throbber
870
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`ASTRAZENECA PHARMACEUTICALS
`
`LP, et al.,
`
`Plaintiffs/Counterclaim—
`Defendants,
`
`CIVIL ACTION NUMBERS:
`
`-vs-
`
`14-cv—O3547—RMB—KMW
`
`INC.,
`SAGENT PHARMACEUTICALS,
`Defendant/Counterclaim—Plaintiff.
`
`ASTRAZENECA PHARMACEUTICALS
`
`LP, et al.,
`
`Plaintiffs/Counterclaim—
`Defendants,
`
`_vs_
`
`GLENMARK GENERICS,
`
`INC. , USA,
`
`Defendant/Counterclaim—Plaintiff.
`
`14-CV-05539-RMB-KMW
`
`15-CV-00615-RMB-KMW
`
`Mitchell H. Cohen United States Courthouse
`
`One John F. Gerry Plaza
`Camden, New Jersey 08101
`July 14, 2016
`
`B E F O R E:
`
`THE HONORABLE RENEE MARIE BUMB
`UNITED STATES DISTRICT JUDGE
`AND A JURY
`
`C)\o(b~qoxU1-uI»K)be
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`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 1
`Mylan Pharms. Inc. V. Astrazeneca AB IPR2016-01326
`
`

`
`m~qOxtnQtoK)m
`
`10
`
`11
`
`12
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`871
`
`A P P E A R A N C E S:
`
`\4CC7"3C"*'.R &
`
`*'.NGT. SH
`
`BY:
`
`John E. Flaherty. ?squite
`Ravin R. Patel, Esqiire
`Attorneys For Astrazeneca
`
`O'M«RV«NY & MYERS LLP
`
`QY: Risa Sarois Pensabene, Esquire
`Will C. Aitz, Esqiire
`Carolyn Wall, Esqiire
`Eber'e R. Schultz, Esquire
`Daniel O'?oyle, Esqiire
`Eric S. Santoro, Esquire "n House Counsel
`Attorneys for Astrazeneca
`
`CARELLA, %YRNfl, C%CCH , otstu N, RRODY & AGNELLO
`BY: Melissa ?. Flax, Esquire
`Christopher J. Biggy, Esquire
`Attorneys for Sagent Pharmaceuticals,
`Generics Inc., USA
`
`Inc., and Glenmark
`
`FOHEY & LARJNER LLP
`
`3Y:
`
`Steven J. Rizzi, Esquire
`Eiane W. Peterson, Esquire
`Debra Lange, Esquire
`{any Kizkalla, Esquire
`Attorneys for Sagent Pharmaceuticals,
`Generics Inc., USA
`
`Inc., and Glenmark
`
`Certified as true and correct as required by Title 28,
`U.S.C., Section 753.
`
`/S/ Theodore M.
`
`Formaroli, CSR, CRR
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 2
`
`

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`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 3
`
`

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`Uhifed Sfafes Disfricf Courr
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 4
`
`

`
`DfiPOS T ON - MCPfiSKfiY
`
`874
`
`Ti‘ DfiPUTY CLERK: All rise.
`
`(OLEN COURT, Jily 14, 2016, 9:08 a.m.)
`
`T{E COURT: Good morning.
`
`RESPONSE: Good morning, Your Honor.
`
`T I COURT: Have a seat.
`
`Okay. Are we ready to continue with the deposition
`
`testimony?
`
`MS. PI?OHHOLO—MfiLLOWfiS: Yes, we are, Your Honor.
`
`T E COJRT: Ms. McCleskey,
`
`come forward.
`
`M
`
`5Rfi TAS: Yes, Your Honor.
`
`(Laighter.
`
`T E COJRT: Good morning.
`
`M
`
`bR« TAS: Good morning.
`
`T E COJRT: Okay. Whenever you're ready.
`
`MS. PIROHHOLO—MmLLOW«S: We 1e”L o"" at Page 140 of
`
`the transcript.
`
`THE COURT: Yes,
`
`thank you.
`
`MS. PIROZZOLO—MjL;OWjS: And Ms. Waldron continues
`
`the questioning on beha’" o" de"endants.
`
`(Deposition read as ‘o1'ows:)
`
`Q. Let's get back to the documents you kept when you were at
`
`the Lombardi Cancer Center.
`
`Did I understand you to say that you did keep
`
`laboratory notebooks?
`
`‘D‘O‘M‘J03U1IAt»K)F1
`
`09:08AM
`
`09:09AM
`
`H
`
`09:09AM
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`
`K) #1
`
`K)R)
`
`R) U)
`
`N ml;
`
`09:09AM
`
`25 .A.
`
`Yes.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 5
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`875
`
`to\otn~4OxU1umtoK)nu
`
`O9MWAM
`
`O9MBAM
`
`H
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Did you have any raw data o:
`
`any kind?
`
`It was in the l
`
`aboratory notebooks.
`
`It would be pas
`
`ted in the lab notebooks?
`
`Why do you think raw data would not be on the same piece
`
`of paper as the lab
`
`notebook?
`
`Q.
`
`Actually,
`
`i don't know one way or the other.
`
`i want
`
`to
`
`know what your parti
`
`cular procedure was.
`
`A. Well, most of t
`
`he time, you're writing the laboratory
`
`notebook.
`
`If you ge
`
`t,
`
`like,
`
`a printout or something,
`
`then you
`
`would paste that in
`
`the laboratory notebook.
`
`H H
`
`Q.
`
`Got it. Did yo
`
`1 keep anything on the computer?
`
`h: K)
`
`A.
`
`Yes.
`
`H Q)
`
`#1 K
`
`F: U1
`
`O9fl0AM
`
`Q. What did you ke
`
`ep on the computer?
`
`Au Well,
`
`rememberi
`
`ng that computers were not as good as they
`
`I would have to enter it into the
`
`FA 0\
`
`F: V
`
`F: (D
`
`FA ‘O
`
`K) C)
`
`K) #1
`
`K)R)
`
`R) U)
`
`K) oh
`
`N W
`
`O9flflAM
`
`O9flDAM
`
`are now, when I got
`
`data,
`
`computer,
`
`like,
`
`into
`
`a graphing program,
`
`for instance, and
`
`then it would draw t
`
`he graph and I would print the graph.
`
`But
`
`the —— but
`
`the data
`
`in the computer was the same as in my --
`
`hopefully, as in my
`
`lab notebook.
`
`Q.
`
`You didn't crea
`
`te,
`
`say,
`
`Word
`
`files and keep them on a
`
`computer?
`
`IX.
`
`Oh, yes,
`
`but that's not data.
`
`Q.
`
`Okay.
`
`see.
`
`What
`
`type o
`
`in"ormaLion or documents, i;
`
`any, would you have
`
`saved on a computer?
`
`A.
`
`The dra"Ls o" L
`
`he paper,
`
`the —— atter
`
`entered the data
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 6
`
`

