Case 1:20-cv-00257-IMK Document 1 Filed 11/13/20 Page 1 of 41 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
` ELECTRONICALLY
` FILED
`Nov 13 2020
` U.S. DISTRICT COURT
` Northern District of WV
`
`COMPLAINT AND JURY DEMAND
`
`(cid:38)(cid:44)(cid:57)(cid:44)(cid:47)(cid:3)(cid:36)(cid:38)(cid:55)(cid:44)(cid:50)(cid:49)(cid:29)(cid:3)(cid:3)(cid:20)(cid:29)(cid:21)(cid:19)(cid:16)(cid:70)(cid:89)(cid:16)(cid:21)(cid:24)(cid:26)
`(cid:45)(cid:88)(cid:71)(cid:74)(cid:72)(cid:3)(cid:44)(cid:85)(cid:72)(cid:81)(cid:72)(cid:3)(cid:48)(cid:17)(cid:3)(cid:46)(cid:72)(cid:72)(cid:79)(cid:72)(cid:92)
`
`ASHLEY SIGLEY
` Plaintiff,
`v.
`TEVA PHARMACEUTICALS, USA, INC.;
`400 Interpace Parkway
`Parsippany, New Jersey 07054
`
`And
`
`TEVA WOMEN’S HEATH, LLC;
`5040 Duramed Road
`Cincinnati, Ohio 45213
`
`And
`
`TEVA BRANDED PHARMACEUTICAL
`PRODUCTS R&D, INC.
`41 Moores Road
`Malvern, Pennsylvania 19355
`
`And
`
`THE COOPER COMPANIES, INC.;
`6101 Bollinger Canyon Road, Suite 500
`San Ramon, California 94583
`
`And
`
`COOPERSURGICAL, INC.,
`95 Corporate Drive
`Trumbull, Connecticut 06611,
`Defendants.
`
`

`

`Case 1:20-cv-00257-IMK Document 1 Filed 11/13/20 Page 2 of 41 PageID #: 2
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`COMES NOW Plaintiff, Ashley Sigley, through her counsel, Motley Rice, LLC, files this
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`Complaint against Defendants Teva Pharmaceuticals, USA, Inc., Teva Women’s Health, LLC,
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`Teva Branded Pharmaceutical Products R&D, Inc., The Cooper Companies, Inc., and
`
`CooperSurgical, Inc. (collectively hereinafter “Defendants”), 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 ParaGard IUD that was inserted
`
`into Plaintiff, and in women throughout the United States. Accordingly, Plaintiff alleges and states
`
`as follows:
`
`I.
`
`INTRODUCTION
`
`1. This is an action for damages relating to the Defendants’ design, manufacture, surveillance,
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`sale, marketing, advertising, promotion, labeling, packaging, and distribution of the ParaGard
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`Intrauterine medical device (“ParaGard IUD or ParaGard”) intended to provide long-term, yet
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`reversible, “non-surgical” contraception for women.
`
`2. The Defendants have a responsibility to produce a safe and effective product, as well as
`
`the responsibility for monitoring the safety of the product in the real world. The Defendants have
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`superior, and in many cases exclusive, access to the relevant safety and efficacy information,
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`including post-marketing complaints and data.
`
`3. To fulfill this essential responsibility, each Defendant must vigilantly monitor all
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`reasonably available information. The manufacturer must closely evaluate the post-market clinical
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`experience with ParaGard and timely provide updated safety and efficacy information to the U.S.
`
`Food and Drug Administration (“FDA”) and to consumers. The Defendants also must carefully
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`monitor its own quality controls post-market to ensure that the ParaGard uniformly conforms with
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`its representations and warranties and with specifications of approval.
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`4. After the FDA approved the ParaGard for sale and it was sold on the market, Defendants
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`became aware of serious safety issues and adverse events associated with the ParaGard. In
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`particular, the Defendants knew or should have known that ParaGard has a susceptibility to break
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`in utero or upon removal, resulting in serious injuries to patients.
