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`11/10/2003 Estes, Bradley, 11/10/2003 (MED)
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` IN THE UNITED STATES DISTRICT COURT
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` FOR THE WESTERN DISTRICT OF TENNESSEE
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` Civil Action No. 01-2373-JPM
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`MEDTRONIC SOFAMOR DANEK, INC., )
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` Plaintiff, )
`
` )
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`vs. )
`
` )
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`GARY K. MICHELSON, M.D., and KARLIN )
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`TECHNOLOGY, INC., )
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` Defendants. )
`
`______________________________________________
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` VIDEOTAPED DEPOSITION OF BRADLEY ESTES
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` (Taken on behalf of the Defendants)
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` Durham, North Carolina
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` November 10, 2003
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`Reported by: Jane Worthen Eaton, RMR, CRR, CMRS
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` Registered Professional Reporter
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` Notary Public
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`Page 1
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`WARSAW2023
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00208
`
`

`

`11/10/2003 Estes, Bradley, 11/10/2003 (MED)
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` P R O C E E D I N G S
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` VIDEOGRAPHER: Starting of tape one on the record
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`at 9:27 a.m. This is the videotaped deposition of Bradley
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`Estes. The Case Number is CV 01-2373-MLV. Today's date
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`is November 10, year 2003. The time is indicated on the
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`video screen. We are located today at Washington Duke Inn
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`at 3001 Cameron Boulevard, Durham, North Carolina. The
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`court reporter is Jane Eaton; my name is Scott Swing,
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`certified legal video specialist. We are both with
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`Russell Court Reporting out of Winston-Salem, North
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`Carolina. At this time the court reporter will swear the
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`witness for the record, please.
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` BRADLEY ESTES,
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` Having first been duly sworn,
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` was examined and testified as follows:
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` VIDEOGRAPHER: At this time counsel will verbally
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`introduce themselves and who they represent, please.
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` MR. GIBSON: Stan Gibson and Devorah Cohen on
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`behalf of Gary K. Michelson, MD and Karlin Technology,
`
`Inc.
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` MR. PABIS: I am Ron Pabis of McDermitt Will and
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`Emery for Sofamor Danek Medtronics, Inc. and Mr. Bradley
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`Estes.
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` VIDEOGRAPHER: You may proceed.
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` EXAMINATION
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`Page 2
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`11/10/2003 Estes, Bradley, 11/10/2003 (MED)
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` BY MR. GIBSON:
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` Q. Good morning. State your name and spell your last
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`name, please?
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` A. Good morning. Bradley Thomas Estes. Last name is
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`spelled E-S-T-E-S.
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` Q. And you have had your deposition taken before,
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`correct?
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` A. Yes, I have.
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` Q. Approximately how many times?
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` A. Four or five times.
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` Q. You had your deposition taken in conjunction with
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`the Osteotech matter involving Sofamor Danek?
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` A. Yes.
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` Q. What other cases have you had your deposition taken
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`in that you can recall?
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` A. There was a class action lawsuit, pedicle screw
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`litigation. I was deposed in that suit. I was also
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`deposed in Acromed suit, the patent infringement suit.
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` Q. Any other lawsuits that you know of that you were
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`deposed in?
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` A. I don't recall.
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` Q. Have you ever testified at trial?
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` A. No, sir.
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` Q. Do you know what product the Acromed lawsuit
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`involved?
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`Page 3
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` Q. Did you recall seeing any of Dr. Michelson's
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`instruments that would be used to place a threaded dowel
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`via a lateral approach?
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` A. I do recall at some point in time seeing some
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`instruments; whether that was the early time period, I
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`don't remember.
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` Q. If you looked at the next page, page 8, that second
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`full paragraph that begins "we discussed."
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` A. I see it.
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` Q. If you want to read that, tell me when you're
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`finished.
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` A. Okay.
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` Q. And then there's a sentence in that paragraph
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`that's about two-thirds of the way in that says "Dr.
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`Michelson reviewed with us some excellent instrumentation
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`developed for placement of the threaded dowel via a
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`lateral anterior approach."
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` A. I see that.
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` Q. Does that refresh your memory in any way as to what
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`Dr. Michelson showed in terms of instruments for an
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`anterior lateral approach?
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` A. No.
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` Q. Did you ever discuss with Mr. Boyd revision of
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`implants?
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` A. Yes.
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`Page 4
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` Q. Do you recall when you first had those discussions?
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` A. No.
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` Q. Do you know if it was in this early time period?
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` A. Not that I recall.
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` Q. Do you recall what you discussed with Mr. Boyd in
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`terms of revision of implants?
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` A. I don't recall any specifics.
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` Q. Did you work on any concepts for revision of
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`implants?
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` A. I don't recall anything specific about that.
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` Q. Did you ever work on the instruments for revision
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`of implants?
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` A. Not that I recall.
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` Q. Let's mark this as 1106.
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` (Exhibit 1106 marked for identification.)
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` BY MR. GIBSON:
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` Q. Exhibit 1106 is another memo from Mr. Boyd dated
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`January 11, 1994; and it has you as a CC with a checkmark
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`next to it?
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` A. I see that.
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` Q. I'm only going to ask you about various features
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`and benefits. If you want to read the first paragraph and
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`read the features and benefits, let me know when you're
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`done.
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` A. Okay.
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`Page 5
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` Q. And if you could tell me if reading that refreshes
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`your memory in any way in terms of the instruments that
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`were provided by Dr. Michelson?
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` A. No, it did not.
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` Q. If you look at number 4, item number 3 in there.
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`It says trephine for core and the disc in certain portions
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`of end plate via drilling over long distracter. Do you
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`see that?
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` A. No. Where are you?
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` Q. It is number 4 under "various features and
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`benefits." It is three in parentheses.
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` A. Okay.
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` Q. Do you see that sentence?
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` A. I see it.
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` Q. Is that the same method being described there that
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`was described in Mr. Boyd's previous or memo of the same
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`day that we just looked at?
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` MR. PABIS: Objection. Calls for speculation.
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` Q. If you want to find it again it is on page 6
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`underneath the sketch.
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` A. It seems that those are consistent.
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` Q. Let's mark this as 1107. Exhibit 1107 is actually
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`two letters to Dr. Michelson from Mr. Boyd; and I wanted
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`to ask you about the second letter which is the fourth
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`page in. If you just turn to the second page of that
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`Page 6
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`letter and answer whether you recognize Mr. Boyd's
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`signature on that second page?
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` A. That appears to be his signature.
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` Q. And do you recall if you look -- we'll go through
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`this item by item so you will have the opportunity to look
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`at it. If you look at item number 1, it says "PLIF set,
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`three sets of 65 instruments per set."
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` A. I see that.
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` Q. Do you recall if you saw a PLIF set of instruments
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`that were provided by Dr. Michelson?
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` A. I did see a PLIF set of instruments from Dr.
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`Michelson.
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` Q. Do you recall if it had approximately 65
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`instruments?
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` A. I don't recall.
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` Q. How many instruments are generally in a PLIF set
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`that was manufactured by Danek or Interfix?
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` MR. PABIS: Objection. Vague.
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` THE WITNESS: There are many different instrument
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`sets while I was there.
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` Q. Approximately how many did some of the instruments
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`in some of them have, do you remember? Looking for your
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`best estimate.
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` MR. PABIS: Objection. Vague.
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` THE WITNESS: I mean there are lists with
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`47
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`Page 7
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`