`
`DfiPOS T ON - MCPfiSKfiY
`
`876
`
`to ma
`
`be th
`
`ke a graph,
`
`that would be saved, o: course, but it would
`
`e data from the lab notebook that
`
`entered.
`
`So it's,
`
`like,
`
`a copy and —— and also the graphics tile, picture a
`
`graph
`
`.
`
`I don't know how you would say that, but
`
`the graph
`
`09:10AM
`
`itse"
`
`,
`
`" guess you would say,
`
`that was saved to the computer.
`
`also, o: course, printed it.
`
`Do you have knowledge as to whether anyone in your group
`
`had documents saved to a computer that had originated from
`
`Astra
`
`Zeneca?
`
`09:11AM
`
`A.
`
`i don't have knowledge about anybody else in my group
`
`"I me.
`
`Did you have any documents originating from Astrazeneca
`
`that
`
`related to Ms. Mccleskey l998 saved to a computer?
`
`09:11AM
`
`09:11AM
`
`K)E‘K)3‘K3E9K33‘
`
`Are you speaking about data?
`
`Anything.
`
`For example --
`
`Saved to a computer?
`
`Yeah,
`
`like a sLa-emenL o_ proposed investigation --
`
`Oh, no --
`
`—— sample requests?
`
`—— no, no.
`
`Did you have data that originated from Astrazeneca saved
`
`computer?
`
`W0.
`
`Did you have any binders or personal notebooks separate
`
`09:11AM
`
`from
`
`your lab notebooks in which you kept
`
`information
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 7
`
`

`
`fiPOS T ON — MCWfiSKfiY
`
`877
`
`regarding McLeskey l998?
`
`A.
`
`I had binders with the tumor data,
`
`th
`
`e tumor measurements
`
`in pictures of mice.
`
`Q.
`
`Any other places where you would have had information
`
`O9fllAM
`
`related to McLeskey 1998,
`
`that we haven't
`
`talked about?
`
`A.
`
`No.
`
`Q.
`
`Now,
`
`you mentioned,
`
`if I understood y
`
`ou correctly,
`
`believe you testified that you destroyed your technical
`
`documents related to Mc.
`
`Leskey l998 in the beginning o;
`
`O9fl2AM
`
`June 2014;
`
`is
`
`that right?
`
`A. Correct.
`
`Q. What did you mean by "destroyed?"
`
`How did you destroy
`
`O9fl2AM
`
`them?
`
`A.
`
`Q.
`
`A.
`
`i just threw them in the trash.
`
`Just a regular trash bin?
`
`Yeah.
`
`Q. Where was this trash bin?
`
`A.
`
`At my school.
`
`Q. What school?
`
`O9fl2AM
`
`Au
`
`The University o;
`
`Maryland School of
`
`Nursing.
`
`Q.
`
`Do you know what happened to the documents after you
`
`threw them in the trash bin?
`
`A“
`
`No.
`
`Q. When you left Lombardi Center and took your
`
`technical
`
`O9fl2AM
`
`documents with you, was it your understanding that that was
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 8
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`878
`
`‘D‘O‘M‘J03U1IAt»K)#1
`
`O9fl2AM
`
`09:13AM
`
`FA
`
`okay by the rules,
`
`by Lombardi's policies?
`
`A.
`
`Q.
`
`i didn't have any understanding about that.
`
`Did you know what document retention policies Lombardi
`
`would have
`
`had in place at the time?
`
`A.
`
`Q.
`
`NO.
`
`When you --
`
`I'll just say "you" to start,
`
`and then we
`
`will be talking about Lombardi Center.
`
`When you got a
`
`document on a project,
`
`say,
`
`a certificate o_
`
`service or MSDS
`
`or something like
`
`that,
`
`what did you do with it?
`
`Where was
`
`something like that kept?
`
`F1 F1
`
`A.
`
`i don
`
`'t know what a certijicate o_
`
`service is.
`
`K: K)
`
`The
`
`—— we were required to keep MSDSS in
`
`the notebook
`
`#1 Q)
`
`in the lab
`
`for all chemicals that we had in the lab,
`
`so that's
`
`FA :5
`
`what we did.
`
`SO MS
`
`Dss would be kept
`
`in the laboratory notebooks,
`
`correct?
`
`(Reading s
`
`topped.
`
`3x .
`
`h'R,L‘ ,,TAS :
`
`apologize.
`
`O9fl3AM
`
`FA U1
`
`FA 0\
`
`F: \J
`
`F: (D
`
`FA ‘O
`
`09:13AM
`
`K) C)
`
`M T M
`
`eA
`
`{* COJRT: Ask it again.
`
`S.
`
`PT?OHHOLO—M?L HOWTSI
`
`You have to read —— he
`
`K) #1
`
`inadverten
`
`tly reread the qiestion.
`
`K)R)
`
`R) U)
`
`K) at
`
`T
`
`{E COURT: Yes.
`
`(Deposition read as
`
`follows:)
`
`Q.
`
`So MSDSs would be kept
`
`in the laboratory notebooks,
`
`O9fl3AM
`
`N W
`
`correct?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 9
`
`

