Defendant, its subsidiaries, affiliates, and other related entities, as well as the employees of the

Transcription

1 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 1 of 21 PageID# 1 FILED UNITED STATES DISTRICT COURT EASTERN DISTRICT OF VIRGINIA TIERK US.OiSTniCIUUuflT CLLH NORFOLK. VA_ Michelle Gazey Plaintiff, Civil Case No: a:/,3cvv// v. COMPLAINT AND DEiMAND Howmedica Osteonics Corp., d/b/a FOR JURY TRIAL Stryker Orthopaedics, Defendant COMES NOW, Plaintiff, Michelle Gazey, by and through the undersigned counsel, and brings this complaint against Defendant Howmedica Osteonics Corp., d/b/a Stryker Othopaedics. and alleges as follows: PARTIES 1. Plaintiff, Michelle Gazey, is a citizen of North Carolina and resides in North Carolina. Asubstantial part ofthe events or omissions giving rise to Plaintiffs claim occurred in Portsmouth, Virginia. 2. Defendant Ilowmedica Osteonics Coip. 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. Defendant does business throughout the United States, including in (he State of Virginia. 3. Upon information and belief, at all times herein mentioned, the employees of Defendant, its subsidiaries, affiliates, and other related entities, as well as the employees of the

2 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 2 of 21 PageID# 2 Defendant's subsidiaries, affiliates, and other related entities, were the agents, servants and employees of Defendant, 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 Defendant, such allocation 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 behalfof Defendant while actively engaged in the scopeof their duties. JURISDICTION AND VENUE 4. This Court has jurisdiction pursuant to 28 U.S.C. 1332(a) as the parties are citizens ofdifferent Slates, and the amount in controversy exceeds the sum or value of $75,000.00, exclusive of interest and costs. 5. Defendant is subject to the in personam jurisdiction ofthis Court, and venue is therefore proper herein pursuant to 28 U.S.C because Defendant did (and does) business within the State ofvirginia and has had continuous and systematic contacts with the State of Virginia, has consented to jurisdiction in the State of Virginia and/or committed atort in whole or in part in the State ofvirginia against Plaintiff as more fully set forth herein. On information and belief. Defendant also advertised in this district, made material omissions and representations in this district, and breached warranties in this district. HIE STRYKER REJUVENATE MODULAR PRIMARY HIP SYSTEM 6. In February Defendant released the Rejuvenate* Modular Primary Ilip System C'Rejuvenate "), the latest evolution in the Defendant's OmniFit and Secure-Fit Hip systems, which was approved for market by the FDA on June The Rejuvenate Rhip is

3 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 3 of 21 PageID# 3 an extension ofthe Stryker Modular Hip, which was approved for market by the FDA on September The Rejuvenate system is dual modular hip replacement prosthesis. It is indicated for patients requiring primary total hip arthroplasty or replacement due to painful joint disease ofthe hip resulting from non-inflammatory degenerative arthritis. 8. Unlike most prosthetic hip implants, the Rejuvenate!!?) is an artificial hip replacement device consisting oftwo 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 ofstryker bearing surface components which comprise the ball or head and an acetabular cup or socket. The bearing surface system or components are unrelated to the method of failure now seen in the Rejuvenate. 9. According to Defendant's materials, the RejuvenateD was developed to optimize anatomic restoration by providing options that offer enhanced stability, proven modularity, and intra-operative flexibility. With a wide range of femoral stem and neck combinations and an extensive range of length, version and offset, upon information and belief the Rejuvenate* was marketed to enable surgeons to better personalize the implant to apatient's unique anatomy. 10. The Rejuvenate* is comprised ofseparate femoral stem and neck components. This offers avariety ofsizing options during surgery. The benefit, according to Defendant's Rejuvenate* Total Hip System Surgical Protocol brochure (-Surgical Protocol"), was that by allowing the surgeon to independently manage leg length, neck version, and femoral offset, the system provides surgeons the ability to better personalize the biomechanics of each patient's hip implant.

