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`NUVASIVE 1019
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00208
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`2nd Edition, 1993
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`Exhibit HVC-7 being a copy of Crock, A Short Practice of
`Spinal Surgery, Springer—Verlag Wein New York, Revised
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`1, Henry Vernon Crock, of 13 Sargood Street, Toorak 3142, Victoria, Australia, retired
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`orthopaedic spine surgeon, say on oath:
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`I have been engaged by NuVasive, Inc. to review and provide comment on a number of
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`publications in the field of spinal surgery. I have been advised that the disclosures and
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`teachings in these publications have been put into issue in a patent lawsuit pending in
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`the United States between NuVasive, Inc. and a subsidiary of Medtronic, Inc., namely,
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`Warsaw Orthopedic, Inc.
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`I have also been engaged to provide comment on certain
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`testimony and contentions arising in connection to this lawsuit.
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`I am being compensated for my time actually spent in working on this matter at my
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`customary rate for consulting matters, and have received no compensation for this
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`declaration from NuVasive, Inc., its representatives, or otherwise beyond that.
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`In
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`addition, I will not receive any added compensation based on the outcome of any
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`proceedings in which my prior work is at issue. Finally, I am not, and never have been,
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`an employee of NuVasive, Inc.
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`I have been provided with a copy of the Federal Court of Australia Practice Note CM7
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`entitled “Expert Witnesses in Proceedings in the Federal Court of Australia” by a
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`representative of NuVasive, Inc. Now shown to me and marked Exhibit HVC-l is a
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`copy of Practice Note CM7. In considering the matters put to me and making this
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`affidavit, I have complied with Practice Note CM7.
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`Experience and Qualifications
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`I have been asked me to provide details of my background and experience, particularly
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`wherein disc material between adjacent vertebral bodies is removed and replaced with
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`one or more fusion—promoting implants for the purpose of forming a bone bridge
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`between the adjacent vertebral bodies to immobilize that spinal segment.
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`I practiced spinal surgery from 1961 until my retirement in 2001.
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`I practiced first at St.
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`Vincent’s Hospital in Melbourne, Australia from 1961 until 1986 and held various
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`titles including Senior Orthopaedic Surgeon. In 1986, I moved to London, England
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`and practiced spinal surgery at various hospitals and held various appointments
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`including Honorary Senior Lecturer and Consultant Spinal Surgeon in the Department
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`of Orthopaedic Surgery at the Royal Postgraduate Medical School, Hammersmith
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`Hospital, and Director of the Spinal Disorders Unit at Cromwell Hospital. I retired in
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`2001 and moved back to Melbourne.
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`I obtained a Doctor of Medicine and Doctor of Surgery (M.B.B.S.) from the University
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`of Melbourne in 1953, a Medical Doctorate (M.D.) from the University of Melbourne
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`in 1967, and a Masters of Surgery (MS) from the University of Melbourne in 1977.
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`In terms of specialised training in surgery, I was made a Fellow of the Royal College of
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`Surgeons in London in 1957 and a Fellow of the Royal Australasian College of
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`Surgeons in 1961.
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`I have received numerous awards and honours during my career, including Officer of
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`the Order of Australia (A0.) in 1984 for services to medicine, especially in the field of
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`orthopaedic surgery, Corresponding Fellow of the Japanese Orthopaedic Association in
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`1990, Honorary Fellow of the Royal College of Surgeons, Edinburgh in 1997,
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`Honorary Member Spine Society of Australia in 2006, and Honorary Doctorate of
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`Science from the University of Melbourne in 2009, the highest honorary award given
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`by a university. In addition, I was elected President of the International Society for the
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`Study of the Lumbar Spine in 1985, and have been awarded the LO Betts Medal by the
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`Australian Orthopaedic Association, the Sir Alan Newton Prize by the Royal
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`Australasian College of Surgeons and the Wood Jones Medal by the College of
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`Surgeons of England.
