Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 1 of 18 1 2 3 4 5 Corey M. Eschweiler, Esq. (Bar No. 6635) GLEN LERNER INJURY ATTORNEYS 4795 South Durango Drive Las Vegas, Nevada 89147 Telephone: (702) 877-1500 Facsimile: (702) 933-7043 ceschweiler@glenlerner.com 8 Colin P. King (Admitted Pro Hac Vice) (UT Bar No. 1815) cking@dkowlaw.com DEWSNUP KING OLSEN WOREL HAVAS MORTENSEN 36 South State Street, Suite 2400 Salt Lake City, UT 84111 Telephone: (801) 533-0400 9 Attorneys for Plaintiff 6 7 10 UNITED STATES DISTRICT COURT 11 DISTRICT OF NEVADA 12 Ryan Q. Claridge, CASE NO.: 2:18-CV-01654-GMN-BNW 13 Plaintiff, 14 vs. 15 I-FLOW CORPORATION, a Delaware corporation; I-FLOW, LLC, a Delaware limited liability company; DJO LLC (f.k.a. DJ ORTHOPEDICS, LLC), a Delaware limited liability company; DJO, INCORPORATED, aka DJO, INC., a Delaware corporation; STRYKER CORPORATION, a Michigan corporation; and STRYKER SALES CORPORATION, a Michigan corporation, 16 17 18 SECOND AMENDED COMPLAINT (JURY DEMANDED) 19 Defendants. 20 Plaintiff, Ryan Claridge, by and through his counsel, complains of Defendants, I-Flow 21 Corporation; I-Flow, LLC; DJO, LLC; DJO, Incorporated, aka DJO, Inc.; Stryker Corporation; and 22 Stryker Sales Corporation, demands a jury trial, and alleges as follows: 23 JURISDICTION 24 1. This Court has subject matter jurisdiction over this action pursuant to the provisions of 28 25 U.S.C. § 1332 as Plaintiff was a citizen of Nevada at the time of his surgery, and is currently a citizen of 26 Nevada, and Defendants are citizens of different states. 27 -1- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 2 of 18 2. 1 This Court has personal jurisdiction over Defendant I-Flow Corporation, a Delaware 2 corporation with its principal place of business in Lake Forest, California. 3 conducted regular and sustained business in Nevada by selling and distributing its products in Nevada. 3. 4 Defendant I-Flow has This Court has personal jurisdiction over Defendant I-Flow, LLC, a Delaware Limited 5 Liability Company, with its principal place of business in California. Defendant I-Flow, LLC, has 6 conducted regular and sustained business in Nevada by selling and distributing its products in Nevada. 7 Defendants I-Flow Corporation and I-Flow, LLC, will be referred to as “Defendant I-Flow.” 4. 8 9 10 This Court has personal jurisdiction over Defendant DJO, LLC (formerly known as DJ Orthopedics, LLC), a Delaware Limited Liability Company with its principal place of business in Vista, California. Defendant DJO, LLC, is registered to do business in the State of Nevada. 5. 11 This Court has personal jurisdiction over Defendant DJO, Incorporated, aka DJO, Inc., a 12 Delaware corporation with its principal place of business in Vista, California. 13 Incorporated, has conducted regular and sustained business in Nevada by selling and distributing its 14 products in Nevada and at all relevant times was doing business in the State of Nevada. Defendants DJO, 15 LLC, and DJO, Incorporated, will be referred to as “Defendant DJO.” 6. 16 Defendant DJO, This Court has personal jurisdiction over Defendants Stryker Corporation and Stryker 17 Sales Corporation, which are Michigan corporations with their principal places of business in 18 Kalamazoo, Michigan. Stryker Sales Corporation is registered to do business in the State of Nevada, and 19 these Defendants have conducted regular and sustained business in Nevada by selling and distributing 20 their products in Nevada, as described below. Collectively, Defendants Stryker Corporation and Stryker 21 Sales Corporation are referred to herein as “Defendant Stryker.” 7. 22 23 The amount in controversy exceeds $75,000 exclusive of interest and costs, and there is complete diversity of citizenship. GENERAL ALLEGATIONS 24 8. 25 Defendants, or one of their subdivisions, agents, or alter egos, designed, tested, 26 manufactured, assembled, labeled, marketed, distributed, and sold pain pumps. 27 /// -2- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 3 of 18 1 2 3 4 5 9. The pain pump is a medical device intended to deliver, via catheter, a continuous dose of pain medication directly into the operative site immediately following surgery. 10. The pain pump is designed and intended to be used with commonly used anesthetics such as bupivacaine, with or without epinephrine, over the course of two days or more. 11. The continuous injection of such medications over time directly into the shoulder joint can 6 cause serious and permanent damage to the shoulder joint cartilage, chondrolysis, the death of the 7 chondrocytes and a complete or nearly complete destruction of cartilage in the shoulder joint. 