UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF ILLINOIS PEORIA DIVISION

Transcription

1 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF ILLINOIS PEORIA DIVISION MARCIA OLSON, ) ) Plaintiff, ) ) Case No: v. ) ) HOWMEDICA OSTEONICS CORP. d/b/a ) STRYKER ORTHOPAEDICS, ) JURY TRIAL DEMANDED ) and ) ) STRYKER CORPORATION, ) ) Defendants. ) COMPLAINT FOR DAMAGES COMES NOW Plaintiff, Marcia Olson, by and through the undersigned counsel, and brings this complaint against Defendant Howmedica Osteonics Corp. d/b/a Stryker Orthopaedics and Defendant Stryker Corporation (collectively Defendants or Stryker ), and alleges as follows: PARTIES 1. Plaintiff, Marcia Olson, is a citizen of the State of Illinois and resides in Chillicothe, Peoria County, Illinois. 2. Defendant Howmedica Osteonics Corp., d/b/a Stryker Orthopaedics, is a corporation organized and existing under the laws of New Jersey, with its principal place of business in Mahwah, New Jersey. Howmedica Osteonics Corp. operates as a subsidiary of Stryker Corporation. Defendant does business throughout the United States, including in the State of Illinois. 3. Defendant Stryker Corporation is a corporation organized and existing under the laws of Michigan, with its principal place of business located in Kalamazoo, Michigan. Defendant does

2 business throughout the United States, including in the State of Illinois. 4. Upon information and belief, at all times herein mentioned, the employees of Defendants, its subsidiaries, affiliates, and other related entities, as well as the employees of the Defendants subsidiaries, affiliates, and other related entities, were the agents, servants and employees of Defendants, and at all relevant times, were acting within the purpose and scope of said agency and employment. Whenever reference in this Complaint is made to any act or transaction of Defendants, such reference shall be deemed to mean that the principals, officers, employees, agents, and/or representatives of the Defendants committed, knew of, performed, authorized, ratified and/or directed such transaction on behalf of Defendants while actively engaged in the scope of their duties. JURISDICTION AND VENUE 5. This Court has subject matter jurisdiction pursuant to 28 U.S.C. 1332(a) as the parties are citizens of different States, and the amount in controversy exceeds the sum or value of $75,000, exclusive of interest and costs. 6. Venue and personal jurisdiction are proper in this Court because the wrongful acts upon which this lawsuit is based occurred, in part, in this District, the Plaintiff resides in this District, and Defendants have certain minimum contacts in this District. Venue is proper pursuant to 28 U.S.C because Defendants are corporations that have substantial, systematic and continuous contacts in this District, Defendants are subject to personal jurisdiction in this District, and a substantial part of the events, acts, or omissions giving rise to the claims in this lawsuit occurred in this District. GENERAL ALLEGATIONS 7. In February of 2009, Defendants released the Rejuvenate Modular Primary Hip System ( Rejuvenate ), which was approved through the FDA s 510(k) process on or about June 2

3 3, The Rejuvenate system is a dual modular hip replacement prosthesis. It is intended for patients requiring primary total hip arthroplasty or replacement due to joint disease of the hip resulting from non-inflammatory degenerative arthritis. 9. The Rejuvenate is an artificial hip replacement device consisting of two basic components: (1) a chromium-cobalt neck that is inserted into a (2) titanium stem. The Rejuvenate system can be used interchangeably with any number of Stryker bearing surface components which comprise the ball or head and an acetabular cup or socket. 10. The Rejuvenate combines the material characteristics of TMZF (Ti-12Mo-6Zr-2Fe) with a plasma sprayed coating of titanium and PureFix HA for the stem and CoCr for the neck. 11. Upon information and belief, Defendants claim that laboratory testing demonstrates the compatibility of these materials without fretting and corrosion. Defendants also claim that this metal alloy has been tested and proven by Defendants to resist the effects of corrosion and fretting. 12. Despite Defendants claims, this combination of materials has been reported to cause fretting and corrosion. Since the 1980s, medical and scientific literature has reported corrosion to be a problem when Ti and CoCr have been used at modular junctions in medical implants. Upon information and belief, Defendants represented and warranted in its marketing and sale of the Rejuvenate that its proprietary materials alleviate these problems. 13. Defendants developed, tested, assembled, manufactured, packaged, labeled, prepared, distributed, marketed, supplied, and/or sold the defective Rejuvenate, either directly or indirectly, to members of the general public within the State of Illinois, including Plaintiff. 14. In April of 2012, Defendants issued an Urgent Field Safety Notice to surgeons and hospitals in the United States regarding the Rejuvenate. 3