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`I have lectured extensively on spinal surgery, including at least 66 guest lectures in at
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`least 17 countries between the years of 1985 and 2001 alone, and extended lecture tours
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`once or twice a year from 1966 until my retirement in 2001 visiting Europe, Russia,
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`Scandinavia, Canada, Japan, USA, Peoples’ Republic of China, Hong Kong, India,
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`Singapore, Indonesia, the Philippines, India, Great Britain, and Saudi Arabia.
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`I pride myself on being a teacher. Following my appointment at St. Vincent’s
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`Hospital, Melbourne in 1961, I became actively involved in undergraduate and post-
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`graduate teaching of orthopaedic surgery and, in particular, spinal surgery. Icontinued
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`training post-graduate fellows in spine surgery after moving to London in 1986.
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`I
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`have trained at least 26 post-graduate fellows from countries ranging from Indonesia,
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`India, Canada, USA, Japan, Scotland, and Pakistan. In terms of teaching positions, I
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`was also Lecturer in Orthopaedic Surgery at Oxford University from 1959-1961,
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`Professorial Associate at St. Vincent’s Hospital, Melbourne from 1961-1986, Visiting
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`Lecturer in the Department of Anatomy at the Royal College of Surgeons of England,
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`Senior Lecturer in the Department of Orthopaedics at the Royal Postgraduate Medical
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`School at Hammersmith Hospital, and Director of Spinal Disorders Unit at Cromwell
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`Hospital.
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`1 have written a multitude of publications regarding spine surgery and served on the
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`editorial boards of the British Journal of Bone and Joint Surgery, The European Spine
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`Society Journal, Neuro-Orthopaedics (now ceased), and The Journal of Orthopaedic
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`Science from the Japanese Orthopaedic Association. Among my publications include 6
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`books, 26 book chapters, and at least 35 papers, all of which were peer-reviewed. My
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`Medical Association prize for Basic Science and Clinical Medicine in 1996. My paper
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`“A Reappraisal of Intervertebral Disc Lesions” originally published in the Medical
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`Journal of Australia in 1970 was in 2005 cited in The Spine Journal of North America
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`as a seminal paper on spinal surgery in the 20th Century.
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`Now shown to me and marked Exhibit HVC-2 is a copy of my curriculum vitae
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`setting out my experience and publications.
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`I was born on Sept 14, 1929 and am currently 82 years of age.
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`I am of sound mind and
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`able to understand completely and fully the contents of the materials I have reviewed
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`and the statements I am making below. Although I am retired, I continue to receive
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`and read various medical journals in my field of expertise, and attend medical
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`conferences and collaborate with others in the field of spinal orthopaedics. For
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`example, I still receive and regularly read publications including the Journal of
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`Orthopaedic Science from the Japanese Orthopaedic Association, the Journal of the
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`British Orthopaedic Association, the Australia and New Zealand Journal of Surgery,
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`and the Journal of the Royal College of Surgeons of Edinburgh.
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`I am also still a
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`member of a variety of spine surgery associations, including the Australia Orthopaedic
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`Association, the British Orthopaedic Association, the Japanese Orthopaedic
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`Association, and am currently President of DISCS — The Diagnostic Investigation of
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`Spine Conditions and Sciatica in London — a charitable trust established in 1993.
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`Currently, my physical health is such that I am not able to handle undue stress, and I
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`am not able to travel long distances to the United States to participate in legal
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`proceedings.
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`I have voluntarily agreed to provide this Affidavit and the evidence contained therein
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`of my own free will. The information contained in this Affidavit comes from my own
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`recollection or from the documents that I identify as having consulted.