8 9 10 11 12 13 12. At all pertinent times, Defendants represented to the public and to health-care professionals that the pain pump was a safe and effective product used for post-operative pain management. 13. At all pertinent times, Defendants represented to the public and health care professionals that pain pumps could appropriately be used in or near the shoulder joint. 14. At all pertinent times, Defendants knew that their pain pumps were not cleared by the 14 United States Food and Drug Administration (“FDA”) for use in the joint space. In fact, Defendants 15 knew that the FDA, as early as 1998, had repeatedly rejected their requests for permission to market these 16 devices for orthopedic use and/or use in the joint space, based on a lack of safety data. 17 15. Defendants actively promoted their pain pumps to orthopedic surgeons for orthopedic use 18 and/or use in the joint space, despite the FDA’s denial of permission to market the device for these 19 indications, and despite Defendants’ failure to test the safety of their pain pumps for joint space use. 20 16. Three times the FDA denied Defendant I-Flow’s applications to add joint-space (intra- 21 articular or synovial cavity) use to its approved indications for use: once in November 1998, when 22 Defendant I-Flow sought clearance for continuous infusion of local anesthetic directly into the intra- 23 articular site; once in February 1999, when Defendant I-Flow sought to add the synovial cavity as a route 24 of administration; and once in March 1999, when Defendant I-Flow sought to add “orthopedic surgery” 25 as an indicated use and “synovial cavity” as an additional route of infusion. In addition, Defendant I- 26 Flow was aware that the FDA had required another manufacturer, McKinley, to remove synovial cavity 27 administration from its indications for use on March 3, 1999. -3- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 4 of 18 17. 1 Nevertheless, in a press release, Defendant I-Flow announced that it had “received 2 approval in June 1998 from the [FDA] to market PainBuster [one of its pain pumps] in the United States 3 for orthopaedic surgery applications.” This was not true. 18. 4 5 Defendant I-Flow made the same misrepresentation in a Form 10-K that it filed with the Securities and Exchange Commission (SEC) on March 31, 1999. 19. 6 The manuals for Defendant I-Flow’s and Defendant DJO’s sales representatives listed 7 labral repairs, such as SLAP repairs (the repair of a “superior labral anterior posterior” tear), like the 8 surgery Ryan Claridge had, as a targeted orthopedic application. 20. 9 Moreover, Defendant I-Flow’s marketing materials instructed physicians to insert the 10 catheter into the surgical wound site, which, in the case of a SLAP repair, would be the joint space. Yet, 11 there was no approval or clearance for use in the joint space, and Defendant I-Flow was aware of this 12 fact. 13 21. Defendant Stryker was no different. Specifically, in a March 31, 1999 press release 14 announcing an agreement between Defendant Stryker and McKinley, its predecessor, Defendant Stryker 15 misrepresented that its pain pumps were approved for orthopedic applications. 16 22. Defendant Stryker knew in 1999 that the FDA had mistakenly cleared its predecessor 17 device (the McKinley Outbound pump) for synovial cavity use (that is, use in the joint space) but had 18 withdrawn that clearance in March 1999 due to an absence of testing data. Yet it did not make any 19 changes in its labeling or instructions for use after learning of the FDA’s revocation of clearance for 20 synovial cavity use. 21 22 23 23. In 2001, Defendant Stryker asked the FDA to add the synovial cavity (the joint space) to its indication for use for the Stryker PainPump II, but the FDA denied the request on June 5, 2001. 24. There was no site-specific orthopedic application (such as shoulder surgery, intra-articular 24 infusion, or infusion into the synovial cavity or joint space) for which Defendant Stryker could legally 25 market its pain pumps. Nevertheless, Defendant Stryker continued to market its pain pumps for off-label, 26 site-specific orthopedic indications that the FDA had twice rejected (in 1999 and again in 2001) and did 27 not tell users of the devices or its own sales people that the FDA had rejected the uses it was promoting. -4- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 5 of 18 25. 1 Defendant Stryker’s 2003 “Guide to Selling PainPumpTM” instructs its sales 2 representatives to “[c]oach the surgeon on catheter placement.” Defendant Stryker’s sales representatives 3 would approach doctors in the operating rooms and encourage them to use the pain pumps intra- 4 articularly in the knee and shoulder, implying that the pumps could be used safely inside the joint space. 