- Confidential
`Robert Stone, Ph.D.
`October 09, 2018
`
`Page 1
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, D.C.
`
`In the Matter of:
`
`)
`
`Inv. No.
`
`
`CERTAIN STRONTIUM-RUBIDIUM
`
`) 337-TA-1110
`
`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
`
`Si ais
`
`Job No. 247455
`
`Pages:
`
`1 - 284
`
`Reported by: Dana C. Ryan, RPR, CRR
`
`
`
`
`10
`
`11
`
`12
`
`13
`
`14
`
`LS
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`U.S. LEGAL SUPPORT
`
`(877) 479-2484
`
`
`
`Bracco Ex. 2004
`Jubilant v. Bracco
`
`IPR2018-01449
`
`Bracco Ex. 2004
`Jubilant v. Bracco
`IPR2018-01449
`
`

`

`-
`Robert Stone, Ph.D.
`Confidential
`2018
`October 09,
`
`bs
`
`2 3
`
`4
`5
`
`6
`7
`
`8
`
`3
`10
`uF
`12
`
`a:
`14
`
`15
`16
`
`17
`18
`
`19
`20
`21
`22
`
`23
`24
`25
`
`2
`
`2
`
`3
`
`4 5 6 7
`
`a
`3
`10
`
`13
`
`| 16
`17
`18
`
`19
`20
`
`Page 2
`
`October 5,
`3:11 a.m,
`
`20168
`
`Videotaped Deposition of ROBERT T.
`STONE, PH.D., held at the law offices of Greenberg
`
`Traurig, LLP, 2101 L Street, Northwest,
`Washington, D.C., before Dana C. Ryan, Registered
`Professional Reporter, Certified Realtime Reporter
`and Notary Public in and for the District of
`Columbia, who officiated in administering the oath
`to the witness.
`
`APPEARANCES
`
`Page 3
`
`ON BEHALF OF THE COMPLAINANT:
`
`JULIE BOOKBINDER, Esquire
`OLEANA IEREGA, Esquire
`
`Greenberg Traurig, LLP
`MetLife Building
`200 Park Avenue
`
`New York, New York 10166
`
`Telephone:
`
`(212) 801-9200
`
`Email: bookbinderjé@gtlaw,com
`Email;
`ieregao@gtlaw.com
`
`and -
`
`MARK G. DAVIS, Esquire
`Goodwin Procter LLP
`
`901 New York Avenue, Northwest
`
`Washington, D.C. 20001
`
`(202) 246-4000
`Telephone:
`Email: markdavis@goodwinlaw.com
`
`12
`13
`14
`15
`16
`
`19
`20
`
`21
`22
`
`23
`24
`25
`
`19
`11
`12
`13
`14
`15
`
`16
`LT
`
`18
`19
`20
`21
`22
`
`23
`24
`25
`
`
`
`
`
`2 to 5
`
`
`APPEARANCES CONTINUED
`
`Page 4
`
`ON BEHALF OF THE RESPONDENTS:
`
`T. C¥ WALKER, Esquire
`Baker & Hostetler LLP
`
`Washington Square, Suite 1100
`1050 Connecticut Avenue, Northwest
`
`Washington, D.C. 20036
`
`(202) 861-1500
`Telephone:
`Email: cwalker@bakerlaw.com
`
`ON BEHALF OF THE UNITED STATES INTERNATIONAL
`TRADE COMMISSION:
`
`BRIAN KOO, Esquire
`U.S. International Trade Commission
`
`Office of Unfair Import Investigations
`500 E Street, Souchwest
`
`Washington, D.C. 20436
`Telephone:
`(202) 205-2580
`Email: brian. koo@usite.gov
`
`Also present:
`Martin Sherrill, Videographer
`John Sun,
`ITC Intern
`
`CONTENTS
`
`EXAMINATION OF ROBERT T. STONE, PH.D.
`
`By Ms, Bookbinder
`
`EXHIBITS
`
`{Attached to the Transcript)
`STONE DEPOSITION
`Exhibit 1
`
`Exhibit 2
`
`Exhibit 3
`
`Report Of Robert T. Stone,
`Ph.D. On Noninfringement Of
`U.S. Patent Numbers
`
`9,750,869, 9,750,870 And
`9,814,826
`
`PAGE:
`
`12
`
`PAGE:
`
`61
`
`
`
`21 (Seep
`
`24
`
`Exhibit 5
`
`
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`