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`Consideration of documents
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`I have been asked to review and comment on five documents, which are now shown to
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`me and marked as follows:
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`(a)
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`Exhibit HVC-3, being a copy of Crock, “Observations on the management of
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`failed spinal operations,” in The Journal of Bone and Joint Surgery, Vol. 58—
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`B, No. 2, pp. 193-199, May 1976 (hereinafter referred to as “my 1976
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`paper”);
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`(b)
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`Exhibit HVC-4, being a copy of Crock, “Anterior Lumbar Interbody Fusion
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`— Indications for its Use and Notes on Surgical Technique,” in Clinical
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`Orthopaedics and Related Research, No. 165, May 1982 (hereinafter referred
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`to as “my 1982 paper”);
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`(C)
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`Exhibit HVC-S being a copy of Fujimaki, et. Al. “The Results of 150
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`Anterior Lumbar Interbody Fusion Operations Performed by Two Surgeons
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`in Australia,” in Clinical Orthopaedics and Related Research, No. 165, May
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`1982 (hereinafter referred to as the “Fujimaki et al. paper”);
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`(d)
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`Exhibit HVC-6 being a copy of Crock, A Practice of Spinal Surgery,
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`Springer-Verlag Wein New York, Revised 1St Edition, 1983 (hereinafter
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`referred to as “my 1983 book”);
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`(6)
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`Exhibit HVC-7 being a copy of Crock, A Short Practice of Spinal Surgery,
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`Springer-Verlag Wein New York, Revised 2nd Edition, 1993 (hereinafter
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`referred to as “my 1993 book”).
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`I was asked to review the publications above and any other materials I deemed
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`necessary and proper in order to render the recollections about my prior publications
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`set forth below. Specifically, I was asked to provide statements on factual matters
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`Witness Statement
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`To my best recollection, I learned of a spinal access technique that uses a direct lateral
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`approach to the spine (90 degrees off of midline) during a visit to a group of spinal
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`surgeons in Hong Kong, which occurred in about 1968. The group in Hong Kong
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`included Dr. Hogsdon of the University of Hong Kong, who is one of the authors of the
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`1956 article, entitled “Anterior spinal fusion: A preliminary communication on the
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`radical treatment on Pott’s disease and Pott’s paraplegia,” in The British Journal of
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`Surgery, Vol. 44, pp. 266-75 (1956).
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`I have a specific recollection of the first spinal fusion surgery in which I used a direct
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`lateral approach to the spine, and that was in a surgery performed in 1970. This direct
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`lateral procedure was performed at the L2/L3 level of the patient, at the site of
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`tuberculosis abscess formation (both in the disc space and in the L2 and L3 vertebral
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`bodies). For this procedure, given it involved access at the L2/L3 region, I used a 12‘h
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`rib incision for access, as discussed in my 1982 paper. This spinal fusion procedure
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`addressed a condition known as “Pott’s Disease,” namely the resection of an abcess
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`formation clue to tuberculosis. The procedure involved partial resection of the L2 and
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`L3 vertebral bodies, as well as partial removal of the L2/L3 disc, and implantation of
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`one or more rib grafts harvested from the patient to create a bone bridge from the L2
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`vertebral body, through the L2/L3 disc space, to the L3 vertebral body. Based on the
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`fusion which occurred at the L2/L3 disc space, it can be said that this procedure
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`involved interbody fusion. The resulting fusion is shown in Figure 8.10 a,b of my 1983
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`book, and the patient is also shown in this book in Figure 8.11. The patient was a nun
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`from New Guinea, and she is still alive today and is in her 90’s.
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`I remain in contact
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`with this patient, as she has written me every year for the last 40 years, and she informs
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`me how she is doing.
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`I know the patient’s name, but I am not revealing her name in
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`this Affidavit because it is my understanding that under Australian law that is
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`confidential information I am not at liberty to disclose.
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`Although I do not specifically recall the first time I performed a spinal interbody fusion
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`procedure other than for Pott’s Disease (that is, focusing solely on interbody fusion and
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`not involving partial resection of adjacent vertebral bodies — which I refer to hereinafter
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`simply as “interbody fusion”) using a direct lateral approach and do not recall the
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`specific patient on which I performed this procedure, Iknow that the first time I
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`performed a spinal interbody fusion procedure using a direct lateral approach was in
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`the early-to-mid-1970’s. In particular, I know that the first spinal interbody fusion
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`procedure using a direct lateral approach occurred after I performed the direct lateral
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`spinal fusion surgery for Pott’s Disease on the patient discussed in the immediately
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`preceding paragraph, and Iknow that it was before the publication of my 1976 paper in
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`which I reported details of two lateral interbody fusion procedures.