`
`5. This action arises from Defendants’ failures and omissions in the design, manufacture,
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`surveillance, sale, marketing, advertising, promotion, labeling, packaging, and distribution of the
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`ParaGard IUD.
`
`6. Defendants’ conduct, as set forth below, violated their obligations under federal and state
`
`law.
`
`II.
`
`THE REGULATORY HISTORY OF THE PARAGARD IUD NEW DRUG
`APPLICATION (“NDA”)
`
`7. On November 15, 1984, the FDA approved the new drug application (“NDA”) pursuant to
`
`§ 505(b) of the federal Food, Drug, and Cosmetic Act for ParaGard, dated September 4, 1984. The
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`NDA was submitted to the FDA by The Population Council. Defendants, holding the NDA, must
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`comply with the requirements for an approved NDA set forth under the federal regulations,
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`including, but not limited to 21 C.F.R. §§314.80 and 314.81.
`
`8. On November 9, 2005, Duramed Pharmaceuticals, Inc., a subsidiary of Barr
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`Pharmaceuticals, Inc., acquired FEI Women’s Health, LLC, which had earlier acquired the
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`ParaGard NDA from The Population Council.
`
`9.
`
`In 2008, Teva USA became the owner of ParaGard NDA when it acquired Duramed
`
`Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., through its purchase of Barr
`
`Pharmaceuticals. When Teva USA acquired Duramed, it also acquired Duramed’s manufacturing
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`facilities, sales force and responsibility for maintaining and updating the labeling for ParaGard and
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`adhering to the mandatory reporting requirements as set forth in 21 C.F.R. §§ 314.80 and 314.81.
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`10. Teva USA manufactured the ParaGard through Duramed, which held the ParaGard NDA
`
`and designed, developed, manufactured, tested, labeled, packaged, distributed, marketed and/or
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`sold the ParaGard IUD through September 2009. In September 2009, Teva USA changed the name
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`of Duramed Pharmaceuticals, Inc. to Teva Women’s Health, Inc., a wholly owned subsidiary of
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`Teva USA. A new entity was not created and no entities were dissolved.
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`11. From September 2009 to August 2017, Teva Women’s Health, Inc. held the ParaGard
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`NDA, and designed, developed, manufactured, tested, labeled, packaged, distributed, marketed
`
`and/or sold the ParaGard IUD throughout the United States. In August 2017, Teva Women’s
`
`Health, Inc. converted into Teva Women’s Health, LLC.
`
`12. From August 11, 2017 to November 1, 2017, Teva Women’s Health, LLC held the
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`ParaGard NDA and designed, developed, manufactured, tested, labeled, packaged, distributed,
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`marketed and/or sold the ParaGard IUD.
`
`13. On November 1, 2017, the Cooper Companies acquired the Teva Women’s Health, LLC
`
`assets, including the ParaGard NDA. From November 1, 2017 to the present, the Cooper
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`Companies and its subsidiary CooperSurgical hold the ParaGard NDA and design, develop,
`
`manufacture, test, label, package, distribute, market and/or sell the ParaGard IUD throughout the
`
`United States.
`
`III.
`
`PARTIES
`
`14.
`
`At all times relevant to this action, Plaintiff, was an individual, citizen, and resident
`
`of the State of West Virginia, in Preston County.
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`15.
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`Defendant Teva Pharmaceuticals USA, Inc. (“Teva Pharmaceuticals” or “Teva
`
`USA”) is a Delaware corporation with headquarters located at 400 Interpace Parkway, Parsippany,
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`New Jersey.
`
`16.
