William B. Trattler, M.D. - February 23, 2016
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` U N I T E D S T A T E S P A T E N T A N D T R A D E M A R K O F F I C E
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` B E F O R E T H E P A T E N T T R I A L A N D A P P E A L B O A R D
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`I N N O P H A R M A L I C E N S I N G , I N C . , )
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`S E N J U P H A R M A C E U T I C A L C O . , L T D . , )
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`& L O M B P H A R M A H O L D I N G S C O R P . , )
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` P a t e n t O w n e r . )
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`* * * C A P T I O N C O N T I N U E D * * * )
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` V I D E O T A P E D D E P O S I T I O N O F W I L L I A M B . T R A T T L E R , M . D .
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` T u e s d a y , F e b r u a r y 2 3 , 2 0 1 6
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` M i a m i , F l o r i d a
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`IPR2015-01099
`IPR2015-01097
`IPR2015-01100
`IPR2015-01105
`
`Lupin EX1120
`Page 1
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`William B. Trattler, M.D. - February 23, 2016
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`Page 2
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`2 (Pages 2 to 5)
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`Page 4
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` A P P E A R A N C E S
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`On behalf of Senju Pharmaceutical Co., Ltd.,
`Bausch & Lomb Incorporated and
`Bausch & Lomb Pharma Holdings Corp.:
`JUSTIN J. HASFORD, ESQUIRE
`Finnegan Henderson Farabow Garrett & Dunner, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`202-408-4000 (P) 202-408-4400 (F)
`justin.hasford@finnegan.com
`
`On behalf of Lupin Limited and Lupin Pharmaceuticals,
`Inc.:
`NATASHA E. DAUGHTREY, ESQUIRE
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018
`212-813-8800 (P) 212-355-3333 (F)
`ndaughtrey@goodwinprocter.com
`(PRESENT BY TELEPHONE)
`
`On behalf of InnoPharma Licensing, Inc.,
`InnoPharma Licensing LLC, InnoPharma Inc.,
`InnoPharma LLC, Mylan Pharmaceuticals Inc.,
`and Mylan Inc.:
`JOSEPH M. JANUSZ, ESQUIRE
`Alston & Bird LLP
`Bank of America Plaza
`101 South Tryon Street, Suite 4000
`Charlotte, North Carolina 28280-4000
`704-444-1000 (P) 704-444-1738 (F)
`joe.janusz@alston.com
`
`Also present:
`Jeffrey Menton, CLVS
`
`
` I N D E X
`
`WITNESS NAME: WILLIAM V. TRATTLER, M.D.
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`Page 5
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` EXAMINATION BY: PAGE
` BY MR. JANUSZ .................................. 9
` -o0o-
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` E X H I B I T S
`
`EXHIBIT DESCRIPTION PAGE
`Exhibit No. 1 Declaration of William D. 11
` Trattler, M.D.
`
`Exhibit No. 2 Declaration of William D. 11
` Trattler, M.D.
`
`Exhibit No. 3 Prolensa prescribing 20
` information
`
`Exhibit No. 4 Eight-page document previously 40
` marked Senju Exhibit 2113
`
`Exhibit No. 5 Bromday prescribing 53
` information
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
`________________________________
`SENJU PHARMACEUTICAL CO., LTD., )
`BAUSCH & LOMB INCORPORATED, and )
`BAUSCH & LOMB PHARMA HOLDINGS ) C.A. Nos.
`CORP., ) 1:14-cv-00667
` ) 1:14-cv-04149
` Plaintiffs, ) 1:14-cv-05144
`vs. )
` )
`LUPIN LIMITED and LUPIN )
`PHARMACEUTICALS, INC., )
` )
` )
` Defendants. )
` )
`vs. )
` )
`INNOPHARMA LICENSING, INC., ) C.A. Nos.
`INNOPHARMA LICENSING, LLC, ) 1:14-cv-06893
`INNOPHARMA, INC., and ) 1:15-cv-03240
`INNOPHARMA, LLC, )
` Defendants. )
`________________________________)
`
`
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`
` VIDEOTAPED DEPOSITION OF WILLIAM B. TRATTLER, M.D.