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`At the time I did my first spinal interbody fusion procedure using a direct lateral
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`approach in the 1970’s, I was not aware of anyone else having done such a procedure
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`before. Still today, I am not aware of anyone else having done such a procedure before
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`I did it in the 1970’s.
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`During the 1980’s and 1990’s, I trained many other spinal orthopaedic surgeons in the
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`spinal fusion techniques described in my 1982 paper and in my 1983 and 1993 books.
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`I am the author of my 1976 paper. This paper was read at the 108th Anniversary
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`Meeting of the Texas Medical Association, San Antonio, Texas, in May 1975. At the
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`time I authored the paper, I was Senior Orthopaedic Surgeon at St. Vincent’s Hospital,
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`University of Melbourne, Australia.
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`3/ ~/“
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`Chow/24mg,
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`I am the author of my 1982 paper. I submitted this paper for publication in September
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`of 1980. At the time I authored the paper, I was Senior Orthopedic Surgeon at St.
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`Vincent’s Hospital, University of Melbourne, Australia
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`I am co—author with Arihisa Fujimaki, MD. and Sir George Bedbrook, MD. of the
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`Fujimaki et al. paper. This paper reports on 150 surgeries performed by my colleague,
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`Dr. Bedbrook, and me, with 100 of those surgeries having been performed by me.
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`I am the author of my 1983 book, and I am also the author of my 1993 book, which is a
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`second edition of my 1983 book.
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`My 1982 Paper
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`My 1982 paper describes spinal fusion procedures that my colleague, Dr. Bedbrook,
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`and I had performed over an 18-year period from 1961 until 1980, when I wrote my
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`1982 paper. As reported in my 1982 paper, by 1980 I had performed approximately
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`1000 operations over the preceding 20 years. See my 1982 paper, at p. 161. As
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`reported in my 1993 book, by the time of the writing of my 1993 book I had performed
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`over 1500 of the described procedures over the preceding 30 years, and had
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`experienced no patient mortality during operation. See my 1993 book, at p. 94.
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`My 1982 paper describes two different approaches or trajectories to be taken to the
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`spinal column for lumbar interbody fusion, namely: (a) an anterior or anterolateral
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`approach or trajectory, which is used in most cases of the lower lumbar region (that is,
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`for intervertebral discs at L4/L5 and LS/Sl), and (b) a direct lateral approach or
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`trajectory (that is, 90 degrees from the midline), which is used in the upper lumbar
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`region (that is, for intervertebral discs at L1/LZ, L2/L3, and L3/L4) and, if permitted by
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`the anatomy, also in some cases of the lower lumbar region.
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`In entitling my 1982 book “anterior lumber interbody fusion,” I used that phrase in a
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`lumbar interbody fusion” to refer to any fusion procedure that made an approach that
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`did not traverse the posterior portion of the spine. In other words, if the approach was
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`anterior of the posterior portions of the spine, it would be considered anterior lumbar
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`spinal fusion. As such, I considered all of the procedures in my 1982 book to be
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`anterior lumbar interbody fusion procedures, regardless of whether the approach was
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`directly anterior, anterolateral, or directly lateral.
