SUPERIOR COURT OF THE STATE OF WASHINGTON IN AND FOR THE COUNTY OF KING CYNTHIA WILSON, individually and as Personal Representative of the Estate of Reba Golden, Deceased, and on behalf of Statutory Beneficiaries VICTORIA MARINCIN, and PAUL D'OYLEY; and VICTORIA MARINCIN and PAUL. D'OYLEY, Individually, Plaintiffs, v. JENS R. CHAPMAN, M.D. and “JANE DOE” CHAPMAN, Husband and Wife; STATE of WASHINGTON, a State; UNIVERSITY OF WASHINGTON, a Division of Washington State; HARBORVIEW MEDICAL CENTER; "JOHN AND JANE DOES’ 1-52, Employees, Agents, or Apparent Agents of the State of Washington, University of Washington, and/or Harborview Medical Center; SYNTHES INC, a Foreign Corporation; NORIAN CORP. a Foreign Corporation; KENSEY, NASH CORP., Foreign Corporation; HANSJORG WYSS and “JANE DOE” WYSS, Husband and Wife; MICHAEL D. HUGGINS and LISA HUGGINS, Husband and Wife; THOMAS B. HIGGINS and NANCY HIGGINS; NO. —13-2-29535-1 SEA COMPLAINT Husband and Wife; RICHARD E. COMPLAINT - 1 RUSH, HANNULA, HARKINS & KYLER, LLP. ‘4701 South 19” Street, Suite 300 TACOMA, WA $8405 “TACORMA: 253-383-5388 FAX: 259-272-5105BOHNER and PATRICIA BOHNER, Husband and Wife; JOHN J. WALSH and DANITA WALSH, Husband and Wife; HERNANDO OLIVAR, M.D. and “JANE DOE” OLIVAR, Husband and Wife; DELMORE J. MORSETTE, M.D. and “JANE DOE” MORSETTE, Husband and Wife; BRIAN K. DAINES, M.D. and “JANE DOE” DAINES, Husband and Wife, Defendants. _ |. PARTIES, JURISDICTION AND VENUE 1.1, Cynthia Wilson is a surviving daughter and personal representative of the Estate of Reba Golden, deceased, She brings this action on behalf of the Estate of Reba Golden, deceased, and on behalf of Ms. Golden's statutory beneficiaries: herself, as a surviving daughter; Victoria Marincin, surviving daughter and Paul D’Oyley, ‘surviving son. 1.2. Jens R. Chapman, M.D., is a medical doctor licensed to practice medicine in the State of Washington. At all times material hereto, Dr. Chapman practiced medicine in king County, Washington as an orthopedic surgeon. Jens R. Chapman, M.D. and “Jane Doe" Chapman are husband and wife and a marital community under the laws of the State of Washington. All acts and omissions complained of against Jens R. Chapman, M.D. were done or omitted by him individually and on behalf of his marital ‘community. At all times material hereto, Dr. Chapman was employed by the State of Washington, through the University of Washington. At all tes material hereto, Dr. Chapman was an employee, agent, or apparent agent of the University of Washington, acting within the course and scope of his employment. At all times material hereto, Dr. ‘Chapman received research and/or institutional support from Synthes, Inc., received : RUSH, HANNULA, HARKINS & KYLER, LLP. COMPLAINT - 2 4701 South 19" Street, Suite 300 TACOMA, Vin S405 TACOMA: 289-909-6308 FAK 289-272-5108,So@mrxearR OW 4 12 13 14 15 16 17 18 19 20 21 22 23 24 25 miscellaneous non-income support, commercially derived honoraria and other non- research-related funding from Synthes, Inc. and was a consultant for or an employee of Synthes, Inc. At all times material hereto, Dr. Chapman was the holder of the Hansjérg ‘Wyss Endowed Chair at the University of Washington, which paid a portion of his compensation and supported his research efforts. At all times material hereto, Dr. Chapman was an employee or agent of Synthes, Inc., Norian Corp. and/or Hansjérg ‘Wyss, acting within the course and scope of employment or agency. 1.3. Defendant Synthes, Inc. (“Synthes’), is a foreign business corporation organized under the laws of the State of Delaware, with its principal place of business located at West Chester, Pennsylvania. Synthes was the United States branch of a large multinational medical device manufacturing corporation that specializes in trauma products, with manufacturing facilities located in Monument, Colorado; West Chester, Pennsylvania; Elmira, New York and Tuttlingen, Germany. On information and belief, defendant Synthes is a wholly owned subsidiary of Johnson & Johnson, a foreign corporation. 1.4, Defendant Norian Corp. ("Norian") was a wholly owned subsidiary of defendant Synthes, with its principal place of business located at West Chester, Pennsylvania. Prior to mid-1999, defendant Norian was located in Cupertino, California and was in the business of manufacturing and selling two tri-calcium phosphate bone cements, called Norian Cranial Repair System (*CRS") and Norian Skeletal Repair System ("SRS"). CRS was a Class II medical device that had been cleared by the USFDA to be marketed for filling defects in the skull. SRS was a class III medical device that had been approved by the USFDA to be marketed for use in the distal COMPLAINT -3 RUSH, HANNULA, HARKINS & KYLER, LLP. TACOMA, WA e408 TACOMA: 253-283-6388 FAX: 253-272-5105Semrnoarnon "1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 radius, a long bone in the arm. Synthes acquired defendant Norian on or about July 21, 1999, whereupon Synthes began exploring new intended uses for the Norian bone cements, with the purpose of eventually obtaining a USFDA-approved use, called an indication, for use of Norian bone cements in the spine. Defendant Synthes has sold defendant Norian to defendant Kensey Nash Corp. 1.5. Defendant Kensey Nash, Corp. is a foreign corporation, incorporated under the laws of the state of Delaware, with its principal place of business located in Exton, Pennsylvania. Defendant Kensey Nash, Corp. is the current owner of defendant Norian Corp. 1.6. Defendant Wyss is a resident of Pennsylvania. Hansjérg Wyss and “Jane Doe” Wyss are husband and wife. All acts and omissions alleged against Hansjérg ‘Wyss were done or omitted by him individually and on behalf of his marital community. Atall times relevant hereto, defendant Wyss was a major stockholder, chief executive officer and/or chairman of Synthes, which bought and owned Norian. 1.7. Defendant Michael D. Huggins was a resident of Pennsylvania during all times material hereto. Defendants Michael D. Huggins and Lisa Huggins are husband and wife. All acts and omissions alleged against defendant Michael D. Huggins were done or omitted by him individually and on behalf of his marital community. At all times material hereto, defendant Mr. Huggins was employed by Synthes as the President of Synthes North America, a subsidiary of Synthes, or President of Synthes Spine, a division of Synthes, where he reported to defendant Hansjérg Wyss. 1.8. Defendant Thomas B. Higgins was a resident of Pennsylvania during all times material hereto. Defendants Thomas B. Higgins and Nancy Higgins are husband IT - RUSH, HANNULA, HARKINS & KYLER, LLLP. COE ene ANS HS Sten Sule 900 TACOMA, Wa 8405 TACOMA: 2503602008, Pak 258-272-5105,and wife. Allacts and omissions alleged against defendant Thomas B. Higgins were done or omitted by him individually and on behalf of his marital community. At all times material hereto, defendant Mr. Higgins was President of Synthes Spine, a division of Synthes, reporting to defendant Mr. Huggins and defendant Hansjérg Wyss. 1.9. Defendant Richard E. Bohner was a resident of Pennsylvania during all times material hereto. Defendants Richard E, Bohner and Patricia Bohner are husband and wife, All acts and omissions alleged against defendant Richard E. Bohner were done or omitted by him individually and on behalf of his marital community. During all times material hereto, defendant Mr. Bohner was employed by Synthes as its Vice President of Operations, reporting to defendants Mr. Huggins and Hansjérg Wyss. 4.10, Defendant John J. Walsh was a resident of Pennsylvania during all times material hereto. Defendants John J. Walsh and Danita Walsh are husband and wife. All acts and omissions alleged against defendant John J. Walsh were done or omitted by him individually and on behalf of his marital community. At all times material hereto, defendant Mr, Walsh was employed by defendant Synthes as its Director of Regulatory and Clinical Affairs, Spine Division and reported to defendants Mr. Bohner, Mr. Huggins and Hansjorg Wyss. 4.11. Defendant State of Washington is a state and a political subdivision of the United States of America. Defendant State of Washington has, as one of its subdivisions, the defendant University of Washington and, in turn, is legally responsible {or its operation, including the actions of the defendant medical center and medical clinics and the actions of the defendant health care professionals alleged herein to be ‘employees and/or agents of the University of Washington performed within the course COMPLAINT - 5 RUSH, NANMULA, HARKINS & KYLER, LLP. TACOMA, WA S008 ‘TACOMA: 253-383-6988 FAK: 253-272-5105and scope of their employment or agency. 1.12. Defendant University of Washington is a division of Washington State. Defendant University of Washington is a university with its main campus, hospitals and health care facilities located in King County, Washington. At all times material hereto defendant University of Washington operated Harborview Medical Center and Universit of Washington Medical Center. At all times material hereto University of Washington, through its subdivisions, employed defendants Jens R. Chapman, M.D., Hernando P. Olivar, M.D., Delmore J, Morsette, M.D., and Brian K. Daines, M.D. and “John and Jane Does" 4 - 52. Atall times material hereto, defendant University of Washington, through its constituent medical centers operated and supervised defendat Harborview Medical Center and its departments, services and clinics including their departments, services and/or clinics of Orthopedic Surgery, Spine Surgery and Anesthesiology and all of the health care professionals employed in and by those services. 1.13. Defendant Harborview Medical Center is a hospital and medical center licensed to provide medical care in Washington State, which is operated by the University of Washington, providing medical services to patients. Harborview Medical Center is located in King County, Washington. At all times material hereto Harborview Medical Center, through its subdivisions, employed defendants Jens R. Chapman, M.D., Hernando P. Olivar, M.D., Delmore J. Morsette, M.D., and Brian K. Daines, M.D. and “John and Jane Does" 1 — 52. 1.14, Hernando P. Oliver, M.D. is a medical doctor licensed to practice medicine} in the State of Washington. At all times material hereto, Dr. Oliver practiced medicine in| : RUSH, HANNULA, HARKINS & KYLER, LLP. cores Are Boh 1 Src Sut 00 TACOMA, WA 840s TACOMA: 260385988, Sx ast a7si08King County, Washington as an anesthesiologist. Hernando P.. Oliver, M.D. and “Jane Doe" Oliver are husband and wife and a marital community under the laws of the State of Washington. All acts and omissions complained of against Hernando P, Oliver, M.D., were done or omitted by him individually and on behalf of his marital community. At all times material hereto, Dr. Oliver was employed by the State of Washington, through the University of Washington. At all times material hereto, Dr. Oliver was an employee, agent, or apparent agent of the University of Washington, acting within the course and scope of his employment. 1.1. Delmore J. Morsette, M.D. is a medical doctor licensed to practice medicine in the State of Washington. Atall times material hereto, Dr. Morsette practiced medicine in King County, Washington as a neurosurgeon. Delmore J. Morsette, M.D. and “Jane Doe” Morsette are husband and wife and a marital community under the laws of the State of Washington. All acts and omissions complained of against Delmore J. Morsette, M.D. were done or omitted by him individually and on behalf of his marital community. At all times material hereto, Dr. Morsette was ‘employed by the State of Washington, through the University of Washington. At all times material hereto, Dr. Morsette was an employee, agent, or apparent agent of the University of Washington, acting within the course and scope of his employment. 1.16. Brian K. Daines, M.D. is a medical doctor licensed to practice medicine in {the State of Washington. At all times material hereto, Dr. Chapman practiced medicine in King County, Washington as a surgeon. Brian K. Daines, M.D. and "Jane Doe” Daines are husband and wife and a marital community under the laws of the State of Washington. All acts and omissions complained of against Brian K. Daines, M.D. were CON eae RUSH, HAUL eae Gate TACOMA, WA 58405 ‘TACOMA: 263-983-5988 FAX: 289-272-5105Seomrnoaeroen " 12 13 14 15 16 17 18 19 20 2 22 23 24 25 done or omitted by him individually and on behalf of his marital community. At all times material hereto, Dr. Daines was employed by the State of Washington, through the University of Washington. At all times material hereto, Dr. Daines was an employee, agent, or apparent agent of the University of Washington, acting within the course and scope of his employment. 1.17. “John and Jane Does" 4 — 10, whose true names are unknown at present, are health care professionals licensed to practice health care in the State of Washington! within the limits of their individual credentials. At all times material hereto, John and Jane Does 1-10 were employed as health care professionals in King County, Washington and members of the University of Washington Medical Center and/or Harborview Medical Center Department of Orthopedic Medicine and/or Spine Clinic. At all times material hereto, defendant John and Jane Does 1 - 10 were employed by the State of Washington, through the University of Washington. At all times material hereto] defendant John and Jane Does 1-10 were employees, agents, or apparent agents of the University of Washington, acting within the course and scope of their employment. 4.18. “John and Jane Does” 11 - 21, whose true names are unknown at present] are health care professionals licensed to practice health care in the State of Washington] within the limits of their individual credentials. At all mes material hereto, John and Jane Does 11 - 21 were employed as health care professionals in King County, Washington and members of the University of Washington Medical Center and/or defendant Harborview Medical Center Department of Anesthesiology. At all times material hereto, defendant John and Jane Does 11 - 21 were employed by the State of ‘Washington, through the University of Washington. At all times material hereto, c RUSH, HANNULA, HARKINS & KYLER, LLP, COMPLAINT - 8 USH, HANNULA, HARKINS & KYLER TACOMA, WA, ‘TACOMA: 265-383-5368 FAX: 269-272-5105defendant John and Jane Does 11 - 21 were employees, agents, or apparent agents of the University of Washington, acting within the course and scope of their employment. 1.19. John and Jane Does 22 - 52, whose true identifies are not presently known, are members of various boards, committees and the like whose duties include direction, supervision, governance and/or oversight of the professional, ethical practice of medicine, the use and employment of operative procedures and/or the use of medical devices by health care professionals within The University of Washington, Harborview Medical Center and University of Washington Physicians. At all times material hereto, defendant John and Jane Does 22 ~ 52 were employed by the State of Washington, through the University of Washington. Atall times material hereto, defendant John and Jane Does 22 - 52 were employees, agents, or apparent agents of the University of Washington, acting within the course and scope of their employment. 1.20. This Court has jurisdiction over the subject matter of and the parties to this lawsuit. ‘ 4.21. Venue is proper in this Court by virtue of the plaintiff's decedent having suffered wrongful death as a result of medical negligence while a patient at defendant Harborview Medical Center. Il, FACTUAL ALLEGATIONS Overview 2.1. On August 17, 2007, Ms. Reba Golden, who was then 67 years old, suffered injury and wrongful death as a result of multiple acts and omissions amounting 10 medical negligence while she was a patient of defendant Jens Chapman, M.D. and the defendant doctors named herein at Harborview Medical Center, Central to her fe |, HANNULA, LER, LLP, COMPLAINT - 9 RUSH, HANNULA, HARKINS. a s LER, LLP, a TACOMA, WA ‘TACOMA: 253-302-5968 FAX: 253-272-5105,wrongful death was the use of a bone cement in her spine, which was manufactured by Norian Corp. and promoted and distributed by Synthes, Inc. The bone cement was defectively designed and manufactured and deceptively labeled by the corporate defendants and unlawfully promoted for use in the human spine as alleged hereafter. The use of Norian/Synthes bone cement in Ms. Golden's spine was the result of the medical negligence, failure to obtain any consent, failure to obtain informed consent, outrageous conduct, criminal profiteering activity and products liability alleged hereafter, At the time material hereto, Reba Golden was 66 and 67 years of age and except for the health issues discussed herein was in excellent health and she led an extremely active and energetic lifestyle. At the time of her fall, she was actively working on construction, adding a second floor to her winter home, adding the space so that her family could comfortably visit her in Honduras during the wintertime. ‘On about May 28, 2007, at 66 years of age, Ms. Golden was working on a hand railing on the stairs to the deck of the new addition and while pulling on a 2 x 4, it suddenly broke loose and she fell backward several feet onto a concrete surface below. She was taken to a clinic and was an inpatient for about 7 days before she even notified any of her family, as she “didn’t want to worry" them; that is how vibrant and independent she was. ‘A doctor in Honduras reviewed her radiology studies and expressed concern that} she had a spot on her lung, which she needed to have checked out on her return to the United States for more definitive care. A friend of hers convinced Ms. Golden that she needed to have her family return her to the United States for medical care. Members of Ms. Golden’s family went to Honduras and brought her back when her doctors indicated : RUSH, HANNULA, HARKINS & KYLER, LLP. CON + Hare Seat a Soe Sats 60 TACOMA WA 80405 ‘TACOMA: 253-983-5368 FAX, 259-272-6108it was safe for her to fly. Ms, Golden's daughter, Cynthia Wilson attended her mother's appointments with both Dr. Martins, the oncologist, and with Dr. Chapman. Dr. Chapman never mentioned| to Ms, Golden that he was going to use Norian bone cement in Ms. Golden's spine. The only bone cement he discussed using was PMMA. The reason Ms. Golden went forward with surgery was not because she was in so much pain she didn't want to live, otherwise, as falsely noted by Dr. Chapman, but because he was adamant that without the surgery, her spine would continue to deteriorate from the cancer in it, which he represented that she had. On about July 8, 2007, the family celebrated Ms. Golden's 67" birthday. In the five weeks since her fall, Ms, Golden had shown marked progress. She was walking, driving, holding her grandchildren and getting stronger. Her progress had been continuous up to that point since her fall. She continued to have pain, but she was improving without any surgical intervention. This progress continued all the way up to the time of her surgery on August 17, 2007. Dr. Chapman never discussed the option of conservative care with Ms. Golden. Reba Golden's Clinical History 2.2. Onabout June 1, 2007, Reba Golden was in Honduras where she had a fall resulting in multiple compression fractures in her spine. Back in Washington State an MRI and a CT were performed, which identified/confirmed a mass in her lung that ‘was subsequently found to be cancer. She sought treatment for her lung cancer with Seattle Cancer Care Alliance (SCA), where she was treated by Renato G. Martins, M.D., M.P.H, Because of her spine fractures, Dr. Martins referred Ms. Golden to the COMPLAINT -11 RUSH, HANNULA, HARKINS 8 KYLER, LLP, TACOMA, WA ‘TACOMA: 263-363-5388 FAX, 268-272-5105Spine Clinic at Harborview Medical Center, where she was first seen on July 5, 2007 by Henry Caron, D.O. X-ray imaging was ordered and completed on that day. The forms requesting Ms. Golden's x-rays identified defendant Dr. Jens Chapman as either the attending or requesting physician. 2.3, The findings of the July 5, 2007 x-rays of Ms. Golden's lumbar spine showed Ms. Golden's L1 vertebral body with approximately 75% height loss anteriorly; L4 with less than a 25% height loss; and moderate disc degeneration throughout Ms. Golden's lumbar spine. The x-ray findings also showed the T-10 compression fracture ]with 50% height loss. 2.4. Dr. Caron ordered an MRI and a CT scan of Ms. Golden's thoracic and lumbar spine and suggested that further evaluation and treatment of Ms. Golden required close coordination with SCCA. 2.5. The MRI and CT of Ms, Golden's thoracic and lumbar spine with and ]without contrast were conducted on July 9, 2007. ‘The T10 vertebral body showed signal abnormality and post-contrast ‘enhancement, which was read, erroneously as it turned out, as being consistent with metastatic lesion. There was mild compression (less than 25% height loss) of the T10 vertebral body, without retropulsion of bony fragments or spinal canal stenosis, There was compression of the L1 vertebral body with approximately 50% height loss and retropulsion of bony fragments causing 0% central canal stenosis, with impingement of the conus at the L1 level. Signal abnormalities and homogeneous enhancement on post-contrast images were read, erroneously as it turned out, as : RUSH, HANNULA, HARKINS & KYLER, LLP. er ncn ‘At at Re Sate 00 TACOMA, WA, S03, Taso at oe 080 Ta asa708being consistent with a metastatic lesion. There was a three column unstable fracture at this level. There was compression of the L4 vertebral body with approximately 25% height loss. There was no retropulsion or spinal canal stenosis associated with this fracture. Signal abnormalities and post-contrast enhancement were also read, again erroneously, as being consistent with a metastatic lesion. 2.6, Ms. Golden's CT scan on July 9, 2007 was compared fo x-rays taken on July 5, 2007 and demonstrated normal alignment of her thoracic spine and disc degeneration at 17-8 and T8-9. A conclusion was reached that there was a pathological compression fracture at T-10, which involved the entire vertebral body, with height loss at T10 being under 20%.. A conclusion was reached that there was a pathological fracture at L1, with height loss of 50%, Retropulsion of bone fragments was noted, which was determined to be causing 50% narrowing of the spinal canal. ‘A conclusion was reached that there was a pathologic fracture at L4 involving the| entire vertebral body, with approximately 25% height loss. 2.7. On July 12, 2007, Jason Wilcox, M.D., a resident, dictated an orthopedic progress report after evaluating Ms. Golden's medical condition and back pain. The note indicates that Dr. Chapman was present for the examination. The conclusion of this evaluation suggested that Ms. Golden had probable metastatic lesions in her thoracic and lumbar spine. She was offered a prescription for trial of a different brace to| support her back. It was stated to Ms. Golden that her oncologist, Dr. Martins, would COMPLAINT - 13 RUSH, HANNULA HARKINS & KYLER, LLP. TACOMA, WA 88405 ‘TACOMA: 269-983-5388 FAX: 259:272-5105,have to make the decisions on the plan for her treatment. It was concluded by Dr. Wilcox, apparently with Dr. Chapman's approval, that Ms. Golden was a candidate for surgery, which would include a posterior approach with resection of bone and any cancer present and the performance of a fusion at the affected level. Conservative measures were also noted as a valid treatment option. 