4 15. In this Urgent Field Safety Notice, Defendants acknowledged that it had received reports of device failure due to heavy metal contamination. The Urgent Field Safety Notice specifically referred to failures at the taper neck junction between the neck and stem due to corrosion and fretting. 16. This corrosion and fretting was exactly the same failure mechanism that Defendants warranted would not occur because of the Rejuvenate system s design and composition. This was also exactly the same failure mechanism that the medical and scientific community had been studying and documenting in modular device design since the 1980s. 17. In the Urgent Field Safety Notice, Defendants went on to describe symptoms and findings identical to those experienced by Plaintiff. 18. Among those symptoms and findings specifically mentioned in the Urgent Field Safety Notice were tissue necrosis, metallosis, adverse soft tissue reaction, and pseudotumor formation. 19. Finally, in July of 2012, Defendants issued a voluntary recall of all Rejuvenate and ABG II stems in the United States. As part of the July 2012 recall notice, Defendants once again cited reports of device failure due to metal fretting and corrosion. PLAINTIFF S REJUVENATE SYSTEM IMPLANTS 20. On June 21, 2011, Plaintiff underwent right total hip replacement surgery performed by Dr. Thomas Mulvey, at Methodist Medical Center of Illinois in Peoria, Illinois. Plaintiff was implanted with a Size #7 Rejuvenate Modular Stem and other Stryker products. 21. Subsequent to implantation of the Rejuvenate hip, Plaintiff began experiencing significant pain, swelling including throat swelling, hives, and hair loss. 22. A diagnostic workup revealed elevated metal ion levels in Plaintiff, including a 4

5 significantly high level of cobalt. 23. As a result of the evaluation, Plaintiff and her physician are currently in the process of determining whether a revision surgery is the best course of action for her. 24. As a direct and proximate result of Defendants placing the Rejuvenate into the stream of commerce, Plaintiff has suffered, and continues to suffer, both injuries and damages including, but not limited to, past, present and future physical and mental pain and suffering; and past, present and future medical, hospital, rehabilitative and pharmaceutical expenses, and other related damages. FEDERAL REQUIREMENTS 25. Federal regulation states: "Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g. seizure." See 21 CFR 7.3(g). Recalls are classified by the FDA in to one of three categories. The designation or category assigned by the Food and Drug Administration to a particular product recall indicate[s] the relative degree of health hazard presented by the product being recalled." See 21 CFR 7.3(m). 26. The FDA categorized the Rejuvenate recall as a Class II recall. A Class II recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." See 21 CFR 7.3(m). 27. Classifying the Rejuvenate recall as a Class II recall confirms by definition that the devices in question were in violation of federal law and that initiation of legal action or seizure would be indicated for these devices. 28. Pursuant to federal law, a device is deemed to be adulterated if, among other things, it 5