`
`Defendant Teva Women’s Health, LLC is a Delaware limited liability company
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`with headquarters located at 5040 Duramed Rd. Cincinnati, Ohio and is and/or was a wholly owned
`
`subsidiary of Defendant Teva USA. Teva Women’s Health, LLC is the product of an August
`
`2017 entity conversion pursuant to Del. Code Ann. Tit. 8, 266, whereby Teva Women’s Health,
`
`Inc., converted into Teva Women’s Health, LLC. Previously, in September 2009, Duramed
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`Pharmaceuticals, which had held the ParaGard NDA since 2005, changed its name to Teva
`
`Women’s Healthcare, Inc. These entities – Duramed Pharmaceuticals (November 2005-
`
`September 2009), Teva Women’s Healthcare, Inc. (September 2009-August 2017), and Teva
`
`Women’s Healthcare, LLC (August -September 2017) are referred to herein collectively as “Teva
`
`Women’s Health”.
`
`17.
`
`Teva Branded Pharmaceutical Products R&D, Inc., is a Delaware corporation with
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`its principal place of business at 41 Moore Road, Malvern PA, 19344.
`
`18.
`
`In September 2017, Teva Women’s Health LLC sold all of its assets, including the
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`ParaGard IUD, to the Cooper Defendants. Thereafter, Teva Women’s Health LLC became a
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`holding company with no tangible assets.
`
`19.
`
`Defendant Cooper Companies, Inc., (“Cooper Companies”) is a Delaware
`
`corporation with headquarters at 66101 Bollinger Canyon Road, Suite 500, San Ramon, California.
`
`20.
`
`Defendant CooperSurgical, Inc., (“Cooper Surgical”) is a Delaware corporation
`
`with headquarters at 95 Corporate Drive in Trumbull, Connecticut and a subsidiary of Defendant
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`Case 1:20-cv-00257-IMK Document 1 Filed 11/13/20 Page 6 of 41 PageID #: 6
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`Cooper Companies (collectively Defendants Cooper Companies and CooperSurgical are referred
`
`herein as the “Cooper Defendants”).
`
`21.
`
`CooperSurgical purchased assets and global rights and business of the ParaGard
`
`IUD in September 2017 for $1.1 Billion, including their manufacturing facility in upstate New
`
`York. The Cooper Companies, as an inducement for Teva to enter into the Assets Purchase
`
`Agreement, guaranteed CooperSurgical obligations under the Assets Purchase Agreement.
`
`22.
`
`23.
`
`At all relevant times, each Defendant acted in all aspects as the agent of each other.
`
`Cooper Defendants knew or should have known that the transfer and conversion of
`
`Teva Women’s Health, Inc. into Teva Women’s Health LLC was intended to thwart potential
`
`creditors from having a claim against Teva Women’s Heath, Inc. or Teva Women’s Health, LLC.
`
`24.
`
`Therefore, the Cooper Defendants are liable pursuant to the Federal Consumer
`
`Protection Acts and West Virginia Consumer Credit and Protection Act and/or other applicable
`
`West Virginia statutes.
`
`25.
`
`The liability of these companies has passed on through various business
`
`instruments and now lies with Defendants.
`
`26.
`
`At times relevant and material hereto, Defendants held the ParaGard NDA and
`
`engaged in the business of, or were successors-in-interest to entities engaged in the business of,
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`researching, developing, designing, formulating, licensing, manufacturing, testing, producing,
`
`processing, assembling, packaging, inspecting, distributing, selling, labeling, monitoring,
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`marketing, promoting, advertising, and/or introducing into interstate commerce throughout the
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`United States, in the State of West Virginia, either directly or indirectly, through third-parties,
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`subsidiaries and/or related entities, the ParaGard IUD. At times relevant to this action, Defendants
`
`communicated with the United States Food and Drug Administration and the United States
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`Case 1:20-cv-00257-IMK Document 1 Filed 11/13/20 Page 7 of 41 PageID #: 7
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`Department of Health and Human Services regarding the regulation, sale, use, and safety concerns
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`related to ParaGard IUDs, which includes managing product recalls, investigating adverse events
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`from ParaGard IUD users, and performing mandatory reporting to the FDA regarding ParaGard
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`IUD. At times relevant to this action, Defendants were involved in regulatory and medical
`
`communications, including but not limited to communications with physicians, doctors, and other
`
`medical personnel. This conduct led to activities giving rise to the causes of action alleged herein.
