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`JESSICA FARSON
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`Plaintiff
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`v.
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`COOPERSURGICAL , INC.,
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`THE COOPER COMPANIES, INC.,
`FEMCARE, LTD. – UK SUBSIDIARY OF )
`UTAH MEDICAL PRODUCTS, INC., and )
`UTAH MEDICAL PRODUCTS, INC.
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`Defendants
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`Case: 2:22-cv-01877-SDM-CMV Doc #: 1 Filed: 04/04/22 Page: 1 of 32 PAGEID #: 1
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF OHIO
`WESTERN DIVISION
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`Case No.
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`PLAINTIFF’S COMPLAINT AND JURY DEMAND
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`NOW COMES Plaintiff, Jessica Farson (hereinafter “Plaintiff” and/or “Ms. Farson”) by
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`and through her counsel, Griffin Purnell LLC and The Henry Law Firm and for her cause of action
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`against Defendants CooperSurgical, Inc., The Cooper Companies, Inc., Femcare, Ltd. – UK
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`subsidiary of Utah Medical Products, Inc., and Utah Medical Products, Inc. (collectively
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`hereinafter “Defendants”), all jointly and severally, as the companies and/or successors in interest
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`to the companies that designed, developed, manufactured, tested, labeled, packaged, distributed,
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`marketed and/or sold the Filshie Clip medical device that was surgically used in Plaintiff and
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`others throughout the United States and the world. Accordingly, Plaintiff alleges and states to the
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`Court as follows:
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`I.
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`INTRODUCTION
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`Plaintiff brings this civil action to recover damages within the jurisdictional limits
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`1.
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`of this Court including all (1) General Damages; (2) Special Damages; and (3) Punitive Damages
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`as well as all other damages allowable under Ohio law as a result of the use, design, manufacture,
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`Page 1 of 32
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`surveillance, sale, marketing, advertising, promotion, labeling, packaging, and distribution of
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`Filshie Clips.
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`2.
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`Plaintiff brings claims fully set forth below asserting: (1) design defect; (2)
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`manufacturing defect; (3) strict liability; (4) negligence; (5) gross negligence; and (6) punitive
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`damages.
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`3.
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`This claim arises from Ms. Farson’s Filshie Clip tubal ligation procedure which,
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`because of Defendants’ actions and omissions, resulted in a series of damages.
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`II.
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`PARTIES
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`4.
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`Plaintiff, Jessica Farson lives in Fremont, Ohio, and is subject to the jurisdiction of
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`this Court, and is deemed to be a resident of the State of Ohio for purposes of venue and
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`jurisdiction.
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`5.
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`Defendant, The Cooper Companies, Inc. (“Cooper Companies”) is a Delaware
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`corporation with its principal place of business located at 6101 Bollinger Canyon Road, in San
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`Ramon, California. For diversity of citizenship purposes, Defendant Cooper Companies, Inc. is a
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`citizen of both Delaware and California. Cooper Companies, Inc. may be served with process by
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`serving its registered agent at 251 Little Falls Drive, Wilmington, DE 19808.
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`6.
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`Defendant CooperSurgical, Inc. (“CooperSurgical”) is a Delaware corporation with
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`its principal place of business located at 95 Corporate Drive in Trumbull, Connecticut.
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`CooperSurgical may be served with process by serving its registered agent at CooperSurgical, Inc.,
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`95 Corporate Drive, Trumbull, CT 06611.
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`7.
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`Defendant Femcare, Ltd. is a UK subsidiary of Utah Medical Products, Inc. with
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`its principal place of business located at 32 Premier Way, Romsey, Hampshire SO51 9DQ, United
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`Kingdom. Femcare, Ltd. – UK Subsidiary of Utah Medical Products, Inc. may be served with
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`Page 2 of 32
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`process by serving its registered agent Karen Elizabeth Glasbey, FemcareUK, 32 Premier Way,
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`Romsey, Hampshire, United Kingdom SO519DQ.
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`8.
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`Defendant Utah Medical Products, Inc. is the parent company of Femcare, Ltd. with
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`its principal place of business located at 7043 South 300 West, Midvale, Utah 84047-1048 and
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`may be served with process by serving its registered agent Ben Shirley at 7043 South 300 West,
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`Midvale, UT 84047.