2.8. Atthe same visit, Ms. Golden filled out a pain questionnaire She rated her overall pain level as -6/10; she noted moderate neck pain and extreme back pain; she noted no arm pain, arm numbness, arm weakness, leg pain, leg numibness or leg weakness. In general, she rated her overall health as very good. She endorsed being limited in bathing and dressing herself and very limited in physical activities. She noted she was limited in work, recreation and daily activities all of the time during the last four weeks; very severe pain was noted to be extremely limiting to all active aspects of her life. Despite her symptoms, she reported she had not been nervous, had not felt “down in the dumps’, downhearted or depressed; that, except for her pain, she felt calm and peaceful. She reported that she definitely did not see herself as more prone to getting sick than other people; that she was definitely as healthy as anybody she knew, that she definitely did not expect her health to get worse and that, mostly, her health was excellent, 2.9. From the July 12, 2007 examination of Ms. Golden, Dr. Chapman wrote a letter to Ms. Golden’s oncologist, Dr. Martins, containing the following description of a much more complex surgery than described in Dr. Wilcox’s clinic note From my end | would like to now proceed with assessment of brain MRI and trunk CT with contrast... .. lam quite worried that we may have to proceed with surgery in this patient due the severity of her vertebral body collapse at L1. Any surgery would likely entail instrumentation toT9 with vertebroplasty of T10, - RUSH, HANNULA, HARKINS & KYLER, LLP. Cenc "204 Sou Sat Sts 900 TACOMA, 2409, TAson one s360 aK. 257208vertebroplasty of L4 and instrumentation with costotransversectomy of the L1 level down to the L2 level 2.10, On July 13, Ms. Golden had an appointment with Dr, Martins. In his clinic note reflecting that visit, Dr. Martins indicated that he believed Ms. Golden had non- small cell lung cancer, which could be successfully treated operatively: In brief, the PET scan suggested that she has a localized, non-small cell lung cancer which would be candidate for curative surgical intervention. ... The MRI, however, suggested, due to the pattern of increased contrast, the lesion in 710 could represent metastasis. After my discussion with Dr. Chapman today, we decided that the patient would benefit from surgical intervention on her spine anyway due to the destruction of L1 and the presence of bone fragments. During] the same procedure, she will have a biopsy of T10 and L4 to other areas that are| abnormal on MRI and if this all comes back negative for malignancy, we would then proceed with addressing her lung .. . [Dr. Chapman] already asked for an MII of the brain to complete her staging, which | certainly agree with . . 2.11. On July 17, 2007, defendant Dr. Chapman requested an MRI of Ms. Golden's cervical spine and brain. Those MRIs came back negative for any metastatic disease. 2.12. Ms. Golden filled out another pain questionnaire on July 19, 2007, which ‘was essentially consistent with the one she filled out on July 12. Her pain continued moderate to severe, but limited to her neck and back... She continued to be limited by her pain, as previously reported. However, she continued to rate her general health as very good; she continued feeling calm and peaceful, except for her pain; and she reported being happy. At no time, she reports, did she feel “down in the dumps,” downhearted, or depressed. She continued with her belief that she was, mostly, as healthy as anyone she knew. 2.13. ACT of Ms. Golden's chest, abdomen and pelvis with contrast was performed on July 19, 2007. This CT scan confirmed the presence of a large, 3.4m x zi RUSH, HANNULA, HARKINS & KYLER, LLP. COMP AINT Ae: ‘AON oat ese Sue 300 TACOMA, Wh 8408 TACOMA. 259:2038888 FAK, 258-272-5105Se@mrxeoanron 1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 2.1 om right upper lobe spiculated cavitary lung mass abutting the pleura, highly suspicious for bronchogenic carcinoma. A right hilar nodal mass measuring 2.0 x 1.6 cm was also detected. The T10, L1 and L4 compression fractures were noted again and termed “highly suspicious” for metastatic disease. Other organs were not found to have any metastatic disease. The medical records of Dr. Martins do not indicate why he did not proceed with the resection and histopathological microscopy of the mass in the upper lobe of Ms. Golden's lung 2.14. On July 19, 2007, Dr. Troy Caron wrote an outpatient record for Ms Golden. He noted that Ms. Golden “has continued to have pain and could not wear the acute brace, and therefore, would like to proceed with surgery.” Dr. Caron described yet another version of surgery planned for Ms. Golden: “our plan is to do a T9 to L2 posterior fusion with L1 corpectomy. We will resect the L1 nerve root on one side. We ‘will also place cement into T9, T10 L2 and L4. Patient was preopped for surgery today. She understood the risks and benefits of surgery which include bleeding, infection, pain, scar pain, damage to blood vessels and nerves, risks of further surgery.” 2.18. A Special Consent Form for Procedural Treatment, which indicates it was filled out on July 19, 2007 described the planned surgery as “T-9 - L2 PSF [posterior spinal fusion], L1 corpectomy [removal, or near removal, of a vertebral body and fusion of the vertebral bodies above and below], Bone Cement T9, T10, L2, L4”. This consent form was unsigned by any health care provider and it was unsigned by Ms. Golden. : RUSH, HANNULA, HARKINS & KYLER, LLLP. COMPLAINT - 16 Boat Hah ieee us soo TACOMA Wh 8405, TRON Zeta 868 A Sensi2.16. On July 25, 2007, Ms. Golden was cleared for surgery, despite an abnormal EKG showing bradycardia, read as normal by the resident examining Ms. Golden, and a lab workup showing a low hematocrit of 35% (normal is 36-45%) and high fibrinogen of 567 (normal is 150-400). Her primary diagnosis was entered as lung cancer. A plan was made to biopsy Ms. Golden's T10 and L4 vertebral bodies. Lung surgery to excise the tumors was planned after the spine surgery. 2.17. On August 16, 2007, Ms. Golden was admitted to Harborview Medical Center for her surgery. As part of her preparation for surgery, Ms. Golden signed one (1), four-page consent form covering two surgeries. The first surgery was a spinal arterial embolization of Ms. Golden's L1 vertebral body, which was performed that day, August 16, 2007. The second surgery was described as “T9 - L2 PSF, L1 corpectomy, 9, T10, L2, L4 vertebroplasty’. For the August 16, 2007 L1 embolization, anesthesia began at 8:46 a.m. and surgery was completed by 10:16 a.m. The embolization was completed uneventfully. 2.18. After Ms, Golden underwent her embolization, the record indicates Dr. Chapman visited her, after her consent form had already been signed, and this time described yet another version of the surgery he was to do the next day: | suggested a converse transversectomy with L1 vertebral reconstruction using bone cement augmentation of the L2 vertebra to achieve a single segment reconstruction at the level below this reconstruction. At L4 we would perform a kyphoplasty with resorbable bone cement or methyimethacrylate at T10-11. We would again perform a bone cement augmentation of that particular vertebra with rod placement. We would obviously biopsy the L1 level and seek to clarify whether these are osteopenic lesions with significant central canal compression or not. Clearly, this is a complex condition with many possible treatment options. The patient consents to major surgery which, in light of its potential magnitude, we may have to split into two or more stages. : RUSH, HANNULA, HARKINS & KYLER, LLP. Cee 4701 South 19" Street, Suite 300 TACOMA, Wa Sots TACOMA 288 980 S30 A BRT 105There is no consent form signed by Reba Golden for this new, multiple-stage, multiple procedure spine surgery described by Dr. Chapman in his note of August 16, 2007, which reflects events occurring after Ms. Golden had already signed the four- page consent form earlier that day for a different procedure. 2.19. Following her August 16, 2007 surgery and prior to her August 17, 2007 surgery, nurses recorded Ms. Golden's blood pressure as 89/47 at 1600 hours on August 16 and 87/43 at 8:00 a.m. on August 17, Records reflect that Ms. Golden was bradycardic throughout her admission from August 16 -— 17. These abnormalities were not addressed or explained prior to surgery on August 17, 2007. She was typed and cross matched and four units of packed red blood cells (PRBC) were ordered. 2.20. The surgery proceeded on August 17, 2007 at about 12:28 p.m. Dr. Chapman's operative report states that Ms. Golden was brought to the OR with multifocal pathological fractures at T10, L1 and L4, Biopsies of T10 and L4 were taken. The surgical pathology report related to these biopsies indicates that they were negative for malignancy. Remarkably, Dr. Chapman's notes do not mention the severe traumatic| origin of Ms. Golden's fractures, which are all consistent with serious trauma secondary to the fall on her back she had while she was in Honduras. 2.21. The procedure that was reportedly performed on Ms, Golden included a vertebral augmentation with tri-calcium phosphate [Norian/Synthes CRS bone cement], at T8, L3 and L4 with cavitation technique. Segmental instrumentation was used from 9 through L3 and a costotransversectomy with laminectomy was performed from T12 through L2, There was a ligation of Ms. Golden's right L1 nerve root, A corpectomy was performed at L1. An anterior arthrodesis with cage placement was performed between 712 and L2. The operative report indicates that the surgery had to be abandoned due to severe hypotension and severe coagulopathy followed by severe COMPLAINT - 18 RUSH, HANNULA, HARKINS & KYLER, LLP. TACOMA, WA 68405 ‘TACOMA: 253-285-5368 FAX: 289-272-5108bleeding.. Ms. Golden suffered cardiac arrest and prolonged resuscitation was attempted. All attempts to revive Ms. Golden failed and she died on the operating table at 6:03 p.m. 2.22. The surgeons were identified in the operative report as Jens Chapman, M.D,, Delmore Morsette, M.D., and Brian Daines, M.D. The anesthesiologist attending was Dr. Hernando Oliver. 2.23. Introduction of the Norian/Synthes bone cement, a tri-calcium phosphate cement, caused severe hypotension, coagulopathy, disseminated intravascular coagulopathy, severe bleeding and cardio-respiratory collapse in Ms. Golden. Blood loss was estimated at greater than 3 liters, which required the transfusion of at least 16 units of PRBCs, 4 units of fresh frozen platelets, 1 unit of six-pack and one unit of six- pack platelets. 2.24. The operative report stated, under “indications,” that Ms. Golden, a 67 year old lady with severe back pain, with an inability to stand straight and an inability to walk was diagnosed with small cell lung cancer and that she was found to have a high grade burst fracture of her L1 with kyphosis and canal compromise of more than 50%. ‘Again, it is remarkable that Dr. Chapman ignored the traumatic origin and nature of Ms. Golden's vertebral body fractures. The record does not document further consultation by Dr. Chapman with Ms. Golden's oncology doctors and there was no discussion to coordinate the surgical procedures on Ms. Golden. 2.26. Defendant Dr. Chapman's operative report indicated that Ms, Golden was medically cleared for an attempt at decompression, spinal realignment, and stabilization after undergoing an extensive workup, brain MRI and other scans. 2.26. Neither the operative report nor any other record indicates that Mrs. Golden was ever told that Norian/Synthes bone cement was to be implanted in her I RUSH, H HARKINS, LLP. COMPLAINT - 19 LH Nasa th Se gute 0 TACOMA, WA. 98405 TACOMA: 253-383-5389, FAK: 283-272-5105spine or that she was ever told about the experimental nature of Norian/Synthes cement! [calcium phosphate]. She was never informed that Synthes/Norian bone cements were not approved for use in the human spine; that the USFDA had specifically disapproved their use in the human spine, that she was being used by Dr. Chapman as a subject in human experimentation using Synthes/Norian bone cement in the human spine without any approval or oversight by any governmental or professional overseeing body, that ‘Synthes and Norian were under criminal investigation for the illicit promotion of their bone cements for use in the human spine, that Dr. Chapman was on the team recruited by Synthes to promote the illicit use of Norian/Synthes bone cements in the human spine and/or that Dr. Chapman had financial and professional ties to Synthes that presented him with a conflict of interest between his loyalties to and preference for ‘Synthes and his duties to Ms. Golden, his patient. She was also not told that the calcium phosphate cements were known to have severe adverse events including severe hypotension, clot formation, coagulopathy, severe bleeding, pulmonary emboli and cardio-respiratory collapse. The record indicates that in addition to Norian/Synthes bone cement, a calcium phosphate cement, Dr. Chapman also made use of methylmethacrylate, an acrylic cement, specifically around the L2 vertebral body to augment bone screw placement. 2.27. Ms. Golden began to bleed profusely during and/or immediately after the L1 corpectomy portion of her surgery, which was performed between 3:31p.m. and 4:39] p.m. Itis clear that she was bleeding heavily from many sites. Ms. Golden developed severe hypotension during the placement of instrumentation and her medical condition deteriorated rapidly, with multiple and prolonged attempts at resuscitation. : RUSH, HANNULA, HARKINS & KYLER, LLP. ere ‘Aol Souk ist Soest Se 900 TACOMA, WA S403 Tasonta zat sen 5360 Tas 253-27251082.28. Dr. Chapman concludes his operative report with the assertion that the medical team supposed that she had died from pulmonary embolism with subsequent rapid onset of disseminated intravascular coagulopathy. 2.2. The surgical report and Ms. Golden's death and manner of death reflect foreseeable events that were well known in advance of the surgery by Dr. Chapman and those in attendance to be consequences of complications caused by the use of Norian/Synthes bone cements in the human spine. 2.30. Following Ms. Golden's death, an autopsy was performed. The autopsy concluded that the fractures in Ms. Golden's spine were caused by blunt traumatic inju and that she did not have metastatic cancer. Instead, the autopsy concluded that Ms. Golden had one mass of non-small cell type carcinoma of the right upper lobe of her lung. She also had some degree of pulmonary emphysema, osteopenia and arteriosclerosis. The cause of death was viewed as resulting from severe retroperitoneal hemorrhage and embolism which was caused by the Norian cement. This cement caused extensive pulmonary emboli and hemorrhages The retroperitoneal hemorrhages originated at the site of the orthopedic surgery of the lumbar spine of Ms. Golden and communicated extensively with the retroperitoneal such that blood loss from the spine collected in the retroperitoneum. The autopsy report was signed by the Chief Medical Examiner, Richard C, Harruss, M.D., Ph.D., on October 26, 2007. 2.31. Thus it can be stated conclusively that Ms. Golden had a curable cancerous lesion in her right lung, that the standard of care required that this lesion and right pulmonary upper lobe be resected in a surgical procedure. Dr. Chapman diverted Ms, Golden from the necessary curative treatment, which would have required a cardiothoracic surgical consult and would have interfered with Dr. Chapman's human experimentation on Ms. Golden. Dr. Chapman performed experimental procedures on COMPLAINT - 24 RUSH, HAMNULA, Hi REINS 8 KYLER: LLP. TACOMA, WA 68408 TACOMA 253-383-5368 FAX: 283-272-5105Ms. Golden and convinced her to undergo these procedures through deceptive practices and misrepresentation of material facts. 2.32. When Dr. Chapman, through the defendant University of ‘Washington/Harborview Medical Center administration risk management division, submitted to the USFDA on July 31, 2009 an adverse event report involving the use of Norian/Synthes CRS bone cement on Joan Bryant and her resulting death on July 6, 2009, he also submitted a report on Reba Golden's August 17, 2007 death following implantation of the same Norian/Synthes bone cement. In Ms. Golden's case, the report admits the death of a: female who experienced intraoperative death due to severe pulmonary embolism (PE) (cement and fat) during major spine surgery including corpectomies, laminectomies, fusion and vertebroplasties. The [patient] also developed intraoperative disseminated intravascular coagulopathy (DIC). [Pulmonary embolism] was recognized minutes after Norian [bone cement] ‘was interjected into the vertebral bodies. [Disseminated intravascular coagulation] developed approximately 30-45 minutes after [pulmonary embolism] After these events, {the patient] was treated with pressors, mechanical ventilation and massive transfusion, but developed cardiopulmonary collapse without response to appropriate resuscitative efforts. An autopsy was performed, finding fat and cement fragments in the pulmonary vasculature. 2.33. Dr. Chapman knew when he wrote his surgical note that all the adverse events Ms. Golden experienced were seen in operating rooms across the United States many times over with the use of Norian/Synthes tri-calcium phosphate bone cements injected into vertebral bodies. He knew full well that patients who had been treated with these bone cements had died because of them. He knew that the pathognomonic manner of death in these patients was exactly like the death of Ms. Golden. He knew ‘that the Norian/Synthes cement he was using to augment bone in Ms. Golden's spine : RUSH, HANNULA, HARKINS & KYLER, LLP. Coes "M01 Sat i Sea Site 305 TACOMA, WA e408 TACOMA: 2503608080 PA 298-272-5108]was specifically prohibited for that use by the US FDA. He also knew, or should have known, that Ms. Golden would very possibly die in the procedure of August 17, 2007 if he used the Norian/Synthes bone cement in her vertebral bones. 2.34. On information and belief, on August 17, 2007, the Norian/Synthes bone ‘cement that defendant Dr. Chapman was to use in the surgery on Ms, Golden's spine was brought directly into the operating suite by a sales representative from defendant Synthes, thereby circumventing the hospital pharmacy department and any controls in place to protect patients in whom medical devices were to be placed at the hospital. The sales representative remained in the operating suite while the Norian/Synthes bone| cement was implanted in Ms, Golden's spine. The presence of a medical device sales representative in the operating suite was completely without Ms. Golden's knowledge or| consent. Dr. Chapman's surgical report and all of his reports and records concerning Ms. Golden's surgery and death are silent on the transport into the operating suite of the Norian/Synthes bone cement by the Synthes sales representative and/or the presence of this sales representative in the operating suite during the operation. 2.36. Dr. Chapman's decision to use Norian/Synthes tri-calcium phosphate bone cement in Ms. Golden's spine represented a serious breach of the standards of medical care and was not only negligent, but reckless. 2.36, Dr. Chapman also withheld information from Ms, Golden concerning an ongoing (since about 2004) federal criminal investigation concerning the illicit ‘development and promotion of Norian bone cements for use in the human spine. The investigation resulted in 2009 in criminal charges against Synthes, Norian and four of ‘Synthes's top executives. Exhibit 1 to this Complaint, incorporated herein by this COMPLAINT - 23 RUSH, HANNUL A HARKINS 8 KYLER, LLP. TACOMA, Win. Sesos TACOMA: 253-283-5388, FAX: 259-272-5105Somrnoaaron 14 12 13, 14 15 16 17 18 19 20 24 22 23 24 25 reference as if fully set forth. Among other charges, the indictment charged that Synthes, Inc. and Norian Corp. and four top executives, Michael D. Huggins, Thomas B| Higgins, Richard E. Bohner and John J. Walsh introduced into state commerce Norian cements as adulterated and misbranded medical devices in violation of Title 21, United States Code, Sections 33(1)a, 362(F)(1), 352(0), 351(f)(1)(B) and 33(a)(1). The indictment charged the two corporations and their executives with numerous other violations of law. They were charged with numerous counts of making false statements to the USFDA investigators. The University of Washington and Harborview Medical Center, through their departments of spine surgery and neurological surgery and orthopedic surgery were fully aware of the nature of the USFDA investigation in 2007, which ultimately resulted in the indictment. The University of Washington, and Dr. Chapman, in particular, had actively participated in the development and testing of Norian bone cements, and their illicit promotion and continued to experiment on humans by using Norian bone cements in their spines despite the fact that they knew that the products were highly dangerous. 2.37. The University of Washington and Harborview Medical Center were aware| that Norian/Synthes bone cements when used in the human spine as in Ms. Golden's surgery were Class III significant risk devices and were in need of the most intensive clinical testing required by the USFDA before approval for use in human beings. They knew that the required USFDA clinical testing for the bone cements had not been performed by the manufacturer, Norian and/or the distributor, Synthes. They proceeded} to allow human experimentation on Ms. Golden, fully realizing that she was at extreme risk of death or injury. : RUSH, HANNULA, HARKINS & KYLER, LLP. coe ae a So Hane dit ot rAContn, WA’ Sos Tew 269 989 5380 WAC bara sion2.38. The University of Washington, Harborview Medical Center and Dr. Chapman participated in the development, testing and promotion of Norian/Synthes bone cements from the earliest stages of the illicit promotion of these devices for use in the human spine. Thus, they were aware, or should have been aware, that the USFDA. did not approve the use of these cements in the spine, which included, but was not limited to, use of these cements in load-bearing applications such as vertebral body augmentation, vertebroplasty, kyphoplasty, or “cavitoplasty’” in treatment of vertebral compression fractures, or use in other procedures to augment vertebral bodies or treat vertebral fractures, or any other form of surgically created void filling surgery in the human spine. 