Jury Trial Demanded. Bayer Pharmaceuticals Corporation, Bayer Healthcare Pharmaceuticals, Inc., Plaintiff,

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Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 1 of 22 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Tricia Prendergast, Plaintiff, Civil Action No: V. COMPLAINT Bayer Pharmaceuticals Corporation,: Bayer Healthcare Pharmaceuticals,: Inc., Berlex Laboratories, Inc., Berlex, Inc. Jury Trial Demanded Defendants. Plaintiff, by and through the undersigned counsel, hereby alleges against Bayer Pharmaceuticals Corporation, Bayer Healthcare Pharmaceuticals, Inc., Berlex Laboratories, Inc., and Berlex, Inc. the following: PARTIES AND CITIZENSHIP 1. Plaintiff is Tricia Prendergast. 2. Plaintiff is a resident of Pennsylvania and is a citizen of the Commonwealth of Pennsylvania. 3. Defendant BAYER PHARMACEUTICALS CORPORATION is, and at times relevant was, a corporation organized under the laws of the State of Delaware with its headquarters and principal place of business at 1400 Morgan Lane, West Haven, Connecticut.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 2 of 22 4. As of January 1, 2008, Defendant BAYER PHARMACEUTICALS CORPORATION was merged into Defendant BAYER HEALTHCARE PHARMACEUTICALS INC. 5. Defendant BAYER HEALTHCARE PHARMACEUTICALS INC. is and at times relevant was, a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 340 Changebridge Road, P.O. Box 1000, Montville, New Jersey 07045-1000. 6. Defendant BAYER HEALTHCARE PHARMACEUTICALS INC. was formerly known as BERLEX, INC., which was formerly known as BERLEX LABORATORIES, INC., and is the same corporate entity as BERLEX, INC. and BERLEXLABORATORIES, INC. 7. Defendant Bayer Healthcare Pharmaceuticals, Inc. is the holder of the approved New Drug Application ("NDA") for the contraceptive device known as Mirena. 8. Defendants BERLEX LABORATORIES, INC. and BERLEX, INC. are, and at all times relevant were, foreign corporations with their headquarters and principal places of business at Montville, New Jersey and with a post office address of P.O. Box 1000, Montville, New Jersey, 07045 and places of business located at 6 West Belt Road, Wayne, New Jersey 07470. 9. Defendants BERLEX LABORATORIES, INC. and BERLEX, INC. were integrated into Bayer HEALTHCAREAG and operate as an integrated specialty pharmaceuticals business under the new name, BAYER HEALTHCARE PHARMACEUTICALS, INC.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 3 of 22 10. Defendants are in the business of designing, manufacturing, and marketing prescription drugs and other women's healthcare products, including the intrauterine contraceptive system Mirena. 11. Defendants regularly and routinely conduct business in Pennsylvania through the sale of Mirena and sells other products in the Commonwealth. 12. Defendants Bayer Pharmaceuticals Corporation, Bayer Healthcare Pharmaceuticals, Inc., Berlex Laboratories, Inc. and Berlex, Inc. shall be referred to herein individually by name or jointly as "Defendants." 13. At all times alleged herein, Defendants include and included any and all parents, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, their predecessors, successors and assigns and their officers, directors, employees, agents, representatives and any and all other persons acting on their behalf. 14. At all times herein mentioned, each of the Defendants was the agent, servant, partner, predecessors in interest, aider and abettor, co-conspirator and joint venturer of each of the remaining Defendants herein and was at all times operating and acting with the purpose and scope of said agency, service, employment, partnership, conspiracy and joint venture. 15. At all times relevant, Defendants were engaged in the business of developing, designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate commerce throughout the United States, either

