— Confidential
`Robert Stone, Ph_D.
`
`2018
`October 09,
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Page 1
`
`WASHINGTON, D.C.
`
`
`
`Inv. No.
`
`337-TA—lllO
`
`) )
`
`In the Matter of:
`
`CERTAIN STRONTIUMeRUBIDIUM
`
`RADIOISOTOPE INFUSION SYSTEMS,
`
`AND COMPONENTS THEREOF:
`
`INCLUDING GENERATORS
`
`CONFIDENTIAL PURSUANT TO PROTECTIVE ORDER
`
`videotaped Deposition of ROBERT T. STONE, PH.D.
`
`Washington, D_C.
`
`Tuesday, October 9,
`
`2018
`
`9:11 a.m.
`
`Job No. 247455
`
`Pages:
`
`1 - 284
`
`Reported by:
`
`Dana C. Ryan, RPR, CRR
`
`
`
`
`
`10
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`ll
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`12
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`13
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`14
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`15
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`16
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`18
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`20
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`21
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`22
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`23
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`24
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`25
`
`
`
`U.S- LEGAL SUPPORT
`
`(877) 479-2484
`
`
`
`Bracco EX. 2004
`
`Jubilant V. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2004
`Jubilant v. Bracco
`IPR2018-01449
`
`

`

`Confidential
`—
`Robert Stone, Ph.D.
`2018
`October 09, 2 to 5
`
`
`
`
`
`
`
`RPE'EARANCES CONTINUED
`
`Page 4
`
`ON BEHALF OF THE RESPONDENTS:
`
`T. CY WALKER. Esquire
`Baker & Hostetler LLP
`
`Washington Square, Sulte 1100
`1050 Connecticut Avenue, Northwest:
`
`Washington. D.C. 20036
`
`(202] 861-1500
`Telephone:
`Email: cwalkembakerlaw.cmn
`
`UN BEHALF OF THE UNITED STATES lN'l'EKNM‘I‘IONM-
`
`TRADE COMKISSION:
`BRIAN K00. Esquire
`
`international Trade Commission
`{1.5.
`Office of Unfair lmport Tnvestigaticms
`500 E Street, Southwest
`Washington. D.C. 20436
`Telephone:
`:20?! 205-2580
`Email: hrian.koa@usitc.gov
`
`Also present:
`Martin Sher-rill. Videographer
`John Sun.
`L'L'C Intern
`
`CONTENTS
`EWINRTIUN DI" ROBERT T. STONE, PH.D.
`
`By MS. Bmkbinder
`
`Page 5
`
`PAGE:
`
`12
`
`'T S
`I
`F!
`E X H I
`{Attached to the Transcript)
`
`STONE DEPOSITION
`
`PAGE:
`
`l
`
`2 3
`
`4
`5
`
`6
`7
`
`8
`
`9
`10
`1].
`12
`
`13
`
`1A
`1.5
`
`16
`1'}
`1.5
`19
`20
`21
`22
`
`23
`24
`25
`
`1
`2
`
`3
`4
`5
`
`6
`7
`8
`
`9
`
`10
`
`Exhibit 1 _
`
`.13
`
`- 16
`1?
`
`18
`
`19
`
`211
`
`21
`
`2-;
`
`Exhibit 2
`
`Exhibit 3
`
`Report Of Robert T. Stoner
`Ph.IJ. 0n Noninfringement of
`
`61
`
`LLS. Patent Numbers
`
`9,750,863. 9.750.370 And
`
`5.514.826
`
`Exhibit 4 _
`
`Exhibit 5
`
`Page 2
`
`October 9, 2015
`9:11 a.:r..
`
`videotaped Deposition of ROBERT '1‘.
`STONE, PH.D., held at the law offices of Greenberg
`
`Traurig. LLP, 2101 1, Street, Northwest‘
`Washington. D.C., before Dana C. Ryan, Registered
`Professional Repuzter. Certified Realtirne Reports:
`and Notary Public in and for the District of
`Columbia, who officiated in administering the oath
`to the witness.
`
`RPFEJ‘ARANCES
`
`Page 3
`
`ON BEHALF OF THE CGMPLAINANT:
`JULIE HODKBINDER, Esquire
`DLEANA IEREGR. Esquire
`
`Greenberg ‘i'raurig. LL?
`MetLiEe Building
`200 Park Avenue
`
`New York. New York 10166
`
`(2121 801-9200
`Telephone:
`Email: bookbinder‘jfijgtiawtom
`Rmai 1:
`ieregaoEgL law . com
`
`and -
`
`MARK G. DAVIS] Esquire
`Goodwin Procter LL?
`
`901 New York Avenue. Northwest
`
`Washington. D.C. 20001
`
`Telephone:
`
`{202} 346-fi000
`
`Email.- markdavzsagmdwinlawtom
`
`
`
`U.S. LEGAL SUPPORT
`(877) 479—2484
`
`
`
`
`
`12
`13
`14
`lb
`16
`
`1.7
`
`19
`211
`
`21
`22
`
`23
`2-1
`25
`
`10
`ll
`12
`1.!
`14
`15
`
`16
`11‘
`
`15
`19
`20
`21
`22
`
`23
`2'1
`25
`
`

