Complaint Unlimited Fee AppliesCal. Super. - 6th Dist.April 1, 2021\OOOQQUl-PUJNp-A NNNNNNNNNt-tr-tr-‘r-tr-tr-tr-tr-tr-tr-t OOQO‘xUl-PUJNHOCOOQONUI-PUJNHO E-FILED 4/1/2021 12:00 AM Clerk of Court Superior Court of CA, County of Santa Clara Timothy M. Clark, Esq. (SBN 284447) 21 C_V378979_ Lauren Welling, Esq. (SBN 291813) ReV'ewed BV- R- walker SANDERS PHILLIPS GROSSMAN, LLC 16755 Von Karman Ave. Ste. 200 Irvine, CA 92606 Tel: 516-741-5600 ext. 8156 Fax: 213-477-2860 tclark@thesandersfirm.com 1we11ing@thesandersfirm.com Attorneyfor Plaintififv THE SUPERIOR COURT OF THE STATE OF CALIFORNIA COUNTY OF SANTA CLARA CASENO; 21CV378979YAEL KIDRON, an individual; JUDGE: Plaintiff, COMPLAINT FOR DAMAGES FOR: VS' 1) NEGLIGENCE 2) STRICT LIABILITY - DESIGN DEFECT TEVA PHARMACEUTICALS, USA, INC; 3) STRICT LIABILITY - TEVA WOMEN’S HEALTH, INC.; TEVA 4 ¥?i‘é?fii$fi$§ fifiiggE TOWOMEN’S HEALTH, LLC; TEVA ) WARN - BRANDED PHARMACEUTICAL 5) FRAUDPRODUCTS R&D, INC; THE COOPER COMPANIES, INC.; and COOPERSURGICAL, INC. 6) NEGLIGENT MISREPRESENTATION 7) BREACH OF EXPRESS WARRANTY 8) BREACH OF IMPLIED WARRANTY Defendants. DEMAND FOR JURY TRIAL Complaint Filed: VVVVVVVVVVVVVVVVVVvvvvvvvv Plaintiff, by and through the undersigned counsel, hereby brings this Complaint for damages against the Defendants, and alleges the following \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O I. INTRODUCTION 1. This is an action for damages relating to the Defendants” design, manufacture, surveillance, sale, marketing, advertising, promotion, labeling, packaging, and distribution of ParaGard Intrauterine medical device (hereinafter “ParaGard IUD”). 2. The ParaGard IUD is an intrauterine device, however, it is regulated as a drug. It is placed into the uterus t0 prevent conception. 3. The ParaGard IUD has a propensity t0 break at the arms upon explant resulting in serious injuries. 4. Plaintiff used the ParaGard IUD, and as a result 0f its use suffered injuries. II. GENERAL ALLEGATIONS 5. Plaintiff, Yael Kidron (“Plaintiff”), by and through Plaintiff” s attorneys, Sanders Phillips Grossman, LLC, brings this action for personal injuries suffered as a result 0f using the defective and dangerous ParaGard IUD. 6. The ParaGard IUD is prescribed to prevent conception, and at all times relevant hereto, were manufactured, designed, tested, packaged, labeled, marketed, advertised, promoted, distributed, and sold by Defendants. On information and belief, Plaintiff used the ParaGard IUD resulting in injuries. III. PARTIES, VENUE AND JURISDICTION 7. At all times relevant to this action, Plaintiff, was an individual, citizen and resident 0f the state 0f California. 8. Plaintiff was implanted With the ParaGard IUD in 2009. It was removed 0n 0r about 20 1 9, resulting in injuries. 9. Defendant Teva Pharmaceuticals USA, Inc. (hereinafter “Teva Pharmaceuticals” or “Teva USA”) is a Delaware corporation with its principal place of business in Parsippany, New Jersey. At times relevant to this action, Teva USA designed, developed, manufactured and marketed the ParaGard IUD at issue. At times relevant to this action, Teva USA communicated With the United States Department of Health and Human Services, Food and Drug Administration (FDA”) regarding the sale, use, and safety concerns related to ParaGard IUDs, \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O Which includes managing product recalls, investigating adverse events from ParaGard IUD users, and performing mandatory reporting t0 FDA regarding ParaGard IUD. 10. At times relevant t0 this action, Teva USA was involved in regulatory communications, and medical communications, including but not limited to communications With physicians, doctors, the Food and Drug Administration and other medical personnel, Which led to activities giving rise t0 failure to warn, negligence, gross negligence, common law fraud, negligent misrepresentation, breach of warranty, and a Violation of consumer protection laws. 11. Defendant Teva Women’s Health, Inc., (“Teva Women’s Health”) is a Delaware corporation With headquarters located at 425 Privet Rd., in Horsham, Pennsylvania and is and/or was a Wholly owned subsidiary 0f Defendant Teva USA, and/or operated as a successor-in- interest t0 Duramed Pharmaceuticals, Inc., a division 0f Barr Pharmaceuticals, Inc., and/or assumed Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., in a name change after its acquisition by Teva USA. Teva Women’s Health, Inc., converted into Teva Women’s Health, LLC in 2017 and continues to operate as Teva Women’s Health, LLC. At times relevant to this action, Teva Women’s Health designed, developed, manufactured and marketed the ParaGard IUD at issue. 12. Defendant Teva Women’s Health, LLC is a Delaware limited liability company With headquarters located at 425 Privet Rd., in Horsham, Pennsylvania and is and/or was a Wholly owned subsidiary of Defendants Teva USA. Teva Women’s Health’s sole member is Barr Pharmaceuticals, LLC, formed under Delaware law With its principal place of business in New Jersey, and the sole member of Barr Pharmaceuticals, LLC, is Teva USA. TWH, LLC is a citizen of Delaware and New Jersey. Teva Women’s Health, LLC is the product 0f an entity conversion pursuant to Del. Code Ann. Tit. 8, 266. Teva Women’s Health, Inc., converted into Teva Women’s Health, LLC and continues t0 operate as a limited liability company instead of an incorporation (Teva Women’s Health, LLC formerly known as Teva Women’s Health, Inc. collectively hereinafter “Teva Women’s Health”). 13. Accordingly, Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., d/b/a Teva Women’s Health Inc., (hereafter referred to as “Duramed”), acquired FEI \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O Women’s Health in 2005 wherein the asset 0f ParaGard was acquired in the deal. Duramed was acquired by Teva USA in 2008 wherein its name was changed to Teva Women’s Health, Inc., a Wholly-owned subsidiary 0f Teva USA. 14. Defendant Teva Branded Pharmaceuticals Products R& D, Inc. (“Teva R&D”) is a corporation With headquarters located at 41 Moores Rd. in Frazer, Pennsylvania (collectively Defendants Teva Pharmaceuticals, Teva Women’s Health and Teva R&D are referred herein as the “Teva Defendants”). At all times relevant to this action, Teva R&D designed, developed, manufactured and marketed the Paragard at issue. At times relevant t0 this action, Teva R&D communicated with the United States Department of Health and Human Services, Food and Drug Administration (FDA”) regarding the sale, use, and safety concerns related t0 ParaGard IUDs. 15. Defendant The Cooper Companies, Inc., (“Cooper Companies”) is a Delaware corporation With headquarters at 6140 Stoneridge Mall Rd., in Pleasanton, California. The Cooper Companies purchased assets and global rights and business 0f the ParaGard IUD in September 2017 for $ 1 .1 Billion, including their manufacturing facility in Buffalo, New York. 16. Defendant CooperSurgical, Inc., (“Cooper Surgical”) is a Delaware corporation With headquarters at 95 Corporate Drive in Trumbull, Connecticut and a subsidiary 0f Defendants The Cooper Companies (collectively Defendants The Cooper Companies and CooperSurgical are referred herein as the “Cooper Defendants”). 17. At all times relevant hereto and alleged herein, The Cooper Defendants conducted and continues to conduct substantial business Within the State of California. 18. At times relevant hereto and alleged herein, the Teva Defendants and Cooper Defendants conducted and continues t0 regularly conduct substantial business Within the State of, which included and continues to include, the research, safety surveillance, manufacture, sale, distribution and marketing of the ParaGard IUD, which is distributed through the stream 0f interstate commerce into the State of California. 