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`9.
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`CooperSurgical is a subsidiary of Defendant Cooper Companies, Inc. Defendant
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`CooperSurgical is a citizen of both Delaware and Connecticut for diversity of citizenship purposes.
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`Cooper Companies, Inc. and CooperSurgical, Inc. are referred to collectively hereinafter as
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`“CooperSurgical.”
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`10.
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`Femcare, Ltd. is a UK subsidiary of Utah Medical Products, Inc., and a citizen of
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`England for diversity of citizenship purposes. Utah Medical Products, Inc. is a citizen of Utah for
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`diversity of citizenship purposes.
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`11.
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`All acts and omissions of the Defendants as described herein were done by its
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`agents, servants, employees and/or owners, acting in the course and scope of its respective
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`agencies, services, employments and/or ownership.
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`III.
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`JURISDICTION & VENUE
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`12.
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`This Court has subject matter original jurisdiction through diversity of citizenship
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`pursuant to 28 U.S.C. §1332(a) because the Plaintiff is a citizen of Ohio, the named Defendants
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`are citizens of different states and the amount in controversy exceeds the sum of value of
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`$75,000.00, exclusive of interest and costs.
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`13.
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`This Court has specific jurisdiction over these Defendants because they
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`purposefully availed themselves of the privilege of conducting business in the state of Ohio and
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`Page 3 of 32
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`established minimum contacts sufficient to confer jurisdiction over these Defendants, and the
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`assumption of jurisdiction over Defendants will not offend traditional notions of fair play and
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`substantial justice and is consistent with constitutional requirements of due process.
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`14.
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`CooperSurgical, Femcare, Ltd., and Utah Medical Products sell their products and
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`intend that they be used by medical professionals treating patients in Ohio.
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`15.
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`At all times relevant hereto and alleged herein, the Defendants conducted and
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`continue to regularly conduct substantial business within the state of Ohio which included and
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`continues to include, the research, safety surveillance, manufacture, sale, distribution and/or
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`marketing of Filshie Clips which are distributed through the stream of interstate and intrastate
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`commerce in the state of Ohio, and within the Northern District of Ohio.
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`16.
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`Venue is proper in this District pursuant to 28 U.S.C. § 1391(b) and 18 U.S.C.
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`§1965 (a) because a substantial part of the events or omissions giving rise to the claim occurred in
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`this District and each Defendant transacts business affairs and conducts activity that gave rise to
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`the claim of relief in this District.
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`IV.
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`FACTUAL BACKGROUND
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`a.
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`17.
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`Plaintiff Brings this Action Because Filshie Clips Injured her after migration.
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`Plaintiff in this action seeks compensation for injuries she sustained in connection
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`from the use of Filshie Clips, a medical device used in tubal ligations.
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`18.
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`This action is brought by Plaintiff. Ms. Farson was implanted with a female birth
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`control device known as a Filshie Clip. In short, this device is intended to cause bilateral occlusion
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`(blockage) of the fallopian tubes by applying a clip onto the fallopian tubes which then anchors
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`and elicits tissue growth, theoretically causing a closure of the tubes. However, in reality, the clips
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`migrate from the tubes wreaking havoc on the female body.
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`b. What is a Filshie Clip and How is it Supposed to Work?
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`19.
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`Filshie Clips are part of the “Filshie Clip system” for laparoscopic tubal ligation
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`which involves applying a titanium clip with silicone rubber lining around each of the fallopian
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`tubes.
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`20.
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`The Filshie Clip works by exerting continued pressure on the fallopian tube,
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`causing avascularization for the 3 to 5 mm area it encompasses. The silicone continues this
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`pressure even after necrosis starts and the fallopian tube decreases in size. Fibrosis then occurs,
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`and the clip is peritonealized if all goes as planned.
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`21.
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`Defendants’ disposable delivery system consists of an applicator which allows
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`insertion into the women’s body to allow the clip to be snaped onto the fallopian tube.
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`22.
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`A women’s choice of birth control is a deeply personal decision, particularly when
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`choosing a long-acting form of birth control like a tubal ligation which should permanently alter a
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`women’s body.
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`c. Background on Filshie Clips and the FDA Process.
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`23.