` Tuesday, February 23, 2016
` Miami, Florida
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`1 The Videotaped Deposition of WILLIAM B.
`2 TRATTLER, M.D. was taken on February 23, 2016,
`3 commencing at 12:19 p.m. at the Dadeland Marriott,
`4 9090 South Dadeland Boulevard, Miami, Florida,
`5 before Michele Anzivino, Registered Professional
`6 Reporter, and Notary Public in and for the State of
`7 Florida.
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Page 2
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`William B. Trattler, M.D. - February 23, 2016
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` E X H I B I T S (Continued)
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`Page 6
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`EXHIBIT DESCRIPTION PAGE
`Exhibit No. 6 Prescribing information for 57
` Xibrom
`
`Exhibit No. 7 Prescribing information for 60
` bromfenac ophthalmic solution
`
`Exhibit No. 8 Document previously marked 91
` Senju 2060
`
`Exhibit No. 9 Document previously marked as 93
` Senju Exhibit 2134
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`Exhibit No. 10 Document previously marked as 99
` Senju 2030
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`Exhibit No. 11 Curriculum vitae 102
`
`Exhibit No. 12 Opening expert report 120
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`Exhibit No. 13 Reply expert report 122
`
`///
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`3 (Pages 6 to 9)
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`Page 8
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`1 THE VIDEOGRAPHER: This begins video media
`2 disc number one, volume one. This is the
`3 videotaped deposition of William V. Trattler,
`4 that's T-r-a-t-t-l-e-r, M.D. in the matter of
`5 Innopharm Licensing, Inc. et al versus Senju
`6 Pharmaceuticals Company Limited, et al, Case Number
`7 IPR2015-00903 and 14-CV-0667-JBS-KMW et al in the
`8 United States Patent and Trademark Office before
`9 the Patent Trial and Appeals Board and the U.S.
`10 District Court for the District of New Jersey.
`11 Today is February 23, 2016. The time is
`12 12:19 p.m. This video deposition is taking place
`13 at the Dadeland Marriott at 9090 South Dadeland
`14 Boulevard, Miami, Florida. This video deposition
`15 has been at the request of Joseph Janusz from the
`16 law firm of Alston & Bird, LLP. My name is Jeff
`17 Menton. I am the certified legal video specialist,
`18 and the court reporter is Michele Anzivino. We're
`19 from Gregory Edwards LLC.
`20 Would counsel please state their appearance
`21 for the record and state whom you represent
`22 starting with the noticing attorney, and then will
`23 the court reporter please swear the witness in.
`24 MR. JANUSZ: Joe Janusz of Alston & Bird on
`25 behalf of the Innopharm entities which are a
`
`Page 7
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`Page 9
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` E X H I B I T S (Continued)
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`EXHIBIT DESCRIPTION PAGE
`Exhibit No. 14 Document, Bates 135
` PROL0333863 - 869
`
`Exhibit No. 15 Document, Bates 140
` PROL0333854 - 862
` -o0o-
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`1 petitioner in the IPR proceedings and a defendant
`2 in the District Court litigation.
`3 MS. DAUGHTREY: And this is Natasha Daughtrey
`4 from Goodwin Proctor on defendant of the Lubin
`5 defendant in the District Court litigation.
`6 MR. HASFORD: Justin Hasford of Finnegan on
`7 behalf of Senju and Bausch & Lomb in both the IPR
`8 and the District Court proceedings.
`9 Thereupon,
`10 WILLIAM V. TRATTLER, M.D.,
`11 having been duly sworn or affirmed, was examined and
`12 testified as follows:
`13 THE WITNESS: Yes, I do.
`14 DIRECT EXAMINATION BY MR. JANUSZ:
`
` Q. Q. Good morning, Dr. Trattler. How are you?
`15
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` Q. Q.
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` A. A. Great, thank you.
`16
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` A. A.
`
` Q. Q. I'm going to go over a few ground rules ahead
`17
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` Q. Q.
`18 of time. Ha -- have you ever depose -- been deposed
`19 before?