`

`
`
`Robert Stone, Ph.3.
`— Confidential
`
`October 09, 2018
`6 to 9
`
`E X H 1 3 I T 3
`
`C O N T 1 N U E D
`
`Page 6
`
`{Attached :0 the Transcript]
`
`$$UN£ UEPOS1TEON
`
`“AGE
`
`l
`
`2
`3
`
`E X H T 3 I T 5
`
`C O N T l N U E D
`
`Page 8
`
`[Attached to the Transcript.)
`STONE DEPOSITION
`
`PACE:
`
`135
`
`
`
`Exhibit.
`
`5 — A!
`5
`
`Exhibit
`
`17‘
`
`6.5. Patel]; Nuliibcl. 9,597,553
`Bates Stamped
`
`FBODDESS_0001 Through 0036
`
`Exhibit
`
`l— m
`
`Exhibit 1 B
`
`ExhibiL 20
`
`Exhibit 2 l
`
`Exhibit. 22
`
`
`
`Exhibit B
`
`Exhibit. 9
`
`E‘xhibit 10
`
`Exhibit
`
`1-)
`
`EXHIBITS CDNTIKJED
`
`“Anna
`S'l’UNS LJEl’OSI'l'iON
`
`to the TrauschpL}
`
`.
`
`Exhibit
`
`1.2
`
`Report of Robert
`
`'1'.
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`'cone.
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`24
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`
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`
`2
`3
`
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`
`Page 7
`
`:JAC-L'
`
`124
`
`EXHLBLTSCONTINUEH
`
`Page 9
`
`mztac‘ned :o the Transcrxp‘c}
`3'90sz 1:5?QSITIGN
`
`PAGE.-
`
`Exhibit 2.1—
`
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`19
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`L2
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`9,?50,aes. 9,750.870 Ami _
`
`thiblt -3
`
`2r-—
`Exhibit
`8
`'
`§,u1q,azs
`133 —
`1.1.9. Patent Number 9, 350.869
`was Stamped —
`
`BRACCOL'I'CUGMCOBZ Through —
`
`
`
`a
`
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`
`5.4
`
`ExiubJ: 15
`
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`mes 'wmped _
`ammzrcncmma Through *
`”0010152 —
`3.5. Patent. Number. 9.814.325
`132
`17
`Exhibit 26
`0.5. Pa:ent Applicafion
`Bates SLamped
`18
`Publication Number
`
`200
`
`BRECCOITC‘GBBIO'LGB ThrKnlg'n
`0001020?
`3.5. Pam-m Number 3.703.352
`
`135
`
`19
`20
`21
`
`
`
`biz. 16
`
`200320172125. Hines Stamped
`JD:-
`ITC 055125369 Through
`600126482
`
`-'J.S. Patent Number 6.626.862.
`22
`22
`Bums Stampeé
`23
`23
`Jm-ITC-nafluaaso Through
`2'!
`2-:
`000128363
`25
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`
`
`Bates Stamped
`BRACC‘CTTCOGGGwRS Thrmmgh
`00004959
`
`Exhibzz 2'!
`
`205
`
`U.S. LEGAL SUPPORT
`(877} 479-2484
`
`

`

`Robert Stone, Ph.D.
`October 09,
`
`Confidential
`10 to 13
`2018
`
`I
`
`I
`
`Page 10
`
`PAGE:
`
`210
`
`21].
`
`245
`
`2??
`
`EXHIBITS CONTINUED
`[Attached to the Transcript!
`STONE DEPOSITION
`
`Exhibit 23
`
`Exhibit 29
`
`Exhibit 30
`
`Exhibit 11
`
`Document Written In Japanese
`Bates Stamped
`J'DI‘ITC' 000131471 Through
`000131432
`
`English Translation Of Stone
`Deposition Mlibit 28. Bates
`Stamped JDI-ITC-DDOIZSBEB
`Through 000129335
`
`Klein Thesis Bates Stamped
`JDI-ITC‘DDDI27743 Through
`000127885
`Bracco CardioGen-Bz User's
`
`Manual Bates Stamped
`
`emccorrcoomnsa Through
`
`00011306
`
`I
`
`|
`
`I
`
`1
`2
`3
`
`4
`5
`6
`7
`
`8
`9
`10
`11
`
`12
`13
`14
`15
`
`15
`
`' 1-?
`
`I 1819
`
`'20
`21
`
`'22
`
`23
`
`'24
`
`I25
`
`PRiDC EE DI N(}S
`
`Page 11'
`
`THE VIDEOGRAPHER: This is the
`videotaped deposition of Dr. Robert T. Stone in
`the matter of Certain Strontium—Rubidium
`
`in the
`Radioisotope Infusion Systems, et .31.,
`United States International Trade Commission in
`Washington, D.C.
`This deposition is being held at
`Greenberg [sic], LLP, on October 9th, 2018, at
`approximately 9:11 a.m.
`My name is Martin Sherrill from US.
`
`legal Support, and I'm the video specialist. The
`court reporter today is Dana Ryan, also from US.
`Legal Support.
`
`will the comsel please state their
`appearance for the record?
`
`(Counsel state appearances for the
`
`video record.)
`THE VIDHIRGEHER: Will the court
`
`reporter please shear in the witness?
`——————————————
`
`enoor.moe,mii,
`
`having been duly sworn. testified as follows:
`..............
`
`
`
`I
`
`I
`
`I
`
`1
`
`2
`3
`4
`
`5
`6
`7
`8
`9
`10
`11
`
`12
`13
`14
`
`15
`16
`
`i 1'?
`
`I 18
`19
`
`|2U
`21
`
`ln
`
`23
`I 24
`25
`
`
`
`10
`‘11
`12
`13
`1a
`15
`16
`1'."
`13
`19
`20
`21
`22
`
`23
`2‘1
`25
`
`mmqmmbme
`MNNNMNl—‘h—‘l—‘l—‘I—‘P—‘l—‘D—‘l—‘I—IUWDhLJNHDKDthmLHerJNF-‘O
`
`Page 12
`swnmnmsrmnmnnnnnomummn
`BY MS. BCOKBINDER:
`
`Q
`A
`
`Good morning, Dr. Stone.
`Good morning.
`
`As you heard, w name is Julie
`Q
`Bookbinder, counsel for the cmplainant in this
`investigation in which the respondents are
`Jubilant DraxIrrege Ind, Jubilant Pharma Limited,
`and Jubilant Life Sciences.
`
`Are you comfortable if we go ahead and
`call the oorrplainant by Bracco?
`A
`Yes.
`
`And can we call the respondents
`Q
`Jubilant or JDI?
`A
`Yes.
`
`Are you familiar with the investigation
`Q
`that we just referenced?
`A
`Yes.
`
`And how are you familiar with that
`Q
`investigation?
`
`I was engaged by counsel to form
`A
`opinions with regard to several different factors,
`
`validity of the patents, et cetera.
`Q
`Could you expand on the et cetera,
`other types of opinions you were engaged to
`
`Page 13
`
`provide?
`Whether or not the products that are
`A
`accused infringed and, again, whether the patents
`were valid.
`
`
`
`Q
`that right?
`A
`
`Okay. You've been deposed before,- is
`
`Yes.
`
`Q
`
`About how many times?
`
`Probably betWeen 15 and 20. maybe more.
`A
`okay. Do you recall how Irony of those
`Q
`arepatent(mses?
`A
`I believe the uajority of those were
`patent cases.
`
`Q
`
`Okay.
`
`So just a reminder on the, kind
`
`of, ground rules for the deposition. You've been
`doing well the first couple of minutes here to
`
`speak clearly. We need to be careful not to speak
`over each other.
`Please let me lmow if you don't
`
`understand a question; I can try to rephrase it.
`we‘ll take a break about every heur.
`If you need
`to take a break at any other time,
`just let me
`lmow. As long as a question is not open. I‘ll ask
`
`you to answer that before taking a break.
`Is there any .. anything about that
`that's not clear?
`
`U.S. LEGAL SUPPORT
`479~2484
`(877)
`
`