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 4 of 22 directly or indirectly through third parties, subsidiaries or related entities, the IUD Mirena. JURISDICTION AND VENUE 16. Plaintiff alleges damages in excess of one hundred, fifty thousand dollars ($150, 000.00), exclusive of costs and interests. 17. This Court has jurisdiction over this action pursuant to 28 U.S.C.A. 1332, as there is complete diversity of citizenship between Plaintiff and Defendants, and the amount in controversy exceeds $150, 000.00, exclusive of interest and costs. 18. Venue is proper in this District pursuant to 28 U.S.C.A. 1391, as a substantial part of the events or omissions giving rise to the claim occurred within this District, including, but not limited to, Plaintiff received treatment for the Mirena IUD in this Commonwealth, the development, design, licensing, labeling, manufacturing and/or marketing of the defective IUD, as well as Defendant's fraud and conspiracy to actively conceal and/or misrepresent information concerning the safety and efficacy of Mirena with the intention and specific desire to mislead the medical, pharmaceutical and/or scientific communities, and users and/or consumers of the Mirena IUD, including Plaintiff. FACTS 19. Mirena is an intrauterine contraceptive system made of flexible plastic that is inserted by a healthcare provider during an office visit.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 5 of 22 20. The Federal Food and Drug Administration (FDA) approved Defendants' New Drug Application for Mirena in December 2000. Today, more than 2 million women in the United States use Mirena. It has been used by more than 15 million women worldwide. 21. The system releases levonorgestrel, a synthetic progestogen, directly into the uterus for birth control. Defendants admit quit is not known exactly how Mirena works, but provide that Mirena may thicken the cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy. 22. The Mirena intrauterine system ("IUS") is designed to be placed within seven (7) days of the first day of menstruation and approved to remain in the uterus for up to five years. If continued use is desired after five years, the old system must be discarded and a new one inserted. 23. The package labeling recommends that Mirena be used in women who have had at least one child suggesting that carrying a child to term may be complicated after Mirena use. 24. Mirena's label does not warn about spontaneous migration of the IUS, but only states that migration may occur if the uterus is perforated during insertion. Additionally, the Mirena label does not disclose the true risks associated with Mirena, including, but not limited to, the risk of it becoming embedded within the body, or the true risk of ectopic pregnancy.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 6 of 22 25. Defendants have a history of overstating the efficacy of Mirena while understating the potential safety concerns. 26. In or around December 2009, Defendants were contacted by the Department of Health and Human Services' Division of Drug Marketing, Advertising and Communications ("DDMAC") regarding a consumer-directed program entitled "Mirena Simple Style Statements Program, a live presentation designed for "busy moms." The Simple Style Program was presented in a consumer's home or other private setting by a representative from "Mom Central", a social networking internet site, and Ms. Barb Dehn, a nurse practitioner, in a partnership with Defendants. 27. The Simple Style Program represented that Mirena use would increase the level of intimacy, romance and emotional satisfaction between sexual partners. DDMAC determined these claims were unsubstantial and, in fact, pointed out that Mirena's package insert states that at least 5% of clinical trial patients reported a decreased libido after use. 28. The Simple Style Program script also intimated that Mirena use can help patients "look and feel great." Again, DDMAC noted these claims were unsubstantiated and that Mirena can cause a number of side effects, including weight gain, acne, and breast pain or tenderness. 29. The portion of the Simple Style script regarding risks omitted information about serious conditions, including susceptibility to infection and the possibility of miscarriage if a woman becomes pregnant while using Mirena.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 7 of 22 30. Finally, Defendants falsely claimed that their program that the system required no compliance with a monthly routine. 31. Plaintiff s physician inserted Mirena in Plaintiff. 32. Through no fault of her own, Plaintiff had complications as a result of the Mirena IUD including but not limited to surgical removal. CAUSES OF ACTION COUNT I DEFECTIVE MANUFACTURING 33. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein, and further alleges as follows. 34. Defendants were and are engaged in the business of selling Mirena in the Commonwealth of Pennsylvania. 35. The Mirena manufactured, marketed, promoted and sold by Defendants was expected to, and did, reach Plaintiff without substantial change in the condition in which it was sold. 36. Defendants have introduced a product into the stream of commerce which is dangerous and unsafe in that the harm of Mirena use outweighs any benefit derived therefrom. The unreasonably dangerous nature of Mirena caused serious harm to Plaintiff. 37. Defendants manufactured, marketed, promoted and sold a product that was not merchantable and/or reasonably suited to the use intended, and its