2.39. The University of Washington, Harborview Medical Center and Dr. Jens Chapman and (in addition to their own, individual negligence) the named health care professionals and departments named herein participated, actively or through their ‘omissions, in allowing Dr. Chapman to practice in violation of medical standards of care, thereby proximately causing Reba Golden’s death. Norian/Synthes Bone Cements lilicitly Promoted For Use In The Spine 2.40. Plaintiffs incorporate herein as if fully set forth Exhibit 1 to this Complaint, which is a certified copy of the Amended Superseding Information in the criminal case United States v. Norian Corporation Synthes, Inc., Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, filed in the United States District Court, Eastern District of Pennsylvania, Cause No. 09-403. Throughout Exhibit 1, “Doctor No. 2” is defendant Jens Chapman, M.D. The “high-ranking Synthes official” mentioned in paragraph 62 of the COM ee RUSH Ae A Sule oe TACOMA, Wa 58408 ‘TACOMA: 253-383-5388 FAX: 259-272-5105“Introduction” section of Exhibit 4 with whom Dr. Chapman met concerning Norian bone cement and vertebroplasty was defendant Hansjérg Wyss. In paragraph 60 of the “Introduction” section of Exhibit 1, the individual who directed Synthes and Norian to illegally “get a few sites to perform 60-80 procedures [illegally using Norian/Synthes bone cement for spinal applications], and help them publish their clinical results[,]’ was defendant Hansjérg Wyss. 2.41. The USFDA is a United States government agency that acts in the interests of public health safety. In its capacity to approve or disapprove medical devices, it requires manufacturers to adhere to scientific standards to demonstrate the efficacy and adverse events associated with the use of a medical device, The approval of a medical device requires that a manufacturer submit a proposal to the USFDA seeking permission to perform a clinical trial to obtain scientific data regarding the medical device. The application to the USFDA is a request for an “Investigational Device Exemption’ (IDE). In addition to various scientific disciplines the proposal has to| be approved by a medicine and bioethics review called an Institutional Review Board (IRB). The goals of this approach are to assure quality control in properly monitored clinical trials that protect the safety of human subjects. In an alternative fashion, the manufacturer of a medical device can request an USFDA approval through a substantial equivalence pre-market notification, also known as 510(k). Without USFDA approval a manufacturer cannot bring medical devices into the stream of commerce in the United States. As part of the approval process the manufacturer is required to include a device's labeling in compliance with the USFDA guidelines. A manufacturer of a medical device is not permitted to promote its device for any use other than the COE ae. RUSH HAN Hae Gata TACOMA, WA 90408 ‘TACOMA: 253-909-6988 FAX: 289-272-5105intended use stated on the label as cleared or approved by the USFDA. A manufacturer is not permitted to promote or test market an investigational device until after the USFDA has approved the device for commercial distribution and cannot represent that the investigational device is safe and effective for the purposes for which itis being investigated. 2.42. Mr. Hansjérg Wyss was the controlling stockholder and ranking executive of Synthes, Inc. and Norian Corp., and the leader of a criminal enterprise consisting of, ‘among others, Synthes, Inc., Norian Corp., Michael D. Huggins, Thomas B, Higgins, Richard E. Bohner, John J. Walsh, Jens Chapman, M.D., University of Washington, Harborview Medical Center and other spine surgeons, the purpose of which was, for profit, by means of surgeries on unsuspecting patients, with reckless disregard for any serious bodily harm done to the patients, development of bone cements for use in the human spine. 2.43. Mr. Wyss established a medical device manufacturing corporation, Synthes, Inc., with specialized products with manufacturing facilities located in Monument, Colorado, West Chester, Pennsylvania, Elmira, New York and Tuttlingen, Germany. Under Mr. Wyss’s direction and guidance, Synthes, Inc. purchased Norian Corporation, which had developed tri-caleium phosphate bone cements. Norian manufactured the bone cements and Synthes promoted, sold and distributed them. 2.44. Mr, Wyss recruited Dr. Chapman, Mr. Huggins, Mr. Higgins, Mr. Bohner, Mr. Walsh and a number of spine surgeons, including Dr. Chapman, to “test market” Norian bone cements through human experimentation using Norian bone cements in the human spine, willfully, negligently and recklessly ignoring USFDA rules and i RUSH, HANNULA, HARKINS & KYLER, LLP. Coane re eo. Sea ute 900 TACOMA, WA. ste TagoWAr 269 989 S368 axe asaregulations and the likelihood of harm to unsuspecting patients. Ms, Golden became a victim of this enterprise when Dr. Chapman operated on her using Norian bone cements| illegally, all for the financial benefit of the criminal enterprise 2.45, In 1999 Mr. Wyss through Synthes, Inc. bought Norian Corp.,. a manufacturer of tri-calcium phosphate bone cements. The Norian cements were used for repair of non-weight bearing long bones and skull injuries. 2.46. The use of these cements in weight bearing bone such as the spine for purpose of augmentation of bone strength is classified by the USFDA as a Class Ill medical device, which is a device presenting high risk for adverse events. Norian bone cements used as a Class Ill medical device are metabolically active and therefore introduce risks of severe toxic effects. Mr. Wyss bought the Norian corporation and its cements for the purpose of introducing the Norian cements as a Class IiI medical devices to augment weight bearing bone, primarily in the spinal column, through augmentation of the vertebral bodies of the spinal column by injection of Norian cements into the vertebral bodies. Mr. Wyss wanted to illegally bypass the testing and clinical trials required to obtain USFDA approval [PMA] for the marketing authorization required under USFDA rules and regulations. Mr. Wyss planned to market Norian/Synthes bone cements for augmentation of vertebral bodies and for that purpose he recruited Dr. Chapman and many other orthopedic surgeons, as well as Mr. Huggins] Mr. Higgins, Mr. Bohner, Mr. Walsh, the University of Washington and Harborview Medical Center. 2.47, The USFDA moved swiftly and instructed Synthes and Norian that they ‘were not allowed to use their bone cements for weight-bearing boney repairs without : RUSH, HANNULA, HARKINS & KYLER, LLP. eee Mao} Soa Sone Sue 300 Se an aioe TACOMA 252636888, TA 260072 5105Socernoaron 1" 2 13 14 15 16 17 18 19 20 21 22 23 24 25 pre-manufacturing authorization (PMA). They were also instructed that if they wanted t apply for an PMA they needed to start with an application for an investigational device exemption (IDE) and then they needed to follow a comprehensive clinical development trajectory that would produce the scientific data required to either approve or disapprove| Norian/Synthes bone cements for such intended use. Mr. Wyss knew that this process: was time-consuming and expensive. He wished to avoid this time and expense. 2.48. Mr. Wyss, Synthes, Inc. and Norian Corp., along with Norian and Synthes ‘executives Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, and various surgeons, including Dr. Jens Chapman, decided rather than comply with the USFDA rules, regulations and instruction, the criminal enterprise would bring Norian/Synthes cements to the marketplace for interstate commerce by an illegal “test market,” in the guise of a surgeon preference study without the required safeguards and approvals required in legitimate clinical trials. Instead of USFDA authorized clinical trials they decided to perform an unapproved clinical study, the “test market,” on 60-80 patients and then promote the use of Norian cements by spine surgeons in an “off-label”, method of use. This test market approach contradicted USFDA regulations. Key participants in the research and development of Norian/Synthes bone cements and the illegal test market were Dr. Chapman, the University of Washington and Harborview Medical Center, Even after Synthes, Inc., Norian Corp. and Mr. Huggins, Mr. Higgins, Mr, Bohner and Mr. Walsh were investigated by the US Department of Justice, (as reflected in Exhibit 1 to this Complaint), the corporations, the corporate executives, Dr. Chapman and the University of Washington and Harborview Medical Center continued with the criminal enterprise and treated Ms. Golden with the Norian/Synthes COMPLAINT - 29 RUSH, HAMNULA HARKINS & KYLER, LLP. TACOMA, Wa sods ‘TACOMA: 253-383-5268 FAX: 253-272-5108bone cement, leading to her death on August 17, 2007 2.49. Hansjorg Wyss conceived of the illegal test market, announced it to Synthes and Norian executives and employees, directed them to implement it, was briefed on the implementation of the test market and directed the test market. At all times defendant Hansjérg Wyss and the members of the enterprise conspired to bring Norian/Synthes cements to the marketplace for treatment of vertebral compression fracture (VCFs), and other uses in the human spine by illegally circumventing USFDA regulatory guidelines and laws through means that, in the State of Washington, amounted to Assault in the Second Degree on unsuspecting patients. 2.50. Aclass Ill device is “adulterated” if itis required to have an approved PMA application and does not have an approved PMA application in effect or if it is required to have an approved IDE and does not have an approved IDE in effect. 2.51. Amedical device is “misbranded’ if the manufacturer of the device has failed to provide the FDA with pre-market notification of a new or non-FDA sanctioned intended use 90 days prior to introducing the device into interstate commerce for such use. 2.52. Norian/Synthes cements were thus adulterated and misbranded products when promoted by the enterprise for use in the human spine, such as in Ms. Golden’s treatment. 2.53. When a manufacturer becomes aware that the medical device has caused serious injury or death, the manufacturer is required by law to file a medical device report (MDR). A medical device is also misbranded if the manufacturer of the device fails or refuses to furnish to the FDA any material information concerning that device COME ANT eat RUSH, HANNULA MAeci ee TACOMA, WA 96408 TACOMA: 269-089.596@ FAK: 268-272-5105,© ent oar on 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that is required to be reported on an MDR. 2.54. The introduction of Norian bone cement into a vertebral body, such as in Ms. Golden's surgery, carries significant risks for the patient. Cement may leak into the circulation and cause pulmonary emboli leading to death or cement may harden prematurely and cause injury to surrounding tissues. Ms. Golden's death was caused by leakage of cement into the pulmonary circulation causing pulmonary embolism, coagulation disorder, severe bleeding and death. 2.58. Prior to 2004 there was no USFDA approval for the use of bone cement injection into a vertebral body for treatment of vertebral compression fractures. In 2004 the FDA approved PMMA (polymethyl-methacrylate) for such use. PMMA was the first product approved by the FDA for vertebral compression fractures. PMMA Is acrylic, not calcium phosphate, cement. 2.56. The acrylic PMMA is exothermic, i.e. it produces heat as it cures. The heat production can damage tissues. Because of this and other drawbacks of PMMA, such as its extreme hardness, several manufacturers, including Synthes, Inc. and Norian Corp. under the direction of Mr. Wyss and with participation of Dr. Chapman, the University of Washington and Harborview Medical Center began to experiment with tri calcium phosphate in designing a vertebral compression fracture treatment device. 2.57. Prior to purchasing Norian Corp., Mr. Hansjérg Wyss and Synthes did not have any experience with osteo-biologic products, Their experience was primarily in trauma products such as metal devices, plates, rods, nails and screws. For this reason, Synthes,, under defendant Wyss's direction and control, bought Norian. Norian was a manufacturer of tri-calcium phosphate bone cements. Norian had developed two COMPLAINT - 31 RUSH, “aoa Siege 5 LLP. ‘TACOMA: 253-383-5368 FAX: 259-272-5105products that were identically formulated as tri-calcium phosphate bone cements, The products were Norian CRS and Norian SRS. Mr. Hansjérg Wyss organized, directed and ran the criminal enterprise because of the enormous commercial opportunity that it presented. In the United States alone, there are more than 500,000 new vertebral ‘compression fractures annually. The criminal enterprise did not want to spend the time or the money to go through the lengthy process for a Class III medical device approval {that the USFDA required. Mr. Hansjérg Wyss, personally and through enterprise members Norian, Synthes, Mr. Michael 0. Huggins, Mr. Thomas 8. Higgins, Mr. Richard] E, Bohner, and Mr. John J. Walsh and other Synthes and Norian employees, recruited and enlisted many orthopedic surgeons, including Dr. Jens Chapman, and neurosurgeons in the United States and trained these surgeons and directed their efforts to obtain approval without regard to the legal authority of the USFDA. 2.58. In the early phase of experimentation, studies were done with patients and animals at the University of Washington hospitals and institutes. In 2002 Dr. Jens Chapman (Ms. Golden’s surgeon), reported the grave danger associated with the use of Norian/Synthes cements, Dr. Chapman reported that Norian/Synthes cements had leaked into the venous circulation in pigs and caused extensive pulmonary emboli. His research also showed that Norian bone cements actually promoted clotting in human blood in test tubes. 2.59. Defendant Mr. Wyss knew about Dr. Chapman's research results and talked personally with Dr. Chapman about the results. He also knew of all of the material factual developments alleged in Exhibit 1. Despite this knowledge, Mr: Wyss and the members of the criminal enterprise, including Dr. Chapman, did not desist, but COME Tee RUSH, HANMULA, He Suse TACOMA, WA 90408 TACOMA: 269-383-5988 FAX: 253-272-5105continued with their illegal human experimentation. Some milestones concerning the knowledge of the dangers associated with the use of Norian/Synthes bone cements are the following: In 2001, Synthes, Inc. and Norian Corp. were informed of several patients who had developed severe hypotension after use of Norian/Synthes bone cements in ‘their spines. In one patient the cements had been carried to the operating room by a Synthes sales representative who had been present in the operating room during the surgeries. Also in other cases, Synthes and Norian employees were present. In addition, several doctors, including Dr. Barton Sachs on January 13, 2003, Drs. Nottingham and Lane and Dr. Hieu Ball on September 19, 2003 and January 22, 2004 reported that they had patients die during the use of Norian/Synthes cements in spine surgeries. 2.60. Mr. Wyss was fully aware of all these events: and even though he was not medically trained or licensed, he proceeded to push forward his illicit human experimentation, also known as a “test market,” which was extremely dangerous and potentially deadly to patients. 2.61. Mr. Hansjérg Wyss participated in all the key meetings concerning the development of Norian/Synthes bone cements and their ilicit promotion for use in the human spine. Mr. Hansjérg Wyss expressly rejected the lawful USFDA approval route for the development of Norian/Synthes bone cements. 2.62. On information or belief, Dr. Chapman participated willingly with a leading role using Norian/Synthes bone cement for spine application in a criminal enterprise ‘with Mr, Wyss, Synthes, Inc., Norian Corp., Mr. Huggins, Mr. Higgins, Mr. Bohner, Mr. Walsh, University of Washington and Harborview Medical Center and others. COMPLAINT - 33 RUSH, Map ee ao LLP. TACOMA: 253-389-6888 FAX: 253-272-5105Seernoaron 44 13, 14 15 16 17 18 19 20 24 22 23 24 25 2.63. In the planning of the unauthorized clinical trials, Hansjérg Wyss and Synthes and Norian decided to promote their bone cements through illegal human experimentation in a criminal enterprise to test market Norian/Synthes bone cements in violation of federal laws and USFDA regulations, and directly ignoring USFDA regulations in place to prohibit such promotion and test marketing. The criminal enterprise included Mr. Hansjérg Wyss, Synthes, Inc., Norian Corp., Mr. Huggins, Mr. Higgins, Mr. Bohner, Mr. Walsh, Dr. Jens Chapman, University of Washington and Harborview Medical Center and other hospitals and spine surgeons throughout the United States. The criminal enterprise, as alleged, has not been previously convicted by a Court in the State of Washington or the United States. As a direct result of the criminal enterprise, as alleged, Ms. Golden suffered Assault in the Second Degree. The 2" degree assault resulted in Ms, Golden's death in a manner that was foreseeably likely to cause her permanent injury and/or death. 2.64. Dr. Chapman failed to secure any consent from Reba Golden whatsoever for any surgery a component of which was use of Norian/Synthes bone cement. 2.65. Any supposed consent for surgery obtained by Dr. Chapman from Reba Golden purportedly authorizing use of Norian/Synthes bone cement in her spine was obtained by Dr. Chapman by misrepresentation and deceit and is therefore void. 2.65. Ms. Golden did not survive the surgery of August 17, 2007. Neither the Personal Representative nor the statutory beneficiaries discovered any of the facts supporting the negligence and other wrongdoing alleged herein to be a proximate cause| of their mother’s death until about September 5, 2012 when the Personal Representative, Cynthia Wilson and her brother, Paul D'Oyley, met with attorney Daniel COE RUSH, Hag A Hane il oo TACOMA, WA 98405 TACOMA: 259-389-5388 FAX: 265-272-5105L. Hannula. Ill, MEDICAL NEGLIGENCE JENS CHAPMAN, M.D., DELMORE J. MORSETTE, M.D. and BRAIN K. DAINES, M.D. 3.1. Plaintiffs reallege sections | ~ I! of this Complaint as if fully set forth. 3.2. Dr. Chapman, Dr. Morsette and Dr. Daines breached the standard of care ‘expected of physicians and surgeons in the State of Washington in the same or similar circumstances in their care and treatment of Ms. Golden's medical condition in, but not limited to, the following ways: They used Norian/Synthes bone cement in her spine; They failed to evaluate Ms, Golden's medical condition in a comprehensive fashion and to base care and treatment on her objective needs; They failed to submit a plan to experiment with a human being, Mrs. Golden, through an Institutional Review Board (IRB), at Harborview Medical Center or the appropriate University of Washington body, to obtain institutional permission and oversight for human experimentation; They did not inform the IRB, or any other oversight body at Harborview Medical Center or the University, that they were using a medical device in an experimental application and neither Harborview nor the University; required that they do so, even though the defendant institutions were aware, or should have been, that Dr. Chapman in particular was routinely conducting these unsanctioned human experiments. Dr. Chapman and the other named defendant surgeons did not get any IRB approval to experiment on Ms. Golden Dr. Chapman did not inform Ms. Golden that he had a conflict of interest in treating her, that he had received money or its equivalent from Synthes, Inc. and/or Norian Corp. and/or Mr. Wyss and/or foundations associated with Mr. Wyss. He did not} PI - RUSH, HANNULA, HARKINS & KYLER, LLP. Ce i Seat Seta Sone 0 ACCU, WA. Ses “TASoU 29 988 8388 it svar si08Se marx eoaron “ 12 13 14 16 16 7 18 19 20 21 22 23 24 26 disclose whether or not he had a financial and/or personal interest in the success of Norian/Synthes bone cements for use in the human spine; Dr. Chapman had a conflict of interest between his loyalties to Ms. Golden as his patient and his loyalties to his corporate sponsors and financial interests so that when Ms. Golden was treated by Dr. Chapman, he preferred his commercial interests with Mr. Wyss, Norian and Synthes above the interest of his patient, Ms. Golden. Dr. Chapman and the surgeons decided to use Norian/Synthes bone cement, or participated in use, contrary to USFDA instructions and applied that cement to Ms. Golden's spine to fortify and augment bony structures in her thoracic and lumbar vertebrae by creating cavities in those vertebrae and injecting Norian/Synthes bone cement in those cavities. Dr. Chapman and the other named defendant surgeons used the Norian/Synthes bone cement in Ms. Golden's spine against strict USFDA instruction, not to do so; Dr. Chapman used the excuse Ms. Golden presented him with to perform extensive surgery on her back and spine as an opportunity to conduct experimentation for his own personal reasons in order to promote the use of Norian/Synthes bone ‘cements in the human spine; Dr. Chapman failed to perform, and the other named defendant surgeons failed to insure the performance of, the necessary laboratory tests to determine Ms. Golden's precise diagnosis; Dr. Chapman failed to perform, and the other named defendant surgeons failed to insure performance of, adequate procedures to stabilize Ms. Golden's back and spine without using her as a subject for human experimentation and failed to treat her COME eee RUSH, HANNA He dats TP TACOMA, WA 8405 ‘TACOMA: 253-383-5368 FAX: 283-272-5105Soertrearon 1 13, 14 15 16 17 18 19 20 21 22 23 24 25 individually to benefit her rather than for the benefit of Dr. Chapman and his interests in, Synthes, Norian and the criminal enterprise alleged elsewhere in this Complaint; Dr. Chapman and the surgeons were aware that there were many methods available to treat Mrs. Golden that would be less risky and more effective than the experimental Norian/Synthes cement, which they knew had been causing severe adverse events of hypotension and thromboembolic disease to the lungs and the heart, in studies and experiments with this cement. 3.3, This recitation of Dr. Chapman's and the other named defendant surgeons’ failures to practice within the standard of care may be amended as discovery progresses. 3.4. These failures to practice within the standard of care, singly and in combination, were negligence, which proximately caused Ms. Golden's injury, wrongful death and damages to Ms. Golden, loss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 3.5. Harborview Medical Center, University of Washington and the State of Washington are liable for all injuries and damages to plaintiff's decedent, and to Reba Golden's statutory beneficiaries proximately caused by Dr. Chapman's and the other named defendant surgeons’ failure to treat Ms. Golden within the standard of care while she was being attended by them by virtue of the doctrine(s) of respondeat superior, master/servant, agency, or apparent agency. IV. FAILURE TO SECURE INFORMED CONSENT JENS R. CHAPMAN, M.D. 4.1. _ Plaintiffs incorporate sections | - II of this Complaint herein as if fully set forth. : RUSH, HANNULA, HARKINS & KYLER, LLP, COMPLAINT - 37 4701 South 19" Street, Suite 300 TACOMA, WA 66406, TACOMA 259.389.5388 ae 288.272 51084.2, Dr. Chapman failed to obtain any consent whatsoever from Reba Golden for any surgery a component of which was use of Synthes/Norian bone cement in her spine. Any supposed consent obtained by Dr. Chapman was secured by misrepresentation and deceit and is therefore void. 4.3. _ Dr, Chapman failed to inform Ms. Golden of his intention to use Norian/Synthes bone cement in her spine and the risks of using Norian/Synthes bone cements in the human spine. He failed to inform her that he had a vested interest in the financial success of Norian/Synthes bone cements’ use in the human spine, Dr. Chapman failed to inform Ms, Golden that Norian/Synthes bone cements were not allowed by the USFDA for use in the human spine. Dr. Chapman failed to inform Ms. Golden that a significant number of patients who had been treated with Norian/Synthes bone cements suffered severe hypotensive episodes, coagulopathy, disseminated intravascular coagulopathy, serious bleeding, cardiovascular collapse, and/or leakage of the cements through the venous blood system into the right heart and from there into the pulmonary tissues. He failed to inform Ms. Golden that in such cases, if Norian/Synthes bone cements leaked, the patient will probably die secondary to cor- pulmonale and respiratory failure. Dr. Chapman failed to provide Ms. Golden with adequate information and education on her alternative care possibilities, including no surgery and conservative care only. 4.4. Areasonable patient adequately informed of altemative courses of care ‘and the material risks associated with the procedures of August 17, 2007 and about the material risks associated with the use of Norian/Synthes bone cement in the human spine would not have consented to those procedures and/or the use of Norian/Synthes : i, HAR iS & KYLE! COMPLAINT - 38 RUSH, HANNULA, HARKINS & KYLER, LLLP. TACOMA, WA 98405 ‘TACOMA: 253-389-6388 FAX: 283-272-5105bone cement. 