`
` A. A. I have, yes.
`20
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` A. A.
`
` Q. Q. Okay. So I'm going to run through this
`21
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` Q. Q.
`22 quickly. I'm sure it's all stuff you've heard before.
`23 You understand that you're under oath in giving your
`24 testimony today, right?
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` A. A. Yes.
`25
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` A. A.
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`William B. Trattler, M.D. - February 23, 2016
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`Page 10
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` Q. Q. Okay. I'm going to ask you a series of
`1
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` Q. Q.
`2 questions today, and I'm going to ask that those
`3 questions be answered. Even though intermittently your
`4 counsel may interject objections, unless he instructs
`5 you not to answer the question I'd ask that you answer
`6 the question.
`
` A. A. Okay.
`7
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` A. A.
`
` Q. Q. We'll -- we're also going to need verbal
`8
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` Q. Q.
`9 answers so that the court reporter doesn't have any
`10 trouble recording what our discussion is here today.
`11 She can't effectively record head nods or shakes or
`12 anything like that, so -- and then we'll take breaks
`13 periodically throughout the day. And the only thing
`14 that I'd ask -- and -- and if you need a break please
`15 let me know obviously. The only thing I'd ask is that
`16 if there is a question pending that you answer the
`17 question before we go into a break.
`
` A. A. Perfect.
`18
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` A. A.
`
` Q. Q. Okay. Have you ever submitted an -- well,
`19
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` Q. Q.
`20 let me start with this actually.
`21 MR. HASFORD: Joe, if it will speed things
`22 along, we can stipulate that he's here pursuant to
`23 this notice.
`24 MR. JANUSZ: Very well, then.
`25 MR. HASFORD: Okay.
`
`4 (Pages 10 to 13)
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`Page 12
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`1 been marked as Exhibits 1 and 2. We'll refer to them
`2 here as Trattler Exhibits 1 and 2, but Trattler Exhibit
`3 1 is Senju Exhibit 2116 in the IPR 2015-00902
`4 proceeding. And Trattler 2 is the same Senju Exhibit
`5 Number 2116 in the 903 proceeding.
`6 These are your declarations that you
`7 submitted in the IPR proceedings, correct?
`
` A. A. Yes.
`8
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` A. A.
`
` Q. Q. Okay. And you understand that -- that the
`9
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` Q. Q.
`10 opinions that -- that you've offered -- and just let me
`11 back up a minute.
`12 Obviously there have been a lot of opinions,
`13 you know, submitted in this case on -- on your behalf.
`14 And so I'd like to try to streamline things as much as
`15 I can. And so, you know, part of what I'm going to do
`16 here is just to try to get you, if you're willing to,
`17 to confirm that the opinions you offered in each of
`18 these declarations are largely similar if that's -- if
`19 that's something you're comfortable with.
`
` A. A. Yes, they are.
`20
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` A. A.
`
` Q. Q. Okay. And -- okay. Now, if I can touch a
`21
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` Q. Q.
`22 little bit on your -- on your background. You --
`23 you're an ophthalmologist, correct?
`
` A. A. Correct.
`24
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` A. A.
`
` Q. Q. Okay. And have you -- I presume you've
`25
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` Q. Q.
`
`Page 11
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`Page 13
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`1 BY MR. JANUSZ:
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` Q. Q. Okay. So have you ever submitted a -- a
`2
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` Q. Q.
`3 declaration in an IPR proceeding before?
`
` A. A. No, this is my first time.
`4
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` A. A.
`
` Q. Q. Okay. And have you ever testified in a
`5
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` Q. Q.
`6 patent case in a District Court proceeding before?
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` A. A. This is my first time, as well.
`7
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` Q. Q. Okay. And so you -- you have testified at a
`8
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` Q. Q.
`9 deposition previously, they just weren't really patent
`10 cases; is that correct?
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` A. A. Correct.
`11
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` Q. Q. Okay. Have you ever testified at a trial
`12
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` Q. Q.
`13 before?
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` A. A. Yes.
`14
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` A. A.