`
`DfiPOS T ON - McPfiSKfiY
`
`879
`
`A.
`
`No, not
`
`in —— not where we had the data. We had separate
`
`notebooé for MSJSS.
`
`Q.
`
`MSDSs had their own notebook?
`
`A.
`
`That's correct.
`
`Q. What about certijicates oj analysis?
`
`A. Didn't usually keep those.
`
`Q.
`
`They're -- why not?
`
`A. Didn't feel that we needed them.
`
`Q.
`
`Who retained custody of documents as they came in on the
`
`McLeskey l998 project?
`
`A.
`
`i don't know what you're talking about, what documents.
`
`Q.
`
`Do you recall how samples got shipped into the "aci‘iLy,
`
`whether, say,
`
`they went
`
`to a mailroom or a specific sample
`
`depository?
`
`A.
`
`They went
`
`to the mailroom.
`
`Q.
`
`And then that —— that would happen?
`
`A.
`
`The mail people would bring them to us.
`
`Q. Would you then keep the samples in your lab?
`
`‘D‘O‘M‘J03U1IAt»K)F1
`
`09:13AM
`
`09:14AM
`
`H
`
`H H
`
`K: K)
`
`H U.)
`
`H ilk
`
`H U‘!
`
`H 0\
`
`H \l
`
`H (I)
`
`09:14AM
`
`H ‘O
`
`A.
`
`Yes.
`
`09:14AM
`
`K) C)
`
`K) #1
`
`K)R)
`
`R) U)
`
`Q.
`
`And did I understand you correctly that at the time you
`
`were a postdoc in Dr. Kern's lab, you were not aware of the
`
`policies and procedures that Lombardi Center had in place with
`
`regard
`
`to retention o:
`
`documents;
`
`is that right?
`
`N ml;
`
`A.
`
`Not only was
`
`i not aware o:
`
`anything they had in place,
`
`09:14AM
`
`N W
`
`was not aware it —— whether they had anything in place.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 10
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`880
`
`Q.
`
`you received ancillary paperwork with samples,
`
`such as
`
`a certificate o_
`
`analysis or something like that,
`
`what would
`
`you hav
`
`r cord d th
`
`r ccipt o_
`
`that document --
`
`(Reading stopped.)
`
`T{E COURT:
`
`"Would you."
`
`(Deposition read as
`
`followsz)
`
`Q.
`
`Would you hav
`
`r corded th
`
`r c ipt o:
`
`: that document
`
`in
`
`your laboratory notebook?
`
`A.
`
`Wo.
`
`Q.
`
`Did Lombardi require you to make copies of anything and
`
`<3\otn~4OxU1antoK)Id
`
`O9fl5AM
`
`O9fl5AM
`
`R:
`
`F1 F1
`
`send them on to a document repository or anything like that?
`
`K: K)
`
`A.
`
`Wo.
`
`#1 Q)
`
`#1 K
`
`Q.
`
`To your knowledge, were the documents that you were
`
`keeping in your lab the only copies?
`
`O9fl5AM
`
`F: U1
`
`A.
`
`As tar as
`
`knew.
`
`FA 0\
`
`F: \J
`
`Q.
`
`Are you aware of whether copies were ever made of your
`
`laboratory notebooks?
`
`F: (D
`
`A.
`
`think not.
`
`FA ‘O
`
`Q.
`
`Who had access to your laboratory notebooks besides you?
`
`O9fl5AM
`
`K) C)
`
`A.
`
`Dr. Kern.
`
`K) #1
`
`K)R)
`
`R) U)
`
`K) at
`
`N W
`
`O9fl5AM
`
`Q.
`
`Anyone else?
`
`A. Well,
`
`the other people in
`
`the lab would have, had they
`
`wanted it, but
`
`i don't know that they ever
`
`did --
`
`(Reading stopped.)
`
`T{E
`
`COURT:
`
`So could have.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 11
`
`

`
`DfiPOS T
`
`ON — MCWfiSKfiY
`
`881
`
`<3kotn~4OxU1umtoK)nu
`
`O9fl5AM
`
`O9fl6AM
`
`H
`
`F1 F1
`
`h: K)
`
`MR. ERfi
`
`TAS:
`
`Pardon me.
`
`(Deposition read as
`
`follows:)
`
`A.
`
`Well,
`
`the other people in
`
`the lab could have had they
`
`wanted it, but
`
`i don't know wha'
`
`:
`
`they ever did —— that they
`
`ever did.
`
`Q.
`
`In the conversation that you just referred to,
`
`when you
`
`communicated with Mr.
`
`Trock,
`
`what did you discuss with
`
`Mr. Trock?
`
`A”
`
`He -- I
`
`think he,
`
`T don't remember a whole lot about
`
`the
`
`conversation,
`
`but he said that he had been just about
`
`to
`
`discard
`
`the data
`
`from --
`
`from this paper when
`
`they called.
`
`Q.
`
`When who ca"
`
`"ed?
`
`#1 Q)
`
`A.
`
`The —— the
`
`lawyers that were doing the Teva thing, Mary
`
`O9fl6AM
`
`#1 K
`
`F: U1
`
`FA 0\
`
`F: \J
`
`F: (D
`
`FA ‘O
`
`Burke and company.
`
`Q.
`
`I'm sorry.
`
`i believe you just said,
`
`"Mary 3urke did not
`
`ask me not
`
`to destroy documents."
`
`A.
`
`She did not say,
`
`Don't destroy documents.
`
`When she said
`
`that,
`
`7 do not know.
`
`Q. Mary
`
`3ur<e never told you to preserve your documents
`
`O9fl6AM
`
`K) C)
`
`related to Mcgeskey l998?
`
`K) #1
`
`A. Correct.
`
`K)R)
`
`R) U)
`
`K) oh
`
`Q.
`
`Did anyone Mary
`
`Burke worked with ever
`
`tell you not
`
`to --
`
`tell you that you must preserve your documen'
`
`:s related
`
`McLeskey l998?
`
`O9fl6AM
`
`N W
`
`A.
`
`No.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 12
`
`