`

`Robert Stone,
`
`October 09, 2018
`
`Confidential
`
`14 to 17
`
`P11. D.
`
`1
`2
`
`3
`4
`
`5
`6
`7
`B
`9
`
`10
`
`11
`12
`
`A
`Q
`
`No.
`Okay.
`
`Is there any reason you can't
`
`Page 14
`
`provide full and truthful testimony today?
`A
`No.
`
`Okay. Did you prepare for today's
`Q
`deposition at all?
`A
`Yes.
`Q
`What did you do to prepare?
`A
`I reviewed the reports that I had
`
`prepared.
`
`I discussed them with counsel. And
`
`that's basically it.
`Q
`Did you review any materials other than
`
`I
`I
`
`.
`
`1
`2
`
`3
`4
`
`5
`6
`7
`a
`9
`
`-10
`
`I11
`12
`
`Page 16
`onimetry and one of those cases related to a
`device which administered a therapeutic to a
`
`patient.
`Q
`
`What type of therapeutic?
`
`In this particular case. it was a
`A
`therapeutic gas.
`Q
`In addition to the patent matters in
`which you've been deposed or testified at trial,
`approximately how many other patent matters have
`
`you been engaged to work on over time?
`
`I'm not sure I understand. What do you
`A
`mean by "patent matters."
`
`your reports?
`A
`Yes.
`
`Q
`A
`
`0
`A
`
`What materials were those?
`Reports andfor declarations by others.
`
`Any other materials?
`I recall the Klein thesis. There were
`
`some others; I don't recall particularly which
`ones.
`
`Do you recall whether you reviewed any
`Q
`materials that were not cited in either of your
`reports?
`a
`Q
`
`I do not have any such recollection.
`Okay. Who's your current employer?
`
`' 13
`I14
`
`I15
`16
`
`!17
`! 18
`
`'19
`20
`
`'21-
`22
`23
`24
`25
`
`0
`
`Sure.
`So have you been engaged, for example,
`
`by a law firm to work on a patent case but it
`didn't come to pass that you were deposed.
`
`I do not recall any at this time that
`A
`that occurred.
`
`Okay. Have you been retained not
`Q
`through a law firm but just by a -- you know, a
`
`private company to consult on —— on their patent
`issues.
`I worked for a —— I'll -- I do recall
`A
`one that did ~— was not w- it did not go to trial.
`However, it was through a law firm that I was
`
`13
`14
`
`15
`16
`
`1?
`18
`
`19
`20
`
`21
`22
`23
`24
`25
`
`1
`2
`3
`
`4
`5
`6
`7
`S
`9
`10
`
`11
`12
`13
`14
`
`15
`16
`1'?
`13
`
`15
`20
`21
`22
`
`
`
`
`A
`Q
`business?
`
`I am my current employer.
`Okay. Do you have a name of your
`
`Page 15'
`'
`'
`.
`
`1
`2
`3
`
`Page 1?
`engaged to do what was called a patent challenge.
`Q
`Was that at the patent office?
`A
`No.
`
`It's called Medical Design
`Yes.
`A
`Solutions. Incorporated.
`Q
`How long have you had that business?
`A
`It was formed in December of 2011.
`Q
`How mnch of your time is spent on
`litigation consulting and other litigation
`Hatters?
`
`A Wt less than SD percent.
`Q
`You said earlier you've heen deposed
`roughly 15 to 20 times. Have you also testified
`before a court or the ITC or other tribunal like
`
`I
`I
`.
`
`4
`5
`6
`7
`8
`9
`- 10
`
`11
`12
`13
`14
`
`Could you explain what you {lean by a
`Q
`patent challenge?
`A
`when a -_ a pharmaceutical company is
`going to put a drug on the market, it's usually --
`my understanding is that they have that they call
`an internal patent challenge to make sure that
`their product would not infringe on anyone else's
`
`product before that particular pharmaceutical in
`particular goes to the FDA for approval. And I
`participated in doing the search to determine if
`that was the case.
`
`that?
`
`A
`Q
`a
`
`15
`16
`Yes.
`1‘?
`About how many times?
`I think four times that I've testified - 13
`
`Do you recall what type of
`Q
`pharmaceutical that related to?
`A
`It was a -- an electrophoretic drug
`delivery device.
`
`before a court or tribunal.
`Q
`Okay. Were those in patent cases?
`A
`Yes.
`Q
`could you just give a high-level
`
`.19
`20
`'21
`I22
`
`Could you explain what an
`Q
`electrophoretic drug delivery device is?
`A
`Specifically, it was a device that has
`a power source internal to it, and it produces an
`
`23
`24
`25
`L____
`
`overview of the technology fndn those about four
`cases?
`A
`
`electrical field across a medication patch which
`I23
`opens up pores in the skin and drives the drug
`24
`into the skin.
`25
`Three of those cases related to pulse
`
`
`11.8. LEKERL EHJPPCHRT
`(877) 479—2484
`
`