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` Q. Q. Okay. And -- and none of those were related
`15
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` Q. Q.
`16 to patent issues?
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` A. A. Correct.
`17
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` A. A.
`
` Q. Q. Okay. Were any of those related to
`18
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` Q. Q.
`19 ophthalmic solutions containing bromfenac?
`
` A. A. No.
`20
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` A. A.
`
` Q. Q. Okay.
`21
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` Q. Q.
`22 (Exhibit No. 1 marked for identification.)
`23 (Exhibit No. 2 marked for identification.)
`24 BY MR. JANUSZ:
`
` Q. Q. Dr. Trattler, you've been handed what have
`25
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` Q. Q.
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`1 performed cataract surgeries before?
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` A. A. Yes.
`2
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` A. A.
`
` Q. Q. Okay. Approximately how often -- and we'll
`3
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` Q. Q.
`4 start in -- in roughly a month. How -- how often
`5 during the course of a month do you perform cataract
`6 surgery?
`
` A. A. Approximately 60 cases a month.
`7
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` A. A.
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` Q. Q. 60 cases a month?
`8
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` Q. Q.
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` A. A. Six-zero, yes.
`9
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` A. A.
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` Q. Q. Six-zero? Okay.
`10
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` Q. Q.
`11 And would that, you know, equate to across
`12 all 12 months of the year?
`
` A. A. Correct. You know, we're not -- we're not
`13
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` A. A.
`14 very seasonal here in Miami.
`
` Q. Q. Right. Fair enough.
`15
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` Q. Q.
`16 And -- and approximately when in your career
`17 did you first perform cataract surgeries?
`
` A. A. So during my residency. My residency was
`18
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` A. A.
`19 from 1993 to 1996. So typically during my second year
`20 of residency is when you start your first cases.
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` Q. Q. Okay.
`21
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` Q. Q.
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` A. A. So in the 1994 to '95 range.
`22
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` A. A.
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` Q. Q. And where was your residency?
`23
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` Q. Q.
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` A. A. At -- at Scheie Eye Institute which is in
`24
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` A. A.
`25 Philadelphia, Pennsylvania. Part of the University of
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`William B. Trattler, M.D. - February 23, 2016
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`Page 14
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`1 Pennsylvania.
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` Q. Q. Okay. If I can have you turn to Trattler
`2
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` Q. Q.
`3 Exhibit 1, which is your declaration in the 902 case,
`4 and just -- just so we are clear, on the front of
`5 Trattler Exhibit 1 if you look at the very bottom you
`6 see the case number ending in 902.
`
` A. A. Yes.
`7
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` A. A.
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` Q. Q. And so when I refer to the 902 case, that's
`8
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` Q. Q.
`9 what I'm looking at.
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` A. A. Okay.
`10
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` A. A.
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` Q. Q. Similarly with the 903 case.
`11
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` Q. Q.
`12 So if I can direct your attention to
`13 paragraph 41 of the declaration, and that appears at
`14 page 13.
`
` A. A. Okay.
`15
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` A. A.
`
` Q. Q. And so in -- in paragraph 41 you acknowledge
`16
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` Q. Q.
`17 that Prolensa is formulated -- formulated at a pH of
`18 7.8, correct?
`
` A. A. Correct.
`19
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` A. A.
`
` Q. Q. And it's your opinion that that formulation
`20
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` Q. Q.
`21 is closer to that of natural tears which you identify
`22 as 7.4 as compared to the pH of Xibrom and Bromday
`23 which are 8.3; is that correct?
`
` A. A. Correct.
`24
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` A. A.
`
` Q. Q. Okay. Are you aware that the pH levels of
`25
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` Q. Q.
`
`5 (Pages 14 to 17)
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`Page 16
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`1 It's your opinion that making an
`2 ophthalmic -- application of an ophthalmic solution
`3 more comfortable for a patient would increase patient
`4 compliance; is that right?
`
` A. A. Definitely.
`5
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` A. A.
`
` Q. Q. Okay. And -- and the idea behind that is
`6
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` Q. Q.