4.5. These failures to adequately inform Ms. Golden of the material risks of the. surgery of August 17, 2007 and the planned use of Norian/Synthes bone cement, singly and in combination, constituted failure to secure informed consent, which proximately, caused Ms, Golden's injury, wrongful death and damages to Ms. Golden, loss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 4.6. Harborview Medical Center, University of Washington and the State of Washington are liable for all injuries and damages to plaintiff's decedent and to Mrs. Golden's statutory beneficiaries proximately caused by defendant Dr. Chapman's failure to secure Ms. Golden's informed consent while she was being attended by him by virtue} of the doctrine of respondeat superior, master/servant, agency, or apparent agency. \. FAILURE TO SECURE INFORMED CONSENT HARBORVIEW MEDICAL CENTER 5.1. Plaintiffs incorporate sections | - II of this Complaint herein as if fully set forth. 5.2. Harborview Medical Center is individually liable for failure to secure Ms. Golden's informed consent by failing to have in place an IRB that reviewed, approved and oversaw Dr. Chapman’s human experimentation on Reba Golden and which assured she was adequately informed and educated concerning the precise nature of the experimentation to be performed on her and the material risks associated with use of Norian/Synthes bone cement in her spine. 5.3. Ateasonable patient adequately informed of alternative courses of care and the material risks associated with the procedures of August 17, 2007 and about the : RUSH, HANNULA, HARKINS & KYLER, LLLP. COME "M0 Seah Se! Sreot Suto 200 TACGMA, WA S408 TROOMA. 253-988-5388 ae 250272.5108material risks associated with the use of Norian/Synthes bone cement in the human spine would not have consented to those procedures and/or the use of Norian/Synthes bone cement. 5.4. These failures to adequately inform Ms. Golden of the material risks of the’ surgery of August 17, 2007 and the planned use of Norian/Synthes bone cement, singly and in combination, constituted failure to secure informed consent, which proximately caused Ms. Golden's injury, wrongful death and damages to Ms. Golden, loss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 5.5. _ University of Washington and the State of Washington are liable for all injuries and damages to plaintiff's decedent and to Mrs. Golden's statutory beneficiaries proximately caused by defendant Harborview Medical Center's failure to insure IRB oversight of Dr. Chapman's human experimentation on Ms, Golden and failure to secure; Ms, Golden's informed consent to an experimental procedure by virtue of the doctrine of respondeat superior, master/servant, agency, or apparent agency. VI. MEDICAL NEGLIGENCE “JOHN AND JANE DOES” 1 - 10 6.1. Plaintiffs incorporate sections | — 1! of this Complaint herein as if fully set forth. 6.2. The physicians, nurses and staff, “John and Jane Does” 1 - 10, who were a part of the orthopedic care of Reba Golden on and after June 5, 2007 culminating in her August 17, 2007 surgery failed to practice within the standard of care expected of medical doctors and nursing staff providing orthopedic care in their respective specialties and according to their credentials. i RUSH, HANNULA, HARKINS & KYLER, LLP. Cone eae ‘4701 South 19° Street, Suite 300 TACOMA, Wa 240 TASoMA 239085560 ES beara sesSomrxoark on 1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 6.3. ‘John and Jane Does’ 4 — 10’s failures to practice within the standard of care may be amended as discovery progresses 6.4. These failures to practice within the standard of care, singly and in combination, were negligence, which proximately caused Ms. Golden's injury, wrongful death and damages to Ms. Golden, loss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 6.5. Harborview Medical Center, University of Washington and the State of Washington are liable for all injuries and damages to plaintiff's decedent, and to Reba Golden's statutory beneficiaries proximately caused by “John and Jane Does" 1 — 10's failure to treat Ms. Golden within the standard of care while she was being attended by ‘them by virtue of the doctrine(s) of respondeat superior, master/servant, agency, or apparent agency. Vil, MEDICAL NEGLIGENCE HERNANDO P. OLIVAR, M.D. and “JOHN AND JANE DOES” 11 - 21 7.4. Plaintiffs incorporate sections | — II of this Complaint herein as if fully set forth. 7.2. The anesthesiologists, nurses and staff in attendance during the surgical procedure of August 17, 2007, including Hernando P. Olivar, M.D. and “John and Jane Does” 11 - 21, failed to practice within the standard of care expected of physicians, anesthesiologists and nurses in the State of Washington in the same or similar circumstances in the following respects: The anesthesiologists and their nurses and staff failed to participate in the decision to use Norian/Synthes bone cement in Reba Golden’s spine. The anesthesiologists and their nurses and staff are responsible for patient safety during an 7 RUSH, HANNULA, HARKINS & KYLER, LLP. Cone ee Are esi iS Gre Sule 00, TACOMA, WA S3a08 TACOMA: 259 95-5368 Fae: 289-272-5108surgical procedure. This is especially true when the surgery involves introduction of drugs and/or medical devices into the patient's body. Because these affect all the functions of the patient, the anesthesiologists and their nurses and staff caring for Ms. Golden should have known that Dr. Chapman and the other named defendant surgeons were using Norian/Synthes bone cement, a class III medical device, in treating Ms. Golden. In the absence of a valid IRB approval for the planned human experimentation, the anesthesiologist and their anesthesiology nurses and staff should not have allowed Dr. Chapman and the other named defendant surgeons to use these Norian/Synthes bone cements because they were known to produce severe hypotension, severe coagulopathy, cardiovascular collapse, pulmonary embolism and death; The anesthesiologist and the anesthesiology nurses and staff had an independent duty to assess the necessity for the planned surgery and Ms. Golden's capacity to withstand the introduction of Norian/Synthes bone cements. The anesthesiologist and the anesthesiology nurses and staff failed to do so; The anesthesiologist and the anesthesiology nurses and staff had the duty to clear Mrs. Golden for the surgical procedure planned for August 17, 2007. To clear a patient for a procedure, the anesthesiologist and the anesthesiology nurses and staff must ascertain what the procedure is for and what drugs and/or devices will be used during the procedure. Itwas the anesthesiologist’s duty, and the duty of the anesthesiology nurses and staff, to ascertain that Norian/Synthes bone cement was planned for use in Ms. Golden’s spine and to confirm that a valid IRB approval for this human experimentation was in place. Absent a valid IRB approval, it was their duty to prevent Dr. Chapman and the other named defendant surgeons from using COMPLAINT - 42 RUSH, HANNULA, HARKING & KYLER, LLP. TACOMA, WA 6405 ‘TACOMA: 253-383-5388 FAX: 263-272-5105eon B Secamrnxoa 12 13 14 15 16 17 18 19 20 241 22 23 24 25 Norian/Synthes bone cements in Ms. Golden's spine. They knew or should have known| that many patients suffered serious injuries and death from Norian/Synthes bone cements secondary to hypotension, vascular problems, coagulation deficits, severe bleedings and cardiovascular death; 7.3. These failures to practice within the standard of care may be amended as discovery proceeds. 7.4. These failures to practice within the standard of care, singly and in combination, were negligence, which proximately caused Ms. Golden injury, wrongful death and damages to Ms. Golden, loss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 7.5 Harborview Medical Center, University of Washington and the State of Washington are liable for all injuries and damages to plaintiff's decedent and to Ms. Golden's statutory beneficiaries proximately caused by Dr. Olivar and those health care professionals affliated with the Anesthesia Department, Unit, or Service who failed to treat Ms. Golden within the standard of care while she was being attended by them by virtue of the doctrine of respondeat superior, master/servant, agency, or apparent agency. Vill, NEGLIGENCE UNIVERSITY OF WASHINGTON, HARBORVIEW MEDICAL CENTER PERSONNEL, “JOHN AND JANE DOES” 22 - 52 8.1. Plaintiffs incorporate sections | -II of this Complaint herein as if fully set forth. 8.2. Plaintiffs reserve the right to state claims for negligence and/or medical negligence against those University of Washington and Harborview Medical Center COMPLAINT - 43, RUSH, HANNULA, HARKINS & KYLER, LLLP. " TACOMA, WA Sodos TACOMA: 253-383-5326 FAX: 289-272-5105persons, boards, committees and the like, “John and Jane Does 22-52,” whose identifies are not presently known, but whose duties include direction, supervision, governance and/or oversight of the professional, ethical practice of medicine, the use and employment of operative procedures and/or the use of medical devices by health care professionals within The University of Washington, Harborview Medical Center, University of Washington Medical Center and University of Washington Physicians. 8.3. These persons, boards, committees and the like failed in their duties to direct, supervise, govern and/or oversee the use and employment of the operative procedures and pre-operative and intra-operative care for Reba Golden in, but not limited to, the following respects: They participated in an illicit clinical development program for Norian/Synthes bone cements’ use in the human spine against the clear cut USFDA instructions and standards of medical care not to do 80; They allowed clinical experimentation on human beings against USFDA requirements and standards of medical care and of good clinical practice and they did not invoke proper review of the clinical experimentation in their hospital. Specifically, but not limited to this allegation, they did not have Institutional Review Board (IRB) control and review over the human experimentation conducted on Reba Golden; They allowed members of their staff, including Dr. Chapman, a conflict of interest in their loyalties to their patients and other corporate financial interests so that when Mss. Golden was treated by Dr. Chapman, he preferred his commercial interests with Mr. Wyss, Norian and Synthes above the interest of his patient, Ms. Golden; and Harborview Medical Center and University of Washington failed to provide Ms. Cc eeeaaeltaed RUSH HAN ae teas NP TACOMA, Ws 84085 TACOMA: 253-383-5388 FAX: 288-272-5105,Golden the necessary supervision of adequate care and treatment by health care professionals in their system. The standard of care requires that a hospital will work in an integrated fashion, which did not occur in Ms. Golden’s case. 8.4. These claims of negligence and/or medical negligence may be amended as discovery progresses. 8.5. These instances of negligence and/or failure(s) to practice within the standard of care, singly and in combination, proximately caused Ms. Golden's injury, wrongful death and damages to Ms. Golden, loss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 86. The State of Washington is liable for all injuries and damages to plaintif’s decedent, her estate and her statutory beneficiaries proximately caused by the negligence and/or medical negligence of the University of Washington and/or Harborview Medical Center persons, boards, committees and the like by virtue of the doctrine of respondeat superior, master/servant, agency, or apparent agency. IX. PATTERN OF CRIMINAL PROFITEERING ACTIVITY 9.1. Plaintiffs incorporate sections | II of this Complaint herein as if fully set forth. 9.2. These alleged facts amount to a pattern of criminal profiteering activity by, among others, Hansjérg Wyss, Synthes, Inc., Norian Corp., Michael D. Huggins, Thomas B. Higgins, Richard E, Bohner, John J. Walsh, Jens Chapman, M.D., University of Washington, Harborview Medical Center and other orthopedic surgeons and neurosurgeons. These defendants constituted a criminal enterprise. The criminal enterprise engaged, for profit, in a pattern of criminal profiteering activity. The criminal COMPLAINT - 45 RUSH, HANNULA HARKINS & KYLER, LLLP. TACOMA, WA 88405 ‘TACOMA: 263-383.5968 FAX: 253-272-5105activity included the Synthes and Norian “test market" and other promotional activities for Norian/Synthes bone cements’ use in the human spine, which criminal enterprise ‘was led by Mr. Hansjérg Wyss. 9.3. The criminal enterprise trained surgeons to introduce Norian/Synthes bone cements into the spines of unsuspecting patients and illicitly promoted Norian/Synthes bone cements for this use. Norian/Synthes bone cements were substances then known to the members of the enterprise to be extremely dangerous and even deadly to humans when used in their spines. This enterprise resulted in multiple violations of patients’ bodily integrity that amounted in the State of Washington to the crime of assault in the second degree, to wit: (1) Aperson is guilty of assault in the second degree if he or she, under circumstances not amounting to assault in the first degree: (a) _ Intentionally assaults another and thereby recklessly inflicts substantial bodily harm; (2a) Except as provided in (b) of this subsection [relating to assault in the second degree with a finding of sexual motivation}, assault in the second degree is a class B felony, RCW 9A.36.021 9.4. This enterprise to conduct illegal human experiments resulted in intentional assaults by injection of Norian/Synthes bone cements into the vertebral bodies and spinal processes of unsuspecting human subjects without their consent, or through misrepresentation and/or deceit , recklessly causing substantial bodily harm on ‘a number of occasions, not less than three, before and after the assault on Reba Golden. ae RUSH, HARA A Hoe Seton TACOMA, WA S805 ‘TACOMA: 253-989-6388 FAX: 289-272-51059.5, Criminal profiteering by violation of RCW 9A.36.021, when done for financial gain, violates the Washington Criminal Profiteering Act. RCW 9A.82 ef seq. Dr. Chapman's injections of Ms. Golden with Norian/Synthes bone cement were acts in furtherance of the enterprise alleged. Within five years of August 17, 2007, more than 3} acts of assault in the second degree were perpetrated by the enterprise. 9.6. Defendant Dr. Chapman's assault in the second degree of Ms. Golden resulted in her death. 9.7. Assault in the second degree, when it results in the death of the victim is, in the State of Washington, murder in the second degree: (1) Aperson is guilty of murder in the second degree when: {b) He or she commits or attempts to commit any felony, including assault, ..., and, in the course of and in furtherance of such crime . . . he or she, or another participant, causes the death of a person other than one of the participants (2) Murder in the second degree is a class A felony. RCW 9A.32.050. 9.8. The assault in the second degree on Ms. Golden by defendant Jens Chapman, M.D., resulted in her death and amounted to murder in the second degree. ‘Similar assaults as a result of the criminal enterprise alleged resulted in death on a number of occasions, not less than three, before and after the death of Ms. Golden. 9.9. Criminal profiteering by violation of RCW 9A.32.050, when done for financial gain, violates the Washington Criminal Profiteering Act. RCW 9A.82 ef seq. Dr. Chapman's injections of Ms. Golden with Norian/Synthes bone cement were acts in furtherance of the enterprise alleged. His assault in the second degree resulted in Ms. COMPLAINT - 47 RUSH, HANNULA WY FUCING SCYLER, Lup. TACOMA, WA $3405 TACOMA: 258-383-5988 FAK: 253-272-5105Golden's death, thus amounting to murder in the second degree. Within five years of ‘August 17, 2007, more than 3 acts of assault in the second degree resulting in the death of the victims were perpetrated by the enterprise, 9.10. Dr. Chapman's injections of Ms. Golden with Norian/Synthes bone cement! and the predicate acts alleged had the same or similar intent, results, accomplices, principals, victims and/or methods of commission, or were otherwise interrelated by distinguishing characteristics including a nexus to the same enterprise and were not isolated events, 9.11. Dr. Chapman, Hansjérg Wyss, University of Washington, Harborview Medical Center, Synthes, Inc., Norian Corp., Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh are liable under RCW 9A.82. 100 for the harm to her person and estate sustained by plaintiffs’ decedent, Ms. Golden, including the harm suffered by her surviving children as a result of her wrongful death, Pursuant to statute, these defendants are also liable for treble the amount of damages suffered by plaintif's decedent and her statutory beneficiaries, for the statutory $250,000.00 penalty for each violation found and for plaintiffs reasonable costs, investigation fees and attorneys’ fees. X. LEADING ORGANIZED CRIME 10.1. Plaintiffs incorporate sections | ~ II and IX of this Complaint herein as if fully set forth, 10.2, Hansjérg Wyss intentionally organized, managed, directed, supervised and/or financed the alleged enterprise, including the persons alleged to comprise the enterprise, with the intent to engage in the patter of criminal profiteering activity : RUSH, HANNULA, HARKINS & KYLER, LLLP. COMPLAINT - 48 4701 South 19° Street, Suite 300 TACOMA, WA. S005 Taso 250 289 5368 rome aa 5108alleged, all in violation of RCW 9A.82.060. Leading organized crime as described herein is a class A felony pursuant to RCW 9A.82.080(2)(a). Plaintiff's decedent and plaintiffs statutory beneficiaries were injured by the enterprise Mr. Wyss led, as alleged herein. 10.3, Mr. Wyss is liable under RCW 9A.82.100 for the harm to her person and estate sustained by plaintiffs’ decedent, Ms. Golden, and for the harm suffered by her surviving children as a result of her wrongful death. Pursuant to statute, Mr. Wyss is also liable for treble the amount of damages suffered by plaintif's decedent and her statutory beneficiaries, for the statutory $250,000.00 penalty for each violation found and for plaintif’s costs, reasonable investigation fees and attorneys’ fees. Xl, OUTRAGE 14.1. Plaintiffs incorporate sections | - Il and IX - 10 of this Complaint herein as if fully set forth. 41.2. Defendants’, including defendants Harborview Medical Center, University of Washington, Wyss, Huggins, Higgins, Bohner, Walsh, and to the extent this conduct implicates the entrepreneurial aspects of the practice of medicine and/or the research and development of medical devices and promotion of the indications for their uses, Dr. Jens Chapman, coordinated efforts to perform unsanctioned human experimentation involving implantation of Norian/Synthes bone cements into the spines of unsuspecting human patients regardless of any danger, harm, damage and even death to/of the unsuspecting human subjects is utterly outrageous and intolerable in a civilized society ‘and amounts to the tort of outrage under the law of the State of Washington. 14.3. These instances of outrageous conduct, singly and in combination, proximately caused Ms. Golden's injury, wrongful death and damages to Ms. Golden, COMPLAINT 48 cua at eee eyloss to her estate and injury and damages to her statutory beneficiaries, as pled in more detail below. 11.4, Besides their individual liability for outrageous conduct, Harborview Medical Center, University of Washington and Washington State are liable for all injuries| and damages to plaintif’s decedent, her estate and her statutory beneficiaries proximately caused by the outrageous conduct of defendant Dr. Jens Chapman by virtue of the doctrine of respondeat superior, master/servant, agency, or apparent agency. Xi, PRODUCT LIABILITY 12.1. Plaintiffs incorporate sections | ~ II of this Complaint herein as if fully set orth. 12.2. Plaintiffs claim liability against Norian Corp. and Kensey Nash, Corp. as product manufacturer and Synthes, Inc., as product supplier based upon Chapter 7.72 RCW, the Product Liability Act; common law strict liability; and negligence. Defendants Norian Corp. and Kensey Nash, Corp., were the product designer and manufacturer; Defendant Synthes, Inc., supplied the product in commerce. The relevant product, Norian bone cements were not reasonably safe at the time they left defendants Norian Corp.'s/Kensey Nash, Corp.'s, and Synthes, Inc.'s control because they were not reasonably safe as designed and were not reasonably safe as manufactured 12.3 Asa proximate result of defendants’ negligence and/or product liability, Reba Golden sustained severe injury and death and her surviving children suffered the destruction and loss of their relationships with their mother, as well as loss and destruction of their consortium interests in their relationships with their mother. COMPLAINT - 50 RUSH, wats ee sor LL. TACOMA: 263-283-5380 FAX: 253-272-6105,12.4, The defendant Kensey Nash Corp. is liable for all injuries and damages to] plaintiff's decedent, and to Ms. Golden's statutory beneficiaries proximately caused by the product liability of defendant Norian Corp. by virtue of the doctrine of product line liability respondeet superior, master/servant, agency, or apparent agency and/or successor or assumed liability, Kensey Nash is also liable under the doctrine of product line liability, under either or both Washington and Pennsylvania law. It acquired all or most of Norian's assets, including all assets necessary to continue manufacturing Norian bone cements, which it has continued to manufacture and sell exclusively to Synthes, continuing to employ the *Norian” name on its packaging according to rights retained by Synthes. Kensey Nash It also acquired all rights to the Norian bone cements, kept almost all of Norian's employees, and produced the products at the same plant, which it also procured. Xtll. INJURIES AND DAMAGES 13.1 Plaintiffs incorporate herein sections | — XII of this Complaint as if fully set forth. 