6 fails to meet established performance standards, or if the methods, facilities or controls used for its manufacture, packing, storage or installation are not in conformity with federal requirements. See 21 U.S.C Pursuant to federal law, a device is deemed to be misbranded if, among other things, its labeling is false or misleading in any particular manner, or if it is dangerous to health when used in the manner prescribed, recommended or suggested in the labeling thereof. See 21 U.S.C Pursuant to federal law, manufacturers are required to comply with FDA regulation of medical devices, including FDA requirements for records and reports, in order to prohibit introduction of medical devices that are adulterated or misbranded, and to assure the safety and effectiveness of medical devices. In particular, manufacturers must keep records and make reports if any of its medical devices may have caused or contributed to death or serious injury, or if the devices have malfunctioned in a manner likely to cause or contribute to death or serious injury. Federal law also mandates that the FDA establish regulations requiring a manufacturer of a medical device to report promptly to FDA any correction or removal of a device undertaken to reduce a risk to health posed by the device, or to remedy a violation of federal law by which a device may present a risk to health. See 21 U.S.C. 360(i). 31. Pursuant to FDA regulation, adverse events associated with a medical device must be reported to FDA within 30 days after the manufacturer becomes aware that (a) a device may have caused or contributed to death or serious injury, or (b) that a device has malfunctioned and would be likely to cause or contribute to death or serious injury if the malfunction was to recur. Such reports must contain all information reasonably known to the manufacturer, including any information that can be obtained by analysis, testing, or other evaluation of the device, and any information in the manufacturer's possession. In addition, manufacturers are responsible for conducting an 6

7 investigation of each adverse event, and must evaluate the cause of the adverse event. See 21 CFR Pursuant to federal regulations, manufacturers of medical devices must also describe in every individual adverse event report whether remedial action was taken with regard to the adverse event, and whether the remedial action was reported to FDA as a removal or correction of the device. See 21 CFR Pursuant to federal regulations, manufacturers must disclose any reportable MDR event or events, including a trend analysis that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, to the FDA within 5 business days after becoming aware of such event or events. See 21 CFR Pursuant to federal regulation, device manufacturers must report promptly to FDA any device corrections and removals, and maintain records of device corrections and removals. FDA regulations require submission of a written report within ten working days of any correction or removal of a device initiated by the manufacturer to reduce a risk to health posed by the device, or to remedy a violation of the Act caused by the device, which may present a risk to health. The written submission must contain, among other things, a description of the event giving rise to the information reported, the corrective or removal actions taken, and any illness or injuries that have occurred with use of the device, including reference to any device report numbers. Manufacturers must also indicate the total number of devices manufactured or distributed which are subject to the correction or removal, and provide a copy of all communications regarding the correction or removal. See 21 CFR Pursuant to federal regulation, manufacturers must comply with specific quality system requirements promulgated by FDA. These regulations require manufacturers to meet design 7

8 control requirements, including but not limited to conducting design validation to ensure that devices conform to defined user needs and intended uses. Manufacturers must also meet quality standards in manufacture and production of the devices. Manufacturers must establish and maintain procedures for implementing corrective actions and preventive actions, and investigate the cause of nonconforming products and take corrective action to prevent recurrence. Manufacturers are also required to review and evaluate all complaints and determine whether an investigation is necessary. Manufacturers are also required to use statistical techniques, where necessary, to evaluate product performance. See 21 CFR Upon information and belief, Defendants failed to timely report adverse events regarding the Rejuvenate ; failed to timely conduct failure investigations and analysis; failed to timely report any and all information concerning product failures and corrections; failed to timely and fully inform FDA of unanticipated adverse effects, increases in the incidence of adverse effects, or device failures necessitating a labeling, manufacturing or device modification; failed to conduct necessary design validation; and, sold a misbranded and adulterated product. COUNT I COMMON LAW NEGLIGENCE 37. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further allege as follows: 38. Defendants designed, manufactured, marketed, detailed, and advertised, both to physicians and consumers, the Rejuvenate. 39. As a result, Defendants had a duty to perform each of these functions reasonably and with reasonable and due care for the safety and well-being of patients in whom the devices would be implanted, including Plaintiff. Defendants failed to reasonably execute these duties. 40. Defendants failed to use reasonable and due care for the safety and well-being of 8