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`Anterior and Anterolateral Approaches Described in my 1982 Paper
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`My 1982 book describes that, for those procedures where an anterior or anterolateral
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`approach is used (for example, in the lower lumbar fusions), the patient is placed
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`supine on the operating table. See my 1982 paper, at p. 158. My 1982 paper describes
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`that, using this anterior or anterolateral approach to the disc space, two parallel cavities
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`would be formed in the disc space, each cavity extending from the anterior aspect of
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`the disc space toward the posterior aspect of the disc space, or in other words, each of
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`these cavities lies in an “anteroposterior” orientation, as illustrated in Figure 2 of my
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`paper, copied below:
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`My 1982 paper then describes that the two parallel cavities may be filled with
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`autogenous bone grafts or “dowels” obtained from the patient’s iliac crest. My 1982
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`paper states that the dowels from the iliac crest were cut to be one size larger than the
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`dowel cavities to ensure a proper fit. See my 1982 paper, at p. 160. My 1982 paper
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`further describes the use of iliac crest grafts with three cortical faces, as illustrated in
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`Figure 4, and also describes the use of purely cancellous grafts. See my 1982 paper, at
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`pp. 160-61. In the case of purely cancellous bone grafts, these too would be harvested
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`from the patient’s iliac crest, albeit from a location more posterior than the location
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`shown in Figure 4. My 1982 paper notes that the purely cancellous grafts are liable to
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`invasion by disc remnants, thus predisposing to non—union. See my 1982, at p. 161.
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`My 1982 paper also describes, specifically with respect to fusions in the L4/L5 disc
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`space, that the great vessels may be retracted towards the midline from the anterolateral
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`surface of the L4/L5 disc space. See my paper, at p. 169. This is done because the
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`typical location of the great vessels (running down the midline) makes a directly
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`anterior placement of the two parallel cavities difficult or impossible. See my 1983
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`book, at p. 79, Fig. 2.44a (illustrating the great vessels running down the anterior
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`midline of the spinal column at the LA/LS disc space). As such, for the L4/L5 disc
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`space, the two grafts would be introduced into the disc space from a location that is
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`offset from the anterior midline, toward the anterolateral surface of the disc space. See
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`my 1983 book, at p. 80, Fig. 2.46a and b; see also my 1993 book, at p. 73, Fig. 2.25:
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`Figure 2.25
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`Again, the reason for the different positioning as shown in Figure 2.25 of my 1993
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`book for the L4/L5 disc space (top) as compared to the L5/Sl disc space (bottom), is
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`due to the location of the great vessels. See my 1993 book, at page 95, Figure 2.50a.
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`In particular, the bifurcation of the great vessels above the L5/Sl disc space enables a
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`more central, or midline, anterior introduction of the implants in the L5/Sl location (as
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`shown in Fig. 2.25 of my 1993 book copied above), whereas the central anterior
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`location of the vessels above L5/Sl requires a more oblique, or anterolateral, trajectory
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`to the disc space (as is also shown in Fig. 2.25 of my 1993 book copied above).
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`Direct Lateral Approaches Described in My 1982 Paper
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`I used direct lateral approaches for lumbar interbody fusion as described in my 1982
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`paper, where possible, because the use of a lateral approach in the upper lumbar region
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`was preferred given it avoids contact with the great vessels.
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`I also used direct lateral
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`approaches for interbody fusion in the lower lumbar region where it was not possible to
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`perform the procedure using an anterior approach, for example, in patients with Grade
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`2 spondylolisthesis, as shown in Figures 7A and 7B of my 1982 paper.
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`My 1982 paper describes, for those procedures where a direct lateral approach is used
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`(for example, the rarer upper lumbar fusions), that the patient is placed in the lateral
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`decubitus position on the operating table with the left loin uppermost. See my 1982
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`paper, at pp. 158, 159. For the lateral approaches to the Ll/L2 or L2/L3 disc space, I
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`would form an “incision running through the bed of the twelfth rib to allow extra—
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`peritoneal exposure of the upper lumbar vertebral column.” See my 1982 paper, at p.