`

` a)
`
`Robert Stone, Ph.
`Confidential
`.
`6 to 9
`2018
`October 09,
`
`I
`
`1
`
`2
`4
`
`BERIBITS CONTINUED
`
`Page 6
`
`{Attached to the Transcript)
`
`STONE DEPOSITION
`
`PAGE:
`
`1
`
`2
`3
`
`EBERHITBITS CONTINUED
`
`Page 8
`
`(Attached to the Transcript)
`STONE DEPOSITION
`
`PAGE:
`
`4 6EERE=theEriia)4aExhibit Exhibit 17 U.S. Patent Number 9,597,053 135
`
`
`
`
`
`
`
`
`
`5
`Bates Stamped
`
`
`
`
`
` it
`
`Exhibit 6
`
`Exhibit §
`
`Exhibit 10
`
`» Be
`
`u be
`
`H “1
`
`21
`
`Exhibit 11
`
`25
`
`1
`
`2
`3
`
`EXHIBITS CONTINUED
`
`Page 7
`
`{
`
`STONE DEPOSITION
`
`to the Transcript)
`
`PAGE
`
`6
`7
`
`- H
`
`im be
`
`a =
`
`nN
`
`24
`25
`
`1
`
`2
`3
`
`FBOO06950001 Through 0036
`
`Exhibit
`
`” o
`
`Exhibit 19
`
`Exhibit 20
`
`Exhibit 21
`
`Exhibit 22
`
`EXHIBITS CONTINUED
`
`Page 9
`
`{Attached to the Transcript}
`STONE DEPOSITION
`
`PAGE:
`
`
`
`
`
`
`
`
`
`
`
`4 Exhibit 23ELeeeeeSeeelExhibit 12 Report Of Robert T. Stone, 124 4
`
`
`5 Ph.D. On Invalidity Of=Ee
`
`
`‘ 7aySL!1.8 Numbers
`
`
`
`7 9,750,865, 9,750,870 AndPiMiwa
`2
`9,814, 826
`8
`exhibit 24 eee
`
`
`
`5 eSeeeeExhibit 13 U.S. Patent Number 9,750,669 133
`
`
`Lo TATAaEBates Stamped
`
`
`
`
`11 BRACCOITCO0010052 ThroughFUaaa|
`
`
`
`12 12 aaeaeoco100s7
`
`
`
`13 PaeeEeeeee14 U.S, Patent Number 9,750,870 133
`
`
`
`1s Bates StampedeTLLEROSEDTR
`
`15 BRACCOTTCO0010108 ThroughHineSERSSSEOEE
`16
`ooor01s2
`ae
`17
`U.S. Patent Number 5,814,626
`17
`Exhibit 26
`U.S. Patent Application
`18
`Bates Stamped
`18
`Publication Number
`
`Exhibit 15
`
`133
`
`200
`
`13
`20
`21
`
`
`
`BRACCOITCO0010163 Through
`00010207
`U.S. Patent Number 6,708,352
`
`135
`
`19
`20
`21
`
`2008/0177126, Hates Stamped
`JDI-ITC-000126369 Through
`000126462
`
`U.S. Patent Number 6,626,862,
`22
`22
`Bates Stamped
`23
`23
`JDI-ITC-000128350 Through
`24
`24
`000128368
`25
`25
`
`
`Exhibit 27
`
`205
`
`Bates Stamped
`BRACCOITCOQ004925. Through
`oooo49ss
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`
`
`