13.2. Asa proximate result of the medical negligence and other wrongful acts alleged herein, Reba Golden experienced pain and suffering prior to her death and her estate sustained, needless health care costs and bills and the expenses of her last illness, her funeral and burial. 13.3. Asa further proximate result of the medical negligence and other wrongful acts alleged herein, Ms. Golden’s statutory beneficiaries, Cynthia Wilson, Victoria Marincin and Paul D’Oyley, suffered the destruction and loss of their relationships with their mother, including, but not limited to, their consortium interests in their mother's OTe RUSH, HAA totus Suto TACOMA, WA. 88405 ‘TACOMA: 263-383-5388 FAK: 258-272:5105love, support, care, affection, guidance, society and companionship. XIV. PUNITIVE DAMAGES 14.1 Plaintiffs incorporate herein sections | ~ XIll of this Complaint as if fully set forth, 14.2. The actions of Norian, Synthes, Inc., Synthes Spine, Synthes North ‘America, and possibly other subsidiaries yet unknown of Synthes; and of the individual defendants Wyss, Huggins, Higgins, Bohner and Walsh; in promoting and using the Norian bone cements on the decedent were outrageous; were driven by an ill motive of profit over the interests of Reba Golden, and/or their reckless indifference to her health and welfare: their actions were such as to demonstrate wilful, wanton or reckless conduct. The federal judge sentencing Huggins, for instance, stated that in his opinion, on a scale of one to ten for criminality, Huggins conduct rated an eleven. The Judge further agreed with the assertion of the United States Attorney that the conduct of the indicted defendants amounted to human experimentation ~ that in the hopes of making millions of dollars in sales, the defendants all but totally disregarded the lives and health of the victims. He found their actions so reprehensible that he deviated above the standard range of the sentencing guidelines for the first time in ten years as a federal judge. 14.3. Asa result, the Plaintiffs are entitled to punitive damages against all the defendants listed in paragraph 14,2, pursuant to Pennsylvania law. XV. WASHINGTON LIMITATIONS PERIOD APPLICABLE 15.1. Washington's statute of limitations applies to all issues, including punitive damages, due to the great disparity between the limitations periods in Washington and Pennsylvania law, and the unfaimess of the Pennsylvania limitations period to the Plaintiffs. . : RUSH, HANNULA, HARKINS & KYLER, LLP. ene AUN Soa Se oar ute 00 TACOWA,WA 86408 TRSOMA 259-368 8908 PA 250272 10515.2 The accrual of the punitive damages claims was also tolled due to the defendants’ fraudulent concealment of their wrongdoing. XVI. AGENCY 16.1 Plaintiffs incorporate herein sections I-XV of this Complaint as if fully set forth. 16.2. Allactions of Defendants Wyss, Huggins, Higgins, Bohner, and Walsh ‘were taken on behalf and as agents of Synthes, Inc. and any division or subsidiary of ‘Synthes and Norian that was involved in any decision or action concerning development} and/or, promotion Norian/Synthes bone cements for use in the human spine and are imputable to those same corporations. WHEREFORE, plaintiffs pray for relief against the defendants, and each of them, as follows: 2. For damages to the Estate of the decedent, Reba Golden, in such amounts as will be proven at time of trial; 3. For pecuniary injuries and damages to the surviving statutory beneficiaries| of Reba Golden: Cynthia Wilson, surviving daughter; Victoria Marincin, surviving daughter; and Paul D’Oyley, surviving son; 4. For the statutory civil penalty of $250,000.00 per violation, pursuant to RCW 9A.82.100(1)(d) against defendants Chapman, Synthes, Inc., Norian Corp., Kensey Nash, Corp., Huggins, Higgins, Bohner, Walsh and the University of Washington and Harborview Medical Center for personal injury and death to Mrs. Golden and injury and damages to her statutory beneficiaries inflicted in the course of a pattern of criminal activity; : RUSH, HANNULA, HARKINS & KYLER, LLP. Ona “70h South iat Seve, Suto 360 TACOMA, Wh Sea0s ASCH 259-269-989 FAK: 208272-51085. For actual and treble damages as allowed by RCW 9A.62.100(4)(d) against defendants Chapman, Synthes, Inc., Norian Corp., Kensey Nash, Corp., Huggins, Higgins, Bohner, Walsh, the University of Washington and Harborview Medical Center for personal injury and death to Ms. Golden and injury and damages to her statutory beneficiaries inflicted in the course of a pattern of criminal activity; 6. For the statutory civil penalty of $250,000.00 against defendant Hansjorg Wyss, per violation, for personal injury to and death of Ms. Golden and injuries and damages to her statutory beneficiaries as a result of his leadership of organized criminal activity, as allowed by RCW 9A.82.100(1)(d). 7. For actual and treble damages as allowed by RCW 9A.82.100(4)(d) against defendant Hansjérg Wyss for personal injury to and death of Ms. Golden and injuries and damages to her statutory beneficiaries as a result of his leadership of organized criminal activity. 8. For prejudgment interest on all liquidated sums; 9. For plaintiff's reasonable costs and fees, including reasonable attorneys’ fees incurred in pursuing this action; 10. For plaintiff's reasonable costs and fees, including costs of investigation and attorneys’ fees incurred in pursuing this action against defendants Hansjorg Wyss, Chapman, Synthes, Inc., Norian Corp., Kensey Nash, Corp., Huggins, Higgins, Bohner, Walsh, the University of Washington and Harborview Medical Center as allowed by RCW 9A.82,100(1)(a) and RCW 9A.82.100(4)(e); and 14. For punitive damages against defendants Synthes, Inc., Norian Corp., Wyss, Huggins, Higgins, Bohner and Walsh in accordance with Pennsylvania law; and : H, HANNULA, HARKINS & KYLER, LLP. ree RUSH, HaTeN Ses aM Bee cate 000 TACOMA, WA 98405, ‘TACOMA: 253-383-5968 FAK: 265-272:510512. For such other and further relief as the Court deems just and equitable. DATED this IN day of August 2013. Rush, Hannula, Harkins & Kyler,4L.P. Attorneys fof Plaiptiffs COMPLAINT - 55, RUSH, HANNULA, HARKINS & KYLER, LLP. {4701 South 18" Stee, Suite 200 TACOMA, WA 98405, ‘TACOMA: 263-383-5368 FAX: 268-272-5105Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 1 of 50 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA UNITED STATES OF AMERICA : CRIMINAL NO.: 09-403 vw : DATE FILED: October 4,2010 NORIAN CORPORATION ' VIOLATIONS: SYNTHES, INC. 18 U.S.C. § 371 (conspiracy —1 count) 21 US.C. §§ 331(a), and 333(a)(1) (introducing into interstate commerce adulterated and misbranded medical ciate” AMENDED SUPERSEDING INFORMATION COUNT ONE ‘THE UNITED STATES ATTORNEY CHARGES: Introduction 1. Atall times relevant to this information: ‘The Defendants a. __Symthes, Inc. (charged elsewhere in this information) (“Synthes”) was a business corporation organized under the laws of the State of Delaware, with its principal place of business located at West Chester, in the Eastern District of Pennsylvania. Synthes isthe United States branch of a large multinational medical device manufacturing corporation which specializes in trauma products, with manufacturing facilities located in Monument, Colorado, ‘West Chester, Pennsylvania, Elmira, New York and Tuttlingen, Germany. b. Defendant NORIAN CORPORATION (“NORIAN”) was a wholly owned subsidiary of Synthes, with its principal place of business located at West Chester, in the Eastern District of Pennsylvania, Prior to mid-1999, defendant NORIAN was located in Cupertino, California and was in the business of manufeeturing and selling two caleium phosphate bone cements, called Norian Cranial Repeir System (“CRS”) and Norian Skeletal Repair System SRS”). CRS was a Class II medical device that had been cleared by the FDA to be marketed for filling defects in the skull, SRS was a Class lI medical device that had'been approved by the EXHIBIT1 ==:Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 2 of 50 FDA to be marketed for use in the distal radius, a long bone in the arm, Synthes acquired defendant NORIAN on or about July 21, 1999, whereupon Synthes began exploring new intended uses for the Norian bone cements, with an eye toward eventually obtaining an indication for use of Norian bone cements in the spine, © Michael D. Huggins (charged elsewhere)(“Huggins”) was employed by ‘Synthes as the President of Synthes North America, a subsidiary of Synthes. In February 2004 ‘Huggins became the President of Synthes Spine, a division of Synthes. 4. Thomas B. Higgins (charged elsewhere)(“Higgins”) was the President of Synthes Spine, adivision of Synthes, reporting to Huggins. In February 2004 Higgins left the position of President of Synthes Spine and became Senior Vice President of Global Stretegy of Synthes, Richard E, Bohner (charged elsewhere)(“Bohner”) was employed by Synthes as its Vice President of Operations, reporting to Huggins. £ John J. Walsh (charged elsewhere)(“Walsh”) was employed by Synthes as its Director of Regulatory end Clinical Affairs, Spine Division, and reported first to Bohner and later to Huggins. ‘The Food and Drug Administration 2. ‘The Food and Drug Administration (“FDA”) is an agency of the United States governmert responsible for protecting the health and safety of the public by assuring, among other things, that medical devices intended for usc in the treatment of humans are safe and effective for their intended uses and that the labeling of such devices bear true and accurate information, Pursuant to this statutory mandate, the FDA regulates the manufacture, labeling, and shipment in interstate commerce of any such devices. 3. ‘Under the federal Food, Drug and Cosmetic Act (Title 21, United States Code,-cr-00403-LDD Document 114 Filed 10/22/10 Page 3 of 50 §§ 301-397, the “FDCA”), and pursuant to Title 21, United States Code § 321(h), the term “device” includes “an. . . implant . . . or other similar or related article. . . whichis. . . intended for use in the treatment or prevention of disease of man. . . or intended to affect the structure or any function of the body of man . . . witich does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” 4. Pursuant to the FDCA, every manufacturer of a new device is fequired to obtain “clearance” or “approval” from the FDA prior to marketing its device. 5. All devices marketed in interstate commerce in the United States fall into one of three regulatory classes under the FDCA. Class III devices are subject to the most stringent regulatory requirements, Class I devices to the least stringent, and Class I! devices to requirements that fall in between, The classification assigned to each device is determined by the _ degree of regulatory control necessary to provide reasonable assurance of the safety and effectiveness of that device for its intended use. 6 Devices that were not in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the FDCA became effective, are automatically assigned to Class Illby operation of law. Such Class III devices cannot legally be marketed in the United States ‘until the manufacturer has submitted to the FDA a pre-market approval (“PMA”) application and the FDA has approved that application, The FDA will not grant pre-market approval unless the information in the PMA application provides the FDA with reasonable assurance that the device is safe and effective when used according to its labeling, 7. The only ways a manufacturer can remove a device from automatic assignment to Class Ill, and thereby avoid the PMA process, are to obtain either an order from the FDA reclassifying the device into Class I or Class Il, ora finding by the FDA that the device is substantially equivalent to a legally marketed device (called a “predicate device”) for which pre~ market approval is not required.Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 4 of 50 8 _ A “significant risk” device is an implant that presents a potential for serious risk to the health, safety or welfare of a human subject, or isa device that otherwise presents a potential for serious risk to the health, safety or welfare of a human subject, 9. Aclinical trial” or “clinical investigation’ is an investigation or research involving one or more human subjects to determine the safety or effectiveness of a device, 10. As part of the pre-market approval or clearance process, the FDA often requires device manufacturers to submit the results of clinical trials or investigations, that is, testing on human subjects, Manufacturers of significant risk devices cannot legally conduct clinical tials or investigations in the United States without first, ‘obtaining the FDA’s permission to do so, by way of an Investigational Device Exemption (“IDE”). Before beginning a clinical trial of a ificant risk device, the device manufacturer is required to obtain the FDA’s approval of the IDE, and a multi-disciplinary group of professionals with backgrounds: in areas like science, E medicine and bicethics called an Institutional Review Board (“IRB”) is required to approve the investigational plan and informed consent form, so that the clinical trial is properly monitored and the human subjects properly protected. In some limited circumstances, an IDE does not need to be filed if the manufacturer is conducting consumer preference testing of the device, but only if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk. The requirements of an IDE to permit clinical trials, and an IRB to oversee clinical trials, combined with the expense of planning and carrying out clinical trials, mean that obtaining pre-market approval from the FDA for a significant risk device often is a long and expensive process. 11, A manufacturer that takes the alternate route of seeking a determination of “substantial equivalence” is required to submit to the FDA “pre-market notification” (also known as a*°510(K)”) no later than ninety days before the manufacturer intends to introduce the device into interstate commerce. Ifthe FDA makes a finding of “substantial equivalence” based on theCase 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 5 of SO ‘manufacturer's pre-market notification, the device is then “cleared” for marketing and can be ‘marketed only for the intended use stated on the label as cleared by the FDA. 12, A manufacturer is required to file a new 510(K) for its previously cleared device if the device is to be changed or modified in a way that could significantly affect its safety or effectiveness, that is, if the manufacturer is planning a significant change to the device's design, ‘material, chemical composition, or manufacturing process. A new $10(K) pre-market notification is also required for a planned major change or modification in the intended use of a device. 13, Tf the manufacturer intends to market the device for a new or different indication for use from that cleared for the predicate device, the new 510(K) notification is required to include supporting information to show that the manufacturer has considered what consequences and effects the new use might have on the safety and effectiveness of the device. 14, Through an expedited, streamlined version of the 510(k) process, a manufacturer seeking to obtain FDA clearance to market a modified version of its own, previously cleared device can submit to the FDA a pre-market notification (also known as a “Special $10(k)") no later than thirty days before the manufacturer intends to introduce the modified device into interstate commerce. If the FDA makes a finding that the manufacturer's modified device is “substantially equivalent” to the manufacturer's original device, the modified device is then cleared for marketing and can be marketed only for the intended use stated on the label as cleared by the FDA. The Special $10(k) process cannot be used when the proposed change or ‘modification to the device affects the intended use of the device. 15, Approval of'a PMA application and clearance of a $10(k) ot Special 510(K) pre- ‘market notification are separate routes for obtaining the FDA's permission to market a medical device, Until a device obtains one of these two forms of permission, it cannot legally be distributed in interstate commerce. 16. Regardless of the route chosen by the device manufacturer in seeking the FDA's permission to market a medical device - whether by 510(k) or Special 510(k) pre-market 5Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 6 of SO notification, or by PMA application — the device manufacturer's application to the FDA is required to contain proposed labels and labeling sufficient to describe the device, its intended ‘use, and the directions for its use. A device is cleared or approved by the FDA on the basis of its intended use, and the FDA-approved use is required to be included in the device's labeling. 17. The manufacturer of a medical device is not permitted to promote its device for any use other than the intended use stated on the label as cleared or approved by the FDA. A manufacturer is not permitted to promote or test market an investigational device until after the FDA has approved the device for commercial distribution, and cannot represent that the investigational device is safe and effective for the purposes for which itis being investigated, 18. A Class III device is “adulterated” if it is required to have an approved PMA. application and does not have an approved PMA application in effect, or if it is required to have ‘an approved IDE and does not have an approved IDE in effect. 19. A medical device is “misbranded” if the manufacturer of the device has failed to ‘ provide the FDA with pre-market notification of a new or non-FDA-sanctioned intended use ninety days prior to introducing the device into interstate commerce for such use, 20. Adevice manufacturer is required to establish and maintain records, make reports, and provide information to the FDA in order to assure that its device is not. adulterated or risbranded, and otherwise to assure the safety and effectiveness of its device, In addition, a device manufecturer is required promptly to report to the FDA a removal of a medical device from the market. 21, Whenever a device manufacturer becomes aware of information from any source that reasonably suggests that the manufacturer's device might have caused or contributed to.a death or serious injury, the device manufacturer is required by law to report that information to ‘the FDA within thirty days in a report called a Medical Device Report (“MDR"). A medical device causes or contributes to a death or serious injury when the death or serious injury was, or might have been, attributed to the medical device, or when the medical device was or may have 6Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 7 of 50 ‘been 2 factor in a death or serious injury. The FDA makes MDRs available to doctors and other ‘members of the public through searchable databases so that the public can be aware of serious risks associated with medical devices. 22, Amedical device is also “misbranded” ifthe manufacturer of the device fails or refuses to furnish to the FDA any material information concerning that device that is required to be reported on an MDR. ‘The Spine 23. The human spine is a structure made up of bone, cartilage, joints, a spinal cord, nerve roots, ligaments, tendons, muscles and a vascular system. ‘The spinal column is a strong ‘and flexible rod starting at the base of the skull and continuing to the pelvis. The spinal column consists of bones connected by joints and supported by ligaments, tendons and muscles. The spinal column gives a person the ability to move his or her upper body in a controlled manner, In addition, the spinal column protects the spinal cord, supports the head, provides an attachment for the ribs, and transmits most of the body's weight to the pelvis, aided by muscles and tendons. 24, Twenty-six pieces of bone known as vertebrae stack up to form the spinal column, which is curved, The curves in the spinal column are important for balance, flexibility, stress absorption and weight distribution in the spine. The vertebrae increase in size down the spinal column to accommodate the enlarging body weight. The vertebrae group into five regions from the top to the bottom: cervical, thoracic, tumbar, sacrum and coceyx. 28, The cervical vertebrae extend from the skull to the shoulders and aid the movement of the neck and head. There are seven cervical vertebrae, referred to as C1 through 7 from top to bottom. The cervical vertebrae are followed by twelve thoracic vertebrae, from 1 at the top (at the shoulders) to T12 at the bottom (ust below the rib cage). Two ribs are connected to each thoracic vertebra, one on either side. The thoracic vertebrae are followed by five lumbar vertebrae, L1 through LS, which connect the upper spine to the pelvis. The lumbarCase 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 8 of 50 vertebrae provide mobility and strength essential for almost all activities of daily living, such as turning, twisting and bending, and actions such as standing, walking and lifting. The sacrum, or 1, isthe large irregular triangular shaped bone below the lumbar region, made of five fused bones and inserted like a wedge between the pelvis bones, held together by two joints. The coveyx is the terminal part of the spine that is commonly known as the tailbone, It comprises three vertebrae fused together. 26. With the exception of the atlas (Cl), the axis (C2), the sacrum and the coceyx, cach cervical, thoracic and lumber vertebra is similarly shaped. A typical vertebra has a large vertebral body in the front (“anterior”) and an arch of bony structures in the back (“posterior”) including two supporting pedicles and two arched laminae. The vertebral body has the appearance ofa bony drum. The exterior vertebral body consists of very hard bone called cortical bone, with more spongy bone marrow, celled cancellous bone, and blood vessels inside, ‘The vertebral bodies support 80% of all loads applied to the spine. ‘The main purposes of the arch of posterior bony structures are to protect the spinal cord and to enable the connection of the vertebrae to muscles and ligaments. The hollow center of the vertebra that is behind the bony drum is known as the spinal canal or vertebral foramen, which contains the spinal cord, the cauda equina (in the lower spine), fat, connective tissue, and the arterial and venous supply of the spinel cord, Under each pedicle, two spinal nerves exit the spinal cord and run through the vertebral foramen to branch out to the body. ‘The Spine Market 27. Osteoporosis is a disease of the bones characterized by abnormally low levels of calcium, in which the bones become fragile and more likely to break. ‘These broken bones, known as fractures, occur in the bony drum vertebral body in the spine, among other bones. ‘Approximately 700,000 fractures of the spine that are called vertebral compression fractures or ‘VCFs occur annually in the United States due to osteoporosis; approximately 270,000 of these 8gCase 2:09-c1-00403-LDD Document 114 Filed 10/22/10 Page 9 of 50 fractures are painful and clinically diagnosed, Most patients are treated conservatively, with bed rest, bracing and pain medicines, but some patients do not respond well to conservative treatment, and suffer serious consequences from VCFs, including loss of height, severe back pain and deformity. 