`
`27.
`
`At all times alleged herein, Defendants were authorized to conduct or engage in
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`business within the State of West Virginia and supplied the ParaGard IUD within the state of West
`
`Virginia. Defendants received financial benefit and profits as a result of designing, manufacturing,
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`marketing, advertising, selling and distributing the ParaGard IUD within the State of West
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`Virginia.
`
`28.
`
`The combined acts and/or omissions of each Defendant resulted in indivisible
`
`injuries to Plaintiff. Each of the above-named Defendants is a joint tortfeasor and is jointly and
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`severally liable to Plaintiff for the negligent acts and omissions alleged herein. Each of the above-
`
`named Defendants directed, authorized or ratified the conduct of each and every other Defendant.
`
`IV.
`
`JURISDICTION AND VENUE
`
`29.
`
`The Court has subject matter jurisdiction over this matter because there is complete
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`diversity of citizenship between the parties and the amount in controversy exceeds $75,000.00,
`
`exclusive of interest and costs. See 28 U.S.C. § 1332. Specifically, as alleged in more detail in the
`
`PARTIES section, Plaintiff is a citizen of the State of West Virginia, while Defendants are citizens
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`of Ohio, New Jersey, Pennsylvania, Connecticut and California.
`
`30.
`
`The Court has personal jurisdiction over Defendants because they have sufficient
`
`minimum contacts such that asserting jurisdiction over the Defendants does not offend traditional
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`notions of fair play and substantial justice. International Shoe v. Washington, 326 U.S. 310, 325
`
`(1945). The Defendants have conducted and continue to conduct substantial and systematic
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`business activities related to ParaGard device in this jurisdiction. Such activities include, but are
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`not limited to: (a) sales of the ParaGard IUD; (b) hiring, training, and deploying employees,
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`including sales representatives, in this jurisdiction; (c) advertising and marketing of ParaGard in
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`this jurisdiction; (d) maintenance of company files and equipment relating to the ParaGard IUD
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`in this case, in this jurisdiction; (e) payment of employee salaries in this jurisdiction; and (f)
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`maintenance of a website directed to all states, including West Virginia. The Defendants also
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`committed tortious acts within the State of West Virginia and caused injury to persons or property
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`within the State of West Virginia arising out of acts or omissions by Defendant outside this state
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`at or about the time of the Plaintiff’s injury, while the Defendants were engaged in solicitation or
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`service activities within the State of West Virginia; and/or, while products, materials, or things
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`processed, serviced, or manufactured by the Defendants were used or consumed within West
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`Virginia in the ordinary course of commerce, trade, or use.
`
`31.
`
`Venue is proper in this District because Plaintiff currently and at the time of
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`implant, resided in this District. See 28 U.S.C. § 1391(b) (2). The Defendants’ ParaGard IUD was
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`marketed, sold, and inserted in this District.
`
`V.
`
`FACTUAL ALLEGATIONS
`
`32.
`
`The ParaGard IUD is an intrauterine device that is intended to provide long-term,
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`yet temporary non-surgical birth control.
`
`33.
`
`The ParaGard IUD is a T-shaped plastic frame made of polyethylene and barium
`
`sulfate that is inserted into the uterus by a healthcare provider. Copper wire coiled around the IUD
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`is intended to interfere with the sperm transport and fertilization of an egg. A monofilament
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`polyethylene thread is tied through the tip, resulting in two white threads, which is intended to aid
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`in the detection and non-surgical removal of the IUD.
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`34.
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`Defendants market and have marketed the ParaGard IUD as providing “continuous
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`pregnancy prevention for as short or long as [the user] want[s]—up to 10 years.”
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`35.
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`Defendants further market and have marketed that the ParaGard IUD can be
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`removed anytime sooner than ten (10) years if the user decides she wants to become pregnant and
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`“may become pregnant as soon as ParaGard is removed.”
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`36.