19. Hereinafter the aforementioned Defendants may collectively be referred t0 as “Defendants.” \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 20. At all relevant times, each Defendant acted in all aspects as the agent and alter ego 0f each other. 21. The Cooper Defendants are liable as successors-in-interest under the California Uniform Fraudulent Transaction Act and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. 22. Upon reasonable belief, Duramed became Teva Women’s Health, Inc., through a name change in 2008. Teva Women’s Health, Inc., then became Teva Women’s Health, LLC through a conversion in 2017. Teva Women’s Health, LLC then sold all of its assets including the ParaGard to the Cooper Defendants in 2017. Teva Women’s Health, LLC became a holdings company With no tangible assets. 23. The Cooper Defendants knew or should have known that the transfer and conversion 0f Teva Women’s Health, Inc., was intended to thwart potential creditors from having a claim against Teva Women’s Heath, Inc or Teva Women’s Health, LLC. Therefore, the Cooper Companies are liable pursuant to Califomia’ Uniform Fraudulent Transactions Act, Cal. CiV. Code §3439, er. seq. 24. The liability 0f these companies has passed on through various business instruments and now lies With Teva Women’s Health, Inc and the Cooper Defendants. 25. At times relevant and material hereto, Defendants were engaged in the business of, 0r were successors-in-interest t0 entities engaged in the business of, researching, developing, designing, formulating, licensing, manufacturing, testing, producing, processing, assembling, packaging, inspecting, distributing, selling, labeling, monitoring, marketing, promoting, advertising, and/or introducing into interstate commerce throughout the United States, and in the State of California, either directly 0r indirectly, through third-parties, subsidiaries and/or related entities, the ParaGard IUD, a drug used in the prevention of pregnancy, implanted in patients throughout the United States, including Plaintiff. 26. At all times alleged herein, Defendants were engaged in the business 0f, 0r were successors-in-interest t0 entities engaged in the business 0f, researching, designing, formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting, \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O distributing, marketing, labeling, promoting, packaging, and/or advertising for sale 0r selling the ParaGard IUD. 27. At all times alleged herein, Defendants were authorized to conduct 0r engage in business Within the state of California and supplied the ParaGard IUD within the state of California. Defendants received financial benefit and profits as a result of designing, manufacturing, marketing, advertising, selling and distributing the ParaGard IUD within the state of California. 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/or co- conspirator and is jointly and severally liable t0 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. 29. The amount in controversy exceeds the jurisdictional limits of this court. IV. FACTUAL ALLEGATIONS 30. The ParaGard IUD is an intrauterine drug that can provide long term birth control, up to 10 years, without hormones. 3 1. The ParaGard drug is a T-shaped plastic frame made of polyethylene and barium sulfate that is inserted into the uterus. Copper Wire coiled around the IUD produces an inflammatory reaction that is toxic to sperm and egg. A monofilament polyethylene thread is tied through the tip, resulting in two White threads, Which aid in the detection and removal 0f the drug. 32. The ParaGard IUD has a propensity t0 break at the arms upon explant resulting in serious injuries. 33. At relevant times, Teva Defendants designed, researched, manufactured, labeled, packaged, promoted, marketed and/or sold the ParaGard IUD at issue after receiving New Drug Application approval from FDA. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 34. In 2008, Teva USA became the owner 0f ParaGard When it acquired Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., through its purchase 0f Barr Pharmaceuticals. 35. Upon information and belief, when Teva USA acquired Duramed, a division 0f Barr Pharmaceuticals, Inc., it also acquired Duramed’s manufacturing facilities, sales force and responsibility for maintaining and updating the labeling for ParaGard. 36. Shortly thereafter, Teva USA changed the name 0fDuramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., to Teva Women’s Health, Inc., a wholly owned subsidiary of Teva USA. 37. On August 3 1, 2009, Duramed Pharmaceuticals, 1110., filed With the Ohio Secretary 0f State a Certificate 0fAmendment to Foreign Corporation Application For License requesting a name change. A new entity was not created, and n0 entities were dissolved. Duramed’s license number did not change. Instead, Duramed changed its name t0 Teva Women’s Health, Inc. 38. Upon information and belief, Teva Women’s Health, Inc., is simply a new name for Duramed Pharmaceuticals, Inc., a division 0f Barr Pharmaceuticals, Inc. 39. Upon information and belief, and for purposes 0f liability and interest, Teva Women’s Health, Inc., is the same entity as Teva Women’s Health, LLC. Teva Women’s Health, Inc., converted into Teva Women’s Health, LLC under the laws of Delaware. Del. Code Ann. Tit. 8, 266. Pursuant t0 Del. Code Ann. Tit. 8, 266, a company that converts from one entity into another is deemed t0 be a continuation of the preexisting company. A conversion does not equate to a dissolution and n0 Winding up takes place. Therefore, Teva Women’s Health, Inc., did not dissolve,windup, or cease t0 exist andliability continues from the corporation to the Limited Liability Company. 40. Upon information and belief on August 11, 2017, Teva Women’s Health, Inc., converted into Teva Women’s Heath, LLC and sold off all of its assets. 41. On September 11, 2017, Teva Defendants sold the ParaGard to Cooper Defendants. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 42. ParaGard is currently sold only in the U.S. and had earned revenues 0f approximately $168 million for the twelve-month period ending June 30, 2017. 43. The Cooper Defendants still manufacture and sell the ParaGard in the U.S. 44. The ParaGard was marketed heavily by Teva Defendants and Cooper Defendants as being safe and effective, and promising fewer side effects than other birth control methods. 45. The marketing and promotional efforts 0f Teva Defendants and Cooper Defendants, their advertisers, and sales force served to overstate the benefits of ParaGard and minimize and downplay the risks. These promotional efforts were made while Teva Defendants and Cooper Defendants fraudulently withheld important safety information from health care providers and the public. 46. Prior to Plaintiff being implanted with the ParaGard IUD, Defendants knew and should have known that the drug was defective and unreasonably dangerous. 47. Teva and Cooper Defendants knew or should have known that ParaGard can and does cause serious harm t0 individuals who use it, due to the risk of the ParaGard’s arm breaking upon removal. 48. Teva and Cooper Defendants knew of these risks from the trials they performed, their post-marketing experience and complaints, third party studies, and their own analysis 0f these studies, but took no action to adequately warn or remedy the defects and instead concealed, suppressed and failed to disclose 0r fix this danger. 49. The product warnings for ParaGard were vague, incomplete or otherwise Wholly inadequate to alert prescribing physicians and patients t0 the actual risks associated with ParaGard. 50. Teva and Cooper Defendants’ marketing and promotion, through its own website, sought to reassure physicians and patients that Defendants’ longstanding record of quality and safety assurance. 