5 Dr. Lonnie Paulos, an orthopedic surgeon who was a consultant to Defendant Stryker from 2000 to 2007, 6 has confirmed this fact. 26. 7 In addition to its instructions to its sales force, Defendant Stryker’s on-line training course, 8 in-service guidelines, a procedure chart, and other marketing materials given to its representatives and to 9 physicians represented that Defendant Stryker’s pain pumps could be used in shoulder surgery and in the 10 shoulder joint space. 27. 11 By promoting their pain pumps for use in the shoulder joint, Defendant I-Flow and 12 Defendant Stryker were also promoting the anesthetics infused by the pumps for use in the shoulder joint, 13 despite the fact that local anesthetics were not approved for continuous intra-articular infusion. 28. 14 15 Scientific and medical literature from 1985 through the 1990s demonstrated the potential toxicity to articular cartilage from bathing joints with various solutions, such as bupivacaine. 16 29. This information was available to Defendant I-Flow and Defendant Stryker. 17 30. In light of this information, by late 2003, the medical community was beginning to 18 recognize glenohumeral chondrolysis as a devastating complication of shoulder arthroscopy. 31. 19 In May 2004, an FDA officer wrote an article in the journal Anesthesiology discussing 20 adverse events reported to the FDA that were associated with the use of pain pump systems for direct 21 anesthetic infusion into a surgical wound. 32. 22 Monitoring the scientific and medical literature is a standard industry practice, so 23 Defendant I-Flow and Defendant Stryker knew or should have known of this publication and potential 24 warning sign. 33. 25 Defendant Stryker in fact learned of the publication in 2005 from a physician that it 26 consulted after learning of chondrolysis reports. 27 /// -5- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 6 of 18 34. 1 On February 11, 2005, Dr. Lonnie Paulos, Defendant Stryker’s consultant, sent a fax to 2 Defendant Stryker alerting it about 30 to 32 cases of chondrolysis that he knew about personally. Dr. 3 Paulos followed this up with an e-mail four days later, on February 15, 2005, to Brady Shirley, Senior 4 Vice President of Stryker Endoscopy, and Don Kelley, General Manager for Orthopedics for Stryker 5 Instruments Mountain States area. 6 importance of this issue” and advised Defendant Stryker that the “only common link is the pain dripping 7 devices [i.e., pain pumps] with Marcain or Lidocain and Epinephrine.” The incidents occurred after the 8 pain pump catheter was placed in the glenohumeral (shoulder joint) space. Dr. Paulos warned that “there 9 will be a huge out pouring of other cases that have been smoldering for several years” when Dr. Charles Dr. Paulos’s communications were meant “to reinforce the 10 Beck presented a paper that summer at the Herodicus Society meeting. 11 recommended” that Defendant Stryker change its labeling “as soon as possible” and proposed that 12 Defendant Stryker do an animal study within thirty to sixty days, neither of which Defendant Stryker did. 35. 13 Dr. Paulos “strongly On August 9, 2005, Dr. Beck called Defendant Stryker reporting that pain pump recipients 14 developed a condition where cartilage died and “flaked off” some six months after Bankart repairs. Nine 15 of thirteen patients who received a Defendant Stryker pain pump after initial shoulder surgery for either 16 Bankart repair or capsular shift were diagnosed with chondrolysis approximately six months after the 17 surgery, and six of the nine required shoulder replacement. 36. 18 Despite the fact that all nine cases met the criteria for Medical Device Reporting (MDR), 19 Defendant Stryker only reported seven of Dr. Beck’s cases to the FDA, and none of the other cases 20 reported to Defendant Stryker by Dr. Paulos. 37. 21 In May or June of 2005, representatives of pain pump manufacturers and distributors, 22 including representatives of Defendant I-Flow and Defendant Stryker, visited Dr. Randy Yee to market 23 pain pumps to him. 38. 24 The representatives told Dr. Yee that he could put the pumps’ catheters in the shoulders 25 and knees and that there was no problem with them. 26 /// 27 /// -6- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 7 of 18 39. 1 Specifically, on information and belief, David Tevebaugh (Defendant I-Flow’s Territory 2 Manager), and/or other employees, agents, or representatives of Defendant I-Flow, told Dr. Yee that the 3 devices were FDA approved and that he could safely use them in the shoulder. 