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`Femcare, the manufacturer of the Filshie Clip, obtained Conditional Premarket
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`Approval (PMA) by the Food and Drug Administration (FDA). The Defendants’ failure to
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`conform with the FDA requirements prescribed in the PMA and violations of relevant state and
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`federal law form the basis of this lawsuit.
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`24.
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`Class III medical devices are those that either “present a potential unreasonable
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`risk of illness or injury or are for a use in supporting or sustaining human life or for a use which is
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`of substantial importance in preventing impairment of human health.” 21 U.S.C. § 360(c)(1)(c)
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`25.
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`Because Filshie Clips are classified as a Class III medical device the FDA evaluated
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`Filshie Clips’ safety and effectiveness prior to granting the product Conditional PMA in 1996.
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`26.
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`At that time, the FDA authorized its commercial distribution. Such approval was
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`contingent upon the FDA’s finding that there was “a reasonable assurance” of the device’s safety
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`and effectiveness.” Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
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`27.
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`However, the PMA imposed certain conditions on Femcare’s distribution of the
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`product, including certain labeling requirements and restrictions on false or misleading advertising.
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`28.
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`The Medical Device Amendments of 1976, 21 U.S.C. § 360(c) et seq. (the "MDA"),
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`expressly preempt certain state law requirements, stating that:
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`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. 21 U.S.C. § 360k(a).
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`29.
`
`In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the United States Supreme Court
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`set forth a two-step analysis for determining whether a claim is expressly preempted pursuant to
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`the statute. 552 U.S. at 321-22.
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`30.
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`First, the court must ascertain whether the federal government has established
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`requirements applicable to the medical device at issue. Id. at 321. The Supreme Court concluded
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`that any Class III device that receives premarket approval, which is specific to individual devices,
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`satisfies this first prong of the § 360k(a) test.
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`31.
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`Second, the court must determine whether the state common law claims relate to
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`safety and effectiveness and impose requirements that are "different from, or in addition to" those
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`imposed by federal law. Riegel, 552 U.S. at 321-22 (quoting 21 U.S.C. § 360k(a)(1)).
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`32.
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`Here, the express preemption provision "does not [, however,] prevent a State from
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`providing a damages remedy for claims premised on a violation of FDA regulations; the state
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`duties in such a case 'parallel,' rather than add to, federal requirements." Riegel, 552 U.S. at 330
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`d. Plaintiff’s Claims are Not Preempted by Federal Law Because They Do Not Impose
`Additional Requirements on the Defendants.
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`33.
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`Personal injuries caused by a medical device were not swept away on the day the
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`MDA was enacted in 1976.
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`34.
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`The PMA process does not establish that a medical device manufacturer and/or
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`distributor are entirely immune from liability.
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`35.
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`§ 360k(a) does not preempt state-law claims against a medical device manufacturer
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`based on duties that parallel federal requirements because such claims do not impose requirements
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`that are “different from, or in addition to” those imposed by federal law.
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`36.
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`State tort law provides a right of action to a person who is injured when a device
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`manufacturer’s noncompliance with federal reporting standards results in a failure to warn of the
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`risks of using a device and causes injury to a patient.
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`e.
`
`
`CooperSurgical, Femcare, Ltd., and Utah Medical Products Design and Promote
`Defective Filshie Clips.
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`37.
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`Defendants, CooperSurgical, Femcare, Ltd., and Utah Medical Products, singularly
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`
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`and in combination, designed, manufactured, sold and distributed Filshie Clips and related
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`equipment utilized in Plaintiff’s tubal ligation.
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`38.
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`For years, Defendants intentionally manufactured sold and distributed Filshie Clips
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`to the public as a quick, easy, and simple form of sterilization. Defendants told women they could
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`use Filshie Clips to effectively prevent pregnancy while the product was in place and that the
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`product was safe. Defendants’ representations were false.
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`39.
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`Created by Marcus Filshie in the late 1970s, more than 12 million women
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`worldwide have undergone tubal ligation with the Filshie Clip method.
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`40.
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`The Filshie Clip works by exerting continued pressure on the fallopian tube,
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`causing avascularization for the 3- to 5-mm area it encompasses. The silicone continues this
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`pressure even after necrosis starts and the fallopian tube decreases in size. Fibrosis then occurs,
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`and the clip is peritonealized. The clips are placed perpendicular to the isthmic portion of the tube,
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`so that it completely encompasses the tube, and the lower edge of the jaw can be seen in the
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`mesosalpinx.