28. Inthe early 1980s, surgeons in France developed a minimally invasive, ot percutaneous, surgery called vertebroplasty to treat VCFs, During the surgery, a needle was inserted through the back of the patient's otherwise unopened skin into the fractured vertebra under general or Jocal anesthesia with the help of image-guided X-ray. Through the needle, the surgeon injected a mixture of bone cement and a contrast agent into the vertebral body, in order to stabilize the fractured bone and alleviate back pain. 29. In the 1990s, a variation on the vertebroplasty surgery, called kyphoplasty, was developed to treat VCFs, The main difference between vertebroplasty and kyphoplasty was that in kyphoplasty a surgical instrument and a balloon were inserted into the compressed vertebral body, in order to create a cavity that elevated or expanded the fractured vertebra to its original shape. Once the instrament was withdrawn, the created cavity was filled with bone cement or a bone void filler mixture, By enlarging the fracture in this manner, kyphoplasty procedures were believed to correct deformity, restore vertebral body height, or both, as well as alleviate back pain, Enlargement of the VCF was commonly called “reduction.” 30, The term “vertebroplasty,” when used in a broad sense, describes any percutaneous surgery in which a mixture of bone cement or bone void filler and a contrast agent are injected into a vertebral body to stabilize fractured bone and alleviate back pain. The term “vertebroplasty” is also used more narrowly to describe a traditional, high-pressure percutaneous procedure in which no cavity is created prior to injection of bone cement into the vertebral body. 31. Both vertebroplasty and kyphoplasty carry the risk of pre-hardened cement leaking out of the vertebral body. Traditional vertebroplasty, in which no cavity is created in the vertebra before injection of the cement, carries the risk of cement leaking out of the vertebral 9Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 10 of 50 body because the cement is injected at high pressure, and because, so that such high pressure injection can take place, the cement is used in a runny form. Cement leakage can cause soft tissue damage. Moreover, because many blood vessels ate near the spine, cement leakage into the venous system can also cause pulmonary embolism and death, 32. Anacrylic bone cement called polymethylmethacrylate or PMMA was the first substance used in vertebroplasty and kyphoplasty procedures. PMMA was much harder than bone; it was exothermic, that i, it gave off heat when injected and as it cured; and it did not remodel to bone. When PMMA was used in vertebroplasty or kyphoplasty surgeries to treat VOFs, its extreme hardness after curing could cause fractures in adjacent vertebrae. In addition, when PMMA was used in vertebroplasty ot kyphoplasty surgeries to treat VCFs, PMMA’s exothermic reaction could cause nerve and sof tissue damage. Most surgeons who used PMMA in vertebroplasty or kyphoplasty surgeries to treat VCFs mixed the PMMA with a contrast agent such as barium sulfate, a process known as “back-table mixing,” PMMA was typically used in a runner, less viscous state for vertebroplasties and a more viscous state for kyphoplasties. 33. Because PMMA had drawbacks when used in vertebroplasty and kyphoplasty surgeries to treat VCFs, medical device manufacturers began exploring altemative bone cements, such as those made from calcium phosphate, Calcium phosphate bone cements (which were sometimes distinguished from acrylic PMMA by being referred to es bone void fillers or bone salts) were much less hard than PMMA they were not exothermic; and over time, under ideal conditions, they would be replaced by new bone growth. 34. Prior to April 2004, during the relevant period here, no bone cement (acrylic or calcium phosphate) was cleared or approved by the FDA for use in treatment of VCFs in vvertebroplasty and kyphoplasty surgeries. On or about April 1, 2004, for the firs time, the FDA cleared an acrylic bone cement for use in kyphoplasty surgeries to treat VCFs.Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 11 of 50 Synthes Develops Norian XR to Treat VCFs 35, Synthes, a medical device manufacturer that had an established market presence in trauma products (that is, products to treat traumatically injured bone), had traditionally ‘manufactured metal medical devices that are properly characterized as “hardware,” including products such as plates, rods, nails and screws. Prior to approximately June 1999, Synthes lacked a market presence in osteobiologie products, In or about June 1999, however, Synthes purchased defendant NORIAN CORPORATION, a manufacturer of bone cements based in Cupertino, California, NORIAN had developed two products, Norian SRS (Skeletal Repair System) and Norian CRS (Cranial Repair System), which were identically formulated calcium phosphate bone cements. 36. Inor about the spring of 2000, Synthes Spine Division (“Synthes Spine”) ‘employees in Product Development (“PD”) interviewed orthopedic spine surgeons, neuroradiologists, and neurosurgeons who used PMMA off-label in performing vertebroplasty and kyphoplasty surgeries to treat VCFs, inquiring as to whether they had used SRS in such surgeries, how SRS had performed in this indication, ways to improve the use of SRS in such surgeries, and — for the many interviewees who had used only PMMA — how often they might ‘use SRS in such surgeries, among other questions. The purpose of these interviews was to create a market for the use in vertebroplasty and kyphoplasty surgeries to treat VCFs of a version of Norian SRS with radiopaque barium sulfate (“Norian SRS-R”), Norian SRS-R was the device in development atthe time that defendant NORIAN and Synthes, Michael D. Huggins, Thomas B. Higgins, and Richard E, Bohner eventually brought to market as Norian XR. 37. nor about June 2000, at the direction of Thomas B. Higgins, two Synthes Spine ‘employees summarized the results of Synthes Spine’s interviews of orthopedic spine surgeons, neuroradiologists and neurosurgeons in a Vertebroplasty Market Investigation Executive ‘Summary (the “Vertebroplasty Summary”), that was distributed to management of Synthes. The Vertebroplasty Summary noted that the most common indication for vertebroplasty was uCase 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 12 of 50 “overwhelmingly osteoporotic compression fractures” and, further, that the ideal material for vertebroplasty would be more radiopaque than PMMA. The Vertebroplasty Summary concluded that the use of vertebroplasty was on the rise; that the technique had tremendous potential as it filled a void in the treatment of VCFs; and that there were currently over half a million VCFs per year in the United States. The Vertebroplasty Summary stated that, among surgeons, there was “excitement about using Norian for vertebroplasties,” and concluded that for Synthes the market potential was considerable, 38, In or about late summer 2000, based on the surgeon interviews, research of literature, and conversations with spine surgeons performing vertebroplasties and kyphoplasties to treat VCFs, Synthes began development of the Synthes Vertebroplasty System for treating VCRs. ‘The Synthes Vertebroplasty System consisted of SRS-R and a group of Class I instruments for approaching an osteoporotic vertebral body and injecting SRS-R in percutaneous surgeries, The instruments were called the Cavity Creation System. 39, Onorabout August 23, 2000, a regulatory employee of Synthes sent an email to ‘Thomas B. Higgins and Richard E, Bohner, among others, stating that “[a}s everyone is well aware, I hope, we do not have a spine indication for Norian SRS at this time.” The email continued that another employee “recently reviewed a vertebroplasty ‘Test Market” forecast for Notian SRS and equipment sent from the spine PD. . . Regulatory is unaware that this is even being considered. We cannot promote the use of SRS for unapproved indications, and this is especially true for use in the spine, where FDA has previously made it clear to Norian that any intra-spinal use would require additional approval. . . We are aware that the spine PD group has been considering developing a delivery system which could be used for vertebroplasty with any substance and which would therefore only be able to be used or promoted for use with autograft or allograft at this time, Such instruments would be Class I- Exempt. However, any suggestion on our part that the instrument could be used with SRS would be considered promotion of an unapproved use of SRS.” 12Case 2:09-c'-00403-LDD Document 114 Filed 10/22/10 Page 13 of 50 40. In or about fall 2000, agents of Synthes, including Thomas B. Higgins, held several meetings with representatives of a company that marketed a bone tamp (“Company A”), +o discuss the possibility of Synthes collaborating with Company A by marketing a calcium phosphate bone cement to be used with Company A’s bone tamp and balloon system in kyphoplasty surgeries. 41. Onor about October 25, 2000, Company A received a Warning Letter from the FDA, directing Company A to cease marketing its bone tamp and balloon system for use in kyphoplasty surgeries, as those devices were not cleared for a vertebroplasty indication. 42. Onor about December 4, 2000, a regulatory employee of Synthes sent an email to ‘Thomas B. Higgins, among others, attaching the FDA’s Warning Letter to Company A, and informing Higgins that “this Warning Letter emphasizes FDA's concerns about claims for general orthopedic device[s) for use in the spine[.]” 43. In or about March 2001, agents of Synthes, including Michael D. Huggins and “Thomas B. Higgins, leamed of two adverse events that had occurred when a spine surgeon known to the United States Attorney (Doctor No. 1) had used Norian CRS off-label in two percutaneous kyphoplasty surgeries to treat VCFs in two patients, and further that each time, the Norian CRS had been carried to the operating room by a Synthes sales representative, who had been present in the operating room during the surgeries. 44, In or about March 2001, a Synthes Spine employee telephoned Doctor No. | to learn details of the two adverse events, This employee learned that during the first surgery, the patient experienced a severe drop in blood pressure, after which the patient took about 20 ‘minutes to stabilize, and which resulted in the patient’s spending three or four days in the hospital’s intensive care unit. During that telephone call, this employee learned that during the second surgery, the patient also experienced a severe drop in blood pressure (also known as “hypotensive episode”) but did not require admission to the intensive care unit. This employeeCase 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 14 of 50 also learned during the telephone call that before the two hypotensive events with Norian CRS, Doctor No. 1 had performed 40 to 50 kyphoplasties, all with PMMA. 45. Onor about April 2, 2001, because of the two hypotensive episodes suffered by the patients of Doctor No. 1, Thomas B. Higgins invited surgeons with an interest in using Norian SRS-R in the spine to treat VCFs to meet with employees of Synthes and defendant NORIAN in Cupertino, California (the “Norian Spine Focus Group”). The Norian Spine Focus Group met with Higgins and other employees of Synthes and defendant NORIAN, so that Doctor No. 1 could present information about his two patients’ hypotensive episodes, and the assembled surgeons could give Synthes and defendant NORIAN and their agents their views on the possible causes of the hypotensive episodes, At that meeting, Doctor No. | presented information about the two hypotensive events, and a discussion followed among the surgeons concerning the possible causes of the hypotensive events, One of the surgeon participants, a prominent spine trauma surgeon known to the United States Attomey (Doctor No. 2), reported that the Norian cement in its pre-hardened state might be interacting with blood and causing problems. At the Norian Spine Focus Group meeting, Doctor No. 2 reported that he believed it was critical that there be a study of the pre-hardened state of Norian cement before it was used in live patients, ‘because in its pre-hardened state, the cement had the potential to interact with tissues and blood in a way that hardened Norian cement did not. 46. Onorabout April 12, 2001, a regulatory employee acting on behalf of Synthes caused an MDR problem report to be filed with the FDA for each of the two adverse events that hhad occurred when Doctor No. 1 used Norian CRS off-label in the two percutaneous kyphoplasty surgeries to treat VCFs, which was a novel use of a Norian cement in the United States. 47. Onor about October 22, 2001, Synthes, defendant NORIAN and Richard B. Bohner leamed from a Synthes Spine employee known to the United States Attorney that Norian ‘would not be cleared by the FDA for a vertebroplasty indication via a 510(k) pre-marketCase 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 15 of 50 notification, but could only be approved by the FDA for a vertebroplasty indication via pre- market approval (PMA), if supported by clinical trials. 48. In or about November 2001, at an annual Synthes Spine sales meeting, Synthes educated its Spine sales force on the Synthes System of providing Norian SRS-R and Cavity Creation System instruments for vertebroplasty surgeries to treat VCFs. 49, Inor about November 2001, at the annual Synthes Spine sales meeting, Synthes presented Doctor No. 2 to speak to the Spine sales force about vertebroplasty and kyphoplasty surgeries to treat VCFs, Doctor No. 2 discussed the serious complications of vertebroplasty and kyphoplasty surgeries to treat VCFs, including leakage of cement into the venous system, which could cause pulmonary embolism and death. 50. In or about November 2001, officials at Synthes held a Management Review Board (“MRB”) meeting. MRB meetings were quarterly meetings at which projects were presented and discussed, The fall 2001 MRB meeting was attended by Michael D. Huggins and ‘Thomas B. Higgins, as well as a high-ranking executive of Synthes known to the United States Attomey, and other Synthes employees. At the fall 2001 MRB meeting, a Synthes Spine employee presented a proposal for an IDE study, that is, an FDA-sanctioned clinical study to obtain the FDA’s approval of SRS-R in a vertebroplasty indication to treat VCFs; however, it ‘was decided that Synthes would not pursue an IDE study, but would instead “get a few sites to perform 60-80 procedures and help them publish their clinical results.” 51. Inor about November 2001, based on Doctor No. 2's presentation on vertebroplasty and kyphoplasty surgeries at the annual Synthes Spine sales meeting, and the serious nature of the complications that Doctor No. 2 discussed, it was decided that Synthes ‘would not introduce the Cavity Creation System in March 2002; instead, a limited test market ‘would be begun, and “at least 50 patients followed up,” before deciding whether to introduce the Cavity Creation System.Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 16 of 50 52, Inor about November 2001, following the fall 2001 MRB Meeting, a high- ranking Synthes official invited Doctor No. 2 to a meeting to discuss with Doctor No. 2 why he ‘was taking such a cautious approach to vertebroplasty, which at that time was growing in popularity among spine surgeons. Doctor No. 2 explained that because hundreds of thousands of ‘older persons had VCFs every year, vertebroplasty could change the standard of care and needed to be investigated. Doctor No. 2 explained that, in his view, clinical studies - which would be ‘expensive and time-consuming — were needed. When the Synthes official responded that Synthes had performed clinical studies on other devices in the past, and they had not worked, Doctor No. 2 reiterated that clinical studies, in which the investigators were independent of the party providing the investment, were essential. $3. Onor about December 20, 2001, pursuant to Synthes's application, the FDA cleared Norian SRS as a general bone void filler via a 510(k) pre-market notification, with a label stating that SRS was intended to fill only bony voids that were “not intrinsic to the stability of the bony structure,” in the extremities, spine and pelvis, and further waming that SRS was not to be mixed with any other substance.' 54, Onor about May 8, 2002, Synthes and defendant NORIAN, through their agents, known to the United States Attorney, participated in a telephone conference call with representatives of the FDA conceming Norian XR. During the conference call, the FDA representatives stated that they were concemed over the imprecision of the spine indication in the 1 The Norian cement to which barium sulphate was added to form Norian XR and that makes up Norian SRS and Norian CRS is not identical to any other calcium ‘based bone cement on the market, Rather, itis a unique formulation that was developed at NORIAN in the 1990s after hundreds of different formulations were tried there and rejected. The final formulation, with its limited strength characteristics, was optimized forthe filling of voids in non-spinal metaphyseal bone, which is located in long bones such as the tibia and femur. Notian’s unique powder blend includes calcium-based components that ~at the time of use ~ are tixed with a sodium phosphate solution, PMMA, on the other hand, does not contain calcium. jvian XR cant bese in wadtional, Nah pressure vertebroplasty procedures because i too thick, and high pressure can cause its quid and suspended particle component 0 separate/dewater, When PMMA jis used in vertebral surgeries in which a cavity is created, such as the surgeries in which Novin XR was used is typically used in a more viscous state than the runny PMMA that is used in traditional vertebroplasty surgeries. 16Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 17 of 50 current indication for use of bone void fillers, and that they understood that surgeons, as a part of their practice of medicine, were using bone void fillers in the spine for load-bearing indications. The FDA asked that Synthes and defendant NORIAN provide additional labeling for Norian XR that specified that spinal load-bearing indications, such as vertebroplasty, were not included in the current indication for use, Synthes and NORIAN, through their agent, promised the FDA that they would not promote Norian XR for vertebroplasty or other load-bearing indications without the appropriate regulatory authority, Synthes and NORIAN, through their agent, added thal they believed that such labeling would create an uneven playing field, as no other manufacturers of bone void fillers had such labeling. The FDA continued to insist on such labeling. 55, Ino about late June 2002, Doctor No, 2 and his colleague, another prominent surgeon known to the United States Attomey (Doctor No. 3), informed Synthes, defendant NORIAN and Thomas B. Higgins, among others, that they had performed pilot studies a the University of Washington with Norian SRS which showed that even small amounts of SRS could generate formation of large volumes of blood clot if SRS escaped from bone into the venous circulation (the “University of Washington studies” or the “pilot studies”). The pilot studies on Jnuman blood in test tubes showed that the calcium contained in the unique formulation of Norian SRS had a unique interaction with blood, providing both a surface on which clot formed and a chemical stimulus to clot formation. The pilot studies further showed dramatic clotting of pig's lung veins — consistent with the human blood tests -- following injection of a small amount of SRS? 56. Onor about June 28, 2002, Doctor No. 2 and Doctor No. 3 reported some of their findings from their pilot studies with Norian SRS to the FDA on an MDR problem report form, 2 __Bycontrast, any risk of embolus that PMMA may pose comes not from how its components interact with blood ~ PMMA is not known to cause or accelerate blood clots ~ but from liquid PMMA escaping into the venous system and only then hardening (polymerizing) a bolus that can obstruct blood flow. Any such risk is even less when PMMA is injected in a ‘more polymerized state, as in kyphoplasty procedures, WWCase 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 18 of SO 57. — On or about October 31, 2002, the FDA issued a Public Health Web Notification (“the Web Notification”) to inform the public about complications that had been reported related to vertebroplasty and kyphoplasty surgeries to treat VCFs, The Web Notification advised that the reported complications were related to the leakage of PMMA during surgeries to treat VCFs, and that those reported complications included pulmonary embolism, respiratory and cardiac failure, and death, ‘The Web Notification stated that PMMA had not been specifically evaluated for the treatment of VCFs, and that there had been “no prospective, randomized, controlled trials to characterize the long-term safety or effectiveness” of either type of surgery to treat VCFs. The ‘Web Notification added that doctors usually modified PMMA to use it in treating VCFs by increasing the amount of contrast agent and changing its handling properties, and that there were “no standardized formulations, biomechanical standards or safety guidelines for the types or amounts of opacifying additives used.” 58, _ Inor about November 2002, Synthes was informed of the October 31, 2002 FDA Web Notification. 59, Onor about November 6, 2002, a Synthes employee known to the United States ‘Attorney sent an email to an employee of Synthes who worked in the Spine Regulatory group concerning Norian XR, which email reiterated that, during the May 8, 2002 conference call with the FDA, Synthes and defendant NORIAN had promised the FDA that “the material would not ‘be marketed for spinal indications such as vertebroplasty.” 60. In or about December 2002, Synthes Spine employees known to the United States Attomey met with and informed the product manager for Norian XR, that Synthes could not rain surgeons to use Norian XR to treat VCFs, as it would be illegal because such training would constitute “off-label” promotion of Notian XR and unethical because the risks of Norian XR accelerating blood clot formation should it leak from the vertebral bodies into the venous system —as shown by the pilot studies — needed to be studied more closely before Norian XR was used to treat VCFs.Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 19 of 50 61. Onorabout December 16, 2002, a Synthes regulatory employee sent an email to a number of Synthes Spine employees knowin to the United States Attorney, concerning Synthes's Norian XR Special 510(k) pre-market notification, which Synthes had submitted on November 18, 2002 without any labeling specifying that spinal load-bearing indications, such as -vertebroplasty, were not included in Norian XR’s indication for use, The email stated that “FDA is having a meeting today with regards to labeling. They are sill pushing for specific wording with regards to no vertebroplasty and non load bearing only and will get back to us in a day or so with comments from the meeting.” 