9 those in whom the Rejuvenate would be implanted, including Plaintiff, and is therefore negligent in the following respects: a. Defendants failed to adequately design and manufacture the Rejuvenate to ensure that it would not corrode, erode, deteriorate, fret, and cause severe metal toxicity in patients, including Plaintiff. The flaws include, but are not limited to, the following: i. The incompatibility of the TMZF titanium alloy with other components; ii. Poor design of the taper neck junction between stem and neck such that movement was predictable; iii. Poor manufacturing practices such that the taper neck junction between the neck and stem do not fit the way they were intended; and, iv. A combination of the above factors leads to the release of metal ions or particles into the body and blood stream causing soft tissue and bony necrosis, pain, metallosis, and premature failure of the Rejuvenate. b. Defendants failed to adequately test the Rejuvenate to ensure that it would not corrode, erode, deteriorate and/or cause severe metal toxicity in the patient, including Plaintiff; c. Defendants failed to conduct anything other than bench testing so that when manufactured and marketed, patients, including Plaintiff, became in essence Defendants' first clinical trial; d. Defendants made affirmative representations that the Rejuvenate would not fret or corrode in the human body. These representations were false and misleading to both physicians and the consumer, including Plaintiff; 9

10 e. Defendants trained its sales force to detail the Rejuvenate utilizing representations that the Defendants knew or should have known were false, leading both surgeons and consumers to reasonably believe that the device would not cause metal toxicity; f. Defendants specifically marketed the Rejuvenate as a safe alternative to other metal-on-metal hip implant devices that had been widely publicized as capable of causing premature failure due to metal toxicity; g. Defendants marketed the Rejuvenate as a "perfect fit" for younger patients due to its modular design, leading physicians and consumers to reasonably believe that the Rejuvenate was superior to other available hip implants when, in fact, the Rejuvenate was so poorly designed, constructed and tested that it had to be recalled from the market approximately three years after it was introduced; h. Defendants failed to manufacture the Rejuvenate to FDA-cleared and/or reasonably proper specifications such that the taper neck junction between the neck and stem prematurely failed causing the release of metal ions or particles into the body and blood stream and severe metal toxicity in patients, including Plaintiff; i. Defendants failed to adequately test the TMZF alloy's compatibility with chromium and/or cobalt components in an effort to prevent corrosion and fretting at the neck/stem taper neck junction of this modular hip replacement device; j. Defendants failed to promptly act upon reports of failures such that the Rejuvenate continued to be implanted in unknowing patients, including Plaintiff, well after it should have been recalled or sales suspended; 10

11 k. Upon information and belief, Defendants chose as its predicate device a system that had known, disastrous failures, had to be redesigned due to design flaws, and has been the subject of protracted litigation filed by patients who have been harmed by defects in the predicate modular device; and, l. Defendants had actual knowledge prior to marketing the Rejuvenate that its TMZF titanium alloy performed poorly when mated with chromium and/or cobalt components. Defendants also knew when it introduced the Rejuvenate to the market that the Stryker Accolade as well as other Stryker devices that were also made of TMZF alloy were experiencing corrosion, fretting, and failure issues at the taper neck junction between the neck and chromium and/or cobalt head or ball. Nevertheless, Defendants either suppressed or ignored the reports and marketed the Rejuvenate anyway, knowing that these dissimilar metals were performing poorly in the market and causing harm to patients when utilized in various hip implant devices. 41. The above conduct shows Defendants failure to exercise reasonable and appropriate care. It was reasonably foreseeable that such negligence would lead to premature device failure as well as severe, permanent, debilitating injury to patients, including Plaintiff. 42. As a direct and proximate result of Defendants negligence, Plaintiff has suffered, and will continue to suffer injury, physical pain and suffering, disability, physical impairment, disfigurement, inconvenience, decreased likelihood for successful revision surgery, emotional distress, mental anguish; loss of the capacity for the enjoyment of life, and medical, nursing and surgical expenses. 43. Defendants misrepresented facts concerning the safety of the Rejuvenate system, 11