`

`
`
`Robert Stone, Ph.D.
`October 09,
`
`Confidential
`10 to 13
`2018
`
`£
`
`:
`
`Page 10
`
`PAGE:
`
`210
`
`211
`
`245
`
`277
`
`EXHIBITS CONTINUED
`(Attached to the Transcript}
`STONE DEPOSITION
`
`Exhibit 28
`
`Exhibit 29
`
`Exhibit 30
`
`Exhibit 31
`
`Document Written In Japanese
`Bates Stamped
`JDI-ITC-000131471 Through
`000131482
`
`English Translation Of Stone
`Deposition Exhibit 28, Bates
`Stamped JDI-ITC-0001293295
`Through 000129338
`
`Klein Thesis Bates Stamped
`JDI-ITC-000127743 Through
`000127889
`Bracco CardioGen-82 User's
`
`Manual Bates Stamped
`BRACCOITCO0011254 Through
`00011306
`
`Page 12
`EXAMINATION BY COUNSEL FOR THE COMPLAINANT
`BY MS. BOOKBINDER:
`
`0
`A
`
`Good morning, Dr. Stone.
`Good morning.
`
`As you heard, my name is Julie
`Q
`Bookbinder, counsel for the complainant in this
`investigation in which the respondents are
`Jubilant DraxImage Inc., Jubilant Pharma Limited,
`and Jubilant Life Sciences.
`
`Are you comfortable if we go ahead and
`call the complainant 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
`
`|
`
`|
`
`|
`
`1
`S
`3
`
`4
`5
`6
`q
`
`a
`9
`10
`ll
`
`12
`13
`14
`15
`
`16
`| 17
`| 18
`19
`
`| 20
`2l
`
`| 22
`
`23
`| 24
`|=
`
`1¢
`11
`12
`13
`14
`1s
`16
`17
`16
`13
`20
`21
`22
`
`23
`24
`25
`
`
`
`1
`
`2
`3
`4
`
`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?
`
`5
`6
`7
`8
`9
`10
`ll
`
`Probably between 15 and 20, maybe more.
`A
`Okay. Do you recall how many of those
`Q
`are patent cases?
`A
`I believe the majority of those were
`12
`Legal Support, and I'm the video specialist. The
`patent cases.
`court reporter today is Dana Ryan, also from U.S.|13
`Legal Support .
`14
`Q
`Okay.
`So just a reminder on the, kind
`
`PROCEEDINGS
`
`Page 11)
`
`THE VIDEOGRAPHER: This is the
`videotaped deposition of Dr. Robert T. Stone in
`the matter of Certain Strontium-Rubidium
`
`Radioisotope Infusion Systems, et al., in the
`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 U.S.
`
`|
`
`|
`
`|
`
`woonmhwoSewehwFH
`NMNYNNHEPEPPPPPPPweWwNHeSOCDOOeHYmhWeYSweYFGS
`
`Will the counsel please state their
`appearance for the record?
`(Counsel state appearances for the
`video record.)
`THE VIDEOGRAPHER: Will the court
`
`reporter please swear in the witness?
`we ee ee ee ee
`
`ROBERT T. STONE, PH.D.,
`having been duly sworn, testified as follows:
`Vela ee Se
`
`
`
`ES
`16
`17
`| 18
`19
`
`| 20
`21
`
`| 22
`23
`24
`
`| 25
`
`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 know if you don't
`
`understand a question; I can try to rephrase it.
`We'll take a break about every hour.
`If you need
`to take a break at any other time,
`just let me
`know. 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)
`
`