4 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 4 of 21 PageID# 4 1I. The Surgical Protocol highlights thai the Rejuvenate combines the material characteristics oftmzf (Ti-12Mo-6Zr-2Fe) with aplasma sprayed coating of commerciallypure Ti and PureFix HA for the stem and CoCr for the neck. Upon information and belief. Defendant claims that laboratory testing demonstrates the compatibility ofthese materials without concern for fretting and corrosion. 12. This alloy was designed and patented by Defendant and is unlike any titanium alloy employed in the manufacture ofother prosthetic hip implants. Defendant claims in its promotional materials for the Rejuvenate that its alloy is both stronger and less rigid than other titanium alloys. Defendant also claims that the particular titanium alloy has been tested and proven by Defendant to resist the affects ofcorrosion and fretting. 13. Despite Defendant's claims, this combination of materials has been reported to cause fretting, galvanization, 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. Svensson et al. Formation of a fulminant soft-tissue pseudo tumor after uncemented hip arthroplasty. Acase report. JB.IS (A) Sep:70(8): Upon information and belief. Defendant represented and warranted in its marketing and sale of the Rejuvenate* that the Rejuvenate@\s proprietary materials alleviate these problems. 14. Defendant holds two patents for modular implant devices. Currently. Defendant has apending application to patent amodular hip prosthesis similar to Rejuvenate. 15. At all times material hereto. Defendant 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 ofvirginia.

5 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 5 of 21 PageID# 5 URGENT SAFETY NOTICES AND RECALLS 16. In April 2012, Defendant issued an Urgent Field Safely Notice to surgeons and hospitals in the United States regarding the Rejuvenate. 17. In this Urgent Field Safety Notice, Defendant acknowledged that it had received reports ofdevice 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. 18. This corrosion and fretting was exactly the same failure mechanism that Defendant had 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. 19. In the Urgent Field Safety Notice, Defendant went on to describe symptoms and findings identical to those experienced by Plaintiff. 20. Among those symptoms and findings specifically mentioned in the Urgent Field Safety Notice were tissue necrosis, metallosis. adverse soft tissue reaction, and pseudotumor formation. 21. Almost immediately following the Urgent Field Safety Notice. Defendant issued a voluntary recall of the Rejuvenate and ABGI1 systems in Canada. In the Canadian recall notice. Defendant stated that it was amending the Instructions for Use for the Rejuvenate to include warnings that Defendant was on notice of the issues described in the Urgent Field Safety Notice above.

6 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 6 of 21 PageID# Finally, during the first week of July of2012. Defendant issued a voluntary recall ofall Rejuvenate and ABC. II stems in the United States. As part ofthe July 2012 recall notice. Defendant once again cited reports of device failure due to heavy metal fretting and corrosion. PLAINTIFF'S REJUVENATE SYSTEM IMPLANT FAILED CAUSING PLAINTIFF TO UNDERGO REVISION SURGERY 23. On April Plaintiff underwent right total hip replacement surgery performed by Dr. Timothy Kavanaugh at Alaska Regional Hospital. Plaintiff was implanted with Rejuvenate*. 24. On October Plaintiff had the acetabular component revision surgery due to component loosening, again performed by Dr. Kavanaugh at Alaska Regional Hospital. 25. Plaintiff subsequently moved to North Carolina and has received treatment for issues related to her hip replacement at Portsmouth Naval Hospital in Portsmouth. Virginia. 26. Subsequent to implantation of the right Rejuvenate hip. Plaintiff began experiencing significant hip pain and discomfort. 27. Diagnostic workup revealed no evidence ofdevice loosening, infection, malposition, or any other explanation for Plaintiffs symptoms. 28. Further diagnostic workup revealed one or more of the following findings: the presence of pseudotumor formation, the existence ofasignificant fluid collection about the hip prosthesis, and/or blood testing indicating the presence ofheavy metal ion contamination. As a result of the evaluation. Plaintiff's physician informed Plaintiff that her Rejuvenate* system would need to be surgically removed and replaced with anew hip replacement system. 29. Due to increased complications with the Rejuvenate, in February Plaintiff had revision surgery at Portsmouth Naval Ilospital in Portsmouth. Virginia to replace the failed 6

7 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 7 of 21 PageID# 7 Rejuvenate* system in her right hip. During the removal. Plaintiffs femur was broken and-the surgeon had to implant a wire to repair it. 30. As adirect and proximate result of Defendant 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. THE FEDERAL REQUIREMENTS 3I. Federal regulation states: Recall means a firm's removal or correction ofa marketed product thai 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 2\ CFR 7.3 (g). Recalls are classified by the FDA into one of three categories. The designation or category "assigned by the Food and Drug Administration to aparticular product recall... indicates] the relative degree of health hazard presented by the product being recalled." See 21 CFR 7.3(m). 32. The FDA categorized the Rejuvenate* recall as a"class II" recall. AClass II [recall] is asituation in which use of or exposure to. aviolative product may cause temporary or medically reversible adverse health Consequences or where the probability ofserious adverse health consequences is remote." See 21 CFR 7.3{m). 33. Classifying the Rejuvenate grecall 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.