40. 4 About this same time, on information and belief, Scott Thurman (Defendant Stryker’s 5 Sales Representative), Ian Rosen (Defendant Stryker’s Sales Representative) and/or other employees, 6 agents, or representatives of Defendant Stryker, made similar representations to Dr. Yee, leading Dr. Yee 7 to believe that pain pumps were safe for use in the shoulder joint. 41. 8 9 10 11 Defendant I-Flow’s and Defendant Stryker’s employees, agents, and/or representatives all failed to inform Dr. Yee that the pain pumps were specifically denied FDA clearance for intra-articular use. 42. In reliance on these representations and nondisclosures of Mr. Tevebaugh, Mr. Thurman, 12 Mr. Rosen, and/or other employees, agents, or representatives of Defendant I-Flow and Defendant 13 Stryker, Dr. Yee began using pain pumps in the shoulder joint for post-surgery pain relief. 14 43. Defendants did not warn Plaintiff Ryan Claridge or Dr. Yee, his surgeon, that pain pumps 15 had been denied clearance by the FDA for orthopedic use and/or use in the joint space and that pain 16 pumps’ safety for such indications had not been established. 17 44. On information and belief, if Defendant I-Flow’s and/or Defendant Stryker’s 18 representatives told Dr. Yee that pain pump manufacturers tried to get FDA clearance to market their 19 pumps for intra-articular use but that the FDA had denied their requests, Dr. Yee would not have put the 20 pump catheters in Ryan Claridge’s shoulder joint. 21 22 45. Defendants did not warn Plaintiff Ryan Claridge or Dr. Yee about the unreasonable risks and dangers of using the pain pump and anesthetic medications in this manner. 23 46. Dr. Yee used the pain pumps in the manner instructed and directed by Defendants. 24 47. In November 2009, the FDA issued a report warning healthcare professionals “to not use 25 [pain pumps] for continuous intra-articular infusion of local anesthetics after orthopedic surgery.” In the 26 same report, the FDA stated that it “has not cleared any [pain pumps] with an indication for use in intra- 27 articular infusion of local anesthetics.” -7- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 8 of 18 48. 1 2 Plaintiff Ryan Claridge grew up in Michigan and was an exceptional multi-sport athlete in high school and college. 49. 3 Ryan Claridge attended college and played NCAA football at the University of Nevada, 4 Las Vegas (UNLV), from 2000 to 2004, under UNLV’s head coach John Robinson, who had previously 5 been the head football coach for USC in the PAC-10 and the Los Angeles Rams in the NFL. Ryan was a 6 star linebacker at UNLV. 50. 7 8 a four-year contract. 51. 9 10 In 2005 Ryan Claridge was drafted by the New England Patriots as a linebacker and given During the summer of 2005 Ryan Claridge suffered a left shoulder injury during the Patriots’ pre-season training camp. 52. 11 Plaintiff Ryan Claridge underwent left shoulder arthroscopic surgery in August 2005 at 12 Seven Hills Surgery Center, Henderson, Nevada, by Dr. Randy Yee. Dr. Yee inserted post-operatively 13 into Ryan’s left shoulder joint an On-Q pain pump manufactured and sold by Defendants I-Flow and 14 DJO. 53. 15 16 shoulder joint for post-operative pain relief. 54. 17 18 The On-Q pain pump infused anesthetic continuously for at least 48 hours into Ryan’s Unbeknownst to Dr. Yee and to Ryan Claridge, the On-Q pain pump killed the living chondrocytes in Ryan’s shoulder cartilage, causing irreversible destruction of his shoulder cartilage. 55. 19 During the following months, as Ryan followed his prescribed physical therapy in 20 preparation to return to active duty with the New England Patriots, the normal expected improvement in 21 range of motion and function and pain relief did not occur. 56. 22 23 In fact, by the last several months of 2005, Ryan’s shoulder worsened. He again saw Dr. Yee about the unusual lack of progress. 57. 24 In January 2006, Dr. Yee did an exploratory arthroscopic examination of Ryan’s left 25 shoulder joint. This surgery occurred at a different surgery center, the Southern Hills Hospital and 26 Medical Center in Las Vegas, Nevada. 27 /// -8- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 9 of 18 1 58. Dr. Yee found extensive cartilage damage during the surgery. He removed dead and 2 damaged cartilage. At the end of the surgery, Dr. Yee inserted into Ryan’s shoulder joint a pain pump 3 manufactured and sold by Defendant Stryker. 