`

`Ph. D.
`Confidential
`Robert Stone,
`
`
`October 09, 2018
`14 to 17
`
`1
`2
`3
`a
`
`5
`6
`7
`8
`9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`
`Page 14
`
`A
`No.
`0
`Okay.
`Is there any reason you can't
`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
`
`I discussed them with counsel. And
`prepared.
`that's basically it.
`Q
`Did you review any materials other than
`your reports?
`A
`Yes.
`Q
`What materials were those?
`A
`Reports and/or declarations by others.
`Q
`Any other materials?
`A
`I recall the Klein thesis. There were
`
`|
`1
`|
`2
`,3
`4
`
`5
`6
`7
`8
`9
`
`| 10
`| 11
`12
`113
`| 14
`| 15
`16
`117
`| 18
`
`Page 16
`oximetry 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?
`A
`I'm not sure I understand. What do you
`mean by "patent matters."
`Q
`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.
`A
`I do not recall any at this time that
`that occurred.
`
`some others; I don't recall particularly which
`ones.
`
`Okay. Have you been retained not
`9
`| 19
`19
`through a law firm but just by a -- you know, a
`20
`20
`private company to consult on -- on their patent
`| 21
`Do you recall whether you reviewed any
`Q
`21
`issues.
`22
`materials that were not cited in either of your
`22
`I worked for a -- I'll -- I do recall
`A
`23
`reports?
`23
`one that did -- was not -- it did not go to trial.
`24
`I do not have any such recollection.
`A
`24
`25
`Q
`Okay. Who's your current employer?
`25
`However, it was through a law firm that I was
`
`
`
`
`
`1
`2
`3
`
`4
`5
`6
`7
`8
`9
`10
`
`11
`12
`13
`14
`
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`—
`
`A
`Q
`business?
`
`I am my current employer.
`Okay. Do you have a name of your
`
`Page 15)
`}
`|)
`Te:
`
`It's called Medical Design
`Yes.
`A
`Solutions, Incorporated.
`0
`How long have you had that business?
`A
`It was formed in December of 2011.
`Q
`How much of your time is spent on
`litigation consulting and other litigation
`matters?
`
`Somewhat less than 50 percent.
`A
`You said earlier you've been deposed
`Q
`roughly 15 to 20 times. Have you also testified
`before a court or the ITC or other tribunal like
`
`|
`||
`
`4
`5
`6
`%
`8
`9
`| 10
`
`ll
`12
`13
`14
`
`Page 17
`engaged to do what was called a patent challenge.
`0
`Was that at the patent office?
`A
`No.
`
`Could you explain what you mean by a
`0
`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 what 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?
`
`Do you recall what type of
`Q
`15
`pharmaceutical that related to?
`A
`16
`Yes.
`A
`It was a -- an electrophoretic drug
`Q
`17
`About how many times?
`delivery device.
`A
`I think four times that I've testified | 18
`Q
`Could you explain what an
`before a court or tribunal.
`| 19
`electrophoretic drug delivery device is?
`Q
`Okay. Were those in patent cases?
`20
`A
`Specifically, it was a device that has
`A
`Yes.
`| 24
`a power source internal to it, and it produces an
`Q
`Could you just give a high-level
`| 22
`electrical field across a medication patch which
`overview of the technology from those about four
`| 23
`opens up pores in the skin and drives the drug
`cases?
`24
`into the skin.
`A
`25
`Three of those cases related to pulse
`
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`

`

`- Confidential
`Robert Stone, Ph.D.
`
`2018 18 to 21
`October 09,
`
`f
`
`+
`
`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.
`0
`Have you ever worked on any engagements
`
`|
`
`|
`
`relating to any other radiopharmaceutical infusion
`systems?
`A
`
`Litigation, no.
`
`How about nonlitigation?
`0
`I have worked on injector systems for
`A
`devices that delivered various
`
`yadiopharmaceuticals 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
`0
`contrast agents, were those elution systems?
`A
`I don't recall.
`
`is a contrast agent
`In general,
`QO
`delivered through an elution system wherein a
`
`A
`
`I do not believe so.
`
`Page 20
`
`Q
`this case?
`
`All right. When were you engaged in
`
`I believe it was approximately in May
`A
`of this year.
`Q
`And do you know about how many hours
`
`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.
`
`Do you know how much has been
`
`A
`
`No,
`
`I don't.
`
`Did you inspect any physical devices in
`QO
`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
`QO
`A
`
`At their headquarters.
`Is that in New Jersey?
`That's their headquarters in New Jersey
`
`1
`
`2
`3
`4
`5
`6
`7
`
`8
`9
`10
`
`11
`12
`13
`
`14
`15
`16
`l7
`18
`
`19
`20
`
`21
`22
`23
`
`24
`25
`
`Page 19
`
`Page 21
`
`
`
`right near Princeton.
`1
`reaction takes place in the system?
`Q
`When did you go up to New Jersey?
`2
`A
`It might be.
`It could be an already
`A
`In September,
`I believe.
`3
`prepared drug, an already prepared contrast agent
`or one that is elution. Those are very similar in|4
`Q
`Which devices did you view there?
`A
`I don't recall the model of the device.
`
`
`
`woweyDWWeWwhe
`MoMNMMNNMHYFeewBEFPHeBeBeWFWMFPSGbeoyAneWwweHYoO
`wowOmHDWm&BRoe
`[oeeeuo8YWSPSoSbwaTHoeweEY
`
`their mechanism of delivery.
`Q
`Can you give an example of a contrast
`agent that is prepared in an elution system on the
`spot?
`
`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 mich a contrast agent as an
`
`agent that produces an image from the -- the
`radioactivity.
`
`5
`6
`7
`8
`9
`10
`11
`12
`
`13
`
`4
`15
`
`Separate from rubidium, are there any
`Q
`other contrast agents in separate -- strike that.
`I'll start again.
`Separate from rubidium, are you aware
`of any other contrast agents that are prepared in
`an elution system?
`A
`I am -- I am not -- looked at that, no.
`
`16
`17
`| 18
`19
`| 20
`21
`| 22
`
`T 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?
`
`I inspected two models.
`A
`About how long did you spend performing
`Q
`that inspection?
`A
`Approximately half an hour.
`Q
`Turing to your inspection at Jubilant,
`where was that?
`That was in Montreal.
`
`PO
`
`Q
`Jubilant?
`
`When did that take place?
`
`Also in September.
`And what devices did you review at
`
`A
`
`There were three different models of
`
`the RUSY-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
`| 24
`qualifications ever been challenged in terms of
`similar to the device -- excuse me -- of the --
`the client thesis.
`(25
`your expertise in the matter?
`
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`