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`1
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`41.
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`The Filshie Clip System was manufactured and promoted prior to 1996 in Europe
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`and elsewhere. In 1996, the Filshie Clip System received Pre-Marketing Approval (PMA) from
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`the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug, and Cosmetic Act
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`1 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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`Page 8 of 32
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`(FDCA) after information was submitted regarding, among other things, the safety and efficacy of
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`the system.
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`42.
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`Subsequently, the Filshie Clip System was marketed and sold throughout the
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`United States, including the State of Ohio.
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`f.
`
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`CooperSurgical, Femcare, Ltd., and Utah Medical Products Failed to Inform
`Patients of the Risks Associated with Filshie Clips.
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`43.
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`It should go without saying that it is of the utmost importance that women know all
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`
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`risks associated with a particular type of birth control given that a women’s choice of birth control
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`can have long-term consequences on her health.
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`44.
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`Filshie Clips pose significant health risk, and the product has subjected untold
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`thousands of women to significant injuries. These injuries stem from the simple fact that Filshie
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`Clips have a propensity to migrate after being placed on the fallopian tubes. Migration of the clips
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`following a normal application is estimated to occur over 25% of the time. The pathophysiology
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`is related to the speed at which peritoneal-like tissue forms over the clip anchoring it to the
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`fallopian tube.2
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`45.
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`The migration of the clip often requires surgical intervention to remove the Filshie
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`Clips from the woman’s body. Defendants neither warned nor adequately informed Plaintiff nor
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`her healthcare providers how frequently these migrations occur or the severity and permanency of
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`the potential injuries even though Defendants had received adverse reports and knew or should
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`have known Filshie Clips had a significant propensity to migrate.
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`46. Women and their doctors depend on Defendants, the manufacturers and distributors
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`of products like Filshie Clips, to be forthcoming about the safety and risks of Filshie Clips. This
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`
`2 G. Marcus Filshie, Female sterilization: medico legal aspects, Reviews in Gynaecological Practice; Vol.1 Summer
`2001.
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`reliance on Defendants was warranted. The regulatory scheme that governs Filshie Clips is
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`premised on a system whereby the manufacturer is responsible for reporting relevant safety
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`information to the public.
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`47.
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`The onus is on the manufacturer to come forward with any safety risks because the
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`public and the U.S. Food and Drug Administration (“FDA”) would otherwise have no insight of
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`adverse events.
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`48.
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`The Plaintiff has suffered as a result of Defendants’ failure to report adverse events
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`involving the Filshie Clip. That failure violated requirements imposed by the Food and Drug
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`Administration (FDA).
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`49.
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`During the premarket approval process, it was reported to the FDA that the Filshie
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`Clip System had a migration incidence of .13%.
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`
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`50.
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`However, the risk of clip migration was significantly higher and continued to
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`increase from year to year since the initial PMA. Despite these increases, Defendants failed to
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`address the Filshie Clips safety issues, even though adverse event reports did or should have alerted
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`them to a product defect causing the device to cause injuries.
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`51.
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`Rather than inform of the risks, CooperSurgical, Femcare, Ltd., and Utah Medical
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`Products tout the benefits of the Filshie Clip version of the bilateral tubal ligation procedure over
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`other available procedures. As noted in the press release regarding the Femcare, Ltd. Purchase, the
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`Page 10 of 32
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`Filshie Clip System was claimed to be “safer than electrocautery and the newer hysteroscopic
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`devices” without mention of the risk of migration associated with the clips.
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`52.
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`Defendants had a duty to act as reasonable manufacturers and distributors of
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`medical devices. They had a duty to continually monitor their product, including, but not limited
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`to, its design, manufacturing, performance, safety profile, and labeling. They had a duty to
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`continually test their product and ensure it was safe and would perform as intended. Yet
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`Defendants breached their duties and, as a result, Plaintiff was injured.
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`Page 11 of 32
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`53.
