintiff also has future
`damages and lives in constant worry that she will have more complications caused by the Filshie
`Clips.
`56. The injuries suffered by Plaintiff were caused by the wrongful acts and omissions
`of Defendants.
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`FIRST COUNT: VIOLATIONS OF THE CONNECTICUT PRODUCTS LIABILITY
`ACT - C.G.S Sec. 52-577m et. seq. (Against All Defendants)
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`57. Plaintiff re-alleges and incorporates by reference each of the foregoing paragraphs
`of this Complaint as if fully set forth herein and further allege as follows:
`58. At all times herein mentioned, Defendants were engaged in the business of
`researching, manufacturing, testing, licensing, fabricating, designing, labeling, distributing, using,
`supplying, selling, marketing, warranting, packaging, warning and advertising the Filshie Clip.
`59. The Filshie Clip is a product within the ambit of the Connecticut Products Liability
`Act - C.G.S Sec. 52- 577m et. seq., and the Defendants are Product Sellers pursuant to C.G.S. §
`52-572m (a).
`60. Defendants owed to Plaintiff and the public a duty to act reasonably and to exercise
`ordinary care in pursuit of the activities mentioned above, and Defendants breached said duty of
`care.
`61. At all times relevant hereto, Defendants owed to Plaintiff and the public a duty to
`act reasonably and to exercise ordinary care with respect to the safe, legal, and proper manufacture,
`license, design, formulation, distribution, production, processing, assembly, testing, inspection,
`research, marketing, labeling, packaging, preparation for use, issuance of warnings with respect to
`use, promotion, advertising, sale, and safety monitoring of the Filshie Clip, and to adequately test
`and warn of the risk and dangers of the Filshie Clip, both before and after sale.
`62. Additionally, Defendants owed to Plaintiff and the public a duty to provide
`accurate, reliable, and completely truthful information regarding the safety and any dangerous
`propensities of the Filshie Clip manufactured, used, distributed, and/or supplied by them and to
`provide accurate, reliable, and completely truthful information regarding the failure of the Filshie
`Clips to perform as intended or as an ordinary consumer would expect.
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`63. Additionally, Defendants owed to Plaintiff and the public a duty to provide
`accurate, reliable, and completely truthful information regarding the safety and any dangerous
`propensities of the Filshie Clips manufactured, used, distributed, and/or supplied by them and to
`provide accurate, reliable, and completely truthful information regarding the failure of the Filshie
`Clips to perform as intended or as an ordinary consumer would expect.
`64. At all times relevant hereto, Defendants breached the aforementioned duties in that
`Defendants negligently and carelessly manufactured, fabricated, designed, licensed, produced,
`compounded, assembled, inspected or failed to inspect, tested or failed to test, inadequately warned
`or failed to warn of the health hazards, labeled, distributed, handled, used, supplied, sold, marketed,
`warranted, packaged, promoted, and advertised the Filshie Clips in that said Filshie Clips caused,
`directly and proximately, the injuries of Plaintiff through failure of the Filshie Clips to perform as
`intended or as an ordinary consumer would expect. Specifically, and in addition to the acts or
`omissions previously identified in this Complaint, Defendants violated the duties of ordinary care
`and skill owed by Defendants to Plaintiff in the following particular respects:
`A. Failing to conduct adequate and appropriate testing of Filshie Clip products
`to ensure they were safe for implantation in the female pelvis;
`B. Putting Filshie Clip products on the market without first conducting
`adequate testing to determine possible side effects;
`C. Putting the Filshie Clip product on the market without adequate testing of
`its dangers to humans;
`D. Failing to recognize the significance of the medical literature, its own
`testing, and/or the testing of, and information regarding Filshie Clips, when
`said literature/testing evidenced such products' potential harm to humans;
`E. Failing to respond appropriately and promptly to the medical literature, its
`own testing, and/or the testing of, and information regarding Filshie Clips,
`when said literature/testing evidenced such products' potential harm to
`humans;
`F. Failing to promptly and adequately warn of the potential of the Filshie Clips
`to be harmful to humans;
`G. Failing to promptly, adequately, and appropriately recommend testing and
`monitoring of Filshie Clip product patients, including patients implanted
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`with the Filshie Clips product, in light of the knowledge that such products
`had the potential to be harmful to humans;
`H. Failing to properly, appropriately, and adequately monitor the post-market
`performance of Defendants' Filshie Clips, as well as said products' effects
`on patients;
`I. Concealing from the FDA, the National Institutes of Health, the general
`medical community and/or physicians, their full knowledge and experience
`regarding the potential that Defendants' Filshie Clips products could be
`harmful to humans;
`J. Promoting, marketing, advertising and/or selling Filshie Clips for use on
`patients given its knowledge and experience of such products' potential
`harmful effects;
`K. Failing to withdraw their Filshie Clips products from the market, restrict its
`use and/or adequately warn of such products' potential dangers, given its
`knowledge of the potential for its harm to humans;
`L. Failing to fulfill the standard of care required of a reasonable, prudent,
`urogynecological medical device manufacturer engaged in the design,
`manufacturer, and marketing of such products, including the Filshie Clips;
`M. Placing and/or permitting the placement of its Filshie Clips product into
`stream of commerce without warnings of the potential for said products to
`be harmful to humans and/or without properly warning of said products'
`dangerousness;
`N. Failing to disclose to the medical community in a timely and appropriate
`manner, facts relative to the potential of Defendants' Filshie Clip product to
`be harmful to humans;
`O. Failing to respond or react promptly and appropriately to reports of their
`Filshie Clips products causing harm to patients;
`P. Disregarding the safety of users and consumers of the Filshie products,
`including Plaintiff, under the circumstances by failing to adequately warn
`of said product's potential harm to humans;
`Q. Disregarding the safety of users and consumers of the Filshie Clip products,
`including Plaintiff, and/or her physicians and/or hospital, under the
`circumstances by failing to withdraw said products from the market and/or
`restricting its usage;
`R. Disregarding publicity, government and/or industry studies, information,
`documentation, and recommendations, consumer complaints and reports
`and/or other information regarding the hazards of Filshie Clip products and
`its potential harm to humans;
`S. Failing to exercise reasonable care in informing physicians and/or hospitals
`using Defendants' Filshie Clip products about its knowledge regarding said
`product's potential harm to humans;
`T. Failing to remove their Filshie Clip products from the stream of commerce;
`U. Failing to test their Filshie Clip products properly and/or adequately so as
`to determine its safety for use;
`V. Promoting its Filshie Clip products as safe and/or safer than other
`comparative methods/products;
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`W. Failure to adequately account for level and severity of the foreign body
`response the Filshie Clip might cause in some patients;
`X. Designing the Filshie Clip applicator in such a way that made clip
`place