`

`- Confidential
`Robert Stone, Ph.D.
`October 09, 2018
`22 to 25
`
`
`
`
`Page 24
`Page 22
`
`1oeaeeeWS1 I don't recall if any generators were actually in
`MS
`
`EaEe 3 oO Did any of the devices have saline in
`
`EE
`
`
`Shaeewe!5 A I don't recall.
`
`(TASaeeeaieGaee,& QO Did any of the devices have a computer
`
`
`
`eapSseae=|7 screen, a monitor?
`a A
`Yes.
`
`ennaPEAenWargoee9 Q Were any of the monitors turned on?
`
`TTI AT don't believe so.
`La Q
`Okay. Did you write your =~ your two
`
`[STeeeEST12 reports yourself?
`
`REEanaeerPed A I prepare the report in collaboration
`
`co
`operas
`15
`Q
`Did you discuss your reports with
`Could you elaborate on that?
`16
`Q
`16
`anyone besides the attorneys?
`the
`When one produces a medical device,
`17
`A
`17
`A
`No.
`18
`product that actually goes out and is sold has to
`18
`Q
`And when you say the "attorneys," are
`19
`be manufactured under good manufacturing
`19
`you referring to Mr. Walker and his team?
`
`
`
`20 in order to get|20procedures and policies. However, A Yes.
`
`21
`to that point, one has to do clinical trials,
`21
`Q
`Did you have any -- or -- strike that.
`22
`verification/validation, and that's often done
`22
`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?
`
`
`
`
`
`I do not recall. There might have been
`A
`3 ies Sites
`
`iarieeeanEneae!4 one phone call with a brief question, but I do not
`NOTES
`If it helps, I'll run through the
`hee
`6
`Q
`
`EEReaveSeDP7 names. You can let me know if you recall speaking
`Reese
`8
`to them.
`9
`9
`10
`10
`11
`11
`12
`12
`13
`13
`
`The older device that you mentioned
`0
`that you sald was similar to the device of the
`Klein thesis, was that a device that had been in
`commercial use?
`A
`I have no idea.
`
`There's a Dr. Murphy.
`It -- it won't help.
`Okay. Well,
`just a couple more.
`Dr.
`-- Mr. VanderVeen (phonetic)?
`(Witness shakes head.)
`
`A
`Q
`
`A
`
`Dr. Lewin (phonetic)?
`Q
`14
`All right. And how long did that
`0
`14
`(Witness shakes head.)
`A
`15
`inspection last at Jubilant?
`15
`And Mr. Clark?
`9
`16
`A
`Forty-five minutes to an hour.
`16
`I've certainly seen Mr, Clark's -- some
`A
`17
`Q
`Both in your visits to Bracco and
`17
`comments from Mr. Clark.
`I do not recall
`| 18
`Jubilant, were any of the devices that you viewed
`18
`discussing them.
`19
`plugged in and able to run?
`1g
`Q
`When you say "comments," could you be
`20
`A
`I certainly did not run any of the
`20
`
`
`
`
`21 I|21devices. I don't know if they were plugged in. more specific?
`22
`don't recall.
`22
`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
`I know I saw a generator on the table.
`A
`25
`
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`