62. Onorabout December 18, 2002, a Synthes regulatory employee gave to various ‘Synthes Spine employees an internal Synthes Regulatory Sign-Off sheet conceming Norian XR Calcium Phosphate Bone Cement, which stated “pllease sign below to indicate acceptance of ‘the attached changes to page 25 of the 510k — addition of wording to the ‘Waring section of the product insert.” The Regulatory ‘Sign-Off sheet was attached to page 25 of the Norian XR Special 510(k) submission. The ‘Synthes Spine employees signed the Regulatory ‘Sign-Off sheet. to indicate their acceptance of the addition of the warning language “not intended for treatment of vertebral compression fractures” on behalf of Synthes, while the Synthes regulatory employee signed the Regulatory Sign-Off sheet as the person responsible for the Norian XR Special 510(k) pre-market notification, 63. Onorabout December 19, 2002, pursuant to Synthes's Special 510(K) pre-market notification, the FDA cleared Norian XR asa general bone void filler, with a label stating that XR was intended to fill only bony voids that were “not intrinsic to the stability. of the bony structure” inthe extremities, spine and pelvis, and further warning that XR. was “not intended for treatment of vertebral compression fractures.” 64, Onor about January 13, 2003, when a spine surgeon known to the United States Attorney (Doctor No. 4) used SRS that had been back-table mixed with barium sulfate in a surgery using the Cavity Creation instruments to treat VCFs, the patient became immediately 19Case 2:09-c1-00403-LDD Document 114 Filed 10/22/10 Page 20 of 50 hypotensive and died on the operating table (‘the first death”), Doctor No, 4 could not rule out the back-table mixed Norian SRS as a cause of the first death, A Synthes Spine sales representative was present in the operating room during the surgery that resulted in the first death, : 65. Onoor about January 28, 2003, Richard E, Bohner sent an email to Thomas B. Higgins, with a copy to Michael D. Huggins, urging that management send an email to the Spine sales force, notifying them that Norian XR should not be promoted for off-label uses. In his email, Bohner argued that Higgins, as President of the Spine Division, should send the proposed email about off-label promotion to the Spine sales force. In his email outlining the proposed communication to the Spine sales force, Bohner gave an example to clarify what off-label uses were forbidden: “{flor exemple, the FDA has required us to include the following warning in the product insert: ‘not intended for treatment of vertebral compression fractures."” After Bohner sent his email to Higgins and Huggins, however, no communication that included both the ‘warning label for Norian XR and an admonition that Norian XR should not be promoted for off- label use was sent to the Spine sales force. 66. Onor about February 25, 2003, a Synthes regulatory employee sent an email to the FDA, asking the FDA representative who had handled the clearance of Norian XR whether, “as long as we clearly inform surgeons that Norian XR must be used with supplemental fixation (ie, pedicle screws), we can indicate it [XR] for compression fractures in the spine?” 67. Onor about February 26, 2003, the FDA representative answered that Synthes could not do so, stating “[ulse in treating compression fractures of the spine is not a cleared use for any of the bone void fillers (MQV product code). This indication is considered a new intended use and requires a PMA and clinical data, Even with proper fixation, the bone void filler in this situation (vertebral compression fractures) would not be used in a way that is ‘non- intrinsic to the stability of the bony structure," which is what the indication for the MQV bone void fillers require.” 20Case 2:09-ct-00403-LDD Document 114 Filed 10/22/10 Page 21 of 50 68. Onorabout February 28, 2003, the Synthes regulatory employee forwarded to several Synthes Spine employees the February 25, 2003 email thatthe regulatory employee had sent to the FDA, along with the email in response from the FDA. 69. Onor about April 4, 2003, Michael D. Huggins forwarded an updated version of the FDA's October 31, 2002 Web Notification - concerning complications that had been reported concerning the leakage of PMMA during vertebroplasty and kyphoplasty surgeries to treat VCFs ~ to Thomas B. Higgins and Richard E, Bohner, as well as other Synthes employees. 70. Onor about September 19, 2003, when a spine surgeon known to the United States Attorney (Doctor No. 5) used Norian XR in a surgery using Cavity Creation instruments to treat VCFs, the patient died on the operating table after suffering a hypotensive episode (“the second death”). Doctor No. 5 noted a cement Jeak, and believed that it was the cause of the episode, and could not rule out Norian XR as a cause of the second death. A Synthes Spine sales representative was present in the operating room duting the surgery thet resulted in the second death, 71, Onorabout September 26, 2003, Synthes Spine employees met with a spine surgeon known to the United States Attorney (Doctor No. 6), who told them that he believed that Norian XR was “potentially dewatering and causing episodes of hypotension.” Doctor No. 6 also stated that, because the Norian XR “test market” was collecting information from surgeons performing vertebroplasty and kyphoplasty surgeries to treat VCFs, he believed that Synthes was required to goto each IRB of each hospital participating in the “test market.” Doctor No. 6 also stated that, in light of Synthes’s “test market” activities, Synthes should go to the FDA immediately to negotiate the removal of the warning on the Norian XR label, “not intended for treatment of vertebral compression fractures,” Doctor No. 6 also stated that, in his view, Synthes had risk management problems and needed more oversight of its clinical and compliance issues. 2Case 2:09-c1-00403-LDD Document 114 Filed 10/22/10 Page 22 of 50 72. — Onorabout October 1, 2003, a Synthes Spine employee sent the minutes of the September 26, 2003 meeting among Doctor No. 6 and the Synthes Spine employees to Thomas B. Higgins and another Synthes employee known to the United States Attomey, among others. 73. Onor about October 1, 2003, a Synthes employee forwarded the minutes of the ‘meeting among Doctor No. 6 and the Synthes Spine employees to Thomas B. Higgins and Richard E, Bohner, stating that he (the Synthes employee) agreed in part with Doctor No. 6's comments about Synthes’s need for better risk management, and asking Bohner to raise this issue ‘with Michael D. Huggins, among others, 74, On or about October 16, 2003, a Synthes Spine employee forwarded to John J. ‘Walsh the February 25, 2003 email that had been sent to the FDA (esking whether Norian XR ‘could be indicated for compression fractures in the spine so Jong as Synthes informed surgeons that Norian XR must be used with supplemental fixation) along with the adverse response that had been received fiom the FDA. 75, Onorabout November 10, 2003, Michael D. Huggins sent an email to Thomas B Higgins, John J. Walsh and others, attaching a press release from a company known to the United ‘States Attorney, which company was a competitor of Synthes, and which was developing a bone void filler for use in the trestment of VCFs (“Company B”). The press release announced that Company B had obtained the FDA’s permission, via an IDE, for Company B to conduct clinical trials ofits bone void filler in vertebroplasty surgeries for the treatment of VCFs. 76. — On or about November 10, 2003, a Synthes Spine employee sent an email to Michael D. Huggins, Thomas B. Higgins, John J. Walsh and Richard E. Bohner, attaching Synthes's initial proposal for obtaining an IDE from the FDA so that Synthes, like Company B, might also.obiain permission to conduct clinica! trials of its bone void filler in vertebroplasty surgeries for the treatment of VCFs (“the IDE proposal”). Synthes never shared the IDE proposal with the FDA. After discussing the Norian XR “test market” and the fact that two 22Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 23 of 50 patient deaths had occurred as part of the “test market,” the IDE proposal discussed competitive activity with other products, stating: Norian XR is the only product that the FDA required to add the [warming bullet) From a competitive standpoint, Noian XR is al a significant disadvantage. All of our competitors are using this bullet asa selling point against Norian XR. Rightly so, many surgeons are listening. ‘The IDE proposal went on to state: Currently, Norian XR is being used off-label to treat VCFs. The FDA has been very conservative regarding the treatment of VCFs and has issued numerous statements, . cautioning companies, . that the use of any material in vertebroplaty ty is off-label. The present state of the approved indication of Norian XR and the FDA bulletin puts Synthes in a compromising position, Synthesis aan increased legal Hk with rand to product liability and medical malpractice, . .We recommend that ‘Syathes pursue an IDE for the usage of Norian XR in treating VCFs... 77. Onorabout January 22, 2004, when a spine surgeon known to the United States ‘Attomey (Doctor No. 7) used Norian XR in a kyphoplasty surgery to treat VCFs, the patient died on the operating table (“the third death”), A hypotensive event occurred, leading to pulmonary embolism; Doctor No. 7 could not rule out Norian XR as a cause of the third death. A Synthes Spine sales representative was present in the operating room during the surgery that resulted in the third death, 78, Fromon or about May 11 to on or about June 18, 2004, an investigator for the FDA conducted an unannounced on-site inspection of defendant NORIAN at the Development Center, 1230 Wilson Drive, West Chester, PA (“the FDA inspection” or “the inspection”). The FDA inspection focused on Norian XR. 79. Onor about June 18, 2004, at the close of the FDA inspection, the investigator for the FDA issued to defendant NORIAN the FDA’s observations concerning the inspection (the “483 observations"). Among other things, the FDA observed that Synthes and defendant NORIAN: a, did not submit an IDE epplication to the FDA prior to initiating the Norian XR “test matket,” whose objectives included evaluating the efficacy of using Norian XR and 23Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 24 of 50 obtaining safety data based on patient complication rates as reported to Synthes by surgeons petforming vertebroplasty or kyphoplasty procedures to treat fractures of the vertebrae; and b. shipped Norian XR in interstate commerce for the purpose of use in vertebroplasty or kyphoplasty procedures to treat fractures of the vertebrae, an indication for which Norian XR bad not been cleared or approved by the FDA. THE CONSPIRACY 80, From in or about May 2002 through at least fall 2004, in the Eastern District of Pennsylvania and elsewhere, defendant NORIAN CORPORATION, together with others known and unknown to the grand jury, agreed, combined, and conspired to: a. defraud the United States and its agencies by impeding, impairing, and defeating the lawful functions of the FDA to protect the health and safety of the public by ‘ensuring that medical devices marketed and distributed in the United States were safe and cffective for their intended uses, thatthe labeling of such devices bore true and accurate information, and that clinical investigation of significant risk devices on humans was oversesn by the FDA; and b. commit an offense against the United States with the intent to defraud or mislead, by introducing into interstate commerce an adulterated and misbranded medical device, Notian XR, for the intended use of treating VCFs through vertebroplasty and kyphoplasty procedures, when Norian XR had not received either pre-market approval or pre-market clearance for that intended use, and when the label of Norian XR bore a warning that the device was “not intended for treatment of vertebral compression fractures,” in violation of Title 21, United States Code, Sections 331(a) and 333(a)(2); and commit an offense against the United States by knowingly and willfully making materially false, fictitious, and fraudulent statements, and representations and falsifying 24Case 2:09-c1-00403-LDD Document 114 Filed 10/22/10 Page 25 of 50 and concealing material facts in a matter within the jurisdiction of the Food and Drug Administration (“FDA”), an agency of the executive branch of the United States, in violation of Title 18, United States Code, Section 1001. MANNER AND MEANS Tt was part of the conspiracy that: 81, Defendant NORIAN, Synthes, Michael D, Huggins and Thomas B. Higgins developed Norian XR for the treatment of VCFs by adding borium sulfate to Norian SRS. 82, Despite the SRS label, which as cleared by the FDA in December 2001 stated that ‘SRS was intended to fill only bony voids that were “not intrinsic to the stability of the bony structure,” and further warmed that SRS was not to be mixed with any other substance, defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins and Richard E, Bohner approved, organized and sponsored an illegal vertebroplasty “test market” for SRS, that is, a “test market” for the use on live persons of SRS back-table mixed with barium sulfate to treat VCFs. 83. Despite the Norian XR label, which as cleared by the FDA in December 2002 stated that Norian XR was intended to fill only bony voids that were “not intrinsic to the stability of the bony structure,” and further warned that Norian XR was “not intended for treatment of vertebral compression fractures,” defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh approved, organized, sponsored and attended surgeon forums at which spine surgeons were tought how to use Norian XR to treat VCFs. 84, Defendant NORIAN, Synthes, Michael D, Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh conducted an unauthorized clinical trial of Norian XR for the treatment of VCFs through an illegal “test market” in which defendant NORIAN and others sold Norian XR to spine surgeons for the intended use of treating VCFs, and gathered safety and efficacy information from those surgeons concerning their use of Norian XR in vertebroplasty 25Case 2:09-c'-00403-LDD Document 114 Filed 10/22/10 Page 26 of 50 and kyphoplasty surgeries to treat VCFs, in order to assess the complications rate of XR and determine whether, in the defendant's view, it was too high. 85, Defendant NORIAN, Synthes, Michael D, Huggins, Thomes B. Higgins, Richard , Bohner and John J. Walsh concealed from spine surgeons and from Synthes’s own Spine sales force the waming bullet on the Norian XR label, “not intended for treatment of vertebral compression fractures.” 86. Defendant NORIAN, Synthes, Michael D. Huggins, Thomas B, Higgins, Richard E, Bohner and John J. Walsh concealed from spine surgeons and from Synthes’s own Spine sales force the pilot study test results indicating that a small amount of uncured Norian SRS and/or Norian XR could accelerate blood clot formation if it escaped from bone into the venous circulation. 87. Defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins and Richard E, Bohner, without having medical professionals review the first death, failed and refused to file an MDR problem report conceming the first death, in order to conceal the first death from the FDA, from spine surgeons and from Synthes’s own Spine sales force. 88, Defendant NORIAN, Synthes, Michael D, Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh introduced into interstate commerce an adulterated and misbranded medical deviee, Norian XR, for the intended use of treating VCFs through vertebroplasty and kyphoplasty procedures. 89, Defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins, Richard E, Bohner and John J. Walsh, without having medical professionals review the second or third deaths, caused to be filed MDR problem reports with the FDA concerning the second and third deaths, which reports were brief, vague and did not mention the terms “vertebroplasty,” “gyphoplasty,” or “vertebral compression fracture” in order to conceal from the FDA and spine surgeons the fact that the second and third deaths had occurred during surgeries to treat VCFs, in which cement leakage had been noted. 26Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 27 of 50 90. After the third death, defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins, Richard B. Bohner and John J. Walsh failed and refused to recall and remove Norien XR from the market and failed and refused to notify the FDA that Norian XR might pose a significant risk to human safety, but instead unrestricted the inventory of Norian XR so that ‘Norian XR could be purchased by any surgeon or hospital. 91. After the third death, having trained approximately fifty carefully selected spine surgeons how to use Norian XR to treat VCFs, and having unrestricted the inventory of Norian XR so that it could be purchased by any surgeon or hospital, defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins, Richard E, Bohner and John J. Walsh informed the Spine sales force that Norian XR was not the subject ofa recall and was not being pulled from the market, all of which led to several additional off-label surgeries to treat VCFs in March and April 2004. 92. Inorder to lull the FDA, to impair and impede its lawful functions, including its function of overseeing device manufacturers, and to avoid FDA scrutiny into the three deaths that had occurred during the illegal “test market,” during May and June 2004 defendant NORIAN, Synthes, Michael D. Huggins, Richard BE. Bohner and John J. Walsh knowingly made a series of false statements to an investigator for the FDA, in which they concealed their knowledge that Norian XR and its predecessor device, Norian SRS, had each been marketed, promoted and tested on human subjects without FDA oversight for the treatment of VCFs, an intended use that had been neither cleared nor approved by the FDA. 93. Inorder further to lull the FDA, to impair and impede its lawful functions, including its function of overseeing device manufacturers, and to avoid FDA scrutiny into the three deaths that hed occurred during the illegal “test market,” during July 2004 defendant NORIAN, Synthes, Micheel D. Huggins, Richard B. Bohner and John J. Walsh knowingly made series of false statements to the FDA in response to the FDA’s observations concerning the inspection the FDA conducted in May and June 2004. 27Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 28 of 50 COVERT ACTS In furtherance of the conspiracy, defendant NORIAN, Synthes, Michael D. Huggins, ‘Thomas B. Higgins, John J. Walsh and others known and unknown to the grand jury, committed the following overt acts in the Eastern District of Pennsylvania and elsewhere: 1. Onvarious dates from in and about summer 2002 through fall 2002, Michael D. Huggins, Thomas B. Higgins and Richard B. Bohner conducted an illegal “test market” for use of ‘SRS and the Cavity Creation System to treat VCFs, by: a. directing employees of Synthes who are known and unknown to the United States Attomey to create a recipe for mixing SRS with barium sulfate to make it more radiopaque, a procedure commonly known as “back-table mixing;" b. distributing the recipe for back-table mixing of SRS and barium sulfate to spine surgeons for their use in vertebroplasty and kyphoplasty surgeries to treat VCFs; © training spine surgeons how to use SRS that hed been back-table mixed with barium sulfate in vertebroplasty and kyphoplasty surgeries to treat VCFs; 4. directing employees of Synthes to attend vertebroplasty and kyphoplasty surgeries in which SRS mixed with barium sulfate was used to treat VCFs; and ¢. gathering safety and efficacy information from spine surgeons who were ‘using SRS mixed with barium sulfate in vertebroplesty and kyphoplasty surgeries to treat VCFs. 2. Onor about September 17, 2002, at a Spine MRB meeting, a Synthes Spine employee made a presentation to Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner, ‘and others to update them on (a) the Norian XR project; (b) the “Test Market that began in September 2002” involving use of Norian SRS in the spine; and (c) “several additional studies to bbe completed by [the University of Washington] Harborview in Seattle.” 3. Onor about November 18, 2002, defendant NORIAN and Synthes caused a ‘Synthes regulatory employee to submit to the FDA the $10(k) submission for Norian XR without the language requested by the FDA in the May 8, 2002 meeting, that is, without any labeling 28Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 29 of 50 specifying that spinal load-bearing indications, such as vertebroplasty, were not included in Norian XR’s indication for use. 4. Onorabout January 16, 2003, Michael D, Huggins, Richard E, Bohner and ‘Thomas B. Higgins held a meeting with Synthes Spine employees known and unknown to the United States Attomey to approve a market introduction plan for Norian XR (“the Norian XR MIP") that described a supposed market for the use of Norian XR in the iliac crest, which is a part of the hip, when, in fact, no such market existed or plan was intended, 5. Onorabout January 16, 2003, at the Norian XR MIP meeting, after a report was made to the meeting participants about the January 13, 2003 death of Doctor No. 4s patient uring a surgery using the Cavity Creation instruments to treat VCFs (hereafter the “first death”), Michael D. Huggins, Thomas B. Higgins and Richard B, Bohner postponed approval of the ‘Norian XR MIP and directed that Doctor No, 4 be contacted to find out more information ‘concerning the first death, 6 Onorabout February 10, 2003, Michael D, Huggins, Thomas B, Higgins and Richard E, Bohner reconvened the Norian XR MIP meeting with Synthes Spine employees and others known and unknown to the United States Attorney, and approved the Norian XR MIP described in the preceding two paragraphs. 7. Inor about late April 2003, at a meeting of Synthes's board of directors, Michael D. Huggins approached a trauma surgeon who was also a member of Synthes’s board of directors and who is known to the United States Attorney (Doctor No. 8), told Doctor No. 8 about the first death, and about the two adverse hypotensive events that had occurred with Doctor No.1's patients, and obtained Doctor No. 8's agreement to participate in an upcoming “Safety Meeting” ‘concerning whether or not Norian XR was safe enough to bring to market. 8. Onorabout July 18, 2003, after having previously received written materials concerning the pilot studies, the two adverse hypotensive events that had occurred with Doctor No. 1's patients, and details regarding the first death, Michael D. Huggins, Thomes B. Higgins 29Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 30 of 50 and Richard E. Bohner held a “Safety Meeting” with Synthes Spine employees and others known to the United States Attomey, including Doctor No. 8 (who participated by teleconference), for the declared purpose of determining whether Norian XR was safe enough to bring to market. 9. Onorabout July 18, 2003, at the Safety Meeting, after hearing a presentation on the pilot studies, the two adverse hypotensive events that had occurred with Doctor No.1's patients, and the first death, Michael D. Huggins, Thomas B. Higgins and Richard B. Bohner decided to continue the illegal Norian XR “test market” that had begun in the summer of 2002 with SRS-R, in order to assess whether the level of risk from using Norian XR to treat VCFs was acceptable or, instead, too high. 10. Onorabout August 14, 2003, Michael D. Huggins and Thomas B. Higgins held a strategic planning meeting attended by Doctor No. 3 and other doctors, both known and unknown to the United States Attomey (the “Strategic Planning Meeting”). 