`

`
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`To:
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`onrn;
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`John Pefiord
`David Brumfleld
`Larry Boyd if)
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`Date:
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`January it, 1994
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`;
`
`Ted Bird
`
`Subject:
`
`NOTES ON THREADED DOWEL CONCEPTS QF 0'3 mm” “" '
`a I. “at UHELDUE‘I
`
`r
`Iru Ill
`1
`Following for your review an
`r: are some of my notes and comments on the
`Michelson technology. These are based
`va
`on my review of information orior to our meeting
`and contain some of the answers to my
`rious questions. which were answered by Dr.
`Michelson on Tuesday, The not s
`r to
`o
`.
`found in the patent application. Let me know i you have any questions or comments.
`
`I.
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`Eatiggs Egatgr
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`fit
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`1.
`
`Instrumentation is guarded to protect against tissue contact and contact with the
`neurovascutar structures.
`instrumentation also features drili stops to prevent over
`drifting. No extrema! retractors {e.g.. lamina Spreaders} are used.
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`instrumentation can be used ALiF. PLIF. as well as laparoscopic implantation for
`anterior use (iaparscocic approach could be anterior or anteroleteral, depending
`on instrumentation used}.
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`3.
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`I;
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`The instrumentation allows for simultaneous removal of the disc/bone and implant
`preparation. Three options are posstoie here: (i) o‘riiir‘reamer to remove and
`contain disc and bone (no distractor present. except in contreietersi side). {2}
`cannuieied rear-nor for drilling over long distractor. and (3) trephine for coring out
`disc and the circular portions of endptate vie drilling over a long distractor.
`psciaiizeo' threadiorms hetp resist unscrewing.
`6. Bone ingrowfh surface texturlng acts to anchor the implant system. Hydroxyeoatite
`coating couid further enhance bone bonding and attachment to the implant
`surface. Dr. Michelson later mentioned that we will need to took at the various
`means of applying the coating. Piasrna spraying may result in excessive
`temperatures. so alternative means (so. ion beam assisted deposition?) will need
`to be explored.
`
`MSD 1043:6'3'!
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`Confidential Information - Patent Prosecution Sensitive
`
`1106_Estes
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`M NUV0278496
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`Page 8
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`Page 8
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`