`7 likely that obviously if a patient's more comfortable
`8 with the drug that they're applying to themselves
`9 they're not going to have any issues applying it; is
`10 that right?
`
` A. A. Correct. If a -- if a medication stings and
`11
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` A. A.
`12 burns on every application, they may be less likely to
`13 put it into their eyes.
`
` Q. Q. Okay. And so it's -- it's your opinion in
`14
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` Q. Q.
`15 this declaration -- in this -- in this paragraph of
`16 your declaration that Prolensa's pH level of 7.8 being
`17 closer to that of natural tears being 7.4 at least in
`18 part contributes to the elimination of burning --
`19 burning and stinging experienced by patients using
`20 Prolensa; is that right?
`
` A. A. Yeah, my th -- my understanding is that that
`21
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` A. A.
`22 would -- by being closer to the natural pH it can help,
`23 and -- you know, as far as reduced burning and
`24 stinging.
`
` Q. Q. Okay. And can you explain -- when you say it
`25
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` Q. Q.
`
`Page 15
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`Page 17
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`1 natural tears in humans can fluctuate beyond the 7.4
`2 that you've identified?
`
` A. A. I think that, you know, pH can be affected by
`3
`
` A. A.
`4 a variety of different things, but I think the average
`5 is considered by most experts to be around 7.4.
`
` Q. Q. Okay. But it can -- it can go -- for
`6
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` Q. Q.
`7 example, it can be lower than 7.4 in certain patients?
`
` A. A. 7.4 is an -- is an average.
`8
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` A. A.
`
` Q. Q. Okay.
`9
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` Q. Q.
`
` A. A. Is -- I think that's an the understanding
`10
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` A. A.
`11 that when we talk about, you know, patients and their
`12 tears it's typically considered that 7.4 is the
`13 average.
`
` Q. Q. Okay. Now, is it your opinion that -- strike
`14
`
` Q. Q.
`15 that.
`16 It's your opinion that if -- well, let me
`17 direct your attention to the last sentence in -- in
`18 paragraph 41. And if you can read that out loud, it
`19 starts with the reduced pH.
`
` A. A. Yes. "The reduced pH and amount of
`20
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` A. A.
`21 surfactant in Prolensa eliminated the burning and
`22 stinging sensation making it more comfortable ensuring
`23 greater patient compliance".
`
` Q. Q. Okay. And so let's talk generally about
`24
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` Q. Q.
`25 that.
`
`1 can help, can you explain what you mean by that?
`
` A. A. Well, obviously there are some formulations
`2
`
` A. A.
`3 of medications that are at pH of 7.4 that still cause
`4 burning and stinging. So you can have irritating
`5 solutions that have a pH of 7.4. So it's a combination
`6 of -- of factors.
`
` Q. Q. Okay. And generally speaking, I mean, would
`7
`
` Q. Q.
`8 your opinion be that -- obviously that there are --
`9 well, let me -- let me -- strike that.
`10 Generally speaking, would your opinion be
`11 that the closer you get to the natural -- the pH of
`12 natural tears, the more likely a solution would be
`13 comfortable for the user?
`14 MR. HASFORD: Objection. Incomplete
`15 hypothetical.
`16 THE WITNESS: Right. So it all depends on so
`17 many factors. So if we the had same solution,
`18 potentially, and again we have to evaluate it, but
`19 if it's closer to the natural -- you know, the pH
`20 of -- of our natural tears is it more likely to be
`21 comfortable. But obviously it depends on, you
`22 know, the actual formulation, it depends on the --
`23 what product we're looking at and all the other
`24 things that go into a formulation.
`25 So again, you could have formulations exactly
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`William B. Trattler, M.D. - February 23, 2016
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`Page 18
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`1 at 7.4 that could be painful and irritating. You
`2 could have pHs -- you could have formulations that
`3 are well off of the pH of 7.4 that's pretty
`4 comfortable in general. So, you know, it's really
`5 going to be this whole factor for try -- you know,
`6 to try to optimize, you know, can help to get the
`7 pH closer to 7.4.
`8 BY MR. JANUSZ:
`
` Q. Q. Okay. And so just -- just so -- just so that
`9
`
` Q. Q.