8 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 8 of 21 PageID# Pursuant to federal law. a device is deemed to be adulterated if, among other things, it 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 USC 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 USC Pursuant to federal law. manufacturers arc required to comply with FDA regulation ofmedical devices, including FDA requirements for records and reports, in order to prohibit introduction of medical devices that arc adulterated or misbranded. and lo assure the safety and effectiveness ofmedical devices. In particular, manufacturers must keep records and make reports ifany of their medical devices may have caused or contributed to death orserious 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 ofa 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 adevice may present a risk to health. Sec 21 USC 3600). 37. 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) adevice may have caused or contributed to death or serious injury, or (b) that a device has malfunctioned and would be likely to cause orcontribute to death orserious injury if the malfunction was to recur. Such reports must contain all information reasonably known to the manufacturer, including any

9 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 9 of 21 PageID# 9 information that can be obtained by analysis, testing, or other evaluation ofthe device, and any information in the manufacturer's possession. In addition, manufacturers are responsible for conducting an investigation of each adverse event, and must evaluate the cause of the adverse event. See 21 CFR Pursuant lo 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 correctionofthe device. See 21 CFR Pursuant to federal regulations, manufacturers must disclose any reportable VIDR event or events, including a trend analysis that necessitates remedial action to prevent an unreasonable risk ofsubstantial harm to the public health, lo 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 anydevice corrections and removals, and maintain records of device corrections and removals. FDA regulations require submission ol'a written report within ten working days ofany correction or removal ofa device initiated by the manufacturer to reduce arisk to health posed by the device, or (o remedy a violation ofthe Act caused by the device, which may present a risk to health. The written submission must contain, among other things, a description ofthe 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 ofall communications regarding the correction or removal. See 21 CFR $ 806.

10 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 10 of 21 PageID# Pursuant to federal regulation, manufacturers must comply with specific quality system requirements promulgated by FDA. These regulations require manufacturers to meet design 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 ofthe devices. Manufacturers must establish and maintain procedures for implementing corrective actions and preventive actions, and investigate the cause of the nonconforming products and take corrective action to prevent recurrence. Manufacturers are also required lo 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 2\ CFR Specifically, it is believed thai with respect lo the Rejuvenate, Defendant failed to timely report adverse events: failed to timely conduct failure investigations and analvsisfailed to timely report any and all information concerning product failures and corrections: tailed to timely and fully inform FDA ofunanticipated 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 amisbranded and adulterated product. FIRST CAUSE OF ACTION {Ngjjjjggnce) 43. Plaintiff incorporates by reference all preceding paragraphs as iffully set forth herein and further alleges as follows: 44. Defendant designed, manufactured, marketed, detailed, and advertised, both to physicians and consumers, the Rejuvenate. 10

11 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 11 of 21 PageID# As aresult. Defendant had aduty to perform each of these functions reasonably and with reasonable and due care for the safety and well-being ofpatients in whom the devices would be implanted, including Plaintiff. Defendant failed to reasonably execute those duties. 46. Defendant failed to use reasonable and due care for the safety and well-beins of those in whom the Rejuvenate would be implanted, including Plaintiff, and is therefore negligent in the following respects: a. Defendant failed to adequately design and manufacture the Rejuvenate* to insure that it would not corrode, erode, deteriorate, fret, and induce severe metal toxicity in the patient. 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 micro motion was predictable: 111. Poor manufacturing practices such that the taper neck junction between the neck and stem do not "fit" the way they were intended: and, iv. Acombination ofthe above factors leads to rapid, severe heavy metal cast oil causing soft tissue and bony necrosis, pain and premature failure of the Rejuvenate*. b. Defendant failed to adequately test the Rejuvenate to insure that it would not corrode, erode, deteriorate and/or induce severe metal toxicity in the patient; c. Defendant failed to conduct anything other than bench testing so that when manufactured and marketed, patients became, in essence. Defendant's first clinical trial: 11