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`The knowledge Defendants have regarding the migration issues involved with the
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`Filshie Clip Systems not only triggers responsibility under Ohio law for product liability, they also
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`imposed parallel duties on the Defendants pursuant to the Food, Drug, and Cosmetic Act (FDCA)
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`to accurately report and update the FDA of the same. These duties, both under Ohio product
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`liability law and the FDCA, are substantially similar. The Ohio product liability law does not
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`impose a higher standard than the FDCA.
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`54.
`
`If Defendants had timely disclosed the propensity and severity of risks associated
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`with use of the Filshie Clips, Plaintiff’s injuries could have been avoided. Instead, Defendants did
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`nothing, and for that, Plaintiff here seeks redress both to compensate her for her losses and to
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`strongly deter future, similar misconduct.
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`Ms. Farson’s experience with the Filshie Clips
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`Plaintiff is Implanted with CooperSurgical/Femcare, Ltd. Filshie Clips.
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`In 2008, Ms. Farson underwent a tubal ligation procedure.
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`The tubal ligation procedure used Filshie Clips.
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`Plaintiff was provided with a Disclosure and Consent for medical and surgical
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`g.
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`55.
`
`56.
`
`57.
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`procedures which included generic risks and hazards associated with the procedure. No mention
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`was made of the risk of migration and the appurtenant damages that could be caused by the Filshie
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`Clips. The only risks mentioned were associated with the ligation procedure itself.
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`58.
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`At the time, and upon information and belief to date, the product information sheet
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`supplied to her healthcare providers made no mention of the actual rate of migration known of the
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`Filshie Clips.
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`Page 12 of 32
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`h.
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`59.
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`Ms. Farson Discovers The Cause of Her Suffering.
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`In September of 2021, Ms. Farson was involved in an unrelated accident which
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`required x-rays and CT scans. While reviewing her imagery Ms. Farson’s doctor discovered one
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`Filshie Clip had migrated and imbedded itself in her pelvic artery and the other had migrated and
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`imbedded itself in her abdomen.
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`60.
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`Plaintiff, faced with continuing to live under the specter of having foreign bodies
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`migrating through her pelvic area and/or causing further damage while imbedded into her intimate
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`muscle and organs, was forced to undergo invasive surgery to remove the clips.
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`61.
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`Unfortunately, a surgery in January of 2022 revealed that both clips posed too much
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`of a threat in their current position to be safely removed. As a result, Ms. Farson continues to live
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`with the complications of the migrated clips and the fear that her condition could change at any
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`time.
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`62.
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`The design, manufacture and warnings of the CooperSurgical, Femcare, Ltd. and
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`Utah Medical Products devices at issue in this case exhibited several defects that violated common-
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`sense consumer expectations, as well as the expectations of the medical professionals involved in
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`gynecological care.
`
`63.
`
`The Filshie Clips, which were warranted, marketed, and purported to be
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`permanently in place on the fallopian tubes, were defective.
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`64.
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`Evidence of the Filshie Clips propensity to migrate was available to Defendants
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`and should have been relayed to the physicians by way of warning on the product packaging or
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`other dissemination of the information.
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`65.
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`To date, Defendants have failed to adequately warn of these dangers, and certainly
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`hadn’t done so at the time Plaintiff consented to the Filshie Clip method of sterilization.
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`Page 13 of 32
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`66.
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`As a result of the design, manufacture, and marketing defects of the Filshie Clips,
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`Plaintiff (and a large number of the women in the world who had submitted to their use) has
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`experienced significant pain, suffering, and surgeries she otherwise would not have had she chosen
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`one of the other methods of sterilization available to women.
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`V.
`
`THE DISCOVERY RULE APPLIES TO THIS MATTER
`
`67.
`
`68.
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`All of the allegations contained in the previous paragraphs are realleged herein.
`
`Plaintiff plead that the discovery rule should be applied to toll the running of the
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`statute of limitations until Plaintiff knew, or through the exercise of reasonable care and diligence
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`should have known, of facts indicating that the Plaintiff has been injured, the cause of the injury
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`and the tortious nature of the wrongdoing that caused the injury.
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`69.
`
`Despite diligent investigation by Plaintiff of the cause of her injuries, the nature of
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`Plaintiff’s injuries and damages and their relation to Filshie Clips and Defendants’ wrongful
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`conduct was not discovered and could not have been discovered, until a date within the applicable
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`statute of limitations.