`10 we have an understanding here, I guess the opposite may
`11 be true if we were talking about solutions where the pH
`12 levels were significantly removed from what the
`13 natural -- what the pH of a natural tear would be; is
`14 that -- is that right?
`
` A. A. Potentially. Again, it all depends on -- on
`15
`
` A. A.
`16 so many different factors. I mean, every -- you have
`17 to look at every formulation. What is the medication.
`
` Q. Q. Right.
`18
`
` Q. Q.
`
` A. A. What are -- what's involved in the -- in the
`19
`
` A. A.
`20 solution.
`
` Q. Q. Okay. And so, for example, if we were --
`21
`
` Q. Q.
`22 hydrochloric acid, for example, right? And that's -- I
`23 don't know what the exact pH level is but we can --
`24 would you agree that it's closer to 1 than it is to the
`25 7.4, which is the pH of natural tears, correct?
`
`6 (Pages 18 to 21)
`
`Page 20
`
`1 yes, all de -- everything is relative to the
`2 situation.
`3 BY MR. JANUSZ:
`
` Q. Q. Okay. Why don't we --
`4
`
` Q. Q.
`5 (Exhibit No. 3 marked for identification.)
`6 BY MR. JANUSZ:
`
` Q. Q. Dr. Trattler, you've been handed what's been
`7
`
` Q. Q.
`8 marked as Trattler Exhibit 3, and Trattler Exhibit 3 is
`9 identified on the bottom right-hand side as Senju
`10 Exhibit 2013.
`11 Do you recognize this to be the prescribing
`12 information for Prolensa?
`
` A. A. Yes.
`13
`
` A. A.
`
` Q. Q. Would you turn to Section 6.1? Do you see
`14
`
` Q. Q.
`15 Section 6 says adverse reactions? 6.1, clinical trial
`16 experience?
`
` A. A. Right.
`17
`
` A. A.
`
` Q. Q. And do you see that there are two separate
`18
`
` Q. Q.
`19 paragraphs under 6.1?
`
` A. A. Yes.
`20
`
` A. A.
`
` Q. Q. Would you go ahead and read the second
`21
`
` Q. Q.
`22 paragraph for me out loud?
`
` A. A. "The mostly commonly reported adverse
`23
`
` A. A.
`24 reaction following the use of Prolensa following
`25 cataract surgery include" --
`
`Page 19
`
`Page 21
`
`
` A. A. Hydrochloric acid is an acid so it would be
`1
`
` A. A.
`2 more acidic, yes.
`
` Q. Q. Okay. And so would you agree that -- that a
`3
`
` Q. Q.
`4 solution containing hydrochloric acid with a much lower
`5 pH would likely cause burning and stinging?
`6 MR. HASFORD: Objection, incomplete
`7 hypothetical.
`8 THE WITNESS: Yeah, so I've never instilled
`9 hydro -- hydrochloric acid in someone's eye so I
`10 can't even comment on that. I don't think it's --
`11 I mean, it seems it could be very dangerous. So I
`12 don't know how to comment on that because it's --
`13 hydrochloric acid is an acid and it causes damage
`14 to the eye. So I don't know how -- how to answer
`15 that question.
`16 BY MR. JANUSZ:
`
` Q. Q. Would you be comfortable prescribing a drug
`17
`
` Q. Q.
`18 that had a pH level of 1 for ophthalmic formulation?
`19 MR. HASFORD: Objection, incomplete
`20 hypothetical.
`21 THE WITNESS: It all -- it all depends what
`22 it is. If it was a lifesaving drug that could sa
`23 -- let's say it was a drug that cured blindness but
`24 it had a pH of 1, it was the only thing available,
`25 and it burned but it was the only thing available,
`
`1 THE REPORTER: I'm sorry. You've got to --
`2 THE WITNESS: Sorry.
`3 THE REPORTER: -- just read it slower.
`4 THE WITNESS: Sure. "The most commonly
`5 reported adverse reactions following the use of
`6 Prolensa following cataract surgery include
`7 anterior chamber inflammation, foreign body
`8 sensation, eye pain, photophobia, and vision
`9 blurred. Those reactions were reported in 3 to 8
`10 percent of patients".