12 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 12 of 21 PageID# 12 d. Defendant 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: e. Defendant trained its sales force to "detail" the Rejuvenate? utilizing representations that the Defendant knew or should have known were false, creating in the minds of both surgeons and consumers that the device would not cause metal toxicity; f. Defendant specitically marketed the Rejuvenate as asafe alternative to metalon-metal bearing surface devices that had been widely publicized as capable ofcausing premature failure due to heavy metal toxicity; g. Defendant marketed the Rejuvenate* as a"perfect fit" for younger patients due to its modular design, creating in the minds of physicians and consumers 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. Defendant failed to manufacture the Rejuvenate to FDA-cleared and or Defendant's own internal specifications such that the taper neck junction between the neck and stem prematurely failed causing metal debris cast-off and severe metal toxicity in patients: i. Defendant failed to adequately test the TMZF alloy's compatibility with chrome cobalt components in an effort to prevent corrosion and fretting at the neck/stem taper neckjunction of this modular hip replacement device: J. Defendant failed to promptly act upon reports ofearly failure such that the Rejuvenate continued to be implanted in unknowing patients by surgeons well after it should have been recalled or sales suspended: 12

13 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 13 of 21 PageID# 13 k. Upon information and belief. Defendant 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, 1. Defendant had actual knowledge prior to marketing the Rejuvenate that its TMZF titanium alloy performed poorly when mated with chrome cobalt components. Defendant also knew when it introduced Rejuvenate to the market that the Stryker Accolade as well as other Stryker devices that were also made oftmzf alloy were experiencing corrosion, fretting, and failure issues at the taper neck junction between the neck and chrome cobalt head or ball. Nevertheless, Defendant either suppressed or ignored the reports and marketed the Rejuvenate anyway, knowing that these two dissimilar metals were performing poorly in the market and causing harm to patients when utilized in various hip implant devices. 47. The above conduct illustrates Defendant's failure to exercise reasonable and appropriate care. It was foreseeable that such negligence would lead to premature device failure as well as severe, permanent, debilitating injury to patients, including Plaintiff. 48. As a direct and proximate result of Defendant's negligence, Plaintiff has suffered, and will continue to suffer, injury, emotional distress, harm and economic loss as alleged herein. SECOND CAUSE OF ACTION (Breach of Express Warranty) 49. Plaintiff incorporates by reference all preceding paragraphs as iffully set forth herein and further alleges as follows: 50. Through their public statements, their descriptions ofthe Rejuvenate, and Defendant's promises relating to the Rejuvenate, Defendant expressly warranted, among other 13

14 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 14 of 21 PageID# 14 things, that the Rejuvenate was effective and safe for its intended use: was designed and constructed of materials that would prevent fretting and corrosion: would last longer than competing hip implant devices; and was more suitable for younger adults than other devices given its purported longevity. 51. These warranties came in the form of(i) publicly-madc written and verbal assurances ofsafety; (ii) press releases and dissemination via the media of uniform promotional information that was intended to create ademand for Rejuvenate* (but which contained material misrepresentations and utterly failed to warn ofthe risks ofrejuvenate ); (iii) verbal assurances made by Defendant's consumer relations personnel to the public about the safety of the Rejuvenate that also downplayed the risks associated with Rejuvenate ; and. (iv) false and misleading written information supplied by Defendant. 52. The most prominent representation made by Defendant was on its website where it expressly warranted that the design, testing, and materials utilized in the Rejuvenate would prevent fretting and corrosion. 53. Plaintiff further alleges that all of the aforementioned written materials are known to Defendant and in its possession, and ii is Plaintiffs reasonable belief that these materials shall be produced by Defendant and be made part ofthe record once Plaintiff is afforded the opportunity to conduct discovery. 54. When Defendant made these express warranties, it knew the purpose for which the Rejuvenate was to be used, and warranted it to be in all respects safe and proper for such purpose. 55. Defendant drafted the documents and/or made statements upon which these warranty claims are based and. in doing so, defined the terms of those warranties. 14