4 59. The pain pumps manufactured and sold by Defendants destroyed Plaintiff Ryan Claridge’s 5 left shoulder, which rendered him unable to play football in the NFL for the New England Patriots or any 6 other team. 7 60. Plaintiff Ryan Claridge’s injuries resulted in severe and permanent injuries and 8 impairments to his left shoulder and very severe lifetime impairments, pain, and restrictions to his 9 activities of daily living. 10 61. As a direct result of the destruction of Plaintiff’s shoulder joint from Defendants’ pain 11 pumps, Plaintiff has suffered multiple harms and losses, including, but not limited to, severe physical 12 pain, mental suffering, loss of the enjoyment of life, past and future medical, surgical, and related 13 expenses, impairment, disfigurement, past and future loss of earnings and earning capacity, and loss of 14 household services. 15 62. Plaintiff learned for the first time in the spring of 2018 that the pain pumps placed in his 16 shoulder joint for post-operative pain relief had killed the living cells of his shoulder cartilage, which led 17 to the destruction of his shoulder joint cartilage and the recent diagnosis of chondrolysis. 18 FIRST CAUSE OF ACTION (Strict Products Liability) Against All Defendants 19 20 63. Plaintiff incorporates by reference the preceding allegations as if fully set forth herein. 21 64. Defendants designed, tested, manufactured, assembled, labeled, marketed, distributed, 22 23 and/or sold pain pumps, including those used in Plaintiff Ryan Claridge’s surgeries. 65. These pain pumps were defectively designed in that, among other things, the continuous 24 infusion of post-surgical anesthetic solution at the delivery rates achieved by the pain pumps can cause 25 permanent shoulder injury, namely, severe chondrolysis and total destruction of cartilage and 26 surrounding tissue. 27 66. As a result of this design defect, Defendants’ pain pumps are unreasonably dangerous. -9- Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 10 of 18 1 67. As a result of their design, the pain pumps were more dangerous than an ordinary and 2 reasonable user of the pain pumps would expect, considering the pain pumps’ characteristics, uses that 3 were foreseeable to Defendants, and any instructions or warnings given by Defendants. 4 5 6 68. Plaintiff Ryan Claridge neither knew nor should have known of the danger posed by use of Defendants’ pain pumps in or near the shoulder joint. 69. Plaintiff Ryan Claridge’s surgeon did not have actual knowledge sufficient to know the 7 danger posed by use of Defendants’ pain pumps in or near the shoulder joint, and Defendants did not give 8 Plaintiff Ryan Claridge or his surgeon sufficient warning regarding the danger posed by use of 9 Defendants’ pain pumps in or near the shoulder joint. 10 11 12 13 14 15 16 70. The design defects in Defendants’ pain pumps were present at the time Defendants manufactured, distributed, and sold the pain pumps. 71. Defendants knew, or reasonably should have known, of the danger posed by use of their pain pumps in or near the shoulder joint. 72. Defendants were required to warn about the danger posed by the foreseeable use of their pain pumps in or near the shoulder joint. 73. Defendants failed to provide an adequate warning to Plaintiff Ryan Claridge or his 17 surgeon at the time Defendants’ pain pumps were manufactured, distributed, and sold, in that, in light of 18 the ordinary knowledge common to members of the community who use Defendants’ pain pumps, 19 Defendants failed to: 20 a. Ryan Claridge and his surgeon; 21 22 b. c. 27 provide a warning that fairly indicated the danger from the pain pumps’ foreseeable use in or near the shoulder joint; 25 26 provide a warning that was understandable to Plaintiff Ryan Claridge and his surgeon; 23 24 provide a warning that was designed to reasonably catch the attention of Plaintiff d. provide a warning that was sufficiently conspicuous to match the magnitude of the danger posed by use of the pain pumps in or near the shoulder joint; - 10 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 11 of 18 e. 1 shoulder joint space had not been established; and 2 f. 3 provide a warning that when used as designed, Defendants’ pain pumps delivered, over time, dangerously high doses of medication directly into the shoulder joint. 4 74. 5 6 provide a warning that the safety and effectiveness of the devices for use in the Defendants’ failure to provide an adequate warning made Defendants’ pain pumps defective and unreasonably dangerous. 75. 7 The pain pumps were unreasonably and dangerously defective because at no time did 8 Defendants conduct adequate testing to determine whether pain pumps placed for infusion in or near the 9 joint space could cause damage to articular cartilage. 10 76. The defects in the pain pumps were a proximate cause of the Plaintiff’s harms and losses. 