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`Notes on Threaded Dowel Co
`January it. 1994
`Page 2
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`7. Greater surface area is achievable via predistraction method. This should result in
`reduced incidents of subsidence. Predistraction allows for a larger and more
`controlled working area.
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`8. Bilateral placement should allow for load bearing further peripherally on the
`stronger cortical bone along the vertebral body rim.
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`9.
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`liiac crest autograit bone is used. This oancelious autogratl is highiv osteogenic
`and should further encourage a strong fusion. Future use of active bone
`suhsfi‘tutes could be envisioned as those materiais become available. Thisis
`placed within a bone press and injected into the implant prior to implantation. The
`compressive preloading is a key feature and advantage or the system
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`II.
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`Hist
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`lal
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`no
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`i
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`F
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`‘L Clnward (1955) was the first to use a single central bone dowel for anterior
`cervical fusion.
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`to Wiiterberger (1.85?) used bilateral bone dowels for posterior lumbar interbody
`fusion.
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`3'. Crock (1981) developed the use of bilateral bone dowels for anterior lumbar
`fusion.
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`All methods use relatively weak autograit or non-osteogenic allograit.
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`ill.
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`the
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`r to i
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`eth d
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`1.
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`Protective tubular member is placed.
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`2. Distraction isaacnieed vie heelson of the bullet-nosed. long distractor.
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`3.
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`A outer sleeve (with engagement teeth) is placed in order to maintain distraction.
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`4. A diameter‘reduclng inner sleeve is placed.
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`5. A oriiii'reefier wl‘h drill stop is than ass-o to remove disc and bone.
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`6. The threaded implant is inserted into this hole. engaging the bone.
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`Overall this method protects against:
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`1. Vessel or soft tissue damage (the outertube provides protection from contact with
`surrounding tissues).
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`2. Over penetration (the fixed drill stops prevent over penetration),
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`3. Debris in wound (the system closed debris is contained within inner sleeve).
`
`MSD 1041678
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`Confidential Information - Patent Prosecution Sensitive
`
`MNUV0278497
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`Page 9
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`Page 9
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`