`
`D+'.POS T ON - MCTn'.SK+'.Y
`
`882
`
`1 Q.
`
`Now,
`
`I believe you said earlier that you recall speaking
`
`2 with three people at Astrazeneca, Dr. Wakeling, Dr. Vose, and
`
`3
`
`a third person whose name you don't remember;
`
`is that correct?
`
`4 A. Correct.
`
`O9fl£AM
`
`5 Q.
`
`Do you recall approximately how many times you spoke with
`
`6 Dr. Wakeling?
`
`7 A.
`
`Twice.
`
`8 Q. Was this Via telephone or by some other means of
`
`9
`
`communication?
`
`09flJAM 10 A.
`
`Telephone.
`
`11 Q.
`
`Who called who?
`
`12 A.
`
`I called him.
`
`13 Q.
`
`Both times?
`
`14 A.
`
`Yes.
`
`O9flJAM 15 Q.
`
`Why did you call Dr. Wakeling?
`
`16 A.
`
`The first time I called to get him to send me the drug
`
`17
`
`and find out how to administer it to mice.
`
`The second time
`
`18 called to tell him we had used the drug he sent the first time
`
`19
`
`and that I needed more drug.
`
`09nJAM 20 Q.
`
`Did Dr. Wakeling require you to fill out any paperwork or
`
`21
`
`do anything in writing before you received samples of drugs?
`
`22 .A. Wot me.
`
`23 Q.
`
`Did he require that someone fill out some sort of
`
`24
`
`paperwork before samples would be shipped?
`
`o9wJAM .25 A.
`
`I don't know.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 13
`
`

`
`DfiPOS T ON - McRfiSKfiY
`
`883
`
`to\otn~4OxU1umtoK)nu
`
`09:17AM
`
`O9:l8AM
`
`H
`
`H H
`
`h: K)
`
`H U.)
`
`H ilk
`
`Q. What did Dr. Wakeling tell you in response to your
`
`request that you wanted AstraZeneca to send you samples of
`
`drugs?
`
`A.
`
`He told me that
`
`should give it to the mice as it
`
`outlined in this paper and that he would ship it.
`
`Q. Basically, an okay—I'll—take—care—of—it
`
`type thing?
`
`A.
`
`Jm—hum.
`
`Q.
`
`A.
`
`{ow many times did you speak with Dr. Vose?
`
`Once —— that —— assume that he was not
`
`the second —— the
`
`person I don‘: know who it is, but --
`
`Q. Right.
`
`A.
`
`——
`
`know I spoke with him once.
`
`Q.
`
`Did you ever communicate with Dr. Wakeling in writing
`
`either by e—mail or letter?
`
`O9:l8AM
`
`H U‘!
`
`A.
`
`Not that
`
`recall.
`
`H 0\
`
`H \l
`
`Q.
`
`Okay.
`
`So you said you spoke with Dr. Vose once;
`
`is that
`
`right?
`
`H (I)
`
`A.
`
`Um—hum.
`
`H ‘O
`
`Q. Was this on the phone?
`
`O9:l8AM
`
`N 0
`
`A.
`
`Yes.
`
`K) #1
`
`K)R)
`
`R) U)
`
`N ml;
`
`Q.
`
`Did you ever have any written communications with him?
`
`A. Wot
`
`to my —— not that I
`
`remember.
`
`Q.
`
`On the one incident —— one instance that you did speak
`
`with Dr. Vose, who called who?
`
`O9:l8AM
`
`N W
`
`A.
`
`called him.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 14
`
`

`
`DfiPOS
`
`T ON - MCPfiSKfiY
`
`884
`
`<3kotn~4OxU1umtoK)nu
`
`09:18AM
`
`09:19AM
`
`H
`
`Q.
`
`A.
`
`Why did you call Dr.
`
`Vose?
`
`Because Dr.
`
`Wakeling told me to call him to get
`
`pre‘ormu'ated drug.
`
`Q.
`
`Do i understand
`
`that you talked to
`
`Dr. Wakeling about
`
`receiving powdered
`
`C
`
`189,780 and Dr.
`
`Vose about obtaining
`
`pre
`
`formulated C
`
`’89,780?
`
`A.
`
`At separate times.
`
`Q.
`
`I'm jus
`
`- -rying to understand.
`
`think " understand the
`
`—— that you
`
`talked to these guys about
`
`two di
`
`”erenL _hings.
`
`Do
`
`inderstand correctly that you talked to
`
`H H
`
`Dr.
`
`Wakeling about receiving powdered
`
`ICI
`
`l82,780?
`
`h: K)
`
`A. Correct.
`
`H U.)
`
`Q.
`
`And the
`
`1 do i unders
`
`tand correctly that you talked to
`
`Dr. Vose abo
`
`ated C
`
`H ilk
`
`it receiving
`
`the pre‘ormu'
`
`189,780?
`
`09:19AM
`
`H U‘!
`
`A. Much la
`
`ter.
`
`H 0\
`
`H \l
`
`H (I)
`
`Q. Much la
`
`ter?
`
`'
`
`That's a good point.
`
`Do yoi reca'l
`
`approximately when,
`
`or do you recall the
`
`approximate dates on which you talked to
`
`Dr. Wakeling?
`
`H ‘O
`
`A.
`
`No.
`
`09:19AM
`
`K) C)
`
`Q.
`
`Year?
`
`K) #1
`
`A.
`
`i don't know.
`
`K)R)
`
`R) U)
`
`Q.
`
`But you know you talked to
`
`Dr.
`
`Vose much later.
`
`What do
`
`you mean by "much later?"
`
`N ml;
`
`A. When :
`
`talked to Dr.
`
`Wakeling initially,
`
`then he sent me
`
`09:19AM
`
`N W
`
`the drug,
`
`then we used the drug in mice and also in in vitro
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 15
`
`