11 77. As a direct result of the use of the pain pumps in Plaintiff Ryan Claridge’s shoulder, 12 Plaintiff has suffered harms and losses, including, but not limited to, severe physical pain, mental 13 suffering, loss of the enjoyment of life, past and future medical, surgical, and related expenses, 14 impairment, disfigurement, past and future loss of earnings and earning capacity, and loss of household 15 services. 16 SECOND CAUSE OF ACTION (Negligence) Against All Defendants 17 18 78. Plaintiff incorporates by reference the preceding allegations as if fully set forth herein. 19 79. Defendants had a duty to design, manufacture, test, inspect, assemble, label, market, 20 distribute, and sell the pain pumps so as to eliminate any unreasonable risk of foreseeable injury. 80. 21 At all relevant times, Defendants breached this duty and failed to use reasonable care in 22 designing, manufacturing, testing, inspecting, assembling, labeling, marketing, distributing, and selling 23 their pain pumps. Defendants’ negligence includes, but is not limited to, the following: a. 24 Defendants failed to conduct a proper assessment and analysis of the design and assembly of the pain pumps; 25 26 /// 27 /// - 11 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 12 of 18 b. 1 Defendants failed to properly test and/or inspect the pain pumps in the 2 environment in which they were to be used to ensure that the pain pumps would be 3 safely used in a manner and for a purpose for which they were made; c. 4 Defendants promoted and marketed their pain pump for use in shoulder surgery even though— 5 i. 6 Use of the pain pump in the joint space had not been cleared by the FDA, and in fact had been specifically rejected by the FDA; 7 ii. 8 Continuous injection of anesthetic medications, through a catheter, directly into the shoulder joint for two or more days had not been 9 adequately tested for safety or effectiveness; 10 iii. 11 The risk of chondrolysis and other serious post-operative problems 12 associated with using the pain pumps as designed and instructed 13 outweighed the possible benefits of such use; iv. 14 Defendants failed to provide adequate warnings and instructions to 15 Plaintiff Ryan Claridge and to physicians and medical providers 16 using the pain pumps; and v. 17 18 81. 19 Defendants failed to recall the pain pumps. Defendants’ negligence was a proximate cause of the Plaintiff’s harms and losses. THIRD CAUSE OF ACTION (Misrepresentation and Fraudulent Concealment) Against all Defendants 20 21 82. Plaintiff incorporates by reference the preceding allegations as if fully set forth herein. 22 83. Defendants had a duty to provide truthful information and to not provide misleading 23 24 information about their pain pumps to surgeons and the public, including the Plaintiff. 84. Defendants, by and through their highest levels of management and leadership, and 25 implemented through their employees, agents, and sales representatives, made misrepresentations or 26 omissions of facts material to physicians to induce them to choose post-arthroscopic surgery use of pain 27 pumps for their patients’ pain relief. - 12 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 13 of 18 85. 1 Defendants’ misrepresentations included, but were not limited to, the following: a. 2 safe; 3 b. 4 That pain pumps had been used for years in other parts of the body, and therefore were safe for use in shoulder joints; 5 c. 6 That post-arthroscopic shoulder surgery pain pump use in the shoulder joint had been tested and testing had determined such use to be safe; and 7 d. 8 That the FDA had approved in some fashion the use of pain pumps in the shoulder joint for post-arthroscopic shoulder surgery pain relief. 9 86. 10 11 That post-arthroscopic shoulder surgery pain pump use in the shoulder joint was Defendants knew or should have known at the time that they made their misrepresentations and omissions that they were false. 87. 12 Defendants, at the highest levels of their management and leadership, caused multiple 13 material misrepresentations and/or omissions to be made to surgeons and others involved in the purchase 14 and use of pain pumps, by and through false and misleading information taught to and disseminated by 15 Defendants’ employees and agents, including pain pump sales representatives who routinely appeared in 16 surgical operating rooms promoting the use of pain pumps to shoulder surgeons, including Dr. Yee. 88. 17 18 Defendants caused the above-described misrepresentations to be made about their pain pumps intentionally, recklessly and without regard for the truth. 