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`ID: 7618239 DktEntry: 6-5
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`No. 11-55120
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`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
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`NEUROVISION MEDICAL PRODUCTS, INC.,
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`Plaintiff,
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`v.
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`NUVASIVE, INC.,
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`Defendant.
`
`On Appeal from the United States District Court
`for the Central District of California,
`Case No. 2-09-CV-6988 R (JEMx)
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`DECLARATION OF MARK D. PETERSON M.D. IN SUPPORT
`OF DEFENDANT'S MOTION FOR STAY OF
`PERMANENT INJUNCTION PENDING APPEAL
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`I, Mark D. Peterson, M.D., state and declare:
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`1.
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`I am an orthopedic surgeon associated with Southern Oregon
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`Orthopedics located in Medford, Oregon. I have personal knowledge of the
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`matters stated herein, except where stated based on information and belief, and if
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`called upon to do so, I would testify competently to them.
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`1
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`PX0409-0001
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`PX0409
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`WARSAW2043
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00208
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`Page 1
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`2.
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`I attended medical school at Oregon Health Sciences University,
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`graduating in 1988. Subsequently, I did my residency and internship in the
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`Department of Orthopedic Surgery at Akron City Hospital. I completed my
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`residency in 1993 and therefore had three fellowships in orthopedic and spinal
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`surgery at the Royal Adelaide Hospital (in Adelaide, South Australia), Queens
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`Medical Center (in Nottingham, England), and North Kansas City Hospital (in
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`Kansas City, Missouri). I have worked continuously since 1994 as an orthopedic
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`surgeon in Medford, Oregon, specializing in spinal surgery.
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`3.
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`I regularly use NuVasive's XLIF® procedure in the course of my
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`surgical practice, and am readily familiar with the XLIF® procedure and
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`NuVasive's NEUROVISION® nerve monitoring system.
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`4.
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`When I first started my orthopedic surgery practice, all lower spine
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`surgery was "open surgery" wherein the spine was accessed from either the front
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`(anterior) or the back (posterior). The NEUROVISION® nerve monitor system
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`was a groundbreaking development that allowed spinal surgeons to access the
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`spine from the side (laterally) in a minimally invasive procedure (NuVasive's
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`XLIF® procedure), with little muscle dissection, less bone work and smaller
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`incisions. This resulted in less blood loss, less operative time, and less pain to the
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`patient as compared to standard open spine surgery.
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`2
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`5.
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`Chronic lower back and leg pain often is a result of the deterioration
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`of the flexible discs between the vertebrae in the lower back. The loss of disc
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`height creates pressure upon the nerve roots and/or spinal cord - resulting in
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`chronic lower back pain and/or pain, numbness, or weakness in the legs. This
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`condition is known as degenerative disc disease ("DDD").
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`6.
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`Until now, NuVasive could only treat patients suffering from DDD by
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`fusing the adjacent vertebrae on either side of the degenerated disc. This involves
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`removing the affected disc and implanting a generally rectangular, hollow plastic
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`device that allows bone to grow from one adjacent vertebrae through the implant to
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`the other adjacent vertebrae. While a dramatic improvement over the traditional
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`anterior and posterior approaches to accomplish spinal fusion, there remains a
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`significant unmet need for patients who may not need fusion yet and who would
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`otherwise benefit from a restoration of disc height while preserving motion
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`between the adjacent vertebrae.
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`7.
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`A small number of companies offer motion preservation implants;
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`however, they are implanted via an anterior approach to the lumbar spine.
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`Approaching the lumbar (lower) spine in this manner (from the front of the patient)
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`is necessarily an "open" procedure based on the need to move the bowels out of the
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`way, and is routinely associated with greater blood loss, longer operative times,
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`longer post-operative recovery, and inherent challenges based on the need to pass
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`3
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`by vital anatomical structures (e.g., the great vessels which lie in front of the spinal
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`column) to reach the spine.
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`8.
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`NuVasive has developed the answer to this unmet need: a total disc
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`replacement device that we are currently studying for use via its minimally
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`invasive (XLIF) technique. I am currently the lead investigator on a clinical trial
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`that NuVasive is conducting for the device, called the "XL-TDR" (for "extreme
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`lateral- total disc replacement). The NEUROVISION® nerve monitoring system
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`is critical to the clinical trials because it is the only nerve monitoring system on the
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`market that allows for safe and reproducible lateral access to the spine.
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`9.
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`The trials are being conducted at 17 sites and will require a total of
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`252 surgeries on patients. Surgeons participating in the clinical trials have enrolled
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`and performed surgeries on 60% of those patients, which means that an additional
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`150 patients still need to be enrolled. On average, approximately 8-10 patients are
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`enrolled in the study each month. At this rate, full enrollment is anticipated to be
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`complete in October 20 11.
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`10.
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`The XL - TDR device is particularly exciting for spinal surgeons
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`because it will provide patients with a device that is designed to relieve the painful
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`symptoms ofDDD, while preserving motion in the back. Once implanted between
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`the vertebrae, the disc is designed to restore height and to replicate the motion
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`characteristics of an intact healthy disc. The ability to maintain motion is
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`important in that it will allow patients more freedom of movement to perform their
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`activities of daily living. It may also minimize the number of patients who will
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`ultimately need fusion surgery, which can cause a degenerative cascade at adjacent
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`discs above and below the site of the original fusion surgery.
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`11.
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`The clinical trials for NuVasive' s new XL - TDR device require
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`lateral access to the spine, which requires use of NuVasive's NEUROVISION®
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`nerve monitoring system. I have already seen the benefits of the XL - TDR device
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`in the clinical trials in which I have been involved, and believe that this device
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`holds great promise for patients who suffer from lower back pain. Their pain will
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`be prolonged if NuVasive is required to stop lending or circulating the
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`NEUROVISION® nerve monitoring system to hospitals, surgical centers and
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`research institutions because the clinical trials cannot be completed with using the
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`NEUROVISION® nerve monitor. The trials would come to a complete halt.
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`12.
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`If the trials are halted, Food and Drug Administration clearance of a
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`promising new medical device would be delayed, resulting in prolonged pain for
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`patients for whom a minimally invasive surgery implanting the XL - TDR device
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`is the best option. As an orthopedic surgeon responsible for patient safety and
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`comfort, it is untenable to me that the legal system would disrupt such important
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`work because of an issue with the name of a product.
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`I declare under penalty of perjury under the laws of the United States of
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`America that the foregoing is true and correct. Executed on January 18,2011, in
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`Medford, Oregon.
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`Mark D. Peterson, M.D.
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`PX0409-0006
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