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`ParaGard is heavily marketed as being “reversible,” “non-surgical,” and can be
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`removed by a healthcare provider “during a routine office visit in just a few minutes.”
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`37.
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`The marketing and promotional efforts of Defendants, their advertisers, and sales
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`force served to overstate the benefits of ParaGard IUD and minimize and downplay the risks.
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`These promotional efforts and marketing statements were made while Defendants negligently and
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`fraudulently withheld important safety information from healthcare providers and the public.
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`38.
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`Prior to Plaintiff being inserted with the ParaGard IUD, Defendants knew and
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`should have known that the drug was defective and unreasonably dangerous.
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`39.
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`Defendants knew or should have known that ParaGard can and does cause serious
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`harm to individuals who use it, due to the risk of the ParaGard potentially breaking in utero and/or
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`upon removal.
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`40.
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`Defendants knew of these risks from the trials they performed, their post-marketing
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`experience and complaints, third party studies, and their own analysis of these studies, but took no
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`action to adequately warn or remedy the defects and instead concealed, suppressed and failed to
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`disclose or fix this danger.
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`41.
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`The product warnings for ParaGard were vague, incomplete, or otherwise wholly
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`inadequate to alert prescribing physicians and patients to the actual risks associated with ParaGard,
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`including, but not limited to, the risk of device breakage that may result in surgical intervention,
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`surgical intervention requiring removal of internal organs, and/or loss of reproductive health and
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`fertility.
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`42.
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`Defendants' marketing and promotion, through its own website, sought to reassure
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`physicians and patients that Defendants’ longstanding record of quality and safety assurance.
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`43.
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`Based upon these representations, upon which Plaintiff and her physician relied,
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`Plaintiff had the ParaGard inserted, believing it would be safe, effective, and reversible, for the
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`entire duration it was inserted and upon removal.
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`44.
`
`Although ParaGard IUD is a device and Defendants market the ParaGard IUD as
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`containing no hormones or other drugs, it is regulated by the FDA as a “drug” and Defendants are
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`required to adhere to the Code of Federal Regulations, Title 21.
`
`45.
`
`Defendants are required to promptly review all adverse drug experience
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`information obtained or otherwise received by the applicant from any source, foreign or domestic,
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`including information derived from commercial marketing experience, post-marketing clinical
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`investigations, post-marketing epidemiological/surveillance studies, reports in scientific literature,
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`and unpublished scientific papers. Defendants, as NDA applicants and holders, must submit all
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`follow-up information on reports forwarded to the applicant by the FDA to the FDA. Defendants
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`must develop written procedures for the surveillance, receipt, evaluation and reporting of post-
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`marking adverse drug experiences pursuant to FDA. 21 C.F.R. § 314.80(b).
`
`46.
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`Defendants must submit to the FDA adverse drug experience information. 21
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`C.F.R. § 314.80(c). Adverse drug experiences are any adverse event associated with the use of a
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`drug in humans, whether or not considered drug related, including any failure of expected
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`pharmacological action. 21 C.F.R. §314.80(a).
`
`47.
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`Despite these obligations, Defendants failed to adequately communicate and report
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`to the FDA the injuries associated with the ParaGard IUD, which resulted in inadequate warnings
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`for physicians and patients.
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`48.
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`On July 25, 2019, Defendants received a letter from the FDA admonishing
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`Defendants for marketing a “false or misleading representation[] about the risks associated with
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`ParaGard,” stating:
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`“[t]he TV ad misbrands ParaGard within the meaning of the Federal Food, Drug and Cosmetic
`Act and makes its distribution violative. 21 U.S.C. 352(n); 331(n). 21 C.F.R. 202.1(d) (1); (e)
`(5). This violation is concerning from a public health perspective because it creates a
`misleading impression about the safety of ParaGard.”
`
`VI.
`
`PLAINTIFF’S USE OF PARAGARD
`
`49.