`
`70.
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`Therefore, under appropriate application of the discovery rule, Plaintiff’s suit was
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`filed within the applicable statutory limitations period.
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`71.
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`Any applicable statutes of limitations have been tolled by the knowing and active
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`concealment and denial of material facts known by the Defendants when they had a duty to disclose
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`those facts.
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`72.
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`The Defendants’ purposeful and fraudulent acts of concealment have kept Plaintiff
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`ignorant of vital information essential to the pursuit of Plaintiff’s claims, without any fault or lack
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`of diligence on Plaintiff’s part.
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`Page 14 of 32
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`Case: 2:22-cv-01877-SDM-CMV Doc #: 1 Filed: 04/04/22 Page: 15 of 32 PAGEID #: 15
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`73.
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`Defendants are estopped from relying on the statute of limitations defense because
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`Defendants failed to timely disclose, among other things, facts evidencing the defective and
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`unreasonably dangerous nature of their Filshie Clips.
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`VI. CAUSES OF ACTION
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`
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`COUNT 1: ALL DEFENDANTS – PRODUCTS LIABILITY – DESIGN DEFECT
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`74.
`
`75.
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`All of the allegations contained in the previous paragraphs are realleged herein.
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`The Filshie Clips are inherently dangerous and defective, unfit and unsafe for their
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`intended use and reasonably foreseeable uses and does not meet or perform to the expectations of
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`patients and their health care providers. These defects were not known to be unsafe by the ordinary
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`consumer who consumes the product with the ordinary knowledge common to the community.
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`76.
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`The Filshie Clips reached their intended consumer without substantial change in
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`the condition in which they were in when they left Defendants’ possession.
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`77.
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`The Filshie Clips were defective in design because they failed to perform as safely
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`as persons who ordinarily use the products would have expected at the time of use.
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`78.
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`The Filshie Clips used in Plaintiff were defective in design, because Filshie Clips
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`risk of harm exceed their claimed benefits. Namely, the Filshie Clips System as designed allows
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`for migration from the implantation site which increases the risk of injury from the foreign body
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`(the clips themselves) as they float freely.
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`79.
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`The design was approved by the FDA without the benefit of the knowledge that
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`Filshie Clips had a greater than .13% risk of migration. The incidence of migration is reported at
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`25%, a significant increase from the .13% currently reflected in the product information sheets.
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`This information was available to the designer, manufacturer, and distributor at the time of the
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`PMA. Further, the increased incidence of migration reported since 1996 was not reported to the
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`Page 15 of 32
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`Case: 2:22-cv-01877-SDM-CMV Doc #: 1 Filed: 04/04/22 Page: 16 of 32 PAGEID #: 16
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`
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`FDA; a continued duty and requirement after obtaining the PMA. Such failure allowed for the
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`defective design to remain the same.
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`80.
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`Plaintiff and her healthcare providers used the Filshie Clips in a manner that was
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`reasonably foreseeable to the Defendants. In fact, they were used precisely as called for in their
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`design.
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`81.
`
`Neither Plaintiff nor her healthcare providers could have by the exercise of
`
`reasonable care discovered the Filshie Clips’ defective conditions or perceived their unreasonable
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`dangers prior to use. To the extent the product information sheet did report the risk of migration,
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`it was clearly understated and unlikely to inform a reasonable consumer/patient or their healthcare
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`providers of the risk of harm.
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`82.
`
`As a result of the foregoing design defects, the Filshie Clips created risks to the
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`health and safety of Plaintiff that were far more significant and devastating than the risks posed by
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`other products and procedures available to treat the corresponding medical conditions, and which
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`far outweigh the utility of the Filshie Clips.
`
`83.
`
`Defendants have intentionally and recklessly designed the Filshie Clips with
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`wanton and willful disregard for the rights and health of the Plaintiff and others, and with malice,
`
`placing their economic interests above the health and safety of the Plaintiff and others.
`
`84.
`
`As a proximate result of the Defendants’ design of the Filshie Clips, Plaintiff has
`
`been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and
`
`impairment, loss of enjoyment of life, loss of care, comfort, and economic damages.
`
`85.
