Case: 11-55120 01/19/2011 Page: 1 of 6
`
`ID: 7618239 DktEntry: 6-5
`
`No. 11-55120
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`NEUROVISION MEDICAL PRODUCTS, INC.,
`
`Plaintiff,
`
`v.
`
`NUVASIVE, INC.,
`
`Defendant.
`
`On Appeal from the United States District Court
`for the Central District of California,
`Case No. 2-09-CV-6988 R (JEMx)
`
`DECLARATION OF MARK D. PETERSON M.D. IN SUPPORT
`OF DEFENDANT'S MOTION FOR STAY OF
`PERMANENT INJUNCTION PENDING APPEAL
`
`I, Mark D. Peterson, M.D., state and declare:
`
`1.
`
`I am an orthopedic surgeon associated with Southern Oregon
`
`Orthopedics located in Medford, Oregon. I have personal knowledge of the
`
`matters stated herein, except where stated based on information and belief, and if
`
`called upon to do so, I would testify competently to them.
`
`1
`
`PX0409-0001
`
`PX0409
`
`WARSAW2043
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`Page 1
`
`
`
`ID: 7618239 DktEntry: 6-5
`
`No. 11-55120
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`NEUROVISION MEDICAL PRODUCTS, INC.,
`
`Plaintiff,
`
`v.
`
`NUVASIVE, INC.,
`
`Defendant.
`
`On Appeal from the United States District Court
`for the Central District of California,
`Case No. 2-09-CV-6988 R (JEMx)
`
`DECLARATION OF MARK D. PETERSON M.D. IN SUPPORT
`OF DEFENDANT'S MOTION FOR STAY OF
`PERMANENT INJUNCTION PENDING APPEAL
`
`I, Mark D. Peterson, M.D., state and declare:
`
`1.
`
`I am an orthopedic surgeon associated with Southern Oregon
`
`Orthopedics located in Medford, Oregon. I have personal knowledge of the
`
`matters stated herein, except where stated based on information and belief, and if
`
`called upon to do so, I would testify competently to them.
`
`1
`
`PX0409-0001
`
`PX0409
`
`WARSAW2043
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00206
`
`Page 1
`
`
`
`Case: 11-55120 01/19/2011 Page: 2 of 6
`
`ID: 7618239 DktEntry: 6-5
`
`2.
`
`I attended medical school at Oregon Health Sciences University,
`
`graduating in 1988. Subsequently, I did my residency and internship in the
`
`Department of Orthopedic Surgery at Akron City Hospital. I completed my
`
`residency in 1993 and therefore had three fellowships in orthopedic and spinal
`
`surgery at the Royal Adelaide Hospital (in Adelaide, South Australia), Queens
`
`Medical Center (in Nottingham, England), and North Kansas City Hospital (in
`
`Kansas City, Missouri). I have worked continuously since 1994 as an orthopedic
`
`surgeon in Medford, Oregon, specializing in spinal surgery.
`
`3.
`
`I regularly use NuVasive's XLIF® procedure in the course of my
`
`surgical practice, and am readily familiar with the XLIF® procedure and
`
`NuVasive's NEUROVISION® nerve monitoring system.
`
`4.
`
`When I first started my orthopedic surgery practice, all lower spine
`
`surgery was "open surgery" wherein the spine was accessed from either the front
`
`(anterior) or the back (posterior). The NEUROVISION® nerve monitor system
`
`was a groundbreaking development that allowed spinal surgeons to access the
`
`spine from the side (laterally) in a minimally invasive procedure (NuVasive's
`
`XLIF® procedure), with little muscle dissection, less bone work and smaller
`
`incisions. This resulted in less blood loss, less operative time, and less pain to the
`
`patient as compared to standard open spine surgery.
`
`2
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`PX0409-0002
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`Page 2
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`
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`Case: 11-55120 01/19/2011 Page: 3 of 6
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`ID: 7618239 DktEntry: 6-5
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`5.
`
`Chronic lower back and leg pain often is a result of the deterioration
`
`of the flexible discs between the vertebrae in the lower back. The loss of disc
`
`height creates pressure upon the nerve roots and/or spinal cord - resulting in
`
`chronic lower back pain and/or pain, numbness, or weakness in the legs. This
`
`condition is known as degenerative disc disease ("DDD").
`
`6.