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 8 of 22 condition when sold was the proximate cause of the injuries sustained by the Plaintiff. 38. As a direct and proximate result of Plaintiffs use of Mirena, she had to undergo surgical removal of the IUD. 39. Defendants placed Mirena into the stream of commerce with wanton and reckless disregard for public safety, including the Plaintiff s health and safety. 40. Defendants knew and, in fact, advertised and promoted the use of Mirena despite their failure to determine the safety and efficacy of such use. As a direct and proximate result of the Defendants' widespread promotional activity, physicians were lead to believe and represented to consumers, including Plaintiff, that the product was safe and effective. 41. Despite the fact that evidence existed showing the use of Mirena was dangerous and likely to place users at serious risk to their health, Defendants failed to disclose and warn of the health hazards and risks associated with Mirena and in fact acted to deceive the medical community and public at large, including Plaintiff and all potential users of Mirena, by promoting it as safe and effective. 42. Defendants knew or should have known that physicians and other healthcare providers began commonly prescribing this product as a safe and effective contraceptive despite its lack of efficacy and potential for serious permanent side effects. 43. There are contraceptives on the market with safer alternative designs in that they provide equal or greater efficacy and far less risk.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 9 of 22 44. As a direct and proximal result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries, required and continues to require medical treatment, and incurred and continues to incur medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against the Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. COUNT II DESIGN DEFECT 45. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 46. Defendants were and are engaged in the business of selling Mirena in the Commonwealth of Pennsylvania. 47. The Mirena manufactured, marketed, promoted and sold by Defendants was expected to, and did, reach Plaintiff without substantial change in the condition in which it was sold. 48. The foreseeable risks associated with the design Mirena include, but are not limited to, the fact that the design or formulation of or formulation of Mirena is more dangerous than a reasonably prudent consumer would expect when used in an intended or reasonably foreseeable manner. 49. Defendants manufactured, marketed, promoted and sold a product that was not merchantable and/or reasonably suited to the use intended, and its

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 10 of 22 condition when sold was the proximate cause of the injuries sustained by the Plaintiff. 50. As a direct and proximate cause of Plaintiffs use of Mirena, she had to undergo pain and suffering and surgical removal of Mirena. 51. Defendants placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety. 52. Defendants knew or should have known that physicians and other healthcare providers began commonly prescribing this product as a safe and effective contraceptive despite its lack of efficacy and potential for serious permanent side effects. 53. There are contraceptives on the market with safer alternative designs in that they provide equal or greater efficacy and far less risk. 54. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries, required and continues to require medical treatment, and incurred and continues to incur medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneysfees and all such other relief as the Court deems appropriate.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 11 of 22 COUNT III NEGLIGENCE 55. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 56. Upon information and belief, Defendants failed to use reasonable care in designing Mirena in that they: a. failed to properly and thoroughly test Mirena before releasing it to market; b. failed to properly and thoroughly analyze the data resulting from the premarketing tests of Mirena; c. failed to conduct sufficient post-market testing and surveillance of Mirena; d. designed, manufactured, marketed, advertised, distributed, and sold Mirena to consumers, including Plaintiff, without an adequate warning of the significant and dangerous risks of Mirena and without proper instructions to avoid the harm which could foreseeably occur as a result of using the Mirena IUD; e. failed to exercise due care when advertising and promoting Mirena; and f. negligently continued to manufacture, market, advertise, and distribute Mirena after Defendants knew or should have known of its adverse effects. 57. A reasonable manufacturer would or should have known that the risks created by Mirena are unreasonably greater than that of other contraceptives and that Mirena has no clinical benefit over such other contraceptives that compensates in whole or part for the increased risk.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 12 of 22 58. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries continues to incur medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. COUNT IV FAILURE TO WARN 59. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 60. Mirena is a defective and therefore unreasonably dangerous product, because its labeling fails to adequately warn consumers and prescribers of, among other things, the risk of migration of the product post-insertion, development of endometriosis resulting from uterine perforation, the risk of embedment of the product, the risk of ectopic pregnancy and/or the possibility that device complication may necessitate hysterectomy. 61. Defendants researched, developed, designed, tested, manufactured, inspected, labeled, distributed, marketed, promoted, sold, and otherwise released Mirena into the stream of commerce and in the course of same, directly advertised or marketed the product to consumers or persons responsible for consumers, and therefore had a duty to warn of the risks associated with the use of Mirena. 62. Mirena was under the exclusive control of Defendants and was unaccompanied by appropriate warnings regarding all of the risks associated with