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`Notes on Threaded Dowel Concepts of Dr. Gary Micheison
`January it. rose
`Page a
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`4. Damage from power instruments (drill stops prevent over drilling),
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`5. Misalignment {various long distractors and individual distractors hold place during
`procedure).
`'
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`6. Loss of distraction (Long & short distractors and outer sieeve maintain distraction).
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`7. Off-center or non-parallel drilling (cavaxial use of instrumentation centered about
`initial placement and confirmation of placement of outlet-nosed distractors assures
`GVUUI ULU yluuuu n.
`“curate n'ar‘ement. outer sleeve engaged in vertebral bodies prevents
`spreading as drills engage}.
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`8. Penetration of sot! tissues or blood vessels (Blunt tips on initial long distractor
`prevents such damage. drill stops prevent over drilling).
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`IV.
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`lee-incrnuneglgnflAngwnrs
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`t.
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`Pro-distraction aiiows the iuii diameter implant to he inserted. This is in contrast to
`other methods. Without the pro-distraction method {key to Michelson) a significant
`portion oi the forward end of the implant is needed for the purpose of separating
`opposing vertebrae. This can be clearly seen in the Spine Tech BAK implant
`where a significant leadain. ramped portion is required, which significantly reduces
`the threaded portion availaoie tor lcsd~bearing and engagement.
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`2. A sharp thread can be used for the Michelson technique due to ore-distraction and
`‘
`protection oi surrounding tissues by use of the external outer sleeve distractor for
`maintenance at distraction.
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`3.
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`l was unclear about the need for an initial discectomy prior to insertion oi the intra-
`discai distractors.
`i was also unclear about the amount of disc that should be
`removed. According to Dr. Michelson. some seieot discectomy may be needed.
`This could be achieved via use oi a simple curette for removing some small
`portion oi disc prior to inserting the initial. bullet-nosed long distractors.
`a) The sequential piecemeal: oi bilateral long distractors are inserted in order to
`assess the ideal disc height. Once the proper distractor size is placed it is very
`clear that the disc has reached its ideal tension. As has been mentioned by other
`surgeons. there is a very clear stopping point at which the annulus is in maximum
`tension and the disc has been restored to its normal disc height. The surgeon will
`determine when a balanced distraction is achieved via either a tactile sensation oi
`a tight fit of the distractor or via actual radiographic confirmation of the re—
`establishment of disc height.
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`The surgeon may need to remove one of the short distractors on one side in order
`to increase disc height during balancing. The anti-sxpuision teeth may resist, but
`instrumentation exists for removing these short distractors in order to piece a
`larger distractor. An atternative procedure allows for the use of the long distractor
`only with the trephine used to drilt over this long distractor. This is especialiy
`
`Confidential Information - Patent Prosecution Sensitive
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`MNUV0278498
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`Page 10
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`Page 10
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`

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`Notes on Threaded Dovvel Concepts of Dr. Gary- Michelson
`January 11, 1994
`Page 4
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`important where lordosis may be achieved via the wedge-shaped long distractors
`that may be used to reestablish the trapezoidal shape of the disc anatomy during
`PLIF. The advantages of the short distractors center around the fact that they may
`be placed and maintain disc height and distraction while the surgeon works on the
`other side. They also allow surgeons to balance the disc space. which may be
`very important for example in the case of reducing a spondylolisthesls.
`
`5.
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`ln many cases a tap is not necessary. One would normally not tap following bone
`and disc removal in Michelson’s preferred method. This is due to the fact that if
`one were to tap prior to inserting the implant it would be possible to accidentally
`crossthread the tapped disc vertebral sndpiates. That is. the very sharp threads
`on the Michelson implant could lhhlalty bite into the vertebral bfid'y‘ cone and
`establish their own thread path as they are inserted. Obviously, it such a disc
`space had been previously tapped and were crossthreaded the implant bone
`interface would be less than ideal. The implant is, therefore. essentially sett-
`tspping and cuts very well into the canceiious vertebral body bone. The tap that is
`provided with the set does allow for ideal tapping in that it compresses the bone
`rather than actually cutténg a trough through the cone and removing valuable bone
`cells. We will need. to test the various alternatives as we proceed with this
`program to determine the need for trapping and advantages/disadvantages.
`
`8. The ideal implant configuration features the following:
`
`1. The preferred material is titanium (commercially pure or timniurn alloy).
`
`2. The implant would be porous coated or textured in order to improve implant
`anchorage,
`
`3. The implant would be coated with hyroxyapatite coating in order to enhance
`bone attachment . bone migration around and thru the implant innerspacs.
`
`4. The implant is only approximately horn in wall thickness. This is strong
`enough for short-term load bearing while a fusion occurs and provides for a
`maimcnt amount at cons within the center of the implant. as well as
`optimized bone bridging and thru-growth into the implant.
`TIM-tIn: uncut..- nun" um, wk:
`"new! inn-n me" he interrupted and selt‘locking if such additional means
`of resisting expulsion are needed.
`The; imn
`IIi‘I
`...
`(I
`IHW may
`to" thread form is sit-tapping. and
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`5:71
`
`(It
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`7.
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`the implant should be pro-loaded with autogratt bone which is compressed
`into the implant until it extrudes out at the pores of the implant.
`
`IBMQ
`
`MSD 1041680
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`Confidential Information - Patent Prosecution Sensitive
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`MNUV0278499
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`Page11
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`Page 11
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