11. Onorabout August 14, 2003, at the Strategic Planning Meeting, Michael D. Huggins noted that Synthes had a “poor record of PMA approvals,” and Huggins and Thomes B. Higgins direoted thatthe illegal Norian XR “test market” would continue, despite a presentation made at the meeting on vertebroplasty and Norian XR and a recommendation by Doctor No. 3 that an FDA study of Norian XR be conducted to gein approval for vertebroplasty. 12. Onorabout August 15 and 16, 2003, Michael D. Huggins, Thomas B. Higgins, and Richard B. Bohner held the first surgeon training meeting of the illegal Norian XR “test market” in San Diego, California (the “San Diego surgeon training"), which included Synthes Spine sales representatives along with spine surgeons who were selected by Synthes based on their experience in performing vertebroplasty, and whose expenses to travel to and attend the training were paid for by Synthes. 13, Onorabout August 15 and 16, 2003, at the San Diego surgeon training organized by Michael D. Huggins, Thomas B. Higgins and Richard B. Bohner, lectures and powerpoint presentations were given to the attendees concerning the use of Norian XR in vertebroplasty to 30Case 2:09-c1-00403-LDD Document 114 Filed 10/22/10 Page 31 of 50 treat VCFs, and a cadaver lab was held during which the surgeons injected Norian XR into the vertebral bodies of cadavers. 14. Onor about August 15 and 16, 2003, at the San Diego surgeon training, Synthes Spine employees distributed notebooks to the attending spine surgeons and sales representatives which thanked them for participating in the Norian XR “test market.” The notebooks included forms? to be used in reordering Norian XR (“test market reorder forms” or “TM forms”), and contained instructions to the sales representatives that they could not reorder Norian XR unless they filled out the “test market” reorder forms with information about each surgery performed with Norian XR, 15. On or about September 16, 2003, Thomas B. Higgins invited a spine surgeon known to the United States Attomey (Doctor No. 9) to give a lecture to the Spine sales force at the Spine Annual Meeting, November 22-24, 2003, concerning the use of Norian XR in vertebroplasty to treat VCFS. 16. Onorabout September 19 and 20, 2003, Michael D. Huggins, Thomas B. Higgins and Richard B, Bohner held the second surgeon training meeting of the illegal Norian XR “test market” in Charlotte, North Carolina (the “Charlotte surgeon training”), attended by Higgins, which followed a format identical in substance to the San Diego surgeon training, and which again included spine surgeons selected by Synthes based on their experience in performing vertebroplasty, and whose expenses to travel to and attend the training were paid for by Synthes. 17, Onorabout September 23, 2003, defendant NORIAN and Synthes, through its agents, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, held a meeting to discuss the second death, the death of Doctor No. 5's patient, which had occurred on 3 ‘The information that Synthes requested in the “test market” reorder forms included whether the patient had a previous VCF; whether the bone was osteoporotic; the number of levels treated (referring to levels ofthe vertebrae); the age of the fracture; the percentage of compression; and whether postural reduction Was attempted. 31Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 32 of 50 September 19, 2003, with others known and unknown to the United States Attorney (the “second. death meeting”). 18. Onor about September 23, 2003, at the second death meeting, after a discussion among the participants recognizing that Doctor No. 5 had “noted a cement leak during injection and feels this was the cause of the incident,” and that, according to Doctor No. 5, “the sales consultant ‘pushed’ this product on him and was unclear as to its status on the market,” Michael 1D. Huggins, Thomas B. Higgins, Richard B. Bohner and John J. Walsh directed that a Synthes Spine employee contact spine surgeons to obtain their views on the possible causes of the second. death; review complications of surgeries associated with the elderly patient population; and research how many MDR problem reports had been filed conceming PMMA, vertebroplasty and kyphoplasty. 19, Onor about October 15, 2003, the Synthes Spine employee reported back to Michael D, Huggins, Thomas B. Higgins, Richard E, Bohner and John J. Walsh that: a, the spine surgeons had been contacted to obtain their views on the possible causes of the second death, and while “one surgeon out of 19 has decided not to use Norian XR until more information is available,” “no one is blaming Norian XR” (although these surgeons were not informed about the pilot studies or the previous death); b, __ elderly patients undergoing surgeries had “increased patient morbidity"; and ©. numerous MDR problem reports had been filed regarding PMMA, vertebroplasty and kyphoplasty. 20. _ Onor about October 24, 2003, defendant NORIAN and Synthes, through their agents, held a meeting to plan the upcoming Norian XR surgeon training forums. At the October 24, 2003 meeting, which was attended not only by employees of Synthes but also by Doctor No. 4, Doctor No. 7 and Doctor No. 9, the participants agreed that:Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 33 of 50 a. —_Synthes would “target spine surgeons as the primary attendees,” and spine sales consultants would attend the forums with their surgeons; and b. Doctor No, 4, Doctor No. 7 and Doctor No. 9 would serve as faculty chairmen for the surgeon forums, which would include both lectures and cadaver labs. 21. Onorabout November 22, 2003, Thomas B. Higgins caused a Synthes Spine employee to make a presentation to the Spine sales force at the Spine Annual Meeting, concerning Norian XR, during which the employee stated that Norian XR’s approved indications included the spine but not vertebral compression fractures, but which was misleading in that the employee did not disclose or otherwise state that Norian XR’s label bore the specific warning, “not intended for treatment of vertebral compression fractures.” 22. Onor about November 24, 2003, Thomas B. Higgins caused Doctor No. 9 to ‘speak about vertebroplasty and Norian XR to the Spine sales force, at the Spine Annual Meeting, 23. Onor about December 10, 2003, Richard E. Bohner wrote a memorandum for distribution to Spine sales consultants and managers, stating that Norian XR was intended only for bony voids or defects that were not intrinsic to the stability of the bony structure, and that Norian XR was intended to be placed or injected into bony voids in the extremities, spine and pelvis, and warned against off-label promotion of Norian XR, but which did not disclose or otherwise state the specific warning on Norian XR’ label, “not intended for treatment of ‘vertebral compression fractures.” 24, Onor about December 1, 2003, John J. Walsh approved the Norian XR ‘Technique Guide for release to the Spine sales force, despite the fact that the Technique Guide did not disclose or otherwise state the specific warning on Norian XR’s label, “not intended for ‘treatment of vertebral compression fractures,” and notwithstanding the fact that the Technique Guide contained x-rays of VCFs, some of which were x-rays of the spine (with depiction of injected SRS) of Doetor No. 4’s patient who had died on the operating table when the doctor used SRS that had been back-table mixed with barium sulfate in a surgery to treat VCFS. 33Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 34 of 50 25. On or about December 31, 2003, defendant NORIAN and Synthes released ‘Norian XR for sale beyond the initial “test market.” 26, Onor about January 10 and 11, 2004, Michael D, Huggins, Thomas B. Higgins, and Richard E, Bohner held the first surgeon forum following the illegal Norian XR “test market” in Dallas, Texas (the “Dallas surgeon training”), at which they delegated to Doctor No. 4 the responsibility to inform the surgeons that Norian XR’s label bore the warning, “not intended for treatment of vertebral compression fractures.” 27. Onor about January 22, 2004, Thomas B. Higgins traveled to San Diego, California, in order to attend the upcoming San Diego surgeon forum scheduled for January 23 ‘through 25, 2004, which surgeon forum was cancelled early in ‘the moming of January 23, 2004 after the third death, that is, the death of Doctor No. 7's patient. 28, Onor about February 12, 2004, defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins, Richard E, Bohner and John J, Walsh made the decision not to recall or remove Norian XR from the market, but instead to unrestrict the inventory of Norian XR, in order to continue marketing Norian XR despite their knowledge ofits potentially harmful effects, 29. Onor about February 10, 2004, defendant NORIAN, Synthes, Michael D. Huggins, Thomas B. Higgins, Richard E, Bohner and John J. Walsh sent or caused to be sent “dear surgeon” leters to spine surgeons, admitting that use of Norian XR to treat VCFs was off- label but explaining that such use was off-label because it was “intrinsic to the stability of the bony structure,” and remaining silent about the warning bullet, while falsely suggesting an equivalence between Norian XR and PMMA when there was none, and further omitting to state that: a ‘Synthes had conducted a “test market” in which it had trained surgeons to use Norian XR to treat VCFs; 34Case 2:09-c1-00403-LDD Document 114 Filed 10/22/10 Page 35 of 50 b. the pilot studies showed that the Norian cements appeared to be thrombogenic agents; and c. three patients had died on the operating table when spine surgeons had used Norian XR off-label to treat VCFs. ‘These various statements and omissions were all made in order to: impair and impede the FDA's function of preventing unauthorized clinical trials, such as the unauthorized clinical trial that defendant NORIAN and others were conducting with Norian XR; deceive the FDA concerning defendant NORIAN and others’ off-label promotion of Norian XR and the dangers posed by Norian XR; and deceive the doctors whom defendant NORIAN and others had trained on the off-label use of Norian XR as to the doctors’ liability to their patients from whom the doctors might not have obtained informed consent, 30. Onor about March 24, 2004, defendant NORIAN and Synthes, through their agent, a Synthes regulatory employee known to the United States Attorney, received an autopsy report on the third death (“the autopsy report") and forwarded the autopsy report to John J. Walsh and others known to the United States Attomey.* 31. Onor about May 12, 2004, defendant NORIAN and Synthes, through a Synthes ‘Spine employee, made false and fraudulent statements to an investigator for the FDA, in that the Synthes Spine employee denied that she had ever promoted the usc of Norian XR off-label to treat VCFs. 32, Onor about May 19, 2004, defendant NORIAN and Synthes, through a Synthes regulatory employee known to the United States Attorney, made false and fraudulent statements “The autopsy report stated that the patient had a history of osteoporosis and a vertebral compression facture, for which a kyphoplasty surgery hed been performed, and that at autopsy, foreign material was found in the L2 vertebral body and in microscopic vessels of the lungs. Despite the new information contained in the autopsy report, which had not been tothe FDA in the original MDR problem report, neither Synthes nor defendant NORIAN filed a ‘supplemental MDR problem report on the third death with the FDA or recalled or removed Norian XR from the market before the FDA inspection, 35Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 36 of 50 to an investigator for the FDA by stating that, in August 2003, Synthes did not have a Vertebroplasty System. 33, Onor about May 19, 2004, defendant NORIAN and Synthes, through a Synthes Spine employee, made additional false and fraudulent statements to an investigator for the FDA, in that the employee stated that in August 2003 Synthes did not have a Vertebroplasty System, 34, On or about May 20, 2004, defendant NORIAN and Synthes, through John J. ‘Walsh, made false and fraudulent statements to an investigator for the FDA, in that Walsh caused to be presented to the FDA investigator a memorandum which stated, in part, that “[wJith the ‘exceptions spelled out in the Waming and Contraindications section of the Instructions for Use, the use of Norian XR in association with Vertebroplasty and Kyphoplasty does not constitute ‘off-label’ use. Many uses of Norian XR in association with Vertebroplasty and Kyphoplasty are ‘completely appropriate and ‘on-label,”” 35, Onor about May 27, 2004, defendant NORIAN and Synthes, through a Synthes Spine employee, made false and fraudulent statements to an investigator for the FDA, in that the ‘employee characterized the summer 2002 “test market” for SRS in the spine as surgeons mixing SRS with barium sulfate “on their own.” 36. Onor about June 2, 2004, defendant NORIAN and Synthes, through e Synthes Spine employee, made false and fraudulent statements to an investigator for the FDA, in that the employee told the investigator from the FDA that he did not know the process for mixing Norian SRS with barium sulfate. 37. Onorabout June 7, 2004, defendant NORIAN and Synthes, through Michael D. Huggins, made false and fraudulent statements to an investigator for the FDA, in that Huggins told the investigator that the Norian XR “test market” discussed at the July 18, 2003 Safety ‘Meeting involved approved indications for Norian XR. 36Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 37 of 50 38. On or about June 16, 2004, defendant NORIAN and Synthes, through Richard B. Bohnet, made false and fraudulent statements to an investigator for the FDA, in that Bohner told the investigator that he knew nothing about a vertebroplasty “test market” for SRS, 39. Onorabout June 16, 2004, defendant NORIAN and Synthes, through Richard E. Bohner, made false and fraudulent statements to an investigator for the FDA, in that Bohner told the investigator that the 34 “test market” cases discussed at the July 18, 2003 Safety Meeting involved onty data that Synthes had collected from what surgeons were doing on their own, rather than a test market conducted by Synthes. 40. On or about June 22, 2004, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh met with Synthes employees in order to plan a response to the FDA's 483 observations made after the FDA inspection, resulting in the false claims by defendant ‘NORIAN and Synthes that: a. the Norian XR “test market” was for cleared indications, rather than the treatment of VCFs; b. the “test market” was not designed to obtain safety and efficacy information from surgeons about use of Norian XR to treat VCFs; and ¢. the two “test market” surgeon training meetings and the surgeon forum had not trained surgeons how to use Norian XR to treat VCFs. 41. On or about July 2, 2004, ina writing submitted to the FDA on behalf of __ defendant NORIAN and Synthes, John J. Walsh admitted that an IDE would be required if defendant NORIAN and Synthes were secking to “establish the safety and efficacy of new uses for Norian XR. ..in the treatment of vertebral compression fractures,” but falsely stated thet “at the time of the test market activities,” defendant NORIAN and Synthes “id not ... intend to market [Norian XR] for the treatment of vertebral compression fractures. Additionally, it wes never our intent to suggest, in any way, that the product should be used for such purpose,” and 37Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 38 of 50 ‘that defendant NORIAN and Synthes “did not promote [Norian XR] for the[ } off-label uses” of treating vertebral compression fractures. All in violation of Title 18, United States Code, Section 371. 38Case 2:09-ct-00403-LDD Document 114 Filed 10/22/10 Page 39 of 50 COUNT TWO ‘THE UNITED STATES ATTORNEY FURTHER CHARGES THAT: 1, The allegations of paragraphs one through 93 of Count One are incorporated here, 2. From on or about August 27, 2003, to on or about January 21, 2004, at West Chester, in the Easter District of Pennsylvania and elsewhere, defendant SYNTHES, INC., introduced, and delivered for introduction into interstate commerce, and caused the introduction and delivery of for introduction into interstate commerce, the Norian XR device, which was adulterated and misbranded in the following ways: (a) _ misbranded in that its labeling lacked adequate directions for use and it did not qualify for an exemption to this requirement, 21 U.S.C. § 352(0(1); {b) _ misbranded in that it failed to provide notice as required by 21 U.S.C. § 360(K) (510(k) of the FDCA), 21 U.S.C. § 352(0); and (©) adulterated in that it required pre-market approval to be marketed for its intended use, 21 U.S.C. §351((1)(B); All in violation of Title 21, United States Code, Sections 331(a) and 333(a)). 39Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 40 of 50 COUNTS THREE THROUGH ONE HUNDRED TWELVE ‘THE UNITED STATES ATTORNEY FURTHER CHARGES THAT: © 4, The allegations of paragraphs one through 93 of Count One are incorporated here, 2. Onor about the dates listed below, at West Chester, in the Eastern District of Pennsylvania and elsewhere, defendant NORIAN CORPORATION introduced, and delivered for introduction into interstate commerce, and caused the introduction and delivery of for introduction into interstate commerce, the below-listed device, namely Norian XR, which was adulterated and misbranded in the following ways: (0) __ misbronded in that its labeling lacked adequate directions for use and it did not qualify for an exemption to this requirement, 21 U.S.C. § 352(9(1); (©) __misbranded in that it failed to provide notice as required by 21 U.S.C. § 360(k) (510(k) of the FDCA), 21 U.S.C. § 352(0); and (©) adulterated in that it required pre-market approval to be marketed for its intended use, 21 U.S.C. § 351(Q(1)(B)s as set out in each count below: Count Ship To ‘Shipment Date 3 ‘San Ramon, CA 08/27/2003 4 Canyon, TX 08/27/2003 5 Plano, TX 08/27/2003 6 Owings Mills, MD 08/28/2003 7 Derby, KS 08/28/2003 | 40Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 41 of 50 [ count Ship To ‘Shipment Date 8 Houston, TX 08/28/2003 9 San Diego, CA 08/28/2003 08/28/2003 08/28/2003 12 Agoura Hills 08/28/2003 13 Amarillo, TX 09/02/2003 4 Amarillo, TX 09/03/2003 15 Walnut Creek, CA 09/04/2003 | 16 ‘Walnut Creek, CA 09/04/2003 "7 Plano, TX (09/09/2003, 18 San Ramon, CA 09/15/2003 19 ‘Owings Mills, MD 09/15/2003 20 Canyon, TX 09/15/2003 a[ Derby, KS 09/15/2003 41Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 42 of 50 [come ‘Ship To Shipment Date 2 Houston, TX 09/15/2003 a | Windermere, FL 09/15/2003 4 ace Plano, TX 09/1: iaiatal| 25 ‘San Diego, CA 09/15/2003 Hee Gig Harbor, WA 09/15/2003 27 Agoura Hills 09/15/2003 |e 28 San Ramon, CA 09/16/2003 29 ‘San Ramon, CA 09/16/2003 30 +4 Amarillo, TX 09/16/2003 31 Amarillo, TX 09/16/2003 32 San Diego, CA 09/16/2003 33 Agoura Hills 09/16/2003 34 Seattle, WA 09/16/2003 35 San Ramon, CA 09/17/2003 42Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 43 of 50 Count Ship To ‘Shipment Date ‘| 36 Wilkes-Barre, PA 09/17/2003 37 Houston, TX 09/18/2003, peut 38 San Ramon, CA. 09/24/2003 39 Seaford, NY 09/26/2003. | — 40 San Diego, CA 09/26/2003 [+ San Ramon, CA. 09/29/2003 42 Houston, TX 09/30/2003 4B Gig Harbor, WA 09/30/2003 Hie San Diego, CA 10/01/2003 45 LL Plano, TX 10/03/2003, 46 ‘Owings Mills, MD 10/06/2003 47 Derby, KS 10/07/2003 48 i San Diego, CA 10/07/2003 49 Houston, TX 10/08/2003 3Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 44 of 50 Ship To Shipment Date 50 San Diego, CA. 10/08/2003 51 ‘Canyon, TX 10/09/2003 32 elite Birmingham, AL 10/10/2003 53 Auburn, IN 10/10/2003 54 Mechanicsburg, PA 10/10/2003 55 San Diego, CA 10/13/2003 56 Plano, TX 10/14/2003 37 San Diego, CA 10/15/2003 58 ‘Auburn, IN 10/16/2003 39 Derby, KS 10/20/2003 60 Plano, TX 10/23/2003 61 Houston, TX 10/24/2003 62 Plano, TX 10/28/2003 63 Houston, TX 10/28/2003 44Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 45 of 50 ‘Count Ship To ‘Shipment Date 64 a Seaford, NY 10/30/2003, 65 Plano, TX 10/31/2003, 66 San Diego, CA 10/31/2003, or San Diego, CA 10/31/2003 68 Seaford, NY 11/03/2003 oo ‘Seaford, NY 11/03/2003 70 ‘Auburn, IN 11/03/2003 n ‘Mechanicsburg, PA 11/05/2003, R Gig Harbor, WA name | B ‘Auburn, IN 11/07/2003 4 San Diego, CA 11/07/2003 75 Amarillo, TX 11/11/2003 16 Mechanicsburg, PA 41/12/2003 1 Plano, TX 11/13/2003 48Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 46 of SO Count Ship To Shipment Date B | Birmingham, AL 11/14/2003 ” ‘Auburn, IN 11/17/2003 80 San Diego, CA 11/19/2003 4 81 Houston, TX 11/20/2003 82 ‘Aubum, IN 11/21/2003, 83 Derby, KS 11/24/2003 84 Seaford, NY 12/01/2003, 85 ‘Auburn, IN 12/04/2003 86 Plano, TX 12/11/2003, |— 87 Windermere, FL 12/12/2003, 88 Mechanicsburg, PA 12/15/2003, 89 Mechanicsburg, PA 12/19/2003 90 il Aubum, IN 12/22/2003 a” Mechanicsburg, PA 12/22/2003 | 46Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 47 of 50 Count Ship To Shinment Date 92 Plano, TX 12/23/2003 93 Derby, KS 12/29/2003 94 Auburn, IN 12/29/2003 9S ‘San Ramon, CA. 12/31/2003 6 Owings Milis, MD 12/31/2003 oT Seaford, NY 12/31/2003 8 Birmingham, AL 12/31/2003, fe afane 99 ‘Canyon, TX 12/31/2003 100 Derby, KS. 12/31/2003 101 ‘Houston, TX 12/31/2003 102 Auburn, IN 12/31/2003 103 Windermere, FL 12/31/2003 at Mechanicsburg, PA 12/31/2003 105 Plano, TX. 12/31/2003 47Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 48 of 50 Count Ship To ‘Shipment Date 106 San Diego, CA. 12/31/2003 107 Gig Harbor, WA 12/31/2003 108 ‘Walnut Creek, CA 01/08/2004 — 109 ‘Walnut Creek, CA. 01/14/1004 Plano, TX 01/20/2004 ul Plano, TX 01/20/2004 H2 Walnut Creek, CA 01/21/2004 Allin violation of Title 21, United States Code, Sections 331(a) and 333(a)(1). 48Case 2:09-ct-00403-LDD Document 114 Filed 10/22/10 Page 49 of 50 NOTICE OF FORFEITURE, L Asa result of the violations of Title 21, United States Code, Sections 331 ‘and 333, set forth in Counts Two through One Hundred Twelve of this Information, defendants SYNTHES, INC,, and NORIAN CORPORATION, shall forfeit to the United States of America any property constituting, or derived from, proceeds obtained directly or indirectly as the result of the violations of Title 21, United States Code, Sections 331 and 333, as charged in this Indictment, including, but not limited to, the sum of $469,800. 2. Ifany of the property subject to forfeiture, as a result of any act or omission of the defendants: a, cannot be located upon the exercise of due diligence; b. has been transferred or sold to, or deposited with, a third party; c. has been placed beyond the jurisdiction of the Court; d. has been substantially diminished in value; or €. has been commingled with other property which cannot be divided without difficulty, itis the intent of the United States, pursuant to Title 18, United States Code, Section 982(6), 49Case 2:09-cr-00403-LDD Document 114 Filed 10/22/10 Page 50 of 50 incorporating 21 U.S.C. § 853(p), (o seek forfeiture of any othor property of the defendants up to the value of the property subject to forfeiture, All pursuant to Title 18, United States Code, Section 982(0)(2). CIES Sorol, ZANE DAVID MEMEGER United States Attorney 50