`11 BY MR. JANUSZ:
`
` Q. Q. And so you understand this is -- this to be a
`12
`
` Q. Q.
`13 listing of adverse reactions that were experienced
`14 during the clinical trials that are described as the
`15 most commonly reported; is that right?
`
` A. A. Yes.
`16
`
` A. A.
`
` Q. Q. Okay. And -- and -- but this is not a list
`17
`
` Q. Q.
`18 of all possible adverse reactions when -- when using
`19 Prolensa; is that right?
`
` A. A. There -- there could be others, but I mean I
`20
`
` A. A.
`21 guess I have this as their label. So I -- you know, I
`22 have this to fall back on as far as the -- what's being
`23 reported in the -- in the prescribing information.
`
` Q. Q. Okay. And -- and just to be clear from --
`24
`
` Q. Q.
`25 from your reading of that paragraph, is there anything
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 6
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`
`William B. Trattler, M.D. - February 23, 2016
`
`Page 22
`
`7 (Pages 22 to 25)
`
`Page 24
`
`1 in that paragraph that indicates to you that the
`2 adverse reactions listed there are the only adverse
`3 reactions identified in the clinical trials of
`4 Prolensa?
`5 MR. HASFORD: Objection, vague and ambiguous.
`6 THE WITNESS: Clearly -- so the way this is
`7 prepared is the FDA -- my understanding is the FDA
`8 evaluates clinical trials and decides what it feels
`9 is relevant to put into the prescribing information
`10 so that we as practitioners, as doctors, can
`11 evaluate a drug based on -- on the prescribing
`12 information to prescribe patients as dosing
`13 information and adverse reactions. So if it's not
`14 listed here there --i t's possible something could
`15 happen in the clinical trial but clearly the FDA
`16 didn't feel it was important enough to list to warn
`17 us as physicians in how we prescribe and treat
`18 patients.
`19 BY MR. JANUSZ:
`
` Q. Q. Okay. And so -- and these -- the adverse
`20
`
` Q. Q.
`21 reactions listed here are identified as having been
`22 experienced by 3 to 8 percent of patients during
`23 testing, right?
`
` A. A. Correct.
`24
`
` A. A.
`
` Q. Q. Okay. Can you identify from this disclosure
`25
`
` Q. Q.
`
`1 means there's inflammation. It's not per -- it's a
`2 sign, not a symptom.
`
` Q. Q. Okay. Let's move to foreign body sensation.
`3
`
` Q. Q.
`4 Can you describe what that is?
`
` A. A. For -- foreign body sensation. That's
`5
`
` A. A.
`6 the def -- that's what it is.
`
` Q. Q. And can you provide any other explanation
`7
`
` Q. Q.
`8 maybe to somebody who's never seen that before? How
`9 would you describe foreign body sensation to somebody
`10 who --
`
` A. A. Right. It's exactly as it says. A foreign
`11
`
` A. A.
`12 body sensation. Sensation feels like maybe again
`13 foreign body sensation.
`
` Q. Q. So -- and when you -- when you say foreign
`14
`
` Q. Q.
`15 body sensation are you -- would that include, for
`16 example, the sensation of a foreign body in the eye or
`17 on -- somewhere in and around the eye?
`
` A. A. Right. It could -- again, it's -- every
`18
`
` A. A.
`19 patient interprets that sensation, but it's basically a
`20 sensation of like something -- a foreign body -- like a
`21 foreign body, some type of particulate that they may
`22 feel or something like that.
`
` Q. Q. Okay. And would you -- well, let me -- let
`23
`
` Q. Q.
`24 me go back.
`25 If, for example, a patient has an eyelash in
`
`Page 23
`
`Page 25
`
`1 which of these adverse reactions was the most commonly
`2 reported by patients?
`
` A. A. It just has these all grouped together.
`3
`
` A. A.
`
` Q. Q. Okay. But there's no -- there's no
`4
`
` Q. Q.