15 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 15 of 21 PageID# The Rejuvenate does not conform to Defendant's representations in that these devices are not safe and instead produce serious and debilitating side effects. 57. As-such. the Rejuvenate did not conform to Defendant's promises, descriptions, or affirmations of fact, and was not adequately packaged, labeled, promoted, or fit for the ordinary purposes for which such devices are used. 58. As a direct and proximate result of the breach of Defendant's warranties. Plaintiff suffers, and will continue to suffer, injury, emotional distress, harm and economic loss as alleged herein. THIRD CAUSE OF ACTION (Breach of Implied Warranty) 59. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges as follows: 60. At the time Defendant marketed, sold, anil distributed the Rejuvenate, Defendant knew of the use for which the product was intended and impliedly warranted the product to be of merchantable quality, safe. lit. and effective for such use. 61. Defendant knew, or had reason to know, that Plaintiff and her physicians would rely on the Defendant's judgment and skill in providing the Rejuvenate for the intended use. 62. Plaintiff and her physicians reasonably relied upon the skill and judgment of Defendant as to whether the Rejuvenate was of merchantable quality, safe. fit. and effective for its intended use. 63. Contrary to such implied warranty, the Rejuvenate was not of merchantable quality or safe or lit or effective for its intended use, because the product was. and is. 15

16 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 16 of 21 PageID# 16 unreasonably dangerous, defective, unfit, and ineffective for the ordinary purposes for which the Rejuvenate system was used. 64. As a direct and proximate result ofthe breach ofimplied warranty. Plaintiff has suffered, and will continue to suffer, injury, emotional distress, harm and economic loss as alleged herein. FOURTH CAUSE OF ACTION (Strict Liability - Failure to Warn) 65. Plainti IT incorporates by reference all preceding paragraphs as iffully set forth herein and further alleges as follows: 66. The Rejuvenate implanted into Plaintiff contained no warnings, or in the alternative, inadequate warnings, as to the risk that the product could cause significant heavy metal toxicity. Similar, although still inadequate, warnings were added in 2012 by Defendant. 67. The warnings that accompanied the Rejuvenate failed to provide that level of information that an ordinary consumer would expect when using the implant in amanner reasonably foreseeable to Defendant. 68. Ilad Plaintiff received a proper or adequate warning as to the risks associated with Rejuvenate, Plaintiff would not have used the product. 69. Ilad Plaintiffs surgeon received a proper or adequate warning as lo the risks associated with using the Rejuvenate*, he would not have recommended the device, would have used an alternative device; or. at aminimum, would have provided Plaintiff with an adequate warning and obtained informed consent. 16

17 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 17 of 21 PageID# As adirect and proximate result of Defendant's failure to warn of these dangers, Plaintiff suffered, and will continue to suffer, injury, emotional distress, harm and economic loss as alleged herein. FIFTH CAUSE OF ACTION (Strict Liability- Desimi Defect) 71. Plainti IT incorporates by reference all preceding paragraphs as iffully set forth herein and further alleges as follows: 72. This is an action for strict liability based upon design defect against Defendant. 73. Defendant's 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. 74. Defendant's Rejuvenate does not perform as safely as an ordinary consumer would expect when used as intended, or in a manner reasonably foreseeable to Defendant. 75. The risks of using Defendant's Rejuvenate outweigh the benefits of using the device. designed. 76. The Rejuvenate g) hip surgically implanted in PlaintiITs body was defectively 77. As adirect and proximate result of the Rejuvenate@'s defective design. Plaintiff has suffered, and will continue to suffer, injury, emotional distress, harm and economic loss as alleged herein. 17