5 1. Based upon these representations, upon Which Plaintiff and her physician relied, Plaintiff had the ParaGard implanted, believing it would be safe and effective, for the entire duration it was implanted and upon removal. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 52. Since 2010, the FDA has received over 1600 reports 0f ParaGard breakage, With over 700 classified as serious. 53. Defendants failure t0 adequately communicate and report t0 the FDA the injuries associated With ParaGard resulted in inadequate warnings. 54. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. Civ. Code §3439, et. seq, any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. VI. PLAINTIFF’S USE OF PARAGARD 55. On information and belief, in 2009, Plaintiff was implanted with Defendant’s ParaGard, at St. Johns Clinic Family Medicine: Mountain View Center: Palo Alto Medical Foundation by Bryan Thom, MD. 56. Plaintiff, a young and healthy woman, wanted a ParaGard because it was a reversible form of birth control that would allow her to conceive in the future. 57. On 0r about July 23, 2019, Plaintiff went to have the ParaGard removed at Family Medicine: Mountain View Center: Palo Alto Medical Foundation, by Meredith Erin Green, MD. 58. Meredith Erin Green, MD, attempted to remove the ParaGard as instructed by Defendants, by grasping the ParaGard strings with forceps and pulling gently. Despite following the instructions provided by Defendants, only a portion 0f the ParaGard was retrieved With one arm missing. 59. On 0r about July 29, 2019, Plaintiff had the missing IUD arm removed Via hysteroscopy at Family Medicine: Mountain View Center: Palo Alto Medical Foundation, by Nicole Wilcox, MD. 60. Prior t0 her procedures, Plaintiff and her doctors were provided With no warning from the Defendants 0f the risk 0f ParaGard failure and injury, nor were Plaintiff and her doctors provided with adequate warning 0f the risk 0f removal 0f ParaGard. This information was known 0r knowable t0 the Defendants. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 61. On information and belief, Plaintiff used the ParaGard IUD manufactured, packaged, marketed, sold and/or distributed by Defendants. The ParaGard reached Plaintiff Without substantial change in the drug’s condition. 62. On information and belief, as a direct and proximate result of using ParaGard, Plaintiff developed serious and/or permanent adverse effects. 63. As a result 0f said injuries, Plaintiff suffered significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, embarrassment, inconvenience, loss of earnings and earning capacity, and have and Will incur past and future medical expenses. 64. 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 t0 manufacture, market, distribute, sell, and profit from sales 0f ParaGard. 65. The Cooper Defendants continue t0 manufacture, market, distribute, sell and profit from sales of ParaGard. 66. Despite such knowledge, Defendants knowingly, purposely, and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers, and the public 0f the increased risk of serious injury associated with using ParaGard. 67. On information and belief, Plaintiff” s prescribing physicians would not have prescribed ParaGard to Plaintiff, would have changed the way they warned Plaintiff about the signs and symptoms of serious adverse effects of ParaGard, and discussed With Plaintiff the true risks of arm breakage and resulting injuries and complications had Defendants provided said physicians With an appropriate and adequate warning regarding the risks associated With the use of the ParaGard IUD. 68. As a direct and proximate result of Defendants’ conduct, Plaintiff suffered injuries, including, but not limited t0, pain, suffering, and loss of reproductive health, Which resulted in damages to Plaintiff in a sum in excess of the jurisdictional limits 0f the Court. 69. The Cooper Defendants and Teva Defendants maintained a duty t0 Plaintiff after the ParaGard was implanted and until it was removed. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 70. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. Civ. Code §3439, et. seq., any other state or federal successor in interest acts or statutes; and the Federal Consumer Protection Act pursuant t0 a fraudulent conveyance or transfer of assets. 71. As a direct result 0f Plaintiff” s use 0f the ParaGard, Plaintiff suffered from having a broken arm 0f the ParaGard in her, causing her damage, including but not limited to pain, suffering, mental anguish, the loss 0f reproductive health, loss of enjoyment 0f life, medical expenses and other out 0f pocket losses and loss of income. VII. DELAYED DISCOVERY 72. Plaintiff incorporates by reference the factual portion 0f this Complaint as if fully set forth herein and additionally, or in the alternative, if same be necessary, allege as follows: 73. Plaintiff plead that the discovery rule should be applied t0 toll the running of the statute of limitations until Plaintiff knew, 0r through the exercise of reasonable care and diligence should have known, of facts indicating that the Plaintiff had been injured, the cause of the injury and the tortuous nature of the wrongdoing that caused the injury. 74. Despite diligent investigation by Plaintiff into the cause 0f her injuries, including consultations With Plaintiff” s medical providers, the nature 0f Plaintiff s injuries and damages and their relation to the Plaintiff” s ParaGard IUD and Defendants’ wrongful conduct was not discovered and could not have been discovered, until a date Within the applicable statute 0f limitations for filing each 0f Plaintiff s claims. Therefore, under appropriate application 0f the discovery rule, Plaintiff’s suit was filed well within the applicable statutory limitations period. 75. Any applicable statutes 0f limitations have been tolled by the knowing and active concealment and denial of material facts known by the Defendants when they had a duty to disclose those facts. The Defendants’ purposeful and fraudulent acts of concealment have kept Plaintiff ignorant of Vital information essential to the pursuit of Plaintiff’ s claims, Without any fault 0r lack 0f diligence on Plaintiff’ s part, for the purpose of obtaining delay 0n Plaintiffs filing 0f their causes 0f action. The Defendants’ fraudulent concealment did result in such delay. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 76. Defendants’ are estopped from relying on the statute of limitations defense because Defendants failed to timely disclose, among other things, facts evidencing the defective and unreasonably dangerous nature of their ParaGard IUD. VII. CAUSES OF ACTION COUNT I - NEGLIGENCE 77. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. 78. At times relevant, Defendants were in the business 0f designing, developing, setting specifications, manufacturing, marketing, selling and/or distributing the ParaGard IUD, including the one that was implanted into the Plaintiff. 79. Defendants had a duty to exercise reasonable and ordinary care in the manufacture, design, labeling, instructions, warnings, sale, marketing, safety surveillance and distribution of the ParaGard s0 as to avoid exposing others t0 foreseeable and unreasonable risks 0f harm. 80. Defendants breached their duty 0f care to the Plaintiff and her physicians, in the manufacture, design, labeling, warnings, instructions, sale, marketing, safety surveillance, and distribution of the ParaGard. 81. Defendants knew that the ParaGard could break upon removal and failed t0 warn Plaintiff of this potential injury. 82. Defendants had a duty to warn Plaintiff, Plaintiffs physician, and/or the medical community of the potential for breakage at the arm(s) upon removal. 