`5 identification of any of those being more commonly
`6 reported than another in this paragraph, right?
`
` A. A. Right. So the purpose of this again is to
`7
`
` A. A.
`8 alert physicians for us to talk to patients, you know,
`9 on what adverse reactions patients may experience with
`10 drops so we can decide first of all which medication
`11 we're going to use and second, counsel patients.
`
` Q. Q. Can you -- let's look at the first one there.
`12
`
` Q. Q.
`13 So the first one identified is anterior chamber
`14 inflammation; is that right?
`
` A. A. Yes.
`15
`
` A. A.
`
` Q. Q. Can you describe anterior chamber
`16
`
` Q. Q.
`17 inflammation?
`
` A. A. Anterior chamber inflammation would be when
`18
`
` A. A.
`19 you -- when a patient is seen in the slit lamp we can
`20 evaluate how much inflammation is inside the eye.
`
` Q. Q. And is this -- is anterior chamber
`21
`
` Q. Q.
`22 inflammation a comfortable side effect of any
`23 ophthalmic solution?
`
` A. A. It has -- anterior chamber inflammation can
`24
`
` A. A.
`25 be asymptomatic or symptomatic. So it's not -- it just
`
`1 their eye, would that be a foreign body sensation?
`
` A. A. That can be one of -- one type of, you know,
`2
`
` A. A.
`3 foreign body sensation. Just usually a minimal, you
`4 know, nothing too bothersome type of thing.
`
` Q. Q. Okay.
`5
`
` Q. Q.
`
` A. A. So, you know, we all have eyelashes in our
`6
`
` A. A.
`7 eyes every day so it's something that you may feel when
`8 you blink a little bit, and it's nothing too
`9 problematic.
`
` Q. Q. Okay. And would you say that foreign body
`10
`
` Q. Q.
`11 sensations are generally comfortable for patients?
`
` A. A. I think they're -- you know, they're --
`12
`
` A. A.
`13 again, nothing -- again, we get eyelashes in our eyes
`14 every day. You might notice it, you might blink your
`15 eyes once or twice. It's nothing too bothersome.
`
` Q. Q. Okay. And are -- are there any foreign body
`16
`
` Q. Q.
`17 sensations that you've -- that have been reported to
`18 you by patients that were uncomfortable for -- for
`19 patients?
`
` A. A. Well, if it gets more, then we're going to
`20
`
` A. A.
`21 call it not foreign body sensation. We're going to
`22 call it pain, right? So you're going to -- foreign
`23 body sensation is just a minimal, you know, sensation.
`24 It's not a -- it's not a real -- you know, it's not
`25 even to the level of discomfort. It's a sensation that
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
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`William B. Trattler, M.D. - February 23, 2016
`
`Page 26
`
`1 somebody might feel.
`
` Q. Q. And so let's go ahead and talk about eye
`2
`
` Q. Q.
`3 pain. Can you -- I presume eye pain is a -- is a -- is
`4 a broad descriptor. Can you -- can you explain what --
`5 what eye pain is?
`
` A. A. A patient reporting pain in and around the
`6
`
` A. A.
`7 eye.
`
` Q. Q. Okay. And can you provide any sort of
`8
`
` Q. Q.
`9 specific examples of what might constitute eye pain?
`
` A. A. I mean, it's a very non-specific word. You
`10
`
` A. A.
`11 know, it's -- that's, you know, a level higher than
`12 foreign body -- body sensation. It's a pain -- pain or
`13 a -- you know, a patient would report that they -- you
`14 know, again, they're typically filling out a
`15 questionnaire, that the eye feels -- you know, they're
`16 feeling pain in their eye. So, for example, someone's
`17 had -- this is -- some of these are patients undergoing
`18 cataract surgery so other eye can feel as if they have
`19 some pain in their eye from catar -- following cataract
`20 surgery.
`
` Q. Q. Following the cataract surgery.
`21
`
` Q. Q.
`
` A. A. Right.
`22
`
` A. A.
`
` Q. Q. And so let's -- let me take a step back on
`23
`
` Q. Q.
`2