`
`DfiPOS 7 ON — MCWfiSKfiY
`
`885
`
`<3\otn~4OxU1antoK)Id
`
`O9flmAM
`
`O%2OAM
`
`h:
`
`studies and we used it all ip.
`
`So I don't know how long that
`
`took, but
`
`T would say a maL_er of months, anyway, maybe a
`
`year.
`
`Then we needed more drug so I called Dr. Wakeling
`
`again,
`
`that's when he told me to call Dr. Vose.
`
`Q.
`
`And the powdered
`
`C
`
`189,780 would have been what you --
`
`what was dissolved in ethanol and then spiked into the peanut
`
`oil?
`
`A. Correct.
`
`Q. When you spoke to Dr. Vose, what did he tell you about
`
`shipping you samples o" pre"ormulated 182,780?
`
`F1 F1
`
`A.
`
`{e said he would.
`
`K: K)
`
`#1 Q)
`
`#1 K
`
`F: U1
`
`ORZOAM
`
`Q.
`
`Did he say anything else?
`
`A.
`
`Vot
`
`to my remembrance.
`
`Q.
`
`Did he require that you do anything before he sent the --
`
`sent
`
`-he "iies o" pre"ormu1ate
`
`d
`
`C
`
`189,780?
`
`FA 0\
`
`A.
`
`Wo
`
`F: \J
`
`F: (D
`
`FA ‘O
`
`Q.
`
`Do you know whether anyone in your lab had to complete
`
`any type o: paperwork before Astrazeneca would send the lab
`
`preformulated l82,780?
`
`O%2OAM
`
`K) C)
`
`A.
`
`i do not know.
`
`K) #1
`
`K)R)
`
`R) U)
`
`K) at
`
`Q.
`
`Who would know?
`
`A.
`
`Possibly Dr. Kern.
`
`Q.
`
`Okay.
`
`And now the third person that you spoke to,
`
`was
`
`this be‘ote or a‘ter you talke
`
`d to Dr. Vose?
`
`O%2lAM
`
`N W
`
`A. Aj-er.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 16
`
`

`
`DfiPOS T ON - McRfiSKfiY
`
`886
`
`to\otn~4OxU1umtoK)nu
`
`09:21AM
`
`09:21AM
`
`H
`
`Q.
`
`A.
`
`Who called who?
`
`called him.
`
`Q.
`
`Did you have any communications in writi
`
`ng with this
`
`third person?
`
`A.
`
`No.
`
`Q.
`
`A.
`
`And what was the purpose of calling
`
`this third person?
`
`i wanted to "nd out what
`
`the —— what
`
`was in the drug
`
`because T was getting ready to publish a paper.
`
`i was getting
`
`ready to write the paper, actually.
`
`Q.
`
`And what did he tell you?
`
`H H
`
`A.
`
`{e told me --
`
`h: K)
`
`Q.
`
`Do you recall the words he used?
`
`H U.)
`
`A.
`
`Wo
`
`H ilk
`
`H U‘!
`
`H 0\
`
`H \l
`
`H (I)
`
`H ‘O
`
`K) C)
`
`K) #1
`
`K)R)
`
`R) U)
`
`N ml;
`
`N W
`
`09:21AM
`
`09:21AM
`
`09:21AM
`
`Q.
`
`But he told you all of the excipients and their
`
`percentages?
`
`A.
`
`He told me what's in the paper:
`
`10 percent ethanol,
`
`10 percent benzyl benzoate and 10 percent benzyl alcohol
`
`brought
`
`to volume with the castor oil.
`
`(Reading stopped.)
`
`MS. PlROHHOLO—M? VITIOWV:-S: Your Honor,
`
`i think there
`
`was a mista<e in reading that.
`
`THE COUQT:
`
`It ' S —— no,
`
`the court reporter took it
`
`down correc-ly,
`
`-haL‘s Line.
`
`(Deposition read as
`
`-01‘ owsz)
`
`I)
`You don't recall whether or not he specified the units O;
`
`Q.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 17
`
`

`
`DfiPOS T
`
`ON — MCWfiSKfiY
`
`887
`
`<3kotn~4OxU1umtoK)nu
`
`O9flQAM
`
`O%22AM
`
`H
`
`measure?
`
`A.
`
`i do not recall
`
`Q.
`
`How did you know to contact this third person?
`
`A.
`
`called the number that was —— that I had been given for
`
`Dr. Vose.
`
`Q.
`
`And somebody else answered?
`
`A.
`
`i don't know if it was somebody else or if it was
`
`Dr. Vose.
`
`Q.
`
`So there —— you're saying —— i‘ "'m understanding you
`
`correctly, you believe it's possible that it was Dr. Vose that
`
`F1 F1
`
`told you the makeup o:
`
`the formulation but you're not sure?
`
`h: K)
`
`A.
`
`Well, it
`
`was whoever answered the phone.
`
`That's all
`
`#1 Q)
`
`#1 K
`
`F: U1
`
`FA 0\
`
`F: \J
`
`F: (D
`
`FA ‘O
`
`K) C)
`
`K) #1
`
`O%22AM
`
`O%22AM
`
`can say about
`
`it.
`
`see.
`
`But you called
`
`Dr.
`
`Vose's direct
`
`line?
`
`Yeah.
`
`called the same number
`
`I
`
`had called previously
`
`to speak with
`
`Dr.
`
`Vose.
`
`K)E‘K)E‘K3
`
`Who gave you
`
`Jr.
`
`Vose's p
`
`hone number?
`
`Dr. Wakeling.
`
`Who gave you
`
`Dr.
`
`Wakeling's phone number?
`
`i don't remember.
`
`Do you recall generally how you knew to call
`
`Dr. Wakeling
`
`K)R)
`
`that he was
`
`the person to call?
`
`R) U)
`
`R) Q
`
`N W
`
`O%23AM
`
`A“
`
`Either Dr. Lippman or Dr. Kern told me, but
`
`i don't know
`
`who or when or anything.
`
`Q.
`
`But do I understand you correctly that you —— with regard
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 18
`
`