`

`— Confidential
`Robert Stone, Ph.D.
`
`2018 18 to 21
`October 09,
`
`(
`
`I'
`
`Q
`
`And that's a wearable device?
`
`Page 18'
`
`Yes.
`A
`Have you ever worked on any litigation
`Q
`or nonlitigation engagements relating to rubidium .
`radioactive elution systems before this case?
`A
`No.
`Q
`Have you ever worked on any engagements
`
`I
`
`I
`
`relating to any other radiophamaceutical infusion
`systems?
`A
`
`Litigation, no.
`
`How about nonlitigation?
`Q
`I have worked on injector systems for
`A
`devices that delivered various
`
`radiopharmaceuticals and contrast agents for
`medical
`imaging.
`Q
`What
`specifically?
`A
`I‘m not at liberty to divulge.
`
`types of radiopharmaceuticals
`
`Q
`A
`
`Okay. Were they elution systems?
`I do not recall.
`
`In the case of devices delivering
`Q
`contrast agents. were those elution system?
`A
`I don‘t recall.
`
`is a contrast agent
`In general,
`Q
`delivered through an elution system wherein a
`
`Page 19
`
`reaction takes place in the system?
`A
`It might be.
`It could be an already
`prepared drug, an already prepared contrast agent
`or one that is elution. Those are very similar in
`
`their mechanism of delivery.
`Q
`Can you give an example of a contrast
`agent that is prepared in an elution system on the
`on”
`
`I know that rubidium, for example,
`A
`definitely prepared on the spot.
`Q
`Do you consider rubidium to be a
`contrast agent?
`
`is
`
`A
`
`It's not so much a contrast agent as an
`
`agent that produces an image from the -- the
`radioactivity.
`
`Separate from rubidium, are there any
`Q
`other contrast agents in separate -- strike that.
`
`1
`
`2
`3
`4
`5
`6
`'3'
`
`8
`9
`10
`
`11
`12
`13
`
`14
`15
`16
`1'?
`18
`
`19
`2i]
`
`21
`22
`23
`
`24
`25
`
`1
`2
`3
`4
`
`5
`6
`'3
`8
`9
`10
`11
`12
`
`13
`
`14
`15
`
`16
`1?
`
`Ifllmmtaem.
`Separate from rubidium are you aware
`
`In
`19
`
`of any other contrast agents that are prepared in
`an elation system?
`A
`I am —— I am not -- looked at that, no.
`
`I 20
`21
`I22
`
`A
`
`I do not believe 30.
`
`Page 20
`
`Q
`this case?
`
`All right. When were you engaged in
`
`I believe it was approximately in May
`A
`of this year.
`Q
`AnddoyouluiovIabouthowrrenyhours
`
`you've worked on this case so far?
`A
`I do not.
`
`Q
`
`Okay.
`
`Do you know —— have you billed
`
`any time yet on this matter?
`A
`My accounting agent has.
`
`Q
`billed?
`
`Okay. Doyouloiowhowrmch has been
`
`A
`
`No,
`
`I don't.
`
`Did you inspect any physical devices in
`Q
`your work in this case?
`A
`Yes.
`
`Q
`
`A
`
`Do you recall which ones?
`
`I inspected devices at -- both at
`
`Bracco and I inspected devices at Jubilant.
`Q
`Starting with your inspection at
`Bracco, where did that occur?
`
`A
`Q
`A
`
`At their headquarters.
`Is that in New Jersey?
`That‘s their headquarters in New Jersey
`
`Page 21
`
`right near Princeton.
`Q
`When did you go up to New Jersey?
`A
`In September,
`I believe.
`Q
`Which devices did you view there?
`A
`I don't recall the model of the device.
`
`I have pictures of it. but I do not recall the
`name of the model.
`
`Okay. Did you inspect more than one
`Q
`model or just one?
`
`1 inspected two models.
`A
`About how long did you spend performing
`Q
`that inspection?
`A
`Approximately half an hour.
`Q
`Turning to your inspection at Jubilant,
`where was that?
`That was in Montreal.
`
`3-5035
`
`Q
`Jubilant?
`
`When did that take place?
`
`Also in September.
`And what devices did you review at
`
`A
`
`There were three different models of
`
`
`
`\flmdmmhfitt-JNH
`mathI—tokomqmmowwiao
`mmqmmfiwwifl
`mnwmp—uommqmmmwmwo
`
`MMNMNMHHHHHHHHHH
`
`MMNMMNHHHHr—IHHHHH
`
`
`
`the RiJBY—FILL that were inspected, and there was a
`model of an older device I believe very, very
`23
`Q
`In your prior engagements have your
`similar to the device —- excuse me —— of the --
`I 24
`qualifications ever been challenged in terms of
`the client thesis.
`I 25
`your expertise in the matter?
`
`
`ILEGHAI. SIJPENDIFT
`[1.8 .
`(877) 479—2484
`
`