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 13 of 22 its use. The warnings given did not accurately reflect the risk, incidence, symptoms, scope or severity of such injuries to the consumer or physicians. The promotional activities of Defendants further diluted or minimized the warnings given with the product. 63. Defendants downplayed the serious and dangerous side effects of Mirena to encourage sales of the product. Consequently, Defendants placed its profits above its customers' safety. 64. Mirena was defective and unreasonably dangerous when it left the possession of Defendants in that it contained warnings insufficient to alert Plaintiff, consumers and the medical community of the dangerous risks and reactions associated with it. Even though Defendants knew or should have known of the risks and reactions associated with Mirena, they failed to provide warnings that accurately reflected the signs, symptoms, incident, scope, or severity of the risks associated with the product. 65. Plaintiff used Mirena as intended and in a reasonably foreseeable manner. 66. Plaintiff could not have discovered any defect in Mirena through the exercise of reasonable care. 67. Defendants, as manufacturers of pharmaceutical drugs and the Mirena IUD, are held to the level of knowledge of an expert in the field and, further, Defendants had knowledge of the dangerous risks and side effects of Mirena.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 14 of 22 68. Plaintiff and the medical community did not have the same knowledge as Defendants and no adequate warning was communicated to her by Defendants or by Defendants to her physician(s). 69. Defendants had a continuing duty to warn consumers, including Plaintiff and her physicians, and the medical community of the dangers associated with Mirena, and by negligently and/or wantonly failing to adequately warn of the dangers associated with its use, Defendants breached their duty. 70. Although Defendants knew, or were reckless in not knowing, of the defective nature of Mirena, they continued to design, manufacture, market, and sell Mirena without providing adequate warnings and instructions concerning the use of Mirena so as to maximize sales and profits at the expense of the Plaintiffs and the public's health and safety, in knowing, conscious, and deliberate disregard of the foreseeable harm caused by Mirena. 71. As a direct and proximate result of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries, required and continues to require medical treatment, and incurred and continues to incur medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 15 of 22 COUNT V STRICT LIABILITY 72. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 73. Defendants are manufacturers and/or suppliers of Mirena and are strictly liable to Plaintiff for designing, creating, manufacturing, distributing, selling and placing Mirena into the stream of commerce. 74. The Mirena manufactured and/or supplied by Defendants was defective in design or formulation in that, when it left the hands of the manufacturer and/or suppliers, it was unreasonably dangerous, it was more dangerous than an ordinary consumer would expect and more dangerous than other contraceptives. 75. Mirena was defective in design or formulation in that, when it left the hands of the manufacturer and/or suppliers, the foreseeable risks exceeded the benefits associated with the design or formulation. 76. Mirena was also defective due to inadequate warnings or instructions because the manufacturer knew or should have known that Mirena created, among other things, a risk of perforation, embedment and migration and associated infections or conditions and the Defendants failed to adequately warn of these risks. 77. Mirena was defective due to inadequate pre-marketing testing. 78. Defendants failed to provide adequate initial warnings and postmarketing warnings or instructions after the manufacturer and/or supplier knew or