`

`Robert Stone, Ph.D.
`October 09,
`
`- Confidential
`
`2018 26 to 29
`
`-
`
`s
`
`Page 26
`Do you have the same rate for your
`
`1
`
`Page 28
`of which were sent in -- spent in schools for
`
`Q
`
`work -- your nontestimonial work as your
`testifying work?
`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
`
`depends on the degree of the work. Compensation
`is sometimes in the form of stock in a company
`
`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
`
`2
`3
`4
`5
`6
`7
`
`8
`3
`
` l 2 3 4 5 6 7 8 3
`
`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.
`Q
`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 tomography,
`but it had applications in various other fields as
`18
`When you were preparing your two
`Q
`well,
`including radiation imaging.
`19
`reports in this case in collaboration with the
`Q
`Throughout your educational and
`attorneys, did you feel at any time that you were|20
`military service, did you work on any
`lacking any information or documents that would be
`21
`radiopharmaceutical infusion stems?
`necessary to prepare the reports?
`22
`A
`While at Stanford, we, as a group,
`A
`I don't recall any such instances.
`23
`
`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
`consistent throughout all of your work on this
`| 13
`case or do you have different rates for the
`14
`different types of work you're doing in this case?
`15
`
`I do not have different types of rates
`A
`other than for travel.
`
`| 16
`17
`
`imaging did you
`
`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, amendor
`supplement?
`A
`
`I believe we found one case where a
`
`date was written wrong, but other than that, no.
`Q
`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.
`
`24
`25
`
`1
`2
`
`3
`4
`5
`6
`
`7
`8
`9
`10
`
`|
`
`|
`
`|
`
`Okay. And since you've walked in
`0
`today, you haven't thought of anything else that
`needs to -- to change in your reports?
`A
`No.
`
`11
`12
`13
`14
`
`worked on concepts for positron emission
`tomography for medical -- magnetic resonance
`
`imaging and for computer tomography.
`Q
`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, shorter half-life
`
`radiopharmmaceutical, but we never brought it into
`production.
`Qo
`
`Do you recall what the
`
`Q
`
`Okay. Could you give me a brief
`
`is
`
`QO
`
`Okay.
`
`So that was in your -- in your
`
`21
`I spent six years in the United States
`A
`Navy -- excuse me.
`22
`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 explain
`25
`United States Navy,
`three years and eight months
`
`Q
`A
`
`Okay. And that was in about the 1970s?
`That would have been in the mid-1970s.
`
`undergrad time after your Navy service?
`A
`Yes.
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`radiopharmaceutical was?
`A
`I've been stretching my memory, and
`overview, please, of your education beginning with|16
`undergraduate?
`17
`that was more than 30 years ago, and I do not
`recall.
`A
`How about if I back up before
`18
`undergraduate.
`19
`Q
`Okay.
`20
`
`MNNMNMNMNrEPRFeeFPPPebnFWwNMFPCoHoHDPaAHRSeweNYYPGS
`woosHDHe&BPH
`NwNMNNNMPPFPFPBFPYPYPHYofWMFE2beOwAHAMW&YWweFESo
`
`