`

`— Confidential
`Robert Stone, Ph.D.
`
`
` October 09, 2018 22 to 25
`
`Page 22
`l — 1
`— 2
`— 3
`— 4
`— E-
`— E
`— 7'
`— e
`— 9
`— m
`— n
`— 12
`— 13
`— M
`—
`15
`Could you elaborate on that“:1
`16
`Q
`16
`the
`Mnen one produces a medical. device,
`1'?
`A
`17
`18
`product that actually goes out and is sold has to
`18
`19
`be manufactured under good manufacturing
`19
`2D
`procedures and policies. However,
`in order to get
`20
`21
`to that point, one has to do clinical trialsr
`21
`22
`verificationfvalioation, and that‘s often done
`22
`
`Did any of the devices have saline in
`
`Page 24
`I don't recall if any generators were actually in
`eleee-
`Q
`peace?
`I don't recall.
`A
`Did any of the devices have a computer
`Q
`screen, a monitor?
`e
`ree-
`Q
`Were any of the monitors turned on?
`e
`den-e believe
`e
`eke- me yee write your -- eeur tee
`reports yeeeeeee
`A
`I prepare the report in collaboration
`with eeeeeeye
`Q
`Did you discuss your reports with
`anyone besides the attorneys?
`A
`No.
`Q
`And when you say the ”attorneys, " are
`you referring to Mr. Walker and his team?
`A
`Yes.
`Q
`Did you have any —— or —— strike that.
`Are you aware that Jubilant has several
`
`23
`24
`25
`
`1
`2
`
`using prototype devices.
`And as long as there are no substantial
`changes between the prototype and the product.
`
`23
`24'
`' 25
`
`other retained experts in this case?
`A
`Yes.
`I'm not aware of all of them.
`Q
`Okay. Did you have any discussions
`
`Page 23
`that data is useful for actually getting approval
`of the device.
`
`1
`2
`
`Page 25
`with any of Jubilant‘s other experts in your work
`on this case?
`
`3 — 3
`— 4
`— e
`— 6
`— ’1
`—
`8
`9
`9
`10
`1D
`11
`11
`12
`1.2
`13
`13
`
`The older device that you mentioned
`Q
`that you said was similar to the device of the
`Klein thesis, was that a device that had been in
`commercial use?
`A
`I have no idea.
`
`14
`15
`16
`17"
`
`18
`19
`20
`21
`22
`
`All right. And how long did that
`Q
`inspection last at Jubilant?
`A
`Forty-five minutes to an hour.
`Q
`Both in your visits to Bracoo and
`
`Jubilant, were any of the devices that you viewed
`plugged in and able to run?
`A
`I certainly did not run any of the
`devices.
`I don't knot-I if they were plugged in.
`don't recall.
`
`I
`
`14
`15
`16
`17"
`
`. 18
`19
`20
`21
`22
`
`I do not recall. There might have been
`A
`one phone call with a brief question, but I do not
`recen-
`If it helps, I'll run through the
`Q
`names. You can let me know if you recall speaking
`to them.
`
`There's a Dr. Murphy.
`It —— it won't help.
`Okay. Well,
`just a couple more.
`Dr.
`—— Mr.
`\FanderVeen {phonetic}?
`(Witness shakes head.)
`
`Dr. Lewin [phonetic] ?
`{Witness shakes head.)
`And Mr. Clark?
`I‘ve certainly seen Mr. Clark's —— some
`
`A
`Q
`
`A
`
`Q
`A
`Q
`A
`
`
`
`I do not recall
`
`comments from Mr. Clark.
`discussing them.
`Q
`When you say "consents, " could you be
`more specific?
`A
`I believe they were expert ——
`
`
`
`Did any of them have generators in
`
`extractions from his report.
`23
`Q
`23
`Q
`What is your billing rate in this case?
`24
`place?
`24
`A
`My billing rate is $450 an hour.
`25
`l iniow I saw a generator on the table.
`A
`25
`
`
`U.S. LEGAL SUPPORT
`
`(877) 479—2484
`
`