18 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 18 of 21 PageID# 18 SIXTH CAUSE OF ACTION (Strict Liability- imaiuilacturinu Detect) 78. Plaintiff incorporates by reference all preceding paragraphs as if set forth herein and further alleges as follows: 79. This is an action for strict liability based on a manufacturing defect. 80. The Rejuvenate is designed for implantation into the human body and to last a minimum of fifteen or more years, 'fhe Rejuvenate was also designed to be compatible with human tissue and bone. 81. "fhe Rejuvenate system implanted in Plaintiff failed causing Plaintiff to underg complicated surgery to remove the defective devices within a short period of time after the original date of implantation. These revision surgeries are technically much more difficult than the original surgery, even for skilled orthopedic surgeons, and involve a very long, difficult io recovery process. 82. fhe Rejuvenate system installed in Plaintiff was not compatible with human tissue and bone. Through a process of fretting and corrosion, the Rejuvenate device released heavy metals into the Plaintiff's body causing severe and permanent destruction of bone and tissue. Defendant failed to manufacture the Rejuvenate in a manner that prevented fretting and corrosion. 83. The Rejuvenate system implanted in Plaintiffs hip contained a manufacturing defect in that the Rejuvenate system implanted in Plaintiffdeparted from its intended design and became more dangerous. 84. As a direct and proximate result of Defendant's manufacturing defect. Plaintiff has suffered, and will continue to suffer, injury, emotional distress, harm and economic loss as alleged herein. 18

19 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 19 of 21 PageID# 19 SEVENTH CAUSE OF ACTION (Violation ol State Deceptive Acts and Practices. Unfair Trade Practices. Consumer Protection. Merchandising Practices and False Advertising Laws) 85. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges as follows: 86. By reason of the conduct as alleged herein, and by inducing Plaintiffand her physicians to use the Rejuvenate through the use of deception, fraud, false advertising, false pretenses, misrepresentations, unfair and/or deceptive practices and the concealment and suppression of material facts, including but not limited to fraudulent statements, concealments and misrepresentations identified herein and above, Defendants violated applicable Federal and State consumer protection, unfair trade practices, deceptive acts and practices, merchandising practices, and false advertising laws, including, but not limited to. the Virginia Consumer Protection Act, Va. Code Ann , etseq. and the Alaska Consumer Protection Act. Alaska Stat. $ el sec/. 87. As a direct and proximate result of Defendant's statutory violations. Plaintiff was implanted with a Rejuvenate system, which would not have occurred had Defendant not used deception, fraud, false advertising, false pretenses, misrepresentations, unfair and/or deceptive practices, and the concealment and suppression ofmaterial facts to induce Plaintiff and her physicians to use the Rejuvenate. 88. By reason of such violations, and pursuant to applicable Federal and State consumer protection, unfair trade practices, deceptive acts and practices, merchandising practices, and false advertising laws. Plaintiff is entitled lo recover all ofthe monies paid for the product: to be compensated for the cost of the medical care arising out of the use of the product; 19

20 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 20 of 21 PageID# 20 and to recover any and all consequential damages recoverable under the law including, but not limited to. both past and future medical expenses: past wage loss; loss of future earning capacity: and, past and future pain, suffering, disability, and emotional distress. Plaintiffis entitled to see compensatory damages, attorneys' fees, injunctive and equitable relief, and other remedies as determined by the Court pursuant to applicable Federal and State consumer protection laws. 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; Rejuvenate ; 2. Awarding the past and future costs of treatment for Plaintiffs injuries caused by the 3. Awarding injunctive relief, includingdisgorgement of all profits made from and monies paid for the Rejuvenate : 4. Awarding damages for Plaintiffs physical pain and suffering; 5. Awarding damages for Plaintiffs mental and emotional anguish: 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. Forsuch further relief as this Court deems necessary, just and proper. 20

21 Case 2:13-cv RGD-TEM Document 1 Filed 07/25/13 Page 21 of 21 PageID# 21 JURY DEMAND Plaintiff herby requests ajury trial, pursuant to Rule 38 ofthe Federal Rules of Civil Procedure, on all claims and issues so triable. Dated: July Respectfully sub/mtted, Emily Mapp Brannon Esq. (VSB No ) Richard J. Serpe. Esq. (VSB No ) Law Offices of Richard J. Serpe, P.C. Crown Center, Suite East Main Street Norfolk, VA Phone:(757) Facsimile : (757) ebrannon@serpcfirm.com rserpefftjscrpcfinn.com Counsel for Plainliff Richard S. Lewis, Esq. Kristcn M. Ward, Esq. FlAUSFELD, LLP 1700 K Street, N.W., Suite 650 Washington, DC Phone:(202) Fax:(202) rlcwisffiihausfclfilp.com kward(ajhaus feldllp.com Co-Counselfor Plaintiff 2\