83. The Cooper Defendants had a continuing duty to warn Plaintiff, Plaintiff’ s physician, and/or the medical community of the potential for breakage at the arm(s) upon removal upon it’s acquisition of ParaGard IUD in September of 2017. Cooper Defendants breached that duty and Plaintiff was harmed. 84. Defendants knew 0r reasonably should have known that the ParaGard IUD was dangerous or likely to be dangerous When used in its intended 0r reasonably foreseeable manner. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 85. At the time of the manufacture and sale of the ParaGard IUD, Defendants knew or should have known that the ParaGard IUD was designed and manufactured in such a manner so as to present an unreasonable risk 0f the fracture 0f the arm 0f the drug upon removal. 86. At the time of the manufacturer and sale of the ParaGard IUD, Defendants knew or should have known that the ParaGard IUD was designed and manufactured t0 have unreasonable and insufficient strength 0r structural integrity t0 withstand normal placement and subsequent removal. 87. At the time of the manufacture and sale of the ParaGard IUD, Defendants knew or 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 t0 remove the fragmented drug, even leading to hysterectomy. 88. Upon acquisition 0f ParaGard IUD from Teva Defendants, Cooper Defendants are charged with the same knowledge that Teva Defendants knew or should have known regarding the risks associated With ParaGard IUD at the time 0fmanufacture and sale, and therefore, all Defendants had a continuing duty t0 warn Plaintiff and her physicians 0r the general health care community of those reasonably known risks. 89. Defendants knew or reasonably should have known that the consumers 0f the ParaGard IUD would not realize the danger associated with using the drug for its intended use and/or in a reasonably foreseeable manner. 90. Defendants breached their duty t0 exercise reasonable and prudent care in the development, testing, design, manufacture, inspection, marketing, labeling, promotion, distribution and sale 0f the ParaGard IUD in, among others, the following ways: a. Designing and distributing a product in which they knew 0r should have known that the likelihood and severity of potential harm from the product exceeded the burden of taking measures t0 reduce or avoid harm; b. Designing and distributing a product in which they knew 0r should have known that the likelihood and severity 0f potential harm from the product \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O exceeded the likelihood of potential harm from other drug available for the same purpose; c. Failing t0 use reasonable care in manufacturing the product and producing a product that differed from their design or specifications; d. Failing t0 use reasonable care t0 warn 0r instruct Plaintiff, Plaintiff’ s healthcare providers 0r 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 t0 perform reasonable pre-and post-market testing of the ParaGard IUD to determine Whether 0r not the product was safe for its intended use; f. Failing to provide adequate instructions, guidelines, and safety precautions, t0 those persons t0 Whom it was reasonably foreseeable would recommend, use, implant and remove the ParaGard IUD; g. Advertising, marketing and recommending the use 0f the ParaGard IUD, while concealing and failing t0 disclose 0r warn of the dangers known by the Defendants to be connected With and inherent in the use 0fthe 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 t0 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 0f serious harm associated with the use of the IUD; k. Failing t0 establish an adequate quality assurance program used in the manufacturing 0f the ParaGard IUD; and \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 1. Failing t0 establish and maintain an adequate post-marketing surveillance program for the ParaGard IUD. m. Failing t0 adequately and correctly report safety information relative to the ParaGard product resulting in inadequate warnings. n. Failing to provide adequate and continuous warnings about the inherent danger 0f breakage with the ParaGard upon removal. 91. A reasonable manufacturer, distributor, and/or seller under the same or similar circumstances would not have engaged in the aforementioned acts and omissions. 92. As a direct and proximate result 0f the Defendants’ design, manufacture, marketing, sale and/or distribution of the ParaGard, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss 0f enjoyment of life, loss 0f reproductive health, comfort, and economic damages. 93. The Cooper Defendants are also liable as a successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. Civ. Code §3439, er. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues so triable as a matter 0f right. COUNT II - STRICT LIABILITY DESIGN DEFECT 94. Plaintiff realleges and incorporates by reference every allegation of this Complaint as if each were set forth fully and completely herein. 95. The ParaGard is inherently dangerous and defective, unfit and unsafe for its intended use and reasonably foreseeable uses and does not meet or perform t0 the expectations of patients and their health care providers. 96. The ParaGard IUD was expected to, and did, reach its intended consumer Without substantial change in the condition in Which it was in When it left Defendants’ possession. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 97. The ParaGard IUD implanted in Plaintiffwas defective in design because it failed t0 perform as safely as persons Who ordinarily use the products would have expected at time of use. 98. The ParaGard IUD implanted in Plaintiff was defective in design, in that the IUD’s risks ofharm exceeded its claimed benefits. 99. Plaintiff and her healthcare providers used the ParaGard IUD in a manner that was reasonably foreseeable to the Defendants. 100. Neither Plaintiff nor her healthcare providers could have by the exercise 0f reasonable care discovered the IUD’s defective conditions 0r perceived its unreasonable dangers prior t0 her implantation 0f the drug. 101. As a result 0f the foregoing design defects, the ParaGard created risks to the health and safety 0f its users that were far more significant and devastating than the risks posed by other products and procedures available t0 treat the corresponding medical conditions, and Which far outweigh the utility 0f the ParaGard. 102. Defendants have intentionally and recklessly designed the ParaGard With wanton and willful disregard for the rights and health 0f the Plaintiff and others, and With malice, placing their economic interests above the health and safety 0f the Plaintiff and others. 103. As a proximate result 0f the Defendants’ design 0f the ParaGard, 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. 104. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues so triable as a matter 0f right. COUNT III - STRICT LIABILITY FAILURE TO WARN \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 105. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. 106. Defendants designed, set specifications, manufactured, prepared, compounded, assembled, processed, marketed, labeled, distributed and sold the ParaGard IUD, including the one implanted into Plaintiff, into the stream of commerce and in the course of same, directly advertised and marketed the drug t0 consumers or persons responsible for consumers. 107. At the time Defendants designed set specifications, manufactured, prepared, compounded, assembled, processed, marketed, labeled, distributed and sold the ParaGard IUD into the stream of commerce, Defendants knew or should have known that the drug presented an unreasonable danger to users 0f the product When put to its intended and reasonably anticipated use. 108. Specifically, Defendants knew or should have known that the ParaGard IUD posed a significant risk that one 0f the arms 0f the drug could break upon removal, resulting in significant injuries. 