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`159; see also my 1983 book, at p. 74; my 1993 book, at p. 88. This twelfth rib incision
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`is one that is known in other fields of surgery, for example to access the kidney, and the
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`incision runs straight along the twelfth rib, from anterior of a direct lateral position to
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`posterior of a direct lateral position. As such, the twelfth rib incision allows a direct
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`lateral trajectory to the spine. For the lateral approaches to the L3/L4 disc space, my
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`1982 paper describes that the incision would be similar to the incision used for the
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`L4/L5 and L5/S1 access, namely, an oblique incision on the left side of the patient,
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`commencing at the midline between the umbilicus and symphysis pubis (although
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`nearer to the umbilicus for the L3/L4 approach) and extending upwards and laterally
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`parallel to the level of the iliac crest. See my 1982 paper, at p. 158. As such, this
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`incision allows a direct lateral trajectory to the L3/L4 disc space.
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`My 1982 paper also describes that, after direct lateral access to the disc space is made,
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`two parallel dowel cavities would be cut into the disc space, and those cavities are
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`oriented “transversely.” By “transversely,” I meant lying in the transverse plane, and
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`as such, by saying that the cavities are oriented transversely, that meant that they are
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`oriented laterally, from side—to-side in the disc space, and not anterior—to—posterior.
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`I
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`would typically use a smaller-diameter, cervical-sized dowel cutting instrument for
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`cutting the cavities in the lateral face of the disc space in the upper lumbar region. See
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`my 1982 paper, at p. 159, Fig. 1 (showing the three dowel cutter sizes, with the smaller
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`one on the left being the cervical-sized dowel cutter). Figure 3 of my 1982 paper (p.
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`160) shows the lateral faces of adjacent vertebrae into which two parallel cavities have
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`been formed:
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`Figure 3 of my 1982 paper was drawn by an artist, Mr. Dale Howat, who I engaged to
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`prepare many of the illustrations used in my publications. It was my normal practice at
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`the time to have Mr. Howat prepare figures such as this in my presence, and we would
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`work together to ensure that the figures illustrated what I intended them to illustrate.
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`Figure 3 accurately makes a diagrammatic representation of what I intended Figure 3 to
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`illustrate, namely, two cavities having been formed in the lateral face of the disc space.
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`The purpose of Figure 3 was not to convey exact dimensions for a particular vertebra,
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`although the dimensions of Figure 3 are generally accurate for typical vertebrae.
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`Figure 3 of my 1982 paper was not included in my 1983 book or in my 1993 book.
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`Although I do not have a specific recollection today as to why Figure 3 was not
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`included in my 1983 and 1993 books, Iknow for certain that its omission was not
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`because I or anyone else deemed the figure to be inaccurate. Indeed, I never have
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`considered Figure 3 of my 1982 paper to be inaccurate, and do not consider Figure 3 to
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`be inaccurate today. Until now, I have never had the accuracy of my drawings called
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`into question.
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`As discussed above, my 1982 paper describes that the two parallel cavities are filled
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`with autogenous bone grafts or “dowels” including both cortical bone and cancellous
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`bone, or alternatively, with purely cancellous bone grafts obtained from the patient’s
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`iliac crest. See my 1982 paper, at pp. 160-61 and Figure 4. Such implants were
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`effective, in my view, because the implants had cancellous bone in contact with the
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`cancellous bone of the vertebrae. This enabled blood flow from the exposed cancellous
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`bone of the vertebral bodies into the cancellous bone of the grafts, thereby facilitating
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`bone growth and effective fusion. Vascular anatomy is one of my specialties and this
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`biological View (vs. mechanical) of fusion is an outcropping of and consistent with my
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`early work in this area. See, e.g., Crock et al., “The Blood Supply of the Vertebral
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`Column and Spinal Cord in Man,” Springer-Verlag New York, 1977.
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`In terms of sizing the implants, my 1982 paper describes that the dowels were typically
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`cut from the iliac crest to be one size larger in diameter than the dowel cavities to
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`ensure a proper fit. See my 1982 paper, at p. 160. My 1982 paper describes that the
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`length of a dowel cavity is checked with a depth gauge and ruler. See 1982 paper, at p.