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 16 of 22 should have known of the extreme risks associated with Mirena and continues to promote Mirena in the absence of those adequate warnings. 79. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries, required and continues to require medical treatment, and incurred and continues to incur medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. COUNT VI BREACH OF IMPLIED WARRANTY 80. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 81. Defendants marketed, manufactured, promoted, distributed and/or sold Mirena as safe for use by the public at large, including Plaintiff, who purchased Mirena. Defendants knew the use for which their product was intended and impliedly warranted the product to be of merchantable quality, safe and fit for use. 82. Plaintiff reasonably relied on the skill and judgment of the Defendants, and as such their implied warranty, in using Mirena. 83. Mirena was not of merchantable quality or safe or fit for its intended use, because it is unreasonably dangerous and unfit for the ordinary purpose for which it was used.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 17 of 22 84. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries, required and continues to require medical treatment, and incurred and continues to incur medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. COUNT VII BREACH OF EXPRESS WARRANTY 85. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows: 86. The aforementioned manufacturing, designing, distributing, marketing, and promoting of Mirena were expressly warranted to be safe by Defendants for Plaintiff and members of the public generally. At the time of the making of these express warranties, Defendants had knowledge of the foreseeable purposes for which Mirena was to be used and Defendants warranted Mirena to be in all respects safe, effective and proper for such purposes. 87. Mirena does not conform to these express warranties and representations because Mirena is not safe or effective for its intended use and may produce serious side effects. 88. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries that required medical treatment and incurred medical and hospital expenses.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 18 of 22 WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. COUNT VIII NEGLIGENT MISREPRESENTATION 89. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 90. Defendants, having undertaken the design, manufacture, marketing, distribution and/or promotion of Mirena, owed a duty to provide accurate and complete information regarding Mirena. 91. Defendants falsely represented to Plaintiff, her physicians and the medical community that Mirena was a safe and effective contraceptive option. The representations by Defendants were in fact false, as Mirena is not safe and is dangerous to the health of its users. 92. At the time the aforesaid representations were made, Defendants concealed from Plaintiff, other consumers and health care providers information about the propensity of Mirena to cause great harm. Defendants negligently misrepresented claims regarding the safety and efficacy of Mirena despite the lack of information regarding this information. 93. These misrepresentations were made by Defendants with the intent to induce Plaintiff to use Mirena, which caused her injuries.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 19 of 22 94. At the time of Defendants' misrepresentations and omissions, Plaintiff did not know of the falsity of these statements and reasonably believed them to be true. 95. Defendants breached their duty to Plaintiff by providing false, incomplete and/or misleading information regarding their product. Plaintiff reasonably believed Defendants' representations and reasonably relied on the accuracy of those representations when agreeing to treatment with Mirena. 96. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered a profound injury that required medical treatment and incurred medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. COUNT IX FRAUDULENT MISREPRESENTATION 97. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 98. Defendants, having undertaken the manufacturing, marketing, dispensing, distribution and promotion of Mirena described herein, owed a duty to provide accurate and complete information regarding Mirena. 99. Defendants fraudulently misrepresented material facts and information regarding Mirena including, but not limited to, its propensity to cause serious physical harm.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 20 of 22 100. At the time of Defendants' fraudulent misrepresentations and omissions, Plaintiff was unaware of the falsity of the statements and reasonably believed them to be true. 101. Defendants knew this information to be false, incomplete and misleading information. 102. Defendants intended to deceive and mislead Plaintiff so that she might rely on these fraudulent misrepresentations. 103. Plaintiff had a right to rely on and did reasonably rely upon Defendants' deceptive, inaccurate and fraudulent misrepresentations. 104. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries that required medical treatment and incurred medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate pursuant to the common law and statutory law. COUNT X FRAUD BY CONCEALMENT 105. Plaintiff incorporates by reference all other paragraphs of this complaint as if fully set forth herein and further alleges as follows. 106. Defendants had a duty and obligation to disclose to Plaintiff that the aforesaid product was dangerous and likely to cause serious health consequences to users when used as prescribed.

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 21 of 22 107. Defendants intentionally, willfully, and maliciously concealed and/or suppressed the facts set forth above from Plaintiff with the intent to defraud her as herein alleged. 108. Neither Plaintiff nor her physicians were aware of the facts set forth in this complaint, and had they been aware of said facts, would not have used this product. 109. As a proximate result of the concealment and/or suppression of the facts set forth above, Plaintiff has proximately sustained damage, as set forth herein. 110. As a direct and proximate result of one or more of these wrongful acts or omissions of the Defendants, Plaintiff suffered profound injuries that required medical treatment and incurred medical and hospital expenses. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate. PRAYER FOR RELIEF Plaintiff demands judgment against Defendants for compensatory, statutory and punitive damages, together with interest, costs of suit, attorneys' fees and all such other relief as the Court deems appropriate pursuant to the common law and statutory law. DATE: January 25, 2013 11517 asowenrw ' 4feea-*o. Dian e M. Nast ID o. 4424) Daniel N. Gallucci (PA Atty. ID No. 81995)

Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 22 of 22 Joanne E. Matusko (PA Atty. ID No. 91059) NastLaw, LLC 1101 Market Street, Suite 2801 Philadelphia, Pennsylvania 19107 Telephone: (215) 923-9300 Facsimile: (215) 923-9302 Email: dnast@nastlaw.com dgallucci@nastlaw.com jmatusko@nastlaw.com Attorneys for Plaintiff JURY DEMAND Plaintiff hereby demands a trial by jury on all triable issues. /s/ Dianne M. Nast

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