`
`Until now, NuVasive could only treat patients suffering from DDD by
`
`fusing the adjacent vertebrae on either side of the degenerated disc. This involves
`
`removing the affected disc and implanting a generally rectangular, hollow plastic
`
`device that allows bone to grow from one adjacent vertebrae through the implant to
`
`the other adjacent vertebrae. While a dramatic improvement over the traditional
`
`anterior and posterior approaches to accomplish spinal fusion, there remains a
`
`significant unmet need for patients who may not need fusion yet and who would
`
`otherwise benefit from a restoration of disc height while preserving motion
`
`between the adjacent vertebrae.
`
`7.
`
`A small number of companies offer motion preservation implants;
`
`however, they are implanted via an anterior approach to the lumbar spine.
`
`Approaching the lumbar (lower) spine in this manner (from the front of the patient)
`
`is necessarily an "open" procedure based on the need to move the bowels out of the
`
`way, and is routinely associated with greater blood loss, longer operative times,
`
`longer post-operative recovery, and inherent challenges based on the need to pass
`
`3
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`PX0409-0003
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`Page 3
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`Case: 11-55120 01/19/2011 Page: 4 of 6
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`ID: 7618239 DktEntry: 6-5
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`by vital anatomical structures (e.g., the great vessels which lie in front of the spinal
`
`column) to reach the spine.
`
`8.
`
`NuVasive has developed the answer to this unmet need: a total disc
`
`replacement device that we are currently studying for use via its minimally
`
`invasive (XLIF) technique. I am currently the lead investigator on a clinical trial
`
`that NuVasive is conducting for the device, called the "XL-TDR" (for "extreme
`
`lateral- total disc replacement). The NEUROVISION® nerve monitoring system
`
`is critical to the clinical trials because it is the only nerve monitoring system on the
`
`market that allows for safe and reproducible lateral access to the spine.
`
`9.
`
`The trials are being conducted at 17 sites and will require a total of
`
`252 surgeries on patients. Surgeons participating in the clinical trials have enrolled
`
`and performed surgeries on 60% of those patients, which means that an additional
`
`150 patients still need to be enrolled. On average, approximately 8-10 patients are
`
`enrolled in the study each month. At this rate, full enrollment is anticipated to be
`
`complete in October 20 11.
`
`10.
`
`The XL - TDR device is particularly exciting for spinal surgeons
`
`because it will provide patients with a device that is designed to relieve the painful
`
`symptoms ofDDD, while preserving motion in the back. Once implanted between
`
`the vertebrae, the disc is designed to restore height and to replicate the motion
`
`characteristics of an intact healthy disc. The ability to maintain motion is
`
`4
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`PX0409-0004
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`Page 4
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`Case: 11-55120 01/19/2011 Page: 5 of 6
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`ID: 7618239 DktEntry: 6-5
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`important in that it will allow patients more freedom of movement to perform their
`
`activities of daily living. It may also minimize the number of patients who will
`
`ultimately need fusion surgery, which can cause a degenerative cascade at adjacent
`
`discs above and below the site of the original fusion surgery.
`
`11.
`
`The clinical trials for NuVasive' s new XL - TDR device require
`
`lateral access to the spine, which requires use of NuVasive's NEUROVISION®
`
`nerve monitoring system. I have already seen the benefits of the XL - TDR device
`
`in the clinical trials in which I have been involved, and believe that this device
`
`holds great promise for patients who suffer from lower back pain. Their pain will
`
`be prolonged if NuVasive is required to stop lending or circulating the
`
`NEUROVISION® nerve monitoring system to hospitals, surgical centers and
`
`research institutions because the clinical trials cannot be completed with using the
`
`NEUROVISION® nerve monitor. The trials would come to a complete halt.
`
`12.
`
`If the trials are halted, Food and Drug Administration clearance of a
`
`promising new medical device would be delayed, resulting in prolonged pain for
`
`patients for whom a minimally invasive surgery implanting the XL - TDR device
`
`is the best option. As an orthopedic surgeon responsible for patient safety and
`
`comfort, it is untenable to me that the legal system would disrupt such important
`
`work because of an issue with the name of a product.
`
`5
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`PX0409-0005
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`Page 5
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`Case: 11-55120 01/19/2011 Page: 6 of 6
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`ID: 7618239 DktEntry: 6-5
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`I declare under penalty of perjury under the laws of the United States of
`
`America that the foregoing is true and correct. Executed on January 18,2011, in
`
`Medford, Oregon.
`
`Mark D. Peterson, M.D.
`
`6
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`PX0409-0006
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`Page 6
`
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