`

`- Confidential
`
`2018 26 to 29
`
`l
`
`J
`
`Page 28
`of which were sent in —— spent in schools for
`
`electronics, nuclear engineering, nuclear safety,
`various aspects of the overall nuclear power and
`
`power generation fields.
`Then with my undergraduate degree at
`Virginia Tech I obtained a bachelor of science in
`
`imaging did you
`
`electrical engineering and a master of science in
`electrical engineering. And then Stanford
`University I obtained a Ph.D.
`in electrical
`engineering with a specialty in medical
`imaging
`and information systems.
`0
`what
`types of medical
`work on in your Ph.D. work?
`A
`The type of imaging that I worked on
`was imaging that would relate to a
`energy—sensitive photon—counting detector
`specifically to be applied to computed tonography.
`but it had applications in various other fields as
`well,
`including radiation imaging.
`'I‘ltnoughout your educational and
`O
`military service, did you work on any
`radiopharmaoeutical infusion stems?
`A
`While at Stanford, we, as a group,
`
`worked on concepts for positron emission
`tomography for medical
`-~ magnetic resonance
`
`imaging and for corputer tomography.
`0
`Okay. And did you work on the imaging
`side of that or the infusion side of those
`
`Page 29
`
`concepts?
`A
`
`side.
`
`At that time I worked on the imaging
`
`So you've never, for example, designed
`Q
`or operated a radiopharmaceutical infusion system?
`A
`While I was at Virginia Tech, we
`
`develOped a concept infusion system to be utilized
`with an alternate, slorter halt-life
`
`radiopharrraceutical, but we never brought it into
`production.
`Q
`
`Do you recall what the
`
`radiopharmaceutical was?
`A
`I‘ve been stretching my n'enory, and
`
`that was more than 30 years ago, and I do not
`recall.
`
`Q
`
`Okay.
`
`So that was in your -- in your
`
`undergrad time after your Navy service?
`A
`Yes.
`
`21
`I spent six years in the United States
`A
`22
`Navy —- excuse me. Well, sorry. Let's do Start
`23
`with undergraduate. One year at Pepperdine
`Q
`We discussed —— earlier we mentioned a
`24
`University as a premed major. Six years in the
`couple of times elution. Can you please aplain
`25
`United States Navy,
`three years and eight months
`
`0
`A
`
`Okay. And that was in about the 1900s?
`That would have been in the mid-19705.
`
`[I.S. LEGAL SUPPORT
`
`(877) 479—2484
`
`Robert Stone, Ph.D.
`October 09,
` l
`
`Page 26
`Do you have the same rate for your
`
`1
`
`Q
`
`work ~— your nontestirronial work as your
`testifying mark?
`A
`Depends on the degree of the work, what
`I‘m doing.
`Sometimes I'm doing -— sorry.
`Q
`You can go ahead.
`A
`No, that's -- it does —— as I said, it
`
`2
`3
`4
`5
`6
`I
`
`8
`depends on the degree of the work. Compensation
`9
`is sometimes in the form of stock in a many
`I 10
`that I'm working for.
`in -~ in | 11
`Q
`Okay.
`So to be more specific,
`this case your rate of $450 an hour,
`is that
`12
`
`I 13
`consistent thrwghout all of your work on this
`14
`case or do you have different rates for the
`different types of work you're doing in this case? I 15
`A
`I do not have different types of rates
`I 16
`other than for travel.
`1?
`
`When you were preparing your two
`Q
`reports in this case in collaboration with the
`attorneys, did you feel at any time that you were
`lacking any information or documents that would be
`necessary to prepare the reports?
`A
`I don‘t recall any such instances.
`
`Okay. You said earlier that you
`Q
`reviewed your reports in preparation for the
`
`Page 27
`
`deposition today and tomorrow; right?
`A
`Yes.
`
`Based on your review, did you find
`Q
`there was anything you needed to revise, amend or
`supplement?
`A
`
`I believe we found one case where a
`
`date was written wrong, but other than that, no.
`0
`Okay.
`Is that a correction you'd like
`
`to make or we'll see if we get there?
`A
`Let's see if we get there.
`
`Okay. And since you've walked in
`Q
`today, you haven't thought of anything else that
`needs to -- to change in your reports?
`A
`No.
`
`O
`
`Okay. Could you give me a brief
`
`overview, please, of your education beginning with
`
`undergraduate?
`A
`How about if I back up before
`undergraduate .
`Q
`mfiW»
`
`18
`19
`20
`21
`22
`23
`
`24
`25
`
`1
`2
`
`3
`4
`5
`6
`
`'3
`a
`
`9
`in
`
`|
`
`'
`
`I
`
`I
`
`. 11
`12
`13
`14
`
`15
`
`16
`
`I 1?
`18
`l B
`20
`
`2 3 4 5 6 .
`
`1 3 9
`
`MMMMMMHHP—‘HI—‘P—‘l—‘l—‘HH
`
`U'lbbUJMi—‘Dmmdmmbhwml—ID
`tow-ammuthI—l
`NNNMMNr—‘I—‘I—‘I—‘HI—II—II—IHr—lmfiwmpommqmmauroido
`
`