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`161. The depths of the cavities are measured to make sure the grafts are long enough
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`to fit the depth of the cavity. See also my 1993 book, at p. 97, Figure 2.51a, b
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`(illustrating implants extending across the length of the cavity into which the implant is
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`inserted). In the case of the lateral implants extending transversely, they were sized to
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`occupy substantially the full transverse width of the two adjacent vertebrae.
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`My 1982 paper states that grafts of 2.5 cm to 2.8 cm in depth are of satisfactory size in
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`most patients. See 1982 paper, at p. 160. My experience was that this was typically
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`true for the upper lumbar applications in which lateral implants were used. In some
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`the iliac crest. In addition, given the shape of the iliac crest, while the longer dowels
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`may include thinner distal portions of the iliac crest graft, I found these implants to be
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`sufficiently strong to be safe and effective intervertebral implants and did not witness
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`any post-operative subsidence of those dowels in those patients who received them via
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`my direct lateral interbody fusion technique.
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`Although my 1982 paper indicates my strong recommendation that autogenous bone
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`grafts be used as the implant, I noted in my 1993 book that non-bone implants such as
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`porous ceramic and titanium implants had by that time also been used by others as
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`substitutes for autogenous interbody grafts. See my 1993 book, at p. 74.
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`1982 Paper, Figures 7A and 7B: Lateral Approach Example
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`Figures 7A and 7B of my 1982 paper (copied below) shows a roentgenogram of a
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`specific case of an interbody implant that has been inserted “transversely,” using a
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`direct lateral approach, such that the implant extends substantially the full transverse
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`width of the two adjacent vertebrae. The 1982 paper notes that the patient here had
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`Grade 2 spondylolisthesis at L4/L5 (lower lumbar), which means that the L4 vertebral
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`body was “slipped” forward above the L5 vertebral body by approximately 50%. In
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`this case (Grade 2 spondylolisthesis) I would have only used one graft, and the notation
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`in the caption of the figure to “grafts” would seem to be incorrect. Also, given the
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`Grade 2 spondylolisthesis condition, it would not have been possible to have inserted
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`the implant using an anterior approach due to the degree of the “slip,” which was not
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`corrected before the lateral graft was implanted. I therefore would have not used the
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`anterior or anterolateral approach typically used at this level, but rather would have
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`used a direct lateral approach. As such, the notation in the caption for Figures 7A and
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`7B of “transversely” (that is, insertion in a transverse plane, or laterally from one side
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`to the other in the disc space) is correct. Figures 7A and 7B of my 1982 paper
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`l7
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`FIGS. 7A AND 78. (A) Lateral View roentgen-
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`ogram of the lumbar spine in a 45-year-old man,
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`showing Grade 2 spondylolisthesis at L44. (B)
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`Interbody grafts have been inserted transversely
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`(one year after operation).
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`Figures 7A and 7B
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`1993 Book, Figures 2.48a-c: Lateral Approach Example
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`Figures 2.48a—c on page 93 of my 1993 book (also shown in my 1976 paper and in
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`Figures 2.47a—b on page 81 of my 1983 book) disclose another example of a spinal
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`fusion technique using a direct lateral approach, this one having been done in the L2/L3
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`disc space. I specifically recall this patient (a Russian female residing in Australia),
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`and specifically recall that I performed the procedure using a direct lateral approach,
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`and placed the implant directly across substantially the full transverse width of the two
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`adjacent vertebrae. This patient, unfortunately, had a complication called discitis due
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`to a previous procedure at a different spinal level than where the lateral interbody
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`fusion was done. The discitis was the result of a diagnostic procedure called a
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`discography, which unfortunately created over-pressurization in an otherwise healthy
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`disc that over time caused erosion of the disc into the adjacent vertebrae resulting in
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`1 8
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`Postmortem histological investigation identified, not only the complication at a
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`different disc level, but also showed that complete fusion in the L2/L3 disc space had
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`not occurred as it should have. Through this investigation it became apparent that the
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`incomplete union of the laterally placed cancellous graft was caused by the infiltration
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`of disc renmants into the cancellous bone graft, which prevented the necessary blood
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`flow into the graft to achieve fusion. The incomplete union was not determined to be
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`the result of the use of the cancellous bone graft in and of itself, and it is not the case
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`that insufficient strength of the cancellous bone graft resulted in fusion not being
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`successfully achieved in this case. In other instances, the use of cancellous grafts
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`placed laterally into the lumbar spine resulted in full fusion, which I suspect was due to
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`more complete disc removal before the insertion of the cancellous grafts such that the
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`vascular flow between the cancellous bone of the vertebral bodies and the cancellous
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`bone of the graft was sufficient to enable the fusion process as desired.