89. Defendants failed to use reasonable care to determine whether their representations were 21 90. Defendants were in a better position than surgeons to know the true facts. 22 91. Defendants had a financial interest in transactions dependent on the facts as represented by 19 20 23 24 25 true. Defendants. 92. Defendants intended that surgeons, including Plaintiff’s shoulder surgeon, would rely on their misrepresentations and omissions. 26 93. 27 omissions. Plaintiff’s physician reasonably relied upon Defendants’ misrepresentations and - 13 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 14 of 18 94. 1 2 Defendants intentionally or negligently did not alter or correct the disseminated information they knew to be misrepresentations or omissions. 95. 3 By reason of Dr. Yee’s reasonable reliance on Defendants’ misrepresentations and 4 omissions of material fact, Dr. Yee implanted Defendants’ pain pumps into Plaintiff’s left shoulder joint 5 in 2005 and 2006, each of which infused anesthetics continuously into Plaintiff’s intra-articular joint for 6 over 48 hours, and each of which caused irreparable destruction to his shoulder cartilage. 96. 7 As a direct and proximate result of Defendants’ intentional and/or reckless 8 misrepresentations, Plaintiff Ryan Claridge has suffered and continues to suffer egregious and lifelong 9 injuries, pain, restrictions, disfigurement, impairments and damages. 97. 10 As a direct and proximate result of Defendants’ intentional and/or reckless 11 misrepresentations, Plaintiff Ryan Claridge has suffered and continues to suffer lifelong medical, 12 medication, and related expenses and costs; the loss of his professional NFL football career; substantial 13 loss of past and future income and benefits; severely impaired earning capacity; and other substantial 14 related economic damages. 98. 15 16 amount to be determined at trial. 99. 17 18 Plaintiff is entitled to recover damages caused by Defendants’ misrepresentations in an Defendants were under a continuing duty to disclose the true facts regarding pain pump use for intra-articular joint use, and knowingly and fraudulently concealed the true facts. 100. 19 Plaintiff and the medical community were kept in ignorance of important information 20 essential to the pursuit of these claims, without any fault or lack of diligence on their part. As a result of 21 Defendants’ fraudulent concealment of the true facts, Plaintiff and the medical community could not 22 reasonably have known or become aware of the dangerous nature of pain pumps in intra-articular joints at 23 the time of Plaintiff’s left shoulder surgeries by Dr. Yee. 101. 24 Any applicable statute of limitations has been tolled by Defendants’ knowing and active 25 concealment and denial of the true facts regarding intra-articular use of their pain pumps. 26 /// 27 /// - 14 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 15 of 18 1 FOURTH CAUSE OF ACTION (Negligent Misrepresentation) Against all Defendants 2 3 102. Plaintiff incorporates by reference the preceding allegations as if fully set forth herein. 4 103. Defendants, in the course of actions in which they had a pecuniary interest, failed to 5 exercise reasonable care or competence in obtaining or communicating information to Plaintiff and/or 6 Plaintiff’s shoulder surgeon. 104. 7 8 misrepresentations and omissions that they were false. 105. 9 10 106. Plaintiff’s physician reasonably relied upon Defendants’ misrepresentations and omissions. 107. 13 14 Defendants intended that surgeons, including Plaintiff’s shoulder surgeon, would rely on their misrepresentations and omissions. 11 12 Defendants knew or should have known at the time that they made their Plaintiff is entitled to recover damages caused by Defendants’ negligent misrepresentations in an amount to be determined at trial. DAMAGES 15 16 108. Plaintiff incorporates by reference the preceding allegations as if fully set forth herein. 17 109. As a direct and proximate result of Defendants’ fault set forth generally above, Plaintiff 18 has suffered and will suffer the following damages, in amounts to be proved at trial: a. 19 General damages for severe physical pain, mental suffering, impairment, disability, 20 disfigurement, and loss of the enjoyment of life suffered by Plaintiff Ryan 21 Claridge; b. 22 treatment and related expenses and care for Plaintiff Ryan Claridge; 23 c. 24 Past and future loss of wages, earnings and earning capacity of Plaintiff Ryan Claridge; 25 d. 26 27 Past, present, and future damages for the costs of medical, surgical, rehabilitative Damages for Plaintiff Ryan Claridge’s loss of household services; and /// - 15 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 16 of 18 e. 1 Plaintiff’s costs of this action, together with interest on special and general 2 damages from the date of occurrence at the legal rate until paid, interest on any 3 judgment awarded herein at the legal rate until paid, and other and further relief as 4 the Court deems equitable and just. PUNITIVE DAMAGES 5 110. 