`

`Robert Stone, Ph.D.
`Confidential
`30 to 33
`October 09, 2018
`
`Page 32
`
`that to be an elution infusion system?
`A
`No.
`
`Okay. Have you -- do you have any
`Q
`experience working with elution infusion systems?
`A
`I have no direct experience working
`with elution infusion systems.
`Q
`Are you familiar with rubidium?
`A
`I'm familiar with many radioisotopes
`I have been
`including rubidium and its concepts.
`
`thoroughly trained in various aspects of
`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
`
`L 2 3 4 5 6 7 8 3
`
`Page 30
`
`your understanding of what elution is?
`
`Certainly. An elute is something that
`A
`is derived typically from something such as an ion
`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
`it's exposed to a surface that has ions that one
`wishes to exchange.
`
`And then based on the ionic potential
`of what is going through the columm versus what is | 10
`attached to the colum, there's an ion exchange.
`|
`12
`And what comes out typically has the ions that
`were originally intended on the column and not the | 13
`ions -- all of the -- the same type of ions that
`| 14
`were in the liquid that went
`through it.
`15
`0
`You mention an ion exchange colum. Do
`16
`
`neutron activation analysis laboratory where I was
`'17
`you consider that to be synonymous with a
`
`generator, or would that be part of a generator in|18 managing day-to-day operations including the
`your understanding?
`19
`operation of the nuke reactor there.
`
`That would be a part of the generator.
`A
`It would act in the same fashion as an ion
`exchange colum.
`Q
`So more specifically than what we
`discussed a few minutes ago, do you have any
`experience working on elution systems?
`
`20
`21
`22
`| 23
`24
`25
`
`What was that nuclear reactor used for?
`Q
`Its major task was for neutron
`A
`activation analysis, and a secondary task was in
`training students who were majoring in nuclear
`engineering.
`Q
`What is neutron activation analysis?
`
`|
`
`
`
`Page 33
`Page 31
`Virtually any material that you put
`A
`1
`With elution systems of various types.
`A
`into a heavy neutron flux -- that is, where there
`2
`Certainly for water purification systems, similar
`is a large number of neutrons -- can absorb
`3
`types of devices, understanding them, other
`neutrons and themselves become radioactive. When
`4
`colums.
`I don't recall the -- the other types.
`they do,
`they decay in a signature fashion, and
`5
`Q
`You mentioned when you inspected the --
`the energy at which they decay is indicative of
`6
`the systems at Bracco and Jubilant, you weren't
`
`sure if the -- if the generator was there, but you|7 what the original material is that went into
`saw one on the table at one of them.
`8
`the -- that neutron flux.
`
`So we had developed a system that could
`9
`I certainly saw one on the table, yes.
`A
`operate to place small quantities of materials
`| 10
`All right. But -- and that's the type
`Q
`into the reactor for various amounts of time and
`ll
`of generator --
`then expose it to a -- an energy discriminating
`12
`A
`I'm sorry.
`detector that could count the level of activity
`13
`Q
`Go ahead.
`
`
`
`A I saw one on the|14Let me correct that. and the particular energies of the photons that
`
`table at both sites now that my memory is jogged.|15 were given off, and from that infer what the
`
`Q
`Okay. Given that it was sitting on the
`16
`original materials were and even their
`
`table, no elutions were -- were taking place while|17 concentrations.
`you were there; right?
`18
`Q
`This work was not directly being
`A
`That is correct.
`19
`applied to the medical field?
`Q
`And for it -- for the elution to be
`20
`A
`Occasionally it was because we could
`occurring, a liquid need -- would need to be
`21
`analyze very small quantities of biological
`flowing through the generator?
`22
`samples, for example, various heavy metals that
`A
`Yes.
`23
`were in it.
`
`So as far as -- so, yes, it had some
`24
`Okay. You mentioned water
`Q
`
`purification. What else are -- would you consider|25 application in the medical field.
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`wonAoObeweheeB
`Bo86BMBmHEPHPHPBeBeeeBePPWomWMHFOobbonHWFwweHYSs
`wooymhWHSeWYBF
`momMmNMMMBEFeeeeeheSeYeWfWNP5S6ewaHHBeewhePS
`
`
`
`
`
`
`
`