`
`DfiPOS T ON - MCPfiSKfiY
`
`888
`
`to this third person,
`
`that it was a man?
`
`A.
`
`Yes.
`
`Q. When you called Dr. Vose the first time, or when you
`
`called Dr. Vose, how did you know it was him that answered the
`
`09uBAM
`
`phone?
`
`A.
`
`I don't remember.
`
`Q.
`
`But you ‘eel conjident that you were speaking to Dr. Vose
`
`the first time?
`
`A. Well,
`
`" certainly believed that I was.
`
`0%23AM
`
`Q.
`
`At
`
`the time, did you believe that the third person that
`
`you were talking to was Dr. Vose?
`
`.
`
`I don't recall what
`
`I believed.
`
`. What do you believe today?
`
`.
`
`.
`
`.
`
`.
`
`I don't believe.
`
`You have no idea who you talked to?
`
`'%ight.
`
`Did you send As:raZeneca dra ,s o
`
`the study protocol
`
`A Q A Q
`
`.A
`
`O%23AM
`
`Q t
`
`hat you were going _o "ollow or
`
`-he research described in
`
`McLes<ey l998?
`
`09:23AM
`
`Z3.
`
`Wo.
`
`Q.
`
`Did you ever provide your lab notebooks or raw data to
`
`Astrazeneca?
`
`Au
`
`Wo
`
`Q.
`
`Did you record when you received samples from AstraZeneca
`
`O%23AM
`
`in YOJI laboratory notebooks?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 19
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`889
`
`‘D‘O‘M‘J03U1IAt»K)#1
`
`O9flMAM
`
`O%24AM
`
`FA
`
`A.
`
`Q.
`
`i don't recall.
`
`What was your general practice with regard to recording
`
`receipt of samples at the time you were postdoc in Dr.
`
`Kern's
`
`lab?
`
`A.
`
`i would unpack them and if they needed refrigeration,
`
`would put
`
`them in the refrigerator or the
`
`freezer as
`
`appropriate.
`
`Q.
`
`Did you have a separate practice as to what you would
`
`record about
`
`the samples received?
`
`A.
`
`No.
`
`F1 F1
`
`K: K)
`
`#1 Q)
`
`Q. Was it your understanding from the beginning of your
`
`postdoc in Dr.
`
`I)
`Kern's lab that Astrazeneca was the source o;
`
`182,780 or was that something you learned later in time?
`
`#1 K
`
`A.
`
`At
`
`the beginning,
`
`i had no idea there was such a thing as
`
`O%24AM
`
`F: U1
`
`FA 0\
`
`F: \J
`
`l82,780.
`
`Q.
`
`How did you come to
`
`find out that?
`
`How did you come to
`
`find out that AstraZeneca would supply l82,78O to the lab?
`
`F: (D
`
`A.
`
`:'m not sure.
`
`O9flMAM
`
`FA ‘O
`
`K) C)
`
`K) #1
`
`K)R)
`
`R) U)
`
`Q. What do yo; —— what is your best recollection?
`
`A.
`
`We had meetings of all the researchers,
`
`the breast cancer
`
`researchers and it may have come up at that, one of those
`
`meetings.
`
`Q.
`
`From the Lombardi side of things, not
`
`the Astrazeneca
`
`K) at
`
`side of
`
`things,
`
`but
`
`from the
`
`Uombardi
`
`side o" things,
`
`was
`
`O%25AM
`
`N W
`
`procuring samples as simple as calling and asking for them, or
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 20
`
`

`
`DfiPOS T
`
`ON — MCWfiSKfiY
`
`890
`
`to\otn~4OxU1umtoK)nu
`
`O9flBAM
`
`O%25AM
`
`H
`
`was there an internal protocol that had to be followed first?
`
`A.
`
`i was not aware of an internal protocol.
`
`Q.
`
`Do you know how long it took in between the time you
`
`talked to Dr. Wakeling and the Lime that you received the
`
`powdered
`
`C
`
`189,780?
`
`A.
`
`think it was a matter of weeks.
`
`Q.
`
`Do you recall how long it took from the time you talked
`
`to Dr. Vose to then receive the preformulated C
`
`189,780?
`
`A.
`
`Probably about
`
`the same.
`
`Q.
`
`And you personally do not recall filling out any forms or
`
`F1 F1
`
`signing anything in regard to samples, correct?
`
`h: K)
`
`A. Correct.
`
`#1 Q)
`
`#1 K
`
`F: U1
`
`O%25AM
`
`Q.
`
`i want
`
`to make sure we're absolutely on the same page.
`
`So before you s-ar-ed, at any time, did you send
`
`Astrazeneca a statemen- o
`
`_ proposed investigation
`
`forms?
`
`FA 0\
`
`A.
`
`Wo
`
`F: \J
`
`F: (D
`
`Q.
`
`Do you know whether or
`
`not
`
`Dr.
`
`Kern had sent AstraZeneca
`
`a sLa_emenL of proposed investigation
`
`forms?
`
`FA ‘O
`
`A.
`
`Wo
`
`O%25AM
`
`K) C)
`
`K) #1
`
`K)R)
`
`R) U)
`
`Q.
`
`Wo, you do not know,
`
`OI DO,
`
`he did not?
`
`A.
`
`Yo,
`
`i don't know.
`
`Q.
`
`Did you fill out any o
`
`-her
`
`"orms
`
`for Astrafleneca before
`
`you started your work on Mc_
`
`Leskey 1998?
`
`K) oh
`
`A.
`
`Wo
`
`O%26AM
`
`N W
`
`Q.
`
`Do you know whether anyone else in your group filled out
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 21
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`891
`
`to\otn~4OxU1umtoK)nu
`
`O9fl%AM
`
`O926AM
`
`H
`
`any other ‘orms ‘or Astraheneca?
`
`A.
`
`i don't know.
`
`Q.
`
`?e‘ore starting the work on --
`
`A.
`
`i don't know.
`
`know nothing.
`
`Q.
`
`Did you personally ever request any samples from
`
`Astrazeneca in writing?
`
`A.
`
`No.
`
`Q.
`
`Okay.
`
`So you received powdered
`
`C
`
`187,780 from Dr. Alan
`
`Wakeling, correct?
`
`A. Correct.
`
`H H
`
`h: K)
`
`#1 Q)
`
`#1 K
`
`F: U1
`
`FA 0\
`
`F: V
`
`F: (D
`
`Q.
`
`Did Dr. Wakeling send the powdered samples directly to
`
`you?
`
`A.
`
`i don't recall.
`
`i got
`
`them, but
`
`don't remember who
`
`they were addressed to.
`
`Q.
`
`You don't have a specific recollection o‘ whether they
`
`came directly to you or whether Dr. Kern gave them to you?
`
`A”
`
`i opened the paccage, or
`
`got
`
`the package.
`
`don't know
`
`1:
`
`" got the package from a mailman or ‘rom Dr. Kern.
`
`' don't
`
`O%26AM
`
`FA ‘O
`
`know.
`
`O9flWAM
`
`K) C)
`
`Q.
`
`Okay. But you opened the package?
`
`K) #1
`
`A.
`
`Yeah.
`
`K)R)
`
`R) U)
`
`Q.
`
`Do you recall approximately when that was when you opened
`
`the package?
`
`K) oh
`
`A.
`
`No.
`
`O%27AM
`
`N W
`
`Q. Was it in 1997?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 22
`
`