12 including but not limited to the fact that it was inherently more dangerous than alternative hip replacement systems on the market, causes metal fretting, corrosion, metallosis, necrosis and other health problems, has a shorter life span, and an increased need for additional surgeries due to premature failure of the Rejuvenate system. 44. Defendants misrepresentations included knowingly withholding material information from the medical community and the public, including Plaintiff, concerning the safety and efficacy of the subject product. 45. At all times material hereto, Defendants knew and recklessly disregarded the fact that the Rejuvenate System was subject to causing fretting and corrosion in patients implanted with the device as compared to safe alternative hip replacement systems. 46. Defendants continued to aggressively market the subject product without disclosing the aforesaid side effects when there were safer alternative methods available. Defendants knew of the subject product s defective and unreasonably dangerous nature, as set forth herein, but continued to design, develop, manufacture, market, distribute and sell the Rejuvenate System so as to maximize Defendants sales and profits at the expense of the health and safety of the public, including Plaintiff, in conscious and/or reckless disregard of the foreseeable harm. 47. As a direct and proximate result of the Defendants conscious and/or reckless disregard for the rights and safety of consumers, Plaintiff suffered serious physical injuries set forth above. 48. The aforesaid conduct of Defendants was committed with knowing, conscious and/or reckless disregard for the rights and safety of consumers, including Plaintiff, thereby entitling the Plaintiff to punitive damages in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. 12

13 WHEREFORE, Plaintiff demands judgment against Defendants for compensatory and punitive damages, together with interest, costs of suit, attorneys fees, and all such other relief as the Court deems proper, and as set forth in more detail in Plaintiff s Prayer for Relief. COUNT II NEGLIGENCE PER SE 49. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further allege as follows: 50. Defendants have an obligation to not violate the law in the manufacture, design, testing, assembly, inspection, labeling, packaging, supplying marketing, selling, advertising, preparing for use, warning of the risks and dangers of the Rejuvenate and otherwise distributing these devices. 51. Defendants acts and omissions constitute an adulteration, misbranding, or both, as defined by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 331(a) and 333(a)(2), and constitute a breach of duty, subjecting Defendants to civil liability for all damages arising there from. 52. Plaintiff, as the purchaser and intended user and consumer of the Rejuvenate, is within the class of persons the statutes and regulations are designed to protect, and plaintiff s injuries are the type of harm these statutes and regulations are designed to prevent. 53. As a direct and proximate result of Defendants negligence, Plaintiff has suffered, and will continue to suffer injury, physical pain and suffering, disability, physical impairment, disfigurement, inconvenience, decreased likelihood for successful revision surgery, emotional distress, mental anguish, loss of the capacity for the enjoyment of life, and medical, nursing and surgical expenses. 54. Defendants misrepresented facts concerning the safety of the Rejuvenate system, 13

14 including but not limited to the fact that it was inherently more dangerous than alternative hip replacement systems on the market, causes metal fretting, corrosion, metallosis, necrosis and other health problems, has a shorter life span, and an increased need for additional surgeries due to premature failure of the Rejuvenate system. 55. Defendants misrepresentations included knowingly withholding material information from the medical community and the public, including Plaintiff, concerning the safety and efficacy of the subject product. 56. At all times material hereto, Defendants knew and recklessly disregarded the fact that the Rejuvenate System was subject to causing fretting and corrosion in patients implanted with the device as compared to safe alternative hip replacement systems. 57. Defendants continued to aggressively market the subject product without disclosing the aforesaid side effects when there were safer alternative methods available. Defendants knew of the subject product s defective and unreasonably dangerous nature, as set forth herein, but continued to design, develop, manufacture, market, distribute and sell the Rejuvenate System so as to maximize Defendants sales and profits at the expense of the health and safety of the public, including Plaintiff, in conscious and/or reckless disregard of the foreseeable harm. 58. As a direct and proximate result of the Defendants conscious and/or reckless disregard for the rights and safety of consumers, Plaintiff suffered serious physical injuries set forth above. 59. The aforesaid conduct of Defendants was committed with knowing, conscious and/or reckless disregard for the rights and safety of consumers, including Plaintiff, thereby entitling the Plaintiff to punitive damages in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. 14