6 As early as 1999, Defendants knew that the FDA had not cleared or approved use of pain 7 pumps in or near the shoulder joint space, but they continued to market and promote pain pumps 8 specifically for orthopedic, joint-space use. 111. 9 Defendants knew that the safety of their pain pumps for orthopedic and joint-space use 10 had not been established, yet they actively marketed and promoted their pain pumps to orthopedic 11 surgeons for orthopedic use, including joint-space use, without ever conducting studies to determine the 12 safety of such use. 13 112. Despite the above, Defendants continued to market pain pumps for joint-space use and did 14 not issue a warning to inform the public that the safety of pain pumps in the joint space had not been 15 established. 16 113. These acts and omissions of Defendants show that Defendants have acted with oppression, 17 fraud, or malice, express or implied, that their conduct was willful and malicious or intentionally 18 fraudulent, or that they engaged in despicable conduct with a conscious disregard of the rights or safety 19 of others, including Plaintiff, consciously and deliberately disregarding known safety measures in 20 reckless disregard of the possible results. Defendants’ conduct makes them liable to Plaintiff for punitive 21 or exemplary damages, in an amount to be subject to proof at trial. 22 PRAYER FOR RELIEF WHEREFORE, Plaintiff prays for judgment in his favor and against Defendants awarding the 23 24 following: 25 1. 26 damages: 27 /// A monetary award sufficient to compensate Plaintiff for the following categories of - 16 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 17 of 18 a. 1 General damages for severe physical pain, mental suffering, inconvenience, 2 impairment, disfigurement, and loss of the enjoyment of life suffered by Plaintiff 3 Ryan Claridge; b. 4 Past, present, and future damages for the costs of medical, surgical, rehabilitative treatment and related expenses and care for Plaintiff Ryan Claridge; 5 c. 6 Past and future loss of wages, earnings and earning capacity of Plaintiff Ryan Claridge; and 7 d. 8 Damages for Plaintiff Ryan Claridge’s loss of household services. 9 2. Punitive damages, in an amount to be subject to proof at trial. 10 3. Plaintiff’s costs of this action. 11 4. Interest on past and future special damage amounts from the date of injury at the legal rate 12 until paid. 13 5. Interest on any judgment awarded herein at the legal rate until paid. 14 6. Such other and further relief as the Court deems equitable and just. 15 JURY DEMAND 16 Plaintiff has requested a jury trial in this case. 17 DATED this 7th day of October, 2019. GLEN LERNER INJURY ATTORNEYS 18 /s/ Corey M. Eschweiler Corey M. Eschweiler Attorneys for Plaintiff 19 20 21 DEWSNUP KING OLSEN WOREL HAVAS MORTENSEN 22 /s/ Colin P. King Colin P. King Attorneys for Plaintiff 23 24 25 26 27 - 17 - Case 2:18-cv-01654-GMN-BNW Document 69 Filed 10/07/19 Page 18 of 18 1 CERTIFICATE OF SERVICE 2 Pursuant to Fed.R.Civ.P. 5(b) and LR 5-1, I hereby certify that service of the foregoing 3 SECOND AMENDED COMPLAINT was made on October 7, 2019, by depositing a copy for 4 mailing, first class mail, postage prepaid, to the following: 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Colin P. King, Esq. DEWSNUP KING OLSEN WOREL HAVAS MORTENSEN 36 S. State St., Suite 2400 Salt Lake City, Utah 84111 Facsimile: (801) 363-4218 Co-Counsel for Plaintiff Kevin A. Brown, Esq. Jill P. Northway, Esq. BROWN, BONN & FRIEDMAN, LLP 5528 S. Fort Apache Rd. Las Vegas, Nevada 89148 Facsimile: (702) 942-3901 Attorneys for Defendant I-Flow, LLC Lee J. Hurwitz, Esq. Mark Crane, Esq. SEGAL MCCAMBRIDGE SINGER & MAHONEY, LTD. 233 S. Wacker Dr., Suite 5500 Chicago, Illinois 60606 Attorneys for Defendant I-Flow, LLC Vaughn A Crawford, Esq. Morgan T. Petrelli, Esq. SNELL & WILMER L.L.P 3883 Howard Hughes Pkwy., Suite 1100 Las Vegas, Nevada 89169 Facsimile: (702) 784-5252 Co-Counsel for Defendants Stryker Corp. and Stryker Sales Corp. 21 22 23 24 25 26 27 Christopher P. Norton, Esq. MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, P.C. 2029 Century Park East, Suite 3100 Los Angeles, California 90067 Facsimile: (310) 586-3202 Co-Counsel for Defendants Stryker Corp . and Stryker Sales Corp. /s/ Miriam Alvarez An employee of Glen Lerner Injury Attorneys - 18 -