`

`- Confidential
`Robert Stone, Ph.D.
`
`2018 34 to 37
`October 09,
`
`Page 34
`
`Q
`
`But this was not introducing a
`
`radioactive material into a person?
`A
`No.
`
`Qo
`
`Okay.
`
`there was
`Not quite. As I indicated,
`A
`a -- that's not quite true. There is more to it
`than that.
`
`0
`
`All right.
`
`So -- so going back to
`
`1
`
`2
`3
`
`4
`
`5
`6
`7
`
`8
`
`rubidium specifically, are you -- can you recall
`what the half-life of rubidium is?
`A
`It's in the order of 72, 78 seconds.
`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
`
`I
`
`9
`|
`| 10
`11
`la2
`| 13
`14
`15
`16
`
`perspective. That's short in that being away from 17
`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
`
`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
`
`fluorodeoxyglucose infusion systems?
`A
`I've not worked with
`
`fluorodeoxyglucose --
`0
`Okay. For -- for --
`A
`-- but --
`
`Q
`
`Go ahead.
`
`No, go ahead.
`A
`As -- for -- for ease of everyone,
`0
`would it be -- would it be okay if we refer to
`
`those as FDG systems?
`A
`That's fine.
`
`relate to its safety in use in humans?
`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
`
`21
`22
`
`23
`24
`
`25
`
`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 35
`human and the tissue and its effect would be
`
`significantly less than if it were the same
`activity but a longer half-life.
`Q
`All right.
`Do you know how rubidium
`can be used in the medical
`imaging context?
`
`A
`Q
`A
`
`Yes.
`Could you explain that a little bit?
`|
`Certainly.
`|
`When the rubidium is injected into the
`| 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 | 12
`off an electronic -- sorry, a positron.
`13
`That positron interacts with the
`14
`electrons and the tissues surrounding it, form
`15
`
`woaFRWewhw
`
`|
`
`Page 37
`
`about what they are?
`the fluro -- FDG is another
`A
`Similarly,
`pharma- -- 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 FDG infusion
`Qo
`system, would that system elute anything?
`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
`
`
`
`
`
`
`
`wo2smWmkeRDoe
`momNMNMNMmMHFFPBPHYBeEPPPMfWMFPSoSbhwmaHRHW&®YWNYYEBG
`wowoanmRwvewwm
`MMNMNMNMNMPPFPYPFPPPPPkeWomWNYFOoiboaHoWFYWhwFPoS
`
`something called an electron-positron pair. That
`electron-positron pair annihilates and gives off
`two photons, approximately .51 million electron
`volts of energy going in exactly opposite
`directions in order to conserve momentum in the
`
`16
`17
`18
`19
`20
`
`system.
`
`exposure -- radiation exposure to the patient and
`why one would want to use the FDG. There are many
`al
`reasons that might -- one might use to determine
`22
`the .51 MEV, are
`And those photons,
`why they would want to use one other than simply
`23
`detected in detectors -- typically an array of
`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 two
`
`
`U.S. LEGAL SUPPORT
`(877) 479-2484
`
`

`

`Confidential
`-
`Robert Stone, Ph.D.
` October 09, 38 to 41
`
`2018
`
`Page 38
`Are you aware of what those other
`Q
`reasons might be?
`
`Might be cost, scheduling, maintenance,
`
`A
`complexity.
`When you say "complexity," are you
`0
`referring to the infusion systems, or what are you
`referring to?
`A
`The details of use.
`
`that?
`
`Q
`
`A
`
`Could you explain what you mean by
`
`What the user has to know, what they
`
`have to deal with, how they have to schedule, et
`cetera.
`
`In your experience, would the elution
`0
`infusion system or the FDG infusion system-have
`
`more complexity 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,
`-- would arrive;
`scheduling when it would rearriv
`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 be performed daily to make
`sure the generator is -- is correct.
`
`Page 39
`So that might be a matter of personal
`
`preference.
`
`An FDG system does not have a
`Q
`generator; right?
`A
`That's -- we've said already, yes.
`
`And, so, it does not require those
`0
`daily OC measures?
`A
`There are some daily QC measures, but
`
`in my understanding.
`they're not as complex,
`Q
`Could you use rubidium in an FDG
`infusion system?
`in my mind, quite
`A
`That would be,
`challenging.
`I've not analyzed that.
`I don't
`think I would want to on the fl