15 WHEREFORE, Plaintiff demands judgment against Defendants for compensatory and punitive damages, together with interest, costs of suit, attorneys fees, and all such other relief as the Court deems proper, and as set forth in more detail in Plaintiff s Prayer for Relief. COUNT III STRICT LIABILITY FAILURE TO WARN 60. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further allege as follows: 61. At the time the Rejuvenate implanted into Plaintiff left Defendants control, it was designed and/or manufactured in a defective condition as it was unreasonably dangerous when put to a reasonably anticipate use; specifically, Defendants failed to warn: a. Of the inherent dangers posed by the Rejuvenate in Plaintiff; b. That the Rejuvenate contained no warnings, or in the alternative, inadequate warnings, as to the risk that the product could cause significant metal toxicity; and/or c. Of such further defects as the discovery and evidence will reveal. 62. Defendants failed to give the warnings set forth in the preceding paragraph despite having received notice through similar claims and lawsuits of serious injury and/or death from Rejuvenate systems that failed during reasonably foreseeable use. 63. Defendants knew or should have known of the unreasonably dangerous and defective conditions of the Rejuvenate, yet Defendants failed to give an adequate warning of the dangers to users in the event of foreseeable use of the implants. 64. The warnings that accompanied the Rejuvenate failed to provide information that an ordinary consumer would expect when using the implant in a manner reasonably foreseeable to Defendants. 15

16 65. Had Plaintiff received a proper or adequate warning as to the risks associated with Rejuvenate, Plaintiff would not have used the product or had it implanted into her body. 66. Had Plaintiff s surgeon received a proper or adequate warning as to the risks associated with using the Rejuvenate, he would not have recommended the device or would have used an alternative device. 67. As a direct and proximate result of Defendants negligence, Plaintiff has suffered, and will continue to suffer injury, physical pain and suffering, disability, physical impairment, disfigurement, inconvenience, decreased likelihood for successful revision surgery, emotional distress, mental anguish; loss of the capacity for the enjoyment of life, and medical, nursing and surgical expenses. 68. Defendants misrepresented facts concerning the safety of the Rejuvenate system, including but not limited to the fact that it was inherently more dangerous than alternative hip replacement systems on the market, causes metal fretting, corrosion, metallosis, necrosis and other health problems, has a shorter life span, and an increased need for additional surgeries due to premature failure of the Rejuvenate system. 69. Defendants misrepresentations included knowingly withholding material information from the medical community and the public, including Plaintiff, concerning the safety and efficacy of the subject product. 70. At all times material hereto, Defendants knew and recklessly disregarded the fact that the Rejuvenate System was subject to causing fretting and corrosion in patients implanted with the device as compared to safe alternative hip replacement systems. 71. Defendants continued to aggressively market the subject product without disclosing the aforesaid side effects when there were safer alternative methods available. Defendants knew of 16