`
`Upon information and belief, on or about February or March 2020, Plaintiff, at the
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`young age of 19, presented to her healthcare provider at Mon Health Obstetrics & Gynecology
`
`located at 2000 Mon Health Medical Park Drive, Morgantown, West Virginia, to discuss options
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`for temporary contraception.
`
`50.
`
`Plaintiff, replying on the representations made in the ParaGard brochures, videos,
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`television and/or print advertisements as to the risks and benefits, as well as relayed by her
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`physician, chose ParaGard IUD over a hormonal oral contraceptive or other temporary birth
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`control method.
`
`51.
`
`Plaintiff, a young and healthy woman, wanted ParaGard because it was a reversible
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`form of birth control that would allow her to conceive in the future.
`
`52.
`
`On March 9, 2020, pursuant to ParaGard’s instructions provided by Defendants,
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`Plaintiff’s healthcare provider inserted a ParaGard IUD into Plaintiff’s uterine cavity at Mon
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`Health Obstetrics & Gynecology located at 2000 Mon Health Medical Park Drive, Morgantown,
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`West Virginia.
`
`53.
`
`On July 13, 2020, after deciding she no longer wanted temporary birth control and
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`wanted the Paragard IUD removed, Plaintiff went to her healthcare provider at Mon Health
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`Obstetrics & Gynecology, located at 2000 Mon Health Medical Park Drive, Morgantown, West
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`Virginia, for removal.
`
`54.
`
`On July 13, 2020, Jane Koch, CRNP, MS, of Mon Health Obstetrics & Gynecology
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`attempted to remove the ParaGard as instructed by Defendants, by grasping the ParaGard by the
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`forceps and pulling gently. Despite following the instructions provided by Defendants, the
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`ParaGard IUD was unable to be removed.
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`55.
`
`Following the first unsuccessful attempt at removal, the following day, on July 14,
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`2020, Plaintiff returned to her healthcare provider at Mon Health Obstetrics & Gynecology and
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`was seen by Dr. Erica Arthurs, MD. Dr. Arthurs attempted to remove the ParaGard as instructed
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`by Defendants, by grasping the ParaGard by the forceps and pulling gently. Despite following the
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`instructions provided by Defendants, the ParaGard was unable to be removed.
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`56.
`
`On or about July 14, 2020, diagnostic imaging was then performed and revealed
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`that Plaintiff’s ParaGard IUD was broken inside of Plaintiff’s uterine cavity.
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`57.
`
`On August 5, 2020, while Plaintiff was under anesthesia, Dr. Erica Arthurs
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`attempted to remove the ParaGard IUD vaginally from Plaintiff’s uterine cavity at Mon Health
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`Preston Memorial Hospital located at 150 Memorial Drive, Kingwood, West Virginia; however,
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`the ParaGard IUD was unable to be removed in its entirety and only a portion of the ParaGard IUD
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`was removed.
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`58.
`
`Due to continued pelvic pain, Plaintiff continued to follow-up with her healthcare
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`provider at Mon Health Obstetrics & Gynecology. Diagnostic imaging revealed the broken piece
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`of the ParaGard IUD was embedded in Plaintiff’s uterine cavity.
`
`59.
`
`On or about September 24, 2020, due to severe abdominal and pelvic pain, Plaintiff
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`presented to J.W. Ruby Memorial Hospital located at 1 Medical Center Drive, Morgantown, West
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`Virginia. Plaintiff was evaluated and diagnostic imaging again revealed the broken piece of the
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`ParaGard IUD was embedded in Plaintiff’s uterine cavity.
`
`60.
`
`Plaintiff was advised by her healthcare provider that she needed surgical
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`intervention to remove the broken piece of the ParaGard IUD.
`
`61.
`
`On October 9, 2020, Dr. Ryan Heitmann, D.O. through a large abdominal incision,
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`surgically removed the broken and embedded piece of the ParaGard IUD from Plaintiff’s uterine
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`cavity at J.W. Ruby Memorial Hospital located at 1 Medical Center Drive, Morgantown, West
`
`Virginia.