109. Defendants had a duty to warn 0f the risk ofharm associated With the use 0f the drug and t0 provide adequate warnings concerning the risk the drug could break upon removal, even if implanted properly and even if the drug remained properly in-place. 1 10. The Cooper Defendants had a continuing duty t0 warn Plaintiff, Plaintiff s physician, and/or the medical community 0f the potential for breakage at the arm(s) upon removal upon it’s acquisition of ParaGard IUD in September of 2017. 111. Defendants failed t0 properly and adequately warn and instruct the Plaintiff and her health care providers With regard t0 the inadequate research and testing 0f the ParaGard, and the complete lack 0f a safe, effective procedure for removal 0f the ParaGard. 112. The risks associated With the ParaGard IUD are of such a nature that health care providers and users could not have recognized the potential harm. 113. The ParaGard IUD was defective and unreasonably dangerous at the time 0f its release into the stream of commerce due t0 the inadequate warnings, labeling and/or instructions accompanying the product, including but not limited t0, the implantation and subsequent removal of ParaGard. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 114. The ParaGard IUD, when implanted in Plaintiff, was in the same condition as when it was manufactured, inspected, marketed, labeled, promoted, distributed and sold by the Defendants. 115. The Defendants intentionally, recklessly, and maliciously misrepresented the safety, risks, and benefits in order to advance their own financial interests, With wanton and willful disregard for the rights and health of the Plaintiff. 116. As a proximate result ofthe Defendants’ design, manufacture, marketing, sale and/or distribution 0f the ParaGard, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss of enjoyment of life, loss ofreproductive health, comfort, and economic damages. 117. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance 0r transfer 0f assets. WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess of $50,000.00, and such other relief as this Court deems just and for a trial by jury on all issues so triable as a matter 0f right. COUNT IV - COMMON LAW FRAUD 118. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. 119. The Defendants have falsely and fraudulently represented and continue to represent to the medical and healthcare community, Plaintiff and her physicians, and/or the public that the ParaGard IUD had been appropriately tested and was found to be safe and effective. 120. The representations made by the Defendants were, in fact, false. When the Defendants made their representations, they knew and/or had reason to know that those representations were false, and they willfully, wantonly, and recklessly disregarded the inaccuracies in their representations and the dangers and health risks t0 users of the ParaGard. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 121. These representations were made by the Defendants with the intent of defrauding and deceiving the medical community, Plaintiff, and the public, and also inducing the medical community, Plaintiff, Plaintiff’s physicians, and/or the public, to recommend, prescribe, dispense, and purchase the ParaGard for use as a form 0f long-term birth control, all 0f which evidenced a callous, reckless, willful, and depraved indifference t0 the health, safety, and welfare 0f Plaintiff. 122. In representations to Plaintiff and/or t0 her healthcare providers, the Defendants fraudulently concealed and intentionally omitted the following material information: a. That the ParaGard was not as safe as other products and procedures available t0 aid in the long-term prevention of pregnancy; That the risk of adverse events With the ParaGard was higher than With other products and procedures available for birth control; The ParaGard IUD was not adequately tested; That the limited clinical testing for ParaGard revealed a higher risk of adverse events, above and beyond those associated With other products and procedures available for birth control; That Defendants deliberately failed t0 follow up 0n the adverse results from clinical studies and/or formal and informal reports from physicians and/or other healthcare providers and either ignored, concealed and/or misrepresented those findings; That Defendants were aware 0f dangers in the ParaGard IUD in addition t0 and above and beyond those associated With other products and procedures available for birth control; That the ParaGard IUD was defective, and that it caused dangerous and adverse side effects, including but not limited t0 unacceptable incidence ofbreakage upon removal; That when the ParaGard IUD needed t0 be removed, the removal procedure had a very high failure rate and/or needed t0 be performed repeatedly; That the ParaGard IUD was manufactured negligently; \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O j. That the ParaGard IUD was manufactured defectively; and k. That the ParaGard IUD was designed negligently and designed defectively. 123. The Defendants were under a duty t0 disclose t0 Plaintiff and her physicians, the defective nature 0f the ParaGard, including but not limited to, the risk ofbreakage prior to and upon removal, Which could result in permanent injury. 124. The Defendants had sole access t0 material facts concerning the defective nature 0f the products and their propensity to cause serious and dangerous side effects and hence, cause dangerous injuries and damage to persons Who used the ParaGard, such as Plaintiff. 125. The Defendants” concealment and omissions of material facts concerning the safety of the ParaGard IUD were made purposefully, willfully, wantonly, and/or recklessly t0 mislead Plaintiff, Plaintiff” s physicians, surgeons and healthcare providers and t0 induce them t0 purchase, prescribe, and/or dispense the ParaGard IUD; and/or t0 mislead them into reliance upon and cause them t0 use the ParaGard IUD. 126. At the time these representations were made by Defendants, and at the time Plaintiff and/or her physicians, used the ParaGard IUD, Plaintiff and/or her physicians were unaware 0f the falsehood of these representations, and reasonably believed them to be true. 127. The Defendants knew and had reason t0 know that the ParaGard IUD could and would cause severe and grievous personal injury to the users of the product and was inherently dangerous in a manner that exceeded any purported, inaccurate, 0r otherwise downplayed warnings. 128. In reliance upon these false representations, Plaintiff and her physicians were induced t0, and did use the ParaGard IUD, thereby causing severe and permanent personal injuries and damages t0 Plaintiff. The Defendants knew or had reason to know that the Plaintiff and her physicians and other healthcare providers had n0 way t0 determine the truth behind the Defendants’ concealment and omissions, and that these included material omissions 0f facts surrounding the use of the ParaGard IUD, as described in detail herein. 129. Plaintiff and her physicians reasonably relied on facts provided by the Defendants Which foreseeably and purposefully suppressed and concealed facts that were critical t0 understanding the real dangers inherent to the use 0f the ParaGard IUD. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 130. Having knowledge based 0n the Defendants research and testing, 0r lack thereof, Defendants blatantly and intentionally distributed false information, including but not limited to assurances t0 Plaintiff, the public, and Plaintiff’s healthcare providers and physicians, that the ParaGard IUD was safe for use as a means of providing long-term birth control and was as safe or safer than other product and/or procedures available and/or on the market. As a result 0fDefendants’ research and testing, 0r lack thereof, these Defendants intentionally omitted, concealed and suppressed the dissemination of certain results of testing and research t0 healthcare professionals, Plaintiff, her physicians, and the public at large. 131. The Defendants had a duty When disseminating information t0 the public to disseminate truthful information; and a parallel duty not t0 deceive the public, Plaintiff, and/or her physicians. 132. The information distributed t0 the public, the medical community, Plaintiff and her physicians by the Defendants included, but was not limited t0 websites, information presented at medical and professional meetings, information disseminated by sales representatives to physicians and other medical care providers, professional literature, reports, press releases, advertising campaigns, television commercials, print advertisements, and/or other commercial media, and contained material representations Which were false and misleading, as well as omissions and concealments 0f the truth about the dangers 0f the use of the ParaGard IUD. 133. These representations, and others made by the Defendants, were false When made and/or were made With the pretense 0f actual knowledge When such knowledge did not actually exist, and were made recklessly and without regard t0 the true facts. 134. The Defendants recklessly and/or intentionally falsely represented the dangerous and serious health and safety concerns inherent in the use 0f the ParaGard to Plaintiff, her physicians and the public at large, for the purpose of influencing the sales of products known to be dangerous and defective, and/or not as safe as other alternatives. 135. At the time the representations were made, Plaintiff and her healthcare providers did not know the truth about the dangers and serious health and/or safety risks inherent in the use 0f the ParaGard. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 136. Plaintiff did not discover the true facts about the dangers and serious health and/or safety risks, nor did Plaintiff discover the false representations of the Defendants, nor would Plaintiff with reasonable diligence have discovered the true facts about the Defendant’s misrepresentations at the time When the ParaGard IUD was surgically implanted into her. 137. Had Plaintiffknown the true facts about the dangers and serious health and/or safety risks of the ParaGard IUD, neither Plaintiff nor her physician would not have purchased, used, or relied on Defendants’ representations and omissions concerning the ParaGard IUD. 138. As a proximate result ofthe Defendants’ design, manufacture, marketing, sale and/or distribution of the ParaGard IUD, Plaintiff has been seriously injured, and sustained severe and permanent injury, pain, suffering, disability, and impairment, loss of enjoyment of life, loss 0f reproductive health, comfort, and economic damages. 139. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts or statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues as triable as a matter of right. COUNT V - NEGLIGENT MISREPRESENTATION 140. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. 141. At relevant times, Teva Defendants negligently provided Plaintiff, her healthcare providers, and the general medical community with false or incorrect information or omitted or failed to disclose material information concerning the ParaGard IUD, including, but not limited t0, misrepresentations regarding the safety of the ParaGard IUD. 142. The information distributed by the Defendant t0 the public, the medical community, the Plaintiff and her healthcare providers, including advertising campaigns, labeling materials, print \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O advertisements, commercial media, was false and misleading and contained omissions and concealment 0f truth about the dangers of the ParaGard IUD. 143. Defendants’ intent and purpose in making these misrepresentations was to deceive and defraud the public and the medical community, including Plaintiff and Plaintiffs” health care providers; to falsely assure them 0f the quality of the ParaGard IUD and the induce the public and medical community, including Plaintiff and her healthcare provider to request, recommend, prescribe, implant, purchase and continue t0 use the ParaGard IUD. 144. The Defendants had a duty to accurately and truthfully represent to the medical and healthcare community, medical drug manufacturers, Plaintiff, her healthcare providers and the public, that the ParaGard IUD had been tested and found t0 be safe and effective for long term birth control. 145. The representations made by the Defendants were, in fact, false. The ParaGard IUD was not safe for human use in its intended and reasonably foreseeable manner. Use of the ParaGard IUD is dangerous as there is a risk that it may fracture upon removal cause significant injury. 146. In reliance upon the false and negligent misrepresentations and omissions made by the Defendants, Plaintiff and Plaintiff’s healthcare providers were induced to, and did use the ParaGard IUD, thereby causing Plaintiff t0 endure severe and permanent injuries. 147. Defendants knew and had reason t0 know that the Plaintiff, Plaintiff’s healthcare providers, and the general medical community did not have the ability to determine the true facts Which were intentionally and/or negligently concealed and misrepresented by the Defendants. 148. Plaintiff and her healthcare providers would not have recommended, and implanted ParaGard IUD had the true facts not been concealed by the Defendants. 149. Defendants had sole access to the material facts concerning the defective nature 0f the ParaGard IUD and its propensity t0 cause serious and dangerous side injuries. 150. At the time Defendants failed t0 disclose and misrepresented the foregoing facts, and at the time Plaintiff was implanted With the ParaGard IUD, Plaintiff and her healthcare providers were unaware 0f Defendants’ negligent misrepresentations and omissions. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 151. The Defendants failed t0 exercise ordinary care in making representations concerning the ParaGard IUD while they were involved in their manufacture, sale, testing, quality assurance, quality control, and distribution in interstate commerce, because the Defendants negligently misrepresented the ParaGard’s high risk of unreasonable and dangerous adverse side effects. 152. The Defendants breached their duty t0 Plaintiff, her physicians, and the medical and healthcare community, by representing that the ParaGard IUD has no serious side effects different from older generations of similar products 0r procedures. 153. Plaintiff and Plaintiff’s healthcare providers reasonably relied upon the misrepresentations and omissions made by the Defendants, Where they concealed and misrepresented facts that were critical t0 understanding the true dangers inherent in the use of the ParaGard IUD. 154. Plaintiff and Plaintiff’s healthcare providers’ reliance on the foregoing misrepresentations and omissions was the direct and proximate cause 0f Plaintiffs injuries. 155. The Defendants knew, and had reason to know, that the ParaGard had been insufficiently tested, 0r had not been tested at all, that the products lacked adequate and accurate warnings, that they created a high risk, and/or higher than acceptable risk, and/or higher than reported risk that they represented a risk of adverse side effects, including, pain and suffering, surgery to remove the product, and other severe and personal injuries, Which are permanent and lasting in nature. 