17 the subject product s defective and unreasonably dangerous nature, as set forth herein, but continued to design, develop, manufacture, market, distribute and sell the Rejuvenate System so as to maximize Defendants sales and profits at the expense of the health and safety of the public, including Plaintiff, in conscious and/or reckless disregard of the foreseeable harm. 72. As a direct and proximate result of the Defendants conscious and/or reckless disregard for the rights and safety of consumers, Plaintiff suffered serious physical injuries set forth above. 73. The aforesaid conduct of Defendants was committed with knowing, conscious and/or reckless disregard for the rights and safety of consumers, including Plaintiff, thereby entitling the Plaintiff to punitive damages in an amount appropriate to punish the Defendants and deter them from similar conduct in the future WHEREFORE, Plaintiff demands judgment against Defendants for compensatory and punitive damages, together with interest, costs of suit, attorneys fees, and all such other relief as the Court deems proper, and as set forth in more detail in Plaintiff s Prayer for Relief. COUNT IV STRICT LIABILITY DESIGN DEFECT 74. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further allege as follows: 75. The Rejuvenate hip surgically implanted in Plaintiff s body was defectively designed. 76. Defendants Rejuvenate is designed in such a way that, when used as intended, causes serious, permanent, and devastating damage to patients. The damage and mechanism of injury have been previously described herein. 77. Defendants Rejuvenate does not perform as safely as an ordinary consumer would 17

18 expect when used as intended, or in a manner reasonably foreseeable to Defendants. 78. At the time the subject Rejuvenate was sold, Defendants knew, or reasonably should have known, of the defective and unreasonably dangerous condition of the Rejuvenate system. 79. At all relevant times, Defendants had a duty to design, manufacture, and/or sell the Rejuvenate such that it was safe, free from defects and would reasonably perform during foreseeable use. 80. Defendants breached their duty of care by carelessly and negligently: a. Designing the Rejuvenate to ensure that it would not corrode, erode, deteriorate, fret, and cause severe metal toxicity in patients, including Plaintiff; b. Failing to adequately test the Rejuvenate to ensure that it would not corrode, erode, deteriorate and/or cause metal toxicity in the patient, including Plaintiff; c. Failing to promptly act upon reports of failures such that the Rejuvenate continued to be implanted in unknowing patients, including Plaintiff, well after it should have been recalled or sales suspended; and/or d. Such further conduct and defects as the discovery and evidence will reveal. 81. The defective conditions that existed when the Rejuvenate was sold were the direct and proximate result of Defendants negligence, which caused Plaintiff to suffer, and will continue to suffer injury, physical pain and suffering, disability, physical impairment, disfigurement, inconvenience, decreased likelihood for successful revision surgery, emotional distress, mental anguish; loss of the capacity for the enjoyment of life, and medical, nursing and surgical expenses. 82. Defendants misrepresented facts concerning the safety of the Rejuvenate system, including but not limited to the fact that it was inherently more dangerous than alternative hip 18

19 replacement systems on the market, causes metal fretting, corrosion, metallosis, necrosis and other health problems, has a shorter life span, and an increased need for additional surgeries due to premature failure of the Rejuvenate system. 83. Defendants misrepresentations included knowingly withholding material information from the medical community and the public, including Plaintiff, concerning the safety and efficacy of the subject product. 84. At all times material hereto, Defendants knew and recklessly disregarded the fact that the Rejuvenate System was subject to causing fretting and corrosion in patients implanted with the device as compared to safe alternative hip replacement systems. 85. Defendants continued to aggressively market the subject product without disclosing the aforesaid side effects when there were safer alternative methods available. Defendants knew of the subject product s defective and unreasonably dangerous nature, as set forth herein, but continued to design, develop, manufacture, market, distribute and sell the Rejuvenate System so as to maximize Defendants sales and profits at the expense of the health and safety of the public, including Plaintiff, in conscious and/or reckless disregard of the foreseeable harm. 86. As a direct and proximate result of the Defendants conscious and/or reckless disregard for the rights and safety of consumers, Plaintiff suffered serious physical injuries set forth above. 87. The aforesaid conduct of Defendants was committed with knowing, conscious and/or reckless disregard for the rights and safety of consumers, including Plaintiff, thereby entitling the Plaintiff to punitive damages in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. WHEREFORE, Plaintiff demands judgment against Defendants for compensatory and 19