`
`62.
`
`Plaintiff and her healthcare providers were provided with no warning from
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`Defendants of the risk of ParaGard failure and injury, nor were Plaintiff and her healthcare
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`providers provided with adequate warning of the risk of removal of ParaGard. This information
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`was known or knowable to Defendants.
`
`63.
`
`On information and belief, Plaintiff used the ParaGard IUD manufactured,
`
`packaged, marketed, sold and/or distributed by Defendants. The ParaGard reached Plaintiff
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`without substantial change in its condition.
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`64.
`
`On information and belief, Plaintiff suffered severe and permanent physical and
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`emotional injuries, endured pain and suffering, required surgical removal of the broken piece of
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`the device, and has suffered economic loss, including incurring significant expenses for medical
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`care and treatment.
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`65.
`
`As a result of said injuries, Plaintiff suffered significant bodily and mental injuries,
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`including but not limited to, pain, suffering, mental anguish, loss of enjoyment of life, medical
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`expenses and other out of pocket losses and loss of income.
`
`66.
`
`At all relevant times, Defendants had knowledge that there was a significant
`
`increased risk of adverse events associated with ParaGard, including arm breakage, and despite
`
`this knowledge Defendants continued to manufacture, market, distribute, sell, and profit from sales
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`of ParaGard.
`
`67.
`
`The Defendants continue to manufacture, market, distribute, sell and profit from
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`sales of ParaGard.
`
`68.
`
`Despite such knowledge, Defendants knowingly, purposely, and deliberately failed
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`to adequately warn Plaintiff, patients, consumers, medical providers, and the public of the
`
`increased risk of serious injury associated with using ParaGard.
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`69.
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`On information and belief, Plaintiff’s prescribing physician would not have
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`prescribed ParaGard to Plaintiff, would have changed the way they warned Plaintiff about the signs
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`and symptoms of serious adverse effects of ParaGard, and discussed with Plaintiff the true risks
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`of arm breakage and resulting injuries and complications had Defendants provided said physicians
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`with an appropriate and adequate warning regarding the risks associated with the use of the
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`ParaGard IUD.
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`70.
`
`As a direct and proximate result of Defendants’ conduct, Plaintiff suffered severe
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`and permanent physical and emotional injuries, endured pain and suffering, required surgical
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`removal of the broken piece of the device, and has suffered economic loss, including incurring
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`significant expenses for medical care and treatment.
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`71.
`
`As a direct result of Plaintiff’s use of the ParaGard, Plaintiff suffered from having
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`a broken arm of the ParaGard in her, causing her damage, including but not limited to pain,
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`suffering, mental anguish, loss of enjoyment of life, medical expenses and other out of pocket
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`losses and loss of income.
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`VII.
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`CAUSES OF ACTION
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` COUNT I: NEGLIGENCE
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`72.
`
`Plaintiff realleges and incorporates by reference every allegation of this Complaint
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`as if each were set forth fully and completely herein.
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`73.
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`At times relevant, Defendants were in the business of designing, developing, setting
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`specifications, manufacturing, marketing, selling and/or distributing the ParaGard IUD, including
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`the one that was inserted into the Plaintiff.
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`74.
`
`Defendants had a duty to exercise reasonable and ordinary care in the manufacture,
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`design, labeling, instructions, warnings, sale, marketing, safety surveillance and distribution of the
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`ParaGard so as to avoid exposing others to foreseeable and unreasonable risks of harm.
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`75.
`
`Defendants breached their duty in that they failed to warn Plaintiffs and their
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`physicians by not reporting the risk of serious defects and life-altering complications described
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`herein that Defendants knew or should have known were associated with ParaGard prior to the
`
`time of Plaintiff's insertion.
`
`76.
`
`Specifically, Defendants breached these duties and violated federal and state law
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`by, inter alia: receiving and failing to warn of or report complaints about ParaGard to the FDA or
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`the public and receiving and failing to warn or report to the FDA and the medical community their
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`Page 15 of 41
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`knowledge and information regarding complaints about ParaGard, including but not limited to
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`instances of breakage, instances of perforation, and instances of migration.