`

`Robert Stone , Ph.D.
`Confidential
`
`
`October 09, 2018
`30 to 33
`
`.
`‘
`.
`your imderstanding of what elution is?
`A
`Certainly. M elute is something that
`
`Page 30 |
`
`I
`
`is derived typically from something such as an ion I
`exchange column where a -- a liquid. or in some
`cases it might be a gas, but typically it's a
`liquid that flows through a -- a container where
`
`I
`
`it‘s exposed to a surface that has ions that one
`wishes to exchange.
`
`.
`
`1
`2
`
`3
`4
`5
`6
`
`7
`8
`
`.
`_
`_
`that to be an elution infusion system?
`A
`No.
`
`Page 32
`
`Okay. Have you -— do you have any
`Q
`experience working with elution infusion systems?
`A
`I have no direct experience workirg
`with elution infusion systems.
`
`Q
`A
`
`Are you familiar with rubidium?
`I'm familiar with "any radioisotopes
`
`9
`I
`And then based on the ionic potential
`of what is going through the column versus what is I 10
`
`1 have been
`including rubidium and its concepts.
`thoroughly trained in various aspects of
`
`| 11
`attached to the column, there's an ion exchange.
`12
`And what cones out typically has the ions that
`were originally intended on the column and not the I 13
`ions -- all of the —— the same type of ions that
`I 14
`were in the liquid that went
`through it.
`15
`Q
`You mention an ion exchange column. Do
`16
`
`radioactive materials of all sorts.
`Q
`And that was through your training at
`Virginia Tech and Stanford?
`A
`No, that was through ~~ well, actually,
`including my on—the—job experience at Virginia
`Tech where we produced many radioisotopes at the
`
`you consider that to be synonymous with a
`generator, or would that be part of a generator in
`your tmderstanzling?
`
`That would be a part of the generator.
`A
`It would act in the same fashion as an ion
`exchange column.
`Q
`So more specifically than what we
`discussed a few minutes ago, do you have any
`experience working on elution systems?
`
`' 1?
`13
`19
`
`20
`21
`22
`I 23
`24
`25
`
`neutron activation analysis laboratory where I was
`managing day—to—day operations including the
`operation of the nuke reactor there.
`
`What was that nuclear reactor used for?
`Q
`Its major task was Eor neutron
`A
`activation analysis, and a secondary task was in
`training students who were majoring in nuclear
`engineering.
`Q
`What is neutron activation analysis?
`
`\omummnwwl—I
`MMNMMMI—‘I—‘J—‘l—‘HHI—II—‘i—IHmnwmr—towmqmmhuuwo
`\Om-u-JmtflihthJl—i
`mthl—‘DmmdmmufimMI—‘D
`
`MMMNMNP—‘P—‘Hl—‘HHHHHH
`
`
`
`
`
`Page 31
`With elution systems of various types.
`A
`Certainly for water purification systems, similar
`types of devices, miderstanding them, other
`colunns.
`I don't recall the —- the other types.
`Q
`You mentioned when you inspected the —‘
`the systems at Eracco and Jubilant, you weren‘t
`sure if the —— it the generator was there, but you
`saw one on the table at one of them.
`
`-
`
`1
`2
`3
`4
`5
`6
`'1'
`3
`
`I certainly saw one on the table, yes.
`A
`All right. But -- and that's the type
`Q
`of generator u
`A
`I'm sorry.
`Q
`Go ahead.
`A
`Let me correct that.
`
`E saw one on the
`
`table at both sites now that my Tremory is jogged.
`Q
`Okay. Given that it was sitting on the
`table, no elutions were —— were taking place while
`
`you were there; right?
`A
`That is correct.
`Q
`And for it -- for the elution to he
`
`occurring, a liquid need —- would need to be
`flowing through the generator?
`A
`Yes.
`
`9
`| 10
`11
`12
`13
`14
`
`15
`16
`1?
`
`. 13
`19
`20
`
`21
`22
`23
`
`Page 33
`Virtually any material that you put
`A
`into a heavy neutron flux -- that is, where there
`is a large number of neutrons -- can absorb
`neutrons and themselves beoone radioactive. When
`they do.
`they decay in a signature fashion, and
`the energy at which they decay is indicative of
`what the original material is that went into
`the ~- that neutron flux.
`
`So we had developed a system that could
`operate to place small quantities of materials
`into the reactor for various amounts of time and
`then expose it to a —- an energy discriminating
`detector that could count the level of activity
`and the particular energies of the photons that
`
`were given off, and from that infer what the
`original materials were and even their
`concentrations.
`
`This work was not directly being
`Q
`applied to the medical field?
`A
`Oceasionally it was because we could
`
`analyze very small quantities of biological
`samples, for example. various heavy metals that
`were in it.
`
`Okay. You mentioned water
`0
`purification. What else are —— would you consider
`
`24
`25
`
`So as far as —~ so. yes. it had some
`application in the medical field.
`
`U.S. LEGAL SUPPORT
`
`(877) 479m2484
`
`
`
`
`