`
`As a result of Defendants’ conduct, Plaintiff has been damaged and continues to
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`sustain damages in an amount to be determined by a jury but in an amount exceeding $75,000.00,
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`as a direct and proximate result of the Defendants’ conduct.
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`Page 16 of 32
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`Case: 2:22-cv-01877-SDM-CMV Doc #: 1 Filed: 04/04/22 Page: 17 of 32 PAGEID #: 17
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`
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`COUNT 2: ALL DEFENDANTS – PRODUCTS LIABILITY –
`MANUFACTURING DEFECT
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`All of the allegations contained in the previous paragraphs are realleged herein.
`
`Defendants designed, set specifications, manufactured, prepared, compounded,
`
`86.
`
`87.
`
`assembled, processed, marketed, labeled, performed medical vigilance, distributed and sold the
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`Filshie Clips that were used on Plaintiff.
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`88.
`
`The Filshie Clips used in Plaintiff contained a condition or conditions, which
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`Defendants did not intend, at the time the Filshie Clips left Defendants’ control and possession.
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`89.
`
`Plaintiff and Plaintiff’s health care providers used the device in a manner consistent
`
`with and reasonably foreseeable to Defendants.
`
`90.
`
`As a result of this condition or these conditions, the product failed to perform as
`
`safely as the ordinary consumer would expect, causing injury, when used in a reasonably
`
`foreseeable manner.
`
`91.
`
`The Filshie Clips were defectively and/or improperly manufactured, rendering
`
`them defective and unreasonably dangerous and hazardous to Plaintiff.
`
`92.
`
`Defendants had a duty to prevent the defective and/or improper manufacturing
`
`defects. This duty parallels the FDCA’s requirement for truthfully and completely reporting
`
`incidents of adverse events, and if necessary, obtaining approval for changes in the design,
`
`manufacture, and warnings/marketing approved by the FDA.
`
`93.
`
`Defendants have intentionally and recklessly manufactured Filshie Clips with
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`wanton and willful disregard for the rights and health of the Plaintiff and others, and with malice,
`
`placing their economic interests above the health and safety of the Plaintiff and others.
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`
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`Page 17 of 32
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`Case: 2:22-cv-01877-SDM-CMV Doc #: 1 Filed: 04/04/22 Page: 18 of 32 PAGEID #: 18
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`
`
`94.
`
`As a proximate result of the Defendants’ manufacture of Filshie Clips, Plaintiff has
`
`been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and
`
`impairment, loss of enjoyment of life, loss of care, comfort, and economic damages.
`
`95.
`
`As a result of Defendants’ conduct, Plaintiff has been damaged and continues to
`
`sustain damages in an amount to be determined by a jury but in an amount exceeding $75,000.00,
`
`as a direct and proximate result of the Defendants’ conduct.
`
`
`
`COUNT 3: ALL DEFENDANTS – PRODUCT LIABILITY – FAILURE TO WARN
`
`96.
`
`97.
`
`All of the allegations contained in the previous paragraphs are realleged herein.
`
`Defendants designed, set specifications, manufactured, prepared, compounded,
`
`assembled, processed, marketed, labeled, distributed and sold the Filshie Clips, including the ones
`
`used on Plaintiff, in stream of commerce and in the course of same, directly advertised and
`
`marketed the device to consumers or persons responsible for consumers.
`
`98.
`
`At the time Defendants designed set specifications, manufactured, prepared,
`
`compounded, assembled, processed, marketed, labeled, distributed and sold the Filshie Clips in
`
`the stream of commerce, Defendants knew or should have known that the device presented an
`
`unreasonable danger to users of the product when put to its intended and reasonably anticipated
`
`use.
`
`99.
`
`Specifically, Defendants knew or should have known that the Filshie Clips posed
`
`an unreasonable risk of migration from the implantation site, resulting in significant injuries.
`
`100. Defendants had a duty to warn of the risk of harm associated with the use of the
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`device and to provide adequate warnings concerning the risk the device could migrate, even if used
`
`properly. This duty parallels the FDCA’s requirement for truthfully and completely reporting
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`
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`Page 18 of 32
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`
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`incidents of adverse events, and if necessary, obtaining approval for changes in the design,
`
`manufacture, and warnings/marketing approved by the FDA.
`
`101. The Defen