156. As a proximate result ofthe Defendants’ design, manufacture, marketing, sale and/or distribution of the ParaGard, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss 0fenjoyment of life, loss ofreproductive health, comfort, and economic damages. 157. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues as triable as a matter of right. COUNT VI - BREACH OF EXPRESS WARRANTY 158. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. 159. At relevant times, Teva Defendants intended that the ParaGard be used in the manner that Plaintiff used it and Defendants expressly warranted that each product was safe and fit for use by consumers, that it was ofmerchantable quality, that its side effects were minimal and comparable to other treatments for long-term birth control, and that they were adequately tested and fit for their intended use. 160. At relevant times, Teva Defendants were aware that consumers, including Plaintiff, would use the ParaGard; which is to say that Plaintiff was a foreseeable user of the ParaGard. 161. Plaintiff and/or her implanting physicians were, at all relevant times, in priVity With the Defendants. 162. ParaGard was expected to reach and did in fact reach its ultimate consumer, including Plaintiff and her implanting physicians, without substantial change in the condition in Which it was manufactured and sold by the Defendants. 163. The Defendants breached various express warranties With respect t0 the ParaGard including the following particulars: 1. The Defendants represented t0 Plaintiff and her physicians and healthcare providers through their labeling, advertising, marketing materials, detail persons, seminar presentations, publications, notice letters, and regulatory submissions that the ParaGard was safe, and fraudulently Withheld and concealed information about the substantial risks 0f serious injury associated with using the ParaGard; m. The Defendants represented t0 Plaintiff and her physicians and healthcare providers that the ParaGard was as safe, and/or safer than other alternative \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O procedures and drugs and fraudulently concealed information, which demonstrated that the ParaGard was not safer than alternatives available 0n the market; and n. The Defendants represented to Plaintiff and her physicians and healthcare providers that the ParaGard was more efficacious than other alternatives and fraudulently concealed information regarding the true efficacy 0f the products. 164. In reliance upon the Defendants’ express warranties, Plaintiff was implanted With the ParaGard as prescribed and directed, and therefore, in the foreseeable manner normally intended, recommended, promoted, and marketed by the Defendants. 165. At the time 0f making such express warranties, the Defendants knew 0r should have known that the ParaGard does not conform to these express representations because the ParaGard was not safe and had numerous side effects, many 0f Which the Defendants did not accurately warn about, thus making the ParaGard unreasonably unsafe for its intended purpose. 166. Members of the medical community, including physicians and other healthcare professionals, as well as Plaintiff and her physicians, relied upon the representations and warranties of the Defendants in connection With use, recommendation, description, and/or dispensing of the ParaGard. 167. The Defendants breached their express warranties t0 Plaintiff in that the ParaGard was not of merchantable quality, safe and/or fit for its intended uses, nor was it adequately tested. 168. The Defendants’ breach constituted Violations of common law principles. 169. As a proximate result ofthe Defendants’ design, manufacture, marketing, sale and/or distribution of the ParaGard, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss 0fenjoyment of life, loss ofreproductive health, comfort, and economic damages. 170. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues as triable as a matter of right. COUNT VII - BREACH OF IMPLIED WARRANTY 171. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. 172. At relevant and material times, Teva Defendants manufactured, distributed, advertised, promoted, and sold the ParaGard. 173. At relevant times, Teva Defendants intended that the ParaGard be implanted for the purposes, and in the manner, that Plaintiff 0r her physicians or surgeons used it and the Defendants impliedly warranted each ParaGard to be of merchantable quality, safe and fit for such use, and t0 have been adequately tested. 174. Defendants were aware that consumers, including Plaintiff or her physicians or surgeons would implant the ParaGard in the manner described by the instructions for use and that Plaintiff was the foreseeable user 0f the ParaGard. 175. Plaintiff and/or her physicians and surgeons were at all relevant times in priVity with Defendants. 176. The Defendants’ ParaGard was expected to reach and did in fact reach consumers, including Plaintiff and/or her physicians and surgeons, Without substantial change in the condition in which they manufactured and sold by Defendants. 177. Defendants breached various implied warranties With respect to the ParaGard, including the following particulars: a. Defendants represented through their labeling, advertising, marketing materials, detail persons, seminar presentations, publications, notice letters, medical literature, and regulatory submissions that the ParaGard was safe and fraudulently Withheld and concealed information about the substantial risks 0f serious injury associated With using the ParaGard; \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O b. Defendants represented that the ParaGard was safe, and/or safer than other alternative drugs or procedures and fraudulently concealed information, which demonstrated that the ParaGard was not as safe or safer than alternatives available on the market; and c. Defendants represented that the ParaGard was more efficacious than other alternative treatments and fraudulently concealed information, regarding the true efficacy 0f the ParaGard. 178. In reliance upon Defendants’ implied warranties, Plaintiff and/or her implanting physicians and surgeons used the ParaGard as prescribed in the foreseeable manner normally intended, recommended, promoted, and marketed by Defendants. 179. Defendants breached their implied warranties to Plaintiff and/or her implanting physicians and surgeons in that the ParaGard was not 0f merchantable quality, safe and fit for its intended use, 0r adequately tested, in Violation of common law principles. 180. As a proximate result ofthe Defendants’ design, manufacture, marketing, sale and/or distribution of the ParaGard, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss 0fenjoyment of life, loss ofreproductive health, comfort, and economic damages. 181. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues as triable as a matter of right. COUNT VIII - VIOLATION OF CONSUMER PROTECTION LAWS 182. Plaintiff realleges and incorporates by reference every allegation 0f this Complaint as if each were set forth fully and completely herein. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 183. Plaintiff purchased and used the ParaGard primarily for personal use thereby suffering ascertainable losses, as a result of the Defendants’ actions in Violation of the consumer protection laws. 184. Had the Defendants not engaged in the deceptive conduct described herein, Plaintiff and her physicians would not have purchased and/or paid for the ParaGard and would not have incurred related medical costs and injury. 