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`77.
`
`Defendants knew that the ParaGard could break upon removal and failed to warn
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`Plaintiff of this potential injury.
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`78.
`
`Defendants knew or reasonably should have known that the ParaGard IUD was
`
`dangerous or likely to be dangerous when used in its intended or reasonably foreseeable manner.
`
`79.
`
`At the time of the manufacture and sale of the ParaGard IUD, Defendants knew or
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`should have known that the ParaGard IUD was designed and manufactured in such a manner so
`
`as to present an unreasonable risk of the fracture of the arm of the drug upon removal.
`
`80.
`
`At the time of the manufacturer and sale of the ParaGard IUD, Defendants knew or
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`should have known that the ParaGard IUD was designed and manufactured to have unreasonable
`
`and insufficient strength or structural integrity to withstand normal placement and subsequent
`
`removal.
`
`81.
`
`At the time of the manufacture and sale of the ParaGard IUD, Defendants knew or
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`should have known that using the ParaGard IUD for its intended use or in a reasonably foreseeable
`
`manner created a significant risk of a patient suffering severe injuries, including but not limited to,
`
`additional surgeries and/or medical procedures in order to remove the fragmented product, even
`
`leading to hysterectomy.
`
`82.
`
`Defendants knew or reasonably should have known that the consumers of the
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`ParaGard IUD would not realize the danger associated with using the drug for its intended use
`
`and/or in a reasonably foreseeable manner.
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`83.
`
`Defendants breached their duty to exercise reasonable and prudent care in the
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`development,
`
`testing, design, manufacture,
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`inspection, marketing,
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`labeling, promotion,
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`distribution and sale of the ParaGard IUD in, among others, the following ways:
`
`a.
`
`Designing and distributing a product in which they knew or should have
`
`known that the likelihood and severity of potential harm from the product exceeded
`
`the burden of taking measures to reduce or avoid harm;
`
`b.
`
`Designing and distributing a product in which they knew or should have
`
`known that the likelihood and severity of potential harm from the product exceeded
`
`the likelihood of potential harm from other drug available for the same purpose;
`
`c.
`
`Failing to use reasonable care in manufacturing the product and producing
`
`a product that differed from their design or specifications;
`
`d.
`
`Failing to use reasonable care to warn or instruct Plaintiff, Plaintiff’s
`
`healthcare providers or the general health care community about the ParaGard
`
`IUD’s substantially dangerous condition or about facts making the product likely
`
`to be dangerous, including pre-and post-sale;
`
`e.
`
`Failing to perform reasonable pre-market and post-market testing of the
`
`ParaGard IUD to determine whether or not the product was safe for its intended
`
`use;
`
`f.
`
`Failing to provide adequate instructions, guidelines, and safety precautions,
`
`to those persons to whom it was reasonably foreseeable would recommend, use,
`
`insert and remove the ParaGard IUD;
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`g.
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`Advertising, marketing and recommending the use of the ParaGard IUD,
`
`while concealing and failing to disclose or warn of the dangers known by
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`Defendants to be connected with and inherent in the use of the ParaGard IUD;
`
`h.
`
`Representing that the ParaGard IUD was safe for its intended use when in
`
`fact, Defendants knew and should have known the product was not safe for its
`
`intended purpose;
`
`i.
`
`Continuing manufacture and sale of the ParaGard IUD with the knowledge
`
`that the IUD was dangerous and not reasonably safe, and failing to comply with the
`
`FDA good manufacturing regulations;
`
`j.
`
`Failing to use reasonable and prudent care in the design, research,
`
`manufacture, and development of the ParaGard IUD so as to avoid the risk of
`
`serious harm associated with the use of the IUD;
`
`k.
`
`Failing to establish an adequate quality assurance program used in the
`
`manufacturing of the ParaGard IUD;
`
`l.
`
`