`
`DfiPOS T
`
`ON — MCWfiSKfiY
`
`892
`
`<3kotn~4OxU1umtoK)nu
`
`O9flWAM
`
`O%27AM
`
`H
`
`A.
`
`Oh, no.
`
`It was way before that.
`
`Q.
`
`A.
`
`Way before that?
`
`So 1996,
`
`1995?
`
`It was before 1993.
`
`Q.
`
`Refore 1993?
`
`A.
`
`Yes.
`
`Q.
`
`How was the powder sample packaged?
`
`Was it in a —— a
`
`bottle or —— how did it arrive,
`
`do you recall?
`
`A.
`
`1
`
`think it was just in a little jar.
`
`Q. Would the receipt of that sample have been logged in the
`
`lab?
`
`F1 F1
`
`A.
`
`No.
`
`O%27AM
`
`h: K)
`
`#1 Q)
`
`#1 K
`
`F: U1
`
`FA 0\
`
`F: \J
`
`F: (D
`
`FA ‘O
`
`Q.
`
`Now,
`
`if ' understand you correctly, Dr. Wakeling gave you
`
`information on administration of the drug, correct?
`
`A. Correct.
`
`Q.
`
`Did Dr. Wakeling send you instructions on how to
`
`formulate the 50-milligram per milliliter concentration of
`
`C
`
`182,780 and ethanol and peanut oil?
`
`A.
`
`{e didn't send them to me, no.
`
`Q.
`
`Did he send you instructions regarding making the
`
`O%28AM
`
`K) C)
`
`formulation?
`
`K) #1
`
`A.
`
`\o.
`
`K)R)
`
`R) U)
`
`K) oh
`
`N W
`
`O%28AM
`
`Q.
`
`A.
`
`ow did you know to do that?
`
`e told me over the phone.
`
`Q.
`
`Okay.
`
`So Dr. Waceling told you how to administer it, and
`
`he also told yoj how
`
`to make the
`
`formulation that's recorded
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 23
`
`

`
`DfiPOS T ON - MCPfiSKfiY
`
`893
`
`in Mcheskey 1998 concerning ethanol and peanut oil?
`
`A.
`
`Exactly.
`
`Q.
`
`And you testified earlier,
`
`I think,
`
`that you were
`
`actually the person that had actually dissolved the
`
`09:28AM
`
`C
`
`189,780 in ethanol and then spiked it into the peanut oil?
`
`A. Correct.
`
`Q.
`
`Why did you use a concentration o: 50—milligrams per
`
`milliliter?
`
`A.
`
`Because that's what Dr. Wakeling said to do.
`
`09:28AM
`
`Q.
`
`Dr. Wakeling did not discuss any sort o
`
`con"idenLialiLy
`
`with you --
`
`NO.
`
`—— when —— when you spoke with him?
`
`No --
`
`Sorry, it needs to be verbal.
`
`Sorry, no.
`
`"‘ you'll turn to Page 698 o‘ ?xhibit 5, do you see a
`
`.
`
`.
`
`.
`
`.
`
`.
`
`A Q A Q
`
`.A
`
`Q .
`
`09:28AM
`
`paragraph headed,
`
`the title Drugs, and then about seven lines
`
`down, w
`
`s C :h
`
`lin d s nt nc
`
`for the experiments depicted
`
`09:29AM
`
`in ?igure 1, 3 and C, 50—milligram per milliliter
`
`preformulated drug in a vehicle o: 10 percent ethanol,
`
`15
`
`percent benzyl benzoate, 10 percent benzyl alcohol brought
`
`to
`
`volume by castor oil was supplied by 3.M. Vose, Zeneca
`
`Pharmaceuticals.
`
`09:29AM
`
`Do you see that?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 24
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`894
`
`Yes.
`
`Is this the preformulated drug that we were just
`
`discussing that you procured via telephone conference with
`
`Dr. Vose?
`
`A.
`
`Yes.
`
`Approximately when did you receive the preformulated
`
`C
`
`187,780 from Dr. Vose?
`
`A. All
`
`can tell you is it was before 1993.
`
`The preformed —— both —— you received both the powdered
`
`C
`
`and the preformulated IC"
`
`before 1993.
`
`Is that what
`
`to\otn~4OxU1umtoK)nu
`
`O9flwAM
`
`O%29AM
`
`H
`
`H H
`
`you're saying?
`
`h: K)
`
`A.
`
`Yes.
`
`O9HmAM
`
`H Q)
`
`#1 K
`
`F: U1
`
`FA 0\
`
`F: V
`
`F: (D
`
`Q.
`
`How do you know that it was before 1993?
`
`A.
`
`In 1993,
`
`received a faculty appointment, and then i was
`
`no longer a postdoc. And at that point,
`
`the animal
`
`experiments were done.
`
`Q. Were you the person that opened the package of the
`
`preformulated C
`
`187,780?
`
`FA ‘O
`
`A.
`
`Yes.
`
`O9fiMAM
`
`K) C)
`
`K) #1
`
`Q.
`
`Do you recall how many preformulated samples were sent to
`
`you?
`
`K)R)
`
`A.
`
`Wo
`
`R) U)
`
`R) Q
`
`N W
`
`O9fiMAM
`
`Q.
`
`A.
`
`Do you recall if those samples were in vials?
`
`Wo
`
`Q.
`
`{ow were —— how were the preformulated samples packaged?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 25
`
`