185. The Defendants engaged in wrongful conduct while at the same time obtaining, under false pretenses, moneys from Plaintiff for the ParaGard, that was implanted into her, and that would not have been paid for had the Defendants not engaged in unfair and deceptive conduct. 186. Unfair methods of competition of deceptive acts 0r practices that were proscribed by law, including the following: a. Representing that goods 0r services have characteristics, ingredients, uses benefits or quantities that they d0 not have; b. Advertising goods or services With the intent not to sell them as advertised; and c. Engaging in fraudulent 0r deceptive conduct that creates a likelihood of confusion and/or misunderstanding. 187. Plaintiff was injured by the cumulative and indivisible nature 0f the Defendants’ conduct. The cumulative effect 0f the Defendants’ conduct directed at patients, physicians and consumers, including the Plaintiff and her physicians, was to create demand for and promote the sale 0f ParaGard. Each aspect 0f the Defendants’ conduct combined t0 artificially create sales 0f the ParaGard. 188. The Defendants have a statutory duty t0 refrain from unfair 0r deceptive acts or trade practices in the design, labeling, development, manufacture, promotion, and sale of the ParaGard. 189. Had the Defendants not engaged in the deceptive conduct described above, Plaintiff would not have purchased and/or paid for the ParaGard, and would not have incurred related medical costs. 190. The Defendants’ deceptive, unconscionable, 0r fraudulent representations and material omissions t0 patients, physicians and consumers, including Plaintiff and her physicians, \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O constituted unfair and deceptive acts and trade practices in Violation 0f the state and Federal consumer protection statutes. 191. The Defendants’ actions, as complained 0f herein, constitute unfair competition 0r unfair, unconscionable, deceptive 0r fraudulent acts, or trade practices in Violation 0f state and Federal consumer protection statutes, , including but not limited t0 the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq. and Unfair Practices Act, Cal. Bus. & Prof. Code § 17000, et. seq. 192. The Defendants have engaged in unfair competition 0r unfair 0r deceptive acts or trade practices or have made false representations in Violation under the statute listed above to protect consumers against unfair, deceptive, fraudulent and unconscionable trade and business practices and false advertising, the Defendants are the suppliers, manufacturers, advertisers, and sellers, Who are subject to liability under such legislation for unfair, deceptive, fraudulent and unconscionable consumer sales practices. 193. Teva and Cooper Defendants engaged in fraudulent behavior regarding the transfer and/or sale 0f assets t0 Cooper Defendants in 2017. Cooper Defendants knew 0r should have reasonably known that the transfer of assets was done in a manner consistent with and in an effort to, deceive potential creditors. 194. Pursuant to the terms of the asset purchase agreement, Teva Women’s Health, Inc., claims to maintain liability for all ParaGard placed prior to the execution of the asset purchase agreement in September of 2017. However, Teva Women’s Health, Inc., converted t0 Teva Women’s Health, LLC and sold off all of its assets. 195. Cooper Defendants knew or reasonably should have known that Teva Defendants converted Teva Women’s Health, Inc., into Teva Women’s Health, LLC after selling off or moving all assets from Teva Women’s Health, Inc. 196. Therefore, Cooper Defendants knew or reasonably should have known that Teva Defendants shuffling 0f assets and subsequent conversions were done t0 thwart potential creditors in Violation of Unfair Practices Act, Cal. Bus. & Prof. Code § 17000, et. seq. and Federal consumer protection laws. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O 197. The Defendants violated the statutes that were enacted t0 protect consumers against unfair, deceptive, fraudulent and unconscionable trade and business practices and false advertising, by knowingly and falsely representing that the ParaGard was fit t0 be used for the purpose for which it was intended, when in fact it was defective and dangerous, and by other acts alleged herein. These representations were made in uniform promotional materials and product labeling. 198. The actions and omissions of the Defendants alleged herein are uncured 0r incurable deceptive acts under the statutes enacted in the states t0 protect consumers against unfair, deceptive, fraudulent and unconscionable trade and business practices and false advertising. 199. The Defendants had actual knowledge of the defective and dangerous condition of the ParaGard and failed to take any action to cure such defective and dangerous conditions. 200. Plaintiff and her implanting physicians and surgeons relied upon the Defendants’ misrepresentations and omissions in determining which product and/or procedure t0 undergo and/or perform. 201. The Defendants’ deceptive, unconscionable or fraudulent representations and material omissions t0 patients, physicians and consumers, constitute unfair and deceptive acts and practices. 202. By reason 0f the unlawful acts engaged by the Defendants, and as a direct and proximate result thereof, Plaintiff has suffered ascertainable losses and damages. 203. As a proximate result ofthe Defendants’ design, manufacture, marketing, sale and/or distribution of the ParaGard, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss 0fenjoyment of life, loss ofreproductive health, comfort, and economic damages. 204. The Cooper Defendants are also liable as successors-in-interest under the California Uniform Fraudulent Transfer Act, Cal. CiV. Code §3439, et. seq., any other state or federal successor in interest acts 0r statutes; and the Federal Consumer Protection Act pursuant to a fraudulent conveyance or transfer 0f assets. WHEREFORE, Plaintiff demands judgment against the Defendants, jointly and severally, for compensatory damages, for punitive damages and for costs, in an as yet unliquidated sum in \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O excess 0f $50,000.00, and such other relief as this Court deems just and for a trial by jury 0n all issues as triable as a matter of right. PRAYER FOR RELIEF Plaintiff incorporates by reference each and every paragraph of this Complaint as though set forth here in full and further prays: 205. So far as the law and this Court allows, Plaintiff demands judgment against each Defendant 0n each count as follows: a. A11 available compensatory damages for the described losses With respect t0 each cause of action; b. Past and future medical expenses, as well as the cost associated With past and future life care; c. Past and future lost wages and loss 0f earning capacity; d. Past and future emotional distress; e. Consequential damages; f. A11 available noneconomic damages, including Without limitation pain, suffering, and loss 0f enjoyment of life; A11 wrongful death damages permitted by law, Where applicable; Disgorgement 0f profits obtained through unjust enrichment; i. Restitution; j. Punitive damages With respect to each cause of action; k. Reasonable attorneys' fees Where recoverable; 1. Costs of this action; m. Pre-judgment and all other interest recoverable; and n. Such other additional, further, and general relief as Plaintiffmay be entitled t0 in law or in equity as justice so requires. DEMAND FOR JURY TRIAL Plaintiff hereby demands a trial by jury as t0 all issues. \OOOQONU‘I-hUJNr-ax NNNNNNNNNr-tp-Hr-KHr-tp-Hr-KH OOQONU‘I-hUJNP-‘OKOOOQONU‘I-hUJNP-‘O Dated: March 3 1 , 2021 Respectfully submitted, Lauren A. Welling, Esq. Sanders Phillips Grossman, LLC. 16755 Von Karman Ave., Suite 200 Irvine, CA 92606 Phone: 516-741-5600 ext. 8156 Fax: 213-477-2860 Email: lwelling@thesandersfirm.com