`

`Page 34
`
`Q
`
`But this was not introducing a
`
`radioactive material into a person?
`A
`No.
`
`0
`
`Okay.
`
`there was
`Not quite. As I indicated,
`A
`a —» that's not quite true. There is more to it
`than that.
`
`Q
`
`All right.
`
`So ~~ so going back to
`
`rubidium specifically, are you —— can you recall
`
`|
`
`l
`
`2
`3
`
`4
`
`5
`E
`”.I'
`
`3
`
`9
`
`what the half—life of mbidium is?
`A
`It's in the order of ?2, 18 seconds.
`
`I
`
`don't recall the last digit.
`Q
`Based on your experience dealing with
`radioactive materials,
`is that a relatively long
`or short half-life?
`A
`Long or short always depends on one's
`
`! 10
`11
`
`'12
`| 13
`14
`15
`16
`
`perspective. That's short in that being away from 1?
`it for a very short period of time it rapidly
`18
`decays to where it's no longer detectable.
`19
`Q
`Does that —— does the __ the decay
`20
`
`relate to its safety in use in hwnans?
`A
`YES.
`
`Does having the short half-life make it
`Q
`safer to use with humans?
`
`A
`
`It means the total dose absorbed by the
`
`Page 35
`human and the tissue and its effect would be
`
`significantly less than if it were the sale
`activity but a longer half-life.
`0
`All right.
`Do you know how rubidium
`can be used in the nedical imaging context?
`
`A
`Q
`A
`
`he
`Could you explain that a little bit?
`Certainly.
`when the rubidium is injected into the
`
`21
`22
`
`23
`24
`
`25
`
`\Dmflmmuhwmk‘
`
`|
`
`I
`
`I
`|
`
`10
`body it typically is absorbed into active tissue,
`11
`particularly muscle tissue, at a more rapid rate
`because of its metabolism. As it decays,
`it gives ' L?
`off an electronic —« sorry, a positron.
`13
`That positron interacts with the
`14
`electrons and the tissues surrounding it, form
`15
`
`sorrething called an electron—positron pair. That
`electron—positron pair amihilates and gives off
`two photons, approximately .51 million electron
`volts of energy going in exactly opposite
`directions in order to conserve rrmentmn in the
`
`16
`1?
`18
`19
`20
`
`system.
`
`
`
`
`
`
`MMNNNNI—‘i—‘l—‘l—‘I—‘HP—‘Q—‘I—‘D—I
`
`mmqmu’lfiwwi—I
`wwwMHowmqmm‘h-wmwo
`mmumms—wmw
`MNNNNMHHl—‘l—‘I—‘HHHHHm-thI-Iokoooqcimpb-MMI—‘c:
`
`21
`22
`the .51 NEW, are
`And those photons,
`23
`detected in detectors -- typically an array of
`why they would want to use one other than simply
`shorter half—life. That doesn't always enter into
`24
`detectors surrounding the heart. And the time of
`the clinician's mind when he makes a decision.
`25
`arrival -- simultaneous time of arrival of tit)
`
`
`~ Confidential
`Robert Stone, Ph.D.
`
`2018 34 to 37
`October 09,
`
`Page 36
`photons at various positions around that ring are
`indicative of where in the tissue that that was
`emitted. And the number is indicative of how much
`of the rubidium had been absorbed in that
`
`particular tissue.
`So an image is allowed to be formed
`from the counting of many of those events, and the
`
`synchronicity of the arrivals allows the position.
`Q
`Are you also familiar with
`
`fluorodeounglucose infusion systems?
`A
`I've not worked with
`
`fluorodeoxyglucose ——
`Q
`Okay. For -~ for -~
`A
`n-but-—
`
`Q
`
`Go ahead.
`
`No, go ahead.
`A
`As -- for —~ for ease of everyone,
`Q
`would it be -- would it be okay if we refer to
`
`those as FDG systems?
`A
`That's fine.
`
`So you mentioned you've not
`Okay.
`Q
`worked with an FDG system before. Are you
`familiar with -- with what they are?
`A
`Yes
`
`Q
`
`Okay. Could you explain a little bit
`
`Page 3?
`
`about what they are?
`the fluro -— EDG is another
`A
`Similarly,
`phan'na— —— radiopharmaceutical which also can be
`absorbed and similarly produce an image in a
`similar fashion but with a different half—life.
`
`And specifically with an PUG infusion
`Q
`system, would that system elute arnrthing?
`A
`It's not ~~ I don't believe it's an
`
`elution.
`solution.
`
`I believe it's an already prepared
`
`And is that typically made in a
`Q
`cyclotron off—site somewhere, not on the —— not on
`the device used for the infusion?
`A
`That's correct.
`
`Are there some reasons that someone
`Q
`would want to use an elution infusion system
`rather than an FDG infusion system for the medical
`imaging?
`
`A
`
`Again, shorter half—life means less
`
`
`
`exposure —— radiation exposure to the patient and
`Why one would want to use the FDG. There are many
`reasons that might
`-— one might use to determine
`
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`D.
`Confidential
`Robert Stone, Ph.
`
`3 8 to 41
` October 09, 2018
`
`Page 38
`Are you aware of what those other
`Q
`reasons might be?
`
`Might be cost, scheduling, maintenance,
`
`A
`carplexity.
`When you say "couplexity," are you
`Q
`referring to the infusion systems, or what are you
`referring to?
`A
`The details of use.
`
`Could you explain what you mean by
`
`I
`I
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`I
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`Page 40
`generator where it was generated over into an
`infusion system would require some amazing
`
`So I would not —- I personally wouldn't
`handling.
`do it. But, again, that's a nonexpert opinion
`looking at it.
`
`All right. Are you familiar with FDA
`Q
`submissions called a new drug application or a
`510(k) application?
`A
`Yes.
`
`What the user has to Imow, what they
`
`I 10
`11
`
`Could you talk a little bit about the
`Q
`differences between those? Do you know: What
`
`that?
`
`Q
`
`A
`
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`muszI—Icnkoonqmw‘hwwa-Io
`
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`
`
`
`MMMMMMHHp—IJ—II—tl—IHr—Ii—IH
`
`have to deal with, how they have to schedule, et
`cetera.
`
`In your experience, would the elution
`Q
`infusion system or the F03 infusion system-have
`
`more oonplexity of. use?
`A
`I don't know that I would specify one
`or the other too much.
`The FDG system would have
`
`to have storage for the material that's used,
`scheduling when it would rearriv —— would arrive;
`whereas -- and —— and be presented to the infusion
`
`system. Whereas the elution system, it can be
`prepared right then, but then there are quality
`controls that need to he performed daily to make
`sure the generator is —— is correct.
`
`preference.
`
`An FDG system does