`
`DfiPOS T ON — MCWfiSKfiY
`
`895
`
`<3kotn~4OxU1umtoK)nu
`
`O9fiMAM
`
`O9KflAM
`
`H
`
`F1 F1
`
`h: K)
`
`#1 Q)
`
`#1 K
`
`A.
`
`I don't recall.
`
`What documentation
`
`accompanied the preformulated
`
`C
`
`187,780?
`
`A.
`
`i don't recall.
`
`Q.
`
`Do you recall whether or not there was documentation
`
`included with the preformulated C
`
`189,780?
`
`A.
`
`i don‘: recall.
`
`Q.
`
`"f you wanted to try to remember, who would you talk to?
`
`A.
`
`Nobody.
`
`i mean,
`
`T —— there's nobody.
`
`think it's lost
`
`to posterity.
`
`Q.
`
`So do T understand correctly that at the time you
`
`received the preformulated IC" ‘87,780, you did not know what
`
`excipients were present in the formulation —— in that
`
`formulation?
`
`O9flflAM
`
`F: U1
`
`A. Correct.
`
`FA 0\
`
`F: \J
`
`Q.
`
`Did you have an understanding that the preformulated
`
`C
`
`182,780 could not be used in humans?
`
`F: (D
`
`A.
`
`Nothing we had in our lab could be used in humans.
`
`FA ‘O
`
`K) C)
`
`O9KflAM
`
`Q.
`
`Were you given specific instructions from Astrazeneca
`
`that it should not be used in humans?
`
`K) #1
`
`A.
`
`i don't recall.
`
`K)R)
`
`R) U)
`
`K) oh
`
`N W
`
`O9fiflAM
`
`Q.
`
`Turning back
`
`to Page 698 in the drug section again,
`
`YOU
`
`see the text that says,
`
`In a vehicle of
`
`10 percent ethanol,
`
`l5
`
`percent benzyl benzoate,
`
`10 percent benzyl alcohol brought
`
`to
`
`volume with castor oil.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 26
`
`

`
`D+'.POS T ON - MCln'.SK+'.Y
`
`896
`
`1
`
`Do you recall who actially wrote that text?
`
`2 A.
`
`i did.
`
`3 Q.
`
`Did you test or analyze the formulation in any way?
`
`4 A.
`
`W0.
`
`09 MAM
`
`5 Q. Were you told that the preformulated ICI 182,780 that you
`
`6
`
`received should not be administered intramuscularly?
`
`7 A.
`
`I was told to administer it sibcutaneously to my --
`
`8 Q. When the person who answered Dr. Vose's phone gave you
`
`9
`
`the excipients present
`
`in the preformulated C
`
`l89,780, were
`
`09nQAM 10
`
`you sworn to secrecy?
`
`11 A.
`
`No.
`
`12 Q.
`
`Why did you want
`
`to include those details in McLeskey
`
`13
`
`1998?
`
`14 A.
`
`That's how I was instructed to write a paper when I was
`
`09nQAM 15
`
`in my predoctoral, was to include such things.
`
`16 Q.
`
`Have you searched your personal
`
`fiiles ‘or all documents
`
`17
`
`relating to either the powdered
`
`C
`
`l89,78O received or the
`
`18 preformulated C
`
`l87,78O that you received?
`
`19 A.
`
`I don't have any personal Si es about this.
`
`O9fiQAM 20 Q.
`
`Did I understand you correctly that you do not recall
`
`21 whether or not
`
`the person that answered Dr. Vose‘s phone told
`
`22
`
`you that the percentages were in weight
`
`to volume or
`
`23 volume—to—volume?
`
`24 A.
`
`I do not recall.
`
`09fiBAM 25 Q.
`
`Did you assume that th p rc ntag s wor
`
`ith r in weight
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca EX. 2049 p. 27
`
`

`
`DfiPOS T ON - MCPfiSKfiY
`
`897
`
`to volume or volume—to—volime?
`
`A.
`
`I don't think I ever thought about it one way or the
`
`other.
`
`Q.
`
`Have you thought about it since McLeskey l998 was
`
`09uBAM
`
`published?
`
`A.
`
`Yes, but
`
`I have no basis for knowing which way it was.
`
`Q.
`
`So as you sit here today, you don't know whether or not
`
`the percentages were in weight
`
`to volume or volume—to—volume?
`
`A.
`
`I do not know.
`
`O9KBAM
`
`Q.
`
`So what did you mean when you said "These studies
`
`indicate that estrogen independence may be achieved"?
`
`A.
`

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