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`1993 Book, Figures 2.583-b: Lateral Approach Example
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`Figures 2.58a—b on page 103 of my 1993 book (and also in my 1976 paper and in
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`Figures 2.58a—b on page 92 of my 1983 book) disclose another example of a spinal
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`fusion technique using a direct lateral approach, this one having been done in the L3/L4
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`disc space. In this case, one instead of two parallel grafts was used, given the size of
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`the disc space. This graft collapsed for the same reason that the graft discussed above
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`and shown in Figures 2.48a-c of my 1993 book collapsed, namely, because of disc
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`remnants having been left in the disc space, which prevented the necessary blood flow
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`to achieve fusion. Again, the incomplete union and subsequent collapse in this case
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`was not the result of the use of a cancellous bone graft in and of itself, and it is not the
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`case that insufficient strength of the cancellous bone graft resulted in fusion not being
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`successfully achieved in this case.
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`SurgicalRecords Wm»)?, l/l/éflflé
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`19
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`It is possible that surgical records may exist, but no such records are in my custody or
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`control, and I have not attempted to obtain them. I did not feel it necessary to review
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`any surgical records in order to provide my factual recollections set forth above, which
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`were qualified in cases where my recollections were not clear. If any such surgical
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`records exist, they may exist with the St. Vincent Hospital in Melbourne, Australia, or
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`with certain other hospitals where I performed surgeries, including Hammersmith
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`Hospital and Cromwell Hospital in London.
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`Responses to Specific Statements About My Work And Publications
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`Iunderstand that various opinions and statements have been made about lateral fusion
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`techniques generally and about my publications in particular. Some of these opinions
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`and statements are copied below. I will address each one in turn.
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`I understand that the following testimony was given by Dr. Barton Sachs in a trial
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`proceeding in the United States:
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`Q. NOW DR. SACHS, IS IT THE CASE UNTIL 1995, NO SURGEON DID ANY
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`SORT OF SPINAL FUSION PROCEDURE FROM A LATERAL APPROACH?
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`A.
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`I WOULD AGREE WITH THAT.
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`I disagree with the statement in ‘][50 above made by Dr. Sachs because I performed
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`spinal fusion procedures, including spinal interbody fusion procedures, from a lateral
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`approach before 1995, and in fact did so as early as the 1970’s. Such procedures are
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`documented in my 1982 paper, as well as my 1976 paper and my 1983 and 1993 books.
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`I understand that US. Patent No. 5,860,973 to Dr. Gary Michelson (the ‘973 patent)
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`makes the following statement: “In the past [prior to the filing of the patent, on June 7,
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`1995], spinal fusion implants have been inserted only from either an anterior or
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`posterior direction, from the front or the back of the patient,” and Dr. Barton Sachs
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`20
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`Long before June 7, 1995, and in fact in the 1970’s, Ihad on multiple occasions
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`inserted spinal fusion implants using a direct lateral approach and into the lateral aspect
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`of the disc space, and I made such laterally inserted implants public in my 1982 paper
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`and other publications.
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`I understand that it has been contended that my 1982 paper does not disclose insertion
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`of a spinal implant from the lateral aspect of the spine. This statement is incorrect.
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`My 1982 paper, as well as my 1983 book and my 1993 book, all disclose insertion of