20 punitive damages, together with interest, costs of suit, attorneys fees, and all such other relief as the Court deems proper, and as set forth in more detail in Plaintiff s Prayer for Relief. COUNT V STRICT LIABILITY MANUFACTURING DEFECT 88. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further allege as follows: 89. According to Defendants, the Rejuvenate is designed for implantation into the human body, to last a minimum of fifteen or more years, and be compatible with human tissue and bone. 90. The Rejuvenate system installed in Plaintiff was not compatible with human tissue and bone, and it released metal ions or particles into Plaintiff s body causing injury. Defendants failed to manufacture the Rejuvenate in a manner that prevented metal fretting and corrosion. 91. The Rejuvenate system implanted in Plaintiff contained a manufacturing defect in that the Rejuvenate system implanted in Plaintiff departed from its intended design and became more dangerous. 92. At the time the subject Rejuvenate was sold, Defendants knew, or reasonably should have known, of the defective and unreasonably dangerous condition of the Rejuvenate system. 93. At all relevant times, Defendants had a duty to design, manufacture, and/or sell the Rejuvenate such that it was safe, free from defects and would reasonably perform during foreseeable use. 94. As a direct and proximate result of the manufacturing defect that existed when the Rejuvenate was sold, Plaintiff has suffered and will continue to suffer, injury, emotional distress and harm as alleged herein. 95. Defendants misrepresented facts concerning the safety of the Rejuvenate system, 20

21 including but not limited to the fact that it was inherently more dangerous than alternative hip replacement systems on the market, causes metal fretting, corrosion, metallosis, necrosis and other health problems, has a shorter life span, and an increased need for additional surgeries due to premature failure of the Rejuvenate system. 96. Defendants misrepresentations included knowingly withholding material information from the medical community and the public, including Plaintiff, concerning the safety and efficacy of the subject product. 97. At all times material hereto, Defendants knew and recklessly disregarded the fact that the Rejuvenate System was subject to causing fretting and corrosion in patients implanted with the device as compared to safe alternative hip replacement systems. 98. Defendants continued to aggressively market the subject product without disclosing the aforesaid side effects when there were safer alternative methods available. Defendants knew of the subject product s defective and unreasonably dangerous nature, as set forth herein, but continued to design, develop, manufacture, market, distribute and sell the Rejuvenate System so as to maximize Defendants sales and profits at the expense of the health and safety of the public, including Plaintiff, in conscious and/or reckless disregard of the foreseeable harm. 99. As a direct and proximate result of the Defendants conscious and/or reckless disregard for the rights and safety of consumers, Plaintiff suffered serious physical injuries set forth above The aforesaid conduct of Defendants was committed with knowing, conscious and/or reckless disregard for the rights and safety of consumers, including Plaintiff, thereby entitling the Plaintiff to punitive damages in an amount appropriate to punish the Defendants and deter them from similar conduct in the future. 21

22 WHEREFORE, Plaintiff demands judgment against Defendants for compensatory and punitive damages, together with interest, costs of suit, attorneys fees, and all such other relief as the Court deems proper, and as set forth in more detail in Plaintiff s Prayer for Relief. PRAYER FOR RELIEF WHEREFORE, Plaintiff seeks judgment in her favor as follows: 1. Awarding actual damages to Plaintiff incidental to the purchase and use of the Rejuvenate in an amount to be determined at trial; 2. Awarding the past and future costs of treatment for Plaintiff s injuries caused by the Rejuvenate ; 3. Awarding damages for Plaintiff s physical pain and suffering; 4. Awarding damages for Plaintiff's mental and emotional anguish; 5. Awarding punitive damages as a result of Defendants conscious and/or reckless disregard for its conduct as alleged herein; 6. Awarding pre-judgment and post-judgment interest to Plaintiff; 7. Awarding the costs and expenses of this litigation to Plaintiff; 8. Awarding reasonable attorneys' fees and costs to Plaintiff as provided by law; and 9. For such further relief as this Court deems necessary, just and proper. JURY DEMAND Plaintiff hereby requests a trial by jury, pursuant to Rule 38 of the Federal Rules of Civil Procedure, on all claims and issues so triable. 22

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